NPA 2024-106

Dokumendiregister	Transpordiamet
Viit	1.8-5/25/767-1
Registreeritud	14.01.2025
Sünkroonitud	15.01.2025
Liik	Sissetulev kiri
Funktsioon	1.8 Rahvusvahelise koostöö korraldamine
Sari	1.8-5 Rahvusvaheline kirjavahetus lennundusohutuse küsimustes: ECAC, ICAO, EASA, Eurocontrol, State Letterid
Toimik	1.8-5/2025
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	Euroopa Lennundusohutusamet
Saabumis/saatmisviis	Euroopa Lennundusohutusamet
Vastutaja	Mari Toodu (Users, Tugiteenuste teenistus, Õigusosakond)
Originaal	Ava uues aknas

Dokument on kokkuvõtte tegemiseks liiga mahukas (1841358 tm).

Failid

CRD 1 NPA 2017-17 Air Taxi and AEMS.pdf

CRD 2 NPA 2017-17 HEMS.pdf

NPA 2024-106(A).pdf

NPA 2024-106(B).pdf

CRD 1 NPA 2017-17 Air Taxi and AEMS.pdf

European Union Aviation Safety Agency

Comment-Response Document (CRD) 2017-17

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 277

An agency of the European Union

CRD 1 to NPA 2017-17 ‘Air Taxi & AEMS’

RELATED NPA: 2017-17 — RELATED OPINION: No XX/202X — RELATED ED DECISION: 202X/XXX/R —

RMT.0492 & RMT.0493

DD.MM.202X [= DATE OF ADOPTION]

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — Air Taxi & AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 2 of 277

An agency of the European Union

In responding to the comments, the following terminology has been applied to attest EASA’s position:

(a) Accepted — EASA agrees with the comment and any proposed amendment is wholly transferred to

the revised text.

(b) Partially accepted — EASA either agrees partially with the comment or agrees with it but the proposed

amendment is only partially transferred to the revised text.

(d) Not accepted — The comment or proposed amendment is not shared by EASA.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — Air Taxi & AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 3 of 277

An agency of the European Union

Individual comments and responses — Air Taxi & AEMS

(General comments) -

comment 32 comment by: Serair

For operators performing various kinds of operations, the option to apply only one regulation to all its operations should be available. For example, in our case, we perform CAT Scheduled operations, AEMS and air taxi operations. These operations are carried out using the same aircrafts and crews, so it would be easier for us to comply only with one of the FTL regulations (CAT or Air taxi/AEMS) instead of both of them. Establishing limitations by kinds of operations may be useful for bigger operators with separated structures, but in our case, it makes it harder to identify and apply the right limitation in each occasion.

response Accepted

The option to apply only a single regulation to all operations is already available.

Nonetheless, the text of the regulation will be further clarified.

Operators may apply ORO.FTL in combination with either CS FTL.1 or CS FTL.2 for their

air taxi or AEMS operations. Operators may not, however, choose CS FTL.2 for their

scheduled and charter operations.

Choosing CS FTL.2 for their air taxi or AEMS operations means that all requirements of CS

FTL.2 apply. ‘Cherry picking’ will not be possible.

Response with regard to ‘multiple (≥ 4) short sectors at night’ (comment #37)

comment 37 comment by: Serair

EASA should take in consideration the existence of operators that perform a high number of sectors with low flight time. In our case, SERAIR delivers press in the Canary Islands, performing 5 sectors of approximately 25 minutes each every night. The limitation of 4 sectors when performing consecutive night duties forces us to have 2 different crews performing those 5 sectors or alternate night and "day" duties in order to maximize crew's productivity. The first option makes the operation costly, and the second one increases the crew's fatigue. The limitation of sectors should be in relation to the flight time of each of them.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 4 of 277 An agency of the European Union

Responses with regard to ‘development of more AMC/GM to ORO.FTL.110’ (comment #103)

comment 103 comment by: UK CAA

Overall Comment Comment: The CAA supports the extensive work that EASA has done to complete this complex rulemaking task. Our comments focus on areas where the proposals lack an element of clarity or consistency and in some cases where the changes in the text have created a different meaning to the original requirements in Subpart FTL. In order to improve clarity and ensure that the application of the requirements is as intended, we believe EASA should consider including some additional guidance, especially where the requirement is intended to deliver a certain level of performance within each operator’s working context. Additional guidance was developed during the Rulemaking group work for ORO.FTL.110 (j) and the UK CAA has also developed guidance on implementing the ORO.FTL.110 requirements. It would support both the industry and the regulators if this material could be included or further developed / supported by EASA for the final Decision material. EASA are requested to consider additional AMC/GM to support application of the requirements, specifically for ORO.FTL.110. Justification: Following the implementation of Subpart FTL, it became clear that some operators required more descriptions of acceptable means of compliance and guidance in order to apply the regulations as intended. This would support the NAA’s with the implementation and oversight of the requirements.

response Accepted

Additional AMC and GM have been included to support the application of the

requirements, specifically as regards point ORO.FTL.110.

comment 138 comment by: CAA-NL

Overall comment The Netherlands supports the EASA work of the complex rulemaking task. Our comments are mainly focused on lack of clarity or consistency. General comment

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 5 of 277 An agency of the European Union

How could ambulance flights and HEMS flights be combined if they are performed by the same operator? This in view of GM1 SPA.HEMS.100 (a) under (d) where the difference between HEMS and Air ambulance is explained. If these 2 flights are performed by 1 operator, they should fall under the same regime. It should be added that FTL for "Air Ambulance flights" with helicopters will fall under the HEMS regime.

response Not accepted

Currently, HEMS flights are operated under Member States’ national regulations, whilst

most Air Ambulance flights are operated under Subpart Q of Council Regulation (EEC) No

3922/91, i.e. the FTL regime differs for both types of operation, even if performed by one

operator.

EASA does not see a reason why the future FTL rules for AEMS should fall under the HEMS

regime.

comment 235 comment by: Federal Office of Civil Aviation (FOCA), Switzerland

The Federal Office of Civil Aviation (FOCA) would like to thank the Agency for the good work and the opportunity to comment on this draft NPA.

response Accepted

comment 429 comment by: Skyshare Union representing NetJets crew members

Several factors combine to make the Air Taxi FTL a much less pleasant regime for crew members. Longer max FDP, shorter min rest of 10 hours (no evening meal), shorter min rest on long range after crossing time zones.

response Noted

It is not clear whether the comment is about the current situation in Air Taxi operations or

the proposed rules.

Responses to Austro Control (comment #569)

comment 569 comment by: Austro Control

Dear all, Austria offers the following comments to this NPA: Comments FTL for AEMS, HEMS, Air taxi operation 1.Page No. Page 9

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 6 of 277 An agency of the European Union

Paragraph No. ORO.FTL.105 Definitions Comment: Even if Air Taxi operation is defined in Article 1 of Reg. 83/2014, it would make sense to add the definition under ORO.FTL.105 for better readability and summarization of all relevant FTL definitions. Justification: See comment Accepted 2. Page No: Page 12 Paragraph No: ORO.FTL.205 (d1) Ziffer2: Comment: “on-board rest” should be added to the definitions under ORO.FTL. 105 – on- board rest covers for air-taxi / inflight and additionally on-board rest on ground Please clarify „ planned in advanced” –for Air taxi – definition is unclear. Justification See comment Proposal (new proposed text, etc.) Planned in advance: Text for example: “before commencing the preceding rest period”. Accepted 3. Page No: Page 21 Paragraph No: CS.FTL.2.205 – FDP – Night duties Comment: Clarification needed on appropriate fatigue risk management in regard to the specific Air taxi – operation/ unplanned/ unscheduled/ Justification: Air taxi operation / small operator will need more and special guidance to be able to comply. Noted The requirement on consecutive night duties has been deleted. The limitation of 4 sectors when performing consecutive night duties will force small operators to have 2 different crews for FDPs of 5 sectors or alternate night and ‘day’ duties in order to maximise productivity. The first option makes the operation costly, and the second one increases crew fatigue. 4. Page No: Page 25-26 Paragraph No: CS.FTL.2.215 in connection with ORO.FTL.215 Comment: It is unclear why the max. FDP is reduced for Air taxi operation only (not applicable for CAT) regarding the counting of positioning time as FDP. Furthermore this would indicate that positioning is more demanding than active flying duty. (b)(ii) should include “additionally” to the 30 min mentioned in (b)(i) e.g.: if driving takes 70 min, a FDP reduction of 20 min is intended without the clarification mentioned above. Justification: See comment Proposal (new proposed text, etc.) “Additionally to the 30 min mentioned in (b)(i) twice the duration of the self-driving time in excess of 60 minutes.” Noted The requirement has been considerably simplified.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 7 of 277 An agency of the European Union

Air Taxi operators make extensive use of positioning and that is far more prolonged than positioning in scheduled CAT operations. The study (Attachment IV to NPA 2017-17) recognises that the impact of the duration of positioning and the mode of transport on pilot fatigue may be significant. On average, every hour of positioning contributed 0.25 to the fatigue score, every hour of flying 0.13. The reduction of the maximum FDP is, therefore, a mitigation measure against long (self- driving) positioning before and after sector duties. The operator needs to specify in its flight time specification scheme the impact of positioning on the maximum FDP depending on the duration of positioning and the mode of transport. 5. Page No: Page 26 Paragraph No:CS. FTL.2.220 Comment :(g) the statement regarding credits for breaks on ground creates uncertainty and is easy to be misunderstood. From our understanding the intention is that the max FDP may only be extended by 3 h anymore – previous (national) rules allowed up to 8h extension of DT. Justification: This will be in conflict with the typical Air taxi operation (early morning departure and late evening return with a hotel stay below minimum rest). Not accepted The operator may extend the basic maximum daily FDP specified in CS FTL.2.205 by up to 50 % of the combined duration of all breaks on the ground. The limit of 3 hours is only on one of the breaks on the ground. 6.Page No: Page 26-27 Paragraph No:CS FTL 2.225 Stand-By Comment: The new stand-by regulation is highly complex and would require additional staff to monitor the various stand-by notification types and “idle times”. Justification: This is not appropriate for smaller Air taxi operation (50 % of Austrian Air taxi operation) and would lead to much more confusion. Partially accepted The requirement has been considerably simplified. Anyway, a small air taxi operator does not need to implement all complex requirements for standby if the type of operation performed is of a simple nature. For example, such operator may decide to apply a response time of 60 minutes for all its flights, thus avoiding complex calculations. 7.Page No: Page 28 Paragraph No: CS FTL.2.235 Rest periods – Air taxi Comment: (b) the explained calculation of nights free of duty after time zone differences calculates with beginning and ending the rotations at the home base. This totally ignores the fact that the majority of Air taxi operations does not start or end the rotation at the home base. But crew members are positioned to the A/C (out of home base), then conduct the rotation, do not return to home base until their duty roster is finished, so the “earned nights” cannot be consumed after the fatiguing rotation. Not accepted The term ‘rotation’ is defined as ‘a series of duties, including at least one flight duty, and rest period out of home base, starting at home base and ending when returning to home

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 8 of 277 An agency of the European Union

base for a rest period where the operator is no longer responsible for the accommodation of the crew member.’ Home base should not be confused with a pilot’s private residence. Hence, an FCM can start a rotation at the home-base airport with a positioning flight to where the aircraft is. The positioning duty is part of the rotation. The purpose of compensatory rest is re-synchronisation to home base after time-zone crossings, regardless of how many duties have been worked out, how many rest periods have been consumed in the meantime, and the actual acclimatisation status of the crew member upon return. Nevertheless, the requirement has been amended to account for rotations that start with one or more duty periods not involving time-zone crossings, i.e. the time elapsed will count from the flight(s) which have caused de-synchronisation of the crew member’s circadian rhythm, not necessarily beginning or ending at home base. 8. Page No: Page 43 Paragraph No: AMC3 ORO.FTL.120 (b)(4) Fatigue risk management (FRM) Comment: All guidance material regarding FRM is tailored to fixed wing operation. Additional guidance material for HEMS should be established as soon as possible. Noted HEMS FTL requirements are not part of this Opinion.

response Responses are given right below each comment.

comment 878 comment by: AESA

There is a problem with the meaning of “charter operations”. UE 965/2012 only include definition for “Air taxi operation”, that means on-demand operations with airplanes of MOPSC of 19 or less. We have not definition for charter operation, so we could accept that, in this context, charter operation means on-demand operation with airplanes of MOPSC of more than 19. But in some cases it makes no sense. For example, AMC1 ORO.FTL.125(a) stablish that for single-pilot charter operations, CS-1 must be followed and for single-pilot air taxi operations, CS-2 apply. Single-pilot operations only can be conducted with aeroplanes below of 5.700kg (sure MOPSC less than 19). ¿What is the difference between charter and air taxi in this case? Since the only definition is for air taxi, we could speak about “Air taxi and AEMS operations” (CS-2) and “Other than air taxi nor AEMS operations” (CS-1). Another possibility would be to include a definition of “charter operations” in definitions of 965/2012, whatever it means.

response Accepted

A definition of ‘charter’ has been inserted.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 9 of 277 An agency of the European Union

comment 881 comment by: Stephanie Selim

General comment on rationale : DGAC regrets that the rationale is not explanatory enough. Indeed, the rationale of this NPA is only a paraphrase of the proposed requirements and brings no explanation on these proposals. Yet, an explanatory rationale can be useful when we there are doubts about the aim of a requirement, or its interpretation and DGAC often falls back on rationales of previous NPA to lighten the meaning of some requirements.

response Not accepted

The rationale in the NPA must be read together with the scientific studies attached to it.

For the sake of brevity, the scientific findings are referred to, but not explained again in

the explanatory part of the NPA.

Also, the NPA builds on the knowledge and experience gained so far from the

implementation of the FTL rules. Assuming that interested parties have such knowledge, it

was felt inappropriate to explain the background again.

comment 910 comment by: EUROCONTROL

The EUROCONTROL Agency welcomes the publication of EASA Notice of Proposed Amendment 2017-17 on 'Flight Time Limitation' for different types of operation. It also thanks EASA for the opportunity that has been given to submit comments. However, the subject of the amendment is considered outside the scope of activities of EUROCONTROL. In addition, despite the fact that it has no comments to make, the EUROCONTROL Agency would like to confirm that it will read with interest the comments on this NPA received from stakeholders and the responses given to them by EASA in its future comment-response document (CRD). Like for NPA 2017-17, EUROCONTROL staff will be given access to CRD 2017-17, for information.

response Noted

Responses to FNAM (comment #1004)

comment 1004 comment by: FNAM

Attachments #22 #23 #24 #25 #26

FNAM (Fédération Nationale de l’Aviation Marchande) is the French Aviation Industry Federation/ Trade Association for Air Transport, gathering the following members:

• CSTA: French Airlines Professional Union (incl. Air France) • SNEH: French Helicopters Operators Professional Union • CSAE: French Handling Operators Professional Union • GIPAG: French General Aviation Operators Professional Union

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 10 of 277 An agency of the European Union

• GPMA: French Ground Operations Operators Professional Union • EBAA France: French Business Airlines Professional Union

And the following associated members:

• FPDC: French Drone Professional Union • UAF: French Airports Professional Union

The comments hereafter shall be considered as an identification of some of the major issues the French industry asks EASA to discuss with third-parties before any publication of the proposed regulation. In consequence, the following comments shall not be considered:

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean FNAM and EBAA France have (or may have) no comments about them, neither FNAM and EBAA France accept or acknowledge them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation.

#Introduction

FNAM and EBAA France thank the EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for AEMS operations throughout Europe in order to warrantee a high level of safety. Due to the complexity of the proposed regulation, at the time being, FNAM and EBAA France fear that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal. Indeed, AEMS operators are not familiar with the EASA FTL schemes and philosophy. Proposed AEMS FTL rules are derivated from current CAT.A FTL rules, with a common basis. Moreover, AEMS operators are still now subject to national FTL rules, which are for France far different from EASA’s proposals. Thus, it is a hard and heavy work for them and us to study, understand and comment EASA’s proposals. Some concepts and wordings still appear confusing to us. FNAM and EBAA France would like to avoid misunderstanding or wrong interpretation of EASA’s proposals. Else, FNAM and EBAA France but also operators’ comments might be inadequate and inefficient. Generally speaking, FNAM and EBAA France think that the proposed requirements for AEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for AEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation. For instance,

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 11 of 277 An agency of the European Union

the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for AEMS, indeed it is not explicit whether:

• All the CS.FTL.2 requirements shall be applicable "in block; or • The CS requirements should apply depending on what is said in the implementing

rule; or • Cherry-picking is allowed

It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of FNAM and EBAA France’s current understanding of this NPA. COMMENTS ON AEMS PROPOSALS

#AEMS Introduction

Organization of each AEMS companies cannot be compared since they are adapted to their national specific needs and requirements. To that extend, the French AEMS market is marginal and specific which make its AEMS operations and organization unique. Thus, French AEMS operations and organization are different from HEMS and Air Taxi operations and their respective organizations. In that way, the French regulation proposed specific requirements for aeroplane emergency missions in order to address specific operational needs. First, since AEMS missions deal with life-threatening emergencies, the AEMS and Air Taxi operations are totally different. In that way, distinguishing AEMS and Air Taxi in 2 separate regulatory texts seems more suitable as no operational comparison can be made between the fundamentals of these different activities. This necessity is strengthened due to the proposed European Air Taxi dispositions based on current European CAT requirements. Indeed, due diverging philosophies, AEMS requirements cannot rely on dispositions linked to CAT requirements. Second, even if AEMS and HEMS operations share the criteria of emergency missions, the nature of these two operations are totally different. Thus, distinguishing AEMS and HEMS in 2 separate regulatory texts seems more suitable as no operational comparison can be

made between the fundamentals of these different operations.  #French AEMS System

Emergency operations are deeply linked with national health, security and safety but also mutual insurances. AEMS French operations are composed with two specific domains:

• Graft and organ transportations • Other emergency transportations (patients, return of hostage, etc.)

In France, AEMS is mostly operated by 2 major private operators on behalf of mutual insurances. Other French AEMS operators also provide mixed services Air Taxi and emergency transportations. The particular case of grafts and organs transportations is an

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 12 of 277 An agency of the European Union

operation conducted by AEMS operators on behalf for the French healthcare system. Thus, this kind of operation depends on the organization of the French healthcare system (the permanence and continuity of care services is a public utility defined in the French Health

Code & a sovereign prerogative), with groupings of medical equipment and skills.   #French Rostering

The current French AEMS organization is based on a H24 availability in case of emergency events such as abroad medical needs, abroad patients, return of hostages, etc. This operational readiness with really short response time is warrantee thanks to the French regulation under the disposals of “astreinte” (French reserve). Such a reserve is limited to 24 hours with a short notification time and is not considered in the duty time. Provided no flights/activities are performed meanwhile on reserve, several consecutive periods are allowed without any rest period between each reserve. Indeed, the French system considers the necessary rest for a pilot is taken during the reserve as the crew is not disturbed and is in a suitable accommodation. The proposed European regulation on standby does not allow the French operators to comply with the French work pace and will lead to have operational gap without any crew available (Cf. Annex 5). Additionally, in France, the most usual rostering is 6 consecutive days ON at home base / 3 days OFF with a need for a H24 operational readiness. Hence, considering the nowadays French reserve system and the proposed current standby, all these new requirements will lead to schedule continuously 3 crews per day in service to cover a H24 availability over 14 days instead of 2 crews within the French current system (Cf. Annex 5). The requested 3 days of rest after 6 days of reserve in French regulation does not appear more fatiguing

than the 1 day of rest for 1 day of proposed European standby.   Besides, since AEMS missions deal with life-threatening emergencies, the notification time for the crew is quite short. Usually, in France, the crew is notified 3 hours before the flight (considering 1 hour of preflight) when the crew is under the disposals of “reserve” according to French regulation. Moreover, during the flight, the current times are in average 2 hours to load and 1 hour to unload the EMS payload. The rostering considers these durations in order to schedule some AEMS operations which usually have the first flight planned at 08:00 depending on the type of emergency. However, the flexibility of the rostering is ensured thanks to the commander’s discretion allowance of 2 hours or more if an unforeseen event occurs after the last take- off or in case of “Force majeure”. These inherent necessary flexibility and reactivity to AEMS operations should persist in the proposed European dispositions in order to address operational needs.

  The usual French AEMS missions are specific to the French national needs and insurance services. One of a typical emergency mission is short-haul flights taking care of two consecutive patients in two different cities. The non-augmented crew (2 pilots) needs a flight duty period of at least 14 hours to perform 4 sectors (Cf. Annex 3). This number of sectors may also be necessary in case of a unique patient transportation with positioning before and after the mission or with picking up the specific medical team at another airport than the home base airport. These kind of sectors shall also count as EMS flights. In that way, the French AEMS activity is based on a 14-hour Flight Duty Period with 2 pilots (non- augmented crew) with 4 sectors and the new EASA proposals should take into account this current organization based on medical and emergency needs.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 13 of 277 An agency of the European Union

Long-haul flights are also frequent in AEMS French operations. For example, in 2014, a lot of AEMS long-haul flights were necessary to repatriate Ebola patients from Freetown in Sierra Leone to Europe due to the lack of medical care on site (Cf. Annex 2). The augmented crew (3 pilots) had a 18-hour Flight Duty Period to perform 4 sectors. In that way, the French AEMS activity is based on a 18-hour Flight Duty Period with 3 pilots (augmented crew) with 4 sectors and the new EASA proposals should take into account this current organization based on medical and emergency needs. Moreover, due to the frequent unforeseen circumstances which are faced in AEMS operations, the commander may often extend the Flight Duty Period in order to finish properly the emergency mission. For example, it happens that the 2 hours planned to load the patient is not sufficient if the patient medical stabilization is difficult (Cf. Annex 4). Indeed, the crew cannot engage the flight back as soon as the patient is not stabilized. In that way, in France, the commander can decide to exceed the Flight Duty Period by 2 hours or more if an unforeseen event occurs after the last take-off or in case of “Force majeure”. However, when the mission is finished (meaning the aircraft and the crew are back at their operating base), the crew has a rest period of at least 24 hours. Most often, operators are even used to schedule at least 36 hours. That is why, FNAM and EBAA France insist on the crucial needs of commander’s discretion that should be at least as flexible in AEMS than in CAT. To sum up, in France, in order to answer to all national and insurance needs, the French regulation allows and ensures for AEMS operations :

• A H24 operational readiness thanks to a 24 hours reserve with short notification time

• The possibility to have several consecutive reserves provided no flights/activities are performed meanwhile on reserve

• 2 hours of commander’s discretion or more in case of “Force majeure” and if an event occurs after the last take off (ideally including just before)

Thus, the French regulation allows up to 18 hours with 4 sectors with a non-augmented flight crew. The real AEMS operations need within this framework are less stringent but require at least:

• 14-hour Flight Duty Period with a non-augmented crew with 4 sectors • 18-hour Flight Duty Period with an augmented crew with 4 sectors

These principles are absolutely necessary and must be taken into account in the EASA’s proposal, otherwise it would be impossible to make some rescue and emergency missions which is neither politically nor socially acceptable (Cf. Annex 2,3,4 & 5). *** #Comparison Impossible With Other Operations As said before, French AEMS operations and organization are different from HEMS and Air Taxi operations and their respective organizations. AEMS operations are specific and

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 14 of 277 An agency of the European Union

unique. Thus, AEMS requirements should not be compared nor be adapted from other requirements specific to other types of operations (Cf. Annex 1). Indeed, AEMS, HEMS and Air Taxi have their own unique philosophy and they cannot be associated since their activities are operationally different. As said in the RIA, no risk has been shown regarding safety or fatigue with the current regulation. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest through reserve with short notification time, and the working pace of 6 days ON / 3 days OFF does not appear more tiring. On the contrary, the working pace of 6 days ON / 3 days OFF is better for the labor organization and is bringing a better quality of life for pilots. Indeed pilots prefer to work 6 days in a row and then be 3 days OFF instead of working 1 day and resting the next day (which appears more tedious and tiring). Thus, the well-functioning current French FTL schemes are enforced for years, no excessive fatigue has been demonstrated and the current national system provides French operators and their crews with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about under-reporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. FNAM and EBAA France strongly ask this option to be considered by the EASA and the Member States: “no change in the existing situation; {...} AEMS continue to be regulated under Subpart Q plus national rules”. In any case, current EMS system and organization should not be call into question by the European regulations. In that way, FNAM and EBAA France ask that Option 0 from RIA should be retained and the national safe regulation kept as they are. Nevertheless, EASA’s AEMS proposals are inherited from Air Taxi requirements and some HEMS requirements are common with AEMS requirements (Cf. Annex 1). This regulatory structure implies significant changes of philosophy and practices for AEMS operations. #AEMS vs AirTaxi

Air Taxi proposed requirements are adapted from the previous FTL CAT aircraft dispositions. Considering the different type of missions, the adapted Air Taxi requirements may not fit to AEMS operations. In that way, distinguishing AEMS from other types of operation in separate regulatory texts seems more suitable as no operational comparison can be made with the AEMS fundamentals of this activity. Actually, Air Taxi and AEMS missions cannot be compared mostly due to the unpredictable character of the activity. All the more since AEMS operations are based on life threatening missions with defined travel through precise sectors which require short time reactions (notification, load, unload, etc.). Although Air Taxi operations rely on client transportations, with no emergency flights. In Air Taxi, the transported client provides a precise flight plan but it is not rare that the client does not stick to his plan and reprograms it in the middle of the Flight Duty Period. In that way, a flexibility is needed to ensure the possibility of adding sectors to the Flight Duty Period even if it has begun (Cf. Comments on Split Duty). In AEMS operations, this flexibility can be an asset but the most important need is to ensure a flexible commander’s discretion. Indeed, the flight plan does not change as often as for Air Taxi operations, but

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 15 of 277 An agency of the European Union

it is not rare that the Flight Duty Period needs to be extended due to unforeseen circumstances during an emergency mission (Cf. Annex 4). Once again, distinguishing AEMS and Air Taxi in 2 separate regulatory texts seems more suitable as no operational comparison can be made between the fundamentals of these different activities.

#AEMS vs HEMS

Moreover, as AEMS and HEMS operations are sharing the emergency type of mission, the EASA proposed to share some requirement between these two operations (Cf. Annex 1). However, HEMS and AEMS missions are different in terms of flight characterization. HEMS non-scheduled and unforeseen missions are generally composed with short flights nearby the HEMS operating base. Thus, several missions can be done during one Flight Duty Period with very short notification time (a few minutes). Although, AEMS missions are based on one long-haul or a couple of short-haul missions, often abroad. Due to the flight times, often only one mission can be performed during a Flight Duty Period. Some missions can be planned in advance (10 hours before flights) but some other are extreme emergency flights and cannot be planned in advance but still usually with one hour notification time. Additionally, HEMS operations in France depends only on French Healthcare System and the HEMS crews shall be available H12 (or H24) depending on the contract with the local hospital. Besides, AEMS crews shall be available H24 not only on behalf for the national Healthcare service but above all for insurance providers’ needs. In that way, the HEMS operations depend above all on the hospital home base needs and activities although AEMS operations depends on the current emergency in France and abroad. Moreover, the crew organization between AEMS and HEMS is diverging. In France, HEMS crew is composed with only one pilot supported with one Technical Crew Member when AEMS flights are performed with at least 2 pilots per crew, 3 in case of augmented long- haul flights. The HEMS crews are often based at hospital, thus, they have the medical team directly on site, despite for AEMS operations, it is not rare to pick up the medical team at another airport than the home base airport. That is why, it is not possible to provide identical requirements for HEMS and AEMS operations since the operational needs are completely different. This is an additional reason for distinguishing AEMS and HEMS in 2 separate regulatory texts seems more suitable as no operational comparison can be made between the fundamentals of these different activities. *** #Conclusion

The impact of the implementation of European FTL regulation for AEMS in France goes beyond the French operators. Thus, it would be appreciated if the RIA addresses more on the social & economic impacts as well as impacts on:

• Graft and organ transportations linked to the national Health care system • Other emergency transportations linked to insurance needs and organization

Since the AEMS is a really specific and independent operation, the EASA’s proposals is blocking on several points. Some points are blocking because they are deeply linked to

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 16 of 277 An agency of the European Union

HEMS dispositions and some others, because they are inherited from Air Taxi requirements:

• The definition of the EMS payload shall ensure to include the aircraft as an EMS payload (the aircraft is equipped for AEMS missions)

• There is no possibility to ensure the activity in case of “Force Majeure” • The 10% allowance between scheduled and actual FDP is not appropriate with the

AEMS operations and needs to be suppressed • The limitations of Flight Duty Period (extended and not extended) are not adapted

to the AEMS operational needs and shall be extended • The acclimatization philosophy does not fit to the operational reality for AEMS

operations and the limitations need to be extended • The commander’s discretion shall be extended for 2 reasons:

1. The limitation is too restrictive considering the AEMS emergency missions 2. The limitation is even more stringent than for Air Taxi and CAT operations

• Several standby cannot be consecutive while it is necessary that crews ensure a continuous operational readiness

• The standby definition must be clarified so that it can allow a range up to 24-hour operational readiness

Thus, the  FNAM and EBAA France agree with option 0 described in the RIA. This option whose choice relies on the Member States (MS) or the EASA’s decision, corresponds to the option 0 described in the RIA : no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The option 0 seems the proper action since a one size fits all model is not applicable to the industry. The well-functioning current national FTL schemes are enforced for years, no excessive fatigue has been demonstrated and more specifically, the current national system provides French operators and their crews with satisfaction. As a consequence, any changes in the FTL schemes in AEMS may take benefit from considering the experience of the existing system and organization instead of creating from scratch a brand new system but inadequate and inefficient. If the Option 0 is not retained by EASA, FNAM and EBAA France ask for this proposed NPA to be amended and reviewed as stated in the following comments distinguishing AEMS, HEMS and Air Taxi. Indeed, a completely new proposal, distinguishing the AEMS from HEMS and Air Taxi is needed as no operational comparison can be made between the fundamentals of these different activities. FNAM and EBAA France insist above all in protecting the amplitude for the Flight Duty Period and the long reserve with short notification time which are necessary to allow emergency missions. In that way, FNAM and EBAA France ask to have new European dispositions that would allow at least:

• 18 hours maximum FDP with 4 sectors with 3 pilots (augmented crew)(Cf. Annex 2)

• 14 hours maximum FDP with 4 sectors with 2 pilots (non-augmented crew)(Cf. Annex 3)

• A standby definition allowing up to 24 hours of operational readiness (Cf. Annex 5) • The possibility to have several consecutive standby provided no flights/activities

are performed meanwhile on standby (Cf. Annex 5)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 17 of 277 An agency of the European Union

• 2h of commander’s discretion with non-augmented crew & 3h with augmented

crew, which are the same  requirements than for CAT operations (Cf. Annex 4)

FNAM and EBAA France ask for this option to be considered in the Comment Response Document (CRD) with the elaboration of a sound RIA. These elements of our proposals for NPA 2017-17 for AEMS form an integrated whole: there are each and all interrelated and interdependent. Moreover, FNAM and EBAA France would be happy to offer its expertise to discuss and study this subject with EASA policy officers. Besides, for clarity reasons, this would imply to separate, regarding the FTL scope, the AEMS from CAT, Air Taxi and HEMS operations. Thus, FNAM and EBAA France hereby:

• Proposes dispositions limited to AEMS • Agrees and adopts for Air Taxi, the EBAA Europe comments published in CRD

However, since the Air Taxi and AEMS requirements are deeply linked (Cf. Annex 1), the Air Taxi dispositions need to be adapted taking into account the AEMS proposals. Thus, FNAM and EBAA France propose changes for AEMS requirements in this Comment Respond Document which have implied to also comment marginally Air Taxi proposals.

response 1. The statement of FNAM and the French EBAA that AEMS operators are not familiar with

the EASA FTL schemes and philosophy is not accepted.

Except for the FDP duration that is subject to national rules, AEMS and single-pilot operations with aeroplanes are covered by Subpart Q of Annex III to Council Regulation (EEC) No 3922/91 since 2008. There are no major differences between the FTL schemes and philosophy of Subpart Q and those proposed by the NPA. 2. The statement that the structure and the references within the NPA lead to confusion regarding the applicability of the certification specifications for AEMS is not accepted. As explained in the NPA, the proposed requirements need to be read together with other requirements of Regulation (EU) No 965/2012 which would be applicable to AEMS operators as well. Point ORO.FTL.125 requires every AEMS operator to customise its FTL scheme on the basis of the applicable implementing rules and CS.FTL.2 requirements considering the type of operation it conducts. Where the implementing rule allows for flexibility, that flexibility is further ‘shaped’ and controlled with the help of CSs. This concept also exists in scheduled and charter operations, and should not be confused with ‘cherry picking’. The flexibility, as embedded in the implementing rules, allows for the continuation of safe practices that existed before the adoption of Regulation (EU) No 965/2012 and for the accommodation of new safe practices, based on clear principles. As usual, EASA will organise workshops in order to familiarise operators and their personnel with the new EU rules during the transition period following their adoption. 3. The statements that AEMS companies from different Member States cannot be

compared and that AEMS and air taxi operations are totally different are not accepted.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 18 of 277 An agency of the European Union

AEMS are international operations by nature. This makes the principles of organisation and

management of AEMS similar across different countries. Hence, AEMS operations in France

do not differ fundamentally from AEMS operations in Germany or Switzerland. The

proposed FTL rules anyway account for specific operational needs as is the case with other

types of operations.

AEMS and air taxi operations indeed present operational specificities which distinguish

them from other types of operations and, where necessary, the proposed rules reflect that

distinction. However, both operations are on-demand operations where periods of intense

and long hours of work alternate with periods of inactivity, and where fatigue originates

from the same sources and builds due to same subjective (physiological) and objective

factors.

Commonalities between AEMS and air taxi operations have been recognised by all leading

experts who participated in the rule drafting. Information about this is provided in the NPA.

As you state, some French AEMS operators provide mixed air taxi and AEMS

transportation, which would not be possible if the two types of operations were totally

different.

4. The statement that the proposed European Union regulation on standby will lead to an

operational gap without any crew available, as it does not allow French operators to assign

several consecutive 24-hour ‘reserve’ periods, is accepted. It should be noted, however,

that the purpose of the EU rules is to establish safe operational practices, not necessarily

using a particular country-specific type of standby/reserve system.

In the field of AEMS, the NPA differentiates between ‘reserve’ periods with a long

notification time > 10 hours (point ORO.FTL.230) and ‘other-standby’ periods (home or

hotel) with a shorter notification time < 10 hours (CS FTL.2.225). It seems that, based on

the notification time, the French ‘reserve’ system is closer to ‘other-standby’ with

notification time < 10 hours.

The French system allows for consecutive 24-hour readiness periods without any rest

period between them, if there is no duty assignment and if the pilot has a sleep opportunity

and is able to take a rest during the readiness period in a suitable accommodation.

This arrangement is acceptable. CS FTL.2.225 has been amended to allow for several

successive other-standby periods of a maximum of 24 hours with a minimum of 8-hour

sleep opportunity period between them, if taken in suitable accommodation and the crew

is not disturbed.

5. The proposal for 4 sectors as regards the basic FDP (2 pilots, non-augmented crew) and

extended FDP with 3 pilots (augmented crew) is accepted. The scientific study conducted

in 2015 by FRMSc Limited revealed that it is the amount of flying that contributes to fatigue

rather than the number of sectors. On the other hand, a 4-sector FDP would allow to

accommodate a larger number of existing operation models that include an aircraft

positioning flight prior to the mission flights. The proposal for an 18-hour extended

maximum FDP with 3 pilots (augmented crew) is not accepted. The FRMSc Limited study

demonstrated that long-duty hours contribute the most to an increase in pilot fatigue

levels and decrease in their performance.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 19 of 277 An agency of the European Union

6. The proposal to make the rule on commander’s discretion (CD) at least as flexible in

AEMS and air taxi as in CAT is accepted.

7. The proposal by FNAM and EBAA France that RIA Option 0 should be selected so that

there would be ‘no change in the existing situation’ and that ‘AEMS continue to be

regulated under Subpart Q plus national rules’ is not accepted. As explained in the NPA,

fatigue in nationally regulated AEMS and air taxi operations has been underreported or not

reported at all. In the five areas where, according to Article 8(4) of Council Regulation (EEC)

No 3922/91 (Subpart Q), national rules are still being applied, namely ‘standby’, ‘rest to

compensate for TZC’, ‘reduced rest’, ‘split duty’ and ‘in-flight rest’, scientific principles have

likely not been considered. The purpose of this rulemaking is to bring the regulation of

fatigue in AEMS and air taxi operations to a level that is commensurate to the most up-to-

date scientific principles and best operational practices. A 2006 Subpart Q does not offer

such scientific approach for objective reasons.

8. The proposal that the 10 % allowance between scheduled and actual FDP is not

appropriate for AEMS operations and needs to be suppressed is accepted. The Opinion will

propose a more performance-based text.

9. EMS payload: please see the response to comments #1035 and #1038.

10. Max FDP for crew member in an unknown state of acclimatation: please see the

response to comment #130.

Responses with regard to ‘nutrition’ (comment #1361)

comment 1361 comment by: European Cockpit Association

AMC1 ORO.FTL.240 Nutrition: Present rule: MEAL OPPORTUNITY The operations manual should specify the minimum duration of the meal opportunity, when a meal opportunity is provided, in particular when the FDP encompasses the regular meal windows (e.g. if the FDP starts at 11:00 hours and ends at 22:00 hours meal opportunities for two meals should be given). It should define the time frames in which a regular meal should be consumed in order not to alter the human needs for nutrition without affecting the crew member’s body rhythms. ECA Proposed wording: An operator shall specify in its operations manual how the crew member’s nutrition during FDP is ensured. During the FDP, there shall be the opportunity for a meal and drink in order to avoid any detriment to a crew member’s performance, especially when the FDP, exceeds 6 hours, or 5 hours for single pilot operations or when to other reasons eating or drinking during flight operations is imposible. The circadin rhythm and the regular meal times have to be taken into consideration.

response Partially accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 20 of 277 An agency of the European Union

The text proposed by ECA is a combination of existing ORO.FTL.240 and AMC1 ORO.FTL.240

text with new elements. Some of the proposed new elements are accepted and will be

added to point ORO.FTL.240.

It should be noted that the specification ‘especially when the FDP exceeds 6 hours’ does

not mean that only FDPs longer than 6 hours must offer meal opportunity. The

requirement is applicable for any FDP duration.

comment 1413 comment by: Airlec Air Espace / Paul Tiba

Established in 1958, Airlec is the oldest French business aviation company. We have majored in the field of air ambulance for about 20 years and are now the specialized French Air Operator in patient transport - about 1,000 patients per year -. Airlec owns and operates eight aircraft including three transcontinental jets - Hawker 1000B Elixir -. We have been continuously investing to provide high-end services to our partners and offer them experienced French specialized medical teams as well as top-of-the-art medical equipments. Moreover, we provide a real bed-to-bed service. Our approach also goes beyond the economical dimension through the development of hardware and protocol for infectious patients, such as Ebola virus. AIRLEC thanks the EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for AEMS operations throughout Europe in order to warrantee a high level of safety. Due to the complexity of the proposed regulation, at the time being, AIRLEC fears that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal. Indeed, AEMS operators are not familiar with the EASA FTL schemes and philosophy. Proposed AEMS FTL rules are derivated from current CAT.A FTL rules, with a common basis. Moreover, AEMS operators are still now subject to national FTL rules, which are for France far different from EASA’s proposals. It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal.

— COMMENTS ON AEMS PROPOSALS —AEMS Introduction

Organization of each AEMS companies cannot be compared since they are adapted to their

national specific needs and requirements. To that extend, the French AEMS market is

specific which make its AEMS operations and organization unique. Thus, French AEMS

operations and organization are different from HEMS and Air Taxi operations and

their respective organizations. In that way, the French regulation proposed

specific requirements for aeroplane emergency missions in order to fit to operational

needs.

French AEMS System

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 21 of 277 An agency of the European Union

Emergency operations are deeply linked with national health, security and safety but also mutual insurances. AEMS French operations is composed with two specific domains: • Graft and organ transportations • Other emergency transportations (patients, return of hostage, etc.) In France, AEMS is mostly operated by 2 major private operators - Oyonair & AIRLEC - on behalf of mutual insurances. Other French AEMS operators provide mixed services Air Taxi and emergency transportations. The particular case of grafts and organs transportations is an operation conducted by AEMS operators on behalf for the French healthcare system. Thus, this kind of operation depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service defined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. The current French AEMS organization ensures to have H24 availability in case of emergency events such as abroad medical needs, abroad patients, return of hostages, etc. This operational readiness with really short response time is warrantee thanks to the French regulation under the disposals of “reserve”. Such a reserve is limited to 24 hours with a short notification time but several consecutive periods are allowed without any rest period between each reserve provided no flights/activities are performed meanwhile reserve. Indeed, the French system considers the necessary rest for a pilot is taken during the reserve as the crew is not disturbed and is in a suitable accommodation. The proposed European regulation on standby does not allow the French operators to comply with the French work pace and will lead to have operational gap without any crew available. Additionally, in France, the most usual rostering is 6 days ON at home base / 3 days OFF with a need for a H24 operational readiness. Hence, considering the nowadays French reserve and the proposed current standby, all these new requirements will lead to have continuously 3 crews in service to cover a H24 availability over 14 days instead of 2 crews with French current system (Cf. Annex 2 - Illustration 4). The requested 3 days of rest after 6 days of reserve in French regulation does not appear more tiring than the 1 day of rest for 1 day of proposed European standby. Besides, since AEMS missions deal with life-threatening emergencies, the notification time for the crew is quite short. Usually, in France, the crew is notified 3 hours before the flight (considering 1 hour of preflight) when the crew is under the disposals of “reserve” according to French regulation. Moreover, during the flight, the current times are in average 2 hours to load and 1 hour to unload the EMS payload. The rostering considers these durations in order to schedule some AEMS operations which usually has the first flight planned at 08:00 depending on the type of emergency. However, the flexibility of the rostering is ensured thanks to the commander’s discretion allowance of 2 hours or more if an unforeseen event occurs after the last take- off or in “Force majeure” case. These inherent necessary flexibility and reactivity to AEMS operations should persist in the proposed European dispositions in order to fit with the operational needs. The usual French AEMS missions are specific to the French national needs and insurance services. One of a typical emergency mission is short-haul flights taking care of two consecutive patients in two different cities. The non- augmented crew (2 pilots) needs a flight duty period of at least 14 hours to perform 4 sectors. This number of sectors may also be

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 22 of 277 An agency of the European Union

necessary in case of a unique patient transportation with positioning before and after the mission or with picking up the specific medical team at another airport than the home base airport. These kind of sectors shall also count as EMS flights. In that way, the French AEMS activity is based on a 14-hour Flight Duty Period with 2 pilots (non- augmented crew) with 4 sectors and the new EASA proposals should take into account this current organization based on medical and emergency needs. Long-haul flights are also frequent in AEMS French operations. For example, in 2014, a lot of AEMS long-haul flights were necessary to repatriate Ebola patients from Freetown in Sierra Leone to Europe due to the lack of medical care on site. The augmented crew (3 pilots) had a 18-hour Flight Duty Period to perform 4 sectors. In that way, the French AEMS activity is based on a 18-hour Flight Duty Period with 3 pilots (augmented crew) with 4 sectors and the new EASA proposals should take into account this current organization based on medical and emergency needs. Moreover, due to the frequent unforeseen circumstances which are faced in AEMS operations, the commander may often extend the Flight Duty Period in order to finish properly the emergency mission. For example, it is not rare that the 2 hours plan to load the patient is not sufficient if the patient medical stabilization is difficult (Cf. Annex 2 – Illustration 3). Indeed, the crew cannot engage the flight back as soon as the patient is not stabilized. In that way, in France, the commander can take the discretion to overpass the Flight Duty Period to 2 hours or more if an unforeseen event occurs after the last take-off or in “Force majeure” case. However, when the mission is finished (meaning the aircraft and its crew are back to their operating base), the crew has a rest period of at least 24 hours and the operators are even used to give at least 36 hours. That is why, AIRLEC insists on the crucial needs of commander’s discretion that should be at least as flexible in AEMS as in CAT. To sum up, in France, in order to answer to all national and insurance needs, the French regulation allows and ensures for AEMS operations: • A H24 operational readiness thanks to a 24 hours reserve with short notification time • The possibility to have several consecutive reserves provided no flights/activities are performed meanwhile reserve • 2 hours of commander’s discretion or more in case of “Force majeure” and if an event occurs after the last take off. Thus, the French regulation allows up to 18 hours with 4 sectors with a non-augmented flight crew. The real AEMS operations need within this framework are less stringent but require at least: • 14-hour Flight Duty Period with a non-augmented crew with 4 sectors • 18-hour Flight Duty Period with an augmented crew with 4 sectors These principles are absolutely necessary and must be taken into account in the EASA proposal, else it would be impossible to make some rescue and emergency missions which is neither politically nor socially acceptable.

#Conclusion The impact of the implementation of European FTL regulation for AEMS in France goes beyond the French operators. Thus, it would be appreciated if the RIA addresses more on the social & economic impacts as well as impacts on:

• Graft and organ transportations linked to the national Health care system

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 23 of 277 An agency of the European Union

• Other emergency transportations linked to insurance needs and organization

Since the AEMS is a really specific and independent operation, the EASA’s proposals is

blocking on several points. Some points are blocking because they are deeply linked to

HEMS dispositions and some others, because they are inherited from Air

Taxi requirements:

The definition of the EMS payload shall ensure to include the aircraft as an EMS payload

(the aircraft is equipped for AEMS missions)

There is no possibility to ensure the activity in case of “Force Majeure”

The 10% allowance between scheduled and actual FDP is not appropriate with the AEMS

operations and needs to be suppressed

The limitations of Flight Duty Period (extended and not extended) are not adapted to the

AEMS operational needs and shall be extended

The acclimatization philosophy does not fit to the operational reality for AEMS operations

and the limitations need to be extended

The commander’s discretion shall be extended for 2 reasons:

• 1) The limitation is too restrictive considering the AEMS emergency missions • 2) The limitation is even more stringent than for Air Taxi and CAT operations

Several standby cannot be consecutive while it is necessary that crews ensure a

continuous operational readiness The standby definition must be clarified so that it can

allow a range up to 24-hour operational readiness

Thus, AIRLEC ask the EASA to consider option 0 described in the RIA : no policy change.

Safety impact, social impact and economic impact are neutral or having a little impact.

The option 0 seems the proper action since a one size fits all model is not applicable to

the industry. The well-functioning current national FTL schemes are enforced since years,

no excessive fatigue has been demonstrated and more specifically, the current national

system provides French operators and their crews with satisfaction.

As a consequence, any changes in the FTL schemes in AEMS may take benefit from considering the experience of the existing system and organization instead of creating from scratch a brand new system but inadequate and inefficient. If the Option 0 is not retained by EASA, AIRLEC asks for this proposed NPA to be amended and reviewed as stated in the following comments distinguishing AEMS, HEMS and Air Taxi. Indeed, a completely new proposal, distinguishing the AEMS from HEMS and Air Taxi is needed as no operational comparison can be made between the fundamentals of these different activities. AIRLEC insists above all in protecting the amplitude for the Flight Duty Period and the long reserve with short notification time which are necessary to allow emergency missions. In that way, AIRLEC asks to have new European dispositions that would allow at least:

• 18 hours maximum FDP with 4 sectors with 3 pilots (augmented crew)

• 14-15 hours maximum FDP with 4 sectors with 2 pilots (non-augmented crew)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 24 of 277 An agency of the European Union

• A standby definition allowing up to 24 hours of operational readiness

• The possibility to have several consecutive standby provided no flights/activities are performed meanwhile standby

• 2h of commander’s discretion with non-augmented crew & 3h with augmented crew, which are the same requirements than for CAT operations

response Please see the response to comment # 1004.

comment 1427 comment by: European Cockpit Association

ECA appreciates that several of its inputs to earlier consultations and deliberations in the RMG are being – at least partially – reflected in this NPA. In particular, the provisions on cumulative flight times and on positioning are important to be kept as proposed and should ideally be further strengthened. At the same time, several of the proposed provisions raise serious safety concerns and should be amended. While these provisions may suit the commercially-driven flexibility and productivity wishes of the operators, they would risk creating significant safety hazards without any meaningful mitigation, and without being backed by scientific evidence. ECA therefore calls upon the Agency to review and revise those provisions to ensure safe air taxi operations also in future. Also, ECA expresses concerns about the proposed Art. XX, in case the intention is to have this Article replace the existing Art. 1(3) of Reg. 83/2014. If this is the intention, an urgent targeted stakeholder consultation on this aspect is required.

response Noted

ECA’s concern is not justified.

The proposed Article XX is to replace Article 9b of Regulation (EU) No 965/2012 which, in

its current version, has exhausted its purpose.

It is necessary to make the scientific review of FTL an ongoing task based on regular

feedback from Member States. EASA actually makes the submission of fatigue-relevant

data by the Member States stricter since without such data any regulatory review would

be impossible or very expensive.

Title p. 1

comment 736 comment by: European Business Aviation Association (EBAA)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 25 of 277 An agency of the European Union

Attachment #47

EBAA recognises the efforts made by the agency together with all the different industry stakeholders including member state representatives in order to develop an effective FTL scheme for Air Taxi Operations. Unfortunately, our analysis shows that the current proposal is slightly different from the version agreed during the rulemaking group. In particular, some key concepts - such as the “passive contact” - are now missing in the published version of the NPA. Moreover, in the way it is presented, the rule can be a challenge for air taxi operators, especially the small ones, which often have more complex operations than normal CAT. As a reminder, simplification was one of the main objectives of this rulemaking process, and as it stands the published NPA do not completely full fill this objective. Here in attachment the comments from EBAA as the European industry representative of Air Taxi Operators.

response Not accepted

‘Passive contact’ does not represent a ‘key concept’; it is a method of notification.

A key concept in the FTL rules is, for example, the undisturbed sleep opportunity.

The opportunity for a ‘passive contact’ shall be included in the Opinion. The operator’s

IFTSS should provide for a method of notification that, as far as possible, avoids disruption

of the crew member’s prior sleep opportunity.

The way NPA text is presented follows the logic of legal proposals, because it is precisely a

legal text, not a procedure in the operations manual.

As usual, EASA will organise workshops in order to familiarise operators and their

personnel with the new EU rules during the transition period following their adoption.

comment 1439 comment by: sprintAir

Dear Sirs, According to the new NPA 2017-17 objective is to develop new rules for i.e. (ATXO) in terms of FTL. We want to ask You if there is possibility of change in terms of the point (6) Article 2 (definitions) of the Commision Regulation (EU) 965/2012, ’air taxi operation' means, for the purpose of flight time and duty time limitations, a nonscheduled on demand commercial air transport operation with an aeroplane with a maximum operational passenger seating configuration ('MOPSC') of 19 or less. As a Charter cargo and charter PAX (MOPSC of 34) passenger configuration air operator, our type of operation is very similar to the ATXO. Crew duty time have a significant impact to our efficiency. Many flights are booked at the last moment. Each operation consist of positioning, commercial and depositioning leg. Kind Regards,

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 26 of 277 An agency of the European Union

response Not accepted

Charter operations with aeroplanes with a MOPSC of more than 19 are operations

conducted under CS FTL.1.

Your approved IFTSS must reflect the specificities of your on-demand cargo and passenger

flights.

Executive Summary p. 1

comment 404 comment by: ANWB MAA

FTL Netherlands is based on scientific research We didn't see the prove of any reap efficiency gains

response Noted

This proposal is also based on scientific research.

comment 612 comment by: Transport Malta–- Civil Aviation Directorate

Rules and regulations for AEMS operations are not described in EU 965/2012, as such implementing FTL schemes for an 'unregulated' operations may require also EU 965/2012 recognition.

response Not accepted

AEMS operations have been subject to Regulation (EU) No 965/2012 since 2012.

comment 793 comment by: Babcock Mission Critical Services Limited

Attachment #48

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 27 of 277 An agency of the European Union

The proposed content of NPA 2017-17 is well-intentioned, and it is desirable that aviation safety is enhanced and maintained. However, EASA has seriously failed to consider absolutely critical differences between what may be considered appropriate for FTLs and other rules in large-scale, scheduled commercial transport, and what serves safety and service in activiites such as HEMS and ATXO (incorporating AEMS). One key example differences include the fact that EMS operations often spend very large proportions of time in standby, because their service is to be available should they be needed. From the data we have reviewed it is not uncommon for less than one EMS flight to occur in an entire standby period (which could be 12h, or even 13h or 14h in duration in some locations in some seasons). Babcock has commissioned Integrated Safety Support and Interdynamics to advise on Fatigue Risk Management Systems design. The organisation has reviewed the proposals within this NPA and provided the attached report: "Mission Critical Services Notice Of Proposed Amendment 2017-17 Response Considerations", Fletcher et al, Integrated Safety Support, 28 February 2018)

response The statement that ‘EASA has seriously failed to consider absolutely critical differences

between what may be considered appropriate for FTLs and other rules in large-scale,

scheduled commercial transport, and what serves safety and service in activities such as

HEMS and ATXO (incorporating AEMS)’ is not accepted.

Many commentators have criticised NPA 2017-17 for not addressing the specificities of the

different type of operations but seem to forget the fact that ATXO and AEMS operations

have so far been governed by the 2006 Subpart Q and old national rules (HEMS: only

national rules), which, as rightfully admitted by Babcock Ltd, ‘have not been tailored to

consider EMS or similar operations’.

In fact, the 2006 Subpart Q and old national rules do not match contemporary practice and

scientific knowledge of human performance limitations and of sleep. They did not properly

address transient and cumulative fatigue, operator and individual responsibilities, the

impact of duty times on circadian rhythm, and crossing of multiple time zones, etc.

EASA developed FTL rules for air taxi, AEMS and HEMS operations with the understanding

that each of these activities has specificities that need to be addressed separately. For

example, the logic behind the rule on standby is the following: point ORO.FTL.225

establishes common principles and a legal opportunity for flexibility according to the type

of operation; CS FTL.1.225 specifies standby in CAT scheduled and charter operations; CS

FTL.2.225 specifies standby in air taxi and AEMS operations; CS FTL.3.225 specifies standby

and duties at the HEMS operating base.

EASA has been working together with industry experts who have provided valuable input

for the development of those CSs depending on the type of operation. EASA has also

commissioned a number of studies for the collection of data. EASA has found the data

obtained to be objective and reliable, and has, therefore, no reason to look for other data

sources.

The statements made in Attachment No 48 are noted.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 28 of 277 An agency of the European Union

For the comments related to HEMS, please see the response to comment # 54.

comment 794 comment by: Yorkshire Air Ambulance

Only "expected to improve safety"? There should really be certainty to improve safety if mandating change.

response EASA is expecting that proposed measures will lead to safety improvements. If there was

no certainty about it, the Agency would not have proposed new requirements.

comment 795 comment by: Babcock Mission Critical Services Limited

Babcock has a large amount of data that provides strong operational and scientific evidence that the constraints proposed in the NPA are both unnessary and unlikely to improve safety. In fact, there are reasons why safety could be measurably compromised should EASA continue down the current path. For example, EASA claims that “Operators…will reap efficiency gains and benefit from a level playing field and improved safety” but all modelling we have done indicates that contracts will not at all be commercially viable if the new rules are implemented because many more pilots would be needed to cover the same contract. This leaves only three options: (1) those contracting in EMS services will pay more for the same service, which is very unlikely in many cases where funds would not be available (2) those contracting in EMS services will use their existing budget to allow for a reduced service to their regions and communities, which is more likely given funds for such services are very often already highly constrained, and (3) a proportion of operators will continue to operate as per their contracts but outside of the new legal requirements, in order that they can commercially survive (it is not possible to know how wide-spread such an approach might be).

response Noted

comment 796 comment by: Yorkshire Air Ambulance

Scientific principles have been used since 1975 in the UK, as the preface to CAP371 - Avoidance of Fatigue in Aircrew - makes clear.

response It is unclear what the comment is about.

comment 797 comment by: Babcock Mission Critical Services Limited

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 29 of 277 An agency of the European Union

It is impossible to see how EASA’s claim that efficiency will be improved when many more staff will be needed, especially when keeping pilots' recency up at remote locations is already sometimes a struggle. On the modelled basis that more pilots would be needed, there is also a factor of where these additional pilots will come from and where all of the (sometimes very rare) simulator training slots will be created from. From all of the data we have seen and modelled, operators will have reduced efficiencies (associated with higher costs), and there is no evidence that safety will be improved and indeed safety might be measurably worsened. Safety could be worse, for example, because pilots will get to fly significantly less, and in many cases (especially in remote locations, at night and in Winter) recency is already a risk. Safety could also be worsened because, on the basis that many new pilot will be needed, there might need to be a lot of inexperienced pilots hired to fill gaps. However, retaining good pilots might be very difficult in EMS given that flying hours are low, and such positions are often very unattractive to younger pilots needing to build hours.

response Noted

comment 798 comment by: Yorkshire Air Ambulance

Are the "efficiency gains" envisaged here either quantifiable or even probable? The NPA fails to demonstrate either.

response It is unclear what the comment is about.

comment 799 comment by: Babcock Mission Critical Services Limited

EASA also claims that the proposed changes are good for “Aircrew members who will benefit from improved harmonisation, safety and efficiency”. However, it is easy to see how crew would dislike the changes a great deal. For example, EMS pilots often commute to a base that is not near their home, due to the seasonal nature of the base and/or the remoteness of the region their EMS are serving. As such, pilots currently only have to commute once per week as they do one week of work (mostly standby) followed by a week or more off of all duty. The proposed changes would mean maximum cycles times would be cut dramatically based on maximum duty times (which count time on standby as duty). This means they are commuting much more often, and there is large amounts of evidence that such commuting, especially on the roads, is much worse for their individual safety than being in standby mode at their base for longer. Also, the more frequent commuting will cost pilots more, which is much less efficient for their personal finances. They may also have their skills eroded if there is a need to hire more pilots for the same amount of work, or if service coverages get cut so that contract budgets remain intact.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 30 of 277 An agency of the European Union

Applicability and timelines p. 1

comment 1401 comment by: Dr Adam Fletcher

I understand the value in having a standardised set of rules within this segment of the industry. However, there are huge differences in EMS/ATXO and the scheduled commercial airlines that the majority of current rules (flowing from the relevant ICAO SARPs) are based on. For example, standby is used relatively rarely in airlines, and crew often get called to duty from standby. However, in EMS (and to a lesser degree ATXO) standby can make up large proportions of work time. Standby in many contexts (e.g. overnight in a 24-hour EMS base) is often valuable for recovery and preparation, since flying is rare. So, standby cannot be counted as full duty in all circumstances, or allowances for signficant extensions can be made, otherwise, the services that exist will not be able to continue to exist. In many EU jurisdictions now, the community only has EMS coverage because flying rules are flexible when the proportion of work time spent flying is low (which means standby is high). In terms of the timeline, there is a critical need to pause for a period of time. One reasons is that there are a major national reviews underway in multiple relevant jurisdictions, including Canada, Australia and New Zealand. For example, all Australian FLT-related regulations and supporting documents will have undergone a substantial review, on behalf of the Board of Directors of the Australian Civil Aviation Safety Authority (CASA) with a final report due to the Board before March 9th, 2018. I know this because one of my team members and I are 40% of the independent review team. The NPA content is not fit-for- purpose, and requires a major rethink before it costs safety, community service standards, and productivity.

response Noted

It is well understood that standby cannot be counted as full duty in all circumstances.

Please, refer to CS FTL.2.225 where the concept of differential calculation of standby for

the purpose of cumulative duty is laid down.

EASA has always drawn upon international experience as far as it is relevant to the unique

nature of the European operating environment. As to the review of fatigue rules conducted

by CASA, one of the recommendations in their final report points into the opposite

direction to that suggested by the commenter — ‘that CASA adopts prescriptive FDP limits

that are more closely aligned with international averages for similar types of operation’.

1. About this NPA p. 3-4

2.1. Why we need to change the rules issue/rationale p. 5-6

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 31 of 277 An agency of the European Union

comment 50 comment by: Wolfgang Zellhuber

In general I am very pleased to see the EASA efforts of harmonisation of FTL in ATXO. Unfortunately I am missing one very important item throughout the entire NPA 2017-17: In commercial air transport by aeroplane for air taxi operations and single-pilot operations many people work as freelance or self-employed personnel (flight crew/cabin crew/a.s.o.). Could you please clarify in GMs and check every point of the entire NPA2017-17 how this NPA could work for freelance/self-employed personnel and how the different clients of the freelance pilots (here: most time competitive operators) should handle and classify their freelance personnel? Please consider: To avoid false self-employment a freelance personnel needs at least several different clients (here: operator) which may be at different home bases, even at different countries and/or time zones. Thank you.

response The constructiveness of the comment is appreciated.

With regard to freelance or self-employed crew members, please refer to the following

points of Regulation (EU) No 965/2012:

ORO.FC.100(e)(2) and ORO.CC(b)(2);

ORO.FTL.115;

ORO.FTL.245; and

CAT.GEN.MPA.100(b)(4) and (5).

Responses with regard to ‘home base’ (comment #127)

comment 127 comment by: VistaJet

Section 2.1 describes accurately that there are significant differences between Scheduled CAT and ATXO operations, hence why subpart Q is a poor fit. It was a one size fits all solution. However the inclusion of ATXO into ORO.FTL with CS.FTL.2 being based squarely on scheduled CAT (CS.FTL.2), means that ATXO operations are again being forced into a FTL scheme that does not fit. The fact that the concept of home base, and adjusting rest at "home base" is the cornerstone of this NPA, proves that the very foundation on which this regulation is built, is not relevant to ATXO. This FTL scheme is written for a Schedueld/Charter airline that departs home base, and then on a relatively short turn-around, returns to home base. The concept of a perpetual roster with extended rest periods at home base is a concept that very few ATXO operators use. Most ATXO operators apply a fixed rotation pattern during which crew members

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 32 of 277 An agency of the European Union

operate in a flexible and dynamic environment, after which they return home for a consolidated "off" block which is a hard reset addressing any cumulative fatigue built up during the rotation. I will supply comments to each section where examples of this mean that this NPA was poorly constructed and based on a foundation which is not rellevant to ATXO or AEMS.

response The comment related to ‘home base’ is partially accepted.

‘Home base’ is defined in point ORO.FTL.105(14) as ‘the location, assigned by the operator

to the crew member, from where the crew member normally starts and ends a duty period

or a series of duty periods and where, under normal circumstances, the operator is not

responsible for the accommodation of the crew member concerned’.

‘Home base’ for scheduled operations is built around the concept of a single airport

location to mitigate potential fatigue issues with aircrew having to commute to different

airports within the same airport system, sometimes at a significantly long distance from

their private place of residence. In air taxi and AEMS operations, the duty scheduling

structure consisting of long block-off times between duty blocks is considered a mitigating

factor; hence, the airport location should not necessarily be a single one. Therefore, in

CS FTL.2.200(a), the term ‘single’ is removed.

The operator assigns a home base to each crew member (point ORO.FTL.200). This is

relevant, for example, for the establishment of the acclimatisation status, calculation of

positioning duties, and determination of compensatory rest. Home base must not be

confused with crew member’s permanent residence. The operator has no control over the

place a crew member has chosen to set up their residence. Commuting or travelling from

the private place of residence to the assigned home base and vice versa, as opposed to

positioning, does not count for duty.

The assigned home base is the place where aircrew start/finish the essential part of their

duties vis-à-vis their employer.

To determine home base, it may be necessary to establish:

(i) the place from which the employee carries out their transport-related tasks;

(ii) the place where they return after the completion of those tasks; and

(iii) the place where their work tools (e.g. aircraft) are to be found.

For on-demand operations, such as air taxi and AEMS, this may be difficult to establish as,

for example, the aircraft location may change every time the crew member receives an

assignment. The qualifier ‘high degree of permanence’, which applies to scheduled and

charter operations, may be a business limiting factor for air taxi and AEMS operations. This

is the reason why it has been removed from subparagraph (a). Nonetheless, the condition

‘from where the crew member normally starts and ends a duty period’ in the definition of

‘home base’ is valid for air taxi and AEMS operations.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 33 of 277 An agency of the European Union

Today, some air taxi operators use the concept of ‘gateway’. The term ‘gateway airport’

does not appear in Subpart FTL and, if used instead of ‘home base’, is a non-compliance

with the requirements on home base. The operator may use ‘gateway airport’ in addition

to home base, for example, as a ‘funnel’ through which positioning flights need to go, but

the operator must clarify what relationship exists between ‘home base’ and ‘gateway’ in

its IFTSS. The home base and a gateway may be the same airport location but may differ.

In other words, the assignment of home base is compulsory, whilst the gateway is an

optional operational solution.

Considering that in air taxi and AEMS operations last-minute changes are typical. If the

recurrent extended recovery rest period is increased when the home base changes, as

currently required for airlines, such measure in air taxi and AEMS operations would most

likely be an unnecessary burden. Therefore, subparagraph (b) has been removed, having

in mind that those operations have a specific duty scheduling structure as mentioned

above.

Also, the concept of ‘home base’ under Subpart Q and Subpart FTL is used for the purpose

of determining the applicable legislation in terms of social security rights and obligations

for flight crew and cabin crew members as per Regulation (EC) No 883/2004 on

coordination of social security systems.

comment 308 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): “Single-pilot operations by aeroplane (SPLO) relate to domestic or intra-European flights, generally shorter than multi-pilot CAT operations, but more challenging than multi-pilot operations. Single pilots often operate under high workload conditions, since the pilot assumes multiple roles. This can make single pilots more vulnerable to fatigue.” Comment: This is not necessarily true for helicopter operation. A well-functioning multi- crew concept comprising a commander and a HEMS technical crew member does not provide a substantially higher workload than for multi-pilot operations. In fact, in many multi-pilot operations the commander will constantly be training or coaching the co-pilot for a command upgrade. That leads to a higher workload than for a professional HEMS technical crew member who has no possibility or ambition to be a pilot.

response Not accepted

Single pilot operations with aeroplanes significantly differ from a typical HEMS crew set-up

consisting of one pilot and one technical crew member in that the single pilot is not being

assisted by another trained member of the crew. The HEMS technical crew’s role is to assist

the pilot in many aspects. The presence of a HEMS technical crew is also a mitigation

measure against pilot fatigue.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 34 of 277 An agency of the European Union

comment 357 comment by: European Helicopter Association (EHA)

BHA (UK) Page 6 - Para 1 "Single-pilot operations by aeroplane (SPLO) relate to domestic or intra-European flights, generally shorter than multi-pilot CAT operations, but more challenging than multi-pilot operations. Single pilots often operate under high workload conditions, since the pilot assumes multiple roles. This can make single pilots more vulnerable to fatigue". Comment: Possibly in a SP F/W environment, not so true in a SP + TCM environment.

response Please see the response to comment #308.

comment 583 comment by: NOLAS

“Single-pilot operations by aeroplane (SPLO) relate to domestic or intra-European flights, generally shorter than multi-pilot CAT operations, but more challenging than multi-pilot operations. Single pilots often operate under high workload conditions, since the pilot assumes multiple roles. This can make single pilots more vulnerable to fatigue.” Comment: This is not necessarily true for helicopter operation. A well-functioning multi- crew concept comprising a commander and a HEMS technical crew member does not provide a substantially higher workload than for multi-pilot operations. In fact, in many multi-pilot operations the commander will constantly be training or coaching the co-pilot for a command upgrade. That leads to a higher workload than for a professional HEMS technical crew member who has no possibility or ambition to be a pilot.

response Please see the response to comment #308.

comment 800 comment by: Yorkshire Air Ambulance

It is possible that fatigue may be greater in a purely Single Pilot F/W cockpit (vs. two pilots), but not necessarily true in a Single Pilot + Technical Crew Member aircraft. The NPA makes a valid assertion that fatigue for TCMs should be managed and controlled by an FTL, but then fails to provide any credit for HEMS pilots who operate within this hybrid crewing structure.

response Please see the response to comment #308.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 35 of 277 An agency of the European Union

comment 803 comment by: Yorkshire Air Ambulance

"Best Practice," is a pejorative term and probably shouldn't be used. Who has sufficient authority to decide what "best practice" is for everyone? Suggest "good practice" as being more acceptable.

response Accepted

comment 1152 comment by: Danish Aviation Association

DAA agrees with the intent to seperate Small and Medium Enterprises (SME) as ATXO operators from CAT Airlines. However, there seems still to be conditions for which the CAT airlines have not been fully modified to SME.

response Noted

comment 1453

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

First paragraph on page 6 It is claimed in the second sentence that single pilot operation is more challenging than multi pilot operation. For HEMS with a HEMS Crew Member, a well-functioning SP+HCM team may very well result in a working environment for the pilot as good as an actual multi crew. The HCM functions like a pilot monitoring and relieves the workload significantly.

response Please see the response to comment #308.

2.2. What we want to achieve - objectives p. 6

comment 40 comment by: ST BARTH COMMUTER

It is a pity that despite being listed in the “Analysis Impacts for Air Taxi and Single Pilot Operations” (Attachment III of this NPA - page 9) as being a company performing single- pilot on demand and scheduled operations, our company was not specifically questioned about the consequences of such proposal in the development of this NPA.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 36 of 277 An agency of the European Union

Unlike stated in that same document (page 10), the increase of crew cost is not 10 to 30%, in our case it will be 100%. Our main activity requires multiple (more than 10) short sector (15min) that have to be performed during daylight since our airport close with sunset, and we also operate AEMS. Reducing the maximum FDP to 8H will force us to use 2 pilots to do the exact same schedule done by 1 today. With the sunset limit, there is no way to do more flights and generate more revenue with this second pilot, so our crew cost will double with no increase in revenue. In our area of operation, the Caribbean, we are competing with airlines from independent islands and US companies with far less restricting rules. Therefore, if this NPA is adopted “as is” you are not creating a “Level playing field” you are simply putting our operations to an end.

response Partially accepted

Please, refer to the response to comment #887.

comment 801 comment by: Yorkshire Air Ambulance

By scientific knowledge, does this refer to the study by FRMSc, which only looked at a very small sample (<20) of air taxi pilots, using their own commercial algorithms such at SAFE? If so, then it's not particularly balanced.

response It is not clear which study you are referring to.

comment 1418 comment by: Svensk Luftambulans

Isn’t there a best practice that has been used in the Nordic countries that should be considered?

response Best practices used in the Nordic countries have also been considered.

2.3. How we want to achieve it - overview of the proposals p. 6-7

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 37 of 277 An agency of the European Union

3. Proposed amendments and rationale in detail p. 8

comment 1478 comment by: Finnish Transport Safety Agency

Article YY Article 8 does not take into account training. It should be clarified that national rules apply to training given in ATOs and DTOs.

response Not accepted

Article 8 of Regulation (EU) No 965/2012 already clarifies that non-commercial operations

shall comply with the applicable flight time limitations established by the national

legislation of the Member State in which the operator has its principal place of business.

Training flights in ATOs and DTOs are considered non-commercial operations.

Draft cover regulation

3.1. Draft cover regulation p. 8-9

Comment #104 on applicability, transition (UK CAA)

comment 104 comment by: UK CAA

Page No: 8 Paragraph No: 3.1 Draft Cover Regulation (Draft EASA Opinion), Article XX Comment: The intent of the monitoring and evaluation of the regulations is supported. This list is management in any type of operation. There appears to be a grammatical error in paragraph two of the text as it refers to “once a year after” when, it would appear, that the intent was “one year after” in terms of submitting the data. However, collecting meaningful data in line with the required list within one year of the regulations becoming applicable would generate a high workload for NAA’s. Embedding the change to the regulations and conducting oversight will be the priority for the NAA’s. We propose that the “one year” requirement for the provision of data is extended to two years to ensure there is sufficient time to establish the methods and process necessary to collect the data in a standardised manner.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 38 of 277 An agency of the European Union

EASA has proposed a date of 2025 for the publication of the first report on this data. It is unclear on what basis this date is derived. EASA are requested to provide clarity on this and ensure that it is appropriate to the finally agreed applicability date of the regulations. Note: The UK CAA has raised a linked comment to this one as referenced on page 68 with regard to the monitoring and evaluation of the regulations. We are requesting support for the NAA’s from EASA to ensure the consistency of the data that is provided for the report. Justification: Sufficient time is provided to NAA’s to develop their processes to collect the required data in a useful and standardised manner. Proposed Text: Propose the text is amended to state that the review data is submitted not less than two years after the date of application. In addition, EASA are requested to clarify the basis behind the 2025 date of the first report on the results of the review once the applicability date for the regulation has been finalised.

response Not accepted

The requirement in paragraph 2 of Article XX that the data collected by the Member States

shall be submitted to EASA at least once a year is kept as it is not expected to be overly

burdensome.

EASA does not expect NAAs to collect the data by themselves. NAAs will typically request

operators to provide their data in a standardised format, which can then be aggregated

and submitted to EASA.

As usual, there will be as a minimum a 1-year transition period after the adoption of the

regulation, meaning that Member States will have sufficient time to establish the methods

and processes necessary to collect data in a standardised manner.

The target date of 2025 was established with the assumption that the regulation would

apply from 2020 after adoption in 2018. This is no longer the case.

When Regulation (EU) No 83/2014 (amending Regulation (EU) No 965/2012 laying down

technical requirements and administrative procedures related to air operations) was

adopted, some of its elements were not entirely based on scientific evidence or the

scientific evidence was weak. Therefore, the regulator requested the inclusion of a binding

clause to conduct a scientific study.

Considering the costs and amount of effort entailed by the two scientific reviews that have

already taken place, EASA has reassessed the need for a future review in a 5-year interval.

Data submitted by the MSs shall help determine when and to what extent the next

scientific review is to take place.

comment 310 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway):

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 39 of 277 An agency of the European Union

“The Agency shall conduct a continuous review of the effectiveness of the provisions concerning flight and duty time limitations and rest requirements contained in Annex III to Regulation (EU) No 965/2012. That review shall involve scientific expertise, where relevant, and be based, as a minimum, on the following operational data collected by the Member States and submitted to the Agency not less than once a year after the date of application of this Regulation:” Comment: Does all the Authorities have the capability for continuous review and to collect this data? “Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” omment: This is highly relevant for operation serving remote areas, where also the mission rate is low. However, here it is important to emphasize that it is not always the location of the HEMS operating base that is relevant, but the actual area served. For example, a helicopter can be based in a city, while serving exclusively remote areas. Also, the wording “ineffective” should perhaps be reviewed as most medical personnel or operators could argue that the majority of road transport could be “ineffective” as compared to helicopter transport.

response Please, see the response to comment #104.

Please, see the response to comment #54.

comment 359 comment by: European Helicopter Association (EHA)

BHA (UK) "That review shall involve scientific expertise, where relevant, and be based, as a minimum, on the following operational data collected by the Member States and submitted to the Agency not less than once a year after the date of application of this Regulation:" Comment: How does EASA envisage national authorities collecting such data? "Article YY "Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State". Comment: Any operator could reasonably argue that all ground EMS provision is "ineffective" in comparison to the skill and delivery speeds of air ambulance staff, thus none of the FTL is applicable.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 40 of 277 An agency of the European Union

response Please, see the response to comment #104.

Please, see the response to comment #54.

comment 585 comment by: NOLAS

response Please, see the response to comment #104.

comment 805 comment by: Yorkshire Air Ambulance

How does EASA envisage national authorities collecting such data? This will be difficult to achieve for all MS with the resources available.

response Please, see the response to comment #104.

comment 806 comment by: Yorkshire Air Ambulance

Any operator could reasonably argue that all ground EMS provision is "ineffective" in comparison to the skill and delivery speeds of air ambulance staff, thus none of the FTL is applicable. This paragraph needs to be reworded and/or reconsidered.

response Noted

comment 876 comment by: Stephanie Selim

Article XX : DGAC thinks that collecting operational data should be a mission of EASA and not of the Member States.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 41 of 277 An agency of the European Union

response Please, see the response to comment #104.

comment 877 comment by: Stephanie Selim

article YY : The current article 8 states: "3. CAT operations with helicopters, CAT operations with balloons and CAT operations with sailplanes shall comply with national requirements. 4. Non-commercial operations, including non-commercial specialised operations, with complex motor powered aeroplanes and helicopters, as well as commercial specialised operations with aeroplanes, helicopters, balloons and sailplanes shall continue to be conducted in accordance with applicable national flight time limitation legislation until the related implementing rules are adopted and apply." The bold text is replaced in this NPA (without being mentioned in edit mode) by « applicable requirements of the national law of the Member State in which the operator has its principal place of business. » This new formulation can lead to confusion. Indeed, it should not be interpreted as national law of the MS regarding labour laws but only flight time limitations regarding safety regulations. So, we ask for a return for the initial formulation. If this demand is not accepted, we ask for a clarification that this new formulation only concerns safety regulations about flight time limitations, and not labour regulation.

response Article 8 has been amended by Commission Regulation (EU) 2018/394, and its current

version differs from the text quoted in your comment.

The scope of Article 8 is limited to FTL requirements.

comment 1328 comment by: Civil Aviation Authority of Norway

On the need for transistion time: The flexibility which is proposed with regard to allow operators to establish individual flight time specification schemes (IFTSS) is supported. Due to the different specificities of these operations, we expect that many operators will use this possibility. The task of establishing an IFTSS and getting this approved will however be quite resource demanding for both operators and the authorities. The regulation must allow time for such applications to be processed before it comes in to effect. We therefore consider it necessary to allow for a transition period of 2-3 years, from the date of publication until the regulation becomes applicable.

response Please, see the response to comment #104.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 42 of 277 An agency of the European Union

comment 1330 comment by: Bartosz Fibingier

Article 8 point 2: "CAT operations with helicopters, other than emergency medical services, and CAT operations with sailplanes shall comply with the applicable requirements of the national law of the Member State in which the operator has its principal place of business." For the moment Reg. 965/2012 covers operations of aeroplanes, helicopters, balloons and sailplanes. CAT OPS with Balloons, should be addressed here unless rule will be implemented after Balloon will be extracted from under EU Reg. 965/2012. Article 8 point 3: 3. Non-commercial operations, including non-commercial specialised operations, with complex motorpowered aeroplanes and helicopters, as well as commercial specialised operations with aeroplanes, helicopters and sailplanes with regard to flight time limitations shall comply with the applicable requirements of the national law of the Member State in which the operator has its principal place of business, or, where the operator has no principal place of business, the place where the operator is established or resides.’ - To simplify, this point could refer to all Non-commercial operations as well as commercial specialized operations. There is no reason why non-commercial specialised operations with other-than-complex motor-powered aircraft should not be covered here (i.e. Balloons and Sailplanes). The rule refers to "applicable" requirements of the national law so and does not mandate the member state to issue a new law.

response Not accepted

Non-commercial operations with non-complex aircraft are not subject to Part-ORO, i.e. not

subject to Subpart FTL. It does not make sense to exclude them from something they are

a priori excluded.

Response to comment #1029 ‘Force majeure’ (FNAM)

comment 1029 comment by: FNAM

FORCE MAJEURE ISSUE AEMS and Air Taxi are deeply linked with national health, security and safety. Current French regulation allows, by sovereign decision of the State, to grant derogation as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For illustrative purposes, the recent missions would not have been possible if this regulation enters into force as it is:

• Hostage taking in Amenas in 2013 • Evacuation of injured journalists in Mossoul in 2016

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 43 of 277 An agency of the European Union

• Airlift between Guadeloupe and Saint Martin in 2017

Therefore, FNAM and EBAA France suggest adding a specific paragraph in this implementing rule allowing pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation or if the State requisitions an aircraft. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : "Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation; la limite est à fixer par le ministre chargé de l'aviation civile." (Ref : CAC D422-12)

response Not accepted

The application of force majeure is governed by national laws.

Force majeure clauses discharge a party from liability if an unforeseen event beyond the

control of that party prevents it from fulfilling its obligations under a contract. Typically,

force majeure clauses cover natural disasters, wars or other acts of God.

The objectives of the EU FTL rules are to ensure that crew members are adequately rested

at the beginning of each flight duty period (FDP), and that the duration and timing of

individual duty periods will enable them to operate to a satisfactory level of efficiency and

safety in all normal and abnormal situations. The FTL rules are, therefore, concerned solely

with the prevention of fatigue and the maintenance of vigilance in flight. They are not

intended to regulate commercial aspects, force majeure, social issues, or lifestyle.

Also, flights that carry out/provide military, customs, police, search and rescue, firefighting,

coastguard or similar activities/services are a priori excluded from the scope of the Basic

Regulation, as well as from the scope of the applicable implementing rules (Article 2(3) of

the Basic Regulation).

comment 1414 comment by: Airlec Air Espace / Paul Tiba

FORCE MAJEURE AEMS and Air Taxi are deeply linked with national health, security and safety. Current French regulation allows, by sovereign decision of the State, to grant derogation as far as

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 44 of 277 An agency of the European Union

national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For illustrative purposes, the recent missions would not have been possible if this regulation enters into force as it is: • Hostage taking in Amenas in 2013 • Ebola patients in 2014 • Evacuation of injured journalists in Mossoul in 2016 • Airlift between Guadeloupe and Saint Martin in 2017 Therefore, AIRLEC suggests adding a specific paragraph in this implementing rule allowing pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation or if the State requisitions an aircraft. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : "Il peut être dérogé aux limitations mentionnées la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution imm diate est nécessaire : a) Pour pr venir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation; la limite est fixer par le ministre chargé de l'aviation civile." (Ref : CAC D422-12)

response Please, see the response to comment # 1029.

comment 1463 comment by: European Cockpit Association

Commented provision: “Article XX - scientific review" ECA strongly supports the principle of an ongoing scientific and operational data driven review process of FTL rules. From the NPA it is unclear whether this new Article XX replaces Art. 1(3) of Reg. 83/2014 or complements it with this new Article specifically focussed on the operations covered by this NPA. If it is the former (i.e. replace), ECA objects to any decisions to be taken on this new Article and calls upon the Agency to formally consult ECA and ETF, and possibly other stakeholders, on this proposal, as it concerns a provision related to operations that are NOT covered by this NPA, and as it has the potential to dilute and delay the existing CAT related review process. Given that Art. 1(3) of Reg. 83/2014 has been the result of extended political discussions – including at the European Parliament – and was a key

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 45 of 277 An agency of the European Union

precondition for many stakeholders to go along with the FTl rules, this technical NPA & rule-making process must not be used to alter the article without a targeted consultation of relevant stakeholders, in particular ECA and ETF. If it is the latter (i.e. complement), we believe that many, if not most, NAAs would have severe difficulties to collect the listed operational data. While we support that NAAs should and do collect such data, we invite the Agency to take steps to ensure it will actually receive such data, and in sufficient quality and quantity. Otherwise this provision will remain without effect, thereby undermining any prospect of carrying out a meaningful evaluation. Also, ECA proposes to delete ‘where relevant’ in: “That review shall involve scientific expertise, where relevant, and be based on …” – i.e. in line with the corresponding provision in Reg. 83/2014. Equally, ECA proposes to review and complement the list of data items, which seems limited. In particular, the listed items should cover issues where this NPA proposes flexibilities (compared to CAT) and which might create safety hazards.

response Please, refer to the response to comment #1427.

ORO.FTL.105

3.1. ORO.FTL.105 p. 9-10

comment 57 comment by: APEM Aviation

(13) "...the time between an aircraft first moves from its parking place for the purpose of taking off until..." is not correct English. The existing wording is more correct. Alternatives would be a) "...the time from when an aircraft first moves...", or b) "...the time between from when an aircraft first moves..."

response Accepted

Initial wording will be kept.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 46 of 277 An agency of the European Union

Response with regard to ‘sector’ (comment #58)

comment 58 comment by: London's Air Ambulance

Paragraph 24 has been amended to relate the definition of a ‘sector’ to aeroplanes only. The new paragraph 29 refers to HEMS and states “A sector flown to position an aircraft … for an EMS flight.” An EMS flight is stated to be a flight by an aeroplane or a helicopter. The amended wording of paragraph 24 is wrong and needs to be reversed to read “…between and aircraft first moving…”

response Noted

Since HEMS-related text has been removed, the definition of ‘sector’ does not need to be

amended and paragraph 24 remains unchanged for the time being.

comment 105 comment by: UK CAA

Page No: 9 Paragraph No: ORO.FTL.105, (13) Definitions “flight time” Comment: The word “total” is missing from this definition and should be included as per PART.FCL.010, Definition for Flight time: “for aeroplanes, touring motor gliders and powered-lift, it means the total time from the moment an aircraft first moves for the purpose of taking off until the moment it finally comes to rest at the end of the flight; for helicopters, it means the total time from the moment a helicopter’s rotor blades start turning until the moment the helicopter finally comes to rest at the end of the flight, and the rotor blades are stopped.” Justification: Consistency Proposed Text: Include the word “total” in the definition in line with the PART FCL definition.

response Accepted

comment 106 comment by: UK CAA

Page No: 10 Paragraph No: ORO.FTL.105, (24) Definitions “sector”

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 47 of 277 An agency of the European Union

Comment: The text within the sector definition has been changed from “aircraft” to “aeroplane”. This appears to contradict the numerous references to ‘aircraft’ throughout the document, including the new EMS definition (which is adapted from the HEMS definition). It is important to maintain the definition to include “aircraft” as the definition of an FDP “means a period that commences when a crew member is required to report for duty, which includes a sector or a series of sectors, and finishes when the aircraft finally comes to rest and the engines are shut down, at the end of the last sector on which the crew member acts as an operating crew member”. All FDP tables (fixed and rotary) are premised on this definition. Sector is also specifically used in the CS FTL.3.205(f) Flight duty period - HEMS Justification: The definition of both FDP and EMS flight contains a reference to sector in terms of describing the flight that applies to both fixed and rotary wing. Maintaining the term “aircraft” within the sector definition aligns it to the FDP, EMS and HEMS definitions and affords the final empty sector of the flight the same privileges as the loaded sectors. It would generate confusion with the use of the FDP definition and application of the requirements in CS 3. Proposed Text: Retain the sector definition as “between an aircraft first moving”.

response Please, see the response to comment #54.

comment 190 comment by: Premium Jet AG

The Home Base definition is not applicable to all Air Taxi operation models in general. It should be reviewed or a different definition must be found.

response Please, see the response to comment #127.

comment 206 comment by: Cat Aviation AG

31) Contactable is defined as being an "active" or "passive" way to contact a crew.

response Not accepted

The term ‘contactable’ does not define an operation as an air taxi operation. A pilot is

contactable while on standby or off-duty in the context of any type of operation, not

necessarily an air taxi operation. The contact method is determined by the operator in its

approved individual FTL scheme.

Please, refer to the definition of ‘standby’ in point ORO.FTL.105(25): ‘“standby” means a

pre-notified and defined period of time during which a crew member is required by the

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 48 of 277 An agency of the European Union

operator to be available to receive an assignment for a flight, positioning or other duty

without an intervening rest period.’

comment 207 comment by: Cat Aviation AG

"(14) Home base or home location" as definition

response Please, see the response to comment # 27.

Response with regard to ‘break’ (comment #233)

comment 233 comment by: Federal Office of Civil Aviation (FOCA), Switzerland

Comment FOCA: A "break" should only count as a break, if its duration is more than 60 minutes.

response Not accepted

No scientific or operational evidence is provided that supports your proposal.

comment 610 comment by: NetJets Europe

ORO.FTL.105 (5) Netjets supports the proposed change

response Noted

comment 807 comment by: Yorkshire Air Ambulance

Poor definition. A break is a period when crew members are "free of all tasks," but a duty period ends when a crew members are "free of all duties." What's the difference? The whole concept of breaks has been introduced for this NPA, without the impact being properly considered.

response Not accepted

While on break and free of all tasks, the pilot is still on duty.

The concept of ‘break’ has been used by AEMS operators well before this NPA; hence, it

could not have been introduced by the NPA.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 49 of 277 An agency of the European Union

comment 808 comment by: Yorkshire Air Ambulance

With the change of text, this definition now excludes rotorcraft, contrary to the explanatory notes.

response Not accepted

In HEMS operations, there are no sectors as segments of an FDP. Therefore, paragraph 24

has been amended to relate the definition of a ‘sector’ in the context of an FDP to

aeroplanes only.

comment 810 comment by: Yorkshire Air Ambulance

Agree definition for single-pilot operation, but elsewhere in the document FDPs and fatigue levels are considered based on SP experience alone, and take no account of shared responsibilities.

response Not accepted

The HEMS technical crew does not share the responsibility for flying the helicopter with

the pilot. Therefore, mixed crew operations are treated as single-pilot operations.

comment 880 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(14) the definition "home base" is not any more important for most of Swiss BA operators. Nevertheless, it should be reviewed.

response Please, see the response to comment #127.

comment 915 comment by: AESA

What is the meaning of the statement “also when the aircraft is on the ground” included in definition of “Augmented flight crew”? include it all the time on the ground, or only the time of the flight that the aircraft is on the ground (i.e. taxi)? If all the time is included, what is the difference between on-board rest and split duty?

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 50 of 277 An agency of the European Union

response Aircrew may have on-board rest while in the air in the context of extended FDP with

augmented crew, or on the ground. If on-board rest is taken on the ground, the time on

the ground is the time spent in Class A or Class B facility, not all the time on the ground.

When non-augmented aircrew is having rest in Class A facility on the ground, this is a break,

in the context of split duty.

comment 967 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(31) should be defined in passive or active contact

response Not accepted

Passive and active contact does not define air taxi operations as such. The contact method

is not a rule, it is rather a means of compliance.

Response with regard to ‘on-board rest’ (comment #1032)

comment 1032 comment by: FNAM

(5) 'augmented flight crew' ADD an ON-BOARD REST DEFINITION ISSUE FNAM and EBAA France think a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. Plus, clarification should be provided to define “when the aircraft is on ground”. As this rest can be taken in the aircraft, the definition shall state that a class A facility is an accommodation when the aircraft is on the ground. Indeed, in the CS FTL.2.220 (split duty), a class A facility is equivalent to an accommodation when the aircraft is on the ground (paragraph (d)). FNAM and EBAA France agree with this logic since it matches all the criteria of the accommodation definition. Hence, in order to clarify it, FNAM and EBAA France suggest adding in the “accommodation” definition that the class A facility is an accommodation when the aircraft is on the ground.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 51 of 277 An agency of the European Union

This shall be applicable for split duty but also for standby, especially for split duty. (cf. split duty and standby comments) Cf. comment 1093 Moreover, FNAM and EBAA France don't understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest. Add in the definition of an “accommodation” that the class A facility is an accommodation when the aircraft is on the ground.

response Your proposal for a definition of ‘on-board rest’ is accepted.

Aircrew in air taxi and AEMS operations may have on-board rest while in the air or on the

ground.

On-board rest in the air, in the context of augmented crew only, is similar to the procedures

for in-flight rest and is taken during the cruise phase of flight (see GM1 CS

FTL.1.205(c)(1)(ii)).

If on-board rest is taken by augmented or non-augmented crew, while the aeroplane is on

the ground, the time on the ground is the time spent in Class A or Class B facility, not the

entire turnaround time.

***

The use of Class A facility by non-augmented aircrew, while the aeroplane is on the ground,

meets the requirements for accommodation in the context of split duty.

Unlike split duty or on-board rest, the time spent on standby cannot be taken on board the

aeroplane.

Therefore, your proposal to add in the definition of ‘accommodation’ that Class A facility

is an accommodation when the aircraft is on the ground is not accepted.

Response with regard to ‘positioning’ (comment #1035)

comment 1035 comment by: FNAM

(29) 'EMS Flight' ISSUE The definition of the different EMS mission and flight must be precised. As for example, an EMS mission shall not include only the EMS payload transportation but also all the flights needed to transport the medical team or equipment.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 52 of 277 An agency of the European Union

PROPOSAL Add a GM to ORO.FTL.105 (29): "GM ORO.FL.105(29) An EMS flight may concern both a flight with the EMS payload or any positioning flights before/after loading/unloading necessary to perform the EMS flight from/to the home base."

response Noted

Please, see second subparagraph of point ORO.FTL.105(29).

Response with regard to ‘aircraft as medical equipment’ (comment #1038)

comment 1038 comment by: FNAM

(29) 'EMS Flight' ISSUE The aircraft by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). Moreover, this definition shall be referred in each and every requirement where the EMS payload is involved. PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the aircraft by itself, blood, organs, drugs);”

response Please, see second subparagraph of point ORO.FTL.105(29).

Response with regard to ‘contactable’ (comment #1041)

comment 1041 comment by: FNAM

CONTACTABLE DEFINITION ISSUE The definition of contactable is necessary in order to ensure the level playing field and the good understanding of the next dispositions. PROPOSAL (31) Contactable “A short period of time during the day, other than on a `day off', during which the company requires a crew member to be at an agreed location for the purpose of giving

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 53 of 277 An agency of the European Union

notification of a duty period which will commence not less than ten hours ahead. The contactable period will be between [*] and [*] local time and shall not exceed 21⁄2 hours. * Times to be inserted by the company. If required, the 21⁄2 hours can be split into 2 separate periods. Such arrangements must be agreed by the CAA.” Source : CAP 371

response Not accepted

The term ‘contactable’ does not define an operation as an air taxi operation. A pilot is

contactable while on standby or off-duty in the context of any type of operation, not

necessarily an air taxi operation. The contact method is determined by the operator in its

approved individual FTL scheme.

Please, refer to the definition of ‘standby’ in point ORO.FTL.105(25): ‘“standby” means a

pre-notified and defined period of time during which a crew member is required by the

operator to be available to receive an assignment for a flight, positioning or other duty

without an intervening rest period.’

comment 1096 comment by: European Cockpit Association

Commented text: ORO.FTL.105 Definitions ‘break’ means a period of time within an flight duty period, shorter than a rest period, counting as duty and during which a crew member is free of all task ECA comment: Any break to be considered for extending flight operations have to be at least one hour.

response Please, see the response to comment #233.

comment 1158 comment by: Danish Aviation Association

Home base: There seems to be different definitions of home base internally in the EU system. Only one definition should be used not to create confusion. Home base has also to do with the social security legislation, which should not be neglected.

response Noted

As regards scheduled and charter operations, the definition of ‘home base’ is fully

harmonised. As regards air taxi and EMS operations, where currently little or no

harmonisation exists, there seems to be different interpretation.

EASA believes that the proposed harmonisation of the FTL requirements also in the domain

of air taxi or AEMS operations would avoid further confusion among the stakeholders.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 54 of 277 An agency of the European Union

Response with regard to the deletion of ‘operating base’ (comment #1039)

comment 1039 comment by: FNAM

(29) 'EMS Flight' ISSUE A sector flown to position an aircraft from or to a place which is not the operating base before or after an EMS flight may also be considered as part of that flight. Indeed, these flights are necessary to ensure the proper AEMS operations and shall not be a burden and limit emergency missions. Additionally, when the last flight is without any passengers, this flight should be considered as an NCC flight. PROPOSAL Modify the last sentence to: “A sector flown to position an aircraft before or after an EMS flight is considered part of that flight”

response Accepted

Response with regard to ‘passive contact’ (comment #1166)

comment 1166 comment by: FNAM

PASSIVE CONTACT FNAM and EBAA France suggest to link the following proposal to the implementing rule ORO.FTL.105 (definitions). PROPOSAL "GM1 ORO.FTL.110 (a) Operator responsibilities - PASSIVE CONTACT A form of passive contact for the notification of roster or duty assignments changes or communication of duty assignments during the reserve may help minimise disruption to established sleep and rest patterns. Passive contact is a form of contact a crew member can avoid. Examples of passive contact are:

• email; • a visit to the operator’s website by the crew member; • inaudible pager; • facsimile transmission; and • text message."

RATIONALE: This point is needed for the robustness of the rule.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 55 of 277 An agency of the European Union

response Partially accepted

‘Passive contact’ is a method of notification during standby and is, therefore, a matter to

be established by the operator in its approved individual FTL scheme in the operations

manual.

Please, refer to AMC3 ORO.FTL.110(a) and GM1 ORO.FTL.110(a).

comment 1183 comment by: SAF

(5) “augmented flight crew” ADD an ON-BOARD REST DEFINITION ISSUE SAF thinks a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby. Moreover, SAF doesn't understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest.

response Please, see the response to comment #1032.

comment 1184 comment by: SAF

(24) ‘sector’ AGREEMENT SAF agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. SAF would like the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 56 of 277 An agency of the European Union

response Noted

comment 1185 comment by: SAF

(29) ‘EMS flight’ ISSUE According to the definition of a sector (§24) in ORO.FTL.105, the notion of sector is not applicable to HEMS operations. However, the notion of sector appears in the EMS flight definition (§29) although the EMS flight definition shall apply for HEMS operations. Besides, the helicopter by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the helicopter by itself, blood, organs, drugs);” Replace the sentence in §29: “A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.” by “A flight flown to position an aircraft to the operating base before or after an EMS flight is considered part of that emergency medical service.”

response Partially accepted

Please, refer to the last sentence of paragraph (29).

comment 1254 comment by: Volkswagen AirService GmbH

Clear definition of contactable required.

response Please, see the response to comment #1041.

comment 1264 comment by: Hélicoptères de France

ADD an ON-BOARD REST DEFINITION ISSUE HDF thinks a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby. Moreover, HDF don’t understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 57 of 277 An agency of the European Union

PROPOSAL Provide a clear and precise definition for on-board rest. #2 (24) ‘sector’ AGREEMENT HDF agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. HDF would like the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters. #3 (29) ‘EMS flight’ ISSUE According to the definition of a sector (§24) in ORO.FTL.105, the notion of sector is not applicable to HEMS operations. However, the notion of sector appears in the EMS flight definition (§29) although the EMS flight definition shall apply for HEMS operations. (Cf. comment #14.3) Besides, the helicopter by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the helicopter by itself, blood, organs, drugs);” Replace the sentence in §29: “A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.” by “A flight flown to position an aircraft to the operating base before or after an EMS flight is considered part of that emergency medical service.”

response Please, see the response to comment #1032 with regard to on-board rest.

Your comment with regard to ‘sector’ is noted.

comment 1327 comment by: Gama Aviation (UK) Ltd

1. Current definition of 'Homebase' is not suitable to all Air Taxi or AEMS operators and is written for scheduled airlines. Definition should be reviewed or another definition more applicable to Air Taxi Operations developed. Some ATXO operators function using the 'Gateway' system which the existing definition does not make allowance for. 2. Add 'Total' to point (13) for consistency with Part FCL definition: “for aeroplanes, touring motor gliders and powered-lift, it means the total time from the moment an aircraft first moves for the purpose of taking off until the moment it finally comes to rest at the end of the flight"

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 58 of 277 An agency of the European Union

response Please, see the response to comment #127 with regard to ‘home base’.

Your proposal with regard to point (13) ‘flight time’ is accepted.

comment 1443 comment by: European Cockpit Association

Commented text: On-board rest ORO.FTL.105 Definitions (5) ’augmented flight crew’ & ‘on-board rest’ ECA Comment: The proposed concept of ‘on-board rest’ as an equivalent to ‘in-flight rest’ is seriously flawed, contrary to available scientific advice such as that obtained by EASA in preparation for the 2010-14 NPA on CAT FTLs, and not a current acceptable practice. As described the ‘rest’ period would include any time spent in the rest facility, including during approach, landing, taxy, turnaround, brief and flight preparation, take-off and departure. At any of these times no meaningful rest will be achievable, and a flight crew member would normally be expected to take part in these phases of flight. Any rest while any activity is taking place on the aircraft, and outside of the Cruise phase, will be heavily disturbed and/or fragmented as flight/activity phases change, and not effective for FDP extension. Were rest only to be permitted starting and finishing within a period of complete inactivity on the aircraft, on the ground, this would effectively be, and fall under, the requirements of split duty. Proposal Remove the concept of ‘on-board rest’ and return to the existing system of ‘in-flight’ rest which already goes far beyond the advice from EASA’s scientific input.

response Not acceptable

The commentator has misunderstood the concept of on-board rest.

Aircrew may have on-board rest while in the air or on the ground.

On-board rest in the air, in the context of augmented crew, is similar to the procedures for

in-flight rest and is only taken during the cruise phase of flight (see GM1 CS

FTL.1.205(c)(1)(ii)).

If on-board rest is taken on the ground, the time on the ground is the time spent in Class A

or Class B facility only, not the entire turnaround time.

Hence, the on-board rest period cannot be taken during critical phases of flight and during

briefings and flight preparation.

comment 1476

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 59 of 277 An agency of the European Union

“(24) ‘sector’ means the segment of an FDP between an aircraft aeroplane first moving for the purpose of taking off until it comes to rest after landing on the designated parking position.” The replacement of the word ”aircraft” in (24) with the word ”aeroplane” makes the definition of ”EMS flight” in (29) inconsistent since ”sector” according to the changed (24) excludes helicopters. It becomes unclear whether positioning in (29) refers to aeroplanes and/or helicopters.

response Please, see the response to comment #58.

comment 1486 comment by: Airlec Air Espace / Paul Tiba

#1 ISSUE The definition of the different EMS mission and flight must be precised. As for example, an EMS mission shall not include only the EMS payload transportation but also all the flights needed to transport the medical team or equipment. PROPOSAL Add a GM to ORO.FTL.105 (29): GM ORO.FL.105(29) An EMS flight may concern both a flight with the EMS payload or any positioning flights before/after loading/unloading necessary to perform the EMS flight from/to the home base. #2 ISSUE The aircraft by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). Moreover, this definition shall be referred in each and every requirement where the EMS payload is involved. PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the aircraft by itself, blood, organs, drugs);” #3 ISSUE A sector flown to position an aircraft from or to a place which is not the operating base before or after an EMS flight may also be considered as part of that flight. Indeed, these flights are necessary to ensure the proper AEMS operations and shall not be a burden and limit emergency missions. Additionally, when the last flight is without any passengers, this flight should be considered as an NCC flight. PROPOSAL Modify the last sentence to: “A sector flown to position an aircraft before or after an EMS flight is considered part of that flight” #4 ISSUE

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 60 of 277 An agency of the European Union

The definition of contactable is necessary in order to ensure the level playing field and the good understanding of the next dispositions. PROPOSAL (31) Contactable “A short period of time during the day, other than on a `day off', during which the company requires a crew member to be at an agreed location for the purpose of giving notification of a duty period which will commence not less than ten hours ahead. The contactable period will be between [*] and [*] local time and shall not exceed 21⁄2 hours. * Times to be inserted by the company. If required, the 21⁄2 hours can be split into 2 separate periods. Such arrangements must be agreed by the CAA.” Source : CAP 371

response 1. Please, see the response to comment #1035.

2. Please, see the response to comment #1038.

3. Please, see the response to comment #1039.

4. Please, see the response to comment #1041.

comment 1503

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

We consider the definition provided for "home base" to be out of touch with current reality. We propose to reconsider this.

response Please, see the response to comment #127.

ORO.FTL.100

3.1. ORO.FTL.100 p. 9

comment 139 comment by: CAA-NL

ORO.FTL.100 Scope Comment: It is suggested to add the requirement for AEMS to the text.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 61 of 277 An agency of the European Union

comment 380

comment by: Joachim J. Janezic (Institute for Austrian and International

Aviation law)

Since EASA would like to extend the scope of FTL to HEMS-CM (for what reason and on what scientific basis?) we have to stress that in many cases this staff is not employed directly by the HEMS operator but rather assigned by voluntary mountain rescue organisations, the Red Cross, etc. Reading the NPA it remains fully unclear how these persons should be treated within a strict system - as the one suggested in the NPA - which presumes that HEMS-CM are employed by the operator so that the operator can plan their shifts.

response Noted

Compliance with the EASA FTL requirements can be achieved by using own flight crew,

crew hired from another organisation or freelance pilots. The responsibilities of operators

and crew members with regard to fatigue risk management are clearly defined in

Regulation (EU) No 965/2012.

Although there are currently no common FTL requirements for HEMS operations, flight

operations with helicopters, including HEMS, are regulated by Regulation (EU) No

965/2012.

Notwithstanding the above, flights that carry out / provide military, customs, police, search

and rescue, firefighting, coastguard or similar activities/services are excluded from the

scope of the Basic Regulation and its implementing rules (Article 2(3) of the Basic

Regulation).

comment 1252 comment by: Volkswagen AirService GmbH

Single pilot operations, HEMS and ATXO are completly different. It makes no sense to combine these under one regulation (or CS) as you can not compare the fatigue load of singe pilot work to multi crew cockpit.

response Not accepted

The purpose of these rules is not to compare fatigue loads of singe-pilot work with multi-

crew cockpit. The purpose is to establish common principles for fatigue risk management.

Where specificities exist, they are addressed separately.

ORO.FTL.110

3.1. ORO.FTL.110 p. 10

Responses with regard to ‘robustness of rosters’ (Netjets comment #55)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 62 of 277 An agency of the European Union

comment 55 comment by: NetJets Europe

ORO.FTL.110 (j) The 33% seasonality is not applicable to Air taxi operations due to the on-demand type of operation. NetJets suggests that it should be modified (eventually at AMC level) in order for operational robustness to be under the operator’s management system with performance indicators to monitor e.g. PIC discretions and exceedances of FDP limits, in order to ensure that the planning of FDPs is effective and within the limits.

response Accepted

Air taxi operations are in most cases on-demand operations that do not have a seasonal

character.

An assessment of FDP exceedances, however, can serve the purpose of improving flight

planning and crew arrangements (see amended proposal for point ORO.FTL.110(k) and

associated GM).

comment 93 comment by: B. Wagner

zu (k): nicht praktikabel, da es zu einem höheren Verwaltungsaufwand kommt, um den prozentualen Anteil zu ermitteln. Dabei kann diese Überschreitung in Mitteleuropa sowieso nur in den drei Monaten mit den längsten Tagen auftreten und ist abhängig vom Auftreten entsprechend später Alarmierungen, die aufgrund ihrer zugrunde liegenden Notfälle nicht vorhersagbar sind. Daraus eine geänderte Dienstplanung zu erzwingen, erscheint wenig sinnvoll.

response Please, see the response to comment #55.

comment 108 comment by: UK CAA

Page No: 10 Paragraph No: ORO.FTL.110 (j) & (k) Operator Responsibilities Comment: Bullet point (j) includes Air Taxi operations within the need to change arrangements where the operation “in that schedule during a scheduled seasonal period” is exceeded by 33%. Bullet point (j) should only be for scheduled and charter operations and Air Taxi operations should be moved into bullet point (k). Justification: Air Taxi operations do not set schedules for a seasonal period as by their nature they are on-demand and short notice operations. Therefore, the assessment of realistic planning would be better represented if they were included in bullet point (k).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 63 of 277 An agency of the European Union

Proposed Text: Bullet point (j) add “except for air taxi and EMS” and insert in bullet point (k) “in air taxi and EMS operations”

response Please, see the response to comment #55.

comment 128 comment by: VistaJet

This point is not relevant to ATXO as there are no seasonal schedules. Suggest to use AMC1 ORO.FTL.110(J) requiring the operator to establish and monitor KPI's for robustness of rosters and perhaps further guidance material can be written for ATXO specifically.

response Please, see the response to comment #55.

comment 141 comment by: CAA-NL

ORO.FTL.110 (j) & (k) Operator Responsibilities Comment: Bullet point (j) includes Air Taxi operations within the need to change arrangements where the operation “in that schedule during a scheduled seasonal period” is exceeded by 33%. Air Taxi operations do not set schedules for a seasonal period as by their nature they are on-demand and short notice operations. Therefore, the assessment of realistic planning should be better represented in the text.

response Please, see the response to comment #55.

comment 155 comment by: VistaJet

ORO.FTL.110 Operator Responsibilities After the initial working group the proposal included the function of "Passive Contact". This function is essential especially in the proposal for it's use in the "Reserve" function. This is necessary to protect the crew's sleep opportunity and allow operations to give less then 10hrs notice where crew are rested and willing to fly on shorter notice. suggest to include highlighted text From the original draught amendment: GM1 ORO.FTL.110 (a) Operator responsibilities - PASSIVE CONTACT

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 64 of 277 An agency of the European Union

A form of passive contact for the notification of roster or duty assignments changes or communication of duty assignments during the reserve may help minimise disruption to established sleep and rest patterns. Passive contact is a form of contact a crew member can avoid. Examples of passive contact are: •email; •a visit to the operator’s website by the crew member; •inaudible pager; •facsimile transmission; and •text message.

response Please, see the response to comment #1166.

comment 183 comment by: Cat Aviation AG

Air Taxi does not have fixed schedules therefore has to be exempted as well. Suggested rewording: (j). except for EMS and air taxi operations, change a schedule..... An Operator establishes via his Management System a robust and safe way to monitor and evaluate trends in schedules and adjust as necessary to avoid fatigue.

response Please, see the response to comment #55.

comment 191 comment by: Premium Jet AG

(J) This definition does not apply to Air Taxi Operations. It should be either excluded or differently specified. Air Taxi Operators do not have schedules. They might be binded to a provision in their manuals to track and ammend their flights. (k)Please attach Guidance Material. Air Taxi need flexibility in their rostering and unforseen changes. Maybe via performance indicators etc.

response Please, see the responses to comments #55, #282 and #283.

comment 205 comment by: Cat Aviation AG

We do not have regular schedules in Air Taxi - and therefore no seasonal periods. Adjust

point (j) by exempting EMS & Air Taxi Operations.

response Please, see the response to comment #55.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 65 of 277 An agency of the European Union

comment 226 comment by: Rabbit-Air Ltd

Exception should also be granted for corporate aviation operators who operate under an AOC. Corporate aviation operator with AOC are often belonging to a big company, and exclusively transporting company passengers for remuneration. Corporate operators planning their schedules maximum on a monthly base, usually even on a 14 day base. As such their does not exist a seasonal period schedule.

response Corporate aviation operations are non-commercial operations, hence they are outside the

scope of the EASA FTL requirements.

comment 231 comment by: Thomas Henselmann

(j): Applies also for Air-Taxi operations since there is usually no schedule as such.

response Please, see the response to comment #55.

Response with regard to ‘roster robustness’ (EBAA comment #282)

comment 282 comment by: European Business Aviation Association (EBAA)

EBAA COMMENT: This point is not applicable to Air Taxi Operations. Suggested change: "(j) except for EMS and air taxi operations,..." Rationale: Air-Taxi does not have ‘Schedules’! EBAA proposes an AMC for monitoring robustness of rosters. Suggested change: NEW AMC2 ORO.FTL.110 (k) OPERATIONAL ROBUSTNESS The operator should describe in its Management System a process to track and trend flight and duty time transgressions and deviations.

response Accepted

comment 283 comment by: European Business Aviation Association (EBAA)

EBAA COMMENT: Guidance material on AMC is needed. Suggested change: NEW. GM2 ORO.FTL.110(k) Operator responsibilities OPERATIONAL ROBUSTNESS OF ROSTERS (AIR TAXI OPERATIONS) Performance indicators for operational robustness may include the following: the use of commander’s discretion; the use of (unplanned) reduced rest; duty time transgressions related to; technical delays; commercial delays;

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 66 of 277 An agency of the European Union

delays due to customer’s plan changes; ATC delays; and the number of on the day changes that impinge on a planned rest period encroaching a local night.

response Accepted

comment 619 comment by: Transport Malta - Civil Aviation Directorate

The scheduling and seasonal period concept is not applicable to Air Taxi operators. We would like to see a more realistic concept of operational robustness for air taxi operations.

response Please, see the response to comment #55.

comment 883 comment by: Stephanie Selim

ORO.FTL.110 (j) : Technical comment – We think that general requirements applicable to air taxi operations should better take into account constraints of this kind of operations. We wonder if that requirement makes sense for air taxi operations which are unpredictable by definition. Proposal: “In the case of scheduled and air taxi operations except for EMS operations, change a schedule or crew arrangements, if the actual operation exceeds the maximum flight duty period on more than 33 % of the flight duties in that schedule during a scheduled seasonal period;”

response Please, see the response to comment #55.

comment 884 comment by: Stephanie Selim

ORO.FTL.110 (k) : Technical comment – We think that general requirements applicable to EMS operations should better take into account constraints of this kind of operations. We wonder if that requirement makes sense for EMS operations which are unpredictable by definition and for which the notion of scheduled FT is a non-sense. And we wonder why it is asked for 33% of the flight duties for operations except EMS during a scheduled seasonal period, and 10 % of FDP in any 3 months for EMS operations. The reason is not explained in the rationale. Proposal: We ask for the deletion of that point.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 67 of 277 An agency of the European Union

response Please, see the responses to comments #55 and #282.

comment 981 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(j) Air Taxi don't have regular schedules and seasonal periods. Therefore should be exempted like EMS. (k) Flexibility in rostering for unforseen changes is needed. Guidance needed.

response Please, see the responses to comment #55, #282 and #283.

comment 1042 comment by: FNAM

ORO.FTL.110 (j) ISSUE – Air Taxi In Air Taxi, it is possible to have only one flight per year on a given route and this kind of operation is unscheduled as it is based on clients’ unpredictable schedules. In that way, the 33% of FDP in a scheduled seasonal period is not representative. The incertitude over max FDP is thus very low for mostly Air Taxi operations. Moreover, the operator should as mitigation describe in its Management System a process to track and trend flight and duty time transgressions and deviations. PROPOSAL Add "(j) except for EMS and Air Taxi operations[...]" Add a new AMC2 ORO.FTL.110(j) NEW AMC2 ORO.FTL.110(j) Operator responsibilities - "MANAGEMENT OF ROSTER CHANGES (AIR TAXI OPERATIONS AND AEMS) The operator should establish a procedure for the notification of roster changes that minimizes the disruption to the crew member’s ability to obtain appropriate sleep and rest.” Add a new GM2.ORO.FTL.110(j) NEW GM2 ORO.FTL.110(k) Operator responsibilities "OPERATIONAL ROBUSTNESS OF ROSTERS (AIR TAXI OPERATIONS) Performance indicators for operational robustness may include the following: the use of commander’s discretion; the use of (unplanned) reduced rest; duty time transgressions related to; technical delays; commercial delays; delays due to customer’s plan changes; ATC delays; and

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 68 of 277 An agency of the European Union

the number of on the day changes that impinge on a planned rest period encroaching a local night.”

response Please, see the responses to comments #55, #282 and #283.

The proposal to add an AMC for the notification of changes to published rosters is also

accepted. It, however, refers to point ORO.FTL.110(a).

comment 1044 comment by: FNAM

ORO.FTL.110 (k) ISSUE – AEMS In AEMS, the operation can never be scheduled due to the emergency specificity of the missions. In that way, the 10% of FDP in any 3 months is far not representative as it is possible to have only few missions over a 3-month period. The incertitude over max FDP is thus very low for mostly AEMS operations. Moreover, the operator should as mitigation describes in its Management System a process to track and trend flight and duty time transgressions and deviations PROPOSAL Suppress the paragraph (k). Add a new AMC2 ORO.FTL.110(j) NEW AMC2 ORO.FTL.110(j) Operator responsibilities - "MANAGEMENT OF ROSTER CHANGES (AIR TAXI OPERATIONS AND AEMS) The operator should establish a procedure for the notification of roster changes that minimizes the disruption to the crew member’s ability to obtain appropriate sleep and rest.” Add a new GM2.ORO.FTL.110(j) NEW. “GM2 ORO.FTL.110(k) Operator responsibilities OPERATIONAL ROBUSTNESS OF ROSTERS (AIR TAXI OPERATIONS) Performance indicators for operational robustness may include the following: the use of commander’s discretion; the use of (unplanned) reduced rest; duty time transgressions related to; technical delays; commercial delays; delays due to customer’s plan changes; ATC delays; and the number of on the day changes that impinge on a planned rest period encroaching a local night.”

response Please, see the responses to comments #55, #282, #283 and #1042.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 69 of 277 An agency of the European Union

comment 1260 comment by: Volkswagen AirService GmbH

No fixed schedules are available in business aviation operations. Planning is subject to frequent changes. Limitations on max. duty times and FDP should be sufficient.

response Please, see the responses to comments #55 and #282.

comment 1331 comment by: Gama Aviation (UK) Ltd

Point (j): Should read "except for EMS and Air Taxi operations,...." Seasonal periods or schedules are not used in Air Taxi operations due to their short notice or on demand nature. Point (k): Many EMS operations are not scheduled therefore changing "schedule or crew arrangement" as a result of FDP exceedances are not always possible. Additionally, no provision for the 4 hour Air Ambulance FDP allowance in Gama Aviation's exisiting FTL scheme increases the liklihood that point k will be a frequently recurring issue for our operation. It's is our view that this is simply not a practical requirement for AEMS operations of the type we operate and allowance must be made for this.

response Please, see the responses to comments #55 and #282.

comment 1389 comment by: Gama Aviation (UK) Ltd

A form of passive contact for the notification of roster or duty assignments, changes or communication of duty assignments during the reserve may help minimise disruption to establish sleep and rest patterns. GM1 ORO FTL 110 Suggest add new point defining Passive Contact Passive contact is a form of contact a crew member can avoid. Examples of passive contact are: (a) E-Mail (b) A visit to the operators Website/Intranet by the crew member (c) Inaudible pager (d) Facimilie transmission (e) Text Message

response Please, see the response to comment #1166.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 70 of 277 An agency of the European Union

comment 1469 comment by: VOLDIRECT

(j) except for EMS operations, change a schedule or crew arrangements, if the actual operation exceeds the maximum flight duty period on more than 33 % of the flight duties in that schedule during a scheduled seasonal period; This point is not applicable to Air Taxi Operations. Suggested change: "(j) except for EMS and air taxi operations,..." Rationale: Air-Taxi does not have ‘Schedules’! How do we monitor exceedances of maximum FDPs on more than 33% of the flight duties in that schedule during a scheduled seasonal period?

response Please, see the response to comment #55.

comment 1480

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

"(k) in EMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months." (k) versus (j). Where is the the rationale for the 10% for EMS operations compared to the 33% in para (j) for other operations like CAT operations with aeroplane.

response Please, see the response to comment #55.

comment 1488 comment by: Airlec Air Espace / Paul Tiba

ISSUE – AEMS In AEMS, the operation can never be scheduled due to the emergency specificity of the missions. In that way, the 10% of FDP in any 3 months is far not representative as it is possible to have only few missions over a 3-month period. The incertitude over max FDP is thus very low for mostly AEMS operations. Moreover, the operator should as mitigation describes in its Management System a process to track and trend flight and duty time transgressions and deviations. PROPOSAL Suppress the paragraph (k). Add a new AMC2 ORO.FTL.110(j) NEW AMC2 ORO.FTL.110(j) Operator responsibilities - "MANAGEMENT OF ROSTER CHANGES (AIR TAXI OPERATIONS AND AEMS) The operator should establish a procedure for the notification of roster changes that minimizes the disruption to the crew member’s ability to obtain appropriate sleep and

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 71 of 277 An agency of the European Union

rest.” Add a new GM2.ORO.FTL.110(j) NEW. “GM2 ORO.FTL.110(k) Operator responsibilities OPERATIONAL ROBUSTNESS OF ROSTERS (AIR TAXI OPERATIONS) Performance indicators for operational robustness may include the following: the use of commander’s discretion; the use of (unplanned) reduced rest; duty time transgressions related to; technical delays; commercial delays; delays due to customer’s plan changes; ATC delays; and the number of on the day changes that impinge on a planned rest period encroaching a local night.” ISSUE Keep the Table 2 coming from the CAT.A regulation and add the possibility, if an operator has a FRM, of increasing the FDP limitations in the Table 2 by. • For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

response Please, see the responses to comments #55, #282, #283 and #1042.

comment 1504

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

(j) It should be taken into account that ATXO do not have regular schedules and seasonal periods. Therefore, an exemption, like for EMS, should be provided. (k) The provisions fall short on providing much needed flexibility in rostering in case of unexpected contingencies. The provision of respective guidance is highly

response Please, see the responses to comments #55, #282 and #283.

ORO.FTL.205

3.1. ORO.FTL.205 p. 10-13

comment 21 comment by: Alpine airlines - FR.AOC.0088

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 72 of 277 An agency of the European Union

50% of our operations are between 2 & 3 sectors per day. For example, our customer need to go somewhere and come back the same day. In our company, the average FDP for 2 sectors per day is 11, 4 hrs, always between 0600 and 2100. We never observe any case of fatigue and no report from pilots in this type of FDP. Currently, the subpart Q is: 1 to 3 sectors: Max FDP = 13 hrs. In the new purpose of Table 5, the maximum possible FDP is 11 hrs (column "up to 4 sectors"), 2 hrs less than subpart Q. We will appreciate a new column in the table 5, including the case of "up to 3 sectors", including 1 hr more of FDP than column "Up to 4 sectors". The table could be like this :

Starting time of FDP Numbers of sectors

Up to 3 4 5 6 7 8 9 10 or more

0600 – 0659 11 :00 10 :00 09 :15 08 :45 08 :15 08:00 08:00 08:00

0700 – 0759 11 :30 10 :30 09 :45 09 :15 08 :45 08 :15 08:00 08:00

0800 – 1259 12 :00 11 :00 10 :15 09 :45 09 :15 08 :45 08:15 08:00

1300 – 1429 11 :30 10 :30 09 :45 09 :15 08 :45 08 :15 08:00 08:00

1430 – 1659 11 :00 10 :00 09 :15 08 :45 08 :15 08:00 08:00 08:00

1700 – 2159 10 :00 09 :00 08 :15 08:00 08:00 08:00 08:00 08:00

2200 – 0359 09:00 08:00 08:00 08:00 08:00 08:00 08:00 08:00

0400 – 0559 09 :15 08 :15 08:00 08:00 08:00 08:00 08:00 08:00

response Please note that Table 5 refers to any single-pilot operation.

For two-pilot ATXO and AEMS operations, Table 1 of CS2 FTL.2.205 applies.

There, for FDPs starting in the range 0600–0814, the proposed FDP is 13 hours, i.e. the same as in Subpart Q.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 73 of 277 An agency of the European Union

Response with regard to ‘planned extensions in ATXO and AEMS operations’ (comment #33)

comment 33 comment by: Serair

To make it easier to apply when performing various types of operations, it would be better to increase the number of sectors to 5 in (d1) (2) (i). (d1) Maximum daily FDP for acclimatised crew members in two-pilot air taxi and AEMS operations with the use of extensions without on-board rest [...] 2) The use of the extension shall be planned in advance, and shall be limited to a maximum of: (i) 5 sectors; or

response Accepted

Replies with regard to Table 5 (comments #41, #42)

comment 41 comment by: ST BARTH COMMUTER

Table 5 for single-pilot operation is too restrictive. The decrease from the starting FDP of 11H should be more gradual. With a “normal” starting of FDP (between 0700 and 0900), the maximum FDP should be at least 10H up to 10 sectors, then decrease to 8H at 12 sectors or more.

response Not acceptable

An FDP of 10 hrs for 10 sectors would be more than the currently applicable limit for two-

pilot operations (see Table 2) where the maximum FDP for the same number of sectors is

9 hrs. From an operational perspective, this is not justified as occurrence data shows that

in single-pilot operations where the workload is not shared, the risk of accidents is much

higher compared with two-pilot crew.

It is not justified from a scientific perspective either. Scientific data shows that fatigue

increases with the increase of the number of take-offs and landings (sectors).

Please, also refer to the response to comment #887.

comment 42 comment by: Airtask Group

Item ORO.FTL.205 (b)(6) would infer that a derogation against table 5 using a 'BREAK' may be applied for?

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 74 of 277 An agency of the European Union

response Although it is not ‘a derogation against Table 5’, extension of FDPs applicable to single-pilot

operations is possible with split duty, i.e. with a break on the ground between the sectors,

under certain conditions.

comment 56 comment by: NetJets Europe

ORO.FTL.205 (b)(6) NetJets supports proposal to have a different maximum FDP table for acclimatised two crew operations for air taxi operations. ORO.FTL.205 (d1) NetJets supports proposal ORO.FTL.205 (d1)(4) NetJets supports proposal ORO.FTL.205 (e) NetJets supports proposal ORO.FTL.205 (f)(1)(i) What does air taxi apply, 2 or 3 hours above the Air taxi table or the ORO.FTL.205.(b) and (e)? If the maximum discretion is added to the OFO.FTL.205 (b) and (e), this becomes complex as it requires one to refer back and forth between various tables. NetJets suggests adding a table to CS with the maximum FDP allowed with PIC discretion for two pilot operations. Complexity example: The Air taxi FDP table has 1-3 sectors in the first column while the CAT only has 1-2. If applying the 3rd sector max FDP it would require then comparing to the CAT table in a different column which could lead to confusion and it becomes complex.

response Your proposal to clarify the requirements on commander’s discretion in a CS is accepted.

Point (f1) is inserted in point ORO.FTL.205 to provide a legal reference, while detailed requirements on commander’s discretion for air taxi and AEMS operations are laid down in CS3 FTL.2.205.

comment 109 comment by: UK CAA

Page No: 11 Paragraph No: ORO.FTL.205 Flight duty period (FDP), (b) (1) Two pilot and Single pilot operations Comment: The addition of the terminology “two-pilot operation other than HEMS”, or “single-pilot operation” could potentially generate confusion on the applicability of the

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 75 of 277 An agency of the European Union

tables to cabin crew members. EASA are requested to clarify the applicability of the tables to cabin crew. The term applicable to “two-pilot operation” needs to be clearly explained in terms of the FDP limit for cabin crew. This could be within the text or within FAQ, stating this applies to all crew members carried where the flight crew consists of a minimum of two pilots. Justification: Clarity of the application of the tables to cabin crew.

response Accepted

Response with regard to ‘mixed operations’ (comment #129)

comment 129 comment by: VistaJet

ORO.FTL.205 states the operator shall establish maximum daily FDP's, but then goes on into great detail with tables and extensions of allowable daily FDP. Surely you have one or the other? As an operator who has different fleets with different dynamics, i.e short haul many sectors, and long haul with 1 or 2 sectors, it is impossible to apply one system to both types of operation. A suggestion would be to take a similar stance to international systems where a standard 14hr max duty limit is set, whereafter the approved FRMS further tailors restrictions specific to the type of operation. In summary ORO.FTL.205 is 100% accurate but operators should be able to work from a single max daily FDP figure and establish a custom limit in accordance with their management systems and FRMS.

response Noted

The aim of point ORO.FTL.205 is to ensure that crew members can operate at a satisfactory

level of alertness rather than make the requirements easier to be applied by operators

with mixed fleets.

Considering the existing differences in complexity of operations, operators, and maturity

of their fatigue management systems, EASA proposal includes both detailed requirements

for less complex operators and a greater flexibility for more complex operators with

mature FRMS.

Response with regard to Tables 3 & 4 (comment #130)

comment 130 comment by: VistaJet

The limits prescribed in Table 3 are excessively restrictive for an AXTO. The base limit should realistically be set at 12Hrs without FRMS, 13Hrs with FRMS.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 76 of 277 An agency of the European Union

ATXO is not the same as scheduled CAT and crew will often spend extended time (days) on the ground after crossing multiple timezones making them unacclimatised, but very well rested. In addition, they have consolidated "OFF" blocks (generally 2 weeks for long haul ATXO) whereby any affects of timezone crossing and cumulative fatigue is addressed. In addition, this NPA is already restricting monthy and annual flight hours limits, reducing the 28 day and annual limit by 20% or more. Duty hours have also been further restricted adding a reduced 14 day limit (110hrs). All of these limits are amounting to having to increase crew head count by 30% minimum which is commercially not viable.

response The comment about Table 3 for air taxi operations is accepted.

NPA 2017-17 did not include specific limits for two-pilot crew in an unknown state of

acclimatisation in air taxi and AEMS operations. Using the limits prescribed in Table 3 for

scheduled CAT operations is not an option for air taxi operations as these limits are not

tailored to them.

CS FTL.2 will include limits for two-pilot crew in an unknown state of acclimatisation, for

air taxi and AEMS operations.

The comments regarding cumulative limits are addressed under the relevant section.

comment 131 comment by: VistaJet

Addressing point (d1) again the 1hr extension at planning stage is too limiting to be set at 4 sectors, or 3 sectors encroaching the WOCL. Propose to improve flexibility here by making it 5 sectors and 4 sectors respectively.

response Accepted

Please, see the response to comment #33.

Response with regard to ‘minimum rest due to planned extensions’ (comment #166)

comment 166 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

D1 (1): The minimum pre- and postflight rest shall be increased by 2 hours. This should be also an option to choose from in case of an extension, as the 60hrs subsequent should only be chosen as a last possiblity. The two hours before and after will give the pilot a better option to recover from fatigue.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 77 of 277 An agency of the European Union

response Accepted

comment 167 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

(d1) (2): The use of extension shall be planned in advance, and shall be limited to a maximum of: (i) 6 sectors when the WOCL is not enchroached; or (ii) 4 sectors when the WOCL is enchroached by 2 hours or less, or (iii) 3 sectors when the WOCL is enchroached by more than 2 hours. An extension cannot always be planned in advance, due to delays and other unforseen circumstances. This will give the operator a better possibility to plan their schedules. Instead of making use of the commanders discretion they can use the extension, which will give the crew members a longer rest period. (e) on-board rest can also be on ground

response Accepted

Please, see the responses to comments #33 and #1262.

Response in relation to Tables #2, #3 and #4 in ATXO and AEMS operations (comment #192)

comment 192 comment by: Premium Jet AG

(b) Table 2: Table should be redone for Air Taxi. Table 3: And increase Legs 1-3 to 12h FDP. Leg 4 upwards FDP fits Table 4: Increase Legs 1-3 to 13h FDP. Rest unchanged (d1) Please revert to previously agreed version with EBAA: sectors 5 instead of 4 and 3 to 4

response Tables 2, 3 and 4 do not apply automatically to air taxi and AEMS operations. The operator

may choose to apply the tables of CS FTL.2 for air taxi and AEMS operations instead. In

such a case, however, the operator must apply the entire CS FTL.2.

As regards Tables 3 and 4, please refer to the response to comment #130.

As regards paragraph (d1), please refer to the response to comment #33.

comment 204 comment by: Cat Aviation AG

Table 2 is very fractured with too many FDP changes every 30' of starting time. AirTaxi's main purpose is flexibility, which will be strongly hampered to administer and manage in

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 78 of 277 An agency of the European Union

planning. Please consider the difference in Operations between scheduled commercial and Air Taxi/EMS. Refer to our comments under 4.5 Conclusion, page 67 of the NPA. Suggest to re-do this table 3 to show following timings: 1-2 Sec = 13hrs // 3-4 Sec = 12hrs FDP. Reasoning refer to our comments under 4.5 Conclusion, page 67 of the NPA. Suggest to re-do this table 4 to show following timings with FRMS: 1-2 Sec = 14hrs // 3-4

Sec = 13hrs FDP. Reasoning refer to our comments under 4.5 Conclusion, page 67 of the

NPA

response Table 2 applies to scheduled operations.

For air taxi operations, Table 9 of CS FTL.2 applies.

Please, refer to the response to comment #1003 in relation to Table 9.

As regards Tables 3 and 4, please refer to the response to comment #130.

Responses in relation to ‘ORO.FTL.205(d1)’ (comment #208)

comment 208 comment by: Cat Aviation AG

(d1) takes away more flexibility than for scheduled operations. Operator will assure robustness of schedule taking into account nature of AirTaxi business. Suggestion i. The maximum daily FDP as calculated as per "Maximum Daily Flight Duty Period (FDP)" can be extended by up to 1 hour. ii. The maximum number of extensions is 2 in any 7 consecutive days. iii. Extensions are not allowed for a FDP of 6 sectors or more. iv. Where a FDP encroaches on the WOCL by up to 2 hours, extensions are limited to up to 4 sectors. v. Where a FDP encroaches on the WOCL by more than 2 hours, extensions are limited to up to 3 sectors. vi. Where a FDP is planned to use an extension, pre and post flight minimum rest is increased by 2 hours or post flight rest only is increased by 4 hours. Where the extensions are used for consecutive FDPs the pre and post rest between the two operations shall run consecutively. vii. Where a FDP is planned encroaching the entire WOCL the maximum FDP is limited to 12 hours.

response Accepted

The principles for FDP extensions in scheduled operations will also apply to air taxi/AEMS

operations.

Please, refer to the comments and responses under section ‘CS FTL.2.205’.

comment 236 comment by: Thomas Henselmann

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 79 of 277 An agency of the European Union

(b) Check table 2 for Air Taxi Operations, a further reduction in Max FDP without FRMS would be a significant burden. Previous limitations proved a reasonable frame for the FDP. Adjusting tables 3&4 for Air Taxi Operations would be highly appreciated. Max FDP for 1- 3 sectors 12h without FRMS and 13h with FRMS can be essential for Air Taxi Operations.

response Please, refer to the responses to comments #130 and #192.

comment 237 comment by: Thomas Henselmann

(d1) decreased sectors (5 to 4) and 4 to 3 when encroaching WOCL might be limiting to Air Taxi operations. Keeping previous regulations would be appreciated.

response Accepted

comment 286 comment by: European Business Aviation Association (EBAA)

(d1) Maximum daily FDP for acclimatised crew members in two-pilot air taxi and AEMS operations with the use of extensions without on-board rest EBAA COMMENTS: 1. The use of extensions in the NPA has been lower down to 4 sectors instead of 5 as previously agreed in the draft IR. - Back to previous agreed versions 2. The use of extensions in the NPA has been lower down to 3 sectors instead of 4 when the WOCL is encroached by more than 2 hours, this is against what has previously been agreed in the draft IR. Back to previous agreed versions

response Accepted

Please, see also the response to comment #33.

Response with regard to ‘FDP extensions’ (comment #288)

comment 288 comment by: European Business Aviation Association (EBAA)

(d1) Maximum daily FDP for acclimatised crew members in two-pilot air taxi and AEMS operations with the use of extensions without on-board rest FOR AEMS: 4h extension at planning stage subject to following conditions: -Dedicated Air Ambulance Air Ambulance Definition:- when the sole reason for the flight is to carry an ill or injured person to a recognised medical facility, or the carriage of a human organ necessary for a transplant operation. A sector flown to position an aircraft to the operating base before or after an Air Ambulance flight is considered part of that flight.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 80 of 277 An agency of the European Union

The company operates a dedicated Air Ambulance service and accordingly the allowable FDP, as per section 7.4.11, may be planned to be increased by up to a maximum of 4 hours. This is referred to as Air Ambulance FDP and to use this allowance the following must apply: • When an ill or injured person is carried a qualified medical attendant must accompany the flight. • The only passengers that may be carried in addition to the patient and medical crew are the immediate family or next of kin; • The crew must have had the full entitlement of rest relating to the preceding duty prior to starting an Air Ambulance flying duty; • Two Pilot Crew; The Ambulance Allowance may be used in order to position an aircraft to transfer a patient and return back to base to enable the aircraft to be available for further life saving work with a fresh crew. This allowance cannot be planned to exceed 4 hours. Upon completion of an Air Ambulance FDP the appropriate full rest period must be taken. There is no limit to the number of Air Ambulance FDP’s that can be undertaken within a roster period and no requirement for extended time before the Air Ambulance FDP can be used again. The use of Commander’s discretion to further extend the Ambulance FDP beyond the extra 4 hours permitted may be exercised only to off-load/deliver the patient or organ to the destination. This is then deemed to be an Extended Ambulance FDP and cannot be planned for. Such discretion cannot be used after the patient or organ has been off- loaded. A discretion report must be submitted with the flight paperwork. Following an Extended Air Ambulance FDP the appropriate full rest period must be taken. In addition at least 48 hours must elapse between the end of one extended Air Ambulance FDP and the start of another extended Air Ambulance FDP. In one Air Ambulance operation involving two or more extended FDP duties (the first of which is positioning to uplift a patient or organ) the necessity for the 48 hours rest may be deferred until return to base. In this case the Commander may reduce the rest following the first FDP by up to 3 hours or to 10 hours in suitable accommodation, whichever is the greater. A pilot can only fly 3 Air Ambulances extended FDPs in any 28 consecutive days. (This ruling shall only apply where extensions exceed one and a half hours); • You may undertake a normal Air Ambulance FDP once rested following an Extended Air Ambulance FDP; • The relevant duty records must show where an FDP was conducted in accordance with this supplement; • The use of split duty to extend the FDP is not permitted. All details to be recorded on form GAL221 - Air Ambulance Commanders Discretion Report

response This seems to be an excerpt from a particular OM or national regulation on air ambulance.

Air ambulance is a normal CAT flight where urgency is not an issue. CS FTL.1 applies.

Response with regard to ‘commander’s discretion’ (comment #290 (EBAA))

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 81 of 277 An agency of the European Union

comment 290 comment by: European Business Aviation Association (EBAA)

(f) Unforeseen circumstances in flight operations — commander’s discretion EBAA COMMENT: The reference table (MaxFDP) needs to be amended for Air Taxi Operations to refer to CS FTL.2.205. Suggested change: amend ORO.FTL.205 (f).

response Not accepted

Point ORO.FTL.205(f1) and associated CS FTL.2 apply to the use of commander’s discretion

in air taxi and AEMS operations.

comment 449 comment by: Cat Aviation AG

For Air Taxi please adjust ORO.FTL.205 (f)1 (i) to refer to ORO.FTL.205 and CS FTL.2.205 as well, so as to clarify which FDP tables are referred to (either to ORO or to the certification specification, if this paragraph applies to both, then both have to be referred to). Furthermore what is the rationale for allowing AEMS to extend the FDP if a patient has to be transported, especially relevance to safety?

response Please, see the response to comment #290.

comment 885 comment by: Stephanie Selim

ORO.FTL.205 (b)(1) : Technical comment – DGAC asks for adding the possibility to extend the basic maximum daily FDP for two-pilot air taxi and two pilot AEMS operations providing that: (i) the basic maximum daily FDP extension is under FRM (ii) the basic maximum daily FDP given in table 2 can be extended by up to one hour. This “one hour extension” is in line with the possibility given by current ORO.FTL.205(b)(3) compared to ORO.FTL.205(b)(2) when the number of sector is lower than 7. Moreover, crew members are acclimatised.

response Not accepted

The FDP extension for two-pilot acclimatised crew is addressed by point ORO.FTL.205(d)

and (d1). Please, refer to the responses to comments #130 and #192.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 82 of 277 An agency of the European Union

comment 886 comment by: Stephanie Selim

ORO.FTL.205 (b)(3) : Editorial comment - The maximum FDP should apply to the same scope of operations as ORO.FTL.205(b)(1) and (2): “The maximum daily FDP for two-pilot operation other than HEMS when crew members are in an unknown state of acclimatisation and the operator has implemented a FRM, shall be in accordance with the following table:”

response Not accepted

HEMS are no longer part of this proposal.

Responses with regard to ‘single-pilot operations’ (comment #887 (DSAC))

comment 887 comment by: Stephanie Selim

ORO.FTL.205 (b)(4) : Technical comment - No specific impact assessment has been developed for single pilot commuting operations. This type of operation is defined by a high number of repetitive short flights during a duty service. Therefore, in the case of single-pilot operations other than HEMS, it is proposed to assess the impact of fatigue of the possibility to extend the maximum daily FDP to 10 hours without limiting the number of sectors providing that flights are only by day in VFR, fights are always between a limited number of well-known airports, and all sectors last less than one hour.

response Accepted

Your proposal seems to depict an existing operation.

Point ORO.FTL.205(b) allows single-pilot operators to establish individual FTL schemes

where the maximum daily FDP is 10 hours irrespective of the number of sectors, provided

that flights are conducted only by day in VFR and each sector lasts for less than 1 hour.

comment 888 comment by: Stephanie Selim

ORO.FTL.205 (b)(6) : Editorial comment - The scope of application should be more precise and apply to two-pilot air taxi and two- pilot AEMS operations only: “By derogation from (b)(1), flight time specification schemes in two-pilot air taxi and two-pilot AEMS operations may specify the maximum daily FDP

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 83 of 277 An agency of the European Union

without the use of extensions for acclimatised crew members in accordance with the certification specification applicable to those operations.”

response Accepted

Clarification on the scope of application is provided as necessary.

comment 889 comment by: Stephanie Selim

ORO.FTL.205 (d) : Editorial comment - The scope of application should be more precise and apply to two-pilot scheduled and two- pilot charter operations only: “Maximum daily FDP for acclimatised crew members in two- pilot scheduled and two-pilot charter operations with the use of extensions without in- flight rest.”

response Accepted

comment 890 comment by: Stephanie Selim

ORO.FTL.205 (d1) : Editorial comment - The scope of application should be more precise and apply to two-pilot air taxi and two- pilot AEMS operations only: “Maximum daily FDP for acclimatised crew members in two- pilot air taxi and two-pilot AEMS operations with the use of extensions without on-board rest”

response Accepted

comment 891 comment by: Stephanie Selim

ORO.FTL.205 (e) : Editorial comment – A more explicit wording is suggested: “Maximum daily FDP with the use of extensions due to in-flight rest or, in the case of AEMS or air taxi operations, due to on-board rest”

response Accepted

comment 892 comment by: Stephanie Selim

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 84 of 277 An agency of the European Union

ORO.FTL.205 (e) : Technical comment – DGAC wonders if it applies to two-pilot operations only or both single and two-pilot operations? If it applies to single pilot operation, an augmented flight crew with one additional pilot may lead to have a maximum FDP higher than the FDP derived from two- pilot operations. This comment apply also to CS FTL.1.205(c) and CS FTL.2.205 Extension of the maximum basic daily FDP due to on-board rest under ORO.FTL.205(e).

response Point ORO.FTL.205(e) applies to augmented flight crew in two-pilot operations where

in-flight / on-board rest is used; hence, it does not apply to operations where the minimum

crew is one or two pilots, i.e. single-pilot or non-augmented two-pilot crew.

comment 893 comment by: Stephanie Selim

ORO.FTL.205 (f)(1)(i) : Technical comment – Following the technical comment on ORO.FTL.205(e) and the answer given, it may be necessary to precise if augmented flight crew refers here to both single and two-pilot operations.

response Please, refer to the response to comment #892.

comment 894 comment by: Stephanie Selim

ORO.FTL.205 (f)(3) : Technical comment – This requirement should also apply to EMS: “The commander shall consult all crew members on their alertness levels before deciding the modifications under subparagraphs 1 and 2 and 7.”

response Accepted

This requirement is included in CS FTL.2 and is applicable to air taxi and AEMS operations.

comment 895 comment by: Stephanie Selim

ORO.FTL.205 (f)(7) : Technical comment – This requirement is new and dedicated to EMS operations. However, should we consider that ORO.FTL.205 (f)(2), (3), (4), (5) and (6) also apply to EMS operations or should we refer

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 85 of 277 An agency of the European Union

only to the applicable CS ? It is suggested that it should also apply to EMS: “The conditions to modify the limits on flight duty, duty and rest periods by the commander in the case of unforeseen circumstances in EMS operations under ORO.FTL.205(f), which occur at or after the reporting time, shall be established on the basis of the relevant certification specifications”

response Please, refer to the response to comment #290.

comment 993 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(b) Table 2 is too complicated and not suitable for Air Taxi. Too many FDP changes - every 30'. Please consider the difference in operations between scheduled commercial and Air Taxi ad-hoc operation. please redo the table. Table 3 Please redo to: 1-2 sectors max 13 FDP, 3-4 sectors max 12 FDP Table 4 Please redo to: 1-2 sectors max 14 FDP, 3-4 sectors max 13 FDP

response Please, refer to the responses to comments #130 and #192.

comment 996 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(d1) The FDP extension two times in any 7 consecutive days of max 1 hour is essential for flexibility. Suggestion: ii. The maximum number of extensions is 2 in any 7 consecutive days iii. Extensions are not allowed for a FDP of 6 sectors or more iv. Where a FDP encroaches on the WOCL by up to 2 hours, extensions are limited to 4 sectors v. Where FDP encroaches on the WOCL by more than 2 hours, extensions are limited to up to 3 sectors vi. Where FDP is planned to use an extension, pre and postflight minimum rest is increased by 2 hours or postflight rest is only increased by 4 hours. Where the extensions are used for consecutive FDP's, the pre and post rest between the two operations shall run consecutively. vii. Where FDP is planned encroaching the entire WOCL, the max FDP is limited to 12 hours.

response Please, refer to the response to comment #208.

comment 1030 comment by: Rabbit-Air Ltd

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 86 of 277 An agency of the European Union

The table 2 is too fractured for Air Taxi operation. It is the benefit to have airplanes waiting for clients! With duty changes every 30 or even 15 minutes operation will be blocked through administration.

response Please, see the response to comment #192.

comment 1033 comment by: Rabbit-Air Ltd

Table 3: Max. FDP of 13 hrs for 1 to 2 sectors is frequently needed and should be considered when re-doing the table. Short positioning following a long range flight or vice versa. For example. 3- 4 sect. = 12hrs. 5- = 11hrs

response Please, see the response to comment #192.

comment 1037 comment by: Rabbit-Air Ltd

Table 4: Max. FDP of 14 hrs incl. FRM for 1 to 2 sectors is occantionally needed and should be considered when re-doing the table. 3-4 sect. Under FRM should be 13 hrs.

response Please, see the response to comment #192.

comment 1048 comment by: FNAM

The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). FNAM and EBAA France suggest clarifying the writing. PROPOSAL Suppress the newly added paragraph (a)(1).

response Not accepted

Paragraph (a)(1) clarifies the concept and scope of applicability of CS FTL.1 and CS FTL.2.

comment 1050 comment by: FNAM

In the paragraph (b), it is not explicit whether:

• All the CS.FTL.2 requirements shall be applicable "in block"; or

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 87 of 277 An agency of the European Union

• The CS requirements should apply depending on what is said in the implementing rule; or

• Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.205 (b) and another in CS FTL.2.205. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. Therefore, FNAM and EBAA France suggest listing the two options in the CS.FTL.2.205 (b) instead of having one described in the IR and one in the CS. PROPOSAL For Air Taxi and AEMS, suppress all FDP limitations (Tables) in the IR ORO.FTL.205 and refer only to the CS in this IR as it is the case for HEMS in the §(b)(7).

response Not accepted

Please, see the response to comment #192.

comment 1051 comment by: FNAM

(b) Regarding the notion of a Daily FDP For small FT, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h.

response Yes, as long as these FDPs are separated by a rest period that is equal to the previous duty

or a minimum rest period.

comment 1054 comment by: Rabbit-Air Ltd

(d) and (d1): Max. FDP extension twice any 7 days by max. 1 hour is reasonable. The flexibility should be maintained when planning FDP with extension! Minimum rest should be increased by either increasing 2 hours pre- and post-flight or 4 hours post-flight rest only. There are too many if and when's possible and do therefore enhance the chance of mistakes.

response Noted

comment 1058 comment by: FNAM

Attachments #55 #56

Table 2

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 88 of 277 An agency of the European Union

Keep the Table 2 coming from the CAT.A regulation and add the possibility, if an operator has a FRM, of increasing the FDP limitations in the Table 2 by (Cf. Annex 2 & 3):

• For Air Taxi operations: 1 hour no matter the number of sectors • For AEMS operations:

o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

In order to mitigate these proposals, a scientific study may assess whether and how it may be possible to have FDP over 14 hours under a FRM Cf. comment 1107 PROPOSAL Add a sentence below the Table 2 to allow, if an operator has a FRM, to increase the FDP limitations in the Table 2 by:

• For Air Taxi operations: 1 hour no matter the number of sectors • For AEMS operations:

o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

response Please, see the responses to comments #192, #993 and #1050.

comment 1060 comment by: FNAM

(d1)(1) Regarding the limitations of the use of the extension (planned in advance), FNAM and EBAA France share EBAA Europe's point of view. It is possible in the CAT FTL regulation to use these extensions for 5 sectors or 4 sectors when the WOCL is encroached by 2 hours or less. Hence, FNAM and EBAA France would like the same dispositions to be applicable for Air Taxi and AEMS operations. PROPOSAL Rewrite the paragraph (2) “(2) The use of the extension shall be planned in advance, and shall be limited to a maximum of: (i) 5 sectors; or (ii) 4 sectors; when the WOCL is encroached by 2 hours or less; or (iii) 3 sectors, when the WOCL is encroached by more than 2 hours."

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 89 of 277 An agency of the European Union

comment 1062 comment by: FNAM

(e) PROPOSAL: Add the following paragraph: “By way of derogation from ORO.FTL.110(a) for AEMS and Air Taxi operations, operator may schedule an additional pilot and schedule an in-flight rest for crew members at any point in time including after reporting time.” RATIONALE: There is no additional fatigue with this disposition compared to if it was intended before, thus the mitigation is included in the proposal.

response This is already possible and does not represent a derogation from point ORO.FTL.110(a),

but requires planning and scheduling of an extended FDP due to on-board rest and

augmented crew. Also, it requires that the subsequent sectors allow for each flight crew

member to take their due on-board rest.

Therefore, your proposal is not accepted.

Please, refer to CS FTL.2.205(b)(11).

comment 1067 comment by: FNAM

FNAM and EBAA France agree with Air Taxi commander's discretion proposals (same as CAT.A FTL's dispositions)

response Noted

comment 1072 comment by: FNAM

(f) FORCE MAJEURE AEMS and Air Taxi are deeply linked with national health, security and safety. Current French regulation allows, by sovereign decision of the State, to grant derogation as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For illustrative purposes, the recent missions would not have been possible if this regulation enters into force as it is:

• Hostage taking in Amenas in 2013 • Evacuation of injured journalists in Mossoul in 2016 • Airlift between Guadeloupe and Saint Martin in 2017

Therefore, FNAM and EBAA France suggest adding a specific paragraph in this implementing rule allowing pilots to derogate from these requirements in case of Force

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 90 of 277 An agency of the European Union

Majeure as it is already the case in the Current French National Regulation or if the State requisitions an aircraft. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : "Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation; la limite est à fixer par le ministre chargé de l'aviation civile." (Ref : CAC D422-12)

response Please, see the response to comment #1029.

comment 1143 comment by: GBAA

ORO.FTL.205 (d1)(1) Flight duty period (FDP) The option to compensate extended duty by 60h extended rest period instead of 36h latest after the period of 168h starting with the first duty hour is very tempting. However, this rest time period extension of extra 24h should only be necessary once for all extensions within this 168h period.

response Please, refer to the response to comment #208.

comment 1168 comment by: Danish Aviation Association

ORO.FTL.205 FDP: The tables seem not to have been changed to accomodate the specifics of the SME single-pilot and two-pilot operations. In Table 5 is the FDP reduced compared to two-pilot operations, but a scientific reason seems not to support that decicion. All tables should be reassessed.

response Not accepted

Scientific studies attached to the NPA show that SPLO are far more fatiguing than a two-

pilot configuration due to increased workload.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 91 of 277 An agency of the European Union

comment 1189 comment by: SAF

(a)(1) The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). SAF suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1).

response Not accepted

Please, refer to the response to comment #1048.

Responses with regard to ‘planning of FDP extensions’ (comment #1262)

comment 1262 comment by: Volkswagen AirService GmbH

Refering to 205 (d1) (2) Extensions shall be planned in advance: As we operate on demand

only, it is not possible to preplan and roster specific duties in advance. All duties are

dependend of each other and are on short notice, only. We may roster undefined periods

of duty, but dedicated duties are not known, yet. If we have to schedule duties in advance

we have to keep available personnell for each duty, every day, even if we do have no tasks.

This is impossible and makes no sense with regard to fatigue management, as well.

response Not accepted

It is possible to plan in advance by preparing a strategic roster of duties, standbys and days-

off.

Extended duties must be also notified in advance to crew members to allow them plan

adequate rest. The maximum and/or minimum time for advance notification of an

extended FDP needs to be established by the operator in accordance with point

ORO.FTL.110 and specified in the OM-A. Notification times may also be established taking

into account the WOCL.

comment 1263 comment by: Volkswagen AirService GmbH

Referring to d1): How much time in advance does the extension need to be planned? This

is not feasible for air taxi operators in most cases and would be useless if kept this way. To

take advantage of the one hour extension, the extension should be fully usable on a tactical

level, notwithstanding any commander's decisions. This is comparable to present

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 92 of 277 An agency of the European Union

extensions granted on a national regulation level (i.e. extension of up to 14 hours twice in

7 days, without prior planning.), which has shown to be valuable.

response Please, see the response to comment #1262.

comment 1343 comment by: Gama Aviation (UK) Ltd

Tables 3 & 4 should be ammended to reflect 1-3 sectors to maintain consistency with the other tables. In table 3, 1-3 sectors should be ammended to 12 hours maximum FDP without FRMS. Suggested Change: 1-3 Sectors = 12 Hours, 4 Sectors = 10 Hours, 5 Sectors = 9Hours 30 Minutes and then 9 hours for the remaining sectors up to the maximum of 8. In table 3, 1-3 sectors should be ammended to 13 hours maximum FDP with FRMS. Suggested Change: 1-3 Sectors = 13 Hours, 4 Sectors = 11 Hours, 5 Sectors = 10Hours 30 Minutes.........

response Tables 3 and 4 do not automatically apply to air taxi and AEMS operations.

Please, refer to the responses to comments #130 and #192.

comment 1364 comment by: Bartosz Fibingier

1) Table 5 Maximum daily FDP* in hours — Acclimatised crew members — single-pilot operation other than HEMS: "The flight time for each sector shall be limited to 4 hours with autopilot and to 2 hours without autopilot" - a requirement is not scaled to the real risk attached. The requirement is considered as overregulating this subject. The extent of the CAT SPL OPS is very limited in general. As of that, exposure to the hazard is limited and automatically lowers the scaled risk level. Due to the type of airplanes and speed range of those aircraft on which this type of OPS is applicable will extremely limit business case and may impact many companies for which CAT OPS is an additional way to sustain positive income (i.e. ATOs). Please analyze and maybe present factual data on the scale of those operations in Europe (preferably compared to World data compared to a number of accidents/incidents in which exceedance of applicable (mentioned above) flight times caused unacceptable higher risk or participated in causal factors to an accident/incident. As per NPA 4.1.4.2 (...) None of these occurrences (12 accidents and 9 serious incidents) were found to contain any information as to whether fatigue was a factor in the occurrence.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 93 of 277 An agency of the European Union

2) point d1) for ATX and AEMS OPS is more restrictive than point d) applicable to SCHED and Charter CAT OPS which is in contradiction to EASA statements in: "2.1. (...) ATXO are on-demand operations, the majority at short notice; they are characterised by frequent standby duties at home, frequent change of schedule, long break periods between duties and time zone crossings. Air taxi pilots on average fly significantly fewer hours per year than scheduled or charter airline pilots. Considerable use is made of positioning of crew and aircraft relative to scheduled flights. (...) In the context of FTL, there are significant differences between ATXO, AEMS, HEMS and SPLO on the one hand, and typical CAT operations on the other. Still, ATXO, AEMS and SPLO are regulated on the basis of duty and flight time limits, and rest requirements of Subpart Q that have been designed for scheduled multi-crew airline operations. In comparison to flight times and duty periods that apply in CAT, ATXO and AEMS require much more flexibility and ability to accommodate often very demanding duties while managing fatigue to acceptable levels. Today, Subpart Q does not to provide that flexibility or the necessary levels of control and mitigation.", and "2.2. The objectives of the EASA system are defined in Article 2 of the Basic Regulation. This proposal will in particular contribute to the high uniform level of civil aviation safety, provide a level playing field for all actors in the common European aviation market, and facilitate the free movement of goods, persons and services."

response The FT values in Table 5 are proposed by the industry.

With regard to planned extensions, please refer to the responses given to comments #33

and #1262.

comment 1366 comment by: Gama Aviation (UK) Ltd

There is no equivalent in EASA for the Dedicated Air Ambulance FTL variation currently used by Gama Aviation Ltd. Should this variation not be possible under EASA, this is likley to have significant adverse impact on the operation of AEMS in our operation. We therefore seek assurances that this variation will still be possible under EASA FTL. Exisiting Variation: Air Ambulance Definition:- when the sole reason for the flight is to carry an ill or injured person to a recognised medical facility, or the carriage of a human organ necessary for a Transplant operation. A sector flown to position an aircraft to the operating base before or after an Air Ambulance flight is considered part of that flight. The company operates a dedicated Air Ambulance service and accordingly the allowable FDP, as per section 7.4.11, may be planned to be increased by up to a maximum of 4 hours. This is referred to as Air Ambulance FDP and to use this allowance the following must apply: • When an ill or injured person is carried a qualified medical attendant must accompany the flight.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 94 of 277 An agency of the European Union

• The only passengers that may be carried in addition to the patient and medical crew are the immediate family or next of kin; • The crew must have had the full entitlement of rest relating to the preceding duty prior to starting an Air Ambulance flying duty; • Two Pilot Crew; The Ambulance Allowance may be used in order to position an aircraft to transfer a patient and return back to base to enable the aircraft to be available for further life saving work with a fresh crew. This allowance cannot be planned to exceed 4 hours. Upon completion of an Air Ambulance FDP the appropriate full rest period must be taken. There is no limit to the number of Air Ambulance FDP’s that can be undertaken within a roster period and no requirement for extended time before the Air Ambulance FDP can be used again. The use of Commander’s discretion to further extend the Ambulance FDP beyond the extra 4 hours permitted may be exercised only to off-load/deliver the patient or organ to the destination. This is then deemed to be an Extended Ambulance FDP and cannot be planned for. Such discretion cannot be used after the patient or organ has been offloaded. A discretion report must be submitted with the flight paperwork. Following an Extended Air Ambulance FDP the appropriate full rest period must be taken. • In addition at least 48 hours must elapse between the end of one extended Air Ambulance FDP and the start of another extended Air Ambulance FDP. In one Air Ambulance operation involving two or more extended FDP duties (the first of which is positioning to uplift a patient or organ) the necessity for the 48 hours rest may be deferred until return to base. In this case the Commander may reduce the rest following the first FDP by up to 3 hours or to 10 hours in suitable accommodation, whichever is the greater. • A pilot can only fly 3 Air Ambulances extended FDPs in any 28 consecutive days. (This ruling shall only apply where extensions exceed one and a half hours); You may undertake a normal Air Ambulance FDP once rested following an Extended Air Ambulance FDP; • The relevant duty records must show where an FDP was conducted in accordance with this supplement; • The use of split duty to extend the FDP is not permitted. All details to be recorded on form GAL221 - Air Ambulance Commanders Discretion Report

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 95 of 277 An agency of the European Union

Air ambulance is a normal CAT scheduled/charter flight where urgency is not an issue.

This means that, for air ambulance, CS FTL.1 applies.

comment 1444 comment by: European Cockpit Association

Commented text: On-board rest ORO.FTL.205 (e) ECA Comment: The proposed concept of ‘on-board rest’ as an equivalent to ‘in-flight rest’ is seriously flawed, contrary to available scientific advice such as that obtained by EASA in preparation for the 2010-14 NPA on CAT FTLs, and not a current acceptable practice. As described the ‘rest’ period would include any time spent in the rest facility, including during approach, landing, taxy, turnaround, brief and flight preparation, take-off and departure. At any of these times no meaningful rest will be achievable, and a flight crew member would normally be expected to take part in these phases of flight. Any rest while any activity is taking place on the aircraft, and outside of the Cruise phase, will be heavily disturbed and/or fragmented as flight/activity phases change, and not effective for FDP extension. Were rest only to be permitted starting and finishing within a period of complete inactivity on the aircraft, on the ground, this would effectively be, and fall under, the requirements of split duty. Proposal: Remove the concept of ‘on-board rest’ and return to the existing system of ‘in-flight’ rest which already goes far beyond the advice from EASA’s scientific input.

response Not accepted

In-flight and on-board rest, while airborne, is only possible during the cruise phase of flight.

On-board rest is also possible while on the ground, unlike in-flight rest. It can be reasonably

expected that meaningful rest will be achievable during such rest periods.

On-board rest in air taxi and AEMS operations is:

(a) a period of a temporary relief of operational tasks, taken by a member of an

augmented crew during the cruise phase of the flight in an on-board facility meeting

the required standard; or

(b) a period of a temporary relief of operational tasks, taken by a member of an

augmented or non-augmented crew in an on-board facility meeting the required

standard, while the aeroplane is on the ground.

comment 1455 comment by: Association of Air Ambulances

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 96 of 277 An agency of the European Union

ORO.FTL.205(b)

There is no mention in this paragraph of the FDP table for two-pilot HEMS which is at

CS.FTL.3.205. Elsewhere in the amended IR there is reference to CS.FTL so it would be

useful and aid clarity if a new paragraph ORO.FTL.205(b)(8) was adding:

“In the case of two-pilot HEMS operations, the FDP limitation stated in CS.FTL.3 (a) Table

1, are applicable.”

It is our opinion that a definition of Multi-Pilot operation rather than Two-Pilot operations.

response Not accepted

HEMS is no longer part of this proposal.

comment 1465 comment by: VOLDIRECT

Table 5 Single Pilot: The table shows number of sectors starting at 4. Air taxi for business is often an eary departure in the morning and a late return in the evening, 2 sectors only. Split duty is used, 2 sectors only. For example, The current DGAC rule enables for a maximum daily FDP of 13:00 hours for 1/2 sectors; table 5 shows 10:00 hours for 4 sectors! We lose 3 hours.

response Noted

Extension by 3 hrs of an FDP of a 10-hr single-pilot operation is already possible with split

duty, i.e. with a break on the ground of 6 hrs spent in accommodation or of more than 6

hrs spent in suitable accommodation, between the sectors.

comment 1481 comment by: Finnish Transport Safety Agency

ORO.FTL.205 (b)(4) Pilots in single-pilot CAT operations in Finnish Lapland fly tourists and locals in an area where other transport possibilities are scarce or non-existing. The operations are flown during the summer season only. These operations have major impact on local economy. At the moment national FTL requirements allow FDP of 10 hours for these operations. The 8 hour FDP stated in ORO.FTL.205 would cause need for additional pilots and additional costs.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 97 of 277 An agency of the European Union

The FDP should be extended to 10 hours in certain conditions, since the nature of the operations is quite different compared other air taxi operations. The number of sectors during the day may be as high as 20 as the flights are very short, usually under 15 minutes. In addition the flights are flown in day VFR and in an environment familiar to pilot. The flight planning and navigation are simple as the flights are similar to each other. This rule would also fit A to A flights, where the sectors are also short and flown locally Proposal: Add new paragraph ORO.FTL.205 (b)(8) as follows: (8) By way of derogation from (b)(4) table 5, the FDP may be extended to 10 hours regardless of the number of sectors in air taxi operations when a) flown in day VFR; and b) route sectors are less than 30 minutes or flown from A to A. However, the total flight time during the FDP may only be maximum 6 hours.

response Please, refer to the response to comment #887.

comment 1505

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

(b) This constitutes a highly presprictive part:

• Table 2 provides a much too complicated scheme and is therefore not suitable for ATXO. There are simply too many FDP changes (every 30' is to high of a change-rate). Please consider the difference in operations between scheduled commercial and Air Taxi adhoc operation. Conclusion: The table needs in any case to be reconsidered, dropped or completely redone.

• Table 3: Change suggestion based on practical expertise 1-2 sectors max 13 FDP, 3-4 sectors max 12 FDP

• Table 4: Change suggestion based on practical expertise 1-2 sectors max 14 FDP, 3-4 sectors max 13 FDP

response Please, refer to the response to comment #192.

comment 1506

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

(d1) An FDP-extension twice in any 7 consecutive days of max 1 hour constitutes an essential for needed flexibility.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 98 of 277 An agency of the European Union

Therefore, we suggest the following: ii. The maximum number of extensions is 2 in any 7 consecutive days iii. Extensions shall not be allowed for an FDP of 6 sectors or more iv. Where a FDP encroaches on the WOCL by up to 2 hours, extensions shall be limited to 4 sectors v. Where FDP encroaches on the WOCL by more than 2 hours, extensions shall be limited to up to 3 sectors vi. Where FDP is planned to use an extension, pre and postflight minimum rest shall be increased by 2 hours or postflight rest shall only be increased by 4 hours. Where the extensions are used for consecutive FDPs, the pre and post rest between the two operations shall run consecutively. vii. Where FDP is planned encroaching the entire WOCL, the max FDP shall be limited to 12 hours.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 99 of 277 An agency of the European Union

ORO.FTL.210 (cumulative limits)

3.1. ORO.FTL.210 p. 13-14

comment 27 comment by: Johannes Brantz

Guaranteed Days off Besides the monthly limit of duty time the German 2. DV LuftBO contains also a number of guaranteed days off per month. As the FTL focusses on a reduction of Fatigue driven by long duty times an additional regulation of guaranteed number of days off (for example 8 days/month) would accomplish the FTL perfectly.

response Point ORO.FTL.210 deals with cumulative duty and FT limits, not with days-off.

Clause 9 of Council Directive 2000/79/EC deals with days-off per month and per year. That

Directive has since its adoption been transposed into each Member State’s national

legislation. Today, both Council Directive 2000/79/EC and Commission Regulation (EU)

No 965/2012 apply in the EU.

A mandatory rest period under Subpart ORO.FTL may be included in a day, or days, free of

duty.

comment 28 comment by: Johannes Brantz

Maximum Duty Hours per year In 2002 there was a proposal made to limit the annual Duty Time to 1800 hours for flight crews that have mobile or flight duty times per year that exceed 20 % of there annual duty hours. The current limit of 190 duty hours in 28 consecutive days would accumulate to 2477 hours per year. Which is 677 hours more than the proposal from 2002 and 477 hours more then the current 2000 hour limit in Germany. So an actual increase of duty hours will counteract the intended reduction of fatigue. The annual duty hour limits should be reviewed combined with the applicable law for vacation days. For example a 2000 hour limit contract should include the vacation days and as well as an 1800 hour limit contract could well see vacation days on top of the 1800 hour limit.

response The annual duty limit is not the product of simply multiplying the 28-day limit with the

number of times 28 days occur in a year.

The currently applicable annual duty limit is 2 000 hours as per Council Directive

2000/79/EC. That Directive deals with cumulative duty period per year. It has since its

adoption been transposed into each Member State’s national legislation. Today, both

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 100 of 277 An agency of the European Union

Council Directive 2000/79/EC and Commission Regulation (EU) No 965/2012 apply in the

EU.

In order to facilitate understanding and implementation, the annual duty limit of 2 000

hours will be included in point ORO.FTL.210.

comment 29 comment by: Johannes Brantz

Equal distribution of Duty time per year I am convinced that an equal distribution of duty time per year will reduce fatigue. However the actual situation is a high number of duty hours in the summer months and less duty hours in the winter months. Currently operators are not held accountable to equalize duty hours. Therefore in order to avoid overtime payments in the summer pilots are scheduled to have extensive days off during the winter months. So that they duty time to the operator in the summer.

response Noted

Council Directive 2000/79/EC, as transposed into Member States’ national legislation,

requires that the maximum annual working time be spread as evenly as practicable

throughout the year.

comment 66 comment by: NetJets Europe

ORO.FTL.210 (a) NetJets supports proposal

response Noted

Please, also refer to the response given to comment #130.

comment 87 comment by: AIR ZERMATT AG

• The total duty periods to which an individual crew member may be assigned shall

not exceed a maximum daily FDP of 14 hours. • FDP of more than 12 hours can only be extended to the max of 14 hours by split

duty. This requires at least one break of a minimum of 120 consecutive minutes during the FDP;

• Additionally, the following rest periods shall apply:

Working days in a row: Min. rest period in hours:

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 101 of 277 An agency of the European Union

4 36 hours

5 60 hours

6 84 hours

Working 7 days in a row must not be allowed!

response Not accepted.

EASA proposes EU-harmonised FTL rules based, as far as possible, on latest scientific

evidence and good practices in Europe.

It is not clear what your comment suggests and what scientific evidence/good practice it

can be related to.

comment 110 comment by: UK CAA

Page No: 13 Paragraph No: ORO.FTL.210 (a)(c)(d) Flight times and duty periods Comment: We believe the insertion of additional text in sub-paragraphs (a), (c) and (d) has changed the meaning and application of the limits. By inserting the text “either of the following limits” implies an either / or meaning suggesting that only one of the limits need to be applied. This would be an incorrect application and generates potential confusion. Justification: The correct application of this requirement. Proposed Text: Delete “either of” in sub-paragraphs (a). (c) and (d), leaving the text at “shall not exceed the following limits” or change “either” to “any”.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 102 of 277 An agency of the European Union

Response with regard to ‘monthly cumulative limits’ (comment #132 (VistaJet))

comment 132 comment by: VistaJet

ORO.FTL.210 duty period limit for 14 days 110 hrs is very limiting. As mentioned previously, almost all ATXO use a rotation style roster (eg. 2 weeks on 2 weeks off) and include significant positioning as a passenger to get to the operating aircraft. 60hrs is already limiting but now to impose a 14 day 110hr limit is VERY restrictive. As mentioned in ATXO cumulative fatigue and acclimatisation is addressed during the consolidated "OFF" block every month. However, to make the operation commercially viable, crew availablity during the on block is essential. As there is NO HOME BASE, crew members are positioned via airline to the place of duty for that rotation. This means, before they have flown a commercial sector they may have accumulated up to 24 Hrs of duty, depending on where there are positioned to. Crew are also positioned frequently during their rotation which again counts towards duty. With the lower limit in the 2nd weel, it means that rotations will have to be cut short, and/or we will not be able to position crew back home after their rotation. From a social, safety and commercial perspective it then makes sense to allow violation of the 110hrs if sending crew home as passengers rather than giving them extended rest away from home, not to violate the 110hrs. Therefore suggest to amend (a)1 60hrs duty in 7 days unless crew member is positioned as passenger to his/her home.

response Partially accepted

The following amendments with regard to the cumulative limits of 110 hours and 60 hours

will be made to point ORO.FTL.210:

Point ORO.FTL.210(a) will be made applicable to scheduled and charter operations.

For air taxi and AEMS operations, point (a1) will be inserted without the limit of 110 hours

as this limit does not appear in Subpart Q.

Also, point (a2) will be inserted to incorporate existing derogation cases from cumulative

requirements, according to which the 60 hours duty limit in air taxi and AEMS operations

may be exceeded by a maximum of 10 hours, provided this exceedance is used solely for

the purpose of positioning a crew member back to their home base for the start of the

extended recovery rest period, under certain conditions.

Your comment with regard to ‘home base’ is not accepted.

comment 193 comment by: Premium Jet AG

(a): (1) & (2) are not based on scientific values. Please rework.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 103 of 277 An agency of the European Union

positioning must be possible after acc. 60h

response Noted

Point ORO.FTL.210(a): (1) and (2) apply to scheduled and charter operators. For air taxi and

AEMS operations, point (a1) will be inserted without the limit of 110 hours as this limit

does not appear in Subpart Q.

It is not clear what scientific values are known to Premium Jet. For example, 60 hrs in

7 days is a cumulative limit that exists under Subpart Q and has been implemented by air

taxi operators so far.

Not everything in the FTL requirements is based on scientific values though. There are also

requirements that are based on experience.

comment 238 comment by: Thomas Henselmann

(a) possible extension on (1)&(2) for possible home proceedings should be regarded.

response Please, refer to the response to comment #132.

comment 291 comment by: European Business Aviation Association (EBAA)

(a) The total duty periods to which an individual crew member may be assigned in scheduled and charter operations and in air taxi and AEMS operations shall not exceed either of the following limits: EBAA COMMENT: Limitations defined in point (1) and (2) are not based on any scientific data. CS FTL.2.210 – Less restrictive daily FDP – more restrictive cumulative flight hours. Suggested change: The 60 and 110 hours limit can be exceeded as long as the exceedance is only used to positioning home as a passenger to begin an ERRP. As a mitigation, EBAA suggests that EERP must include at least 3 local nights. Rationale: • Not scientific • Not affect the safety of flight – not a fatigue issue. • Under specific mitigation measure. The NPA allows Air-Taxi operators the freedom to apply two different maximum FDP structures (ORO.FTL.210 & CS.FTL.2.205) depending on the maximum number of flight hours assigned to a crew member. If we adopt the reduction in the cumulative flight hours allocated to each crew member (in 28 and 84 days, and in 12 consecutive calendar months) then the daily FDP allowed to be applied can be increased up to a maximum of 15 hours twice in any 7-day period.

response Please, refer to the responses to comments #132 and #193.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 104 of 277 An agency of the European Union

comment 450 comment by: Cat Aviation AG

a) (2) should be removed. Point 1 and 3 are sufficient for robustness of air taxi schedule. For Home Positioning of a crew as passenger this not restriction can be exceed.

response Please, refer to the response to comment #132.

comment 735 comment by: European Business Aviation Association (EBAA)

ORO.FTL.210 Flight times and duty periods (a) The total duty periods to which an individual crew member may be assigned in scheduled and charter operations and in air taxi and AEMS operations shall not exceed either of the following limits: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. EBAA COMMENT: Limitations defined in point (1) and (2) are not based on any scientific data. CS FTL.2.210 –Less restrictive daily FDP – more restrictive cumulative flight hours. Suggested change: The 60 and 110 hours limit can be exceeded as long as the exceedance is only used to positioning home as a passenger to begin an ERRP. As a mitigation, EBAA suggests that EERP must include at least 3 local nights. Rationale: • Not scientific • Not affect the safety of flight – not a fatigue issue. • Under specific mitigation measure. The NPA allows Air-Taxi operators the freedom to apply two different maximum FDP structures (ORO.FTL.210 & CS.FTL.2.205) depending on the maximum number of flight hours assigned to a crew member. If we adopt the reduction in the cumulative flight hours allocated to each crew member (in 28 and 84 days, and in 12 consecutive calendar months) then the daily FDP allowed to be applied can be increased up to a maximum of 15 hours twice in any 7-day period.

response Please, refer to the responses to comments #132 and #193.

comment 1001 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(a) 2 should be removed. (1) and (3) are sufficient for robustness of Air Taxi shcedule. This restriction can be exeeded in case of a positioning of a crew as passenger back home.

response Please, refer to the responses to comments #132 and #193.

comment 1024 comment by: Stephanie Selim

(a)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 105 of 277 An agency of the European Union

Technical comment- Experience feedbacks on scheduled CAT FTL show that regulations should frame in an adequate manner flight and rest time limitations while keeping flexibility for operational hazards which sometimes occur. Margins exist for FDP with commander’s discretion but don’t exist for duty times, which can be a problem when arriving at duty time limit for cumulative duty times. Thus, in order to allow operators to manage that kind of hazard with an acceptable level of safety, DGAC proposes to assess the implementation of flexibilities allowing return positioning of crew members in the case where duty times on a given period are exceeded.

response Please, refer to the responses to comments #132 and #193.

comment 1025 comment by: Stephanie Selim

(e)(1) Technical comment – With this paragraph, AEMS operations don’t have any flight time limit to apply if they choose the basic FDP definition given in ORO.FTL.205(b)(6) (and CS FTL.2.205 table 1). Indeed, in the case of AEMS operations, ORO.FTL.210(e)(1) defines ‘total flight time’ by referring to the basic FDP definition given in ORO.FTL.205(b)(1), and ORO.FTL.210(e)(2) refers to the basic FDP definition given in ORO.FTL.205(b)(6) but the associated definition of the ‘total flight time’ in the CS FTL.2.210 applies only to ATXO. Therefore, DGAC wonders what flight time limitations apply to AEMS.

response Accepted

AEMS operations were mistakenly removed from point (e)(1).

comment 1026 comment by: Stephanie Selim

(e)(1) Editorial comment – The table number needs to be corrected: “in accordance with (c). In such case, table 21 in ORO.FTL.205(b)(1) shall apply; or”

response Accepted

The numbering of the table will be corrected.

comment 1027 comment by: Stephanie Selim

(e)(1) Editorial comment – The table number should be added to be coherent with ORO.FTL.210 (e)(1): “in accordance with the limits specified in the certification specifications applicable to air taxi operations. In such case, table 1 in CS FTL.2.205 for air taxi shall apply.”

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 106 of 277 An agency of the European Union

comment 1057 comment by: Rabbit-Air Ltd

3 local nights (suggestion EBAA) would hinder crew planning of a small operator having minimum crew available! Preferred suggestion of CatAvi using extended rest of 36 hrs incl. 1 local night is reasonable.

response Partially accepted

It is not clear to which requirement of point ORO.FTL.210 the comment refers. In principle,

60 hours of extended recovery rest, including 3 local nights, are proposed under point

ORO.FTL.205(d1) as additional mitigation measure for ATXO and AEMS operators to

compensate for the extended daily FDPs without in-flight rest.

However, since the requirement for 3 local nights of extended recovery rest may put undue

burden on small operators with limited pilot resources, it seems reasonable to remove it.

Operators shall anyway comply with point ORO.FTL.235(d) ‘Recurrent extended recovery

rest periods’, i.e. minimum 36 hours including 2 local nights. Those 36 hours are increased

to 48 hours twice every month.

comment 1074 comment by: FNAM

(a) ISSUE FNAM and EBAA France propose to exceed these limits when crew members are positioning home to begin an extended recovery rest period. As a mitigation, the next extended recovery rest period to the positioning shall include at least 3 local nights. PROPOSAL "(a) The total duty periods to which an individual crew member may be assigned in scheduled and charter operations and in Air Taxi and AEMS operations shall any of the following limits: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. These limits can be exceeded to positioning home if the next consecutive extended recovery rest includes at least 3 local nights."

response Please, refer to the responses to comments #132 and #193.

comment 1086 comment by: FNAM

(e) ISSUE

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 107 of 277 An agency of the European Union

The scope of the disposition is confusing. Indeed, the scope concerns respectively:

• Air Taxi and AEMS: first sentence in (e) • Only Air Taxi for (e)(2) although the referred CS FTL.2.205 applies for AEMS and

Air Taxi operations

Besides due to the possible evolution of the regulation notably for the CS, the IR shall not refer directly to a precise CS number, such as CS FTL.2.205. Moreover, the CS should have been clearly named in a manner to identify easily to which paragraph of the IR it refers. Furthermore, in the paragraph (e), it is not explicit whether:

• All the CS.FTL.2 requirements shall be applicable "in block"; or • The CS requirements should apply depending on what is said in the implementing

rule; or • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210(c) and another in CS FTL.2.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. Therefore, FNAM and EBAA France suggest listing the two options in the CS.FTL.2.210 instead of having one described in the IR and one in the CS. Cf. comment 1132 PROPOSAL Rewrite clearly for Air Taxi and AEMS the 2 options in CS. “(e) The total flight time to which an individual crew member may be assigned in Air Taxi and AEMS operations is established in accordance with the limits specified in the certification specifications applicable to Air Taxi and AEMS operations” and then refers to the 2 options in CS.

response Noted

Point (e) is deleted. The total FT limits applicable to scheduled/charter operations are

applicable to air taxi and AEMS operations, as has been the case so far.

comment 1145 comment by: GBAA

ORO.FTL.210 (a)(3) Flight times and duty periods The term "spread as evenly as practicable throughout that period (of 28 days)" does not make any sense for an operator with a floating fleet. Usually two persons per position are employed each applied for period of 14 days on an specific airplane. The remaining time of the month is travel and rest time. So in this way, the potential maximum 190 hours of duty are limited by the 110 hours limitation in any 14 consecutive days anyway.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 108 of 277 An agency of the European Union

response Please, refer to the responses to comments #132 and #193.

comment 1176 comment by: Danish Aviation Association

ORO.FTL.210: This is another example, where CAT airlines rules are implied on SME ATXO operators. There is a lack of scientific analysis and data. These flight times and duty periods should be deleted and replaced with limitations based on scientific data, fatigue reports and flight safety reports and allow for mitigation measures under the FRMS.

response Please, refer to the responses to comments #132 and #193.

comment 1266 comment by: Volkswagen AirService GmbH

Referring to (c): This table differs from CS.FTL.2.210. It is unclear to us which table needs to be applied. Please clarify.

response Accepted

Corrections are made as necessary.

comment 1367 comment by: Bartosz Fibingier

"(1) in accordance with (c). In such case, table 1 in ORO.FTL.205(b)(1) shall apply" - As per eur-lex there is no table 1 under ORO.FTL.205(b)(1), it starts with table 2 Maximum daily FDP — Acclimatised crew members.

response Accepted

Corrections are made as necessary.

comment 1368 comment by: Gama Aviation (UK) Ltd

We believe that the limitations in (a) 1) & 2) are not based on scientific data, and that whilst there is less restrictive daily FDP more restrictive cumulative flight hours have been applied. Suggest that the 60 hour and 110 hour limits may be exceeded, but only for the purposes of positioning crew home as a passenger to begin an extended rest & recovery period.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 109 of 277 An agency of the European Union

Additionally, the NPA allows the operater the choice between two different maximum daily FDP structures (ORO.FTL.210 or CS.FTL.2.205) depending on the minimum number of flight hours assigned to a crew member. If the reduction in lower cumulative hours is adopted, then the daily FDP allowed to be applied should be increased to a maximum of 15 hours twice in any 7 day period.

response Please, refer to the responses to comments #132 and #193.

comment 1386 comment by: Swiss Air-Ambulance Rega

Rega does 24 h on STBY with 6 h consecutive break and, in addition, to start night STBY, 180 min. breaks with at least one break of minimum 120 consecutive min. before in the daytime. Proposed amendment: The total duty periods to which an individual crew member may be assigned shall not exceed a maximum daily FDP of 14 hours. FDP of more than 12 hours can only be extended to a maximum of 14 hours by split duty. This requires at least one break of a minimum of 120 consecutive minutes during the FDP. Additionally, the following rest periods shall apply: Working days in a row and min. rest period in hours: 4 days: 36 hours 5 days: 60 hours 6 days: 84 hours Working 7 days and more in a row must not be allowed

response Not accepted

Please, refer to the responses to comments #132 and #193.

comment 1394 comment by: European Helicopter Association (EHA)

Deutscher Hubschrauber Verband / DHV (Germany) Paragraph No: ORO.FTL.210 (d)(1)(2)(3) Comment: There is no obvious reason to limit the total flight time per crew member except for the total flight time per year (in accordance with German FTL: 900 hours) Justification: Proven FTL system Proposed Text: delete (1) and (2), amend (3) to show „900 hours per calendar year“

response Please, refer to the responses to comments #132 and #193.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 110 of 277 An agency of the European Union

comment 1412 comment by: Dr Adam Fletcher

The inclusions in this section illustrate exactly why a major rethink of this approach is needed. In the case of flight time limits, the vast majority of EMS pilots will never get near them. This is because flying in EMS is generally relatively rare compared to standby hours (often in a ratio of 1 hours flying to 10 or more hours standby, as can be suppported by data from the EU). However, the duty periods, should they include standby, will force many existing operations to severely reduce services to their communities. For example, in many remote parts of Europe and also many populated ones, it is common to use a 7 day on and 7 day off roster. This typically means 72 hours per week made up of perhaps 7 hours flying, a small number of hours of other duty (e.g. checking weather, completing paperwork), with the majority of time spent in standby, which could include time to sleep, watch movies, or study. If standby is counted as duty, then many operations will not be viable, and safety, community service and productivity will all predictably suffer.

response Noted

Please, refer to the responses to comments #132 and #193.

For the purpose of calculating maximum daily FDP, only airport standby is counted as FDP.

The method of calculation of the time spent on home/hotel standby for the purpose of

calculating cumulative limits (point ORO.FTL.210) takes into account the response time.

comment 1507

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

Suggestion: (a)2 must be removed. (1) and (3) are sufficient for the robustness of an ATXO-schedule. This restriction might be exceeded in case of a positioning of a crew as passenger at home.

response Please, refer to the responses to comments #132 and #193.

ORO.FTL.215 (positioning)

3.1. ORO.FTL.215 p. 14

comment 46 comment by: VDV M

Time spent positioning for the calculation of consecutive rest prior next FDP should take into account the number of positioning sectors (like when changing more than one way of

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 111 of 277 An agency of the European Union

transport), flying as a passenger a direct fligth of 12hours, or 3 flights of 3 hours each, although resulting in a similar total lenght of travel is a different experience. Similarly mitagtions for better comfort classes (business or first) should be provided.

response Partially accepted

There will be a differentiation between positioning as a passenger and positioning as an

operating crew. As regards comfort classes, there is no scientific evidence to suggest that

they influence flight crew fatigue levels.

comment 196 comment by: Premium Jet AG

clarify positioning. self driving counts only for the driver as FDP in a special way. And it must be inline with FRMS.

response Please, refer to the responses to the comments under section ‘CS FTL.2.215’.

comment 219 comment by: ADAC Luftrettung gGmbH

Wird die Reisezeit zur Heimatbasis als duty time oder FDP angesehen?

response Travel time to home base is not positioning.

Please, refer to the definition of ‘positioning’ in ORO.FTL.105(18).

comment 274 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Positioning duration below 3 hours shall not count as duty period

response It is not clear what is meant under ‘positioning’ here.

Please, refer to the definition of ‘positioning’ in ORO.FTL.105(18).

comment 383

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To ORO.FTL.215(c): It is expected that most European HEMS operators will apply for deviations according to Article 22 Basic Regulation and flight time specification schemes according to ORO.FTL.125.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 112 of 277 An agency of the European Union

Since this will lead to a deviation from the CS (but not from the Part-ORO.FTL itself!) it remains unclear what effect such a deviation might cause on the rule ORO.FTL.215(c) stating "…in accordance with the certification specification…". The possibility to obtain an approval for a deviation should be addressed in this rule.

response Not accepted. The possibility to deviate from the CSs is, however, limited in scope by point

ORO.FTL.215(c) itself, i.e. an IFTSS shall specify the impact of positioning on the maximum

FDP.

A deviation from the CSs should not breach the implementing rules. This is the reason why

the IFTSS are subject to approval by the competent authority.

comment 451 comment by: Cat Aviation AG

for comments to (c) pls refer to CS FTL.2.215 for AirTaxi.

response Noted

comment 1031 comment by: Stephanie Selim

(c) Technical comment- The provision is proposed to be specific to air taxi operations. However, there is no rational to limit it only to this type of operations (apart from the probability of occurrence which seems higher for air taxi operations). The effect on fatigue can be supposed to be similar for all kind of operations. It is therefore proposed to modify ORO.FTL.215(c): "flight time specification schemes established in accordance with the applicable certification specifications applicable to air taxi operations shall specify the impact on the maximum FDP of:”

response Not accepted

There is currently no CS FTL.1.215 for positioning in scheduled and charter operations,

meaning that operators should comply with the applicable implementing rule.

ORO.FTL.220 (Split duty)

3.1. ORO.FTL.220 p. 14

comment 67 comment by: NetJets Europe

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 113 of 277 An agency of the European Union

ORO.FTL.220 (a)(2) NetJets supports proposal

response Noted

Support appreciated.

Response in relation to ‘split duty’ (comment #1040 (DSAC))

comment 1040 comment by: Stephanie Selim

Technical comment – Since flight time can’t be scheduled in advance in air taxi and EMS operations, the same applies to breaks on the ground. Still in order to ensure an efficient period of rest for the crew members during the break, it seems important to keep a principle of planning even with a very short notice (in order to have adequate flexibility to cover unforeseen activities). Therefore, an additional point is proposed in ORO.FTL.220(a): “(a)(3) In the case of air taxi and EMS operations, and by way of derogation from ORO.FTL.110, a split duty and an additional break on the ground may be planned at any point in time including after reporting. When a break on the ground is added within the FDP, the operator recalculates the maximum FDP in accordance with ORO.FTL.220.“

response The concept is accepted.

This flexibility will be added in point ORO.FTL.220 with the necessary adaptations required

for legal certainty.

comment 1043 comment by: Stephanie Selim

(a)(2) Editorial comment – Regulation refers to the basic maximum daily FDP: “the possibility to extend the basic maximum basic daily FDP taking into account the duration of the break or, in the case of air taxi and EMS operations, breaks on the ground, the facilities provided to the crew member to rest and other relevant factors;” However, by applying this proposal of changing “prescribed under point ORO.FTL.205(b)” by “basic maximum daily FDP”, we found some ambiguities on the fact that all FDP defined under ORO.FTL.205(b) are not clearly mentioned as “basic FDP” ? · ORO.FTL.205(b)(6) does not define any basic FDP according to the wording and the corresponding CS FTL.2.205 is not defined as a basic FDP. Therefore, does it means that air taxi and AEMS operations cannot apply FDP extensions with split duty when applying ORO.FTL.205(b)(6) ? · ORO.FTL.205(b)(7) does not define any basic FDP for HEMS according to the wording while the corresponding CS FTL.3.205 define a maximum basic FDP. Proposal: add the word basic where missing in the text of PART ORO and CS or come back to the previous wording “prescribed under point ORO.FTL.205(b)”.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 114 of 277 An agency of the European Union

response Accepted

Point ORO.FTL.220(a)(2) will be clarified as regards air taxi/AEMS operations.

comment 1089 comment by: FNAM

ISSUE The rule needs to allow split in post planning phase or in operation phase. PROPOSAL Add the following paragraph: “By way of derogation from ORO.FTL.110(a), for AEMS and Air Taxi operations, a split duty may be scheduled at any point in time including after reporting time.” RATIONALE: There is no additional fatigue with this disposition compared to if it was intended before, thus the mitigation is included in the proposal. Cf. comment 1135

response Accepted

Please, refer to the response to comment #1040.

comment 1091 comment by: FNAM

(a) ISSUE FNAM and EBAA France suggest coming back to the break definition. In any case, a break has to be taken on the ground. Therefore, the wording “or, in the case of Air Taxi and EMS operations, breaks on the ground,” is unnecessary and should be suppressed since it may only lead to misunderstanding. Cf. comment 1133 PROPOSAL Suppress the wording “or, in the case of Air Taxi and EMS operations, breaks on the ground,”.

response Not accepted

The wording ‘break on the ground’ is already used in the existing implementing rule.

comment 1103 comment by: European Cockpit Association

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 115 of 277 An agency of the European Union

Commented text: ORO.FTL.220 Split duty; (c) split duty shall not follow a reduced rest. ECA comment: add: (d) split duty is not allowed while being on alert. Reasoning: unclear wording - operators already looking for a possibility to combine breaks on ground during being on alert with split duty - there is a need for clarification, that this not to be used to extend the time of being on alert)

response Not accepted

A break is, by definition, a period during which the crew member is free of all tasks, i.e.

they are having a rest period. Being alert is presumably a state where the crew member is

on duty or awaits to be called for duty, i.e. they are on standby. ‘Standby’ is not part of the

FDP, whereas ‘break on the ground’ is.

comment 1159 comment by: GBAA

ORO.FTL.220 (b) Split duty "The break(s) on the ground shall count in full as FDP" makes it very difficult to calculate and the clarity of the statements, how long a break can be, is impaired unnecessarily. Example: A 3 hour flight is followed by a maximum break and another 4 hour flight. Now, the client likes to know the latest departure time of the second leg. Let's assume the operator uses 60 minutes for post- and pre-flight duties and travelling (30 minutes after and 30 minutes before the flight - the latter counts as FDP I suppose). Moreover, let's assume the maximum FDP is 13 hrs (It is very hard to use any figures out of the proposed table of max. FDP since it is way too much depended of the check-in time). So, the operator will have a FDP of 1h preflight+3h flight+0.5h preflight+4h flight=8.5h. This results in a maximum break of 4h (also regarding postflight). But, 50% of that will again extend the FDP in this case. So, new max. FDP is 13h+2h=15h. Now, the break can be longer by 2h which is then a maximum break of 6h. Having a 6h break equals 50%=3h extension or 16h in total which allows a break of 7.5h which extends... and so on. In the last mentioned iteration, the latest departure would be 12h after the first departure which is not the lastest possible. This procedure is anything else but practicable! As an alternative, Austria solved this issue by switching at more than a 6 hours break from extending the FDP by 50% to simply having an addition FDP of 1 hour and keeping the regular maximum FDP.

response Not accepted

The proposed alternative is not clear. An extension of 1 hour of the regular maximum FDP

is incomparable with an extension of 3 or more hours (50 % of all breaks). The time for

break, or breaks, is a period of time within an FDP during which a crew member is free of

all tasks and has a rest opportunity.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 116 of 277 An agency of the European Union

The time for post- and pre-flight duties and travelling is part of the FDP and is fixed by the

operator (30 minutes as a minimum). The longer the breaks (but not longer than the

minimum rest), the lesser the impact of post- and pre-flight duties and travelling on the

FDP.

comment 1446 comment by: European Cockpit Association

Commented text: “Split duty, breaks on the ground” References p.14 ORO.FTL.220 (a) (2) p.26 CS FTL.2.220 (a) & (b) p.32 CS FTL.2.220 no. 27 ECA Comment: The CS2 introduces the idea of multiple breaks on the ground between different sectors being available to add together for the purposes of a split duty FDP extension. There is no scientific basis for this suggestion, indeed scientific advice previously received by EASA advocates “limiting the fragmentation of sleep as afar as possible” in order for it to provide meaningful rest. This ‘split-split duty’ enables the complete opposite of that advice, providing only fragmented rest opportunities that should not be usable for the extension of FDP under split duty. Proposal: Only one continuous and undisturbed break in an FDP should be available for the extension of that FDP under split duty. The ‘split-split duty’ must be prohibited.

response Not accepted

In a 24-hour-a-day industry, breaks can happen for various reasons. In fact, there is

scientific evidence demonstrating that breaks from a continuous performance of a

required task are important to maintain a consistent and appropriate level of performance.

A break spent in a suitable accommodation where the crew can obtain rest/sleep

opportunity is an effective mitigation measure against fatigue.

comment 1466 comment by: VOLDIRECT

(c) says that split duty shall not follow a reduced rest. This is NOT compatible with air taxi operations, where early morning / late return typical flights for business, require a split duty during the day.

response Not accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 117 of 277 An agency of the European Union

A minimum rest period should be assigned after an early morning / late return duty prior

to reporting for another duty. The break is shorter than the minimum rest but is not

reduced rest in the sense used in point ORO.FTL.235(c).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 118 of 277 An agency of the European Union

ORO.FTL.225 (Standby)

3.1. ORO.FTL.225 Standby and duties at the airport p. 14-15

Responses in relation to ‘standby’

comment 452 comment by: Cat Aviation AG

for comments refer to CS FTL.2.225. Standby for Air Taxi Ops.

response Noted

comment 1093 comment by: FNAM

(e) ISSUE

In the CS FTL.2.220 (split duty), a class A facility is equivalent to an accommodation. FNAM and EBAA France agree with this logic. In the same philosophy and to ensure consistency, FNAM and EBAA France would like Class A facility to be considered as an accommodation for standby also. Therefore, FNAM and EBAA France suggest adding it in the paragraph (e) and precising it in the definition of an accommodation (cf. comment 1032). PROPOSAL Add a GM to CS FTL.2.220 for Air taxi and AEMS operations whose content is the following: “A Class A facility is an accommodation.”

response Accepted

Please, refer to GM3 CS FTL.2.225 ‘Standby’.

comment 1279 comment by: Volkswagen AirService GmbH

Standby is different in ATXO from charter or scheduled operations. We do not standby only

for a particular flight. We are on standby in a general manner for any type of duty. Stby is

a regular service in ATXO. FTL 225. does not reflect this fact.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 119 of 277 An agency of the European Union

Point ORO.FTL.225 applies to all types of operations. The specific requirements for air

taxi/AEMS operations are contained in CS FTL.2.225. The structure of the FTL regulation

has been clarified in the explanatory text of NPA 2017-17.

comment 1281 comment by: Volkswagen AirService GmbH

Refers to (b) "shall be in the roster".

As we operate on demand only, it is not possible to preplan and roster specific duites. All

duties are depending on each other and are on short notice. We may roster undefined

periods of duty, but dedicated duties are not known in advance. If we have to schedule all

duties in advance, we have to keep available personnel for each duty, every day, even if

we have no tasks. This makes no sense with regard to fatigue management as well. Flights

and duties are planned in our operations on short-term basis only.

response Noted

Your comment refers to point (a) of point ORO.FTL.225.

Please note that ‘standby in the roster’ does not mean that the start and end time of

standby shall be in the roster too. The operator may apply strategic planning to rosters.

Start and end times may be notified later on, at short notice, but still in advance to provide

crew members concerned with the opportunity to plan adequate rest.

comment 1293 comment by: Volkswagen AirService GmbH

Referring to (f): Standby at home or at hotel should be possible for 24 h as long as a

sufficient reporting time (eg. 3 hours) is granted.

response Noted

It is possible. Please, refer to CS FTL.2.225.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 120 of 277 An agency of the European Union

comment 1325 comment by: Babcock Mission Critical Services Limited

Passive & Active Standby The nature of EMS standby is very different to that of scheduled commercial aviation, which does not rely on standby to a major degree at all. Even in busier EMS operations, were most of the requirement is to be available on-demand, coupled with a need for crew to sometimes fly multiple short sectors at short notice, the actual time spent at the EMS base on call or on duty is significantly higher and generally less demanding. This is especially the case during night shift, where crew can most frequently sleep throughout the night in suitable accommodation on base. There are other permutations, however, and the differences between them are critical to consider before writing regulations. We urge EASA to reconsider its position on counting Standby as duty, as described in the report submitted to EASA via comment 793 (Mission Critical Services Notice of Proposed Amendment 2017-17 Response Considerations, Fletcher et al, Integrated Safety Support, February 2018).

response Not accepted

Point ORO.FTL.225 stipulates that airport standby is a duty period for the purpose of

cumulative duties and rest, but it is not an FDP. The period of other standby (which is

different from airport standby) in a suitable accommodation (at home or hotel) is not

automatically considered a duty period. It is usually a percentage (0 to 100%) depending

on the response time.

Please, also note that airport duty is different from airport standby.

ORO.FTL.235 (Rest)

3.1. ORO.FTL.235 p. 15

Responses in relation to ‘rest’.

comment 15 comment by: Aliparma/FOPh

Rationale: a lot of Airtaxi Operators are homebased on small airports / cities and often crew members lives in the sorroundings. It means less than 30 minutes travelling to / from home. For this reason I would add point 3 to ORO FTL.235 as follows: (a) Minimum rest period at home base.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 121 of 277 An agency of the European Union

(1) The minimum rest period provided before undertaking an FDP starting at home base shall be at least as long as the preceding duty period, or 12 hours, whichever is greater. (2) By way of derogation from point (1), the minimum rest provided under point (b) applies if the operator provides suitable accommodation to the crew member at home base. 3) By way of derogation from point (1) and for air taxi operations only, the minimum rest provided under point (b) applies if the travelling time to residence, temporary accomodation or suitable accomodation is less than 30 minutes from the Home base. (b) Minimum rest period away from home base. The minimum rest period provided before undertaking an FDP starting away from home base shall be at least as long as the preceding duty period, or 10 hours, whichever is greater. This period shall include an 8-hour sleep opportunity in addition to the time for travelling and physiological needs.

response Not accepted

Operators that need more flexibility than that allowed for under point ORO.FTL.235(a) and

(b) may use the option provided under point ORO.FTL.235(c) to further reduce rest periods

at home base or at outstation.

comment 16 comment by: Aliparma/FOPh

I would add point 7) to c1 c1) Reduced rest for air Taxi operations : 1)... 2)... 3)... 4)... 5)... 6)... 7) the travelling time to/ from the Home base.

response Accepted

comment 68 comment by: NetJets Europe

ORO.FTL.235 (c1) NetJets supports proposal

response Your support is appreciated.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 122 of 277 An agency of the European Union

comment 201 comment by: Premium Jet AG

(a): Mitigation already under limitation for BA 80/210 and 625 Point 7: No scientific data dased on. See study and correct or remove.

response The comment is not clear.

Point ORO.FTL.235 does not have a point (7).

comment 453 comment by: Cat Aviation AG

ref our comments and details refer to CS.FTL 2.235 c) - which seems more restrictive than CS.1 - what is the rationale?

response CS FTL.2.235(c) refers to planned reduced rest periods and takes into account the specific

characteristics of air taxi and AEMS operations.

comment 1053 comment by: Stephanie Selim

(c) Technical comment – This subsection ORO.FTL.235(c1) applies only to air taxi whereas CS FTL.2.235(c) refers to both air taxi and AEMS. A clarification is needed.

response Accepted

Text clarified.

comment 1098 comment by: FNAM

(c1) ISSUE The aim of (c1) is unclear and may lead to misunderstanding. Indeed: 1/ On the one hand, the paragraph (c1) refers to certification specifications for Air Taxi and is only applicable for Air Taxi. On the other hand, the corresponding certification specification is applicable for Air Taxi and AEMS operations. There is no CS applicable for the sole Air Taxi operations on this matter. 2/ For Air Taxi Operators, according to the current wording, both paragraph (c) and (c1) apply. This is not consistent.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 123 of 277 An agency of the European Union

Therefore, there is a need to clarify the scope of the paragraph (c) and (c1) or to withdraw the paragraph (c1). PROPOSAL

• Suppress the paragraph (c1)

• Change the scope of paragraph (c): “(c) […] except for AEMS and Air Taxi operations “; AND

• Add in the scope of the paragraph (c1) the AEMS operations

response 1. Accepted. Text clarified.

2. Accepted. Text clarified.

3.2. Draft certification specifications - CS FTL.1 p. 18

comment 565 comment by: Rüdiger Neu

Bei der Nutzung von individuellen CS, sowohl auf der Basis von Betreibern oder Ländern, wird das Ziel der EASA eine Harmonizierung zu bekommen klar verfehlt. Der Wettbewerb würde außerdem erschwert werden, da ein neuer Betreiber die CS des Vorgängers nicht nutzten kann und bei einer Übernahme eine CS nur mit hohem Kostenaufwand bzw. garnicht erstellen kann, da er sich an die Vorgaben halten muss.

response Noted

The purpose of certification specifications (CSs) is clearly defined by the legislator.

CSs are non-binding technical standards issued by EASA, which indicate the means to

demonstrate compliance with Regulation (EU) 2018/1139 and with the delegated and

implementing acts adopted on the basis thereof, and which are used by persons and

organisations for the purpose of certification.

CS FTL.2.100 p. 21

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 124 of 277 An agency of the European Union

comment 161 comment by: Safety and Compliance Manager

Attachments #73 #74

FTLs prescribed by EASA have increased the levels and frequency of Fatigue and Stress reported by Crew. Please see CHIRP editorials attached (relevant information in yellow). These were published 1 year and 2 years after entry in force of the regulation and the analysis is alarming. The proposed FTLs in CS-FTL2 have not taken into account the fatigue reports done by the crew these past 2 years! Why? Evidence has shown that CS-FTL1 is much safer than what was published in part FTL. And EASA must take into account this reality. The proposed FTL decrease safety.

response These statements are not accepted.

EASA has used scientific reports and advice (referenced in NPA 2017-17 and in CRD 2010-

14) to develop CS FTL.1 and CS FTL.2.

GM1 CS FTL.2.100 p. 21

comment 1334 comment by: ENAC

“An AEMS flight may include positioning the aeroplane after the patient is unloaded from the aeroplane to enable it to return to a suitable location for the next AEMS flight”. We propose to consider also the positioning flight before the patient is loaded.

response Accepted

This concept has already been reflected in definition (29) of ‘AEMS operation’.

GM1 CS FTL.2.100 will be complemented.

comment 772 comment by: AECA helicopteros.

Positioning is not defined for AEMS, only for Air taxi (CS FTL 2.215).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 125 of 277 An agency of the European Union

response CS FTL.2 applies to air taxi and AEMS operations.

comment 1087 comment by: Stephanie Selim

Technical comment- This GM does not bring any additional guidance, since everything is already in ‘EMS flight’ definition (cf. last sentence). Moreover, it brings confusion with the commander’s discretion impossibility to extend FDP after the last take-off if the patient is not on board (see also CS FTL.2.205 corresponding comment). It is proposed to delete it.

response Not accepted

Even if commander’s discretion cannot be used after the last take-off, if the patient is not

on board, the operation still benefits from the greater number of sectors and the longer

duration of the FDP allowed under CS FTL.2.

CS FTL.2.200 (Home base)

CS FTL.2.200 p. 21

Replies in relation to home base

comment 48 comment by: Wolfgang Zellhuber

In air taxi operation a high percentage of freelance pilots/personnel are working. Due to the fact that (to avoid a status of false self-employment) a freelance pilot needs at least two different operators, there is a high possibility that these two operators have different home bases. For example one operator has home base EDDM, the other operator EDMA. The driving distance/time between the two aerodromes is 84km/50minutes. How shall a pilot, and more important, how shall the two operator handle that situation if they consider either EDDM or EDMA as only homebase or if the pilot has a regular "change" of the home base (when the pilot is flying for the operator based at EDDM-> EDDM is the home base, when the pilot is flying for the operator at EDMA-> EDMA is the home base) which requires the pilot to have a rest of 72 hours? This situation would ruin the pilot because he/she is not able to work and earn his/her living costs.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 126 of 277 An agency of the European Union

In fact EASA would justify this with safety reasons. In some cases this argument could be rejected. To use the above example again: If the pilot has his/her permanent residence have way between the two aerodromes the hazards/risks are equaliy spread. And even if the pilot was living at one of the two aerodromes the other aerodrome is still in a 90 minutes travelling time. Please consider that such regulation could have/could be - a competitive disadvantage of freelance personnel, - against the freedom of professional practice The NPA 2017-17 pushes many operator in situations of uncertainty. Please clarify the relevant issues.

response Noted

Please, refer to the response to comment #127.

Home base is the place form which a crew member normally starts and ends a duty period,

including a positioning flight. The assignment normally appears in the crew member’s

individual schedule/roster.

A freelance pilot working for two operators will have two home bases from which they

start their duty periods.

comment 69 comment by: NetJets Europe

CS FTL2.200 (a) Opportunity to clarify what does "high degree of permanence" mean? CS FTL2.200 (b) NetJets proposes that the requirement of CS.FTL2.200 (b) is only applicable if the change of home base is the requirement of the operator and not at the request of the crewmember. In air taxi operations, some operators provide the crew members with the opportunity to temporarily change their home base between rotations or to begin a rotation from a place (temporary home base) different from the normal home base. When this is at the request of the crewmember, the crewmembers have to ensure that they have adequately planned and used the rest opportunity to rest. In these cases, it is not the operator that requires the change and the operator is not responsible for the travelling time between homebases.

response Noted

Home base is the place from which a crew member normally starts and ends a duty period,

including a positioning flight.

Please, refer to the response to comment #127.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 127 of 277 An agency of the European Union

comment 134 comment by: VistaJet

The concept of home base is not so simple for ATXO. As many operators use gateway airports crew may move location from one gateway to the next on the following rotation. Also, the base of operations is not where the aircraft are, so cannot be used. A high degree of permanence needs to be further clarified for ATXO.

response Noted

Home base is the place from which a crew member normally starts and ends a duty period,

including a positioning flight.

Please, refer to the response to comment #127.

comment 168 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

(c) If the change of homebase is on request of the pilot (b) does not apply. Rest periods as described in ORO.FTL.235 will apply in this case.

response Noted

Please, refer to the response to comment #127.

comment 194 comment by: Premium Jet AG

(a) due to the business models of business aviation it should be taken into account that gateways are used. Anyhow a mutual agreement between the operator and the employee should be possible without the increased recovery rest period.

response Please, refer to the response to comment #127.

comment 240 comment by: Thomas Henselmann

(a) the definition home base might not apply to some Air Taxi operations. Please review the option towards a mutual agreement on duty and rest periods on the basis of a gateway concept without extended rst periods for air taxi operations.

response Please, refer to the response to comment #127.

comment 293 comment by: European Business Aviation Association (EBAA)

CS FTL.2.200 Home base — air taxi and AEMS

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 128 of 277 An agency of the European Union

(a) The home base is a single airport location assigned with a high degree of permanence. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning.“ EBAA COMMENT: Due to the nature of the business employee and operator should be able to mutually agree on changing the Homebase on a rotation/duty period basis without being restricted by the recurrent extended recovery rest period SUGGEST CHANGE: Review the point in accordance. RATIONALE: today some business aviation operators/business models use the concept of gateway. The rule needs to consider this situation.

response Please, refer to the response to comment #127.

comment 423 comment by: Skyshare Union representing NetJets crew members

We propose an amendment to (b) to add “...is positioning unless undertaken on an off- duty day at the request of the crew member.” Reasoning: We use ‘gateway’ airports, where we report for a tour of duty but we have no aircraft based. From the gateway airport NetJets positions us, in duty time, to meet our aircraft. NetJets allows us to change gateway for personal reasons, for example if we have homes in more than one country or want to spend time temporarily somewhere else. The protections in CS.FTL.2.200 (b) regarding travelling time being ‘positioning’ do not affect the use of temporary gateways where the switch is made during a tour (we simply start the tour at one gateway and end at another). Travel to gateway is always duty (flight duty or positioning) regardless whether it’s a permanent or temporary gateway. However, when the switch is made during off-duty days this regulation inconveniently requires the travel from permanent to temporary gateway to be counted as positioning. For example if we drive with our family to another country to use another gateway for an extended vacation, this regulation would require that drive to be counted as positioning and duty time, which is an unfair burden on the company and risks us losing this facility.

response Please, refer to the response to comment #127.

comment 769 comment by: AECA helicopteros.

Determine the concept of ‘high degree of permanence’. Our proposal is include as definition.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 129 of 277 An agency of the European Union

response Please, refer to the response to comment #127.

comment 770 comment by: AECA helicopteros.

Question needing answer by regulation: In case of base change for emergency reasons, the pilot need specific training, regarding the new base?.

response Please, refer to the response to comment #127.

comment 804 comment by: Babcock Mission Critical Services Limited

It could be understood that if you have a pilot assigned to one AEMS home base and you scheduled this pilot to one or several duties to another base, the operator must let him rest 72 hours with 3 local nights between the positioning and the first duty. We think it must only apply if you change the home base of the pilot as a permananent assignment, not as a result of, for example, if a pilot is sick and you need to roster immediately another pilot assigned to other home base. Revise “Home base” definition: CS FTL.2.200 Home base — air taxi and AEMS (a) The home base is any location assigned to the crew member with a high degree of permanence. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is considered Positioning in accordance with ORO.FTL.215. CS.FTL.3.200 Home Base – HEMS (a) The home base is any location assigned to the crew member with a high degree of permanence. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is considered Positioning in accordance with ORO.FTL.215 GM.CS.FTL.2/3.200 (a) Home Base

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 130 of 277 An agency of the European Union

In case of a touring pilot, their main place of residence may be considered as their home base. In this case fatigue protection is provided by all travelling to/from a HEMS operating base, as being considered as positioning within the FDP.

response Please, refer to the response to comment #127.

comment 897 comment by: Stephanie Selim

CS FTL.2.200 (b) : Editorial comment – Wording similar to CS FTL.1.200 is suggested: “In the case of a change of home base, the first recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning.”

response Please, refer to the response to comment #127.

comment 1061 comment by: Rabbit-Air Ltd

review definition of home base. Home location (incl. not exclusivly an airport) would match better to Ait Taxi.

response Please, refer to the response to comment #127.

comment 1101 comment by: FNAM

ISSUE Due to the specific operation of Air Taxi and AEMS, and in order to have the same philosophy than in HEMS, FNAM and EBAA France propose the possibility to have multiple airport bases for Air Taxi and AEMS operations. PROPOSAL Add in CS the possibility to have multiple home base such as: "(a) The home base is assigned to each crew member with a high degree of permanence and may either be: (1) a single operating base; or (2) multiple operating bases if the travelling time between any of these operating bases does not exceed 120 minutes under usual conditions (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning or flight duty period."

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 131 of 277 An agency of the European Union

response Please, refer to the response to comment #127.

comment 1369 comment by: Gama Aviation (UK) Ltd

Due to the nature of ATXO operations, the operator should be able to change the home base, if mutally agreed, on a per rotation/duty period basis without subsequent restriction of extended recovery rest period. Some ATXO operators use the Gateway concept for crew reporting and this should be accounted for.

response Please, refer to the response to comment #127.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 132 of 277 An agency of the European Union

CS FTL.2.205 (FDP)

CS FTL.2.205 p. 21

comment 43 comment by: VDV M

In air taxi operations, last minute changes to flight schedules are quite frequents. Flight crew once advised of an impending flight duty, should therefore take appropriate actions to be adequate rested for the incoming duty. In case of changes to schedules, longer duties than planned, flight crew will therefore lack of proper rest. Some sort of mitigation should exist in case of major flight schedule changes. The same applies to food and drink opportunities, not all airports allow crew to introduce personal food into the airport environment, therefore extended than planned fligth schedule should allow for crew to maintan their operational robustness.

response Accepted

Changes to the flight plan and crew schedule after an assigned FDP has already started

need to be managed by the operator for fatigue-related risks under its SMS or FRMS.

In addition, changes to crew schedule after reporting are allowed in unforeseen

circumstances under commander’s discretion or split duty. In both cases, mitigation

measures are foreseen, including a requirement for the consent of crew members,

provision of suitable accommodation, and nutrition in the case of split duty (ref.: point

ORO.FTL.220).

comment 44 comment by: VDV M

The time in advance to which an impending flight duty is communicated to a flight crew member will have a major effect on the previous rest the crew member will consciosly be able to take.

response Accepted

This is already captured in point ORO.FTL.110.

comment 47 comment by: VDV M

Air taxi operations, by their nature, differently to scheduled operations, require fligth crew to fully prepare the aircraft not only from a purely cockpit point of view (FMS, performance calculations..), but also from a technical point of view (covers removal, pin removal, engine covers, etc..).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 133 of 277 An agency of the European Union

Not specifying an absolute minimum pre/post-flight duty, will lead too much discretion to operators. Furthermore operators should be required to specify different pre/post-flight in case of adverse weather climate where lenghty aircraft preparation are required. For example in winter in nordic countries aircraft needs to be fully drained by water based fluids to avoid damages, and catering equipment to be removed to avoid freezing. Similarly pre flight duties are longer as aircrafts need to be unfrozen before being powered up (not talking in this comment of deicing-anticing fluid application). Similarly as RNP guidelines require operators to implement procedures in their manuals when crew members are expected to update avionics database, these procedures should indicate the average time needed, so to be taken into account in pre/post-flight duties.

response Noted

As per AMC1 ORO.FTL.210(c), the operator needs to specify pre-flight and post-flight duty

times taking into account the type of operation, the size and type of aircraft used, and

airport conditions.

Your comment also confirms that pre- and post-flight duty times are context driven.

Therefore, it makes no sense to establish mandatory absolute minimum times for every

operator.

Please note that post-flight duty counts as duty period. The operator is responsible to

monitor roster robustness, in particular to monitor whether the actual post-flight duty time

is longer than that established in the OM. The operator has to ensure that the time

allocated for post-flight duties is adequate, since rest or shortened rest could potentially

impact on fatigue.

Pre-flight and pre-departure duties are part of the ground duties. Ground duties are part

of the FDP. The operator has the responsibility to specify reporting times that allow

sufficient time for ground duties.

Responses in relation to Tables 9 and 10 of CS FTL.2 (previous Tables 1 and 2)

comment 111 comment by: UK CAA

CS FTL.2.205, Flight Duty Period Comment: From page 21 there are 6 paragraphs referring to CS FTL.2.205, for clarity they should all be uniquely identified: (a), (b), (c), etc. For the final documentation, EASA are requested to ensure the regulations are clearly identified with uniquely numbered sections and subsections. Justification: Clarity

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 134 of 277 An agency of the European Union

response Accepted

Changes have been made to ensure that implementing rules and CSs are clearly identified

by assigning unique numbers to sections and subsections.

comment 142 comment by: CAA-NL

CS FTL.2.205, Flight Duty Period Comment: From page 21 there are 6 paragraphs referring to CS FTL.2.205, for clarity they should all be uniquely identified: (a), (b), (c), etc.

response Please, refer to the response to comment #111.

comment 737 comment by: European Business Aviation Association (EBAA)

CS FTL.2.205 Flight duty period (FDP) — air taxi and AEMS - Night duties in air taxi and AEMS Night duties in air taxi and AEMS operations under ORO.FTL.205(b)(6) and (d1) Night duties in air taxi and AEMS operations comply with the following: (1) When establishing the maximum FDP for consecutive night duties, the number of sectors is limited to 4 sectors per duty. (2) The operator applies appropriate fatigue risk management to actively manage the fatiguing effect of night duties of more than 10 hours in relation to the surrounding duties and rest periods. EBAA comment: due to the high frequency, short flight at AEMS this is not achievable for some operators Suggested change: to have a limit of 4 sectors after 3 nights

response Partially accepted.

EASA decided to remove this CS. However, a new CS3 FTL.2.205 requires that disruptive

duties be assigned under appropriate FRM mitigations, in a similar manner as that for

scheduled and charter operations.

comment 777 comment by: AECA helicopteros.

CS ORO FTL 2.205. This code is repeated 6 times, without specific differences. This makes difficult its administrative reference.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 135 of 277 An agency of the European Union

comment 825 comment by: Babcock Mission Critical Services Limited

We find the layout and alphanumeric referencing within CS.FTL.x.205 to be ambiguous and hence confusing. In each case, there is more than one instance of the heading, but with different suffixes, e.g. – AEMS, - ATX and AEMS, - HEMS, etc. and in some cases the only differentiation is the line of text below the header in italics. We recommend that EASA revises the layout of these requirements and/or provide unique alphanumeric references in each case, in order to remove ambiguity and potential confusion, and for ease of reference.

response Accepted

comment 905 comment by: Stephanie Selim

General editorial comment – Number the subsection of CS FTL.2.205, respecting the order of ORO.FTL.205: (a) Maximum daily FDP without extensions under ORO.FTL.205(b)(6) (b) Night duties in two-pilot air taxi and two-pilot AEMS operations under ORO.FTL.205(b)(6) and (d1) (c) Maximum daily FDP with extensions without on-board rest under ORO.FTL.205(d1)(4) (d) Extension of the maximum basic daily FDP due to on-board rest under ORO.FTL.205(e) (e) Unforeseen circumstances in AEMS operations — commander’s discretion (f) Unforeseen circumstances in air taxi and AEMS — delayed reporting

response Accepted

comment 909 comment by: Stephanie Selim

Editorial comment – The scope of application should be more precise and apply to two-pilot air taxi and two- pilot AEMS operations only as referred to ORO.FTL.205(b)(6) and (d1): Title: “Night duties in two-pilot air taxi and two-pilot AEMS operations under ORO.FTL.205(b)(6) and (d1)” Text: “Night duties in two-pilot air taxi and two-pilot AEMS operations comply with the following:”

response Please, refer to the response to comment #737.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 136 of 277 An agency of the European Union

comment 1003 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Table 1 is too fractured with too many FDP changes every 15' to 30'. This is far to complicated for Air Taxi operation. WOCL period, most limitations in FDP, now starts already at 1700h reference time. Please consider the difference between scheduled commercial and Air Taxi. Please redo the table.

response Noted

Under Subpart Q, a 13-hour FDP starting at 17:00 hrs will fully encroach on the WOCL, i.e.

will be limited to 11 hrs.

The same 11 hrs are required for duties starting at 17:00 according to Table 1.

comment 1104 comment by: FNAM

ISSUE Due to the high frequency, short flight at AEMS, the proposal may not achievable for some operators with the 4 sector limitation. PROPOSAL Modify the CS.2.205 such as: "(1) When establishing the maximum FDP for consecutive night duties, the number of sectors is limited: (i) For Air Taxi , to 4 sectors per duty (ii) For AEMS, for more than 2 consecutive night duties, to 4 sectors per duty (2) ....”

response Please, refer to the response to comment #737.

comment 1162 comment by: GBAA

CS FTL.2.205 (2) Flight duty period (FDP) — air taxi and AEMS What does "appropriate fatigue risk management" mean to extend the 10h of night flying? How can it be achieved by a small company with 3 aircraft depending on night flights which the client requests? For instance, flying from Paris to Kinshasa during the night. First leg to Niamey takes about 6:00h and the second leg to Kinshasa about 3:45h. Preparation of 1h plus a fuel stop of 45 minutes equals a total FDP of 11:30h. Currently, the Subpart Q states that "whenever a FPD including an extension starts in the time bracket from 2200h to 0459h the duration of the FDP shall be reduced to 11:45h." The new proposal would not allow this unless a costly study is prepared and accepted most probably only for this specific route which takes place maybe only once or twice a year. Why isn't it possible to keep the old rule?

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 137 of 277 An agency of the European Union

response Please, refer to the response to comment #737.

comment 1372 comment by: Gama Aviation (UK) Ltd

The limitation of 4 sectors in consecutive night shifts is not a practical restriction for short sector length and high frequency operations of the type operated by Gama Aviation, and has significant potential for adverse restriction in the operation of AEMS services in Scotland. Suggest night duties be restricted to a maximum of 3 consecutive shifts in according with exisiting regulations: Should any duties be scheduled to be carried out in any part of the period between 0200to 0459 local time, for a minimum of 2 and a maximum of 3 consecutive nights, then crew members must be free from all duties by 2100 hours local time before covering the block of consecutive night duties, such that crew members can take a rest period during a local night. The operator may roster crew members for either 2 or 3 consecutive night duties, but must ensure that the duty preceding this series of duties finishes by 2359 hours local time (2 nights) or 2100 hours local time (3 nights). OR The 4 sector limit only becomes applicable after the 3rd consecutive night shift in AEMS operations.

response Please, refer to the response to comment #737.

comment 1508

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

As a general remark: Table 1 is much too fractured and entails too many FDP changes every 15-30 minutes. This is far too complicated for an ATXO. Please consider the difference between scheduled commercial AO and ATXO. We strongly suggest to reconsider, redo and or drop this table completely.

response Please, refer to the response to comment #737.

comment 135 comment by: VistaJet

This table is overly complex and is near impossible to work with in an operational capacity.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 138 of 277 An agency of the European Union

Having start times separated by as little as 14min is quite frankly unworkable. In the ATXO/VIP charter environment it is impossible to plan the feasibiltiy of a trip where a delay of 15 min will put you into discretion. The nature of the This table will almost certainly result in a high % of non-compliance. Again, a simple hard limit with FRMS customising limits based on the scope of the operation is far more practicle in all instances. It is unnecessary to have an overly complex FTL table AND FRMS. Suggest to have similar to the FAA Part 135, a simple 14Hr FDP limit.

response Please, refer to the response to comment #737.

comment 169 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

Table: Maximum daily FDP in hours - Acclimatised crew members in two-pilot air taxi and AEMS operations Number of sectors will remain the same, except 9and 10 will be the same 0600-0800 13:00 12:30 11:30 11:00 10:30 10:00 10:00 0801-0900 13:30 12:30 11:30 11:00 10:30 10:00 10:00 0901-1200 14:00 13:30 12:30 11:00 10:30 10:00 10:00 1201-1300 13:30 13:30 12:30 11:00 10:30 10:00 10:00 1301-1400 13:00 12:30 12:30 11:00 10:30 10:00 10:00 1401-1600 12:00 11:30 11:30 11:00 10:30 10:00 09:00 1601-1700 11:30 11:00 10:30 10:00 10:00 09:00 09:00 1701-0430 11:00 10:30 10:00 10:00 09:00 09:00 09:00 0431-0600 12:00 11:30 11:00 10:30 10:00 09:00 09:00 This table needs to be simplified. Our suggestion is above. 15 min sectors are not working for us, as our clients change timings a lot. At 9 secotrs we would suggest to make it 9 or more.

response The table will be reworked to remove granularity and allow for a step longer than

15 minutes, for simplicity.

comment 195 comment by: Premium Jet AG

Table 1: is not inline with other requirements (CAT OPS) Table 2: Suggestion: Acc. ORO.FTL.205(d1)add sector 5 and with poss. FRMS extension up to 14hFDP (6) limit should be extended if FRMS is used delayed reporting: Far too complex.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 139 of 277 An agency of the European Union

response The comment is not clear.

comment 209 comment by: Cat Aviation AG

this table 1 is too fractured with too many FDP changes every 30' of starting time. AirTaxi's main purpose is flexibility, which will be strongly hampered to administer and manage in planning. WOCL period most limitations in FDP now starts already at 1700h reference time! Suggest to redo table taking into consideration the difference in Operations between scheduled commercial and Air Taxi/EMS. Refer to our comments under 4.5 Conclusion, page 67 of the NPA.

response Please, refer to previous responses regarding Table 1.

comment 294 comment by: European Business Aviation Association (EBAA)

CS FTL.2.205 Flight duty period (FDP) — Maximum daily FDP without extensions EBAA COMMENT: MAJOR ERRORS in Table 1- Not consistent with neither the ORO (main CAT OPS) nor with the previous versions. Suggested change: EBAA suggests to correct this table to be in ling on the FRMC table (Table 2: Revised basic FDP table). Rationale: to be provided by EBAA

response Your statement about ‘major errors’ is not accepted.

The table was actually developed by EBAA and provided to EASA. One correction is

required for reference time ‘0830-0844’ for the ‘4 Sectors’ column; it should read ‘13:00’

instead of ‘12:30’.

However, the table will be simplified and the maximum FDP will be 13 hours, as for

airliners.

comment 702 comment by: Captain M Alcaide GVI

Although I have read the document, I haven't found the rationale behind the increase of maximum daily FDP, I guess must be based on some studies. 14 hours for two pilots is a very long period regardless of your operation CAT or ATXO, I dare say it will always be more stressful and fatiguing for the later. It's not about cumulative duties, obviously ATXO pilots fly much less than airline pilots. Flying ATXO requires objectively more time before the flight and more time after the flight, again I can't understand the support for an increase in maximum FDP. I have flown this kind of operation for a long time, first in the Air Force flying transport category civilian aircraft (i.e. Airbus 310 300) and for some time under two

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 140 of 277 An agency of the European Union

CAT Operators flying for a corporation and I can assure you that the same flight i.e. Madrid- Mexico is going to be more fatiguing for as than for an airline crew, and nevertheless the rationale is to increase FTL for ATXO. I really don't understand as we all share the same air space....I don't think the survey behind the studies is well done or has been made with some bias in mind. Yes ATXO pilots fly less hours, but when they fly they are as humans as airline pilots, and more time, regardless of previous rest, brings same consequences, a fatigue pilot is prone to error.

response Accepted

The table will be simplified and the maximum FDP will be 13 hours, as for airliners.

comment 814 comment by: NetJets Europe

CS FTL.2.205 Table 1 Netjets supports this table. Correction required on line reference time "0830-0844" for the "4 Sectors" column, it should read "13:00" instead of "12:30";

response Please, refer to the response to comment #702.

comment 835 comment by: Yorkshire Air Ambulance

Quite probably the most absurdly complex table that only EASA could have derived.

response Air ambulance flights are covered by CS FTL.1.

comment 1064 comment by: Rabbit-Air Ltd

table is too fractured and rises questions to scientific relevance when using 30' or even 15' steps. The flexibility in operation for VIP's is lost resp. The administation to meet the requirement is far to big!

response Please, refer to previous responses in relation to the table.

comment 1105 comment by: FNAM

ISSUE There are six CS FTL.2.205 with exactly the same title, which introduces complexity, uncertainty and may lead to misunderstanding. FNAM and EBAA France suggest adding precisions in the title of this paragraph in order to quickly make the link with the involved ORO paragraph.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 141 of 277 An agency of the European Union

PROPOSAL Replace the title of this CS by: “CS FTL.2.205(b)(1)”

response Partially accepted

comment 1106 comment by: FNAM

ISSUE Cf. comment 1050 In the paragraph (b), it is not explicit whether:

• All the CS.FTL.2 requirements shall be applicable "in block";or • The CS requirements should apply depending on what is said in the implementing

rule;or • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.205 (b)(1) and another in this CS FTL.2.205. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. PROPOSAL FNAM and EBAA France suggest listing the two options in this CS.FTL.2.205 renaming it “CS FTL.2.205(b)(1)” instead of having one Table in the IR and one Table in the CS.

response Not accepted

Please, refer to the responses to the comments in the ‘General comments’ section and in

section ‘ORO.FTL.205’.

comment 1107 comment by: FNAM

Attachments #75 #76

Table 1 ISSUE As explained here below, FNAM and EBAA France suggest putting all the Tables i.e limitations of FDP for Air Taxi and AEMS operations in the CS. 1/ Withdraw for Air Taxi and AEMS operations the Table 2 from the IR ORO.FTL.205 (b)(1) and put it in the CS as the OPTION 1, allowing, if an operator has a FRM, to increase the FDP limitations in the Table 2 by (Cf. Annex 2 & 3):

• For Air Taxi operations: 1 hour no matter the number of sectors

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 142 of 277 An agency of the European Union

• For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

In order to mitigate these proposals, a scientific study may assess whether and how it may be possible to have FDP over 14 hours under a FRM Cf. comment 1058 2/ OPTION 2: Redo the table 1 of this CS to ensure it can be used for Air Taxi and AEMS operations, taking into account that for Table 2 of the ORO.FTL.205(b), if an operator has a FRM, it is possible to increase the FDP limitations in the Table 2 by (Cf. Annex 2 & 3):

• For Air Taxi operations: 1 hour no matter the number of sectors

• For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

In order to mitigate these proposals, a scientific study may assess whether and how it may be possible to have FDP over 14 hours under a FRM Cf. comment 1058 PROPOSAL OPTION 1: Table 2 of the ORO.FTL.205 (b)(1) + if an operator has a FRM, the operator may increase the FDP limitations in the Table 2 by:

• For Air Taxi operations: 1 hour no matter the number of sectors

• For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

OR OPTION 2: New table (redo table 1 form this CS) taking into account that for Table 2 of the ORO.FTL.205(b), if an operator has a FRM, it is possible to increase the FDP limitations in the Table 2 by:

• For Air Taxi operations: 1 hour no matter the number of sectors

• For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards

response Not accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 143 of 277 An agency of the European Union

Both air taxi- and AEMS-related Table 1 and Table 2 are in CSs, not in the IR.

comment 1116 comment by: European Cockpit Association

Commented text: Table 1 ECA Comment: Table 1 does not reflect the purpose of the Rulemaking group anymore - in the context of other proposals of the NPA 2017-17. The sense was, that a single pilot flight crew should not have longer active working time than 12 hours dual pilot within a possibly by breaks extended longer alertness- (working-) time. Limiting factor is the minimum time of rest within 24 hours. Any time spent on standby/alertness plus post- and pre-flight- duties has to be counted for the cumulative duty limits. Suggesting max limit 12 hours depending on reporting time and to be prolonged by breaks of more than one hour up to 16h.

response Not accepted

As regards single-pilot operations, please refer to Table 5.

comment 1163 comment by: GBAA

CS FTL.2.205 Flight duty period (FDP) — air taxi and AEMS Maximum daily FDP without extensions A total FDP of 14h plus 3 sectors is very nice, but only in the most favorable time of the day. Outside this time frame, it becomes very complicated. A couple of minutes later or earlier check-in can decided about 15 minutes extra. Is this intended?

response Please, refer to the previous responses in relation to the table.

comment 1370 comment by: Gama Aviation (UK) Ltd

Error in Table 2. 08:30-08:44, 4 Sectors should read 13:00 and not 12:30. Table should be reviewd for accuracy.

response Please, refer to the previous responses in relation to Table 2.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 144 of 277 An agency of the European Union

comment 1445 comment by: European Cockpit Association

Commented text: “Flight duty Period (incl. night and unknown state of acclimatisation)” Reference CS FTL.2.205 Table 1 ECA Comment: All 3 scientific evaluations to the CAT FTL rulemaking process upon which this NPA is based recommend the maximum FDP at night be limited to 10 hours. Only one of these evaluations considered a reduction in FDP for multiple sectors of 30 mins, the other evaluations recommended more. Whilst under the CS2 regime (only in conjunction with lower cumulative flight time limits) there is justification for FDP reduction as of only the 4th sector, this reduction should be a minimum of 45mins per sector. Proposal: The table should be amended to ensure a maximum night FDP of 10 hours (and the related FDP for crews in an unknown state of acclimatisation should reflect this), and FDP reduction for sectors beyond the 3rd of 45 minutes minimum.

response Not accepted

The proposal is about air taxi and AEMS flights, not about scheduled operations.

comment 1482 comment by: Airlec Air Espace / Paul Tiba

AIRLEC suggests putting all the Tables i.e limitations of FDP for Air Taxi and AEMS operations in the CS. - Withdraw for Air Taxi and AEMS operations the Table 2 from the IR ORO.FTL.205 (b)(1) and put it in the CS, allowing, if an operator has a FRM, to increase the FDP limitations in the Table 2 by • For AEMS operations: o 2 hours until 4 sectors o 1h30 for 5 sectors o 1h for 6 sectors and onwards - In CAT.A FTL regulation, it is possible to have extensions of the FDP for 5 sectors. This should be the same for Air Taxi and AEMS operations. PROPOSAL Update this table and replace it by the one provide for CAT operations in CS.FTL.1.205(b) Maximum daily FDP with extension. Moreover, if an operator has a FRM, it is possible to increase the FDP limitations in this Table by: • For AEMS operations: o 2 hours for 1 to 4 sectors o 1h30 for 5 sectors In order to mitigate these proposals, a scientific study may assess whether and how it may be possible to have FDP over 14 hours under a FRM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 145 of 277 An agency of the European Union

response Noted

The tables relevant for air taxi and AEMS operations are contained in CS FTL.2.

The table with the FDP extensions will be reworked.

comment 70 comment by: Rega / Swiss Air-Ambulance

1. CS FTL.2.205 (1) (page 23 of 70 NPA 2017-17) Existing proposed CS FTL.2.205 (1): the FDP is limited to 3 sectors; Adaption requested by the writer for CS FTL.2.205 (1): … the FDP is limited to 4 (four) sectors; Justification: · The AEMS & Air Taxi Ops is quite often influenced by ultimate customs or technical (fuel) stops required by national authorities/aeroplane range limitations thus exceeding the proposed "limitation to 3 sectors". This to be able to reach the final destination (pick- up of patient) and continue to the point of disembarkation of patient or fly (back) to the point of origin to disinfect the AEMS aeroplane; · Flight crew members are also with 4 (ISO 3) sectors able to get on-board rest according: o CS FTL.2.205 (2) (... 2 consecutive hours for those flight crew members at control during the last landing ...); o To the individual FRMS in order to get at least twice 2 hours per maximum FDP according CS FTL.2.205 (i) and (ii); · The limitation of sectors to 3 is senseless as the extension of FDP using on-board rest shall be linked to at least 4 possible sectors. Otherwise the extension of FDP using on- board rest makes operationally no sense; · I will give EASA below three examples of recent Rega/Swiss Air-Ambulance AEMS missions where 4/5 sectors were of ultimate necessity to conduct the mission successfully: o Zürich, Switzerland LSZH - Abidjan, Cote d'Ivoire DIAP (custom stop) - Korhogo, Cote d'Ivoire DIKO (patient pick-up) - Abidjan, Cote d'Ivoire DIAP (custom stop) - Zürich, Switzerland LSZH (patient drop-off); o Bangkok, Thailand VTBD (patient pick-up) - Paro, Bhutan VQPR (patient pick-up) - Lahore, Pakistan OPLA (fuel stop due to max. take-off weight limitations at Paro, VQPR) -

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 146 of 277 An agency of the European Union

Baku, Azerbaijan UBBB (fuel stop due to range limitations) - Zürich, Switzerland LSZH (patient drop-off); o Santa Cruz, Bolivia SLVR (crew layover to avoid sleeplessness of the flight crew at high altitude at La Paz) - La Paz, Bolivia SLLP (patient pick-up) - Santa Cruz, Bolivia SLVR (fuel stop due to max. take-off weight limitations at La Paz, SLLP) - Fortaleza, Brazil SBFZ (fuel stop due to range limitations) - Sal, Cape Verde, GVAC (fuel stop due to range limitations) - Zürich, Switzerland LSZH (patient drop-off) --> this mission was flown under the ULR regime. Urs Nagel Member of EASA RMT.0346 Rega Swiss Air-Ambulance P.O. Box 1414 CH-8058 Zuerich Switzerland +41 79 401 95 01 [email protected]

response Accepted

comment 99 comment by: Mario Broesel

I would recommend to keep CS FTL.2.205 Table 1 and Table 2 which shows the maximum daily FDP without and with extensions more simple. It`s quality not quantity that counts. It is a good deal if the maximum allowed FDP depending on her start reference time, but fewer rows with larges time frames would keep it more clearly and easy to use in daily business.

response Please, refer to the previous responses in relation to Tables 1 and 2.

comment 136 comment by: VistaJet

This table is easier to work with than Max FDP without extension. However, this table would improve operational robustness if the max FDP could be increased by a further hour up to a maximum of 14hrs, with an approved FRMS. In addition, the ORO.FTL.205 table has an additional sector. It is does not make sense that the ATXO has fewer sectors allowed at it is never a repetitive schedule as is the case in scheduled CAT.

response Noted

Please, refer to CS1 FTL.2.205.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 147 of 277 An agency of the European Union

comment 170 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

Table: Maximum daily FDP in hours - Acclimatised crew memebers in two-pilot air taxi and AEMS operations with extension without on-board rest: FDP can be extended by up to 1 hour, if no on board rest or augmented crew are applicable. The regulations according to ORO.FTL205 (d1) apply. The extension is already regulated in ORO.FTL205 very briefly. It contradicts with the rules stated.

response Noted

The table with the maximum daily FDP with extension without on-board rest is contained

in CS2 FTL.2.205.

comment 212 comment by: Cat Aviation AG

Table 2 is rather too fragmented, over complicated to manage. Also no extension possible from 1900-0614h start time. What is the rationale for further restriction here? Suggest to manage this simpler by : adding 1 hour to max FDP in 2 crew ops acclimatised, and define some criteria for robustness of schedule.

response Please, refer to the previous responses in relation to the tables.

comment 241 comment by: Thomas Henselmann

Table 2 not consistent with CAT Ops, should be defined for more than 4 sectors. With FRMS a maximum of 14h max FDP should be possible with extension.

response Please, refer to the previous responses in relation to the tables.

comment 365 comment by: European Helicopter Association (EHA)

BHA (UK) Table 1 Comment: Quite probably the most absurdly complex table that only EASA could have derived.

response Your statement is not accepted.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 148 of 277 An agency of the European Union

Table 1 was developed and provided to EASA by EBAA.

comment 866 comment by: ACM AIR CHARTER

FDP extensions after 1900LT (CS.FTL.2.205 table 2) NPA 2017-17 does not consider the type of operation that ACM as a long range business aircraft operator conducts on a regular basis (single long range sectors with block times greater than 10 hours, 3 to 4 times per month). Customers using ultra-long range capable aircraft (e.g. GLEX, G550, FA7X, BBJ, ACJ) schedule their flights with an evening departure and arrival in the morning. Our flight crews are facing night flights with flight times over 10 hours around 3-4 times per calendar month with long rest periods – often greater than 36 hours – in between those flights. In general, crews on GLEX, FA7X and BBJ within our company tend to fly in total only 4 to 6 days per calendar month while total working days (including positioning and FDPs) vary between 7 and 10 days per calendar month. To be able to conduct those flights with a single two-pilot crew, FDP extensions for those evening/night departures up to one hour are required and feasible with current FTL regulations according EU-OPS, subpart Q. With implementation of CS FTL.2.205 – table 2, those extensions are no longer permitted. Over the past four years (2014-2017), ACM conducted 217 flights with actual block times greater than 10:00hrs, which covers more than 40% of our total hours flown on BBJ, GLEX and FA7X. 150 of these flights required a FDP extension up to 12 hours. These flights are considered as the major backbone of our company, and 70 % of the flights on our long range fleet of aircraft would no longer be possible with the implementation of CS 2.205 table 2. To continue the business relationship with our customers, ACM demands to keep the existing possibilities of FDP extensions of 1 hour when flight duty encroaches or covers the WOCL. It is worth to mention that over the entire time of operation, not a single fatigue-related incident was reported. Since ACM is not the only operator performing these kind of flights, the negative impact on the industry would be significant, e.g. an increase in proceeding costs, the requirement to hire additional pilots and the obligation to perform crew changes at places with poor airline connections. In addition, positioning would be more time consuming, tiring and cost intensive. Another operational concern is to maintain recent experience requirements for each pilot (3 take-offs and landings within 90 days as PF) due to the lack of sectors flown when augmenting the flight crew, which would result in additional simulator costs for the operator.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 149 of 277 An agency of the European Union

response Accepted

Banning extensions after 1900 until 0614 will ground ATXO flights that are currently

operated with non-augmented two-pilot crew, and which are anyway allowed under

Subpart Q of EU-OPS, where the extension between 2200–0459 is fixed to 11:45 hrs.

The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 911 comment by: Stephanie Selim

Technical comment – Table 2 presents maximum FDP with extensions. However, extended FDP in Table 2 is derived from the basic maximum daily FDP under ORO.FTL.205(b)(6) (=> table 1 of CS FTL.2.205). Table 2 is not derived from the basic maximum daily FDP under ORO.FTL.205(b)(1) as we can see that the maximum FDP with 3 sectors and a start at 0700 is extended by 1h30 (which is not permitted according to ORO.FTL.205(d1)). A second table 2 (2bis) should therefore be derived from the basic maximum daily FDP under ORO.FTL.205(b)(1).And table 2 should be a derived in a third table 2 (2c) to include the possibility for the operator to extend the basic maximum daily FDP given in table 2 of ORO.FTL.205 by up to one hour for two-pilot air taxi and two pilot AEMS operations providing that the basic maximum daily FDP extension is under FRM (possibility introduced in the technical comment on ORO.FTL.205(b)(1)).

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1005 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Table 2 This table is too fragmented, over complicated to manage. Also no extension possible from 1900-0614h. What is the rational for restrictions here? Please redo the table.

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1069 comment by: Rabbit-Air Ltd

Table 2: No extension possible from 1900-0614: no reference found! What is the reason for this restriction? This table should be redo…

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1109 comment by: FNAM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 150 of 277 An agency of the European Union

response Accepted

Numbers have been added to the CSs to facilitate cross-referencing.

comment 1119 comment by: European Cockpit Association

Commented text: Table 2 ECA Comment: This table does not reflect the purpose of the Rulemaking Group anymore - also in the context of other proposals of the NPA. The sense as proposed by the Rulemaking group was, that a single pilot flight crew should not have longer active working time than 10 hours within a possibly by breaks extended longer alertness- (working-) time. Limiting factor is the minimum time of rest within 24 hours. Any time spent on standby/alertness plus post- and pre-flight- duties has to be counted for the cumulative duty limits. suggesting max limit 10 hours depending on reporting time and to be prolonged by breaks of more than one hour up to 16h which is in line with max. FDP in case of in-flight-rest.

response Table 2 refers to non-augmented two-pilot crew of air taxi and AEMS operations, and not

to single-pilot flight crew as your comment suggests.

comment 1120 comment by: European Cockpit Association

ECA comment: ECA supports the compromise as achieved by the Rulemaking Group: The operator may assign, between two extended recovery rest periods, a block of not more than 2 consecutive FDPs extended to a maximum of 14:45 h alertness (15:30 hours FDP to allow for pre- and post- flight duties) and including a reduced rest period between the 2 consecutive FDPs, provided that: - The rest period preceding the first FDP is at least 36 hours including 2 local nights. The last night before extended duties of more than 14hours has to be taken at the HEMS operating base - The reporting time is between 06:30-11:59

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 151 of 277 An agency of the European Union

- Any time of the extension of the FDP of more than 10 hours is equalled by the time of breaks and which are used for relaxing. Only the time of breaks which are longer than one hour can be used to extend the FDP. - The rest period after completion of the two consecutive FDPs of more than 14 hours is extended to include 3 local nights - The rest period between the two consecutive FDPs shall allow the possibility for 8 hours uninterrupted sleep if WOCL is enclosed and is minimum 08:30h; If the WOCL is not enclosed, the rest period cannot be reduced below 10 hours. In case of the use of commander’s discretion the following min rest time has to be prolonged by the time of the extension of FDP by commander’s discretion.

response Noted

comment 1164 comment by: GBAA

CS FTL.2.205 Flight duty period — air taxi and AEMS Maximum daily FDP with extensions without on-board rest Between 1900h-0614h, a maximum of 11h is too less! I brought already an example from Paris to Kinshasa which would be feasible in an FDZ of 11:30h. Why does the extension start from 0615? If the check-in time is postpone by 15 minutes, it will bring an additional 30 minutes compared to a check-in time of 0600h. This calls for optimizing... Why not simply add one hour extra?

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1186 comment by: Danish Aviation Association

CS.FTL.2.205 Table 1 & 2: Tables should be reconsiddered as mentioned in earlier comments (ORO.FTL.205). Limitations in Table 2 should be changed to allow to more than 4 sectors subject to FRMS analysis.

response The tables will be reworked. Please, refer to CS1 and CS2 FTL.2.205.

comment 1203 comment by: FNAM

ISSUE In CAT.A FTL regulation, it is possible to have extensions of the FDP for 5 sectors. This should be the same for Air Taxi and AEMS operations. PROPOSAL

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 152 of 277 An agency of the European Union

Update this table and replace it by the one provided for CAT operations in CS.FTL.1.205(b) Maximum FDP with extension. Moreover, if an operator has a FRM, it is possible to increase the FDP limitations in this Table by:

• For Air Taxi operations : 1 hour

• For AEMS operations: o 2 hours for 1 to 4 sectors o 1h30 for 5 sectors

In order to mitigate these proposals, a scientific study may assess whether and how it may be possible to have FDP iver 14 hours under a FRM.

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1371 comment by: Gama Aviation (UK) Ltd

Table 2 should be extended beyond 4 sectors for consistency.

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1509

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

General remark: Table 2 is again too fragmented and burdensome, as well as overly complicated in order to manage it. No extension possible from 1900-0614h, which is further limiting factor. The logic for these restrictions is not discernible. Please reconsider, redo and/or completely drop the table.

response The table will be reworked. Please, refer to CS2 FTL.2.205.

comment 1522 comment by: General Aviation Manufacturers Association / Hennig

The General Aviation Manufacturers Association (GAMA) appreciates the opportunity to file comments about the important topic of Flight Time Limitations (FTL). GAMA appreciates the work undertaken by the European Aviation Safety Agency (EASA) and the associated rulemaking team to advance the issue of FTL. FTL is always a complicated topic about which to advance policy. GAMA appreciates EASA having considered the latest science in the field. GAMA, however, has concerns about the NPA proposing a framework that may overcomplicate compliance for an operator. An example of a component of the EASA proposal that overcomplicates FTL are the Flight Duty Period (FDP) allowances laid out in Tables 1 and 2 for air taxi and emergency medical

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 153 of 277 An agency of the European Union

service operations with aeroplanes. The proposal includes a duty period based on start time and is further complicated by the number of sectors in which the flight crew operates. GAMA views this framework as extremely difficult for a typical operators to comply with and encourages EASA to continue to work with the stakeholders to establish a simpler structure to FTL for these operators.

response The tables will be reworked. Please, refer to CS1 and CS2 FTL.2.205.

Responses in relation to ‘FDP extensions with augmented crew’

comment 2 comment by: TipTaf

Many ATXO operated aircrafts (GLEX, G550) have a crew rest facility that reclines to 80 deg back angle to the vertical but the total length available for rest is of 160 cm or less making impossible to have a proper rest to pilots taller than 160 cm. To avoid a possible miss interpretation of the definition of class A rest facility, my personal suggestion is to amend the definition of Class A rest facility giving a minimum required total length of the bunk bed or other surface.

response Partially accepted

The length and width must be adequate to accommodate a physically average person,

otherwise it will not meet Class A facility standards.

comment 45 comment by: VDV M

class A facility, which are the best comfort in terms of inflight rest and therefore provide the most usable flight duty, do not take into account a total lenght and width. 80deg or a fully horizontal bed, without the possibility to fully extend one owns legs and stretch are of no use. Given the small size nature of business jets, operational procedures should be established by the operator to limit the noise produced in the galley, and/or passenger interference direct or indirect (eg. flight attendant push call buttons) while crew memebers are having inflight rest.

response Accepted

Class A facility is a bunk. If that bunk does not have adequate length and width, it will not

meet Class A specifications. Your proposal for operational procedure to limit noise levels is

already included in the text.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 154 of 277 An agency of the European Union

comment 83 comment by: SHug

Extension of the maximum basic daily FDP due to on-board rest under ORO.FTL.205(e)

1. (i) with one additional flight crew member: 1. (A) up to 15 hours with class B rest facilities; or 2. (B) up to 16 hours with class A rest facilities;

2. (ii) with two additional flight crew members: 1. (A) up to 16 hours with class B rest facilities; or 2. (B) up to 24 hours with class A rest facilities,

provided all the following conditions are met: (1) the FDP is limited to 5 sectors; justification: flights with 2 additional flight crew member are far less tiring than with only 1 additional flight crew member by experience. 5 sectors are operationaly needed to operate globally.

response Not accepted

An average crew member needs approximately 7–8 hours continuous uninterrupted

restorative sleep within any 24-hour period, as found by scientists. This means that an

individual FDP of an average crew member may be up to 16–17 hours with on-board rest,

without additional mitigation measures provided by the FRMS.

In-flight/on-board rest with augmented crew is intended for use on one or two long

sectors. This is to allow time for in-flight rest (minimum rest for crew being at the controls

is 2 hours) in the cruise phase of flight. This is likely to be impossible with 5 shorter sectors

as it may prevent good rest opportunities from being available.

comment 96 comment by: B. Wagner

Diese Tabelle erlaubt FDP bis zu 18:00h, mit der in (6) genannten Regel sogar 19:00h. Voraussetzung hierfür ist lediglich das Einhalten von "on-board rest" in der vorgeschriebenen Länge. Wenn solch lange Dienstzeiten möglich sind in einem Umfeld, wo die Ruhemöglichkeiten deutlich schlechter sind als auf einer HEMS Station, was begründet dann die viel restriktiveren Dienstlängen im HEMS Betrieb aus CS FTL.3.205 FDP HEMS? Eigentlich müsste es umgekehrt sein und die Dienstzeiten HEMS bei entsprechender Ruhemöglichkeit deutlich länger ermöglicht werden als bei AEMS oder ATXO.

response Not accepted. HEMS is not part of this proposal.

comment 112 comment by: UK CAA

Page No: 24

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 155 of 277 An agency of the European Union

Paragraph No: CS FTL.2.205 Flight Duty Period (3) (a)(b) – Air Taxi and AEMS - On-board rest facilities Comment: We propose that EASA considers developing AMC / GM for the specifications for the Class A and B rest facilities for both air taxi and scheduled and charter operations. Experience of the application of “minimum specifications” without understanding the detail of the facilities they were based on and the level of sleep they should be able to provide, has been a challenge for regulators. The purpose of the in-flight / on-board rest facility is to enable the crew to sleep, not just meet a very simple technical specification for the seat. Justification: Clarity and to ensure that the facility provided enables the crew to achieve the level of rest and sleep required to be able to safely extend the duty.

response Accepted

As regards air taxi/AEMS aeroplanes, it may be difficult to ensure separation between the

flight crew compartment and the cabin, as well as to guarantee full comfort as regards

noise, light and disturbances. However, the operator is not fully relieved from the

responsibility to mitigate, as much as possible, the impact of light and noise on crew.

comment 113 comment by: UK CAA

Page No: 24 Paragraph No: CS FTL.2.205 (6) & (9) Flight Duty Period – Air Taxi and AEMS Comment: Editorial. Suggest that a single type of hours / minutes reference is maintained throughout the bullet points, either hours and minutes or just minutes. Justification: Clarity and consistency of referencing.

response Accepted

comment 137 comment by: VistaJet

CS FTL.2.205 Flight Duty Period - Air Taxi and AEMS (9) having the flexibilty to add a fresh crew member to achieve augmented duty time limits is an excellent function, as due to space limitations on ATXO aircraft it is more comfortable to limit the time of 3 crew augmentation. The ability to add a crew member on a tech stop means adding a crew member who has managed to have longer rest in a more comfortable facility (hotel) and will improve safety. However, the limit of 1h30 for the first sector on a potential 17hr FDP makes no sense.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 156 of 277 An agency of the European Union

Suggest to maintain the function of allowing 2 Flight Crew to complete the first sector, adding a 3rd crew member during the tech stop, as long as all crew members who require it, achieve 150min on-board rest.

response Accepted

The limit of 1h30 under point (11) has been removed.

comment 159 comment by: Safety and Compliance Manager

FTL proposed do not allow to plan flights in Taxi Aviation, where maximum flexibility is required. Basic Rule in Business Aviation : schedules change, ofter and last minute. Here is an example of Daily Ops in a Business Aviation company with large aircraft: client A decides to depart 30 minutes earlier, or 30 minutes later, or later in the evening, or earlier in the morning, or add a stop to pick / drop a passenger. With the proposed FTL, this means that I need to organise a crew change or make a night stop somewhere because suddenly we are 15 minutes too short! Safetywise here are the high risks : - Proposed FTL are much too complicated and are already bringing a lot of stress to the planners in our company, any tiny change will require a thorough analysis of the FTL. - Proposed FTL are complicated, with the massive schedule changes operators face daily, mistakes will happen, which will bring tension with Crew, planer, clients, making crew fly stressed. - A crew change needs at least 48h to plan, to get last minute permits to make a night stop takes time. We might have to force the crew to make a night stop in unsafe places (Flying to South Africa or China for example, don't offer many safe places to rest) : this will increase stress in our crew, that prefer to extend the duty rather than do a short rest somewhere. - If a client is 30 minutes late for the last leg (stuck in trafic), how will the crew deal with it, when they will have to inform the passenger that they have to cancel the flight because they will be overduty of 15 minutes? High level of stress and in the end, they will prefer to do the fligth rather than facing a stressful situation. - Proposed FTL are complicated, restrictive, with no flexibility : owners will prefer to fly "Private", where FTL are less restrictive and there will be much less stress for everyone. - Proposed FTL will force to many deviations.

response Not accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 157 of 277 An agency of the European Union

EASA believes that with an FDP of 13–14 hours non-augmented and 15–17 hours

augmented, all changes due to delays and additional stops can be accommodated.

However, the tables will be simplified to remove granularity.

comment 160 comment by: Safety and Compliance Manager

The new CS must allow the Operator to use its FRMS (which must be approved by National authorities). The FRMS should allow the Operator to draw FTL in order to Operate Commercially. FRMS monitors effectively the Fatigue and give the oportunity to the operator to review the FTL in order to increase safety. FTL implemented through the FRMS are safer, adapted and relevant to the operation. Applying stringent FTL will bring stress, reduce safety and the FRMS becomes irrelevant, as we have no choice but to apply the regulations, therefore monitoring and training become totally are irrelevant.

response Accepted

comment 211 comment by: Cat Aviation AG

change for Option with one additional flight crew under (i) (A) up to 16 hours with class B rest facilities (B) up to 18 hours with class A rest facilities Reasoning refer to our comments under 4.5 Conclusion, page 67 of the NPA.

response Not accepted

However, it is possible that the 16-hr period in Class A (three pilots) be increased by 1 hour

if the FDP includes a consecutive 150-minute on-board rest period for each flight crew

member at the controls during the last landing, and by 2 hours if the operator has a

functioning FRMS.

comment 243 comment by: Thomas Henselmann

(6) The limit should be extended under FRMS (e.g. one additional hour)

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 158 of 277 An agency of the European Union

comment 244 comment by: Thomas Henselmann

(9) Time limit 1:30h should be extended or exchanged with adequate rest time onboard for the acting crew on the first sector.

response Please, refer to the response to comment #137.

comment 455 comment by: Cat Aviation AG

point (9): pls clarify and suggested text: the frist sector of an FDP requiring an augmented flight crew may be accomplished with two flight crew members, if during the whole FDP, the minimum onboard rest of 150mins per crew is observed and the freshest crew member conducts the landing.

response Please, refer to the response to comment #137.

comment 624 comment by: Transport Malta - Civil Aviation Directorate

Re (5) - The inclusion of the term and provision of cabin crew in air taxi operations may give rise to mis interpretations. Although CAD agrees with any rule making task clarifying the qualification and training requirement for personnel providing any safety related duties on board, the inclusion of cabin crew under Air Taxi FTL may be mis-leading.

response Noted

comment 632 comment by: Cristina BENZ

Extension of the maximum basic daily FDP due to on-board rest under ORO.FTL.205(e) (i) with one additional flight crew member: (A) up to 15 hours with class B rest facilities; or (B) up to 16 hours with class A rest facilities; (ii) with two additional flight crew members: (A) up to 16 hours with class B rest facilities; or (B) up to 24 hours with class A rest facilities, provided all the following conditions are met: (1) the FDP is limited to 5 sectors; justification: flights with 2 additional flight crew member are far less tiring than with only 1 additional

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 159 of 277 An agency of the European Union

flight crew member by experience. 5 sectors are operationaly needed to operate globally.

response Please, refer to the response to comment #83.

comment 860 comment by: NetJets Europe

CS FTL.2.205 Netjets support the proposal CS FTL.2.205 (9) Why is there a limit of 01h30 for first sector? What needs to be guaranteed is that the flight crews have the minimum on-board rest time in order to extend the maximum FDP.

response Please, refer to the response to comment #137.

comment 912 comment by: Stephanie Selim

Editorial comment – Number the subparagraph of CS FTL.2.205 Extension of the maximum basic daily FDP due to on-board rest under ORO.FTL.205(e) in a similar manner to CS FTL.1.205(c): “(13) The on-board rest facilities comply with one of the following descriptions: – a. ‘Class A rest facility’ means a bunk or other surface that allows for a flat or near flat sleeping position. It reclines to at least 80° back angle to the vertical. – b. ‘Class B rest facility’ means a seat in an aircraft cabin that reclines at least 45° back angle to the vertical, has a seat width of at least 20 inches (50 cm) and provides leg and foot support. provided all the following conditions are met: (i1) the FDP is limited to 3 sectors; (ii2) the minimum on-board rest period is a consecutive 90-minute period for each crew member and 2 consecutive hours for those flight crew members at control during the last landing. (2) The maximum basic daily FDP in air taxi or AEMS operations may be extended due to on-board rest for flight crew: (i) with one additional flight crew member: (A) up to 15 hours with class B rest facilities; or (B) up to 16 hours with class A rest facilities; (ii) with two additional flight crew members: (A) up to 16 hours with class B rest facilities; or (B) up to 17 hours with class A rest facilities, (34) The operator describes means to provide darkness and noise mitigation in the operations manual and ensures that these means are available to all crew members during on-board rest. The operator establishes a procedure in the operations manual to ensure that crew members are not disturbed during on-board rest.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 160 of 277 An agency of the European Union

(45) The minimum on-board rest in Class A or B on-board rest facility for each cabin crew member is: Table (56) The limits specified in (2) for pilots may be increased by 1 hour, if the FDP includes a consecutive 150-minute on-board rest period for each flight crew member. (67) All time spent in the rest facility is counted as FDP. (78) The minimum rest at destination is at least as long as the preceding duty period, or 14 hours, whichever is greater. (89) The first sector of an FDP requiring an augmented flight crew may be accomplished with two flight crew members, if that sector does not exceed 01h30.

response Noted

comment 925 comment by: Stephanie Selim

Technical comment- In (6), DGAC woulld like to add the possibility to increase the limits for pilots, under FRM, by 1 hour. This FDP extension can be combined with the one hour extension when the FDP include a consecutive 150 minutes on-board rest period for each flight crew member. In that case, the maximum daily FDP is limited to 18 hours. This provision is justified by long range operations. For instance, the limits proposed in the NPA would not permit some long range AEMS operations for medical repatriation. Proposal : “(6) The limits for pilots may be increased by 1 hour: (i) if the FDP includes a consecutive 150-minute on-board rest period for each flight crew member, or (ii) if the operation has implemented a FRM. (6a) The increase of limits for pilots under (6)(i) and (6)(ii) can be cumulated but in that case the maximum daily FDP remains limited to 18 hours”.

response Partially accepted

comment 930 comment by: Stephanie Selim

Technical comment- In the (1), in the case of AEMS, DGAC would like to add the possibility to add a 4th sector providing that this additional segment is dedicated to position the aircraft back to its operating base with only crew member on board and the aircraft medical equipment. This possibility should be under FRM. This provision is necessary to ensure continuity of aeroplane emergency medical service by returning to the operating base for the next AEMS flight, which would not be possible with a limitation to 3 sectors. Proposal : “In the case of AEMS operations, the FDP may be increased to 4 sectors under FRM providing that the 4th sector is a sector flown to position the aircraft back to the operating base with only crew members on board and no cargo.”

response Partially accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 161 of 277 An agency of the European Union

The FDP should be limited to 4 sectors (without an FRMS) to reflect the typical air

taxi/AEMS operation, including a stop to a customs airport (not an entry airport) and one

aircraft positioning sector.

comment 931 comment by: Stephanie Selim

Technical comment – Does the subparagraph CS FTL.2.205 Extension of the maximum basic daily FDP due to on- board rest under ORO.FTL.205(e) apply to two-pilot operations only or both single and two- pilot operations ? If it applies to single pilot operation, an augmented flight crew with one additional pilot may lead to have a maximum FDP higher than the FDP derived from two- pilot operations.

response Not accepted.

Point ORO.FTL.205(e) is based on a minimum of two-pilot operation which can be

augmented by one or two additional pilots.

comment 942 comment by: AESA

Class A rest facility doesn’t stablish a minimum width of the facility. It could be supposed that a bunk that recline at least 80º will have width enough, but in case of other surfaces it could be necessary to define a minimum width.

response Please, see previous responses regarding on-board rest facilities.

comment 1007 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

(i) change option with one additional flight crew (A) up to 16 hours with class B rest facilities (B) up to 18 hours with class A rest facilities (ii) (A) up to 18 hours with class B rest facilities (B) up to 20 hours with class A rest facilities

response Please, refer to the response to comment #632.

comment 1070 comment by: Rabbit-Air Ltd

1 additional flight crew having class A rest facility: max. daily FDP should be extended to 18 hrs.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 162 of 277 An agency of the European Union

response Maximum daily FDP may be extended by 1 hour under the condition of a consecutive 150-

minute on-board rest period for each flight crew member at the controls during last

landing, and by 2 hours under an FRMS.

comment 1071 comment by: Rabbit-Air Ltd

(5) should be less restrictive then for pilots

response The comment is not clear.

comment 1073 comment by: Rabbit-Air Ltd

(6) fully agree to comment of CatAvi. Simplify by using 16 resp. 18 hrs.

response The comment is not clear.

comment 1075 comment by: Rabbit-Air Ltd

(9) remove time restriction 1h30 and add the need that all required minimum in-flight- rest is assured.

response Accepted

comment 1121 comment by: FNAM

Attachments #77 #78

Cf. comment 1124 ISSUE Due to the difference of activities between EMS flights and Air Taxi operations, FNAM and EBAA France suggest differentiating the extended limitations of the FDP for Air Taxi and AEMS operations. Besides, additional extensions of the extended maximum basic daily FDP should be described if the operator has a FRM (Cf. Annex 2 & 3). PROPOSAL 1 The maximum basic daily FDP in Air Taxi or AEMS operations may be extended due to on- board rest for flight crew with one additional crew member:

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 163 of 277 An agency of the European Union

Extended maximum basic daily FDP No FRM

Additional extension of this FDP

Extended maximum basic daily FDP with FRM and with pause

Air Taxi

Class B facility 15h The extended maximum basic

daily FDP for pilots may be increased by 1 hour if the FDP includes a consecutive 150- minutes on-board rest period for each flight crew member.

The extended maximum basic daily may be increased by 2 hours if:

• the FDP includes a consecutive 150- minute on-board rest period for each flight crew member; AND

• Under a FRM

Class A facility 16h

AEMS These AEMS limits apply only if there is a consecutive 120- minutes on- board rest period for each flight crew member; otherwise Air Taxi limits here above shall apply.

Class B facility 16h

The extended maximum basic daily FDP for pilots may be increased by 1 hour if the FDP includes a consecutive 150- minutes on-board rest period for each flight crew member.

The extended maximum basic daily may be increased by 2 hours if:

• the FDP includes a consecutive 180- minute on-board rest period for each flight crew member; AND

• Under a FRM

Class A facility 17h

For PEQ 4: all these limitations of maximum FDP may be increased by 1 hour. PROPOSAL 2 Otherwise, FNAM and EBAA France propose a second solution and asks to replace the proposal with the CAP 371 dispositions: When carrying out an AEMS flight, the allowable FDP in the company’s approved FTL scheme may be increased by up to a maximum of 4 hours, subject to the conditions being met:

• Where an FDP is extended under the terms of this provision, a qualified medical attendant must accompany the EMS payload

• The crew must have had the full entitlement of rest relating to the preceding duty prior to starting an EMS duty

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 164 of 277 An agency of the European Union

response Partially accepted

Please, see previous responses.

With regard to the FDP with ‘pause’, please refer to CS FTL.2.220 related to split duty with

break(s) on the ground.

It should be crystal clear, however, that the breaks do not ‘pause’ or stop the duty time as

they are part of the FDP.

comment 1124 comment by: FNAM

Attachments #79 #80

(6) Cf. comment 1121 ISSUE Due to the difference of activities between EMS flights and Air Taxi operations, FNAM and EBAA France suggest differentiating the extended limitations of the FDP for Air Taxi and AEMS operations. Besides, additional extensions of the extended maximum basic daily FDP should be described if the operator has a FRM (Cf. Annex 2 & 3). PROPOSAL 1 The maximum basic daily FDP in Air Taxi or AEMS operations may be extended due to on- board rest for flight crew with one additional crew member:

Extended maximum basic daily FDP No FRM

Additional extension of this FDP

Extended maximum basic daily FDP with FRM and with pause

Air Taxi

Class B facility 15h

The extended maximum basic daily FDP for pilots may be increased by 1 hour if the FDP includes a consecutive 150- minutes on-board rest period for each flight crew member.

The extended maximum basic daily may be increased by 2 hours if:

• the FDP includes a consecutive 150- minute on-board rest period for

Class A facility 16h

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 165 of 277 An agency of the European Union

each flight crew member; AND

• Under a FRM

AEMS These AEMS limits apply only if there is a consecutive 120- minutes on-board rest period for each flight crew member; otherwise Air Taxi limits here above shall apply.

Class B facility 16h

The extended maximum basic daily FDP for pilots may be increased by 1 hour if the FDP includes a consecutive 150- minutes on-board rest period for each flight crew member.

The extended maximum basic daily may be increased by 2 hours if:

• the FDP includes a consecutive 180- minute on-board rest period for each flight crew member; AND

• Under a FRM

Class A facility 17h

attendant must accompany the EMS payload

The crew must have had the full entitlement of rest relating to the preceding duty prior

to starting an EMS duty

response Please, see previous responses.

comment 1125 comment by: FNAM

(1) ISSUE Due to the specificity of the AEMS and Air Taxi activities, it is essential to allow the extension of FDP due to on-board rest to 4 sectors. As a mitigation, FNAM and EBAA France suggest reducing the extension of the FDP of 30 min from 4 sectors.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 166 of 277 An agency of the European Union

PROPOSAL There is a reduction of 30 minutes between the allowed extended FDP for 1-3 sectors and the allowed extended FDP from 4 sectors and further.

response Please, see previous responses.

comment 1126 comment by: FNAM

(9) ISSUE FNAM and EBAA France thank the EASA for introducing this possibility. However, FNAM and EBAA France would like this disposition to be also applicable for the last sector. Furthermore, FNAM and EBAA France understand the necessity of having a maximum time for the first or last sector of the FDP but a 1h30 limitation is too short. Instead, the mitigation could be introduce thanks to a minimum on-board rest rather than a limitation of time for the sector. PROPOSAL Replace the paragraph (9) by the following: “(9) The first or last sector of an FDP requiring an augmented flight crew may be accomplished with two flight crew members, if the flight crew members have the minimum on-board rest as required.”

response Please, see previous responses.

comment 1128 comment by: FNAM

ISSUE Add the notion of “burn off” coming from the CAP 371. The mitigation is included in the proposal. PROPOSAL Add the following paragraph: “To take advantage of this facility the division of duty and rest between those crew members being relieved must be kept in balance. It is unnecessary for the relieving crew member to rest in between the times relief is provided for other crew members. The flight following completion of duty is classed as positioning.”

response The comment is not clear.

comment 1165 comment by: GBAA

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 167 of 277 An agency of the European Union

CS FTL.2.205 Flight duty period — air taxi and AEMS Extension of the maximum basic daily FDP due to on-board rest Does a couch or flat reclined and arranged seats also qualify as class A? (9) Why not more than 01:30h? Wouldn't it be better that the rest requirements of each crew member needs to be fulfilled with preceding conditions (1)-(8).

response Please, see previous responses.

comment 1297 comment by: Volkswagen AirService GmbH

Business aviation aircraft are in general too small to host two full crews. Crew rest area

or similar facility is available for single person only. An extension of the maximum

extended FDP to 18 h with this facility must be possible. Otherwise the aircraft will not

be able to fly their intended long range profiles.

response Noted

comment 1301 comment by: Volkswagen AirService GmbH

An extension of 2 hours with one additional crew member is required for our operations.

Most business aviation aircraft are not equipped for 2 additional crewmembers and

experience shows that 1 additional crewmember is sufficient. The duration of sleep is

more important. Having too many people on board just decreases space and increases

stress.

response Noted

comment 1378 comment by: Gama Aviation (UK) Ltd

Point (6) - With FRMS, the limit should be able to increase by one additional hour to a maximum of 2 hours. Point (9) - 01h30 should be changed to "if the flight crew members achive the minimium on-board rest required. (There is no scientific justification for a restricted sector length)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 168 of 277 An agency of the European Union

response Please, see previous responses.

comment 1449 comment by: European Cockpit Association

Commented text: “Extension of FDP extension with on-board rest” Reference CS FTL.2.205 (6) Comments In this section it is permitted that FDPs extended by ‘on-board’ rest (which should be in- flight rest – see other comments) be increased by an extra hour if each pilot gets a minimum of 2hr 20mins in the bunk. Given that research on the subject indicates that at most 75% of actual time in the rest facility is usable for FDP extension, which would already not provide for the basic values of FDP extension with in-flight rest this arbitrary extra hour is entirely without foundation. It is a similar measure to the extra hour in CAT FDP extension if one sector is more than 9 hours and there are no more than 2 sectors, which is equally arbitrary and unsupported by scientific advice. The one sector >9hrs provision at least provides for approximately 2hrs 45mins rest per crew member, so 150mins is a significant reduction in standard from even this level. Proposal Remove the extra hour FDP extension on top of in-flight rest FDP extension available if each flight crew member gets 150 mins consecutive rest.

response Not accepted

Not all rules are based on scientific studies. Some are based on good and efficient

operators’ practices, as well as on experience.

It is not clear on what scientific grounds 2hrs 45min is considered a standard, whilst 150

min (2hrs 30 min) is not.

comment 1467 comment by: VOLDIRECT

Table 2: FDP start time > 1900: no extensions not allowed. This is a problem for air taxi. Today we are authorized to 11:00 FDP for 1-2 sectors.

response Please, see previous responses.

comment 1490 comment by: Airlec Air Espace / Paul Tiba

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 169 of 277 An agency of the European Union

ISSUE Due to the difference of activities between EMS flights and Air Taxi operations, AIRLEC suggests differentiating the extended limitations of the FDP for Air Taxi and AEMS operations. Besides, additional extensions of the extended maximum basic daily FDP should be described if the operator has a FRM. AIRLEC proposes to replace the proposal with the CAP 371 dispositions: When carrying out an AEMS flight, the allowable FDP in the company’s approved FTL scheme may be increased by up to a maximum of 4 hours, subject to the conditions being met: • Where an FDP is extended under the terms of this provision, a qualified medical attendant must accompany the EMS payload • The crew must have had the full entitlement of rest relating to the preceding duty prior to starting an EMS duty CRUCIAL ISSUE Due to the specificity of the AEMS and Air Taxi activities, it is essential to allow the extension of FDP due to on-board rest to 4 sectors. As a mitigation, AIRLEC suggests reducing the extension of the FDP of 30 min from 4 sectors.

response Please, see previous responses.

comment 1510

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

response Please, see previous responses.

comment 143 comment by: CAA-NL

CS FTL.2.205 Flight Duty Period (3) (a)(b) – Air Taxi and AEMS - On-board rest facilities Comment: EASA should consider developing AMC / GM for the specifications for the Class A and B rest facilities for both air taxi and scheduled and charter operations to avoid misunderstanding about the interpretation of the requirement.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 170 of 277 An agency of the European Union

response Noted

Specifications for in-flight rest facilities (Class 1, 2 and 3) for scheduled/charter operations

are already included in CS FTL.1.

Specifications for on-board rest (Class A and B), as proposed with this Opinion under CS

FTL.2, relate to air taxi and AEMS operations.

There cannot be acceptable means of compliance (AMC) to the certification specifications

(CSs) because operators may deviate from the CSs subject to EASA assessment and

subsequent competent authority (CA) approval.

It is unclear what needs to be further explained in the current standard of Class A and B by

means of guidance material (GM).

CS FTL.2.205 p. 24-25

Responses in relation to ‘commander’s discretion’

comment 34 comment by: Serair

Unforeseen circumstances in AEMS operations - commander's discretion. Comments to point (a) Commander's discretion extension shouldn't be more restrictive in AEMS than in CAT or air taxi operations. Our experience in combined types of operations shows that compared with Air taxi or CAT operations, the chances to encounter unforeseen circumstances is higher in AEMs operations. Tipicall unforseen circumstances in AEMS are the delayed reporting of the patient due to it's own condition, the slow processing in airport security checkpoints and lack of planification of medical services. More than once our crew has waited over an 1 hour after positioning due to these unforeseen circumstances. Comments to point (c) Point (c) is not related with commander's discretion, it should be placed in "rest periods" CS.FTL.2.235

response It should be possible for an operator to anticipate typical delays, and not call them

‘unforeseen circumstances’.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 171 of 277 An agency of the European Union

The concept of CMD is based on exceptionally needed extensions due to circumstances

that cannot be predicted, such as weather conditions, peak traffic, or technical issues.

Extensions beyond the FDP limits should not be made frequently or on a regular basis.

The intention behind the use of the term ‘unforeseen circumstances’ is to prevent

operators from continually rostering flight and duty times to their maximum limits and

from regularly relying on extensions to achieve their operational goals.

Further, operational experience, hazard identification and risk assessments can be utilised

to predict potential disruptions or delays.

The lack of a sound organisational and safety culture within the operator should not be

compensated by the frequent use (or misuse) of commander’s discretion.

The proposal to make the rule on commander’s discretion at least as flexible for air

taxi/ATXO operations as in CAT operations is accepted.

comment 454 comment by: Cat Aviation AG

as for AirTaxi please refer to our comment under ORO.FTL.205. f) (7) our comment no 449.

response Please, refer to the response to comment #449.

comment 626 comment by: Transport Malta - Civil Aviation Directorate

The competent authority has come across several cases where the maximum FDP needed to be extended due to unforeseen circumstances in air taxi operations (e.g. security situation at destination would not allow for overnight stays or to provide for minimum rest). Suggest text to this effect be included for air taxi operations.

response Accepted

Practical guidance has been included as to what events may constitute ‘unforeseen

circumstances’.

comment 943 comment by: Stephanie Selim

Technical comment- Extensions proposed for AEMS apply to the maximum basic daily FDP and not the maximum daily FDP. Therefore, it applies to both the basic FDP under ORO.FTL.205(b)(1) and (6), but it excludes the possibility to combine the commander’s discretion with split duty and FDP extensions due to on board rest. Moreover, no rationale is given to reduce

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 172 of 277 An agency of the European Union

the commander’s discretion by one hour compared to air taxi, regular and charter operations. Additionally, commander’s discretion may be essential in emergency flight like organ transportation which is characterized by many delays/waiting times. Indeed, in France it is the same medical team who removes the organ and who transplants this organ. So, flight crews who fetch medical team to bring them to the hospital where the organ removal takes place have to wait for the medical team to go to the hospital where the transplantation will take place. Yet, if the medical team has to remove the heart, which is the last organ to be removed, the flight crew will have to wait for hours if all the other organs of the patient have to be removed. The RIA does not take into account this specific kinf of AEMS operation which needs great flexibility. Thus, it is proposed to replace this paragraph of CS FTL.2.205 by ORO.FTL.205(f)(1)(i): “For AEMS operations, the maximum daily FDP which results after applying points (b) and (e) of point ORO.FTL.205 or point ORO.FTL.220 may not be increased by more than 2 hours unless the flight crew has been augmented, in which case the maximum flight duty period may be increased by not more than 3 hours; The maximum basic daily FDP may be increased for AEMS by up to 1 hour unless the flight crew has been augmented, in which case the maximum FDP may be increased by up to 2 hours;

response Partially accepted

CS6 FTL.2.205 applies to commander’s discretion in air taxi/AEMS operations where the

IFTSS is based on CS FTL.2, and not on point ORO.FTL.205(f)(1)(i).

Your statement that the commander’s discretion in air taxi/AEMS operations excludes the

possibility to combine commander’s discretion with FDP extensions due to on-board rest

(augmented crew) is not correct.

However, allowable extensions have been increased by 1 hour, and the possibility to

combine commander’s discretion with split duty has been added.

comment 946 comment by: Stephanie Selim

(b) Technical comment- According to ORO.FTL.105 ‘EMS flight’ definition, immediate and rapid transport is essential not only for ill or injured persons. Accordingly it is proposed to modify CS FTL.2.205 Unforeseen circumstances in AEMS operations — commander’s discretion: “If on the final sector within the FDP the allowed increase of up to 21 hour or up to 32 hours as applicable is further exceeded because of unforeseen circumstances after take- off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off for the final sector, the allowed increase may only be exceeded where immediate and rapid transportation is essential as defined in ORO.FTL.105 ‘EMS fight’ to transport the patient.”

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 173 of 277 An agency of the European Union

comment 948 comment by: Stephanie Selim

(c) Technical comment – In the case of AEMS, the provision gives the possibility to reduce the rest period following the FDP. However, why is this provision applicable only "away from base" ? Why is it different from scheduled and air taxi operations ?

response Not accepted. It is not different. AMC1 ORO.FTL.205(f) states that the use of CMD should

be avoided at home base.

For air taxi/AEMS operations, the entire requirement on CMD is in the CSs, meaning that

the operator’s IFTSS may deviate from the CSs subject to EASA positive assessment and

competent authority (CA) approval.

comment 1077 comment by: Rabbit-Air Ltd

Unforseen circumstances do impact flight duty and its needed extension in both EMS and Air Taxi! Air Taxi should be included.

response Not accepted. CS6 FTL.2.205 ‘Flight duty period (FDP) — commander’s discretion’ is

applicable to both air taxi and AEMS operations.

comment 1129 comment by: FNAM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 174 of 277 An agency of the European Union

FORCE MAJEURE AEMS and Air Taxi are deeply linked with national health, security and safety. Current French regulation allows, by sovereign decision of the State, to grant derogation as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For illustrative purposes, the recent missions would not have been possible if this regulation enters into force as it is:

• Hostage taking in Amenas in 2013 • Evacuation of injured journalists in Mossoul in 2016 • Airlift between Guadeloupe and Saint Martin

Therefore, FNAM and EBAA France suggest adding a specific paragraph in this implementing rule allowing pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation or if the State requisitions an aircraft. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure» : "Il peut être dérogé aux limitations mentionnées la présente section dans les conditions suivantes: 1. Vols urgents, dont l'exécution immédiate est nécessaire: a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites prétablies. 3. Vols exécutés dans l'intérèt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation; la limite est fixer par le ministre chargé de l'aviation civile.” (Ref : CAC D422-12)

response Noted

Please, see the response to comment #1029.

comment 1130 comment by: FNAM

Attachment #81

(a) ISSUE

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 175 of 277 An agency of the European Union

The paragraph (a) of this CS proposes a 1 hour commander’s discretion for non-augmented flight crew operations. FNAM and EBAA France wonder how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for non- augmented flight crew operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by non-augmented flight crew operations in case of emergency for the patient. Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour Besides, in CAT.A FTL regulation, there is a possibility of a commander’s discretion of up to 2 hours for non-augmented flight crew and up to 3 hours for augmented flight crew. For augmented flight crew a more than 2 hours commander’s discretion is frequently used (Cf. Annex 4). These dispositions should also be applicable for EMS flights. Hence, FNAM and EBAA France suggest for AEMS operations a 2 hours commander’s discretion for non-augmented flight crew and a 3 hours commander’s discretion for augmented flight crew. PROPOSAL Change the paragraph (a) to take into account the following dispositions (already accepted for CAT operations):

• Up to 2 hours of commander’s discretion for non-augmented flight crew.

• Up to 3 hours of commander’s discretion for augmented flight crew.

response Accepted

comment 1131 comment by: FNAM

ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of EMS flights, which encompasses the following EMS payload (medical personnel, medical supplies such as equipment including the aircraft, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the EMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the aircraft, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for EMS payload, for

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 176 of 277 An agency of the European Union

the present or next EMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the aircraft. That is why FNAM and EBAA France suggest replacing the term patient used in the paragraph (b) by the EMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport the MEDICAL PERSONNEL, MEDICAL SUPPLIES SUCH AS EQUIPMENT INCLUDING THE AIRCRAFT, BLOOD, ORGANS OR DRUGS, ILL OR INJURED PERSONS AND OTHER PERSONS DIRECTLY INVOLVED.”

response Accepted

comment 1375 comment by: Gama Aviation (UK) Ltd

Commander's discretion for AEMS operations is not consistant with CAT/ATXO operations for no apparent reason. Suggested Change: (a) Maximum daily FDP may be increased for AEMS by upto 2 hours, or up to 3 hours for augmented crew. (b) On final sector, within the the FDP allowed increase of up to 2 hours or 3 hours as applicable. Additionally in (b), "patient" should be replaced by AEMS Payload for consistency.

response Accepted

The flexibility allowed for under Part-CAT and Subpart Q with regard to commander’s

discretion is also made available for air taxi/ATXO operations.

comment 1492 comment by: Airlec Air Espace / Paul Tiba

ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for non- augmented flight crew operations. AIRLEC wonders how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for non- augmented flight crew operations, with no reported inherent safety issue through

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 177 of 277 An agency of the European Union

experience. This 2 hours commander’s discretion is frequently used by non-augmented flight crew operations in case of emergency for the patient. Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. Besides, in CAT.A FTL regulation, there is a possibility of a commander’s discretion of up to 2 hours for non-augmented flight crew and up to 3 hours for augmented flight crew. For augmented flight crew a more than 2 hours commander’s discretion is frequently used (Cf. Annex 2 – Illustration 3). These dispositions should also be applicable for EMS flights. Hence, AIRLEC suggests for AEMS operations a 2 hours commander’s discretion for non- augmented flight crew and a 3 hours commander’s discretion for augmented flight crew. PROPOSAL Change the paragraph (a) to take into account the following dispositions (already accepted for CAT operations) • Up to 2 hours of commander’s discretion for non-augmented flight crew. • Up to 3 hours of commander’s discretion for augmented flight crew. ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of EMS flights, which encompasses the following EMS payload (medical personnel, medical supplies such as equipment including the aircraft, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the EMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the aircraft, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for EMS payload, for the present or next EMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the aircraft. That is why AIRLEC suggests replacing the term patient used in the paragraph (b) by the EMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport the MEDICAL PERSONNEL, MEDICAL SUPPLIES SUCH AS EQUIPMENT INCLUDING THE AIRCRAFT, BLOOD, ORGANS OR DRUGS, ILL OR INJURED PERSONS AND OTHER PERSONS DIRECTLY INVOLVED.”

response Accepted

The flexibility allowed for under Part-CAT and Subpart Q with regard to commander’s

discretion is also made available for air taxi/ATXO operations.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 178 of 277 An agency of the European Union

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 179 of 277 An agency of the European Union

Responses with regard to ‘delayed reporting’

comment 146 comment by: VistaJet

This feature is unusable in current format. The format is far too complex and tracking this will be nearly impossible in ATXO. The guidance material would be sufficient which will allow the operator to establish solution which works for their operation. Suggest to default to: CS FTL.2.205 Flight duty period (FDP) — air taxi and AEMS — delayed reporting Operator procedures for delayed reporting should: (a) specify a contacting mode; (b) establish minimum and maximum notification times; and (c) avoid interference with sleeping patterns when possible

response Accepted

The text has been simplified.

comment 227 comment by: Cat Aviation AG

This is used very rarely in Air Taxi operations. Given the minor usage for AirTaxi, the rule is defined too complex for practical use. There is also the question of contacting a crew. If we define the modes of contact, also define a difference for crew who are still at home or in hotel vs already en-route to the airport and then just 2-3 key points of the limitations on FDP this has. If a crew is still at home or hotel, the delayed reporting has not really a influence on fatigue as crew remains in rest location.

response Noted

Please, refer to the response to comment #146.

comment 1123 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

This rule is too complex for practical use. Differences should be made when contacting the crew if they stay at home/hotel or at the airport FBO.

response Noted

Please, refer to the response to comment #146.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 180 of 277 An agency of the European Union

comment 36 comment by: Serair

CS FTL.2.205 (d) (1) Correction (1) one notification of a delay leads to the calculation of the maximum FDP according to (3) or (4);

response Please, refer to the response to comment #146.

comment 114 comment by: UK CAA

Page No: 25 Paragraph No: CS FTL.2.205 (d) Flight Duty Period – air taxi and AEMS Comment: Bullet points under point (d) contain incorrect references. Bullet point 1 and 5 refer to alphabetical rather than numerical references. Justification: Clarity Proposed Text: Bullet point (1) should refer to “according to (3) and (4)” and bullet point (5) should refer to “as an exception to (1) and (2)”.

response Please, refer to the response to comment #146.

comment 425 comment by: Skyshare Union representing NetJets crew members

There’s an error in CS.FTL.2.205 (d)(1) where it refers to “(c) or (d)” where it means “(3) or (4)”. Independent of the above error, as currently written there is a loophole which would allow operators to get around the max FDP for duties starting late in the day. We would like to propose that this loophole be closed and the shorter of the two max FDP should apply, as in (d)(4) or else some additional rest should be added both to mitigate the longer than normally safe day and as disincentive to exploit the loophole.. For our operations the impacts is likely negligible as a delayed start will usually mean a whole new plan, and we don’t believe NetJets would exploit the loophole deliberately, but for our competitors it’s possible this will impact them more. Reasoning: CS.FTL.2.205 (d)(3) allows the operator to ‘plan’ a duty with a report time of 0845 (max FDP 13:45) and then ‘delay’ the report time to 1244 but still retain the 13:45 max FDP versus the normal 13:00 limit for a duty commencing at 1244.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 181 of 277 An agency of the European Union

response Please, refer to the response to comment #146.

comment 776 comment by: AECA helicopteros.

Referred to FTL 205(d)(3)).- Flight Duty Period.- FDP. Air Taxi and AEMS (d) If the crew member is informed of the delayed reporting time, the FDP is calculated as follows: (1) … (2) … (3) when the delay is less than 4 hours, the maximum FDP is calculated based on the original reporting time and the FDP starts counting at the delayed reporting time Delete paragraph (3) Justification.- ORO.FTL.205, establish; (g) Unforeseen circumstances in flight operations — delayed reporting The operator shall establish procedures, in the operations manual, for delayed reporting in the event of unforeseen circumstances, in accordance with the certification specifications applicable to the type of operation. Why this limitation for AEMS?

response Noted

Please, refer to the response to comment #146.

comment 861 comment by: NetJets Europe

CS FTL.2.205 Netjets support the proposal CS FTL.2.205(d)(1) Where it refers to "(c) or (d)" it should refer to "(3) or (4)" instead.

response Please, refer to the response to comment #146.

comment 949 comment by: Stephanie Selim

Editorial comment – The numbering needs to be corrected and should be presented as in CS FTL.1.205(d) (f) Unforeseen circumstances in air taxi and AEMS — delayed reporting (1a) The operator may delay the reporting time in the event of unforeseen circumstances, if procedures for delayed reporting are established in the operations manual. (2b) The operator keeps records of delayed reporting.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 182 of 277 An agency of the European Union

(3c) Delayed reporting procedures establish a notification time allowing a crew member to remain in his/her suitable accommodation when the delayed reporting procedure is activated. (4d) If the crew member is informed of the delayed reporting time, the FDP is calculated as follows: (i1) one notification of a delay leads to the calculation of the maximum FDP according to (iiic) or (ivd); (ii2) if the reporting time is further amended, the FDP start counting commences 1 hour after the second notification or at the original delayed reporting time if this is earlier; (iii3) when the delay is less than 4 hours, the maximum FDP is calculated based on the original reporting time and the FDP starts counting at the delayed reporting time; (iv4) when the delay is 4 hours or more, the maximum FDP is calculated based on the more limiting of the original or the delayed reporting time and the FDP starts counting at the delayed reporting time; (v5) As an exception to (ia) and (iib), when the operator informs the crew member of a delay of 10 hours or more in reporting time and the crew member is not further disturbed by the operator, such delay of 10 hours or more counts as a rest period.

response Please, refer to the response to comment #146.

comment 961 comment by: AESA

Text “… according to (c) or (d);” must be “… according to (4) or (5);”

response Please, refer to the response to comment #146.

comment 963 comment by: AESA

Text “As an exception to (a) and (b)…” must be “As an exception to (1) and (2)…”

response Please, refer to the response to comment #146.

comment 1079 comment by: Rabbit-Air Ltd

This rule is too complex. When contacting the crew, difference should be made if they stay at home/hotel or already at the airport. Even though, rest facilities at an airport FBO may vary which may influence waiting time positively or negatively.

response Please, refer to the response to comment #146.

comment 1303 comment by: Volkswagen AirService GmbH

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 183 of 277 An agency of the European Union

Flexibility in departures is core business of ATXO. Delayed reporting must be possible any

time without any consequences on the FDP, as long as notification reaches the crew prior

leaving the suitable accomodation. Keep it simple.

response Please, refer to the response to comment #146.

comment 1315 comment by: Volkswagen AirService GmbH

Delayed reporting is core business and must be possible without any constraints if a crew member is notified in time at the hotel or at the home base. (in times = prior leaving)

response Please, refer to the response to comment #146.

comment 1377 comment by: Gama Aviation (UK) Ltd

Section unnecessarily complex and not applicable to ATXO, on demand short notice operations. Suggested Change: Operator procedures for delayed reporting should: (a)Specify a method of contact (b)Establish minimum and maximum notification times (c)Avoid interference with sleeping patterns where possible

response Please, refer to the response to comment #146.

comment 1473 comment by: VOLDIRECT

DELAYED REPORTING: Curent NPA is far to complex to Air Taxi Operations please revert back to GM verssion. Or use the CS. Suggested change: CS FTL.2.205 Flight duty period (FDP) — air taxi and AEMS — delayed reporting Operator procedures for delayed reporting should: (a) specify a contacting mode; (b) establish minimum and maximum notification times; and (c) avoid interference with sleeping patterns when possible Rationale: Rule over complex then not applicapble to on demand operations.

response Please, refer to the response to comment #146.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 184 of 277 An agency of the European Union

comment 1511

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

General remark: This rule is far too burdensome for a practical use in the industry.

response Please, refer to the response to comment #146.

comment 144 comment by: CAA-NL

CS FTL.2.205 (d) Flight Duty Period – air taxi and AEMS Comment: Bullet points under point (d) contain incorrect references. Bullet point 1 and 5 refer to alphabetical rather than numerical references.

response Please, refer to the response to comment #146.

CS FTL.2.210 Cumulative flight times

CS FTL.2.210 p. 25

Responses with regard to ‘cumulative duty periods and flight times’

comment 147 comment by: VistaJet

CS FTL.2.210 Flight Times and Duty Periods These limits do not seem reasonable. Looking at both the FAA and other international authorities, the limits imposed here, although unlikely to be breached, are far more limiting than anywhere else. I think it is worth re-iterating that creating a level playing field should not be an exclusively European phenomenon. Air carriers, especially on long haul, are competing with global players, not just the European market. The commission should seek not to limit European operators to the point of being non-competitive on the global stage.

response Accepted

The cumulative block hours should be the same as in Subpart Q. Thus, the limits under

point ORO.FTL.210 would apply to both scheduled and unscheduled air taxi/AEMS flights.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 185 of 277 An agency of the European Union

Indeed, the scientific study conducted by FRMSc Limited, which was commissioned by the

EBAA/ECA, demonstrated that the amount of work in air taxi/AEMS operations is relatively

low in terms of cumulative FT, total days free of duty, and consecutive days of duty.

However, account should be taken of the fact that the cumulative block hours in air taxi

operations in European States allowable under Subpart Q (OPS 1.1100) are: 900 block

hours in a calendar year and 100 block hours in 28 consecutive days.

Therefore, CS FTL.2.210 has been deleted. The proposal reverts to Subpart Q, thus the

limits under point ORO.FTL.210 apply to both scheduled and air taxi/AEMS flights.

comment 228 comment by: Cat Aviation AG

conditional on ORO.FTL.2.210. Under normal circumstances based on historic fact, AirTaxi Crew rarely reaches the high hours of total flight time as what scheduled air crew attains. Thus suggest to limit it to 2 defining factors 1) 90 hours in 28 days consecutive days 2) 625 hours in 12 consecutive calendar months

response Please, refer to the response to comment #147.

comment 441 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

CS FTL.2.210 The total flight time of the sectors on which an individual crew member in air taxi operations is assigned as an operating crew member under ORO.FTL.210(e) shall not exceed: (1) 100 hours of flight time in any 28 consecutive days (2) 900 hours of flight time in any calender year (3) 1000 hours of flight time in any 12 consecutive calender month There should be no difference between commercial operators and air taxi. As the impact the flown hours have on fatigue is the same.

response Please, refer to the response to comment #147.

comment 628 comment by: Transport Malta - Civil Aviation Directorate

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 186 of 277 An agency of the European Union

Clarification request, would an air taxi operator be able to switch between one scheme and another?

response Noted. As explained in the NPA, the air taxi/AEMS operator needs to choose between CS

FTL.1 and CS FTL.2, and then develop its individual FTL scheme based on the chosen set of

requirements.

comment 1127 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

conditional on ORO.FTL.2.210 Based on historic fact, Air Taxi Crew hardly ever reaches the maximum hours of flight time. Suggest to limit it to 2 defininf factors 1) 90 hours in 28 consecutive days 2) 625 hours in 12 consecutive calender months

response Please, refer to the response to comment #147.

comment 1132 comment by: FNAM

Cf. comment 1086 ISSUE It is not explicit whether:

• All the CS.FTL.2 requirements shall be applicable "in block"; or • The CS requirements should apply depending on what is said in the implementing

rule; or • Cherry-picking is allowed

response Please, refer to the response to comment #147.

comment 1133 comment by: FNAM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 187 of 277 An agency of the European Union

ISSUE Considering the seasonality of the French AEMS activity, these limits may be a burden to complete properly emergency missions. Additionally, no fatigue justification nor RIA are provided to justify the 20% reduction of ORO.FTL.235(c) limitations. PROPOSAL Option 1: Keep only ORO.FTL.235(c) limitations for AEMS operations OR Option 2: Modify the CS FTL.2.210 limitations to: “(1) 100 hours of flight time in any 28 consecutive days; (2) 625 hours of flight time in any 12 consecutive calendar months.”

response Please, refer to the response to comment #147.

comment 1494 comment by: Airlec Air Espace / Paul Tiba

#1 ISSUE It is not explicit whether: • All the CS.FTL.2 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210(c) and another in CS FTL.2.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. Therefore, AIRLEC suggests listing the two options in the CS.FTL.2.210 instead of having one described in the IR and one in the CS. PROPOSAL Rewrite clearly for Air Taxi and AEMS the 2 options in CS. #2 ISSUE Considering the seasonality of the French AEMS activity, these limits may be a burden to complete properly emergency missions. Additionally, no fatigue justification nor RIA are provided to justify the 20% reduction of ORO.FTL.235(c) limitations. PROPOSAL Option 1: Keep only ORO.FTL.235(c) limitations for AEMS operations OR Option 2: Modify the CS FTL.2.210 limitations to: “(1) 100 hours of flight time in any 28 consecutive days; (2) 625 hours of flight time in any 12 consecutive calendar months.”

response Please, refer to the response to comment #147.

comment 1512

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 188 of 277 An agency of the European Union

From the point of view of the practice: Air taxi crews hardly ever reach the maximum hours of flight time. Therefore, we propose to limit it to two factors: #1: 90 hours in 28 consecutive days #2: 625 hours in 12 consecutive calender months.

response Please, refer to the response to comment #147.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 189 of 277 An agency of the European Union

CS FTL.2.215 (Positioning)

CS FTL.2.215 p. 25-26

Responses with regard to ‘positioning’

comment 84 comment by: SHug

should also be applicable to AEMS

response Accepted

CS FTL.2.215 is applicable to both air taxi and AEMS operations.

comment 229 comment by: Cat Aviation AG

For simpler application, we suggest for positioning of more than 1 hour or when using 2 modes of transport, FDP is reduced by 30 mins. To instill a penalty for self driving leads to social isolation of crew, if the hotel or airport are in a remote location; it should be the crews' decision, if they like to self-drive in such situations (which are not the norm but an occasional sensible choice) . As this choice is resulting in an FDP penalty, Operators may restrict this option, which leads to less comfort for crew.

response Partially accepted

Positioning is the practice of transferring crew from place to place as passengers on ground

or air transport at the request of the operator. Long distances travelled for positioning may

be a factor influencing the subsequent onset of fatigue and cannot be crews’ decision only.

Please, also refer to the response to comment #569 on positioning.

If commuting between a crew member’s residence and the reporting point (airport, home

base or gateway) takes longer than 90 minutes, the crew member should arrange for

temporary accommodation nearer to the reporting point.

comment 267 comment by: ACM AIR CHARTER

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 190 of 277 An agency of the European Union

CS FTL.2.215 (b) (ii) Please clarify: Only twice the duration of self-driving time in excess of 60 minutes has to be deducted? Example: driving time 1:00h --> Max. daily FDP – 30 min driving time 1:30h --> Max. daily FDP – 60 min (2x30min) driving time 3:00h --> Max. daily FDP – 4h (2x2h) or: Is the operator required to deduct twice the duration of self-driving time IF in excess of 60 minutes, i.e. driving time 1:30h --> Max. daily FDP – 3hrs driving time 3:00h --> Max. daily FDP – 6hrs

response Please, refer to the response to comment #229.

comment 442 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

CS FTL.2.215 If an operator positions a crew member, the following shall apply: (a) positioning after reporting but prior to operating shall be counted as FDP but shall noch count as a sector. (b) all time spent on positioning shall count as duty period. There should not be any addiotnal reduction on the FDP or there should be a differentiation on the booking class of the transport mode e.g. Positioning by plane differentiation between positioning in Economy or business class. As well there should be no difference between the positioning of the commercial and charter airlines to air taxi. Positioning has again the same impact to all crew members, no matter which plane they are flying. Point b (i) and (ii) is not practical for Air taxi operators.

response Noted

Point ORO.FTL.215 and the definition of ‘positioning’ apply to any type of operation,

including air taxi and AEMS operations; no need to repeat the implementing rule under a

CS.

FDP reductions may be necessary when positioning time or the use of more than one main

mode of transport (excluding taxi ride) has the potential to increase crew fatigue.

This is especially relevant for air taxi operations.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 191 of 277 An agency of the European Union

According to the FRMSc Limited scientific study conducted for the EBAA and the ECA, which

is used as a basis for this rulemaking task, every 1 hour of positioning increases fatigue

scores by 0,25. For comparison, 1 hour flight time increases fatigue scores by 0,13.

CS FTL.2.215 does not contain any differentiation between positioning in economy or

business class as there is no available evidence to suggest that positioning in business class

is less fatiguing than positioning in economy class. If positioning on certain routes and

modes of transport and economy class is particularly fatiguing, then the operator should

account for this impact.

comment 531 comment by: ADAC Luftrettung gGmbH

Question: Does travelling time to the home base count as duty time or FDP?

response Not accepted. This requirement is about self-driving for positioning and not self-driving

for commuting between a hotel / private residence and an airport. Please, refer to point

ORO.FTL.215 which explains the difference between positioning and travelling.

comment 633 comment by: Cristina BENZ

should also be applicable to AEMS

response Accepted

comment 703 comment by: Captain M Alcaide GVI

I don´t understand this point, most ATXO pilots drive themself to work, and most conmutes take at least more than 30 min, so that means a reduction on a daily basis? or is it only when out of base? is it different really...the reality again is that an ATXO (or HEMS) pilot live very differently than an airline pilot, but again we all sense fatigue...as any human...and even fully rested fatigue affect humans equally, not working for a week doesn't allow to work for 18 hours in a row in a hostile enviroment.

response Not accepted. This requirement is about self-driving for positioning and not self-driving for

commuting between a hotel / private residence and an airport. Please, refer to point

ORO.FTL.215 which explains the difference between positioning and travelling.

comment 862 comment by: NetJets Europe

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 192 of 277 An agency of the European Union

CS FTL.2.215 (a) NetJets supports the proposal in general however has a couple of comments. Would a 15-30 minute taxi ride after an airline from a major airport count as a different transport mode? e.g. Crew positions from EGLL to LFPG then has a taxi for 15 minutes to go to LFPB. In the majority of cases, crew positioning is to major airports and crew are then required to travel to a secondary aerodrome where the aircraft is located. This is normally accomplished by taxi and for close by aerodromes is not more than 15-30 minutes. This also occurs the other way around where a 15min taxi ride is required from the secondary airport to a major airport to position via airline. Since normal travelling times of 30 minutes is included on the rest periods (e.g. 10 hours minimum rest away from home base is based on 8 hours rest opportunity, 1 hour travelling time (2 x 30 min) and 1 hour for physiological needs), NetJets proposes that a different mode of transport is only accounted for if the time is more than 30 minutes. This would accommodate the short taxi to the secondary airport and also reduce the FDP for long taxi rides (above 30minutes) which we believe is the objective of the requirement. NetJets also proposes that GM is provided as to when the positioning time starts and ends. Does the positioning end upon airline arrival or should it take into account the disembarking and baggage collection? This has an impact as a 50 minutes airline plus 15 minutes for baggage collection could end up being more than 1 hour. This needs clarification. Additionally, plese clarify if this is for after reporting but prior to operating? After reviewing the scientific study, it says that "more than two transport modes"; not more than one (except self-driving), so can CS FTL.2.215 (a) be changed to "more than two transport modes"?

response The proposal for GM is accepted.

The change in CS FTL.2.215(a) to ‘more than two’ transport modes, one of which obviously

includes a taxi ride is not accepted; the purpose of this requirement is to limit the fatiguing

effect of positioning where more than one main mode of transport is used. A taxi ride is

not ‘main’ mode of transport.

comment 1034 comment by: Stephanie Selim

Technical comment – The CS FTL.2.215 is proposed to be specific to air taxi operations. However, there is no rational to limit it only to this type of operations (apart from the probability of occurrence which seems higher for air taxi operations). The effect on fatigue can be supposed to be similar for all kind of operations. DGAC suggests that provisions of this CS should be extended to CS 1 too.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 193 of 277 An agency of the European Union

comment 1036 comment by: Stephanie Selim

(b)(ii) Editorial comment – To be consistent with CS FTL.2.215(b)(i), 30 minutes should be added: “30 min plus twice the duration of the self-driving time in excess of 60 minutes.”

response Noted

CS FTL.2.215 has been simplified.

comment 1134 comment by: FNAM

ISSUE These dispositions are not specified in CAT.A regulation, therefore, FNAM and EBAA France ask for the suppression of this paragraph. Moreover, the paragraph (a) has no practical sense since if a crew member leaves his home walking, takes a train and then a shuttle to go to the airport, the maximum FDP will always be reduced by 30 minutes. PROPOSAL Suppress this CS.

response Not accepted

Commuting from one’s private residence to the home base is not ‘positioning’ as per given

definition.

comment 1139 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Too complicated and difficult to overview. Air Taxi Crews often like to have a rental car, mainly in remote areas. This for social reasons and flexibility during their layover. Operator would need to restrict and make crews unhappy. Selfdriving or positioning as passenger should not be distinguished.

response Not accepted

Travelling during a layover is not ‘positioning’ as per given definition.

comment 1170 comment by: GBAA

CS FTL.2.215 (b) Positioning — air taxi operations What is the purpose of the reduction of the FDP "twice the duration of the self-driving time

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 194 of 277 An agency of the European Union

in excess of 60 minutes"? Why for all going in the car? A small company cannot afford to have several people on standby. If one crew member due to flying becomes sick, a replacement needs to be organized. The most flexible way is going by car. For instance, the way from Munich to Zürich takes about 4 hours. The new proposal will consume 6.5 hours of FDP which are 2.5 hours more than the current regulation. Even if the crew members are only been driven by a colleague, they are punished with extra 2.5 hours FDP. For what purporse?

response Not accepted. This requirement is about self-driving for positioning and not self-driving for

commuting between a hotel / private residence and an airport. Please, refer to point

ORO.FTL.215 which explains the difference between positioning and travelling.

comment 1304 comment by: Volkswagen AirService GmbH

A difference must be implemented between positioning prior to and after a FDP. Otherwise

a positioning after duty will decrease the preceeding FDP. As proceedings are usually

organized on short notice, it should be mandatory to choose the most save, fast,

economical and comfortable method instead of trying to shorten times due to self driving.

response Not accepted.

The difference between positioning prior to and after an FDP is already addressed in the

Regulation (see point ORO.FTL.215). Positioning prior to an FDP is considered part of that

FDP, but not a sector. Positioning after an FDP is counted only as duty period.

comment 1373 comment by: Gama Aviation (UK) Ltd

Further definition of Transport Modes is required. Does this include a taxi from the airport to hotel, or airport bus from airport to hotel? Should be in line with scientific study (FRMSC) and more than two transport modes instead of one.

response Not accepted

A taxi ride from airport to hotel, or an airport bus from airport to hotel, is not positioning

but travelling.

Please, refer to the definition of ‘positioning’ in point ORO.FTL.105 (18).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 195 of 277 An agency of the European Union

comment 1513

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

This provisions are much too constraining in real life scenarios and moreover burdensome to control/comply with: Air taxi crews in many cases get themselves rental car. This makes sense particularly when they stay in remote places. Shuold this provision be enacted, operators would be forced to restrict the crews' freedom of movement. Moreover, self- driving or riding as a passenger should not be distinguished.

response Travelling during a layover is not ‘positioning’ as per given definition.

CS FTL.2.220 (Split duty)

CS FTL.2.220 p. 26

Responses with regard to ‘split duty’

comment 148 comment by: VistaJet

The way the new split duty function has been structured is very good, however the only addition which would really enhance this function is to allow operators to use this function post planning phase in the case of unforseen circumstances. For example, after the first sector there is a significant passenger delay, crew could be put into an airport hotel and make use of the exended ground time to rest. This would provide a bit more operational flexibility.

response Accepted

Please, refer to the response to comment #1040.

comment 197 comment by: Premium Jet AG

Unforeseen circumstances should be incorporated due to the kind of operation. Meaning split in postplanning pahse and operational phase.

response Please, refer to the response to comment #1040.

comment 230 comment by: Cat Aviation AG

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 196 of 277 An agency of the European Union

it would be helpful if we can apply split duty also during operation phase and post operation. AirTaxi "schedules" change frequent and during a trip and we should be able to make use of this option in the most flexible and efficient way.

response Please, refer to the response to comment #1040.

comment 242 comment by: ACM AIR CHARTER

(g) Please clarify: 1. Does that mean that the time enroaching the WOCL does not reduce the 50% extension of the basic maximum FDP and, if spent in a suitable accomodation? 2. Does it mean the time exceeding 6 hours is in all cases not to be considered, even if spent in suitable accomodation.

response Noted

Since suitable accommodation is always required for a single break of 6 hours or longer, or

when encroaching on the WOCL, the exception provided for under this paragraph creates

confusion and would otherwise make FDP calculations very complex, if the combined

duration of all breaks is taken into account; it has, therefore, been removed.

comment 630 comment by: Transport Malta - Civil Aviation Directorate

We Suggest amendment to clarify break may be in a suitable accommodation or on board the aircraft as proposed in notes.

response Accepted

Please, refer to the response to comment #242.

comment 704 comment by: Captain M Alcaide GVI

30 minutes minimum time for post and preflight duties and travelling is totally out of reality. I fly a Gulfstream 650 and I can assure you that post and preflight duties only cover more than that, if you have to add transport... If an operator can extend the maximum daily FDP up to 50% of the combined duration of the breaks, days can be really long for a crew.... I don't see the safety rationale behind, only the practical profit Operator cause

response Noted

30 minutes is the minimum time; actual times are based on operator observations and

included in the OM. The safety benefit is that the break is part of the FDP (i.e. it does not

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 197 of 277 An agency of the European Union

pause the FDP) and the crew member has a rest opportunity on the ground, on board or

in a suitable accommodation, which may be used for restorative sleep.

comment 867 comment by: NetJets Europe

CS FTL.2.220 NetJets supports the Split duty proposal in general however has a comment on point (g) CS FTL.2.220 (g) Item (g) needs to be clarified as it has been interpreted as requiring suitable accommodation when the total combined break time is greater than 6 hours in order to use the extension. NetJets suggests deleting the second part of the sentence as suitable accommodation is always required for breaks above 6 hours or encroach the WOCL, or changing it to: "an operator may extend the basic maximum daily FDP specified in CS FTL.2.205 by up to 50 % of the combined duration of all breaks on the ground, with the exception of the individual break time exceeding 6 hours or encroaching the WOCL if spent in other than suitable accommodation"

response Please, refer to the response to comment #242.

comment 1045 comment by: Stephanie Selim

Editorial comment – To be consistent with CS FTL.1.220: “The following applies in the case of split duty with one or more breaks on the ground in air taxi and AEMS operations: The increase of limits on flight duty, under the provisions of ORO.FTL.220, complies with the following:”

response Accepted

comment 1046 comment by: Stephanie Selim

(f) Editorial comment – To be consistent with CS FTL.1.220: “an extension of the maximum basic daily FDP due to split duty cannot be is not combined with an extension due to on-board rest;

response Accepted

comment 1135 comment by: FNAM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 198 of 277 An agency of the European Union

Cf. comments 1089 ISSUE The rule needs to allow split in post planning phase or in operation phase. Besides, when a split duty is added, the operator recalculates the maximum FDP from the initial reporting time including the extension due to the split duty. Within this new legal framework, the operator can change the flight times scheduled after the break(s) of the split duty. Due to the activity, there is a possibility of doing it several times (several breaks are allowed). As a mitigation, in terms of fatigue, there is no change compared to if it had been scheduled from the beginning. The crew member has all the time spent in the break of the split duty to anticipate the fatigue for the next flight times. PROPOSAL Add the following paragraph: “By way of derogation from ORO.FTL.110(a), for AEMS and Air Taxi operations, a split duty may be scheduled at any point in time including after reporting time by successively adding one or more break(s). When a break is added within the initial FDP, the operator recalculates the maximum FDP taking into account the duration of the break(s) and the operator can change the flight times scheduled after the break(s) of the split duty.” RATIONALE: As a mitigation, in terms of fatigue, there is no change compared to if it had been scheduled from the beginning. The crew member has all the time spent in the break of the split duty to anticipate the fatigue for the next flight times. Thus, the mitigation is included in the proposal.

response Please, refer to the response to comment #1040.

comment 1136 comment by: FNAM

ISSUE Cf. comment 1091 FNAM and EBAA France suggest coming back to the break definition. In any case, a break has to be taken on the ground. Therefore, the wording “break on the ground” is unnecessary and should be replaced by the sole wording “break” since it may only lead to misunderstanding. PROPOSAL Replace the wording “break on the ground” by “break”.

response Not accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 199 of 277 An agency of the European Union

‘Break on the ground’ is already used in point ORO.FTL.220, prior to the introduction of

air taxi/AEMS operations.

comment 1137 comment by: FNAM

(f) ISSUE The paragraph (f) is unclear and needs to be rephrased. When a crew member is on on-board rest, considering the extension of the FDP with augmented flight crew, the on-board rest does not count for split duty for this given crew member. PROPOSAL Rephrase the paragraph (f).

response Not accepted

The same is used in CS FTL.1.220 and there are no claims it is unclear.

comment 1175 comment by: GBAA

CS FTL.2.220 (e) Split duty — air taxi operations and AEMS What does suitable accommodation mean? Acc. to ORO.FTL.105 Definitions (4), "‘suitable accommodation’ means, for the purpose of standby, split duty and rest, a separate room for each crew member located in a quiet environment and equipped with a bed, which is sufficiently ventilated, has a device for regulating temperature and light intensity, and access to food and drink." So far, a regular hotel room would fulfil all requirements. However, the last point implies that the operator is paying for food and drinks which is not true. This topic has to be cleaned up of misunderstandings. What about a room at a small bed and breakfast (B&B) during the day or even during night? There won't be any food available… CS FTL.2.220 (g) Split duty — air taxi operations and AEMS The new proposal constrain the possibilities for split duties during the night compared to the existing regulations. E.g. a trip with 2 legs from 2000h-2400h and 1030-1200h flight time. New proposal Checkin 1900h with max. FDP of 11h Flight 2000h-2400h Check-out 0:30h until 0030h 9h break for a check-in at 0930h -> FDZ will increase by 4.5h to 15:30h or until 10:30h Check-in 0930h Flight cancelled, since FDZ runs out at the time of departure!!!! Existing in Germany Checkin 1900h with max. duty of 18h and block time of 10h

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 200 of 277 An agency of the European Union

Flight 2000h-2400h, 4h block Flight 1030h-1200h, 1,5h block Check-out 1230h, 1730h duty Ok! Existing in Austria Checkin 1900h with max. FDP of 13h, WOCL is not considered during the break Flight 2000h-2400h Check-out 0:30h until 0030h 9h break, more than 6 hours counts for 1 hour of FDZ Check-in 0930h Flight 1030h-1200h, 1,5h block Check-out 1230h Total FDZ = 1+4+0.5+1+1+1.5+0.5 = 9.5h, another 3.5 hours left!!! ==> Although time for sleep from 0100h until 0830h is given, the new proposal does not leave enough room for flexibility.

response Noted

A split duty break that encroaches on the window of circadian low (WOCL) with a suitable

accommodation provided allows for the extension of the maximum FDP.

comment 1206 comment by: Danish Aviation Association

CS.FTL.2.200 Split Duty: In case of unforseen circumstances should it be possible to split in post planning or operations phase.

response Please, refer to the response to comment #1040.

comment 1277 comment by: Volkswagen AirService GmbH

Our operations has applied national duty time regulations for a long time without any issues. This included the ability to extend the maximum daily FDP to 18 hours with at least a minimum of 3 hours on-ground rest period. (g) effectively limits us to a maximum extended FDP of only 17 hours. This reduces our operational capabilities.

response Not accepted. It is not clear how paragraph (g) limits your maximum FDP to 17 hours. In

fact, according to paragraph (g), an extension of the maximum daily FDP by 50 % of the

combined duration of all breaks is allowed.

comment 1305 comment by: Volkswagen AirService GmbH

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 201 of 277 An agency of the European Union

Referring to 220 (c): Rather than applying fixed times it should be possible to log the actual times. The operator shall describe in his operations manual to apply actual times without having to define specific values.

response Not accepted

CS FTL.2.220(c) states that the minimum total time for post- and pre-flight duties and

travelling is 30 minutes. The operator may apply whatever method for the actual times as

long as these actual times do not fall below the minimum time established here.

comment 1380 comment by: Gama Aviation (UK) Ltd

For AEMS operations, split duty should be allowed in the operational and post planning phases due to unforseen circumstances.

response Please, refer to the response to comment #1040.

comment 1447 comment by: European Cockpit Association

Commented text: “Split duty, breaks on the ground” References ORO.FTL.220 (a) (2) CS FTL.2.220 (a) & (b) CS FTL.2.220 no. 27 ECA Comment: The CS2 introduces the idea of multiple breaks on the ground between different sectors being available to add together for the purposes of a split duty FDP extension. There is no scientific basis for this suggestion, indeed scientific advice previously received by EASA advocates “limiting the fragmentation of sleep as afar as possible” in order for it to provide meaningful rest. This ‘split-split duty’ enables the complete opposite of that advice, providing only fragmented rest opportunities that should not be usable for the extension of FDP under split duty. Proposal: Only one continuous and undisturbed break in an FDP should be available for the extension of that FDP under split duty. The ‘split-split duty’ must be prohibited.

response Not accepted

The scientific advice about limiting the fragmentation of sleep as far as possible refers to

the sleep opportunity in any 24-hr period; this proposal preserves an uninterrupted 8-hr

sleep period in any 24-hr period. As regards breaks in the context of split duty, they are

mostly performed during the day due to delays.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 202 of 277 An agency of the European Union

If the WOCL is encroached, the break must be taken in suitable accommodation. The break

does not ‘pause’ the FDP.

comment 1523 comment by: General Aviation Manufacturers Association / Hennig

The proposal's shift from the current nationally regulated framework for "split duty" may significantly impact operations between certain city pairs. While the concept of "split duty" is in itself a positive mechanism to extend duty days, EASA may have underestimated the impact on how current operations are conducted in the shift to the pan-European regulatory framework. GAMA requests that EASA to review the proposed concept for split duty (which we recommend be maintained) but ensure that there is a full understanding of the local issues that may arise based on the existing approach at the Member State level. GAMA is concerned that the NPA may not have fully considered the impact on operations and the resulting cost to the operator to maintain operations.

response Noted

Local issues are typically dealt with by the operator’s IFTSS, applying for deviations from

the applicable CSs or for exemptions from the implementing rules (IRs).

GM CS FTL.2.220(c) p. 26

comment 49 comment by: Wolfgang Zellhuber

With several hundred aerodromes/operating sites in Europe and several thousands around the world it is impossible to establish and specify (as required by CS FTL.2.220(c)) post,- pre-flight duty and travelling times for every possible aerodrome and aerodrome conditions. e.g. at EDDM: Pending on the actual parking situation at the aerodrome itself you may experinece different ground transportation time on the airside of the aerodrome, variable between 3 and 25 minutes. How should an operator know about these circumstances if a parking position of an aeroplane is established approximately 10 minutes before arriving at EDDM? And EDDM is an aerodrome with almost perfect infrastructure. Even well experienced pilots, working in the ATXO for several know one thing: ATXO operator will never know, how situations develop an a day-to-day-basis, or even on an hour-to-hour-basis. During summer time you may wait at Nice/LFMN some hours to get fuel. The next day fuel will arrive within seconds. Please give the operator some helping hand (GMs) on how to establish a - in your opinion -compliant procedure.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 203 of 277 An agency of the European Union

This text is meant to serve an average case. It does not imply that the operator must

establish post- and pre-flight duty times for each aerodrome. This will be clarified in the

related GM.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 204 of 277 An agency of the European Union

CS FTL.2.225 (Standby)

CS FTL.2.225 p. 26-27

Responses in relation to ‘standby’

comment 71 comment by: Rega / Swiss Air-Ambulance

2. CS FTL.2.225 (b)(3) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(3): … for the purpose of CS.FTL.2.210(a) …; Question of the writer referring to CS FTL.2.225 (b)(3): Shoudn't it say ORO.FTL.2.210(a) instead of CS.FTL.2.210(a) in this context? · The link to CS.FTL.2.210(a) does not make sense as CS FTL.2.210 deals with maximum flight time and not with standby duty limitations: · Be aware that also in the following pages of NPA 2017-17 CS FTL.2.210 are referenced:

o Page 32 of 70; o Page 33 of 70.

response Accepted

comment 72 comment by: Rega / Swiss Air-Ambulance

3. CS FTL.2.225 (b)(4) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(4): standby is followed by not less than 10 hours of rest period; Adaption requested by the writer for CS FTL.2.225 (b)(4): standby is followed by not less than 8 (eight) hours of rest period; Justification: · The raison d'être of any AEMS (and HEMS) operator and therefore flight crew member is standby. This to be able to provide medical assistance to people in need according to ORO.FTL.105 and the definition "EMS flight" (29); · It must be expected that EASA understands that flight crew members are assigned by the operator for some 20 to 40% of their duty days as standby days without being called for an FDP. The rest of the duty days are consumed by FDP or office/training/positioning/etc. duties; · A flight crew member assigned for AEMS standby other than airport standby does per se not suffer from so called cumulative fatigue; · To certain amount social (family) activities can be performed during standby other than airport duty;

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 205 of 277 An agency of the European Union

· A flight crew member serving e.g. several days of consecutive standby duty other than airport (at home) has the opportunity to go to bed immediately(!) after standby other than airport standby ceases at home; · That means that pre-rest period duties like having a light meal, changing to nightdress, taking a shower, etc. can and shall be done before the end of the preceding period of standby other than airport standby; · Logically commuting has not to be taken into account; · As the maximum duration of standby other than airport standby is 16 hours (see CS FTL.2.225 (b)(1)) I do stress that the rest period following standby other than airport standby shall be … not less than 8 hours … instead of the NPA proposed 10 hours; · Mathematically and logically the maximum 16 hours of standby other than airport standby added by the recommended 8 hours of rest period result in a total of 24 hours and therefore fit perfectly into a 24 hour calendar day; · Otherwise 16 added by 10 hours result in 26 hours and throw the flight crew member out of the 24 hour window of time that defines a calendar day.

response Accepted

Based on scientific evidence and advice, a minimum of 8 hours’ sleep opportunity should

be included in the crew rest period while the crew is at the operating base.

Please, see also the response to comment #1004.

comment 73 comment by: Rega / Swiss Air-Ambulance

4. CS FTL.2.225 (b)(6) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(6): if standby ceases within the first 6 hours, the maximum FDP counts from reporting; Adaption requested by the writer for CS FTL.2.225 (b)(6): if standby ceases within the first 8 (eight) hours, the maximum FDP counts from reporting; Justification: · The raison d'être of any AEMS (and HEMS) operator and therefore flight crew member is standby. This to be able to provide medical assistance to people in need according to ORO.FTL.105 and the definition "EMS flight" (29); · For a flight crew member not being called for an AEMS mission it can be assumed that this individual flight crew member has ample of time to rest in the morning as long as his/her body clock allows; · During standby other than airport standby the individual flight crew member is able to rest and to fulfill at least to a certain amount at home social duties at his/her discretion until called to report for a FDP; · Assuming that standby other than airport standby commences e.g. at 05:00 local time (LT) and the (average) response time is 90 minutes and fully appreciating

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 206 of 277 An agency of the European Union

Table 1 under CS FTL.2.205 Flight duty period (FDP) – air taxi and AEMS (page 22 of 70) will lead again and again to situations where a flight crew checking-in at e.g. 15:00 LT has not enough FDP remaining to conduct even an AEMS mission within the Europe theater of operation. This, as a serious AEMS operator assigns 90 minutes between reporting at the designated reporting point and subsequent take-off for the purpose of an AEMS flight; · Conclusion: The remaining period of FDP is simply not enough to seriously conduct even an AEMS mission within the Europe theatre of operation.

response Accepted

CS FTL.2.225(b)(6), (7), (8), (9) and (10) have been deleted.

The mitigation measure already available under ‘(2) The operator’s standby procedures are

designed to avoid that the combination of standby and FDP leads to more than 18

consecutive hours awake time’ allows for the control of the FDP length.

comment 74 comment by: Rega / Swiss Air-Ambulance

5. CS FTL.2.225 (b)(7) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(7): if standby ceases after the first 6 hours, the maximum FDP is reduced by the amount of standby time exceeding 6 hours; Adaption requested by the writer for CS FTL.2.225 (b)(7): if standby ceases after the first 8 (eight) hours, the maximum FDP is reduced by the amount of standby time exceeding 8 (eight); Justification: · The adapted paragraph CS FTL.2.225 (b)(7) is in line with the adapted paragraph CS FTL.2.225 (b)(6); · For details, refer to my comments made under comment 4. CS FTL.2.225 (b)(6) (previous page).

response Noted. CS FTL.2.225(b)(7) has been deleted.

comment 75 comment by: Rega / Swiss Air-Ambulance

6. CS FTL.2.225 (b)(8) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(8): if the FDP is extended due to on-board rest according to CS FTL.2.205(e) or split duty according CS FTL.2.220, the 6 hours of points (6) and (7) are extended to 8 hours;

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 207 of 277 An agency of the European Union

Adaption requested by the writer for CS FTL.2.225 (b)(8): if the FDP is extended due to on-board rest according to CS FTL.2.205(e) or split duty according CS FTL.2.220, the 6 hours of points (6) and (7) are extended to 8 hours; è Delete CS FTL.2.225 (b)(8) Justification: · The raison d'être of any AEMS (and HEMS) operator and therefore flight crew member is standby. This to be able to provide medical assistance to people in need according to ORO.FTL.105 and the definition "EMS flight" (29); · For a flight crew member not being called for an AEMS mission it can be assumed that this individual flight crew member has ample of time to rest in the morning as long as his/her body clock allows; · During standby other than airport standby the individual flight crew member is able to rest and to fulfill at least to a certain amount at home social duties at his/her discretion until called to report for a FDP; · Considering that a flight crew member assigned for standby other than airport standby has at home the unrestricted possibility to rest at his/her discretion whenever deemed necessary, it makes absolutely no sense to limit the FDP that is extended due to on board rest according to CS FTL.2.205(e); · This with respect to CS FTL.2.205 (2) where it is stipulated that for FDP extended due to on-board rest the following conditions must be met:

o (... 2 consecutive hours for those flight crew members at control during the last landing ...);

· Conclusion: o Delete CS FTL.2.225 (b)(8) in total without replacement as it restricts

unnecessarily and unjustified the application of a FDP extended due to on-board rest after standby other than airport standby;

o This as the mitigation per se is the possibility for on-board rest during the AEMS mission with augmented flight crew;

o Otherwise medium- to long-range AEMS missions with augmented flight crew using the possibility for on-board rest will not be possible anymore over night;

o Referring to the adopted CS FTL.2.225 (b)(6) & (7) (see above) the extension of FDP in case of split duty according CS FTL.2.220 is no more necessary.

response Accepted. CS FTL.2.225(b)(8) has been deleted.

comment 76 comment by: Rega / Swiss Air-Ambulance

7. CS FTL.2.225 (b)(10) (page 27 of 70 NPA 2017-17) Existing proposed CS FTL.2.225 (b)(10): if a crew member is undisturbed and is able to remain at his/her place of rest between 13:00 and 17:00 at the local time where the crew member is acclimatized, the time spent before 13:00 does not reduce the maximum FDP.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 208 of 277 An agency of the European Union

In such case, the maximum FDP is only reduced by the amount of standby after 17:00 in excess of 6 hours (or 8 hours for augmented crew or split duty); Adaption requested by the writer for CS FTL.2.225 (b)(8): if a crew member is undisturbed and is able to remain at his/her place of rest between 13:00 and 17:00 at the local time where the crew member is acclimatized, the time spent before 13:00 does not reduce the maximum FDP. In such case, the maximum FDP is only reduced by the amount of standby after 17:00 in excess of 6 hours (or 8 hours for augmented crew or split duty). The rest period under point (4) may be reduced by the 4 hours of rest resulting of the time between 13:00 and 17:00 where the crew member has had the possibility for rest; Justification: · Referring to my comments number six (above) the slashed sentence above (or 8 hours for augmented crew or split duty) shall be deleted in order to be congruent; · As a crew member is able to rest between 13:00 and 17:00 it shall be understood that that this 4 hours are not considered standby other than airport standby duty according CS FTL.2.225 (b)(1); · Saying this it must be understood that the maximum standby other than airport standby period of time according CS FTL.2.225 (b)(1) may result in an end of the standby other than airport standby duty that is conflicting with a 24 hours calendar day and the emphasis to keep the crew member concerned in a 24 hours routine (16 hours of standby other than airport standby followed by 8 hours rest period); · Therefore, the rest period according CS FTL.2.225 (b)(4) may be reduced to not less than 4 hours.

response Partially accepted. CS FTL.2.225(b)(6), (7), (8), (9) and (10) have been deleted.

comment 80 comment by: SHug

(b)(1): The maximum duration of standby other than airport standby is 16 hours. This limit may be extended by the number of hours between 23:00 and 07:00 or between 13:00 to 17:00 during which the crew member is undisturbed and is able to remain at his/her place of rest at the local time where the crew member is acclimatised, if the standby encompasses that period; justification: in reality it is not possible to sleep the hours from 13:00 until 17:00 and therefore the extension by this time period increases fatigue risk (b)(10): "In such case, the maximum FDP is only reduced by the amount of standby after 17:00 in excess of 6 hours (or 8 hours for augmented crew or split duty);" justification: without this change, this point would counteract the target of mitigating fatigue risks and would allow the operator to avoid the need of compensating long standbytimes.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 209 of 277 An agency of the European Union

response Partially accepted. CS FTL.2.225(b)(10) has been deleted.

comment 115 comment by: UK CAA

Page No: 27 Paragraph No: CS FTL.2.225(b)(11) Standby – air taxi and AEMS Comment: It is recommended that EASA considers developing a general AMC or GM for all types of operation on the term “reasonable time”. Justification: Clarity on the term “reasonable time” and its application within the determination of “response time”. Proposed Text: AMC or GM text - “Operator’s standby procedures should detail the “response time” such that it reflects: sufficient allowance for the crew member to prepare themselves for work (physiological needs) from the time they receive the operators call to leaving the place of rest; and, the contracted allowance for travelling time from place of rest to reporting point, or where that is not detailed, the travelling time guidance that the operator references in their scheme. This may mean that the response time is different for reporting from standby at home and when away from base.”

response Accepted

comment 149 comment by: VistaJet

The standby function is very complex and again very difficult to verify compliance. A major issue here is the duty penalty. With duty hours already reduced, and with the significant amount of positioning as a passenger in ATXO, the penalty should never be more than 25% standby counting towards duty. As the rotation model includes a consolidated "off" block, crew are never on extended standby periods without having a long off period to compensate.

response Please, see the response to comment #73.

comment 198 comment by: Premium Jet AG

Point 4: needs to be corrected to 8h because of suitable location - physical needs could have been covered during standby. Point 3: What happens if standby starts in middle of period (e.g. 0500). Please clarify.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 210 of 277 An agency of the European Union

response Please, see previous responses relating to ‘standby’.

comment 239 comment by: Cat Aviation AG

Standby at home or in hotel should not affect FDP - as crew can fully relax in a quiet and familiar environment. Standby is a larger part of what in a way defines AirTaxi operations, up to 40% of their duty days are on standby with no call for duty. It needs to be noted, that crew are fully paid for that time. In this time crew has ample rest to manage their fatigue and circadian clock. Therefore and by logical and mathematical calculation, the required rest following a standby duty should be 8 hours (16hrs sby + 8hrs rest = 24 hour day). Standby at home should not impose a penalty on FDP. The 25% of standby duty counting as Duty time is fair.

response Please, see previous responses relating to ‘standby’.

comment 245 comment by: Thomas Henselmann

(4) Stanby rest should be reduced to 8h when at home or hotel.

response Please, see previous responses relating to ‘standby’.

comment 426 comment by: Skyshare Union representing NetJets crew members

We would like to propose that the definition of ‘response time’ is changed to mean the time interval between activation and leaving the place of rest, and the percentages amended as follows: Response time of 60 minutes or more - 25% Response time of 30-59 minutes - 50% Response time of under 30 minutes - 100% Reasoning: All standby other than at the airport follows the same rules, regardless whether at home or at a hotel on tour. The percentage of standby other than at the airport (i.e. standby at home or hotel standby) that counts towards duty limits depends on the ‘response time’ which is defined as the time from activation to reporting at the airport. The shorter the response time the higher the percentage. This is presumably designed to protect a crew with a shorter response time, which is unable to rest as efficiently. However, the real factor that determines how efficiently one can rest is the time interval between activation and leaving the place of rest (as opposed to arriving at the reporting place).

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 211 of 277 An agency of the European Union

For our current 45 minutes to leave the hotel plus an assumed 30 minutes traveling time from hotel to FBO, this means that under the proposed Air Taxi FTL regime hotel standby would count 50% towards limits rather than the current 25%. However for a hotel with less than 15 minutes traveling time to FBO that would be 100%. Conversely for hotels further away than 45 minutes the 25% applies. In each of these cases, the time limit from activation to leaving the place of rest is 45 minutes so the ability of the crew to rest and the impact on fatigue is identical so it makes little sense the duty counts 100% or 25% depending on the travelling time.

response Partially accepted

The time to reach the designated reporting point from a private place of rest (e.g. one’s

private residence) is the travelling time for which the crew member bears responsibility.

Crew members should consider arranging for temporary accommodation closer to their

home base if the travelling time from their residence to the home base exceeds 90 minutes

(GM1 ORO.FTL.200). To arrive at work fit for duty and not exhausted due to long hours of

travelling to the airport of departure, crews are advised to arrange for temporary

accommodation (hotel room, rented apartment or the like). This is the main reason why a

response time of 90 minutes or more will only be accounted at 25 %, and response times

of less than 90 minutes are rated at higher percentages.

Unlike travelling time, however, the time for a local transfer from a place of rest (hotel) to

the designated reporting point is typically the operator’s responsibility. Indeed, it makes

no sense to penalise the crew member’s standby duty times by applying a lower

percentage just because the operator did not manage to arrange for a rest facility closer

to the airport.

These two situations and associated responsibilities need to be balanced, as well as

arranging for a rest facility closer to the reporting point and shorter travelling / local

transfer times should be incentivised.

Therefore, the percentages and definition of response time, proposed with NPA 2017-17,

remain unchanged, but new guidance material (GM2 CS.FTL.2.225) recommends that

when arranging for a local transfer from the crew member’s standby location to the

designated reporting point, the operator should avoid transfers that exceed 90 minutes

and, if possible, should provide suitable accommodation at or near the crew’s designated

reporting point. This GM mirrors the recommendation addressed to crew members

(GM1 ORO.FTL.200).

comment 443 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

CS FTL.2.225 Standby (b) Standby other than airport standby:

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 212 of 277 An agency of the European Union

Standby is very common for air taxi operators. If standy is at a accomodation (home or hotel) it should count as rest period. All pilots should have the possibility to rest during their standby time, they should not be disturbed or assigned to any duty during this time. Therefore the maximum standby time should be increased to 24 hours, given a suitable accomodation with rest facilities, and suitable fatigue training in how to rest even during day time. If contacted they should have a suitable time period to report to the airport, according to airport, and aircraft time. There is also a difference if crews are contacted passively, meaning by email, company app, ect. than with an active contact, i.e. telephone call. If crews are contacted passively the will not be woken up during their rest period, meaning no disturbance, which implies same recover from fatigue as no contact at all. In case crew is actively disturbed during their rest, duty or flight duty period will begin.

response Accepted

comment 634 comment by: Cristina BENZ

(b)(1): The maximum duration of standby other than airport standby is 16 hours. This limit may be extended by the number of hours between 23:00 and 07:00 or between 13:00 to 17:00 during which the crew member is undisturbed and is able to remain at his/her place of rest at the local time where the crew member is acclimatised, if the standby encompasses that period; justification: in reality it is not possible to sleep the hours from 13:00 until 17:00 and therefore the extension by this time period increases fatigue risk (b)(10): "In such case, the maximum FDP is only reduced by the amount of standby after 17:00 in excess of 6 hours (or 8 hours for augmented crew or split duty);" justification: without this change, this point would counteract the target of mitigating fatigue risks and would allow the operator to avoid the need of compensating long standbytimes.

response Please, see previous responses relating to ‘standby’.

comment 705 comment by: Captain M Alcaide GVI

The phrase "the FDP counts from start of the FDP" is poorly worded... So the idea is to have a crew 4 hours at airport stand by followed by 14 hours duty....so 16 hours in a row....flying a machine around...I can't see the increase in safety in this operation...taking into account the lack of standardization on ATXO crews. I'd say this jeopardizes safety.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 213 of 277 An agency of the European Union

Cases, as in the example given, are recognised as potentially leading to increased fatigue

levels and are, therefore, mitigated by a cap of 16 hours combined duration of airport

standby and assigned FDP. Aircrew should be able to spend airport standby in a crew room

or other accommodation.

comment 706 comment by: Captain M Alcaide GVI

So home standby begins day in day out (just for 10 hours) for a week in example, and every day a crew might be alerted for a duty that would imply at least 18 hours of awake time (how do you control times at home??? how do you control undisturbed rest) This is all clearly a way for operators to maximize their flexibility BUT surely not and increase in safety... I understand it's really difficult to regulate but I can't see any safety improvements...Operators will use it to increase their commercial reach...

response Noted. The requirement for 18 hours awake time is not a target to be reached at any time.

It includes responsibilities for operators (to establish their policies and procedures for

verification), and also for crew members to maximise the use of rest opportunities for

recuperative sleep.

comment 778 comment by: AECA helicopteros.

Which criteria apply in the event that the standby period takes place in the home of the pilot? Can in this case be extended up to 24 hours ?.

response Please, refer to CS FTL.2.225(b)(1).

comment 779 comment by: AECA helicopteros.

(b) (3) the reference to the CS FTL 2.210 (a) is not correct, because (a) does not exist in CS FTL 2.210

response Accepted. The correct reference was point ORO.FTL.210(a).

Please, see also previous responses relating to ‘standby’.

comment 811 comment by: Babcock Mission Critical Services Limited

CS FTL.2.225 Standby — air taxi operations and AEMS (b)(3)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 214 of 277 An agency of the European Union

This articles refers for "the purpose of CS.FTL.2.210 (a), but that point of the CS hasn't got an (a) or (b). It refers just to air taxi ops. This appears to be a typographical error by EASA. The reference to “CS.FTL.2.210 (a)”, should read “ORO.FTL.210 (a)”.

response Accepted. The correct reference was point ORO.FTL.210(a).

Please, see also previous responses relating to ‘standby’.

comment 868 comment by: NetJets Europe

CS FTL.2.225 (b)(3) and CS FTL.2.225 (c) NetJets comments that the response time concept is not compatible for air taxi operations. e.g. travelling time has an influence on response time where 15 minutes travelling time could mean 60 minutes response time while a travelling time of 45 minutes could mean a response time of 90 minutes. NetJets believes that the response times and the counting of different percentages towards the cumulative duty limits is applicable to AEMS where they have different levels of response times. NetJets proposes that for Air Taxi operations, standby other than airport standby should only count 25% towards the cumulative duty limits.

response Noted

Please, refer to the response to comment #426.

Air taxi operators may choose to apply only 25 % with a response time of 90 minutes, the

other options being inappropriate for their operations.

comment 1049 comment by: Stephanie Selim

Editorial comment – To be consistent with CS FTL.1.225: “The limits on flight duty, duty and rest periods in air taxi operations or AEMS are modified in accordance with the following: The modification of limits on flight duty, duty and rest periods under the provisions of ORO.FTL.225 complies with the following:”

response Accepted

comment 1080 comment by: Rabbit-Air Ltd

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 215 of 277 An agency of the European Union

When using Standby at home or in the hotel there is no need for a penalty in FDP. Required rest should be 8 hrs (like "Reserve").

response Please, see previous responses relating to ‘standby’.

comment 1138 comment by: FNAM

Attachment #82

ISSUE: The paragraph (a)(2)(ii) is not clear: the maximum combined duration of airport standby and assigned FDP has to be extendable to a 24 hours period (Cf. Annex 5). PROPOSAL: Rephrase the paragraph (a)(2)(ii) to make it clear that the maximum combined duration of airport standby and assigned FDP may be extendable to a 24 hours period.

response Please, see previous responses relating to ‘standby’.

comment 1140 comment by: FNAM

Attachment #83

ISSUE: This paragraph (b)(1) is unclear and needs to be rephrased. 1/ The maximum duration of standby other than airport standby has to be extendable to a 24 hours period (Cf. Annex 5). 2/ Besides, the paragraph (b)(1) should be rephrased: It is not clear if the wording “if the standby encompasses that period” refers to:

• Both periods: [23:00 to 07:00] and [13:00 to 17:00] • The period [23:00 to 07:00] • The period [13:00 to 17:00]

PROPOSAL: Rewrite the paragraph (b)(1) to:

• Make it clear that the maximum duration of standby other than airport standby is extendable to a 24 hours period

• Clarify the wording “if the standby encompasses that period” to highlight the fact that it refers to both periods:[23:00 to 07:00] and [13:00 to 17:00]

response Please, see previous responses relating to ‘standby’.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 216 of 277 An agency of the European Union

comment 1141 comment by: FNAM

ISSUE: (b)(3) FNAM and EBAA France do not understand why these values have been chosen and would like to take up the disposition of the CAT.A FTL regulation. Besides, the paragraph CS.FTL.2.210(a) does not exist. PROPOSAL Replace the paragraph (3) by the following: “(3) 25 % of time spent on standby other than airport standby counts as duty time for the purpose of ORO.FTL.210;”

response Please, see previous responses relating to ‘standby’.

comment 1142 comment by: FNAM

ISSUE: Air Taxi operators need to be able to lower the 10h rest period to 8h if:

• the standby is made at a suitable location (home/hotel); and • the stand is followed by another standby

Indeed, the pilot physiological needs had been covered during the standby and so, the pilot does not need additional time to the 8h of sleep duty. PROPOSAL: Modify (b)(4): "(3) The standby is followed by a minimum rest period: (a) Air Taxi (i) Not less than 8 hours if:

• The standby is made at a suitable location (home/hotel); and • The standby is followed by another standby

(ii) Not less than 10 hours in the other cases”

response Please, see previous responses relating to ‘standby’.

comment 1144 comment by: FNAM

Attachment #84

ISSUE: For AEMS operations, consecutive period of standby are required. Due to the life- threatening missions and the low probability to have several consecutive missions, it

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 217 of 277 An agency of the European Union

should be possible for the operators to verify ex-post Standby that the crew have not been disturbed. In that way, the 12 hours of sleep opportunity between 23:00 and 07:00 and 13:00 and 17:00 should count as a rest period, as the crew member are already fully rested (Cf. Annex 5). PROPOSAL: Modify (b)(4) "(1) The standby is followed by a minimum rest period: (a) For Air Taxi: {...} (b) For AEMS: (i) The minimum rest period is reduced by the time when the crew member is undisturbed and had sleep opportunities if:

• The standby is taken in suitable accommodation; and • The standby is followed by another standby; and • Either or both of the following:

o The crew member was undisturbed during the period [23:00 to 07:00]; o The crew member was undisturbed during the period [13:00 to 17:00];

(ii) Not less than 10 hours in the other cases”

response Please, see previous responses relating to ‘standby’.

comment 1148 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Standby at home or in a hotel should not affect FDP due to the fact that crew can fully relax in a quiet and familiar environment. It is the crews responsibility to manage their fatique and circadian clock. When applying standby at home or in a hotel, there is no need for a penalty in FDP. Required rest should be 8 hours.

response Please, see previous responses relating to ‘standby’.

comment 1308 comment by: Volkswagen AirService GmbH

If standby (other than at airport) does not lead to a duty, it must be possible to add the

next stby period without rest. Otherwise we have to proceed crews to the aircraft position

(off base) just to have crews in standby for an early departure or additional flight. This is

not possible due to required man power & costs involved.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 218 of 277 An agency of the European Union

response Partially accepted

Standby in suitable accommodation is followed by not less than 10 hours of rest period,

unless during the standby period a sleep opportunity of not less than 8 hours is provided

in suitable accommodation, between 22:00 and 08:00, during which the aircrew member

is undisturbed and is able to remain at their place of rest at the local time where the aircrew

member is acclimatised.

comment 1309 comment by: Volkswagen AirService GmbH

(b)(3) referenced CS.FTL.2.210(a) does not exist. Maybe Error?

response Please, see previous responses relating to ‘standby’.

comment 1310 comment by: Volkswagen AirService GmbH

Standby is different in ATXO from charter or scheduled operations. We do not stand by only for a particular flight. We are on standby in a general manner for any type of duty. Stby is a regular service in ATXO. CS FTL 2.225 does not reflect this fact. If standby (other than at airport) does not lead to a duty, it must be possible to add the next stby period without rest. Otherwise we have to proceed crews to the aircraft position (off base) just to have crews in standby for an early departure or additional flight. This is not possible due to required man power & costs involved.

response Please, see previous responses relating to ‘standby’.

comment 1329 comment by: Babcock Mission Critical Services Limited

CS FTL.2.225 Standby – AEMS (b) (1) We don´t agree that standby other than airport facility limits to 16 hours. We understand that rostering a standby at home, close to the airport, must allow at least 7 consecutive days. If we see at what it is said for HEMS, in CS FTL.3.225, this limitation refers to a standby in an HEMS operating base which does not equal as to be at home. What´s the difference in fatigue between be at an airport with suitable accommodation and to be in an HEMS operating base?

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 219 of 277 An agency of the European Union

Any case, this interpretation will affect to the Flight times and duty periods described in ORO.FTL.210. So if there is no consideration of change, we don´t agree with the times periods in 7/14/28 consecutive days We recommend to describe a standby at home / hotel (suitable accommodation), when it is placed close to the base (not more than 1 hour) and limit the maximum period of standby to 7 consecutive days. We urge EASA to reconsider its position on counting Standby as duty, as described in the report submitted to EASA (Mission Critical Services Notice of Proposed Amendment 2017- 17 Response Considerations, Fletcher et al, Integrated Safety Support, February 2018).

response Please, see previous responses relating to ‘standby’.

comment 1374 comment by: Bartosz Fibingier

"CS FTL.2.225(b)(3) Time spent on standby duty counts as duty time for the purpose of CS.FTL.2.210(a)" - CS FTL.2.210(a) has not been presented in this proposal. The proposed text of CS FTL.2.210 includes points from (1) to (3) only. CS FTL.2.210 Flight times and duty periods — air taxi operations The total flight time of the sectors on which an individual crew member in air taxi operations is assigned as an operating crew member under ORO.FTL.210(e) shall not exceed: (1) 80 hours of flight time in any 28 consecutive days; (2) 210 hours of flight in any 84 consecutive days; and (3) 625 hours of flight time in any 12 consecutive calendar months. In the context of proposed CS FTL.2.210, text presented in CS FTL.2.225(b)(3) has no sense. CS FTL.2.210 refers to flight time, and CS FTL.2.225(b)(3) refers duty time which is two different things. If the intention is to increase the flight time (CS FTL.2.210), that should be clearly stated CS FTL.2.225(b)(3). By the way, all CS's proposed in the text of this NPA lack dot between CS and FTL, so dot in the text of CS FTL.2.225(b)(3) should be removed.

response Please, see previous responses relating to ‘standby’.

comment 1381 comment by: Gama Aviation (UK) Ltd

(3) Should be in line with CAT ops. Suggest: Time spent on standby other than airport standby counts as 25% duty time. (4) Operators should be able to lower to 8 hours if the standby is made at a suitable location (home/hotel) and if followed by another standby (The physioloical needs having been covered during the standby)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 220 of 277 An agency of the European Union

response Please, see previous responses relating to ‘standby’.

comment 1450 comment by: European Cockpit Association

Commented text: “Standby” References CS FTL 2.225 (b) (1), (9) & (10) CS FTL.2.225 no.28 Comments: The concept is introduced here of any hours spent on standby between 1300-1700 not counting towards the standby duration or FDP if called out. It appears to represent a supposedly guaranteed and enforced nap between these hours (in a functioning home setting), so claiming that they are spent actively resting. This idea is unworkable in practice and it will not be possible to gain or enforce a 4 hour nap in the middle of the day, making this concept nothing more than a route to excuse dangerously long awake-times on standby and call-out. The idea was repeatedly floated in CAT FTL discussions and rejected then. Proposal: Include all time between 1300 and 1700 as normal standby.

response Please, see previous responses relating to ‘standby’.

comment 1452 comment by: European Cockpit Association

Commented text: CS FTL 2.225 (b) (3) (i) & (ii) ECA Comment: Factoring of standby time to 25% for cumulative duty purposes, makes it unlimited in reality. Considering the mathematics against any cumulative duty limit, or even the 2000hr annual working time limit (taking into account legal minimum leave and day off requirements) factoring by 25% allows the entire life of the individual, when both asleep and awake, to be spent on standby. Even a factoring by 50% would only just have an effect, but making a difference only if very onerous periods of standby are combined with other duty. Operations under the CS2 regime involve very significant periods of standby, making this a much more serious issue than in CAT. Proposal: ECA recommends deletion of 25% factoring, and the only factoring levels permitted being 100% or 75%.

response Please, see previous responses relating to ‘standby’.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 221 of 277 An agency of the European Union

comment 1514

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

Again an impractical prescriptive rule by its nature: Standby at home or in a hotel should not affect FDP, due to the fact that a crew can in any case relax in a quiet and familiar environment. It is upon the crews' self-responsibility to manage their fatigue and circadian rythm. When applying standby at home or in a hotel, there must be no room for any penalty in FDP. As a general rule: Required rest should be set at 8 hours.

response Please, see previous responses relating to ‘standby’.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 222 of 277 An agency of the European Union

CS FTL.2.230 (Reserve)

CS FTL.2.230 p. 27-28

Responses in relation to ‘reserve’.

comment 22 comment by: Benedikt Steiner

CS FTL.2.230 Reserve - air taxi operations comment: this Reserve must be available also for AEMS and therfore the title should be changed as follows CS FTL.2.230 Reserve - air taxi and AEMS

response Accepted

comment 38 comment by: Flying Group Luxembourg

One important change to NPA 2017-17 is required to avoid losing all flexibility of planning without creating an increased workload for crew by an abnormally high Standby and its consequences on family life and duty. The proposed change is concerning “Reserve” as per CS FTL 2.230 out of NPA 2017-17. I provide you with the Rationale, and the new proposed text (adding a paragraph). If you agree, could you bring this to EASA’s attention? It will definitely have more weight and be beneficial to all of us and have more weight… Rationale In Air Taxi operations, having a crew on a 10 hour minimum notification time as per (e), prevents a flexible planning that goes beyond a crew intensive Airport Standby and other Standby. Indeed, a Crew having had a normal night of sleep, being at home under a “Reserve” Status, would not be plannable if a Commercial opportunity arises and a Crew is needed. This is the essence of unscheduled Air Taxi, being responsive to unforeseen Commercial opportunities in a cost-effective way (well-balanced Aircraft to Crew ratio). Being on Reserve means that the crewmember is available to fly but is not obliged to stay at a Standby location. The crewmember will most of the time be at home or doing activities while maintaining fit to fly. The original text under (e) suggests that, under some conditions, provided the crew had 8 hours of sleep, being notified 2 hours before actually going to bed at 22:00 Hours, the well- rested crew would be able to report at i.e. 08:00 Hrs. at the reporting point.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 223 of 277 An agency of the European Union

Assuming the same crew is on Reserve, and the opportunity arises in the early morning, this same crew would only be available 10 hours after notification, in this same condition earliest at 16:00Hrs. It is obvious that applying CS FTL 2.230 under its current form would lead to a more fatigued crew, which cannot be the intent. Proposed amendment CS FTL.2.230 Reserve — air taxi operations The operator assigns duties to a crew member on reserve under the provisions of ORO.FTL.230 complying with the following: a. An assigned FDP after reserve counts from the reporting time. b. Reserve times do not count as duty period for the purpose of ORO.FTL.210 and ORO.FTL.235. c. The operator specifies a number of consecutive reserve days within the limits of ORO.FTL.235(d). d. To protect an 8-hour sleep opportunity, the operator rosters a period of 8 hours, taking into account fatigue management principles, for each reserve day during which a crew member on reserve is not contacted by the operator. e. Minimum notification time for any duty is 10 hours that may include the 8-hour sleep opportunity under f. The Notification time for Flight duty can be reduced to 2 hours if the notification occurs after an acclimated local night, provided:

1. the Crew had 8 hours of uninterrupted sleep 2. the Crewmember is available to report in the next two hours, else 3. the reporting time will take into account the physical needs of the crew and the

expected travelling time from the Crew’s location to the Reporting point.

g. Reserve time does not count as recurrent extended recovery rest.

response Not accepted

The essence of reserve is the long notification time of more than 10 hours. Reserve is

actually a type of standby with long notification time compared to standby in suitable

accommodation where there is no specification as to how early the crew member should

be notified.

The well-established principle in air taxi and AEMS operations of transforming pilot

readiness into a duty applies here as well. Reserve does not count towards cumulative

limits or rest, exactly because of the long notification and, consequently, response time.

Reserve may be used by operators that need it in addition to other standby options.

Should the operator wish a shorter notification time, it can use the option of standby in

suitable accommodation.

comment 81 comment by: SHug

This paragraph shall also be applicable to AEMS

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 224 of 277 An agency of the European Union

response Accepted

comment 150 comment by: VistaJet

CS FTL 2.230 Reserve This is what most ATXO operators will be using as it most closely resembles the state of "readiness" that crews are on during a rotation, and this is the same for almost all ATXO operators. When crews are on rotation, but no flights are scheduled, they are able to perform daily activities unrestricted and no minimum response time is specified, or made compulsory. So this basically a "reserve" function. However, should a trip come up and the crew accept then the 10hrs should not be a limit. For example, if the crew are at breakfast and are asked if they can accept a trip for a departure in a couple of hours, they should be allowed to go. There is little sense in delaying the trip 10hrs, potentially giving them a long haul flight at the end of the day after they have been awake since breakfast. Reserve is very useful, and with a minor modification would be what all ATXO operators use for crew who are on rotation, but have no trips scheduled. Suggest to amend point (e) to read; - Minimum notification time for any duty is 10hrs that may include the 8-hour sleep opportunity under (d) unless the crew member is contacted and accepts the duty via passive contact. This will protect crew who are in rest, but allow crew who are in a well rested state to accept the trip sooner than 10hrs, which is far beneficial from a safety and commercial point of view.

response Please, refer to the response to comment #38.

comment 199 comment by: Premium Jet AG

Please add passive contact and include the AEMS.

response Noted. The method of communication should be agreed between the crew member and

the operator and should take fatigue management principles into account.

comment 246 comment by: Thomas Henselmann

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 225 of 277 An agency of the European Union

(e) notification time should be reduced when accepted by the crew, not affecting sleep. (contact via non audible methods, e.g.email, sms..)

response Please, refer to the response to comment #38.

comment 456 comment by: Cat Aviation AG

AirTaxi has no regular schedules or rosters and reserve days rostered are not applicable to us. Reserve days are a typical commercial scheduled operations tool.

response Please, refer to the response to comment #38.

comment 635 comment by: Cristina BENZ

This paragraph shall also be applicable to AEMS

response Correct

comment 707 comment by: Captain M Alcaide GVI

This is a new concept and might be a good one, I don't understand the first phrase "the operator assigns duties to a crew member on reserve..." as I understand reserve is a situation other that duty or stand by without any obligation but to be activated in a certain time frame. So it should refer as "the operator assigns a reserve to a crew member..."

response Accepted

comment 780 comment by: A, #813, ECA helicopteros.

Why AEMS are excluded from Reserve, having regulation for Air Taxi and HEMS? Means that we won´t be able to apply this concept (Reserve) in AEMS.

response ‘Reserve’ is also applicable to AEMS operations.

comment 813 comment by: Babcock Mission Critical Services Limited

What about reserve for AEMS? We recommend the same described for HEMS.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 226 of 277 An agency of the European Union

In addition, amend proposed CS.FTL.2.230 to include AEMS

response ‘Reserve’ is also applicable to AEMS operations.

comment 869 comment by: NetJets Europe

CS FTL.2.230 Netjets supports the proposal in general, with a suggestion for item (e) CS FTL.2.230 (e) Netjets suggests item (e) is ammended to add at the end "... unless crew is contacted via passive contact and has accepted the duty".

response Please, refer to the responses to comments #38 and #199.

comment 976 comment by: AESA

CS FTL.2.230 doesn’t include the concept “reserve” for AEMS operations. On the other hand, “reserve” is defined in CS FTL.3.230 for HEMS operations. What is the reason?

response ‘Reserve’ is also applicable to AEMS operations.

comment 1052 comment by: Stephanie Selim

(d) Technical comment- In air taxi and AEMS operation, the possibility of passive notifications should be introduced. In that case, the passive notification is not considered as a contact as referred in CS.FTL.2.230(d), and therefore, a passive notification can be sent at any time during the 8-hours sleep opportunity. The proposal is: "(d) To protect an 8-hour sleep opportunity, the operator rosters a period of 8 hours, taking into account fatigue management principles, for each reserve day during which a crew member on reserve is not contacted by active mean by the operator." A new GM is also proposed.

response Please, refer to the response to comment #199.

comment 1082 comment by: Rabbit-Air Ltd

No reserve applies to small operators.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 227 of 277 An agency of the European Union

response Please, refer to the response to comment #38.

comment 1146 comment by: FNAM

(e) ISSUE: If the notification of an assignment for any duty is non-intrusive, the 10 hours should start counting from the notification time. This is what is done in real life and this should be added in the paragraph (e). PROPOSAL Replace the paragraph (e) by the following: “(e) Minimum notification time for any duty is 10 hours that may include the 8-hour sleep opportunity under (d). If the notification of an assignment for any duty is done on a passive- mode, the 10 hours start counting from the notification time.” RATIONALE: If this sentence is not added, the principle of Reserve will never be used by operators.

response Not accepted

In all cases, the notification time starts counting from the moment the crew member has

been notified.

Point (e) has nothing to do with your proposal; it specifies that during the notification time

(which is not less than 10 hours), the crew member may have an 8-hour sleep opportunity.

This sleep opportunity does not ‘pause’ the notification time.

comment 1151 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Air Taxi has no regular schedules or rosters and reserve days. Reserve day rosters are not applicable to Air Taxi operators.

response Noted. Operators are not forced to apply ‘reserve’ if they do not use it.

comment 1192 comment by: GBAA

CS FTL.2.230 (c)/(f) Reserve — air taxi operations (c) The operator specifies a number of consecutive reserve days within the limits of ORO.FTL.235(d). (f) Reserve time does not count as recurrent extended recovery rest. GM1 ORO.FTL.230 Reserve RECURRENT EXTENDED RECOVERY REST

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 228 of 277 An agency of the European Union

So, instead of having 2x1 and 2x2 day off somewhere in the world, it would be better to have a certain amount (maybe 8) days off a home and the reserve days be available during the remaining days within 10 hours. Otherwise, the extended rest period will be changed a lot of time and the spare time is very hard to plan for each crew member. Moreover, crew members have chosen such a non-scheduled business aviation operation as their lifestyle. Why is this flexible scheme pressed into the scheduled aviation world?

response Not accepted

Reserve cannot count towards rest time, because the recuperative rest period must be free

of any duty or readiness for duty.

The rest period under Subpart ORO.FTL (which is a safety requirement) may or may not

overlap with the single day free of duty.

comment 1311 comment by: Volkswagen AirService GmbH

There is no difference between a rest time off base and a reserve. Reserver makes no sense unless it is used to shorten the rest time at home.

response Please, refer to the responses to comments #38 and #119.

comment 1379 comment by: Gama Aviation (UK) Ltd

Ammend to include AEMS operations in Reserve.

response Noted. ‘Reserve’ is also applicable to AEMS operations.

comment 1398 comment by: Bartosz Fibingier

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 229 of 277 An agency of the European Union

CS FTL.2.230 (f) higher level of flexibility should be reconsidered. For example, in case of being in reserve for the 3 days, a crew member will fill no negative effect of being in reserve the unless the suitable location is provided. In many CAT ATX OPS, crew members are flying in the scheme: 2 weeks ON and 1 or 2 weeks OFF. Taking into account reality of ATX OPS on many occasions pilots do not perform any flight in 7 days after which extended recovery rest is mandatory. Please consider following proposal: Update to a ORO.FTL.235(d) Recurrent extended recovery rest periods (a) Flight time specification schemes shall specify recurrent extended recovery rest periods to compensate for cumulative fatigue. The minimum recurrent extended recovery rest period shall be 36 hours, including 2 local nights. (b) The time between the end of one recurrent extended recovery rest period and the start of the next extended recovery rest period shall not be more than 168 hours. (c) The recurrent extended recovery rest period shall be increased to: (1) 2 local days twice every month, or (2) in case of CAT ATX and AEMS OPS, extended recovery rest period increased to 168 hours once every month. (d) In case of CAT ATX and AEMS OPS using mainly the standby or reserve time in flight time specification schemes, time between the end of one recurrent extended recovery rest period and the start of the next extended recovery rest period mentioned in letter (b) may be extended by 24 hours for every 48 consecutive hours between any duty periods.

response Noted

Please, refer to point ORO.FTL.235(d).

When applying an individual scheme including block of duties followed by a block of days-

off, the operator may roster an ERRP longer than 36 hours (which is, in principle, a

minimum value).

comment 1515

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

Note that ATXO have no regular schedules nor rosters nor reserve days. Reserve day- rosters are generally not applicable to ATXO.

response Noted. Operators are not forced to apply ‘reserve’ if they do not use it.

comment 116 comment by: UK CAA

Paragraph No: GM1 CS FTL.2.230(d) – Reserve – air taxi operations

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 230 of 277 An agency of the European Union

Comment: This guidance should be considered as applicable to the ORO for all types of operations. Justification: Consistency Proposed Text: GM1 CS FTL.2.230 (d) becomes GM3 ORO.FTL.230

response Accepted

The proposed text will be duplicated under both CS FTL.1 and CS FTL.2.

The reference to 8-hour sleep opportunity exists only in the CS text.

comment 708 comment by: Captain M Alcaide GVI

Curiously enough free of duty days are not mentioned in the document so it might seem that operators can schedule as duty, stand by and reserve every day ("surrounding days") of their crews.

response Subpart ORO.FTL of Regulation (EU) No 965/2012 contains safety requirements for

sufficient rest periods.

The rest period is a period free of all duties, reserve and standby. In addition to Regulation

(EU) No 965/2012, the Working Time Directive (Council Directive 2000/79/EC) applies as

transposed in members states national regulations. It contains requirements for days-off.

CS FTL.2.235 (Rest)

CS FTL.2.235 p. 28-29

Responses in relation to ‘rest’

comment 19 comment by: Aliparma/FOPh

(c) REDUCED REST 1) the minimum reduced rest period under reduced rest arrangements at home base are 12 hours or 10 hours when the travelling time to residence, temporary accomodation or suitable accomodation is less than 30 minutes from the Home base. 1a) the minimum reduced rest period under reduced rest arrangements out of home base are 10 hours

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 231 of 277 An agency of the European Union

response Not accepted.

ORO.FTL.235(a) and (b) prescribes minimum rest requirements. ORO.FTL.235(c) deals

with arrangements that may allow for a shorter rest period than that specified in

ORO.FTL.235(a) and (b). In all cases the duration of rest period is guaranteed and does

not depend on the time for travel.

comment 23 comment by: Benedikt Steiner

The note (ii) on page 29 of 70 must be canceled as it opens the door the ignore the table on top of this page.

response Not accepted

Note (ii) does not cancel the table. Note (ii) is about the minimum rest away from home

base and applies together with note (i). The derogation provided under note (ii) may apply

when the home base is a stopover in a rotation and not the end of the rotation (when (i)

will apply anyway).

Please, note that the derogation under note (ii) can only be used once between two

recurrent extended recovery rest periods (i.e. once in 7 days), if the operator provides

suitable accommodation to the crew member at the home base.

Please, note too that after a maximum of a 7-day mission (168 hours) and up to

60 cumulative duty hours, the crew member must take an extended recovery rest period

in any case.

comment 35 comment by: Joeri Meeus

The text of the table is not inline with the previous sentence (last sentence of page 28). The table on page 29 state : Time elapsed (h) between reporting for the first duty period involving .... The should be, to be in line with the previous sentence rephased into : Time elapsed (h) between reporting for the first Flight duty period involving ....

response Not accepted

The first flight that crosses four one-hour time zones may be a positioning flight that is not

an FDP, but a duty period. A positioning flight with such time difference can also negatively

impact on the crew member’s acclimatisation status.

comment 82 comment by: SHug

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 232 of 277 An agency of the European Union

(b)(2) (ii) Away from home base, if an FDP involves a 4-hour time difference or more, the minimum rest between this FDP and the following FDP is at least as long as the preceding duty period, or 14 hours, whichever is greater. By way of derogation from point (b)(2)(i) and only once between 2 recurrent extended recovery rest periods as specified in ORO.FTL.235(d), the minimum rest provided under this point (b)(2)(ii) may also apply to home base if the operator provides suitable accommodation to the crew member justification: This would give the operator the possibility to always ignore the time zone difference compensation in the table under point (b)(2)(i) just by offering a hotelroom at home base. This would greatly increase the fatique risk and destroy the flight crew members social life at home.

response Please, refer to the response to comment #23.

comment 117 comment by: UK CAA

Page No: 29 Paragraph No: CS FTL.2.235, (b) (3) – Rest periods – air taxi and AEMS Comment: The text of the definition of eastward / westward transition has been changed such that it significantly affects the application of the requirement. The requirement was based on the fatigue science developed to manage the combination of significant directional time zone changes and was developed to apply to any sequence of these types of rotations. It is strongly recommended that the original definition as quoted in the CRD 2010-14 and as applicable to CS FTL.1 is retained. Justification: These changes affect the application of the requirement and goes against the development of the requirement within the original Subpart FTL rulemaking process. This will generate confusion and incorrect application of this requirement to manage significant directional time zone changes in either direction or either sequence of rotations. Proposed Text: Amend to read: “Eastward-Westward and Westward-Eastward transition means the transition at home base between a rotation crossing 6 or more time zones in one direction and a rotation crossing 4 or more time zones in the opposite direction.”

response Not accepted

EASA and national competent authorities have found that the previous ‘unofficial’

definition proposed in CRD 2010-14 was not entirely based on fatigue science.

First of all, the table in CS FTL.2.235 does not indicate any direction of the rotation,

following which a rest to compensate an at least 4-hour time zone difference should be

provided. This means that the minimum of 4 hours’ difference to the reference time applies

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 233 of 277 An agency of the European Union

to any direction of the rotation and the proposal to treat one of them differently (i.e. only

if crossing 6 or more time zones) in the case of combinations is not substantiated.

Second and most important, the rest to compensate a time zone difference of 4 hours or

more in the case of a transition between a rotation in one direction and a rotation in the

opposite direction stems from scientific results that show that the adaptation after

eastbound flights is slower than after westbound flights. This means that a rotation with

a 6-hour TZC eastwards followed by a rotation with a 4-hour TZC westwards will be more

fatiguing than a rotation with a 6-hour TZC westwards followed by a rotation with a 4-hour

TZC eastwards. According to the proposed text, this combination is equivalent in terms of

fatigue. There is no scientific evidence to substantiate this equivalence.

comment 133 comment by: VistaJet

CS FTL.2.235(a)(2) Rest Periods is excessive for rotational style operations especially long haul. The very definition of long haul means that the flight will encroach on one for the parameters (early start/night/late finish) on every duty. Again the effects of international operations are addressed during the "OFF" block where crew have a consolidated block to recover. Along with all the other restrictions imposed with this NPA operators will be severly impacted by this. ATXO in this NPA is already having to accept, lower hour limitations and duty limitations. It is understood that disruptive schedules create fatigue however in the short term this can be addressed by adding an increment to the rest period immediately after the duty, after which the effects of long term fatique are dealt with during the OFF block. Would suggest adding 3Hrs to the minimum rest following an early start, late finish or night duty with the extended rest remaining 36hrs with 2 local nights.

response Not accepted

CS FTL.2.235(a)(2) is about disruptive duties, four or more in a row, following which the

cumulative fatigue increases at a higher rate than following a single disruptive duty.

Therefore, cumulative fatigue is mitigated by a longer-extended recovery rest.

comment 151 comment by: VistaJet

CS FTL2.235 Rest Periods (b)(2) This table is extracted from CS FTL1.235 and has no place in ATXO. ATXO does not perform scheduled out and back flights on a perpetual roster. ATXO flights are a rotation of

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 234 of 277 An agency of the European Union

successive flights which may go in any direction. A typical on haul rotation will take crew progressively around the world or randomly in any direction. This table does not make provision for complex operations or progressive re- acclimatisation. This is an attempt at one size fits all which is exactly what this CS was meant to avoid, not embrace.

response Not accepted

The table in CS FTL2.235(b)(2) provides for compensatory rest at home base regardless of

the progressive re-acclimatisation during complex rotations.

The term ‘rotation’ is defined in CS FTL2.235(b)(1).

Acclimatisation is addressed by point ORO.FTL.105(1) and related guidance material (GM).

comment 152 comment by: VistaJet

CS FTL2.235 Rest Periods (b)(3) Again this is directly from CS FTL1.235 incorporated for scheduled airlines on out and back trips, with a perpetual roster. Not for complex ATXO with block roster pattern. Suggest to remove.

response Not accepted

Please, refer to previous responses in the section, in particular to comment #151.

comment 153 comment by: VistaJet

CS FTL2.235 (c) Reduced Rest Point (7) There is absolutely not reason to put an arbitrary flight time limit on the preceding 7 days leading up to the reduced rest even. It is conceivable in long haul to do 2 x 12 hour flights on day 1 and 2 then not fly for a couple of days, then require a crew to do a 3hr flight followed by a reduced rest period in order to execute another 3 hour flight the next day. Under this point it would not be possible to complete this flight even though it is clear to see that there is no safety implication. There is no scientific data backing the decision to impose a 24Hr flight limit in this restriction. Suggest to remove.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 235 of 277 An agency of the European Union

response Accepted

comment 200 comment by: Premium Jet AG

Table should be amended in following topics: Remove max time reference, maybe acclimisation and bio rythm could be taken into account. Rework Home Base due to different ops models in business aviation.

response Not accepted

Please, refer to previous responses in the section, in particular to comment #151.

comment 325 comment by: Thomas Henselmann

Table doesn`t refelct actual acclimatisation status of the flight crew, since it only accounts for return flights. Limiting Air Taxi operations without benifit towards fatigue.

response Not accepted

Please, refer to previous responses in the section, in particular to comment #151.

comment 326 comment by: Thomas Henselmann

(7) Flight time is not the only contributing factor, suggest to remove this point.

response Accepted

comment 431 comment by: Skyshare Union representing NetJets crew members

One impact of the reduction in min rest from 11 to 10 hours is that it will not allow us to seek a proper evening meal and still have 8 hours available for sleep (10 hours includes 8 hours for sleep, 1 hour travelling time, leaving only1 hour for ‘physiological needs’ which is the time it takes us to wake, shower, dress, check out and take breakfast). This makes the scheduled nutrition opportunity all the more important. Currently, the nutrition opportunity is often scheduled at an unrealistic time, including before crew food is delivered, immediately after breakfast and so on. If an evening meal is to be impossible the nutrition opportunity needs to be realistically scheduled and we would like enhanced protection compared to what is proposed. For example, if rest time allocated is to be less than 11 hours, a nutrition opportunity must be provided within 4 hours of the end of the preceding duty, with food available.

response Partially accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 236 of 277 An agency of the European Union

Nutrition opportunities should not interfere with, or further reduce, sleep.

comment 444 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

CS FTL.2.235 (a) Disruptive Schedules: (1) Rest periods according to ORO.FTL235 a and b shall be maintained. However, is suitable accomodation at home base is provided the minimum rest can be reduced to 10 hours. (b) Time zone differences As many air taxi operators have no fixed base for all their pilots, but operate with an open base concept the minimum rest after passing 4 or more hours time zone difference within the beginning and the end of one flight duty period the rest time should be increased to 14 hours or the preceeding duty period, whichever is greater. If during one rotation time zone rest applied more than twice the recurrent extended recovery rest period shall be increased to a minimum of 60 hours including 3 local nights. (c) Reduced rest: Rest can be reduced by up to 2 hours, but never less than 9 hours. If reduced rest is planned the following FDP shall not be more than the given rest period or maximum FDP according to ORO.FTL.205, whichever is less. Reduced rest can only be applied twice in 7 consecutive days. If reduced rest is planned the following rest period shall be increased by the time the previous rest period was reduced by.

response Noted

Point ORO.FTL.235 is applicable to all types of operations as this is the implementing rule.

It provides the legal grounds for the development of CSs for different types of operations.

comment 567 comment by: Cat Aviation AG

Table not applicable nor useful to biz model of AirTaxi. Flights often proceed continuously in one direction of time zone differences and not return to home base. Thus table does not reflect that crew is acclimatized progressively during the trip. A penalty of 5 local nights after a 12hrs time zone difference is not taking into account, that often crew rests at location for 1 week, and then return to home base. Why would crew need 5 rest nights after a week of no duties? Suggest to find a simple way to account for time zone differences.

response Not accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 237 of 277 An agency of the European Union

Flights may not return to home base, but the crew member returns to home base. Please,

refer to previous responses in the section, as well as to the section on ‘home base’.

comment 568 comment by: Cat Aviation AG

(3) this must be clearer defined. How or when this east-west or west-east transition applies. If a crew starts a duty away from homebase, after it had 5 days rest at that "away" location, then why not applying the normal rest calculation between 2 flights at home base, if a suitable location is provided? Especially if prior and post those flights east-west and west-east, crew had plenty of rest.

response Noted.

Please, refer to previous responses in that section.

Fatigue science has proven that time zone crossings in general expose flight crew members

to a greater sense of disorientation or jet lag than employees in other modes of

transportation. Alternating rotations without re-synchronisation at home base can be not

only very fatiguing and pose a risk to safety but can also lead to health issues.

comment 570 comment by: Cat Aviation AG

This CS.2. is more restrictive than ORO.FTL.235 "reduced rest". what is the rationale? suggest to remove at least point 4,5,7.

response Not accepted

The combination of reduced rest, long flight times and time zone crossings potentially leads

to higher fatigue risk than in the cases where these are isolated assignments.

comment 636 comment by: Cristina BENZ

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 238 of 277 An agency of the European Union

This would greatly increase the fatique risk and destroy the flight crew members social life at home.

response Please, refer to the response to comment #23.

comment 709 comment by: Captain M Alcaide GVI

In case number one, a crew might have a 14 hours day, begining their day at 0900 (they departed home at 0800) for a Madrid Zurich Amsterdam Madrid finished at 2300 (getting home an hour after, I can tell that's almost imposible in this type of aviation) and begin again at 1000 (leaving home at 0900) for another 1100 hour day up to three sectors, not standardized as in an airline, but flying from Madrid to London City and then to Brussels and then to Malaga.... and that's a safer operation.... I still don't see how flying unscheduled might support a longer operation in a safer way than an airline, and ONLY (that's the only rationale I find behind this NPA) because this is only made twice a month...can fatigue be prevented as an ON/OFF switch? can fatigue be prevented for having more time off? or you can be tired even if you are on your first day of work after a week off? Fatigue is not prevented through the lack of duties for some times, fatigue must be prevented when on the job and I cannot see how if you extend work hours in a usually more demanding job as ATXO is compared to airlines.

response Noted

comment 710 comment by: Captain M Alcaide GVI

I think there should be a difference in (ii). Regarding the time difference, only takes into account from 4 hours on and I think it is different (as it is stated on the preceding table for rest at home base) based on time lapse. So it should be specified over 4 hours (14 hours rest) and over 6 hours at least (16 hours rest), not only over 4.

response The minimum rest prior to the FDP is at least as long as the preceding duty period, or

14 hours, whichever is greater.

Please, also refer to the response to comment #23.

comment 871 comment by: NetJets Europe

CS FTL.2.235 (a) NetJets supports the proposal CS FTL.2.235 (b) As a general comment, this is complex to monitor and to comply with correctly for air taxi operations as air taxi operations do not necessarily operate to and back.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 239 of 277 An agency of the European Union

response Please, refer to previous responses in this section, and in particular to comment #151.

comment 1055 comment by: Stephanie Selim

(a)(1)(ii) Technical comment – It is noted that the second FDP limitation is the same for two-pilot and single pilot operations.

response Noted

CS FTL.2.235 is not applicable to single-pilot operations.

comment 1056 comment by: Stephanie Selim

(b)(2)(i) Table - Editorial comment – It is suggested to simplify the title of the table to avoid having an incomplete sentence and to be consistent with the provision which refers to “home base”: “Table Minimum consecutive local nights of rest at home base initial reference time of the first FDP involving at least a 4-hour time difference to the reference time to compensate for time zone differences” Moreover, column 2, line 1, add the word "flight" in "for the first flight duty period"

response Accepted

comment 1059 comment by: Stephanie Selim

(c) Technical comment – This subsection CS FTL.2.235(c) seems to apply to both air taxi and AEMS operations whereas ORO.FTL.235(c1) refers only to air taxi. It is noted that CS FTL.2.235(c) does not comply with ORO.FTL.235(c).

response Accepted

comment 1084 comment by: Rabbit-Air Ltd

Table: Table is not applicable to Air Taxi. Missions are often planned through increasing time zones, giving the crew the oportunity to gradually adopt the time shift. Further last mission for several days but only flying to the destination and few days later flying to home base with lots of rest days in between. This topic should be simplified.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 240 of 277 An agency of the European Union

response Please, see previous responses to comments in this section.

comment 1085 comment by: Rabbit-Air Ltd

response Please, see previous responses to comments in this section.

comment 1147 comment by: FNAM

(b) The following comment for Air Taxi may be extended to AEMS operations. ISSUE This table is not applicable for Air Taxi operations as it makes complex rotations. This table is only applicable on return flights. Badly written and doesn't take into account progressive acclimatization. PROPOSAL Remove or amend the table. In particular get rid of the Maximum time reference in the table. Need to consider instead acclimatization / body clock. Home base reference need to be sorted out because do not apply to all business aviation operations.

response Please, see previous responses to comments in this section.

comment 1149 comment by: FNAM

ISSUE The total flight time limitation is not based on scientific data. The EASA’s proposals should refer to the scientific study and, in that way, remove the limitation. PROPOSAL Remove (7)

response Please, see previous responses to comments in this section.

comment 1150 comment by: FNAM

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 241 of 277 An agency of the European Union

ISSUE Cf. Comment 1098 The scope of this point is unclear and may lead to misunderstanding. Indeed: On the one hand, the paragraph ORO.FTL.235(c1) refers to certification specifications for Air Taxi and is only applicable for Air Taxi. On the other hand, the corresponding certification specification is applicable for Air Taxi and AEMS operations. Thus, there are two different reduced rest AEMS dispositions :

• In ORO.FTL.235(c) • In CS FTL.235(c)

Therefore, there is a need to clarify the scope of the paragraph (c) and (c1) or to withdraw the paragraph (c1). PROPOSAL

• Suppress the paragraph (c1)

• Change the scope of paragraph (c): “(c) [...] except for AEMS and Air Taxi operations “; AND

• Add in the scope of the paragraph (c1) the AEMS operations

response Please, see previous responses to comments in this section.

comment 1161 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Table is not applicable to Air Taxi. Missions are often planned through increasing time zones, giving the crew the opportunity to gradually adapt the time shift. A penalty of 5 local nights after a 12 hours time zone difference is not taking into account, that often crew rest at location for 1 week and than return to home base. There is no reason for the crew having 5 nights rest after a week of no duties? Topic should be simplified.

response Please, see previous responses to comments in this section.

comment 1197 comment by: GBAA

CS FTL.2.235 (a) Rest periods — air taxi and AEMS - Disruptive schedules This rule is way too complicated and actually not applicable. The air taxi is per definition non-scheduled! All flights are arranged within hours or days. It is very hard to track all of

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 242 of 277 An agency of the European Union

the mentioned conditions. In addition, there are usually lots of rest times in between the flights to compensate for the early and late flights. CS FTL.2.235 (b) Rest periods — air taxi and AEMS - Time zone differences Just to confirm that flights with a stop-over at the home base with the necessary rest time during the rotation (e.g. for 14 days) is still regarded as rest time during rotation. So, there is no need for extra days off? After the rotation ends, the minimum rest time as specified applies.

response Please, see previous responses to comments in this section.

comment 1335 comment by: ENAC

Point(3) There are no scientific evidences proving that crossing less than 6 time zones in the first rotation in any direction can provide enough acclimatization for taking another rotation in the opposite direction with no limit of time zones, after resting at home base less than 3 nights. Furthermore, scientific studies have proven that rotations eastward require more rest at home base compared with rotations westward. This provision is not taken into consideration in the CS. We suggest to delete the specific numbers 6 and 4 relating to the time zones and re-edit point (3) as (2) (iii) in order to relate the eastward-westward and vice-versa provisions under 4 time zones as in points (2) (i) and (2) (ii). We also propose to emend the CS FTL.1.235 in the same way since amendment of CS FTL.1.235 is not included in this NPA. Furthermore, the provision prescribes 3 nights of rest “at home base”. We propose to amend the CS in order to prescribe 3 nights independently if the rest is taken place at home base or in other locations.

response Accepted

comment 1382 comment by: Gama Aviation (UK) Ltd

Table not applicable to ATXO/AEMS due to reference to rotations which not all operators use. Table is poorly worded and does not account for progressive acclimatisation.

response Please, see previous responses to comments in this section.

comment 1385 comment by: Gama Aviation (UK) Ltd

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 243 of 277 An agency of the European Union

Point (7) is not supported by the scientific data and should be removed as unnecessarily restrictive for ATXO.

response Please, see previous responses to comments in this section.

comment 1461 comment by: European Cockpit Association

Commented text: “Disruptive Schedules” Reference: CS FTL.2.235 (a) ECA Comment: The provisions here effectively permit 7 continuous days of disruptive schedules despite this being some of the most fatiguing type of operation. In the EASA CAT FTL rulemaking process the Agency stated that it accepted the advice of its 3 scientific advisers and several Member States that after consecutive disruptive schedules the minimum rest period should contain 3 local nights. Although EASA did not follow this statement in the rules, it should nonetheless be followed here. ECA also believes that an extended rest period should be required after 4 consecutive disruptive schedule duties, as suggested for CAT operations. Proposal: Permit a maximum of 4 consecutive disruptive schedule duties, and require a minimum rest period of 3 local nights after any block of disruptive schedules.

response Noted

Unlike scheduled flights, most of air taxi/AEMS missions are organised around blocks ‘on

duty’ and blocks ‘off duty’. Those off-duty block periods usually contain more than 3 local

nights. In addition, the cumulative limit of 60 duty hours in any period of 7 consecutive

days, and the ‘extended’ recovery rest period for every 7 days, still applies to air taxi/AEMS

missions.

comment 1516

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

The table provided is not applicable to ATXO and again is much too complicated. Note that ATXO-missions are often planned through various timezones, providing the crew the chance to gradually adapt to the time shift. A penalty of five local nights after a 12 hours time zone difference is not taking into account, that often crews get to rest at a location e.g. for a full week and it is after this break that they return to their home base. There is no compelling reason why a crew should have five nights of additional rest time after a being off duty for a full week. We strongly advise to reconsider this.

response Please, see previous responses in this section.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 244 of 277 An agency of the European Union

comment 1524 comment by: General Aviation Manufacturers Association / Hennig

GAMA is concerned that the proposal to introduction of a requirement for a rest period at home base following a change in time zones may significantly increase required crews for a typical operator that frequently crosses time zones (see, CS FTL.2.235 (b)). GAMA requests that EASA review the impact and associated cost on those operators that conduct operations that crosses multiple time zones to avoid, because significant changes in required flight crews should be expected if the proposed requirement for a home base rest period is advanced.

response Please, see previous responses to comments in this section.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 245 of 277 An agency of the European Union

Draft AMC/GM — Subpart FTL

3.3. Draft AMC/GM - Subpart FTL - SECTION 1 p. 42

Responses in relation to ‘GM1 ORO.FTL.105(1) “ACCLIMATISED”’

comment 1063 comment by: Stephanie Selim

General editorial comment – Reference to CS FTL will need to be updated according to their final numbering. For instance GM1 ORO.FTL.105 (1) Definitions ACCLIMATISED (d)(1) and (2): the reference to “CS FTL.235(b)(3)” should be replaced by “CS FTL.1.235(b)(3) and CS FTL.2.235(b)(2)”.

response Noted

GM1 ORO.FTL.105(1) has been deleted, since now the definition explains better the

acclimatisation status.

comment 575 comment by: Cat Aviation AG

Refer to comments under CS.FTL.2.235 (b) (2)- table for acclimatization has to be redone, simplified and taking into account nature of biz aviation.

response Noted

comment 1095 comment by: Rabbit-Air Ltd

Simplify table

response Noted

Responses in relation to ‘GM1 ORO.FTL.105(17) “OPERATING CREW MEMBER”’

comment 1517

comment by: Swiss Aerodromes & GASCO (General Aviation Steering Committee

Switzerland)

Note: All crew members on a flight carrying out safety-relevant duties, must be considered as part of the operating crew of the aircraft. Other individuals must be classified as passengers.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 246 of 277 An agency of the European Union

response Not accepted

Load masters also carry out safety-relevant duties but are not subject to Subpart ORO.FTL.

In addition, there may be other crew members, such as assistants to unaccompanied

children, who carry out non-safety-critical duties.

comment 576 comment by: Cat Aviation AG

Definition should be aligned. This NPA is drafted under the aspects of safety and therefore all crew members on a flight and carrying out safety relevant duties, are considered operating crew, others are considered a passenger.

response Please, refer to the response to comment #1517.

comment 1177 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

Definition must be aligned. The NPA is drafted under the aspects of safety and therefore all crew members on a flight carrying out safety relevant duties, are considered operating crew, others are considered as passenger.

response Please, refer to the response to comment #1517.

Responses in relation to ‘AMC1 ORO.FTL.110(a)’

comment 202 comment by: Premium Jet AG

Please add: The operator should establish a procedure for the notification of roster changes that minimises the disruption to the crew member’s ability to obtain appropriate sleep and rest.

response Accepted

comment 1313 comment by: Volkswagen AirService GmbH

This is not possible in ATXO due to the nature of on-demand flights. Rosters might show

intended duties, but specific duties (all of them) are not predictable at all. This would

increase man power beyond economical reasonability. Many duties (availability) are spent

at home or at the hotel.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 247 of 277 An agency of the European Union

response Noted

AMC1 ORO.FTL.110(a) applies to scheduled operations.

For air taxi/AEMS operations (see AMC2 ORO.FTL.110(a)), as a minimum, the roster should

contain the extended recurrent rest period (ERRP).

Responses in relation to ‘AMC2 ORO.FTL.110(a)’

comment 154 comment by: VistaJet

AMC2 ORO.FTL.110(a) The requirement to roster extended rest 7 days in advance is a major issue in ATXO. In ATXO Crew have a set roster period of "On" and "OFF". The most common pattern being 2 weeks on, 2 weeks off, published up to a year in advance. During the "ON" pattern extended rest needs to be notified in advance, but with no limit. Crew availablity during the "on" pattern cannot be limited by having to roster the extended rest 7 days in advance. For example: A crew are rostered on an aircraft for 2 weeks. On day 2 the aircraft goes AOG and is down for 3 days. It is imperitive that these non-productive days can be classed as extended rest as long as the crew have been notified as such. If not the aircraft will be down for 3 days, only available for another 2 days before being unavailable for another 2 days due to crew in extended rest. This is not acceptable on any level. Suggest to change to; "Extended recovery rest periods should be published in advance"

response Not accepted

A 7-day advance notification does not prevent an operator from introducing changes to

the rostered ERRP when circumstances so require, as in the example given. Therefore, an

additional AMC is proposed to deal with roster changes both in scheduled and in on-

demand operations.

comment 327 comment by: Thomas Henselmann

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 248 of 277 An agency of the European Union

For Air Taxi Operations scheduled flight rosters do not apply, so extended recovery rest periods have to be provided according actual flight schedule with short notice.

response Noted

In air taxi operations, strategic rosters are typically prepared and they can be notified to

crew members in advance.

Please, also refer to the response comment #154.

comment 571 comment by: Cat Aviation AG

Assignment of rosters for crew can be published 7 days in advance, that is OK. As commented on earlier, in AirTaxi there is a lot of standby at home or hotel, which results in no duty. Crew is getting ample rest. Suggestion is that Operator has a solid FRM, allowing for flexible planning with the ad-hoc business and at the same time assuring, enough crew rest is provided. Schedule changes are common and operator should retain that option of flexibility as long as the pre- and post flight rest to crew are granted. We should also define the mode of crew contact, so as not to interfere in rest time, which will assure robustness of schedule. As a side note, labour laws in most countries also prescribe a minimum for rest to be granted and communicated (not just for crew but for all employees).

response Noted

Please, refer to the response comment #154.

comment 816 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

AMC2 ORO.FTL.110(a) Rostered extended recovery rest periods should be announced beforehand. Air Taxi companies should have the possibility to use extended recovery rest periods once they occure within the 168 hours time frame. It is quite often, that the crews have extended rests caused by the booking situation. Air Taxi companies would loose their flexibility and income if they can't use those spontaneous extended rests.

response Please, refer to the response to comment #154.

comment 1092 comment by: Rabbit-Air Ltd

(EBAA comment) 10 days in advance seem to be too long. Usually in the last week before a mission begins there are quite some changes maybe impacting scheduling. Suggestion is to publish not later than 5 days in advance.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 249 of 277 An agency of the European Union

response Please, refer to the response to comment #154.

comment 1198 comment by: GBAA

AMC2 ORO.FTL.110(a) Operator responsibilities PUBLICATION OF ROSTERED REST PERIODS IN AIR TAXI, AEMS AND HEMS OPERATIONS In an operation where the rotation usually lasts 14 days and the sold flights are take place within hours, there is no possibility to plan extended rest times reliably ahead of time. Of course, the rule ORO.FTL.235(d) is monitored and controlled, but to plan seriously in advance is not possible. If there are two consecutive nights without any duty, this period will become an extended rest period and the 168h period is reset. The result is a permanent change of when the extended rest times take place.

response Please, refer to the response to comment #154.

comment 1314 comment by: Volkswagen AirService GmbH

Not possible in ATXO due to nature of on-demand flights. Rosters might show intended

duties but position of the extended recovery rest periodes must be flexible according

actual performed tasks. Makes no sense with regard to FRMS. This rule might lead into a

proceeding in order to grant the recovery rest even though (eg.) a flight to home base

might result in a much greater recovery.

response Please, refer to the response to comment #154.

comment 1475 comment by: VOLDIRECT

PUBLICATION OF ROSTERED REST PERIODS IN AIR TAXI, AEMS AND HEMS OPERATIONS Rostered extended recovery rest periods should be published at least 7 days in advance. This is not possible in AIR TAXI where the customer demand is fast moving and last-minute known. Suggested change: AMCx ORO.FTL.110 Operator responsibilities - "PUBLICATION OF ROSTERS (CAT OPERATIONS OTHER THAN AIR TAXI OPERATIONS) The operator should roster a minimum of 3 days off per calendar month at least 10 days in advance. The operator should establish a procedure for the notification of roster changes that minimises the disruption to the crew member’s ability to obtain appropriate sleep and rest.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 250 of 277 An agency of the European Union

response Noted

Days-off are not subject to this Regulation whereas rest periods, including extended

recurrent rest periods (ERRPs), are.

comment 1525 comment by: General Aviation Manufacturers Association / Hennig

GAMA is concerned that the proposed requirement to publish extended recovery rest periods seven days in advance does not consider the existing and socially accepted working scheme of 14 days on / 14 days off in the air taxi industry. This is an existing practice within the industry and enacting a requirement as proposed in AMC2 ORO.FTL.110(a) would force significant changes to this approach to scheduling. GAMA recommends that EASA revisit this proposed requirement in context of the practices long in use within the air taxi operator industry.

response Please, refer to the response to comment #154.

Responses in relation to ‘AMC1 ORO.FTL.125(a)’

comment 896 comment by: Stephanie Selim

Technical comment – Under new AMC1 ORO.FTL.125(a), the following question needs to be addressed: does CS FTL.1.205(c) apply to two-pilot operations only or both single and two-pilot operations ? If it applies to single pilot operation, an augmented flight crew with one additional pilot may lead to have a maximum FDP higher than the FDP derived from two-pilot operations.

response Noted CS FTL.1 applies to single-pilot operations along with the implementing rules. For the time being, single-pilot configuration excludes augmented crew operations. Hence, no extensions of the FDP are allowed due to augmented crew as well as due to operator’s extensions.

comment 1068 comment by: Stephanie Selim

(a) Technical comment – CS FTL.1 should be reassessed for single pilot operations. See technical comments on ORO.FTL.205(e) and CS FTL.1.205(c).

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 251 of 277 An agency of the European Union

Please, see also the response to comment #896.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 252 of 277 An agency of the European Union

Responses in relation to ‘GM1 ORO.FTL.200’

comment 390

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To GM1 ORO.FTL.200: Even if this is GM only, we would like to express our astonishment and surprise about the fact that EASA is willing to advise adult human beings (pilots and HEMS-CM) how they should arrange the conduct of life of themselves and their families. This is not only interference with their private and family life but even more an expression of not realizing and accepting the limits of EASA's scope which is "aviation safety" – nothing more, nothing less.

response Not accepted

This proposal is about aviation safety. It does not regulate people’s social life. Crews are

not required to change their residence. For the sake of safety of flight operations, in order

to arrive at work fit for duty and not exhausted due to long hours of travelling to the airport

of departure, crews are advised to arrange for temporary accommodation (hotel room,

rented apartment, or the like).

comment 540 comment by: ADAC Luftrettung gGmbH

This paragraph suggests to arrange for accommodation close to base for a crew member who is living more than 90 minutes away from his assigned home base. This is contradicting the fundamental right of free movement. Also the new regulation may lead to have shifts at the base. This will lead to more travelling time and this also leads to less spare time for pilot, which is needed for recreation.

response Not accepted

EASA does not see how using temporary accommodation closer to the base during days on

contradicts the fundamental right of free movement.

Please, see the response to comment #390.

comment 561 comment by: Rüdiger Neu

Hier wird empfohlen, dass ein Besatzungsmitglied, wenn es weiter als 90 Minuten von der Station entfernt wohnt, sich vor Ort eine Unterkunft besorgt. Dies ist ein Eingriff in die Grundrechte, auch wenn es sich nur um eine Empfehlung handelt. Man möchte hiermit die Regelung, welche Arbeitnehmer stark einschränkt, legitimieren.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 253 of 277 An agency of the European Union

response Please, see the response to comment #390.

comment 731 comment by: ADAC

Diese Regelung stellt einen Eingriff in Grundrechte dar und ist justiziabel.

response Please, see the response to comment #390.

comment 752 comment by: DRF-Luftrettung

response Please, see the responses to comments #390 and #540.

comment 1202 comment by: GBAA

GM1 ORO.FTL.200 Home base TRAVELLING TIME

Does rule does not make any sense since the location of the aircraft is important. If the aircraft is located at the home base, then this remark makes sense, but if the aircraft is located in different places, the location of the home base is irrelevant.

response Noted

This is addressed to crew members, not to operators, and concerns travelling from own

residence to home base where the CM reports for duty or for positioning. If the location of

the aircraft and the location of home base differ, the operator shall arrange for positioning,

not for travelling.

Please, see also the responses to comments #390 and #540.

comment 1425 comment by: Bartosz Fibingier

Use of the word "should" implies it should be an AMC, and not a GM. In case GM is used intentionally, the text should be rephrased to indicate its informatory (not obligatory) purpose. Many EU NAAs is using GMs as a basis to issue findings to the operators.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 254 of 277 An agency of the European Union

response Please, see previous responses to comments in this section.

comment 1435 comment by: FinnHEMS Oy

This is not convinient in a country of long distances like Finland where most pilots live in the south and more than half of the bases are situated longer than 500km from crew members’ homes, the longest base beeing 1000km away. SUGGESTION: Delete this GM

response Please, see previous responses to comments in this section.

Typically, EMS bases provide for suitable accommodation for crew members. Then, this

GM would not be needed. For cases where the base is situated 500 km away from the crew

member’s residence, the operator may arrange for crew positioning and account this as

duty.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 255 of 277 An agency of the European Union

Responses in relation to ‘AMC1 ORO.FTL.225 and GM1 ORO.FTL.225’

comment 817 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

AMC1 ORO.FTL.225 Standby see comments to CS.FTL.2.225

response Please, see the responses to comments related to CS FTL.2.225.

comment 879 comment by: NetJets Europe

AMC1 ORO.FTL.225 NetJets supports the proposal, however, it is NetJets understanding that the provision of AMC1 ORO.FTL.225 (b) will allow for a standby period followed by minimum rest as per ORO.FTL.235 and then followed by another standby period. Under this provision, then the first standby would not be counted as standby. If this is the case, then NetJets suggests adding GM to explain this scenario. NetJets also suggests that point (b) needs to be clarified if this is applicable to airport standby as well. The reason is, that airport standby in accommodation is not the same as standby other than airport where suitable accommodation is available.

response Accepted

Clarification has been provided.

comment 1359 comment by: European Cockpit Association

Commented text: (b) If a minimum rest period as specified in ORO.FTL.235 is provided before reporting for the duty assigned during the standby, this time period should not count as standby duty. ECA Comment: unclear: Either the pilot is on standby, then it cannot possibly be rest time, or the pilot is on rest - which makes it imposiible to be on standby - standby and rest have to exclude themselves!

response Correct. The rest period puts an end to the standby period.

comment 1407 comment by: Swiss Air-Ambulance Rega

Here, an awake time of 18 hours is mentioned, so the rule leaves a lot of leeway.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 256 of 277 An agency of the European Union

response Noted

The operator needs to include in the OM specific procedures designed to avoid excessive

awake times. Chapter 7 of the operator’s OM is subject to approval by the competent

authority.

comment 178 comment by: Marc Rothenhäusler

Hier wird von einer Wachzeit von 18h gesprochen davon sind wir mit 15:30Uhr weit davon entfernt!

response Please, refer to the response to comment #1407.

comment 562 comment by: Rüdiger Neu

Hier wird von einer Wachzeit von 18 Stunden gesprochen, somit lässt die Regelung doch noch sehr viel Spielraum.

response Please, refer to the response to comment #1407.

comment 1360 comment by: European Cockpit Association

Commented text: GM1 ORO.FTL.225 Standby Scientific research shows that continuous awake time in excess of 18 hours can reduce the alertness and should be avoided. ECA comment: This is an important factor to avoid fatigue in flight operation and should be a more prescriptive rule, at least a CS!

response Please, refer to the response to comment #1407.

comment 1430 comment by: Bartosz Fibingier

GM1 ORO.FTL.225 Standby AWAKE TIME Scientific research shows that continuous awake time in excess of 18 hours can reduce the alertness and should be avoided. 1) it should be either GM2 or it should be combined with GM1 ORO.FTL.225 Standby on page 44. 2) at the end of the sentence "if possible" should be added.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 257 of 277 An agency of the European Union

response Please, refer to the response to comment #1407.

comment 1471

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

EASA should specify which scientific study this GM refers to.

response Please, refer to ICAO Doc 9966 for more information about the impact of continuous time

awake on crew member alertness and performance.

The longer an individual remains awake, the worse their alertness and performance

become. This is due to an increasing homeostatic pressure for sleep associated with the

longer period of wakefulness. Sleep is the only way to reverse the effects of extended

wakefulness.

Responses in relation to ‘GM1&2 ORO.FTL.230’

comment 1083 comment by: Stephanie Selim

DGAC would like to add a new AMC ORO.FTL.230 "passive notification" linked with our comment on ORO.FTL.230 and our proposal of new GM ORO.FTL.230 : AMC ORO.FTL.230 "passive notification" “In the case of passive notification during the 8-hour sleep opportunity, a minimum duration between the end of this 8-hour period and the reporting hour should be defined by the operator.”

response Not accepted

In principle, during ‘reserve’, a duty is assigned with a minimum of 10 hours’ advance

notification. Otherwise, it would be ‘standby’.

According to your proposal, the notification (passive or active) may be sent during the sleep

period; this means less than 10 hours in advance of assigned duty. While asleep, the crew

member cannot plan the duration of their sleep in order to match operator’s expectations.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 258 of 277 An agency of the European Union

Therefore, the notification (passive or active) should be sent before the 8-hour sleep

opportunity, so that the crew member becomes aware of the upcoming duty and plan their

sleep period accordingly.

comment 577 comment by: Cat Aviation AG

Reserve duties are not planned or of much relevance in AirTaxi operatoins, as not reflecting the actual businesss model.

response Noted

Operators are not forced to apply ‘reserve’ if they do not use it.

comment 1433 comment by: Bartosz Fibingier

response Noted

comment 578 comment by: Cat Aviation AG

no reserve duties in AirTaxi and thus no notification in advance requirement. Not coherent with AirTaxi business model.

response Operators that do not apply ‘reserve’ do not need to use this GM.

comment 820 comment by: Air Hamburg Luftverkehrsgesellschaft mbH

ORO.FTL.230 Reserve see comments to CS.FTL.2.225

response Please, see the responses to comments in relation to CS FTL.2.225.

comment 1100 comment by: Rabbit-Air Ltd

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 259 of 277 An agency of the European Union

N/A to small operator. No reserve exists.

response Operators that do not apply ‘reserve’ do not need to use this GM.

comment 123 comment by: UK CAA

Page No: 45 Paragraph No: GM1 ORO.FTL.230 Reserve, RECURRENT EXTENDED RECOVERY REST Comment: The reassignment of this GM now means that this would be the third GM to ORO.FTL.230. The reference to the 3rd GM should be amended as proposed below. Justification: Clarity. Proposed Text: Amend to read: ‘GM3 ORO.FTL.230 Reserve’

response Noted

Point ORO.FTL.230 does not contain any reference to notification; therefore, all GM that

was initially transposed from CS FTL.1.230 to the implementing rule should be transposed

to the relevant CSs (i.e. CS FTL.1.230 and CS FTL.2.230) where they belong.

comment 1076 comment by: Stephanie Selim

DGAC would like to add a new GM to ORO.FTL.230 "passive notification" linked with our proposal of new AMC ORO.FTL.230 and our comment on CS.FTL2.230 : Proposal of a new GM for passive notification: “PASSIVE NOTIFICATION – Passive notification is a form of notification during reserve that will not disturb a crew member who is sleeping a crew member can avoid. Examples of passive notification means are email or a visit to the operator’s website

response Not accepted

Please, refer to the response to comment #1083.

comment 1193 comment by: GBAA

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 260 of 277 An agency of the European Union

In a small operation with only a couple of pilots, the flexibility to react on changes needs to be given. Pilots can become sick or simply needs to have an extended rest for more than one day, although they were planned to be available or on reserve. Other pilots need to jump in. The probability to be called in for duty is low, but needs to be possible. The reserve can take up to the entire month and it impairs a lot to assign every 8th day firmly scheduled since the replacement rotation might take longer. Potentially on that day with the planned extended rest time, a flight might take place. In Germany and Austra, there is currently a requirement that 96 so called "einzelne dienstfreie Tage" or "single days free of duty" at home(!) need to be provided per year, or 8 per month, plus 28 days of vacation. Usually, these 8 single days free of duty are planned as a block and the remaining days are currently planned as standby at home. If the standby is not activated it will count as rest time. In essence, this standby days at home are reserve days. Why can't inactivated reserve days be regarded as rest time? So, instead of having 2x1 and 2x2 day off somewhere in the world, it would be better to have a certain amount (maybe 8) days off a home and the reserve days be available during the remaining days within 10 hours. Otherwise, the extended rest period will be changed a lot of time and the spare time is very hard to plan for each crew member. Moreover, crew members have chosen such a non-scheduled business aviation operation as their lifestyle. Why is this flexible scheme pressed into the scheduled aviation world?

response Not accepted

‘Reserve’ is not ‘standby’. Neither ‘reserve’ nor ‘standby’ can be retroactively accounted

for a rest period. Days-off under the ‘single days free of duty’ rule are not rest periods,

although a rest period may be included in a day-off. Rest periods need to be evenly

distributed within a month or year and not planned as a block as this is against the fatigue

management principles.

Responses in relation to ‘GM1 ORO.FTL.235’

comment 1102 comment by: Rabbit-Air Ltd

Unlike Subpart Q this regulation increases likelyhood of "negative social impact". Small operators loose flexibility, complex tables make it almost impossible to grant customer's plans, crews are more restricted in different ways. This could result in turning down business because flexibility is lost, resulting in staff reduction.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 261 of 277 An agency of the European Union

Impact assessment

Ib. CRD table of comments and responses — impact assessment (AEMS and air taxi operations)

comment 1406 comment by: Dr Adam Fletcher

The data provided in this section is seriously inadequate to justify the content of the document, both scientifically and from a risk-based point of view. Much of the data is aged, such at the 2012 data in Table 1. There are much more relevant and up to date data available. For example, my team and I have been working closely with a range of Babcock Mission Critical Services operations, in seven countries in Europe, for the past two years collecting sleep, fatigue, performance and other data. By the end of our 2018 program of work we will have collected more than 5,000 days and nights of data in EMS operations, both fixed-wing and rotary-wing. This sort of data could be shared, in a deidentified way, with permission from Babcock management.

response Noted

The fact that the number of annual missions dates back to 2012 does not change the IA

from an FTL perspective. Table 1 is a snapshot of the business activity of year 2012 that

justified the regulatory proposal. If this activity has increased during the next years, this

would further support taking regulatory action for the harmonisation of the FTL schemes

across the EU, especially as regards cross-border AEMS missions.

comment 1440 comment by: Bartosz Fibingier

Values presented by Poland in Table 3.1 should be given, as well, in a bigger context. It needs to be marked that 4 operators out of 5 mentioned in the Survey are/were as well ATOs. Which are/were operating the same single pilot aircrafts for both training as well as for CAT ATX-OPS and local flights (i.e. sightseeing flights). The overall impact on the statistics is that mixed Training and CAT operations lowers the overall duty time (as training flights do not have such constraints to record all the duty time) but increase overall flight time (by adding training and local flights). It is as well worth mentioning, that in the majority of those operations, pilots are not scheduled specifically for CAT duty but on many occasions, availability of the pilot is established on-the-spot immediately after the client requests a flight. Often those are ATO instructors additionally qualified for the CAT OPS.

response Noted

The statistics for Poland show the total number of flight hours and not the overall duty

time. The total number of flight hours, regardless of how they have been accumulated, is

relevant for the assessment of pilot fatigue. A training flight does not contribute less to

pilot fatigue than a flight with passengers onboard.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 262 of 277 An agency of the European Union

comment 579 comment by: Cat Aviation AG

Option 0 states "a negative social impact" is to be expected if no change and all remains status quo under Subpart Q. We would disagree with this point, as historically no negative social impact for the majority of operators' crew exist. To the contrary, if we start to limit freedom of hotel location selection and self-driving transport mode to crews, this has a higher negative social impact. Unhappy crew might have a negative impact on safety.

response Noted

The proposal does not limit the freedom for flight crews to select a hotel location or the

mode of transport for self-driving. A negative social impact is to be expected because flight

crews may not easily change from air taxi / AEMS operations to scheduled and charter

operations due to the rolling 1 000-flight-hours-per-12-consecutive-calendar-months limit.

comment 1110 comment by: Rabbit-Air Ltd

response Noted

The NPA explains sufficiently clear that Subpart Q is not appropriate for AEMS and air taxi

operations.

comment 1500 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

The Swiss Business Aviation Association (SBAA) shares the conclusion of EASA that a fully prescriptive approach would lead to a negative economic impact on operators engaged in ATXO. However, SBAA strongly differs from the conclusion drawn by EASA, stating at the same time minor positive economic impacts if a flexible approach is pursued. Actually, the opposite is the case. As stated before with regards to several sections of the NPA, the practical handling of the proposed changes to the rules would certainly lead to a prohibitive rise in economic burdens on the side of the operators engaged in ATXO. Calculations of our association have turned out that the workforce at the level of the single operator would need to rise in the magnitude +50% in crew members to be compliant with the new rules as laid out in the NPA. These calculations do not take into account that the needed augmentation in the flying workforce cannot be regarded as a stand-alone factor: In order to comply with the proposed regulation, the single operator must also calculate with a reinforcement of its "back office", as planning (ex ante an operation) and controlling (ex post an operation) has to assure compliance at any given time. These tasks are generally performed by the flight operations department of the single air taxi operator-company. This means that, should the proposed rules be enacted as proposed in the NPA, the operator companies would be faced not only with the need to beef up their overall

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 263 of 277 An agency of the European Union

workforce but in any case also with the need to introduce new internal and external compliance mechanisms and processes, which in turn create the need for additional training of the crews and the operations personnel, thus accelerating the spiral of rising overhead costs for the single air taxi operator. Having said this, the impacts cannot be regarded as "minor positive" for ATXO companies, but must be judged as overall highly negative from the point of view of the representatives of business aviation operators. As such, the statement "It may reasonably be assumed that for air taxi and AEMS operators, it will also take approximately 2000 working hours to develop and document an individual flight time specification scheme that deviates from the certification specifications as has been reported by CAT aeroplane scheduled and charter operators. However, these are one-off costs." (as stated in section 4.4.4.2 Air taxi and AEMS, see p. 64/70) could not possibly be further from the reality for operators engaged in ATXO. Our association strongly questions this one-sided and unsubstantiated estimate. The assumption that the projected "2000 working hours" are "one-off costs"is disputed by our association, e.g. because this number does not take into account the staff training required to implement new (and complex) rules within an organization. Instead our association calculates with as least double the overall number of working hours stated in the NPA that would be needed to implement a new scheme, as proposed in the new regulation. This estimate does not take into account the external costs generated by suppliers of a business aviation company (e.g. project management, expert advisory, accounting support, legal advice).

response Noted

There is no evidence, and the IA did not conclude, that the economic impact would be

‘… in the magnitude +50% in crew members to be compliant with the new rules as laid out

in the NPA.’

As regards the 2 000 hours, these may only be needed if the IFTSS deviates from CS FTL.2

for AEMS operations. Should the IFTSS remain within the certification specifications, no

such impact is expected.

comment 1518

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

The Swiss Aerodromes Association (SAA) has a genuine interest in supporting the business aviation, which carries out ATXO. We are highly sceptical of the approach taken by EASA with this NPA and consider its content to be highly prescriptive by its nature. The assumptions about the impacts laid out in the respective section of the NPA seem doubtful to us. We specially question the assumptions on the burdens, which ATXO companies might face under the rules proposed by the NPA. We fear that - specially ATXO companies operating from Switzerland, with its generally high operating costs - would greatly suffer under the new set of rules of the NPA. Therefore, we strongly recommend to seriously reconsider enacting such endangering rules to an ever important branch of aviation.

response Noted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 264 of 277 An agency of the European Union

EASA has received no evidence that air taxi operators ‘would greatly suffer under the new

set of rules of the NPA’.

comment 156 comment by: VistaJet

So from the conclusion we gather that a flexible approach is the most beneficial stance on all accounts. NPA 2017-17 is a highly complex, overly rigid FTL scheme further mandating the implementation of FRMS. The additional manpower and systems required to operate within compliance of this NPA and fully implement FRMS is significant and will have a major impact on all operators. The scheme does not allow flexibility for an international operator such as VistaJet to apply seperate restrictions to the short haul European fleet, as aposed to the long-haul global fleet, and everything in-between. The FTL was designed for Schedule CAT operations and relies heavily on the concept of home base, with a perpetual roster of "out and back" rotations. ATXO does not work like this. Operators use a forecast "on pattern/off pattern" methedology where crew need to be available and flexible for the ON pattern, and then have a consolidated OFF pattern where cumulative fatigue and time zone crossing effects are addressed. This also allow optimum social patterns for crew as the pattern can be forecast indefinately. In addition, the aircraft are not based anywhere, and crew will keep migrating around the world. Progressive acclimatisation is not catered for under this NPA, neither is the rotation methedology. Finally, a main objective of this NPA is to create a level playing field among European Operators. This is incredibly short sighted as ATXO operators are not protected by freedoms of the air in the same manor as scheduled airlines. Operators have to face competition from all global players and therefore need to remain commercially competitive on a global scale, not a European one. This NPA if implemented as is, will most certainly drive operators such as ourselves, to move the long range fleet outside of Europe. This is far from beneficial for Operators or the EU community alike, but may be necessary to remain competitive. We hope that our concerns are taken seriously and the Agency seriously consider finding a more flexible approach for regulating FTLs.

response Noted

NPA 2017-17 explains clearly the benefits compared to the 2008 Subpart Q requirements,

which are not suitable to modern air taxi and AEMS operations. The proposal is based on

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 265 of 277 An agency of the European Union

data and duty tables established by scientists, and the scientific study was commissioned

by the EBAA/ECA.

It does not mandate FRMS generally.

comment 210 comment by: Cat Aviation AG

We absolutely support the notion, that safety is the driving factor in creating or adjusting regulations. Reviewing this NPA, one is lead to believe that the key importance of what Air Taxi operations stands for is lost or misunderstood. This business model exists, due to its flexibility for the passengers using this mode of transport. Air Taxi crew are flying a fraction of time compared to commercialy scheduled operating crew, seen on a monthly, yearly or daily basis of FDP or DP. Air Taxi crew often remain a few days up to a week at a destination with the passenger, thus resting on site 4-7 days, before undertaking the next flight duty. On average an air taxi crew member accummulates a total duty time (DP) of 300-400hrs a year (compared to airliners with 900-1000hrs DP). As derived from traffic figures in 2011, BA traffic accounts for 7% of all traffic. The fatigue survey study was conducted amongst a small number of pilots or operators, in our opinion not enough to be a representative figure on scientific research. Amongst the accident reports received during 5 years (2012-2017), none could be identified as being clearly caused by fatigue. Overall many of the suggested new regulations in this NPA are overly complicated, not practical to be applied in everyday operation. This could lead to more mistakes in the planning process due to Human Factor (HF) issues and misinterpretation of the rule. Rules should be established in a clear, practical and easy to apply manner to maintain and enhance the overall safety aspects. We would argue that the impact this NPA has on the economical & social aspects are hardly minor positive or minor, but rather negative in financial and social aspects. We foresee a heavy financial impact, as more crew would be needed to retain similar flexibility as currently available under Subpart Q. Per our calculation an estimation of 50% more headcount are required. Having to control Crews' rest location to minimise the positioning time penalty, means less favorable hotel location for crews (near airports isof cities = negative social impact). More crews needed to maintain flexibility of the trips leads to less well geared teamwork (they barely meet) less flying hours for pilots might also lead to be a safety concern. Air Taxi flexibility is further limited by increased restrictions to airport access and scarce slot availabilities. To put it rather direct and critical, if the HNI's and multinational companies, no longer see the benefit of using Air Taxi services, due to prohibitive costs or too restricted flexibility, the impact on Swiss operators and business' economy is major.

response Noted

EASA does not share the view that the scientific study (Attachment IV to NPA 2017-17) on

fatigue conducted by FRMSc Limited ‘was conducted amongst a small number of pilots or

operators...’ and ‘not enough to be a representative figure on scientific research’.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 266 of 277 An agency of the European Union

The proposal is based on data and duty tables established by scientists, and the scientific

study was commissioned by the EBAA/ECA.

comment 1023 comment by: European Cockpit Association

We believe that “Option 0 – No policy change” would work quite well for most Member States, although ECA agrees, that there is room and need for improvement. We do recognize that “Option 1 – Flexible approach” would have the benefit of forcing the operators to demonstrate a safe operation. This will be quite costly and not practicable for many small operators and would also at the end lead to significant barriers of entry. This approach will also have a negative social impact as well as a more than “medium” negative economic impact. “Option 2 – Fully prescriptive approach” would, as stated in the NPA, have a “Positive low benefits” for safety pertaining to the risk of fatigue. ECA disagrees with this statement. For many operators/member states the envisioned safety benefits to guard against fatigue could be nullified due to the extra amount of duty days and commuting, which in itself is causing extra stress and fatigue that would be introduced. Furthermore, the regulation would have a negative impact on the service in way too many other cases. As already mentioned above, it will have a negative impact on social aspects for the “customers” (i.e. the patients - due to a lowered availability of the service), the public and the crew members. This approach would force many operators to raise their staffing significantly. This additional staffing would raise the costs remarkably. Also, due to the lack of suitably experienced, qualified crew members with the proper attitude cockpit personal available for hiring, this could lead to accepting lowered standards and a lack of recency (the same amount of missions would have to be flown by a substantially higher number of crew members). In ECA’s view, the above suggested approach with some understood and (scientifically) proven rules, as the basics for avoiding fatigue (like cumulative/minimum limits 2000hrs/year, 190hour/28days, min time available for sleep, min days off-duty in a period) - should be the basis of any air-operation and therefore be an implementing rule. On the other hand most of the other regulations should be AMC/guidance material to give local authorities the possibility to use their knowledge and experience to find a safe regulation, serving the needs of their HEMS/rescue system. This approach would have the positive benefit of raising safety levels, with minor social and economic impact.

response Noted

The duty tables for air taxi and AEMS operations have been jointly constructed by the EBAA

and ECA.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 267 of 277 An agency of the European Union

ECA did not disagree with the conclusions and recommendations of the scientific study

(Attachment IV to NPA 2017-17) on fatigue conducted by FRMSc Limited and

commissioned by the EBAA/ECA. The scientific findings, supported by the EBAA/ECA, form

the foundation for this proposal.

comment 1479 comment by: GBAA

In Germany and Austria, the option 1 reduces the guaranteed days off. In these two countries, you will get at least 96 days off without duty and at least 28 days of vacation. I haven't seen something like this in option 1; just 6 days per month and nothing else. Why is the social impact then negative with option 0 and positive with option 1? It is acutally vice versa!

response Noted

Nothing in the proposal reduces the days-off or annual-leave days as established by the Working Time Directive (COUNCIL DIRECTIVE 2000/79/EC of 27 November 2000 concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation concluded by the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA))

comment 1501 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

The Swiss Business Aviation Association (SBAA) is asked to provide its overall conclusion on the proposed rules, as stated in the current NPA. As an organization with the goal of protecting our members' interests, we cannot support the notion that the rules, as designed in the current NPA will produce a benefit for operators engaged in ATXO. The reason the NPA fails to fulfill the expectaions of our industry stems from the fact that the proposed rules were drafted without taking into account the basic constraints, economic mechanisms and operational peculiarities under which our industry operates. Whereas our association unconditionally welcomes the enhancement of the general safety-level in aviation, the NPA clearly fails in delivering on this unquestioned goal. Instead, the NPA pursues - even without intention - a rather prescriptive approach, leading to unbearable burdens on the operators, were the new rules to be enacted as laid out in the NPA. A gross weakness of the NPA is also the fact that there is no estimate on the impact of the proposed rules on the member states. This renders the regulatory impact assessment of the NPA inconclusive, or at least ambiguous. As a bottom line, our association rejects, in spite of the good intention to increase overall safety, the NPA in its current form and content. Finally, we generally question the gains in aviation safety by producing rules that are complex. Our notion is the opposite: More paperwork leads to less safety.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 268 of 277 An agency of the European Union

response Noted

Your statements deliberately neglect the numerous scientific studies and analyses this

proposal builds upon.

comment 1154 comment by: Rabbit-Air Ltd

As a small corporate operator flying under an AOC we were keen on awaiting the NPA concerining FTL schemes for Air taxi charter and AEMS operators. But analyzing the outcome of these FTL schemes is not acceptable to the corporate and taxi charter operation. The "old" FTL scheme of EU-OPS subpart Q is by far a better regulation framework than the new ones under CS-FTL2 and ORO Part FTL. We all of the aviation community / Industry are striving for the same goals: Safety First, then efficiency and effectivity. We all know that Fatigue and unstable rosters can have negative side effects on flight operation and flight safety. But the proposed regulations and FTL schemes to follow, if realized will lead to a lot of Businessjet operator cancelling their AOC's and changing to NCC OPS, which is really not what we are looking for here is what is not considered by this NPA:

• Corporate operators / Business aviation crews have total different mission scenarios than Airlines have, thus rosters are not seasonal, 14 days rosters, or monthly rosters are often used

• Those kind of flight activities have different rest time availabilities, i.e. transatlantic flights with several days of layovers without any flights, then further flights to other continents not returning to home base quite on the contrary to classical airline flights, so the Time zone difference tables are not reflecting this at all

• Average yearly business jet production hours in the industry are about 350 to 400 hours. Very often Pilots produce average maximum 150 to 200 flight hours per year!! Not to be comparable with Airline Industry where a lot of pilots reach 900 hours per year.

• Overall the table presented in CS-FTL2 and ORO.FTL are not practicable at all, even with Planning software modules dispatchers and Roster/ Mission planning department will have huge problems to plan Businessjet rotations within this high complex, complicated FTL regulaiton framework. It will be prone to mistakes during the planning process.

• The whole FTL regulation for air taxi charter, corporate aviaton and AEMS operations should be adaptable to their individual mission profiles and using a taylored and from the respective NAA approved FRMS scheme allowing a stable and safe but still flexible Flight Operation for the Businessaviation. These schemes should be based upon operational statistical data by the individual operator and be approved after consultation with the Competent authority by an AltMoc, for instance.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 269 of 277 An agency of the European Union

response Noted

NPA 2017-17 clearly explains the benefits compared to the 2008 Subpart Q requirements,

which are not suitable to modern air taxi and AEMS operations.

The duty tables for air taxi and AEMS operations have been jointly constructed by the EBAA

and ECA.

comment 1519

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

The Swiss Aerodromes Association is an advocate for a strong decentralized aviation in Europe. As such, we cannot support the notion that the rules, as designed in the current NPA will produce a benefit for operators engaged in ATXO. We therefore reject this NPA and strongly suggest to reconsider the impacts on the business aviation, which represents an important factor to many renowned companies all over the world and to all economies of the various EASA member states.

response Noted

Your statements deliberately neglect the numerous scientific studies and analyses this

proposal builds upon.

comment 124 comment by: UK CAA

Page No: 68 Paragraph No: 4.6 Monitoring and evaluation Comment: The intent of the monitoring and evaluation of the regulations is supported. However, NAA’s will need more active support from EASA to be able to deliver the data required. Also, this list of information would be relevant to all Subpart FTL operations and we believe EASA should consider the wider application of this type of data collection. It is strongly recommended that EASA should consider developing a clear communication plan and supportive activities and guidance to enable this requirement to be successful. Justification: To ensure consistency of data from all NAA’s, EASA will need to run workshops, provide standardised templates and guidance to enable the operators and NAA’s to provide the information requested. If EASA does not actively support the NAA’s, the data it receives will be extremely variable and inconsistent across countries. This could generate a misleading picture of the application and impact of the regulations.

response Accepted

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 270 of 277 An agency of the European Union

As in the case of FTL in the area of scheduled and charter operations, EASA will organise

workshops, provide standardised templates and guidance to enable operators and NAAs

implement the rules.

comment 1410 comment by: Dr Adam Fletcher

These criteria need a major rethink for the EMX/ATXO sector. For example, the list includes factors that are largely irrelevent (e.g. time zone crossing). It completely misses absolutely critical variables and factors (e.g. the amount of standby relative to flying and other duty, the prevalence of standby that allows for valuable rest versus standby that demands a high state of readiness, and the prevalence of seasonal versus fixed bases). Also, some metrics could mislead (e.g. fatigue reports would ideally be increasing over time as reporting culture improves, especially if fatigue management is a new concept for a operation).

response Noted

Please, refer to the numerous scientific studies and analyses this proposal builds upon.

comment 1477 comment by: GBAA

4.1.6 Air Taxi Why do you put air taxi operation on the same level as scheduled airline operations? They are completely different in the way they are conducted. In air taxi operation, you will find hardly anybody with more than 500 block hours per year, while the scheduled airline pilots fill their maximum 900 hours by the end of October each year. Plus, the passengers have a completely different expectation in both worlds. Just compare air taxi operations with car taxi operation where a driver leaves the place without you, because he needs to have some rest now... I can hardly believe that you being the passenger won't be upset with some guys doing nothing but waiting for you the entire day and the eventually leave without you. You cannot compare that with the scheduled airlines.

response Noted

comment 1500 comment by: SBAA Swiss Business Aviation Association / Helene Niedhart

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 271 of 277 An agency of the European Union

opposite is the case. As stated before with regards to several sections of the NPA, the practical handling of the proposed changes to the rules would certainly lead to a prohibitive rise in economic burdens on the side of the operators engaged in ATXO. Calculations of our association have turned out that the workforce at the level of the single operator would need to rise in the magnitude +50% in crew members to be compliant with the new rules as laid out in the NPA. These calculations do not take into account that the needed augmentation in the flying workforce cannot be regarded as a stand-alone factor: In order to comply with the proposed regulation, the single operator must also calculate with a reinforcement of its "back office", as planning (ex ante an operation) and controlling (ex post an operation) has to assure compliance at any given time. These tasks are generally performed by the flight operations department of the single air taxi operator-company. This means that, should the proposed rules be enacted as proposed in the NPA, the operator companies would be faced not only with the need to beef up their overall workforce but in any case also with the need to introduce new internal and external compliance mechanisms and processes, which in turn create the need for additional training of the crews and the operations personnel, thus accelerating the spiral of rising overhead costs for the single air taxi operator. Having said this, the impacts cannot be regarded as "minor positive" for ATXO companies, but must be judged as overall highly negative from the point of view of the representatives of business aviation operators. As such, the statement "It may reasonably be assumed that for air taxi and AEMS operators, it will also take approximately 2000 working hours to develop and document an individual flight time specification scheme that deviates from the certification specifications as has been reported by CAT aeroplane scheduled and charter operators. However, these are one- off costs." (as stated in section 4.4.4.2 Air taxi and AEMS, see p. 64/70) could not possibly be further from the reality for operators engaged in ATXO. Our association strongly questions this one-sided and unsubstantiated estimate. The assumption that the projected "2000 working hours" are "one-off costs"is disputed by our association, e.g. because this number does not take into account the staff training required to implement new (and complex) rules within an organization. Instead our association calculates with as least double the overall number of working hours stated in the NPA that would be needed to implement a new scheme, as proposed in the new regulation. This estimate does not take into account the external costs generated by suppliers of a business aviation company (e.g. project management, expert advisory, accounting support, legal advice).

response Please, refer to the response to comment #262.

comment 1518

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 272 of 277 An agency of the European Union

operating from Switzerland, with its generally high operating costs - would greatly suffer under the new set of rules of the NPA. Therefore, we strongly recommend to seriously reconsider enacting such endangering rules to an ever important branch of aviation.

response Please, refer to the response to comment #262.

comment 156 comment by: VistaJet

So from the conclusion we gather that a flexible approach is the most beneficial stance on all accounts. NPA 2017-17 is a highly complex, overly rigid FTL scheme further mandating the implementation of FRMS. The additional manpower and systems required to operate within compliance of this NPA and fully implement FRMS is significant, and will have a major impact on all operators. The scheme does not allow flexibility for an international operator such as VistaJet to apply seperate restrictions to the short haul European fleet, as aposed to the long haul global fleet, and everything in-between. The FTL was designed for Schedule CAT operations and relies heavily on the concept of home base, with a perpetual roster of "out and back" rotations. ATXO does not work like this. Operators use a forecast "on pattern/off pattern" methedology where crew need to be available and flexible for the ON pattern, and then have a consolidated OFF pattern where cumulative fatigue and time zone crossing effects are addressed. This also allow optimum social patterns for crew as the pattern can be forecast indefinately. In addition, the aircraft are not based anywhere, and crew will keep migrating around the world. Progressive acclimatisation is not catered for under this NPA, neither is the rotation methedology. Finally, a main objective of this NPA is to create a level playing field among European Operators. This is incredibly short sighted as ATXO operators are not protected by freedoms of the air in the same manor as scheduled airlines. Operators have to face competition from all global players and therefore need to remain commercially competitive on a global scale, not a European one. This NPA if implemented as is, will most certainly drive operators such as ourselves, to move the long range fleet outside of Europe. This is far from beneficial for Operators or the EU community alike, but may be necessary to remain competitive. We hope that our concerns are taken seriously and the Agency seriously consider finding a more flexible approach for regulating FTLs.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 273 of 277 An agency of the European Union

response Noted

comment 210 comment by: Cat Aviation AG

response Noted

comment 1519

comment by: Swiss Aerodromes & GASCO (General Aviation Steering

Committee Switzerland)

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 274 of 277 An agency of the European Union

response Please, refer to the response to comment #262.

comment 740 comment by: Captain M Alcaide GVI

I don't think those numbers are right, 102 air taxi aircraft in Spain?? Although I have access to the EBAA I have never recibed a survey coming from them....I have been flying a Gulfstream for a Spanish corporation since 2007. So is it a good study? should it be used???

response Noted

comment 849 comment by: Yorkshire Air Ambulance

Information regarding Wiltshire Air Ambulance is no longer correct and should be removed.

response Noted

comment 78 comment by: Rega / Swiss Air-Ambulance

9. Option 1 – Flexible approach (page 65 of 70 NPA 2017-17) By mistake only HEMS and air taxi is mentioned in the whole chapter. Question of the writer referring to Option 1 – Flexible approach: Why did EASA forget to mention AEMS along with air taxi in the context of individual flight time specification schemes? Urs Nagel Member of EASA RMT.0346 Rega Swiss Air-Ambulance

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 275 of 277 An agency of the European Union

P.O. Box 1414 CH-8058 Zuerich Switzerland +41 79 401 95 01 [email protected]

response Noted

comment 1023 comment by: European Cockpit Association

response Please, refer to the response to comment #262.

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 276 of 277 An agency of the European Union

comment 1154 comment by: Rabbit-Air Ltd

• Corporate operators / Business aviation crews have total different mission scenarios than Airlines have, thus rosters are not seasonal, 14 days rosters, or monthly rosters are often used

response Noted

comment 1411 comment by: Swiss Air-Ambulance Rega

European Union Aviation Safety Agency CRD 1 to NPA 2017-17

Individual comments and responses — air taxi and AEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 277 of 277 An agency of the European Union

In our opinion, the implementation would lead to a reduction in safety, excessive rise of the overall HEMS operating costs and the danger of social tension due to the risk of lower salaries. Therefore, we propose to deny the mandatory implementation of the EASA FTL and support option 0 of the NPA 2017-17 as stated on page 67 article 4.5 and alternatively give the suggestions stated below. Suggestion: Due to different operating structures (state vs. commercial or charity funded organizations), different tasks & responsibilities defined by the state and the different geographical environment within the EASA territory, a one-size-fits-all approach does not work and it should be left to the national authorities to regulate FTL (closeness to operators, practical knowledge of operations). E.g. Switzerland has a FTL regulation in place since 1990, which has proven itself as effective and efficient in regards to safety and quality For cross border operations, member states should regulate FTL with bilateral agreements.

response Noted

comment 1410 comment by: Dr Adam Fletcher

response Noted

CRD 2 NPA 2017-17 HEMS.pdf

European Union Aviation Safety Agency

Comment-Response Document (CRD) 2017-17

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 585

An agency of the European Union

CRD 2 to NPA 2017-17 ‘HEMS’

RELATED NPA: 2017-17 — RELATED OPINION: No XX/202X — RELATED ED DECISION: 202X/XXX/R —

RMT.0492 & RMT.0493

DD.MM.202X [= DATE OF ADOPTION]

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 2 of 585

An agency of the European Union

In responding to the comments, the following terminology has been applied to attest EASA’s position:

(a) Accepted — EASA agrees with the comment and any proposed amendment is wholly transferred to

the revised text.

(b) Partially accepted — EASA either agrees partially with the comment or agrees with it but the proposed

amendment is only partially transferred to the revised text.

(d) Not accepted — The comment or proposed amendment is not shared by EASA.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 3 of 585

An agency of the European Union

Individual comments and responses — HEMS

comment 54 comment by: PRESIDENT & SECRETAIRE GENERAL DU SYNDICAT

COMMENTAIRES SNPNAC SUR LA NPA 2017/17 Il est nécessaire de laisser les États membres, l'organisateur du temps de travail des

navigateurs opérant en SMUH et SMUA, en fonction des spécificités propres à chaque

région de Santé.

Les appels d'offres sont constitués par les cahiers des charges rédigées par les autorités

de Santé régionales suivant un schéma national.

En France, les entreprises de transport public qui ont reçu un agrément SMUH ou SMUA

sont rémunérées par le ministère de la Santé grâce aux fonds publics.

Pour mettre en œuvre une telle NPA et en particulier le titre CS FTL.3.2.10, il faut créer

un système associatif comparable à celui de la REGA suisse ou de l'ADAC allemand.

This would behaviour the impact financial important that they need to the mise en place

d'un nouveau mode d'organisation du travail des navigateurs à travers cette NPA

2017/17. Malheureusement, le fonctionnement du Transport sanitaire français par voie

aérienne, repose entièrement des entreprises privées.

Il existe au niveau national une convention collective des personnels navigants

techniques des exploitants d'hélicoptères, qui dans son annexe II organisent le temps de

travail et de reposer des navigants en SMUH.

Il est donc impératif de laisser les partenaires sociaux s'entendre pour réformer cette

convention sur le temps de travail des navigants.

L'application de cette NPA constituait l'arrêt du fonctionnement du Transport sanitaire en

France.

Les entreprises de transport public sous agrément SMUH ou SMUA ont déjà investi

beaucoup d'argent pour répondre aux appels d'offres de renouvellement ou de création

de marchés de SAMU héliportés.

L'état français n'a plus les moyens de financer ce service aux populations et de modifier

cette NPA, le temps de travail dans ce domaine très spécifique de l'aéronautique.

Le danger de cette réorganisation prévue par ce nouveau texte est que notre système de

transport sanitaire héliporté cesse de fonctionner à cause des coûts d'exploitation que

trop chers.

Des centaines d'hommes et de femmes se sont trouvés privés d'emploi, sans pouvoir

continuer d'assurer ce service de transport sanitaire, indispensable à nos concitoyens.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 4 of 585

An agency of the European Union

Pour toutes ces raisons, le SNPNAC, syndicat principal des navigateurs, représentant de

98% des équipements en France, s'oppose à l'application de ce texte et demande son

retrait définitif.

English version It is necessary to leave the Member States, the organizer of the working time of the navigators operating in SMUH and SMUA, according to the specificities specific to each region of Health. Calls for tenders are made up of the specifications drafted by the regional health authorities according to a national plan. In France, public transport companies that have received a SMUH or SMUA accreditation are remunerated by the Ministry of Health from public funds. To implement such a NPA and in particular the title CS FTL.3.2.10, it is necessary to create an associative system comparable to that of the Swiss REGA or the German ADAC. This would be important for the financial impact that they need to set up a new way of organizing the work of browsers through this NPA 2017/17. Unfortunately, the operation of French Air Transport by air rests entirely with private companies. There is a collective agreement at the national level for the technical flight crews of helicopter operators, who in Annex II organize the working and resting time of aircrew in HEMS. It is therefore imperative to let the social partners agree to reform this convention on the working time of seafarers. The application of this NPA constituted the cessation of the operation of the Transport sanitaire in France. The SMUH or SMUA licensed public transportation companies have already invested a lot of money to respond to the call for tenders for the renewal or creation of helicopter-borne UAS markets. The French state no longer has the means to finance this service to the population and to modify this NPA, the working time in this very specific field of aeronautics. The danger of this reorganization foreseen by this new text is that our helicopter transport system ceases to function because of the operating costs that are too expensive. Hundreds of men and women have been deprived of jobs, without being able to continue providing this health transport service, which is essential for our fellow citizens. For all these reasons, the SNPNAC, the main union of navigators, representing 98% of the equipment in France, opposes the application of this text and asks for its final withdrawal.

response Noted

The impact assessment (IA) to NPA 2017-17 did not evaluate the impact of the proposed

FTL requirements for HEMS on Member States’ health care and social systems from a

macroeconomic perspective.

Regulation (EU) No 965/2012, in general, and the FTL requirements, in particular, do not

regulate social aspects, although enhanced safety requirements may result in social

benefits for individuals.

From a safety perspective, the IA estimated that the potential safety benefit for HEMS

operators would be limited.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 5 of 585

An agency of the European Union

Recognising the importance of HEMS operations for the European communities as well as

the diversity in HEMS systems established in the Member States, EASA decided to separate

the HEMS proposal from further rulemaking process under RMT.0492 & RMT.0493.

A future common FTL framework in the domain of HEMS that provides for flexibility and

continuation of existing safe practices, will likely be established under RMT.0494 FTL rules

for helicopter commercial operations. Feedback from stakeholders indicates that while

there is no unanimous support for RMT.0494, there is enough strong support from a

significant number of stakeholders to recommend keeping the rulemaking task in the EPAS.

It should be noted, however, that the analysis of fatigue-related safety events

demonstrates that a direct link between fatigue, FTL and safety events is very often not

evident. Fatigue cannot easily be isolated from other (human) factors that influence crew

performance. Also, the investigation of fatigue can vary considerably depending on the

background, expertise and focus of the safety investigator(s) involved. There is no agreed

definition of a ‘fatigue-related safety occurrence’. It is well known that the current system

of investigation of aviation occurrences is not particularly apt to identifying pilot fatigue as

an immediate contributing factor.

Member States’ national regulations applicable to HEMS are in most cases the result of a

political compromise. Some of these regulations may be lacking contemporary scientific

understanding of human performance limitations and of sleep science.

For example, transient and cumulative fatigue and its impact on circadian rhythm may not

be very well addressed. On the other side, national regulations do not increase compliance

costs and are, therefore, preferred by operators.

comment 85 comment by: Nils Boether

Auf der Luftrettungsstation Christoph 31 Berlin wird bereits seit 2 Jahren aufgrund gestiegener Einsatzzahlen ein Doppelschichtsystem auf einer Primär- Retttungshubschrauber-Tagstation 9 Monate pro Jahr umgesetzt. Im einklang mit der 2.DVLuftBO und den in den Arbeitsverträgen festgelegten Arbeitsstundenzahlen (2000h exklusive Urlaub) wurde eine Betriebsvereinbarung für das Schichtmodell festgelegt. Diese Betriebsvereinbarung wird bei Inkrafttreten der neuen EASA FTL auf den meisten "Rettungshubschraubertagstationen" in ähnlicher Form angewendet werden müssen. Sollten keine weiteren Regelungen zur neuen EASA FTL bezüglich der Arbeitszeiten/- tagen von Hubschrauberbesatzungen im HEMS Flugbetrieb geben, halte ich die neuen EASA FTL für einen Rückschritt. Vor allem für die Flugsicherheit. Zur Beründung meiner Meinung, die sich vor allem aus den Erfahrungen des Schichtbetriebs auf der Rettungshubschraubertagstation Chritoph 31 begründet: 1. gemäß 2. DVLuftBo sind die Dienstperioden aufgrund von Ruhezeitenverkürzungen auf 8,5 Stunden im Sommerhalbjahr auf 4 Tage beschränkt. Im Schichtbetrieb gibt es diese Beschänkungen nicht mehr. Daraus resultieren längere Dienstperioden 7-8Tage die meist

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 6 of 585

An agency of the European Union

belastender sind, als 4 Tage am Stück auf der Station zu verbringen, um dann wieder eine längere Erholungphase zu erhalten. 2. Aufgrund des höheren Personalaufwands durch eine Doppelschicht wird die Erholungszeit meist auf das Minimum beschränkt (7-8Tage Dienst, dann 48Stdn Pause, dann oft wieder 7-8Tage Dienst). Im aktuellen Schichtbetrieb Christoph 31 eine übliche Praxis. 3. Die längeren Dienstperioden führen zu mehr Arbeitstagen, da die Arbeitsstundenleistung pro Arbeitstag sinkt. Um noch Zeit mit der Familie/Freunden zu verbringen, ist ein tägliches Pendeln oft notwendig. Das tägliche Pendeln führt zu einer weiteren Belastung. 4. Sollten die neuen EASA FTL eingeführt werden, sollten Regelungen über maximale Dienstperioden (4-5 Tage), sowie Regelungen über Wochenendarbeit und Ruheperioden festgelegt werden. 5. Ich sehe mit den neuen EASA FTL keine Erleichterung auf die Hubschrauberbesatzungen zukommen. Eher eine zusätzliche Belastung und Erschwernis der Arbeitsbedingungen.

response Please see the answer to comment # 54

comment 86 comment by: AIR ZERMATT AG

Attachments #1 #2

General comments to the NPA FTL 2017-17 with reference to Figure 1 (see attachment):

• Overall, the draft regulation is too complex in order to be operationalized; • The implementation of the proposed FTL regulation would require to hire

additional crew members in order to be compliant; • The significant need of more crew members would lead to a gap of qualified

personnel – because the qualified personnel is not available. Overall market is not sufficient to sustainably feed the market with the demand of qualified personnel organically;

o New crew members must be hired and trained to meet the basic HEMS requirements, leading to excessive training costs;

o More crews with low experience would be on duty due to the induced demand by EASA FTL (today even if prospects meet the EASA requirements, the upgrading to a HEMS pilot is based on an individual assessment/personal fit) à this would reduce today’s high safety and quality levels.

• Hiring additional crew members leads to a rise of salary costs, which then together with the higher training costs lead to an excessive rise of the overall HEMS operating costs.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 7 of 585

An agency of the European Union

o Equally-staying turnover, but higher salary costs will lead to lower overall salaries. à this would lead to social tension and lower the attractiveness of the job, enlarging the gap of qualified personnel.

o Further the increase of costs, lead to an increase of pressure for commercial rescue companies. In order to cope with higher expenditures, turnover must be increased, hence more risks are being taken by the crews in order to execute more HEMS missions in order to increase turnover. à this would reduce today’s high safety and quality levels.

• Due to an induced rise of crew members, each crew member conducts less actual flight time, hence builds slower experience. à this would reduce today’s high safety and quality levels.

Conclusion: In the opinion of the industry the implementation would lead to a reduction in safety, excessive rise of the overall HEMS operating costs and the danger of social tension due to the risk of lower salaries. Therefore, the industry suggests to deny the mandatory implementation of the EASA FTL and supports the option 0 of the NPA 2017-17 stated on page 67 article 4.5 and alternatively gives the suggestions stated below. Suggestion from the industry:

• Due to different operating structures (state vs. commercial or charity funded organizations), different tasks & responsibilities defined by the state and the different geographical environment within the EASA territory, a one-size-fits-all approach does not work and it should be left to the national authorities to regulate FTL (closeness to operators, practical knowledge of operations). E.g. Switzerland has a FTL regulation in place since 1990, which has proven itself as effective and efficient in regards to safety and quality;

• For cross border operations, member states should regulate FTL with bilateral agreements.

response Please see the answer to comment # 54

comment 218 comment by: ADAC Luftrettung gGmbH

Die bisher verwendete Regelung der FDuRZ in der 2.DV LuftBO, welche auf einer wissenschaftlichen Studie beruht, hat sich in der Vergangenheit bewährt. In 50 Jahren HEMS Betrieb hat es keinen Flugunfall auf Grund von Fatigue gegeben. Sie ermöglicht ein Maximum an Flugsicherheit bei gleichzeitiger Aufgabenerfüllung. Verglichen mit der Tätigkeit eines Piloten im gewerblichen Passagier-/Cargotransport, der während eines Flugdienstes zum Großteil fliegerische Tätigkeiten wahrnimmt, ist der zeitliche Anteil an fliegerischen Tätigkeit eines HEMS-Piloten pro Diensttag deutlich geringer. Wartezeiten an der Einsatzstelle und bei Patientenübergabe beinhalten wenige bis keine fliegerischen Tätigkeiten und führen deshalb zu weniger Ermüdung als die

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 8 of 585

An agency of the European Union

ununterbrochene Flugüberwachung/-durchführung eines Airline-Piloten der eine 16h- FDP durcharbeiten darf. Bei Einführung der FTL Regelung wie sie zum jetzigen Zeitpunkt geplant ist, wäre die deutschlandweite Einführung von Schichtdienst im HEMS-Flugbetrieb unausweichlich. Dies würde für Piloten die nicht in der direkten Umgebung der Heimatstation wohnen zu erheblich mehr Diensttagen und damit zu erheblich mehr An/Abreisezeit sowie Reisekosten führen. In meinem Fall würde daraus der mit der FTL beabsichtigte Flugsicherheitsgewinn nicht nur negiert, sonder sogar umgekehrt. Im Endeffekt würde die erhöhte Reisezeit zu einer erheblichen Mehrbelastung führen. Ein Umzug in die Nähe der Heimatstation ist aus persönlichen Gründen nicht möglich. Der durch die FTL verursachte indirekte Umzugszwang (Erbringung der Arbeitsleistung ohne Umzug finanziell/zeitlich nicht mehr durchführbar) stellt ein Eingriff in meine Grundrechte dar. Eine Kopplung der Flugzeitbegrenzung an einen Autopiloten ist nicht sinvoll, da ein Autopilot im Primärflugbetrieb nur sehr eingeschränkt nutzbar ist. Im Sekundärflugbetrieb ist dieser zwar eher nutzbar, jedoch kann nicht generell von einer Entlastung durch einen AP ausgegangen werden.

response Please see the answer to comment # 54

comment 434 comment by: ANWB MAA

As the HEMS operations are highly effected by local circumstances (commuting distances, duration average flight, remote areas, number of missions a day) it would be more feasible and make more sense to have a national FTL that will be applicable to all HEMS operators operating in that specific country. This FTL should be a performance based FTL (see option 1 next paige). To obtain a level playing field any operator applying for a HEMS operation will fulfil the requirements of that country. The national FTL needs to be based on scientific research taking all the mentioned above into account. The proposal as it is right now will drive the national healthcare to high costs. An investment for a country without any prove that the present FTL isn't safe enough or doesn't fit the local HEMS operation. As long as the proposal provide deviations for specific areas (remote) and countries (norway specifically mentioned) there still will be no level playing field. The question is if the EU countries really bother about the level playing field at this point if the required investments will be so high. Perhaps a survey at that point can be worthwhile. Worrisome is it to see that the helicopter industry has an important influence on the proposals. In this NPA an inexplicable distinction is made for the operations with or without autopilots. No evidence is given why this give such a longer FDP or FT. On average the costs will raise with at least 1 miliion euro per year for the HEMS operation in the Netherlands.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 9 of 585

An agency of the European Union

response Please see the answer to comment # 54.

comment 440 comment by: UFH French Helicopters Association

The Union Française de l’Helicoptere (UFH) is the French Helicopter association. Our organization is the French member of the European Helicopter Association. It gathers the 6 bodies that are representing the helicopter industry in France, including the SNEH, which is the Rotorcraft commercial operators association, and the helicopter branch of the FNAM. Concerning the present NPA 2017/17, logically, our analysis has been twined with the one that has been provided by FNAM. The comment that have been sent to the agency are obviously almost identical, in order to mark our full approval of it.

response Please see the answer to comment # 54.

comment 445 comment by: Hélicoptères de France

Attachments #3 #4 #5 #6 #7 #8

Introduction: The comments hereafter shall be considered as an identification of some of the major issues the French industry asks EASA to discuss with third-parties before any publication of the proposed regulation. In consequence, the following comments shall not be considered:

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean Hélicoptères de France has (or may has) no comments about them, neither Hélicoptères de France accepts or acknowledges them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation. General comments : Hélicoptères de France thanks EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for HEMS operations throughout Europe in order to warrantee a high level of safety. However, considering the HEMS national specificities (French HEMS missions represent 17% of the European HEMS missions), a proportionate approach tailored to the local specificities needs to be considered. The current RIA of this NPA should be further developed for a better maturity and should take into account the French national specificities. (Cf. comments #59 to 64) Generally speaking, Hélicoptères de France thinks that the proposed requirements for HEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for HEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 10 of 585

An agency of the European Union

For instance, the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for HEMS, indeed it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed (Cf. comments #18.1, #25, #30.1, #39, #40) It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of Hélicoptères de France’s current understanding of this NPA. At the time being, Hélicoptères de France fears that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal. *** # French Organization In France, the HEMS is a peculiar matter since it is a public service delegation from the Directorate of Health Care Supply (Direction Générale de l’Offre des Soins – DGOS) branch of the French Health Ministry. HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service defined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State (Civil Security, Gendarmerie or Army) for the sake of the DGOS. Regarding the private operators, there are 49 HEMS bases (corresponding to a total of 47 HEMS helicopters) in metropolitan France and overseas (including in Cayenne and in the Reunion Island) whose air transport business is conducted by 5 operators. These operators’ helicopters are based at the hospital for which they work and are permanently equipped with medical equipment. The contracts are awarded by each hospital or are pooled at pilot hospital which is responsible for the public contract and which, in some cases, spreads the flight hours between each hospital keeping a helicopter based for its sanitary transport needs. Additionally, the State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure", in respect of the sovereignty of each Member State facing major health crisis. Although delegated to private operators, the HEMS in France remains a public service mission whose latitude for the application of the newly proposed Article 8 of this NPA applies for the Member States at any time. *** #2 major characteristics 2 major characteristics arise from the French healthcare organization:

• The operational readiness with really short response time in order to warrantee the patient’s odds of survival (3 work paces are in force in France : H12, H14 and H24 operations; to simplify, only the H12 example will be developed afterwards)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 11 of 585

An agency of the European Union

• The unpredictability of the flight times This is the current French HEMS organization, linked with the French Health Ministry nowadays. In France, the President of the Republic and his government has made the commitment to the French people to warrantee an access to emergency care in less than 30 minutes from anywhere on the French territory. Considering the unpredictability of the HEMS operations, the flight times are not known in advance and cannot be scheduled ex-ante. Hence, all the CAT.A FTL philosophy (building a FDP and a DP around sectors [FT] and computing the duration of the required rest that has to be taken before the next FDP as Max [12h ; Previous DP]) does not suit the HEMS operations. The FDP’s content cannot be scheduled in advance (unscheduled allocation in a scheduled FDP). Hence, the attempt to adapt the CAT.A FTL implementing rules to the specificities of the HEMS leads to a dead-end since the philosophy is completely different. Therefore, it may be considered if elaborating a new regulation from scratch would not be more appropriate. *** # French rostering organization In France, the most usual rostering is usually 7 days ON at home base / 7 days OFF (implying a rest period + FDP < 24h, 7 times in a row), with a need for a H12 operational readiness (or a 12h shift in H24). This proposed European regulation, does not allow the French operators to comply with the French work pace defined and contracted by the French healthcare system. Moreover, in order to ensure a better quality of teamwork and to enhance safety, the French rostering organization is the same for pilots and doctors, they work in the same time slots (H12 or H14). Hence, all these new requirements will lead to amend all the French Health National practices (to that extend, the analysis of EASA would gain from considering further all economic and social issues it will raise). Indeed, considering the French work pace: On the one hand, in the proposed European regulation, there is a minimum duration for pre- flight of 30 minutes. This new requirement of a 30 minutes pre-flight will imply either a 30 minutes increase of the FDP or a 30 min decrease of the operational readiness. In France, 7%i of flights saving lives would be impossible with a 30 minutes pre-flight. (cf. illustrative Table in attachment) On the other hand, in the proposed European regulation, there is a minimum duration for post- flight at the end of (the last flight time of) the FDP of 15 minutes (and Hélicoptères de France would like to highlight the fact that the definition of this post-flight seems unclear and may lead to confusion). This new requirement of a 15 minutes post-flight at the end of (the last flight time of) the FDP will imply both a 15 minutes increase of the DP and a 15 minutes decrease of the time slot available for the required rest. Besides, if the FDP is lasting more than 10h, a 1 hour break is requested in the proposed dispositions of the NPA for single pilot + 1 TCM operations. In France all scheduled effective operational FDPs are 12h as explained before, so the 1h break requirement will always need to be fulfilled. Just as for flight times, due to the unpredictability of the HEMS missions, the break has to be unscheduled and the operator should ensure ex-post that the break requirement has been fulfilled for pilots. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Else, this will would overlap with national social regulations and the definition of working time.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 12 of 585

An agency of the European Union

Therefore, considering the French work pace, in order to have a 12h operational readiness with the proposed FTL European requirements, there is always a need for at least a 12h30 max FDP (which implies a 12h45 DP) with a 1h unscheduled time period allowed for physiological needs (which cannot be a rest period free of all duties). As a consequence, the time slot available for rest is 11h15 (24h – 12h45 = 11h15) while the rest required by this NPA would be 12h45. Therefore, all French HEMS operators will need to use systematically reduced rest and thus, all French HEMS operators will need to have a FRM (which seems disproportionate to the size of the involved operators). Moreover, as soon as there is one scheduled FDP lasting more than 12h (always the case in France since there is always a need for at least a 12h30 FDP), no more than 4 consecutive FDPs can be scheduled. Thus, the usual French rostering 7 days ON at home base / 7 days OFF cannot be respected, despite its efficiency in terms of safety, fatigue and quality of life for crews, has been proven from experience. As said in the RIA, no risk has been shown regarding safety or fatigue with the current regulation. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest, and the working pace of 7 days ON / 7 days OFF does not appear more tiring. On the contrary, the working pace of 7 days ON / 7 days OFF is better for the labor organization and is bringing a better quality of life for pilots who do not live near the HEMS operating base. Indeed pilots prefer to work 7 days in a row and then be 7 days OFF instead of working 1 day and resting the next day (which appears more tedious and exhaustive). # Conclusion The impact of the implementation of European FTL regulation for HEMS in France goes beyond the French operators. It is a complete change of the whole French Health care system which might be necessary. Thus, it would be appreciated if the RIA addresses the impacts on the national policy for emergency access to care and the Government Health policy, etc. Many lifesavings would be impossible with proposed FTL schemes. (Cf. attachments S1, S2, S3 and S4) As a consequence, 3 options emerge and are listed here below, ranked according to their level of relevance for Hélicoptères de France: # OPTION A or option 0 of the RIA This option, whose choice relies on the Member States (MS) or EASA’s decision, corresponds to the option 0 described in the RIA: no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The solution 0 is the proper answer to a one size fits all model which is not applicable to the industry. The FTL shall stay in the hand of the local authority. The well functioning current national FTL schemes are enforced since years, no excessive fatigue has been demonstrated and the current national system provides French operators with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about underreporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. Hélicoptères de France strongly asks this option to be considered by EASA and the Member States: “no change in the existing situation; HEMS continue to be regulated under MS national rules”. # OPTION B This option consists in a total revamp of the NPA 2017-17 for HEMS. Hélicoptères de France asks for a completely new proposal, distinguishing the HEMS from AEMS and Air Taxi as no operational

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 13 of 585

An agency of the European Union

comparison can be made between the fundamentals of these different activities and respecting the following principles:

• The “Flight time” (instead of “sector” whose definition is now restricted to aeroplanes) in all the requirements should not be scheduled as they cannot be in real life

• The duration of pre-flight, post-flight or inter-flights should be suppressed and replaced by “a sufficient time determined by the operator and specified in the operating manual” (in France, 7%i of flights saving lives would be impossible with a 30 minutes preflight, cf. illustrative Table in attachment)

• No limitations on the number of consecutive FDP lasting more than 12h should be made between 2 extended recovery rest periods

• For single-pilot + 1 TCM operations, in the case of a FDP lasting more than 10h, the break should be unscheduled and the operator should ensure ex-post that the break requirement has been fulfilled for pilots as they cannot be in real life

• The commander’s discretion prior to take-off under unforeseen circumstances needs to be extended to all the EMS payload and not only limited to the patient and extended up to 2 hours for 1 pilot + 1 TCM operations (in France, 3%i of flights saving lives would be impossible with a commander’s discretion capped to 1 hour, cf. illustrative Table in attachment)

• The limitations of the maximum values for continuous FT need to be increased by at least 1 hour

• The limitations of the maximum values for total flight time within a FDP need to be increased by at least 1 hour

• The 10% allowance between scheduled and actual FDP is not appropriate with the HEMS operations and needs to be suppressed

• The standby needs to be reviewed else it will never be used These elements of the aforementioned proposal form an integrated whole, they are each and all interrelated and interdependent.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 14 of 585

An agency of the European Union

*** The 3 options all respect the general FTL philosophy and the learnings of fatigue impact assessments. This proposal would increase by 20% the French State budget allocated for the HEMS activity which is not affordable according to the French State. Since the objective of this regulation is not flight safety but the harmonization of the different national regulations regarding HEMS, the text should not have the opposite effect leading to less level playing field. If the proposed dispositions are inapplicable, there may be non-binding opt-in / opt-out system possibilities (through the newly proposed Article 8 of this NPA). Misunderstanding or interpretation of National level of a far too complex regulation for small operators might also lead to lower level playing field.

response Please see the answer to comment # 54.

comment 457 comment by: FNAM/SNEH

Attachments #9 #10 #11 #12 #13

FNAM (Fédération Nationale de l’Aviation Marchande) is the French Aviation Industry Federation/ Trade Association for Air Transport, gathering the following members:

• CSTA: French Airlines Professional Union (incl. Air France) • SNEH: French Helicopters Operators Professional Union • CSAE: French Handling Operators Professional Union • GIPAG: French General Aviation Operators Professional Union • GPMA: French Ground Operations Operators Professional Union • EBAA France: French Business Airlines Professional Union

And the following associated members:

• FPDC: French Drone Professional Union • UAF: French Airports Professional Union

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean FNAM and SNEH have (or may have) no comments about them, neither FNAM and SNEH accept or acknowledge them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 15 of 585

An agency of the European Union

General comments : FNAM and SNEH thank EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for HEMS operations throughout Europe in order to warrantee a high level of safety. However, considering the HEMS national specificities (French HEMS missions represent 17% of the European HEMS missions), a proportionate approach tailored to the local specificities needs to be considered. The current RIA of this NPA should be further developed for a better maturity and should take into account the French national specificities. (Cf. comments #517 to 521) Generally speaking, FNAM and SNEH think that the proposed requirements for HEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for HEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation. For instance, the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for HEMS, indeed it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

(Cf. comments #473, #478, #496, #510, #511) It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of FNAM and SNEH’s current understanding of this NPA. At the time being, FNAM and SNEH fear that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal. *** # French Organization In France, the HEMS is a peculiar matter since it is a public service delegation from the Directorate of Health Care Supply (Direction Générale de l’Offre des Soins – DGOS) branch of the French Health Ministry. HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public servicedefined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State(Civil Security, Gendarmerie or Army) for the sake of the DGOS. Regarding the private operators, there are 49 HEMS bases (corresponding to a total of 47 HEMS helicopters) in metropolitan France and overseas (including in Cayenne and in the Reunion Island) whose air transport business is conducted by 5 operators. These operators’ helicopters are based at the hospital for which they work and are permanently equipped with medical equipment.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 16 of 585

An agency of the European Union

The contracts are awarded by each hospital or are pooled at pilot hospital which is responsible for the public contract and which, in some cases, spreads the flight hours between each hospital keeping a helicopter based for its sanitary transport needs. Additionally, the State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure", in respect of the sovereignty of each Member State facing major health crisis. Although delegated to private operators, the HEMS in France remains a public service mission whose latitude for the application of the newly proposed Article 8 of this NPA applies for the Member States at any time.

*** #2 major characteristics 2 major characteristics arise from the French healthcare organization:

• The unpredictability of the flight times

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 17 of 585

An agency of the European Union

On the one hand, in the proposed European regulation, there is a minimum duration for pre-flight of 30 minutes. This new requirement of a 30 minutes pre-flight will imply either a 30 minutes increase of the FDP or a 30 min decrease of the operational readiness. In France, 7%i of flights saving lives would be impossible with a 30 minutes preflight. (cf. SNEH illustrative Table in attachment) On the other hand, in the proposed European regulation, there is a minimum duration for post-flight at the end of (the last flight time of) the FDP of 15 minutes (and FNAM and SNEH would like to highlight the fact that the definition of this post-flight seems unclear and may lead to confusion). This new requirement of a 15 minutes post-flight at the end of (the last flight time of) the FDP will imply both a 15 minutes increase of the DP and a 15 minutes decrease of the time slot available for the required rest. Besides, if the FDP is lasting more than 10h, a 1 hour break is requested in the proposed dispositions of the NPA for single pilot + 1 TCM operations. In France all scheduled effective operational FDPs are 12h as explained before, so the 1h break requirement will always need to be fulfilled. Just as for flight times, due to the unpredictability of the HEMS missions, the break has to be unscheduled and the operator should ensure ex-post that the break requirement has been fulfilled for pilots. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Else, this will would overlap with national social regulations and the definition of working time. Therefore, considering the French work pace, in order to have a 12h operational readiness with the proposed FTL European requirements, there is always a need for at least a 12h30 max FDP (which implies a 12h45 DP) with a 1h unscheduled time period allowed for physiological needs (which cannot be a rest period free of all duties). As a consequence, the time slot available for rest is 11h15 (24h – 12h45 = 11h15) while the rest required by this NPA would be 12h45. Therefore, all French HEMS operators will need to use systematically reduced rest and thus, all French HEMS operators will need to have a FRM (which seems disproportionate to the size of the involved operators). Moreover, as soon as there is one scheduled FDP lasting more than 12h (always the case in France since there is always a need for at least a 12h30 FDP), no more than 4 consecutive FDPs can be scheduled. Thus, the usual French rostering 7 days ON at home base / 7 days OFF cannot be respected, despite its efficiency in terms of safety, fatigue and quality of life for crews, has been proven from experience. As said in the RIA, no risk has been shown regarding safety or fatigue with the current regulation. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest, and the working pace of 7 days ON / 7 days OFF does not appear more tiring. On the contrary, the working pace of 7 days ON / 7 days OFF is better for the labor organization and is bringing a better quality of life for pilots who do not live near the HEMS operating base. Indeed pilots prefer to work 7 days in a row and then be 7 days OFF instead of working 1 day and resting the next day (which appears more tedious and exhaustive). *** # Conclusion The impact of the implementation of European FTL regulation for HEMS in France goes beyond the French operators. It is a complete change of the whole French Health care system which might be necessary. Thus, it would be appreciated if the RIA addresses the impacts on the national policy for emergency access to care and the Government Health policy, etc. Many lifesavings would be impossible with proposed FTL schemes. (Cf. attachments S1, S2, S3 and S4)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 18 of 585

An agency of the European Union

As a consequence, 3 options emerge and are listed here below, ranked according to their level of relevance for FNAM and SNEH: # OPTION A or option 0 of the RIA This option, whose choice relies on the Member States (MS) or EASA’s decision, corresponds to the option 0 described in the RIA: no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The solution 0 is the proper answer to a one size fits all model which is not applicable to the industry. The FTL shall stay in the hand of the local authority. The well-functioning current national FTL schemes are enforced for years, no excessive fatigue has been demonstrated and the current national system provides French operators with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about under- reporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. FNAM and SNEH strongly ask this option to be considered by EASA and the Member States : “no change in the existing situation; HEMS continue to be regulated under MS national rules”. # OPTION B This option consists in a total revamp of the NPA 2017-17 for HEMS. FNAM and SNEH ask for a completely new proposal, distinguishing the HEMS from AEMS and Air Taxi as no operational comparison can be made between the fundamentals of these different activities and respecting the following principles:

• Basing an alternative proposal on: o 14h Standby / 10h Rest with a commander’s discretion applicable in case

of unforeseen circumstances o short-time operational readiness for ready-to-go EMS take-off o rostering of 7 days ON / 7 days OFF o flight time limitations to be discussed within this frame

FNAM and SNEH ask for this option to be considered in the Comment Response Document (CRD) with the elaboration of a sound RIA. Moreover, FNAM and SNEH would be happy to offer its expertise to discuss and study this subject with EASA policy officers. Besides, for clarity reasons, this would imply to separate, regarding the FTL scope, the HEMS from CAT, Air Taxi and AEMS operations. # OPTION C If these 2 first options are not retained, FNAM and SNEH ask for this proposed NPA to be amended and reviewed as stated in the following comments. The proposed requirements, as it is, will lead to amend Health National regulations and it will request more crew, more constraints, more costs with a low added safety value as stated in the RIA. The main proposals are laid down here below:

• The “Flight time” (instead of “sector” whose definition is now restricted to aeroplanes) in all the requirements should not be scheduled as they cannot be in real life

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 19 of 585

An agency of the European Union

• The travelling time between multiple HEMS operating bases of the home base should be increased a minima to 120 minutes (instead of 60 minutes) and in case of change of home base, the ERRP after starting duty (and not the one prior to starting duty) should be increased to allow the continuity of the operations

• The duration of pre-flight, post-flight or inter-flights should be suppressed and replaced by “a sufficient time determined by the operator and specified in the operating manual” (in France, 7%iof flights saving lives would be impossible with a 30 minutes preflight, cf. SNEH illustrative Table in attachment)

• No limitations on the number of consecutive FDP lasting more than 12h should be made between 2 extended recovery rest periods

• The limitations of the maximum values for continuous FT need to be increased by at least 1 hour

• The limitations of the maximum values for total flight time within a FDP need to be increased by at least 1 hour

• The 10% allowance between scheduled and actual FDP is not appropriate with the HEMS operations and needs to be suppressed

• The standby needs to be reviewed else it will never be used

These elements of the aforementioned proposal form an integrated whole, they are each and all interrelated and interdependent.

response Please see the answer to comment # 54.

comment 524 comment by: ADAC Luftrettung gGmbH

This new regulation aims to increase flight safety on one hand and harmonization of the natonal regulations on the other hand. But harmonization does not make sence in this context, when different requirements of member states are not considered.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 20 of 585

An agency of the European Union

With the 2. DVLuftBO § 22-23 of the German FTL regulation, there is a well proven FTL regulation exspecially for HEMS in force for years, that is based on a scientific studie and takes into account the special circumstances in our country our environment.Today we have a history of more than 50 years of HEMS operation in Germany. Never in this period of time FTL or fatigue have been reported as a reason for an accident or incident. International accident investigations in HEMS operations (referenced in Attachment II of NPA 2017-17) that identified fatigue as a major contributor to the accident have one thing in common: exceedance of existing regulations. Therefor new regulations won’t mitigate the risk since they don‘t fight the root cause. Formal error: expert opinions discussed in RMT.0492 / RMT.0493 are not considered in the rule making. NPA development and publication without implementation of interested parties. What scientific research results lead to the definition of maximum daily flight time and length of duty periods? There is no reference to any special study focusing on HEMS. In fixed wing operations a 16h FDP is allowed although pilots need to be alert all the time to react to any unforeseen event e.g. warning lights et cetera. In HEMS operations cockpit time is limited to single legs with an average length of less than 20 minutes. This discriminates HEMS against fixed wing pilots. There is no similar regulation for CAT operations with helicopters other than HEMS. Instead national law of the member states is still in place that allows for much more flight time. This is a disadvantage for HEMS pilots. Due to the possible variations of split duty the length of a daily duty period is not predictable in advance. With that uncertainty planning is impossible for crews as well as operators. Today rescue helicopter availability time in Germany is limited to 14:45h (+ pre- and post flight checks). To cover this period in accordance with NPA 2017-17, it would be necessary to implement shift duties. This will lead to an additional requirement of up to 30% more CHPL pilots. Such an amount of qualified personnel is currently not available on the market (extra cost, strong social impact on working conditions of pilots). This impact is insufficiently considered in the NPA development. Additional number of pilots in combination with constant level of mission frequency and flight time will lead to less mission experience for every single crew member that needs to be compensated with additional training and training flights (high financial impact). Impact on privacy and fundamental rights due to reduced rest prerequisite to sleep at home base. Crew members have to stay on base during their rest period although they are free of duty. Due to the diversity of possible exemptions, NPA 2017-17 is difficult to handle for the personnel because they need to calculate FDP and duty time in relation with breaks all the time. Advance planning of mission availability is not possible.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 21 of 585

An agency of the European Union

For crew living more than 90 minutes away from home base, guidance material recommends to consider making arrangements for temporary accommodation closer to their home base. This is an unacceptable interference with fundamental rights and has high financial impact either on crew or on operator. Limitation of flight time depending on autopilot availability is not self-explaining, because there is no legal need to use the autopilot. Question: What scientific data led to these limits with or without autopilot? If this limitation is based on fixed wing operation research, is it allowed to transfer the same times to rotor wing operation without further research? A comparative study performed by DLR in 2017 showed in preliminary results that by changing the roster to 2-shift duties, subjective stress was increased by additional travel time, more frequent changes between duty periods and private time, unreliable/unplannable shift changes etc. This leads to a decrease of flight safety rather than an intended increase.

response Please see the answer to comment # 54.

comment 546 comment by: Rüdiger Neu

Ziel der Verordnung soll eine Erhöhung der Flugsicherheit und eine Harmonisierung der Vorschriften sein. Eine Harmonisierung macht dabei aber keinen Sinn, wenn die unterschiedlichen Bedürfnisse und Belange der Mitgliedsstaaten dadurch nicht mehr berücksichtigt werden können. In Deutschland gibt es mit der 2. DVLuftBO eine seit vielen Jahren bewährte FTL-Regelung für HEMS, welche auf einer wissenschaftlichen Studie basiert und die speziellen Bedingungen des Betriebs unseres Landes berücksichtigt. Seit über 50 Jahren gibt es nun HEMS in Deutschland. In den ganzen Jahren ist es noch zu keinem Flugunfall oder Incident aufgrund von Flugdienst- und Ruhezeiten bzw. „Fatigue“ gekommen. Ggf. Formfehler, da auf die Experten der RMT.0492 / RMT.0493 nicht eingegangen wurde und nun die NPA eigenständig entworfen und veröffentlicht wurde. Worin liegen die wissenschaftlichen Erkenntnisse für die Festlegungen, insbesondere der Flugstundenzahlen und Länge der jeweiligen Perioden? Der NPA ist zu entnehmen, dass keine spezielle Studie in Hinblick auf HEMS erhoben wurde? Eine 16h-FDP ist im Flächenflugbereich problemlos möglich und dies obwohl die Piloten in der gesamten Zeit aufmerksam sein müssen, da jeden Moment eine Warnlampe oder anderes Ereignis stattfinden könnte. Im HEMS Betrieb besteht die fliegerische Aufgabe bei einem Rettungseinsatz in zeitlich kurzen Legs von durchschnittlich < 20 Minuten. Insofern besteht hier eine deutliche Benachteiligung.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 22 of 585

An agency of the European Union

Da es noch keine FTL für die Arbeitsfliegerei gibt könnte diese avisierte Regelung eine Benachteiligung darstellen. Durch die verschiedenen Varianten der Split Duty ist für den Piloten zum Dienstbeginn nicht klar, wie lange die FDP dauern kann. Dies macht eine Dienstplanung sowohl für den Piloten als auch für das Unternehmen unmöglich. Da in Deutschland oftmals die Vorhaltezeit eines Rettungshubschraubers bei max. 14:45 Stunden liegt (zuzüglich der Vor- und Nachflugkontrollen), würde dies zwangsläufig zu einem Schichtdienst führen, wodurch die Anzahl der CHPL Piloten bis zu 30% aufgestockt werden müsste. Eine solche Anzahl von qualifizierten Piloten ist zurzeit auf dem Markt nicht verfügbar (hohe finanzielle Aufwendung, starker Einfluss auf die sozialen Bedingungen der Piloten). Dieser Impact ist im Rahmen der NPA nicht ausreichend berücksichtigt. Eine Erhöhung der Pilotenanzahl bei gleichbleibender Einsatzfrequenz führt bei dem einzelnen Besatzungsmitglied zu einer geringeren Einsatzerfahrung, die dann ggf. durch Schulungen und Übungsflüge kompensiert werden müsste. (hohe finanzielle Aufwendung). Einschränkung und Eingriff in die Privatsphäre und Grundrechte, da bei reduced rest auf Station geschlafen werden muss. Die Besatzungsmitglieder wären über Tage auf Station „eingesperrt“, obwohl sie in der Ruhezeit frei hätten. Die vorgeschlagene Regelung ist nicht praxistauglich, da der Pilot ständig die Zeiten im Auge haben muss. Eine Vorausplanung der Einsatzverfügbarkeit ist somit unmöglich. Wohnt man mehr als 90 Minuten von der Station entfernt, so wird im guidance material empfohlen sich in der Nähe eine Unterkunft zu suchen. Dies beschränkt die freie Wahl des Wohnorts und stellt einen unzulässigen Eingriff in die Grundrechte dar. Die Abhängigkeit der Flugzeitbegrenzung gekoppelt an einen Autopiloten (AP) kann nicht nachvollzogen werden, da die Nutzung des AP nicht zwingend ist. Fragestellung hierzu: Auf welcher Datenbasis wurde die Flugzeitbegrenzung mit und ohne AP festgelegt? Falls die Festlegung aus der Flächenfliegerei stammt, ist sie überhaupt auf die Hubschrauberfliegerei übertragbar? Die vergleichende Studie der DLR in 2017 hat gezeigt, dass subjektiv die Belastung durch die Reisezeiten, den Wechsel zwischen Dienstbetrieb und Privat, sowie die unregelmäßigen/unplanbaren Wechselzeiten der Schichten durch das Einsatzaufkommen zugenommen hat und dadurch die Flugsicherheit eher gefährdet als verbessert wird.

response Please see the answer to comment # 54.

comment 572 comment by: FinnHEMS Oy

Attachment #14

FinnHEMS Oy, as the national administrative unit for HEMS-operations in Finland, has the following general comments regarding the NPA 2017-17:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 23 of 585

An agency of the European Union

FinnHEMS is in favor of harmonization and standardization of the European regulations for helicopter operations to guarantee a high level of safety taking into account our following comments. It shall be noted that in this NPA it is indeed acknowledged that there are no indications that the existing FTL requirements for HEMS, which are currently under national authority approvals, pose a flight safety problem. The current finnish national regulation OPS M3-2 has made possible HEMS duty periods of 24-72 hours taking account the minimum standby time without duties during duty periods and the minimum rest time required after the duty period. This system has been in use for over 10 years in Finland and is proven to be very suitable concerning the national circumstances. Preliminary results of an ongoing research of the Finnish Institute of Occupational Health together with FinnHEMS Research and Development Unit focusing on the “Working hours, sleep and sleepiness in HEMS personnel in Finland” reveals quite clearly that pilots and HEMS crew members experience little low alertness on duty regardless of whether the duty period is 24 or 48 hours. This study confirms the experience of the finnish HEMS branch during the last over ten years. These preliminary results are attached to this comment and the final report later this year will be available upon request. The HEMS Duty Shifts up to 72 hours should be made possible also in the future to preserve effectiveness in operations because Finland is a sparsely populated country with long distances (up to 1000km) between crew homes and HEMS bases. Several well proven mitigating actions are presently used to minimize the risks of tiredness during duty periods. These are for example the effective use of FRMS, strict requirements of rest without duties within duty periods, automated calculations of actual required rest requirements and use of standby by crews. As a conclusion, FinnHEMS: (1) strongly requests that HEMS would be separated from this set of regulation and a new NPA specific for HEMS FTL to be developed, taking into account relevant and updated scientific knowledge, when available or; (2) if (1) above is not possible, then FinnHEMS requests that the "Active Standby"-concept suggested by the finnish aviation authority Trafi is added to the rule (to be able to continue to operate as per today)

response Please see the answer to comment # 54.

comment 637 comment by: Oya Vendée Hélicoptères

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 24 of 585

An agency of the European Union

Attachments #15 #16 #17 #18 #19

• OYA Vendée Hélicoptères : French helicopter operator in l'Ile d'Yeu

• SNEH: French Helicopters Operators Professional Union

Introduction: The comments hereafter shall be considered as an identification of some of the major issues OYA Vendée Hélicoptères asks EASA to discuss with third-parties before any publication of the proposed regulation. In consequence, the following comments shall not be considered:

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean OYA has (or may has) no comments about them, neither OYA accepts or acknowledge them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation.

General comments : OYA thanks EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for HEMS operations throughout Europe in order to warrantee a high level of safety. However, considering the HEMS national specificities (French HEMS missions represent 17% of the European HEMS missions), a proportionate approach tailored to the local specificities needs to be considered. The current RIA of this NPA should be further developed for a better maturity and should take into account the French national specificities. (Cf. comments #696 to 700) Generally speaking, OYA thinks that the proposed requirements for HEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for HEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation. For instance, the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for HEMS, indeed it is not explicit whether: All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed

(Cf. comments #653, #658, #676, #689, #690)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 25 of 585

An agency of the European Union

It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of OYA’s current understanding of this NPA. At the time being, OYA fears that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal.

*** # French Organization In France, the HEMS is a peculiar matter since it is a public service delegation from the Directorate of Health Care Supply (Direction Générale de l’Offre des Soins – DGOS) branch of the French Health Ministry. HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public servicedefined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State(Civil Security, Gendarmerie or Army) for the sake of the DGOS. Regarding the private operators, there are 49 HEMS bases (corresponding to a total of 47 HEMS helicopters) in metropolitan France and overseas (including in Cayenne and in the Reunion Island) whose air transport business is conducted by 5 operators. These operators’ helicopters are based at the hospital for which they work and are permanently equipped with medical equipment. The contracts are awarded by each hospital or are pooled at pilot hospital which is responsible for the public contract and which, in some cases, spreads the flight hours between each hospital keeping a helicopter based for its sanitary transport needs. Additionally, the State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure", in respect of the sovereignty of each Member State facing major health crisis. Although delegated to private operators, the HEMS in France remains a public service mission whose latitude for the application of the newly proposed Article 8 of this NPA applies for the Member States at any time.

*** #2 major characteristics 2 major characteristics arise from the French healthcare organization:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 26 of 585

An agency of the European Union

• The unpredictability of the flight times

This is the current French HEMS organization, linked with the French Health Ministry nowadays. In France, the President of the Republic and his government has made the commitment to the French people to warrantee an access to emergency care in less than 30 minutes from anywhere on the French territory. Considering the unpredictability of the HEMS operations, the flight times are not known in advance and cannot be scheduled ex-ante.Hence, all the CAT.A FTL philosophy (building a FDP and a DP around sectors [FT] and computing the duration of the required rest that has to be taken before the next FDP as Max [12h ; Previous DP]) does not suit the HEMS operations. The FDP’s content cannot be scheduled in advance (unscheduled allocation in a scheduled FDP). Hence, the attempt to adapt the CAT.A FTL implementing rules to the specificities of the HEMS leads to a dead-end since the philosophy is completely different. Therefore, it may be considered if elaborating a new regulation from scratch would not be more appropriate. *** # French rostering organization In France, the most usual rostering is usually 7 days ON at home base / 7 days OFF (implying a rest period + FDP < 24h, 7 times in a row), with a need for a H12 operational readiness (or a 12h shift in H24). This proposed European regulation, does not allow the French operators to comply with the French work pace defined and contracted by the French healthcare system. Moreover, in order to ensure a better quality of teamwork and to enhance safety, the French rostering organization is the same for pilots and doctors, they work in the same time slots (H12 or H14). Hence, all these new requirements will lead to amend all the French Health National practices (to that extend, the analysis of EASA would gain from considering further all economic and social issues it will raise). Indeed, considering the French work pace: On the one hand, in the proposed European regulation, there is a minimum duration for pre-flight of 30 minutes. This new requirement of a 30 minutes pre-flight will imply either a 30 minutes increase of the FDP or a 30 min decrease of the operational readiness. In France, 7%i of flights saving lives would be impossible with a 30 minutes preflight. (cf. SNEH illustrative Table in attachment) On the other hand, in the proposed European regulation, there is a minimum duration for post-flight at the end of (the last flight time of) the FDP of 15 minutes (OYA would like to highlight the fact that the definition of this postflight seems unclear and may lead to confusion). This new requirement of a 15 minutes post-flight at the end of (the last flight time of) the FDP will imply both a 15 minutes increase of the DP and a 15 minutes decrease of the time slot available for the required rest.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 27 of 585

An agency of the European Union

Besides, if the FDP is lasting more than 10h, a 1 hour break is requested in the proposed dispositions of the NPA for single pilot + 1 TCM operations. In France all scheduled effective operational FDPs are 12h as explained before, so the 1h break requirement will always need to be fulfilled. Just as for flight times, due to the unpredictability of the HEMS missions, the break has to be unscheduled and the operator should ensure ex-post that the break requirement has been fulfilled for pilots. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Else, this will would overlap with national social regulations and the definition of working time. Therefore, considering the French work pace, in order to have a 12h operational readiness with the proposed FTL European requirements, there is always a need for at least a 12h30 max FDP (which implies a 12h45 DP) with a 1h unscheduled time period allowed for physiological needs (which cannot be a rest period free of all duties). As a consequence, the time slot available for rest is 11h15 (24h – 12h45 = 11h15) while the rest required by this NPA would be 12h45. Therefore, all French HEMS operators will need to use systematically reduced rest and thus, all French HEMS operators will need to have a FRM (which seems disproportionate to the size of the involved operators). Moreover, as soon as there is one scheduled FDP lasting more than 12h (always the case in France since there is always a need for at least a 12h30 FDP), no more than 4 consecutive FDPs can be scheduled. Thus, the usual French rostering 7 days ON at home base / 7 days OFF cannot be respected, despite its efficiency in terms of safety, fatigue and quality of life for crews, has been proven from experience. As said in the RIA, no risk has been shown regarding safety or fatigue with the current regulation. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest, and the working pace of 7 days ON / 7 days OFF does not appear more tiring. On the contrary, the working pace of 7 days ON / 7 days OFF is better for the labor organization and is bringing a better quality of life for pilots who do not live near the HEMS operating base. Indeed pilots prefer to work 7 days in a row and then be 7 days OFF instead of working 1 day and resting the next day (which appears more tedious and exhaustive).

*** # Conclusion The impact of the implementation of European FTL regulation for HEMS in France goes beyond the French operators. It is a complete change of the whole French Health care system which might be necessary. Thus, it would be appreciated if the RIA addresses the impacts on the national policy for emergency access to care and the Government Health policy, etc. Many lifesavings would be impossible with proposed FTL schemes. (Cf. attachments S1, S2, S3 and S4) As a consequence, 3 options emerge and are listed here below, ranked according to their level of relevance for OYA: # OPTION A or option 0 of the RIA This option, whose choice relies on the Member States (MS) or EASA’s decision, corresponds to the option 0 described in the RIA: no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The solution 0 is the proper answer to a one size fits all model which is not applicable to the industry. The FTL shall stay in the hand of the local authority. The well-functioning current

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 28 of 585

An agency of the European Union

national FTL schemes are enforced for years, no excessive fatigue has been demonstrated and the current national system provides French operators with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about under-reporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. OYA strongly asks this option to be considered by EASA and the Member States : “no change in the existing situation; HEMS continue to be regulated under MS national rules”. # OPTION B This option consists in a total revamp of the NPA 2017-17 for HEMS. OYA asks for a completely new proposal, distinguishing the HEMS from AEMS and Air Taxi as no operational comparison can be made between the fundamentals of these different activities and respecting the following principles:

• Basing an alternative proposal on: o 14h standby / 10h Rest with a commander's discretion applicable in case

of unforseen circumstances o short-time operational readiness for ready-to-go EMS take off o rostering of 7 days ON / 7 days OFF o flight time limitations to be discussed within this frame

OYA asks for this option to be considered in the Comment Response Document (CRD) with the elaboration of a sound RIA. Moreover, OYA would be happy to offer its expertise to discuss and study this subject with EASA policy officers. Besides, for clarity reasons, this would imply to separate, regarding the FTL scope, the HEMS from CAT, Air Taxi and AEMS operations. # OPTION C If these 2 first options are not retained, OYA asks for this proposed NPA to be amended and reviewed as stated in the following comments. The proposed requirements, as it is, will lead to amend Health National regulations and it will request more crew, more constraints, more costs with a low added safety value as stated in the RIA. The main proposals are laid down here below:

• The “Flight time” (instead of “sector” whose definition is now restricted to aeroplanes) in all the requirements should not be scheduled as they cannot be in real life

• The duration of pre-flight, post-flight or inter-flights should be suppressed and replaced by “a sufficient time determined by the operator and specified in the operating manual” (in France, 7%iof flights saving lives would be impossible with a 30 minutes preflight, cf. SNEH illustrative Table in attachment)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 29 of 585

An agency of the European Union

• No limitations on the number of consecutive FDP lasting more than 12h should be made between 2 extended recovery rest periods

• The limitations of the maximum values for continuous FT need to be increased by at least 1 hour

• The limitations of the maximum values for total flight time within a FDP need to be increased by at least 1 hour

• The 10% allowance between scheduled and actual FDP is not appropriate with the HEMS operations and needs to be suppressed

• The standby needs to be reviewed else it will never be used

These elements of the aforementioned proposal form an integrated whole, they are each and all interrelated and interdependent.

***

The 3 options all respect the general FTL philosophy and the learnings of fatigue impact assessments. This proposal would increase by 20% the French State budget allocated for the HEMS activity which is not affordable according to the French State. Since the objective of this regulation is not flight safety but the harmonization of the different national regulations regarding HEMS, the text should not have the opposite effect leading to less level playing field. If the proposed dispositions are inapplicable, there may be non-binding opt-in / opt-out system possibilities (through the newly proposed Article 8 of this NPA). Misunderstanding or interpretation of National level of a far too complex regulation for small operators might also lead to lower level playing field.

response Please see the answer to comment # 54.

comment 802 comment by: European Helicopter Association (EHA)

The European Helicopter Association (EHA) is in favor of harmonization and standardization of the European regulations for helicopter operations to guarantee a high level of safety. However, when harmonization is mainly pursued in the name of a level playing field that is hardly applicable to FTL schemes, we believe that the main objective is destined to fail. The concept of level playing field is also reflected in the NPA where it is indeed acknowledged that there are no indications that the existing FTL requirements for HEMS, which are currently under national authority approvals, pose a flight safety problem.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 30 of 585

An agency of the European Union

We believe and are providing evidence through our comments, that this NPA instead of increasing the overall safety of the HEMS operations, will potentially create more problems like for example having to amend in some countries the national health regulations, having to require more crew, more constraints and more costs with a low added safety value. The European HEMS operations is characterized by a vast number of different operating patterns. The diversified operating patterns have been developed and matured over a long period of time and are necessary to perform safe and affordable HEMS operations in very different operating environments and in accordance with different requirements (including national laws concerning ambulance and rescue services). The different operating patterns are the result of many factors (as presented in the EHA/EHAC FTL data collection), many of them with a direct impact on suitable FTL schemes. We believe that harmonizing and standardizing European HEMS FTL requirements is not practicable unless the harmonization and standardization is at a framework level where the actual details are left up to the national authorities. It is the EHA’s opinion that the parts of the NPA pertaining to HEMS have been conceived using a general lack of supporting data, an incomplete pre‐RIA report and very few relevant or outdated scientific publications concerning fatigue in HEMS operation. Furthermore, obtaining sufficient data during the rule making process has been a challenge. The specific objective of this proposal was to establish an improved and proportionate Europe-wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices. We feel that this has not been achieved. Therefore, we are of the opinion that the new FTL requirements for HEMS, as envisioned in the NPA, will force many operators to use Article 14‐6 or 22-2 flexibility provision and apply for an Individual Flight Time Specification Scheme (IFTSS), i.e. “Option 1 – Flexible approach”. This means that the objectives of the new FTL for HEMS will not be achieved as far as contributing to the high uniform level of civil aviation safety, providing a level playing field and facilitate the free movement of goods, persons and services. EHA believes that “Option 2 - Fully prescriptive approach” would make it very difficult to recruit suitable experienced/qualified crew members and at the same time it will lead to a lack of recency (the same amount of missions would be flown by a substantially higher number of crew members (in many cases by as much as 44% more crew members sharing basically same amount of missions). To maintain the same level of service and safety standard, the cost increase would typically run in the range of 20% to 49%. Although HEMS is a Commercial Air Transportation (CAT) task, HEMS are typically a public service matter funded by tax money. The health authorities in many Member States will not be able to handle these type of cost increases. The alternative is a substantial reduction of the overall level of safety and/or service, but this is a scenario that cannot be accepted either. Additionally, the risk of fatigue will potentially increase, in many cases, due to heavy commuting. EHA agrees that “Option 1 - Flexible approach” could work as it would have the benefit of forcing the operators to demonstrate a safe operation. According to information given to the EHA, an operator with only two HEMS operating bases has estimated a cost, excluding authority fees, of up to 300 000 € to establish an IFTSS and then 20 000 € per year to maintain it. Another operator with 12 HEMS operating bases has estimated a cost, excluding authority fees, of 600 000 € to establish, and then another 40 000 € per year to

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 31 of 585

An agency of the European Union

maintain, an IFTSS. As obtaining an IFTSS is quite costly, this will not be practicable for many small operators or their customers (state, county etc.) and at the end, it would also prevent new operators to enter the market or for established operators to expand. Another important concern is that the FTL itself would still limit somehow what can be achieved with an IFTSS, thus leading to many of the negative safety impacts of “Option 2 – Fully prescriptive approach”. In conclusion, it is EHA’s view that EASA has been given an impossible task under the present circumstances and that at least for the time being, the only suitable solution for HEMS FTL is “Option 0 – No policy change” as it will have a neutral safety impact, if operations remain predominantly in the Member State that issues the Air Operator Certificate. EHA would be happy to assist EASA during the development of a new NPA specific for HEMS FTL where relevant and updated scientific knowledge, when available, is used.

response Please see the answer to comment # 54.

comment 870 comment by: Stephanie Selim

DGAC France would like to thank EASA for this NPA and the harmonisation it will bring in terms of flight times limitations.

response Please see the answer to comment # 54.

comment 872 comment by: Stephanie Selim

General comments about HEMS operations : However, considering the HEMS operations, we think that this NPA is not mature enough and this subject would need a sound RIA taking into account the different types of organisations in the different countries. Currently, this RIA does not consider the national health care systems. It appears to us that this NPA does not fit the French organisation of health care and would lead to an additional expense of 15 million euros according to French Health’s Ministry that it will not be possible to engage for the State, for a benefit in terms of safety which is not demonstrated by the RIA. HEMS organisation in France: In France, HEMS is a public service delegation from the Directorate of Health Care Supply (Direction Générale de l’Offre des Soins – DGOS) branch of the French Health’s Ministry. HEMS depends on the organisation of the French healthcare system (the permanence and continuity of care services is a public service defined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. The financing of HeliSMUR (helicopters provided for Emergency Medical Services in France) is guaranteed by a national endowment allocated to hospitals headquarters of HeliSMUR by the Health’s Ministry.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 32 of 585

An agency of the European Union

HEMS in France is both operated by private operators and State (Civil Security, Gendarmerie or Army) for the sake of the DGOS. Regarding the private operators, there are 49 HEMS bases (corresponding to a total of 47 HEMS helicopters) in metropolitan France and overseas (including French Guyana and Reunion Island) whose air transport business is conducted by 5 operators. These operators’ helicopters are based in the hospital for which they work and are permanently equipped with medical equipment. Only 11 HeliSMUR bases can have a highly complementarity with the State helicopter fleet due to their proximity to coastal zone or mountain zone, allowing rapid support in the case of reduced availability of the HeliSMUR. The contracts are awarded by each hospital or are pooled at a pilot hospital which is responsible for the public contract and which, in some cases, spreads the flight hours between each hospital keeping a helicopter based for its sanitary transport needs. In France, the most usual rostering is usually 7 days ON at HEMS base / 7 days OFF, with a need for a H12 operational readiness (or a 12h shift in H24). The operating range of HeliSMUR is 12 hours for 16 bases (15 helicopters), 14 hours for 15 bases (14 helicopters) and 24 hours for 18 bases (18 helicopters). The organizations of session are built on similar working hours for doctors and crews, ie 12 hours or 14 hours, to facilitate their operation on similar work schedules. These principles consolidate the quality and safety of teamwork, whether medical or flying. Contrary to other European countries, helicopters are located on the landing platform of hospitals rather than domestic aerodromes. This location is useful to avoid ground relays when aircraft are positioned on airfields away from hospitals. This positioning of the helicopters on the hospitals allows triggering without wasting time for the patient, medical teams being close to the crews. HeliSMUR are helicopters equipped with biomedical equipment to take care of patients which are fixed in the passenger compartment for safety, which does not allow to quickly transfer the equipment to another aircraft. In 2016, the annual HeliSMUR activity represented 11,000 HEMS interventions for victims outside hospitals and 17,500 HEMS interventions for urgent transfers of patients between hospitals. The current policy is to reinforce the use of the helicopter vector in these time slots of activity, thanks to an increased recourse of the doctors control centre for this means of intervention to optimize its availability with regard to the saved time for the victim and the operating cost of this vector. HEMS pilots workload in France: Currently, the flight time per crew remains low with an average of 1h30 per day, which requires increased vigilance from operators and pilots to maintain skills. The periods of inactivity for the crews are currently significant in view of averages of 1h30 flight time per 12h duty time. Flight crews fly between 90 and 150h a year, which is very low for professional flight crews, and far from what is developed in the NPA. It is also underlined that single-pilot operations in HEMS are now not “real” single-pilot operations as pilots are assisted by a TCM who can alleviate the pilot’s tasks. HEMS operations are mostly urgent missions unpredictable in time, of short flight time (between 30 minutes to 45 minutes, and less than 50 NM), most for vital traumatic emergencies where the rapid availability of the medical teams and the helicopter remains the priority standard and outside the hospital domain like near a road during an accident. Other missions of longer flight time where hospital medical teams ensure between two hospitals with known FATO the care of a patient whose state urgently requires intensive treatment of resuscitation during his transfer (flight time between 45 minutes to and 75 minutes). Most of them deal with cardiac surgery, neurosurgery and paediatric vital emergencies. Economic impact of the NPA:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 33 of 585

An agency of the European Union

Regarding the economic dimension for France, the new regulation will have a huge economic impact on the public expenditure of the French State and ultimately on the population in the HEMS service. According to the French Health Ministry, the impact would represent an additional expense of 15 million euros, which it will not be possible to engage for the State. In the event that the need for an increase in the number of pilots and TCM to carry out the activity is not possible for reasons of unavailable resources or budgetary cost, the reduction in the amplitude of access to the helicopter HEMS would be considerable with a loss of 1 825 hours or 152 days of availability for emergency medical service operations. This situation is not acceptable for France. Conclusion: In France, the President of the Republic and his Government have made the commitment to guarantee an access to emergency care in less than 30 mn from everywhere on the French territory. This assumes both operational readiness for EMS, especially thanks to ready-to-go helicopters take-offs, and unpredictability of flight times. The proposed measures of this NPA regarding for example the break for FDP over 10 hours (CS.FTL.3 205 (b)(2)), or the minimum duration of the pre-flight (which activates FDP) and post- flight duties (CS.FTL.3 205 (b)(4)) are non-consistent with the unpredictable nature of HEMS operations. Moreover, they will have a huge economic and social impact in France. In addition, reducing duty time will increase the number of pilots needed to guarantee the same HEMS activity, which could become an issue considering both the lack of experienced pilots on the labour market and the reduction of flying time per pilot who already fly very few hours per year as commercial pilots and for whom fatigue is not an issue, which creates a new risk of skill maintenance. Finally, this NPA, which is presented as not being an improvement for safety in the RIA, will have negative impacts on safety, besides negative social and economic impacts. That is the reasons why DGAC France would like the future FTL opinion not to take consideration of HEMS operations as proposed and choses the option 0 described in the RIA (no policy change). However, if this French position is not accepted, we provide hereafter detailed comments about proposed measures on HEMS in the HEMS part of the NPA.

response Please see the answer to comment # 54.

comment 873 comment by: Stephanie Selim

General comment on duty times : This NPA places on the same level flights to perform an air-taxi or EMS operation on one hand, and return flights at home base when no passenger is on-board on the other hand. We assume that these return flights at home base with no passenger on-board are not CAT flights (even if the flight is performed with an EMS aircraft equipped with medical supplies). Alleviations should be provided to allow pilots and their aircraft to come back to home base.

response Please see the answer to comment # 54.

comment 874 comment by: Stephanie Selim

General comment on implementation :

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 34 of 585

An agency of the European Union

As a general comment, we also would like to ask for a 2 years deadline for this new regulation, as it will be a big change for operators, especially for HEMS operators if our proposal to remove HEMS from this text is not accepted. It should be noted that the subject is complex, especially for small operators, which includes for instance the definition of individual schemes and FRM. Regarding requirements submitted to FRM, experience has shown that it’s necessary to develop data and skills, and a 2 year period to implement such an FRM seems to be an appropriate time frame.

response Please see the answer to comment # 54.

comment 875 comment by: Luftfahrt-Bundesamt

Attachments #20 #21

The LBA would like to give the following general comment: The implementation of the provisions envisaged with NPA 2017-17 would have a massive negative impact on the emergency medical service operations subject to public law in Germany as well as for air taxi operations. For HEMS, for example, our national provisions in accordance with §§ 21 to 22 of the 2. DV LuftBO (2nd national implementing order of the German regulation governing the operation of aviation products) would be superseded by the envisaged amendments on the EU level. In this connection we recognize no benefit of the proposed amendments. On the contrary: According to the "ADAC" emergency medical operations in Germany could not be carried out except with shift duties which would result in a remarkable increase in costs and in an increasing pilots' discontent. Establishing shift duties requires approx. 30% more staff. However, on the European market for experienced pilots there is not enough qualified personnel available who would meet the requirements of Regulation (EU) 965/2012. Consequently, maintaining the civil rescue system in Germany, as implemented and established today, would not be possible. Several years would pass for the recruiting and qualification of new staff, which could then only be ensured by a corresponding transitional period and with enormous costs. At this point we would like to refer to the comments of "ADAC and Air Hamburg. The objections made are obvious to us and can only be reiterated. Consequently, we would like to refrain from further comments on the individual points and instead, fully support the statements of ADAC and Air Hamburg. ADAC and Air Hamburg should independently use the CRT. Nevertheless, to enable better identification, please find enclosed the corresponding comments in PDF format.

response Please see the answer to comment # 54.

comment 972 comment by: Vesa REMES

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 35 of 585

An agency of the European Union

EASA has requested a statement from the operators concerning the new NPA. In the background there is probably an effort to harmonize regulations and a concern over the alertness of the flight staff during work. Because of the concern over the personnel alertness and sufficient rest during working hours and also over a longer working period, we would like to present a few counterproductive matters with respect to the new legislation. The nature of HEMS work differs considerably from normal commercial aviation: the working hours are not uninterrupted work for the whole period, but include quiet periods of standby time without duties during which it is possible to rest and recuperate. Between the flight tasks the personnel stays in home-like premises, where it is possible to retire to rest at any hour. Personnel is encouraged to use this option for their benefit. The National Institute for Health and Welfare has completed an alertness survey for SHT's flight staff in 2017. The results show that the flying personnel do not see the present working schedule as a burden and is very well able to keep alert during the working shift. For these reasons it would be rational for the legislation to take into account the exceptional nature of the HEMS work. The working and rest periods are monitored minute by minute during the working shifts and also between the shifts according to the Finnish aviation regulation on working hours OPS M3-2. If the regulated rest periods are not fulfilled, the duty is discontinued. Also, if the personnel are experiencing fatigue they consider influencing their performance, they have a right to discontinue the duty. There are no sanctions to personnel if the duty is discontinued. Present working schedule is well tolerated and well liked among the personnel. It has been adhered to for over 10 years with Finnish Regional State Administrative Agency's (AVI) approval. Against statistical odds, there has been no accidents during that time, which indicates the safety and successfulness of the system. Changing of the working schedule to make shifts shorter would lead to each worker to have double amount of shorter shifts, meaning less rest days. This kind of working schedule was tried out among the HEMS crew members at the beginning months of the base FH30. The collective experience among the HEMS crew members following the reduction of the rest days was the accumulation of fatigue. Change between day and night shift led to disruption of the circadian rhythm. It was considered difficult to get daytime rest between shifts. Present working schedule allows more rest days over a certain period, leading to a better recovery. Changing the present schedule would also lead to part of the personnel having to spend nights between shifts at the workplace due to insufficient traffic communication or long distances. Also the commuting time would double. Both factors would have a detrimental impact on recovery. Refering to above mentioned matters we put forth a proposition for EASA to consider the special characteristics of the HEMS work and the established operating methods that have proved effective over the years and to allow the operations to be continued in accordance with national regulations. Signed

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 36 of 585

An agency of the European Union

Jouni Romppanen Pilot

Markus Lumme Pilot

Anssi Vuolle Pilot

Jonne Lundberg Pilot

Petteri Jokinen Pilot

Olli Piirainen Pilot

Heikki Aarela HEMS crew member

Petteri Rusi HEMS crew member

Juha Leppänen HEMS crew member

Simo Ahti HEMS crew member

Teppo Koskue HEMS crew

Antti Pesonen Pilot

Hannu Elomaa Pilot

Olli Kylänpää Pilot

Jarmo Hillberg Pilot

Ari Suutarinen Pilot

Aaron Marttila HEMS crew member

Juha Taaveli HEMS crew member

Timo Jaarinen HEMS crew member

Mika Arponen HEMS crew member

Juhani Tomminen HEMS crew member

Marc Roiha HEMS crew member

Samuli Nykänen Pilot

Ville Pääkkönen Pilot

Antti Peurala Pilot

Pertti Matilainen Pilot

Jari Fomin Pilot

Ville-Pekka Kilpeläinen Pilot

Juuso Pykälistö Pilot

Janne Virtanen HEMS crew member

Vesa Remes HEMS crew member

Ville Mikkonen HEMS crew member

Satu Yliherne HEMS crew member

Pekka Leppänen HEMS crew member

Matti Mikkonen HEMS crew member

Marko Sorsa HEMS crew member

response Please see the answer to comment # 54

comment 1006 comment by: MBH SAMU

Attachments #27 #28 #29 #30 #31

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 37 of 585

An agency of the European Union

• Mont Blanc Hélicoptères (MBH) : French helicopter operator in the Alps

• SNEH: French Helicopters Operators Professional Union

Introduction: The comments hereafter shall be considered as an identification of some of the major issues MBH asks EASA to discuss with third-parties before any publication of the proposed regulation. In consequence, the following comments shall not be considered:

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean MBH has (or may has) no comments about them, neither MBH accepts or acknowledge them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation.

General comments : MBH thanks EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for HEMS operations throughout Europe in order to warrantee a high level of safety. However, considering the HEMS national specificities (French HEMS missions represent 17% of the European HEMS missions), a proportionate approach tailored to the local specificities needs to be considered. The current RIA of this NPA should be further developed for a better maturity and should take into account the French national specificities. (Cf. comments #985 to 989) Generally speaking, MBH thinks that the proposed requirements for HEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for HEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation. For instance, the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for HEMS, indeed it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 38 of 585

An agency of the European Union

(Cf. comments #926, #933 #958, #975, #977) It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of MBH’s current understanding of this NPA. At the time being, MBH fears that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal.

*** #2 major characteristics 2 major characteristics arise from the French healthcare organization:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 39 of 585

An agency of the European Union

• The unpredictability of the flight times

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 40 of 585

An agency of the European Union

*** # Conclusion The impact of the implementation of European FTL regulation for HEMS in France goes beyond the French operators. It is a complete change of the whole French Health care system which might be necessary. Thus, it would be appreciated if the RIA addresses the impacts on the national policy for emergency access to care and the Government Health policy, etc. Many lifesavings would be impossible with proposed FTL schemes. (Cf. attachments S1, S2, S3 and S4) As a consequence, 3 options emerge and are listed here below, ranked according to their level of relevance for MBH: # OPTION A or option 0 of the RIA This option, whose choice relies on the Member States (MS) or EASA’s decision, corresponds to the option 0 described in the RIA: no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The solution 0 is the proper answer to a one size fits all model which is not applicable to the industry. The FTL shall stay in the hand of the local authority. The well-functioning current

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 41 of 585

An agency of the European Union

national FTL schemes are enforced for years, no excessive fatigue has been demonstrated and the current national system provides French operators with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about under-reporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. MBH strongly asks this option to be considered by EASA and the Member States : “no change in the existing situation; HEMS continue to be regulated under MS national rules”. # OPTION B This option consists in a total revamp of the NPA 2017-17 for HEMS. MBH asks for a completely new proposal, distinguishing the HEMS from AEMS and Air Taxi as no operational comparison can be made between the fundamentals of these different activities and respecting the following principles:

• Basing an alternative proposal on: o 14h standby / 10h Rest with a commander's discretion applicable in case

of unforseen circumstances o short-time operational readiness for ready-to-go EMS take off o rostering of 7 days ON / 7 days OFF o flight time limitations to be discussed within this frame

MBH asks for this option to be considered in the Comment Response Document (CRD) with the elaboration of a sound RIA. Moreover, MBH would be happy to offer its expertise to discuss and study this subject with EASA policy officers. Besides, for clarity reasons, this would imply to separate, regarding the FTL scope, the HEMS from CAT, Air Taxi and AEMS operations. # OPTION C If these 2 first options are not retained, MBH asks for this proposed NPA to be amended and reviewed as stated in the following comments. The proposed requirements, as it is, will lead to amend Health National regulations and it will request more crew, more constraints, more costs with a low added safety value as stated in the RIA. The main proposals are laid down here below:

• The “Flight time” (instead of “sector” whose definition is now restricted to aeroplanes) in all the requirements should not be scheduled as they cannot be in real life

• The duration of pre-flight, post-flight or inter-flights should be suppressed and replaced by “a sufficient time determined by the operator and specified in the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 42 of 585

An agency of the European Union

operating manual” (in France, 7%iof flights saving lives would be impossible with a 30 minutes preflight, cf. SNEH illustrative Table in attachment)

• No limitations on the number of consecutive FDP lasting more than 12h should be made between 2 extended recovery rest periods

• The limitations of the maximum values for continuous FT need to be increased by at least 1 hour

• The limitations of the maximum values for total flight time within a FDP need to be increased by at least 1 hour

• The 10% allowance between scheduled and actual FDP is not appropriate with the HEMS operations and needs to be suppressed

• The standby needs to be reviewed else it will never be used

These elements of the aforementioned proposal form an integrated whole, they are each and all interrelated and interdependent.

***

response Please see the answer to comment # 54

comment 1019 comment by: European Cockpit Association

ECA welcomes the idea of a common approach to the FTL for operations of emergency medical services by aeroplanes and helicopters. At the same time, we note with disappointment that the content of the NPA 2017-17 deviates significantly from the recommendation of the rulemaking group (RMT.0346) involved in the drafting phase.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 43 of 585

An agency of the European Union

In ECA’s view, the proposal as it stands - will not help to prevent fatigue in HEMS operations. Often the HEMS bases are located in (sometimes very) remote areas, where living is not attractive, jobs for partners are poorly available and/or where limited education opportunities (e.g. for children) are available.. Pilots are often not willing to live in these areas with their families and are usually commuting – sometimes long distances – from their living space to their working places. The laws of many countries do not allow to force the employees to move their home close to the working place. The new rule would – like it is proposed – lead to shift duty at the majority of the HEMS bases, with the effect of a lot of additional duty days for the flight crews, to fulfill the obligations of their working contract. This leads forcibly to less days for recreation. This effect is exaggerated by additional time spent on commuting during the off days, which should be used for recreation and recovery from fatigue. While the flight crew is spending less time at home, their family is usually demanding them more during their days at home with family business, again preventing them from adequate rest. Taking into account, that HEMS operations – although commercial operations – is usually/often financed by charity organizations, social insurance, registered societies or else, with the consequence of (sometimes very) limited financial assets, this regulation can have a dramatic impact on these operations. Servicing times of HEMS operations will be cut down, where limited funds or a low mission rate will not allow/justify additional staffing. This altogether would lead to a major social and economic impact – in contradiction to EASA perception in the NPA - for the vast majority of HEMS operations in Europe. To avoid these fundamental disadvantages there are two possibilities to raise the level of safety, by limiting the disadvantages to an acceptable level. One is to follow the recommendations of the rulemaking group. This would have the effect, that the duty and stand by times would be significantly cut down to a safer level in most of the operations, with only a limited and tolerable negative economic and social impact. E.g. HEMS business in many operations is highly seasonal due to the usual operation of a HEMS helicopter during daylight. In summertime working times of 250 hours in a month are not unusual – and even up to 300 hours is not rare. With the recommendation of the RMG the amount of duty hours within 28 days would be reduced to 190 hours in 28 days. Presently it is in some countries possible to have up to 7 conductive duty days with rest times below 10 hours; the proposal of the RMG would reduce the nights with a rest of below 10 hours to one night in between to extended recovery rest periods. This are only two examples of the huge improvements of the regulation recommended by the RMG. This recommendation is underlined by a study of the DLR, therefore exactly geared to the needs of this business – in contrast to the studies mentioned in the NPA. The second solution is a different approach, which assures safe fatigue rules, a certain amount of harmonization, although being able and flexible enough to adopt to local and approved systems, with much less economic and social impact: Some of the general HEMS limitations should be shifted to the implementing rules; like cumulative duty times within 28 days, minimum of time available for sleeping within 24 hours and between two duties, maximum time awake, maximum duty days and minimum off days in a defined period and maximum active time within being on alert times. This should give a solid, safe and fatigue limiting basis for all HEMS operation. In this case the other routine related limitations should be shifted to AMC or the guidance material to give

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 44 of 585

An agency of the European Union

the local authorities the possibility to adopt their own FTL-scheme adjusted to flight safety, their experience and the needs of their health system. EASA has acknowledged (also in the NPA) that there are no indications that the existing FTL requirements for HEMS, which are under national authority approvals, pose a flight safety problem. It does not mean that there are operations that could not be run in a better/safer way/course. But to our knowledge there is only one accident all over Europe during the whole history of HEMS operation which has a proven direct relationship to fatigue; the BK117 at Weilheim/Teck on September, 28th of 2005 (BFU 3X171-05). The BFU found, that as one of the major systematic reasons for this accident, the overall load of the pilot, especially the amount of additional activities he was assigned to (including his private situation), had led to this tragic event. BFU states in the report, that he made no use of taking relief for his additional duties. This assists the opinion of our HEMS experts, that the major problems in the present operation schemes are not the long duties itself, rather than cumulative fatigue and break times which are not used for relaxing, but for other tasks and functions during long duties.

response Please see the answer to comment # 54

comment 1178 comment by: SAF

Attachments #32 #33 #34 #35 #36

• SAF Group : French helicopter operator • SNEH: French Helicopters Operators Professional Union

Introduction: The comments hereafter shall be considered as an identification of some of the major issues SAF asks EASA to discuss with third-parties before any publication of the proposed regulation. In consequence, the following comments shall not be considered:

• As a recognition of the third-parties consultation process carried out by the European Parliament and of the Council;

• As an acceptance or an acknowledgement of the proposed regulation, as a whole or of any part of it;

• As exhaustive: the fact that some articles (or any part of them) are not commented does not mean SAF has (or may has) no comments about them, neither SAF accepts or acknowledge them. All the following comments are thus limited to our understanding of the effectively published proposed regulation, notwithstanding their consistency with any other pieces of regulation.

General comments:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 45 of 585

An agency of the European Union

SAF thanks EASA for the will of harmonizing the applicable dispositions in terms of flight time limitations for HEMS operations throughout Europe in order to warrantee a high level of safety. However, considering the HEMS national specificities (French HEMS missions represent 17% of the European HEMS missions), a proportionate approach tailored to the local specificities needs to be considered. The current RIA of this NPA should be further developed for a better maturity and should take into account the French national specificities. (Cf. comments #1246 to 1250) Generally speaking, SAF thinks that the proposed requirements for HEMS would benefit and enhance safety in being clearer and more user friendly. The proposed requirements for HEMS show numerous inconsistencies (there are some numbering issues, nonsenses and contradictions leading to misunderstandings of this NPA). Therefore, it is really hard for the Profession to elaborate final and comprehensive comments due to the difficulty in comprehension of this proposed regulation. For instance, the structure and the references within this NPA lead to confusion regarding the applicability of the Certification Specifications for HEMS, indeed it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

(Cf. comments #1199, #1208, #1226, #1239, #1240) It is feared that the complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation which is contrary to the safety goal. In order to comment properly the proposed requirements, the stakeholders need to understand the whole proposition. Numerous points merit clarification. The comments made thereafter need to be analyzed in light of SAF’s current understanding of this NPA. At the time being, SAF fears that each and every stakeholder will interpret this NPA according to its understanding which might act as a hindrance to the level playing field contrary to the initial goal.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 46 of 585

An agency of the European Union

services is a public servicedefined in the French Health Code & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State(Civil Security, Gendarmerie or Army) for the sake of the DGOS. Regarding the private operators, there are 49 HEMS bases (corresponding to a total of 47 HEMS helicopters) in metropolitan France and overseas (including in Cayenne and in the Reunion Island) whose air transport business is conducted by 5 operators. These operators’ helicopters are based at the hospital for which they work and are permanently equipped with medical equipment. The contracts are awarded by each hospital or are pooled at pilot hospital which is responsible for the public contract and which, in some cases, spreads the flight hours between each hospital keeping a helicopter based for its sanitary transport needs. Additionally, the State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure", in respect of the sovereignty of each Member State facing major health crisis. Although delegated to private operators, the HEMS in France remains a public service mission whose latitude for the application of the newly proposed Article 8 of this NPA applies for the Member States at any time.

*** #2 major characteristics 2 major characteristics arise from the French healthcare organization:

• The unpredictability of the flight times

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 47 of 585

An agency of the European Union

be considered if elaborating a new regulation from scratch would not be more appropriate.

*** # French rostering organization In France, the most usual rostering is usually 7 days ON at home base / 7 days OFF (implying a rest period + FDP < 24h, 7 times in a row), with a need for a H12 operational readiness (or a 12h shift in H24). This proposed European regulation, does not allow the French operators to comply with the French work pace defined and contracted by the French healthcare system. Moreover, in order to ensure a better quality of teamwork and to enhance safety, the French rostering organization is the same for pilots and doctors, they work in the same time slots (H12 or H14). Hence, all these new requirements will lead to amend all the French Health National practices (to that extend, the analysis of EASA would gain from considering further all economic and social issues it will raise). Indeed, considering the French work pace: On the one hand, in the proposed European regulation, there is a minimum duration for pre-flight of 30 minutes. This new requirement of a 30 minutes pre-flight will imply either a 30 minutes increase of the FDP or a 30 min decrease of the operational readiness. In France, 7%i of flights saving lives would be impossible with a 30 minutes preflight. (cf. SNEH illustrative Table in attachment) On the other hand, in the proposed European regulation, there is a minimum duration for post-flight at the end of (the last flight time of) the FDP of 15 minutes (SAF would like to highlight the fact that the definition of this postflight seems unclear and may lead to confusion). This new requirement of a 15 minutes post-flight at the end of (the last flight time of) the FDP will imply both a 15 minutes increase of the DP and a 15 minutes decrease of the time slot available for the required rest. Besides, if the FDP is lasting more than 10h, a 1 hour break is requested in the proposed dispositions of the NPA for single pilot + 1 TCM operations. In France all scheduled effective operational FDPs are 12h as explained before, so the 1h break requirement will always need to be fulfilled. Just as for flight times, due to the unpredictability of the HEMS missions, the break has to be unscheduled and the operator should ensure ex-post that the break requirement has been fulfilled for pilots. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Else, this will would overlap with national social regulations and the definition of working time. Therefore, considering the French work pace, in order to have a 12h operational readiness with the proposed FTL European requirements, there is always a need for at least a 12h30 max FDP (which implies a 12h45 DP) with a 1h unscheduled time period allowed for physiological needs (which cannot be a rest period free of all duties). As a consequence, the time slot available for rest is 11h15 (24h – 12h45 = 11h15) while the rest required by this NPA would be 12h45. Therefore, all French HEMS operators will need to use systematically reduced rest and thus, all French HEMS operators will need to have a FRM (which seems disproportionate to the size of the involved operators).

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 48 of 585

An agency of the European Union

Moreover, as soon as there is one scheduled FDP lasting more than 12h (always the case in France since there is always a need for at least a 12h30 FDP), no more than 4 consecutive FDPs can be scheduled. Thus, the usual French rostering 7 days ON at home base / 7 days OFF cannot be respected, despite its efficiency in terms of safety, fatigue and quality of life for crews, has been proven from experience. As said in the RIA, no risk has been shown regarding safety or fatigue with the current regulation. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest, and the working pace of 7 days ON / 7 days OFF does not appear more tiring. On the contrary, the working pace of 7 days ON / 7 days OFF is better for the labor organization and is bringing a better quality of life for pilots who do not live near the HEMS operating base. Indeed pilots prefer to work 7 days in a row and then be 7 days OFF instead of working 1 day and resting the next day (which appears more tedious and exhaustive). # Conclusion The impact of the implementation of European FTL regulation for HEMS in France goes beyond the French operators. It is a complete change of the whole French Health care system which might be necessary. Thus, it would be appreciated if the RIA addresses the impacts on the national policy for emergency access to care and the Government Health policy, etc. Many lifesavings would be impossible with proposed FTL schemes. (Cf. attachments S1, S2, S3 and S4) As a consequence, 3 options emerge and are listed here below, ranked according to their level of relevance for SAF: # OPTION A or option 0 of the RIA This option, whose choice relies on the Member States (MS) or EASA’s decision, corresponds to the option 0 described in the RIA: no policy change. Safety impact, social impact and economic impact are neutral or having a little impact. The solution 0 is the proper answer to a one size fits all model which is not applicable to the industry. The FTL shall stay in the hand of the local authority. The well-functioning current national FTL schemes are enforced for years, no excessive fatigue has been demonstrated and the current national system provides French operators with satisfaction. Besides, in the EMS safety risk assessment of this NPA, it is written that “Even with the caveats about under-reporting of fatigue as a causal factor it would appear from the occurrence data that the controls that have been in place to manage fatigue in European EMS have generally been effective. Compared to the social benefits from EMS operations in terms of patient safety and health (see below), the overall safety balance (flight safety v patient safety) is very positive”. SAF strongly asks this option to be considered by EASA and the Member States: “no change in the existing situation; HEMS continue to be regulated under MS national rules”. # OPTION B This option consists in a total revamp of the NPA 2017-17 for HEMS. SAF asks for a completely new proposal, distinguishing the HEMS from AEMS and Air Taxi as no

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 49 of 585

An agency of the European Union

operational comparison can be made between the fundamentals of these different activities and respecting the following principles:

• Basing an alternative proposal on: o 14h standby / 10h Rest with a commander's discretion applicable in case

of unforseen circumstances o short-time operational readiness for ready-to-go EMS take off o rostering of 7 days ON / 7 days OFF o flight time limitations to be discussed within this frame

SAF asks for this option to be considered in the Comment Response Document (CRD) with the elaboration of a sound RIA. Moreover, SAF would be happy to offer its expertise to discuss and study this subject with EASA policy officers. Besides, for clarity reasons, this would imply to separate, regarding the FTL scope, the HEMS from CAT, Air Taxi and AEMS operations. # OPTION C If these 2 first options are not retained, SAF asks for this proposed NPA to be amended and reviewed as stated in the following comments. The proposed requirements, as it is, will lead to amend Health National regulations and it will request more crew, more constraints, more costs with a low added safety value as stated in the RIA. The main proposals are laid down here below:

• The “Flight time” (instead of “sector” whose definition is now restricted to aeroplanes) in all the requirements should not be scheduled as they cannot be in real life

• The duration of pre-flight, post-flight or inter-flights should be suppressed and replaced by “a sufficient time determined by the operator and specified in the operating manual” (in France, 7%iof flights saving lives would be impossible with a 30 minutes preflight, cf. SNEH illustrative Table in attachment)

• No limitations on the number of consecutive FDP lasting more than 12h should be made between 2 extended recovery rest periods

• The limitations of the maximum values for continuous FT need to be increased by at least 1 hour

• The limitations of the maximum values for total flight time within a FDP need to be increased by at least 1 hour

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 50 of 585

An agency of the European Union

• The 10% allowance between scheduled and actual FDP is not appropriate with the HEMS operations and needs to be suppressed

• The standby needs to be reviewed else it will never be used

These elements of the aforementioned proposal form an integrated whole, they are each and all interrelated and interdependent.

response Please see the answer to comment # 54

comment 1207 comment by: Skärgårdshavets Helikoptertjänst Ab

Skärgårdshavets Helikoptertjänst Ab (SHT) supports option 0, in which operations are to be continued in accordance with national regulations. NPA 2017-17 does not take sufficient account of national special characteristics nor of the established operating methods that have proven effective over the years. The Regional State Administrative Agency (AVI) is the national authority that monitors compliance with the Working Hours Act (605/1996). AVI can grant exemptions from the provisions of the Working Hours Act when the deviation is well founded. In Finland, HEMS operations are based on the principle of immediate readiness, for which reason AVI has exempted the operations from the provisions of the Working Hours Act.

response Please see the answer to comment # 54

comment 1253 comment by: Finnish Helicopter Pilots Association FHPA

Attachments #37 #38 #39 #40 #41

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 51 of 585

An agency of the European Union

Finnish Helicopter Pilots Association FHPA’s comments to NPA 2017-17

Finnish Helicopter Pilots Association FHPA represents all Helicopter Emergency Medical Services pilots flying in Finland. Our members consist only of HEMS Rotary Wing pilots and currently approximately 70 percent of HEMS pilots are members of the Finnish Helicopter Pilots Association. FHPA is part of Finnish Pilots Association FPA. Finnish HEMS operations are fully government funded by Ministry of Social Affairs and Health. FinnHEMS is a non-profit administrative organisation, which is owned by hospital districts. The current FinnHEMS contract is for two flight operators operating six HEMS bases in the country and is a ten year contract. Operators are Skägårdshavets Helikoptertjänst (3 bases + 1 air ambulance base outside of FinnHEMS contract) and Babcock Scandinavian AirAmbulance (3 bases). HEMS operations are conducted 24/7 under Visual Flight Rules with Night Vision Imaging System NVIS aided night operations and Instrument Flight Rules. Five operating bases have on duty crews of 1 pilot plus HEMS Technical Crew and one base has on duty crew of two pilots. National aviation regulation OPS M3-2 issued by Finnish Civil Aviation Authority, which regulates and rules HEMS duty and flight time limitations in Finland. OPS M3-2 was issued back in 2003 and minor adjustments were made in 2008. This means that Finnish HEMS operations have been following the same crew flight and duty time limitations for 15 years. There are zero examples where the limitations of OPS M3-2 have resulted in reduced aviation safety. To this day the total number of fatal or airframe loss accidents in Finnish HEMS operations is zero. Mainly our HEMS duty shift consists of two consecutive flight duty periods. FDP is 24 hours and shall include a total rest time regulated by OPS M3-2. For example in single pilot HEMS operations the first FDP shall include at least 9 hours of time which shall not include any duties, i.e rest time. There should be at least a 2 hour period between duties that shall contain no duties for it to count as rest. Rest time counts as FDP time. Also the first FDP in single pilot HEMS operations is allowed to contain a maximum of 11 hours of flight time. The second and third FDPs are more strict and limit flight and duty time even more. The minimum rest time for 3 consecutive FDPs (72h) in SP HEMS operations is 33 hours, 27 hours for multi pilot HEMS operations. See 7.2 “Flight and duty time limitations” in OPS M3-2. The three northern HEMS bases use 3 consecutive FDPs that shape a HEMS working shift during weekends. OPS M3-2 limits the maximum duty time per 30 day period to 192 hours, which can be raised to 216 hours for a mandatory reason. But for example the BSAA HEMS pilots’ collective agreement limits duty time per a calendar month to 168 hours maximum, 160 hours if any training takes place during said month outside duty shifts. Hours are then counted as overtime all the way to the regulation maximum or less hours are planned for the next month to compensate. Pilot’s permission is needed for overtime work. BSAA publishes 4 month rosters at a time, collective agreement requires so.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 52 of 585

An agency of the European Union

HEMS pilots’ flight hours remain remarkably low annually (60 to 200 flight hours a year, even when working full roster) compared to the current maximum allowed by authorities (900 flight hours). It is rarely that the pilots have their active duty time arrive to maximum within FDPs and are not permitted to continue duty. Still, backup crews are rostered. The majority of pilots do not live in the vicinity of HEMS bases, on the contrary. Travelling between home and workplace may be significant and takes a considerable amount of time. Many of the pilots have commute time between home and work in excess of three hours and travel by plane. For example majority of BSAA pilots commute by regional commercial flights from southern Finland to northern HEMS bases. Travelling by public transport is more challenging during weekends and certain holidays, etc. fewer regional commercial transport flights or none at all. Time spent during work travelling does not count as rest time for the required rest periods. The now proposed FTL model does not suit these commuters at all. Also, the proposed FTL model makes it practically impossible for the Northern bases to continue operating. The unanimous opinion of every FHPA member is to not have our current flight and duty time limitations and roster model changed from OPS M3-2 radically. We stand with the HEMS operators and Finnish CAA on this issue and agree on our common goal to maintain this overall very proven and working duty scheme. It is extremely important to note that hospital districts require all HEMS pilots to be proficient in Finnish language, this limits the pilot pool available to HEMS operations in Finland. The already marginal pilot offering would not be sufficient enough to meet the increased demand of HEMS pilots this proposed FTL model brings. Attached are current FCAA’s OPS M3-2 and two Aero Medical Examiners’ educated opinions (they view the current rostel model as positive and working) regarding the current roster model plus few statements from EU directive.

Respectfully, Helsinki 27.02.2018 Toni-Petteri Nikulin

Chairman of the Board, Finnish Helicopter Pilots Association FHPA Marko Malinen Vice Chairman

response Please see the answer to comment # 54

comment 1255 comment by: Skärgårdshavets Helikoptertjänst Ab

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 53 of 585

An agency of the European Union

The Finnish aviation regulation on working hours OPS M3-2 enables 4x24h standby shifts, but AVI’s exemption limits the working time of pilots to 2x24h in HEMS operations. In addition to the maximum flight time, OPS M3-2 specifies the minimum rest time for each 24h shift. AVI’s exemption requires that both flight time and rest time be monitored actively.

response Please see the answer to comment # 54

comment 1256 comment by: Skärgårdshavets Helikoptertjänst Ab

The working and rest time monitoring system automatically reports any deviations from the maximum and minimum working and rest time requirements to a reporting system, where they are analysed monthly. Based on these analyses, most of the deviations relate to the nature of the job, i.e. the unit is still carrying out a task when the shift ends, or completing a task takes significantly longer than normal. Due to active monitoring, deviations due to some other reason are rare.

response Please see the answer to comment # 54

comment 1257 comment by: Skärgårdshavets Helikoptertjänst Ab

Attachment #42

The National Institute for Health and Welfare completed an alertness survey on SHT’s flight staff in 2017. Based on the survey, the pilots or Hems Crew Members (HCMs) do not especially suffer from tiredness. Short conclusion of the research; “Results show that pilots and HEMS Crew Members experience only infrequently low alertness on duty, regardless of whether their duty is 24 hours or 48 hours. When they do experience low alertness, it is most often related to waking up from sleep at night, in the morning or after a nap. Other experiences of low alertness are rare: within all 48h duties (n=104), only 3 individuals (n=23) in 4 duties experienced low alertness that was not related to waking up from sleep. There was no statistically significant difference in the amount of sleep on duty between those who didn’t experience low alertness and those who did.”

response Please see the answer to comment # 54

comment 1258 comment by: Skärgårdshavets Helikoptertjänst Ab

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 54 of 585

An agency of the European Union

A new HEMS base started operations in 2012. Twelve-hour standby shifts were tested at the new base, but according to HCMs, 12h standby shifts are more demanding than standby shifts of 24h or longer. As a result, by agreement with the employer 12h standby shifts were discontinued.

response Please see the answer to comment # 54

comment 1259 comment by: Skärgårdshavets Helikoptertjänst Ab

Finland is a sparsely populated country where distances are long. For this reason, the staff does not live next to the base. Shifting to 12h standby shifts would have a negative or very negative impact on over half of SHT’s flight staff. This would require that SHT have to rent a flat close to each base to make it more practical for staff members who live far from the base to complete several 12h standby shifts. Therefore, the 12h model would increase the costs and reduce the wellbeing of the staff.

response Please see the answer to comment # 54

comment 1261 comment by: Skärgårdshavets Helikoptertjänst Ab

Even though the number of HEMS tasks is high, the number of flight hours for each pilot is small. Depending on the base, the average flight time is 8-14 minutes per task, and the total number of flight tasks in the three bases is around 7000 a year. Flight times will become even shorter in the future when two new bases will be established in Finland. This means that the pilots must acquire flight hours, including NVIS and IFR, outside the standby shifts in order to fulfil the recency requirements, which will increase costs and make planning of shifts more difficult. Recent experience is not subject of this NPA but it may have impact to it. Skärgårdshavets Helikoptertjänst Ab, Pilots and HEMS Crew Members.

response Please see the answer to comment # 54

comment 1362 comment by: B. Wagner

Alle folgenden von mir eingestellten Kommentare beziehen sich nur auf die Regelungen der NPA in Bezug auf HEMS. AEMS, SPO und ATXO werden mangels Kenntnis der Strukturen und Arbeitsweise nicht von mir kommentiert. Die Kommentare stellen lediglich meine persönliche Meinung dar. Die Neuregelung hat gemäß Executive Summary folgende zwei wesentliche Ziele im Bereich HEMS: Harmonisierung und Verbesserung der Flugsicherheit. Das soll gemäß der übergeordneten Grundverordnung ohne oder mit geringen wirtschaftlichen und sozialen Einschränkungen erfolgen. Im Folgenden werden die beiden Ziele im Einzelnen beleuchtet.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 55 of 585

An agency of the European Union

Aus der Sicht eines HEMS Piloten erscheint die Idee, eine Harmonisierung der Flugzeitenregelung auf europäischer Ebene anzustreben zunächst logisch, um eine Chancengleichheit zwischen den Betreibern bei Ausschreibungen europaweit zu ermöglichen. Jedoch ergibt ein genauerer Blick auf die nationalen Besonderheiten der einzelnen Rettungsdienststrukturen ein differenziertes Bild, das den Ansatz der Harmonisierung in diesem Bereich in Frage stellt. Die Luftrettung in jedem einzelnen Land basiert auf den vorhandenen nationalen Rettungsdienststrukturen. Diese sind aufgrund der unterschiedlichen Voraussetzungen wie Geographie, Infrastruktur, Ausbildungslevel der Rettungsdienstmitarbeiter, Verfügbarkeit von Fachkräften, nationalen und teilweise regionalen Gesetzen und vielen weiteren Faktoren europaweit sehr inhomogen aufgestellt. In vielen Ländern haben sich über die Jahre Luftrettungssysteme entwickelt, die genau zu ihrem Bodenrettungssytem passen und die dort vorhandenen Lücken schliessen. Entsprechend wurde auch die nationale Gesetzgebung in Bezug auf Flugdienst- und Ruhezeiten über die Jahre dem jeweiligen Bedarf angepasst entwickelt und in vielen Jahren mit Millionen von Flugstunden in der Praxis erprobt. Dabei sollte immer (und für Deutschland ist es tatsächlich so) die Einsatzbereitschaft zum Wohle des Patienten im Vordergrund stehen, jedoch ohne dabei ein inakzeptables Risiko einzugehen. Die hervorragende Unfallstatistik der letzten Jahre im Bereich der Luftrettung in Bezug auf Fatigue zeugt von diesem funktionierenden Grundsatz und der Effektivität der bestehenden Gesetzgebung. Zum Herstellen einer Chancengleichheit müsste also zunächst die Harmonisierung der Struktur des Rettungswesens allgemein auf europäischer Ebene erfolgen. Solange dies nicht der Fall ist, werden Ausschreibungen für Stationen in unterschiedlichen Regionen immer sehr stark voneinander abweichende Anforderungen auf die Verfügbarkeit und auch sehr stark unterschiedliche Auslastungen der Crews zur Folge haben. Diesen Unterschieden müsste das neue Regelwerk Rechnung tragen. Das wird nur möglich durch ein großes und unübersichtliches Regelwerk mit vielen Ausnahmen und Sonderregelungen. Je komplexer die Neuregelung jedoch wird, umso höher ist zum einen die Belastung für die Besatzungen bei der Umsetzung (erhöhte Arbeitsbelastung --> verminderte Situational Awareness --> erhöhtes Risiko von Fehlern) und zum anderen das Risiko der falschen oder unterschiedlichen Auslegung von Abschnitten der Texte. Dabei besteht im Prinzip ja schon jetzt Chancengleichheit für die Betreiber, da die Anforderungen an die Verfügbarkeit für alle gleich in der Auschreibung definiert sind. Ein einfacher Satz im Abschnitt HEMS FTL, der die Nutzung der jeweils geltenden nationalen Regelungen für den Ort der ausgeschriebenen Station verbindlich vorschreibt, egal von welcher Behörde das AOC ausgestellt wurde, könnte also schon zu der angestrebten Chancengleichheit und Rechtssicherheit führen. Somit bleibt als weitere Begründung zur Neuregelung der FTL im Bereich HEMS eine erwartete Steigerung der Flugsicherheit. Dies soll durch wissenschaftlich belegte Ruhezeitmodelle sichergestellt werden, die geeignet sind, Fatigue zu vermeiden und die Arbeitsbelastung der Besatzungen so zu limitieren, dass zu jedem Zeitpunkt innerhalb einer Dienstperiode eine ausreichende Fitness möglich ist. Dass heißt also zunächst, geeignete Modelle zu entwickeln. Dafür sind jedoch die in der NPA referenzierten Studien in keinster Weise geeignet. Keine der Studien betrachtet das sehr spezielle Umfeld HEMS, erst recht nicht europaweit übergreifend. Die

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 56 of 585

An agency of the European Union

Ruhezeitmodelle, die zur Entwicklung der NPA als Grundlage genommen wurden, berücksichtigen alle nicht den speziellen Arbeitsrhythmus in der Luftrettung. Die Auslastung hängt von dem Einsatzaufkommen ab, dass nicht vorhergeplant werden kann und auch immer starken Schwankungen unterliegt. Dementsprechend sind die vorgeschlagenen zeitlichen Beschränkungen weder praxistauglich noch wissenschaftlich belegt. Stattdessen tragen sie an vielen Stellen nicht den Erfordernissen der Luftrettung Rechnung und führen zu einem Mehrbedarf an Piloten und eine Verteilung der Einsätze und damit Flugzeit auf eine größere Anzahl von Piloten. Im Endergebnis sind also mehr Piloten mit weniger Erfahrung im Einsatz, was meiner Meinung nach genau das Gegenteil der Zielsetzung bewirkt, nämlich eine Reduzierung der Flugsicherheit. Abschliessend kann man also sagen, dass mit dem vorliegenden Entwurf keines der angestrebten Ziele erreicht werden kann. Dafür sind aber Nebenwirkungen im wirtschaftlichen und sozialen Bereich zu erwarten, denen bei der Beurteilung durch die EASA viel zu wenig Beachtung beigemessen wurde. Zum einen führt der zusätzliche Bedarf an qualifiziertem Personal zu hohen Kosten für die Betreiber, die diese auf die Gesundheitssysteme umlegen müssen. Sollte dies nicht möglich sein, ist die Existenz dieser Betreiber gefährdet. Zum anderen führt die Einschränkung von Bereitschaftszeiten zu einer geringeren Abdeckung des Rettungsbedarfs und somit direkt zu gesundheitlichen Folgen für die betroffenen Patienten. Eine weitere Einschränkung im sozialen Bereich betrifft die Attraktivität des Arbeitsplatzes in der Luftrettung. Durch die vorgeschlagene Neuregelung werden Dienstmodelle in Frage gestellt, die sich seit Jahren etabliert und mit zur Attraktivität des Berufes beigetragen haben. Fallen diese weg, könnte das zu einer Abwanderung des eh nur spärlich vorhandenen qualifizierten Personals in ander Bereiche der Industrie führen und somit ebenfalls dazu beitragen, die Flugsicherheit zu reduzieren, da damit auch Erfahrung abwandert. Diese Risiken sollten realistischer beurteilt werden und bei der Neufassung der vorliegenden NPA ausreichend Beachtung finden. Lösungsvorschlag: Implementierung der Teile ATXO und AEMS und Beibehaltung der nationalen Regelungen im HEMS Bereich bei gleichzeitiger Sicherstellung der Chancengleichheit durch verbindliche Vorgabe, welche nationalen Regelungen wo Anwendung finden.

response Please see the answer to comment # 54

comment 1376 comment by: Swiss Air-Ambulance Rega

Attachment #44

With the NPA 2017-17, EASA is aiming to achieve a harmonised, Europe-wide regulation on flight times for emergency medical services by air (HEMS and AEMS) and commercial air transport (CAT).

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 57 of 585

An agency of the European Union

The comments and suggested additions to this NPA generally refer only to emergency medical services by air (EMS operations; HEMS and AEMS), unless specified otherwise. In Europe, there are currently a myriad different regulations on flight times and rest periods. In the scope of EASA’s vision and mission to bring about a complete harmonisation of aviation standards, in a nearly five-year process the draft of harmonised flight time limitations (FTL) was prepared in this NPA 2017-17 by external experts as well as EASA employees. A Europe-wide FTL regulation is meant both to increase flight safety and achieve a “level playing field” for the implementing companies, as sought by EASA. In addition, this would facilitate the regulatory oversight by EASA and the responsible national aviation authorities. The extent to which EASA has any authority at all to regulate aviation competition in the scope of its “level playing field” objective must be critically scrutinised, because this mission cannot be identified from the existing Basic Regulation (Regulation (EC) No 216/2008); however, this is not the subject of these comments. As clearly demonstrated by the documents and statements of the expert group (RMT), it was very difficult and sometimes even cumbersome for the expert group itself to reach a consensus on the very different national EMS operations for the draft regulation. In this draft, the harmonisation, which is reasonable in many cases, made it necessary to sacrifice likewise reasonable as well as tried-and-tested regulations on national and various flight time and rest time rules. However, these non-harmonised regulations have taken the national needs of EMS operations into account much more comprehensively than the present draft ever could. In addition, there have been no known severe incidents, accidents or even fatalities in several million air rescue missions in Europe in recent decades, which are based on shortcomings in the national flight time and rest time regulations or shortcomings as a result of fatigue and/or lack of sleep. In many countries, the FTL regulations already have a scientific basis, for example, the Second Implementing Regulation of the Aircraft Operations Order (DVLuftBO) in Germany or the Rega Flight Time and Rest Time Regulations approved by the Swiss Federal Office of Civil Aviation (FOCA). Conversely, the scientific and operational foundations of the planned EASA FTL regulation in accordance with NPA 2017-17 are not comprehensible. No known studies on fatigue or lack of sleep specifically relating to air rescue were included in the NPA. The comparative study by DLR (German Aerospace Center) in 2017 showed that subjectively the strain has increased as a result of travel time, the switch between service duty and private, as well as the irregular/unpredictable shift changes caused by deployment, and in consequence, flight safety is more at risk than improved. Even EASA concludes in its Regulatory Impact Analysis (RIA) that the introduction of the harmonised FTL rule will not lead to an improvement in air safety, but it is associated with high costs for companies and the entire economy. In the event of the present draft not being applied, the impact for HEMS is assessed as neutral according to No 4.4 (Impact Assessment), whereas application, which is associated with substantial costs and outlay, would only have a slightly positive effect. In the event of a complete implementation, the expected consequences in EASA’s view would even be “highly negative” in terms of the social and economic consequences, with a minimal positive impact on safety at most. The situation is different for AEMS operations, because these are coordinated with the air taxi operations regulations. In our view, there are substantial disadvantages in the areas of

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 58 of 585

An agency of the European Union

“standby other than airport standby” and “extension of max basic FDP due to on-board rest”, which distinctly affect the raison d'être of repatriation operations. In consideration of the information and the results and forecasts of EASA in the NPA 2017- 17 as well as our own experience from over 65 years of air rescue operations by helicopter and fixed-wing aircraft, we firmly believe that such a compulsory harmonisation of air rescue operators in Europe should be avoided. Both the cost-consequence estimate for the planned implementation of EASA’s FTL regulation and for the case of non-implementation do not allow for any other sustainable and reasonable outcome. We therefore make the following P r o p o s a l :

1. To follow option 0 as stated on page 67 (para 4.5) and to reject the submitted draft NPA 2017-17 for HEMS operators.

2. To continue to uphold the existing national flight time and rest time regulations and to continue to adapt them to the national requirements of the respective air rescue and medical systems in the States through the national authorities in coordination with EASA.

Alternatively, if the above proposals cannot be taken into consideration, contrary to expectations, we urge the consideration of the following comments and additions to the presented draft NPA 2017-17.

response Please see the answer to comment # 54.

comment 1417 comment by: Svensk Luftambulans

As one of two HEMS operators in Sweden we operate three HEMS bases in Sweden and this NPA will have a major impact in our operation and economics, but most important on flight safety. As several of the HEMS bases in Sweden are in sparsely populated areas with few missions (average 800 / year). Sweden like the rest of Nordic countries have established 24 hours stand-by schemes and in our case normally 5/15 roster that minimise commuting but still have a good safety record. In Sweden today, the HEMS don’t have National coverage but the intention is to build up a National coverage. This will increase the total number of operational HEMS units. This NPA will demand an additional increase of crew members to employ. Our estimate is a 30% increase of pilots and HEMS crew members. Safety: EASA has acknowledged, and you can also see this in the NPA, that there are no indications that the existing FTL requirements for Helicopter Emergency Medical Services (HEMS), under National authority approvals, poses a flight safety problem. So, the only goal is merely to harmonize and standardize. This, however, will create risks in other areas. A substantial increase in the number of crew members for Swedish operators, will most probably not lead a substantial increase in the number of HEMS missions.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 59 of 585

An agency of the European Union

A reduced number of missions and flight time per crew member will lead to lost skill and currency that cannot completely be compensated for by more training. A large increase in the demand for crew members, especially pilots, may lead to a shortage of suitable pilots. It will also be difficult to find these pilots at the same time as we increase the number of HEMS units to have the National coverage. As we operate MP and SP day and night with NVIS and also IFR we have high requirements when recruiting. For the operators to reduce the experience requirements (down to the authority requirements) and/or accept less suitable crew members can have a negative impact on the established safety level. Public safety may decrease as the availability of helicopters due to increased costs can’t be financed and the planed National coverage can’t be fulfilled. There is also a risk that crew members will suffer more from fatigue when commuting more frequently to remote bases in rural areas. Economy: Decreased productivity and increased cost for crews due to increased cost for salaries, pensions, training (initial and recurrent). Extra helicopters or Simulators may be necessary to provide extra training for non‐current pilots. This will also lead to extra cost for maintenance, maintenance personnel, insurance, etc. The health authorities will bear the cost in many instances. The cost of commuting and/or extra housing/living quarters will increase for the crew members (or the operators). Social impact: As the health authorities will bear the added cost there may be a decreased availability of helicopter when they cut down on existing bases and the plan to have a national coverage will be endangered. This can lead to a reduced quality of life for some patients that will not reach an adequate level of care in time. There may be a destructive effect on crew members social life through increased frequency of commuting and more periods away from home. Individual Flight Time Specification Schemes EASA does not want to force operation that is currently run in a safe manner to change drastically. Mitigating measures can be put in place by, or that are already in place with operators can be used to achieve an adequate level of protection against fatigue. One of the most important is the crew members ability and requirement to cancel operations when they reach FTL limitations or even earlier if they feel not fit for flight. This happens in average five to ten times a year in our operations. This ability and obligation is one of the key factors in the safety records in terms of FTL in “Nordic” operations how do one describe that. Option 1 – Flexible approach” would have the benefit of forcing the operators to demonstrate a safe operation. This will be quite costly and not practicable for many small operators and would also at the end lead to significant barriers of entry. Costs that would enhance safety more if spent on other safety issues like crew training. As said earlier there is no indication that FTL is a safety issue. Conclusion

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 60 of 585

An agency of the European Union

We therefore urge EASA to incorporate “Nordic” schemes to the regulation that has been in operational use with a safety record and in an SMS perspective is well balanced between cost and safety.

response Please see the answer to comment # 54

comment 1474 comment by: Finnish Transport Safety Agency

Attachment #45

Finland would like to thank EASA for development of further FTL rules. We support the proposed FTL rules for CAT air taxi operations, emergency medical service operations with aeroplanes and CAT single-pilot operations with few comments. However, for emergency medical operations with helicopters (HEMS) we propose another solution. In Finland’s opinion HEMS operations should comply with the applicable requirements of the national law of the Member State in which the operator has its principal place of business. The proposed FTL requirements as they are, would require Finnish HEMS operators to hire at least 25% more crew. This would lead to lack of qualified and experienced pilots, and lack of financial recourses to continue operations at the same level as now. It should also be estimated what effect of more pilots flying less hours would have in the flight safety. The HEMS operations are required in Finland by law, in order to ensure equal availability of medical services for all inhabitants. The main problem in the proposed FTL requirements is the lack of possibility for rolling 24 h standby. The proposed NPA would also cause problems for helicopter operators who operate both HEMS and other CAT and SPO to roster and calculate flight and duty hours. It would be less problematic to include all helicopter operations under the EASA FTL rules at the same time. Common FTL requirements, if established, should take into account the different nature of HEMS operations within and between countries. The HEMS operational area and accessibility, the number and length of the operations, geographical environment, weather and use of VFR/IFR/NVIS operations differ. If HEMS operations will be included in the FTL requirements later on, it would be utmost important to include possibility for rolling 24 hours standby period. This has been common practice in Finland for 15 years and in use also in other European countries. There has been recent study (see attachment) of working hours, sleep and sleepiness in HEMS personnel in Finland. Results show that pilots and HEMS crew members experience only infrequently low alertness on duty. If FTL requirements for HEMS are laid down, Finland proposes the concept for rolling 24 hours standby period, which we have named active standby. Active standby includes active duty and inactive duty, and may last up to 72 hours. During this period crew stays at the base, and flight time and active duty time are limited during the rolling 24 h period. During inactive duty crew has possibility to rest. Active standby concept works well in Finland, as

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 61 of 585

An agency of the European Union

average active duty during 24 h period may be as low as 3,5 hours. It also takes into account the unpredictable nature of HEMS operations. One Finnish operator has tested 12 h standby roster, which HEMS crew experienced heavier than rolling 24 h standby roster. Most of the Finnish HEMS pilots live far away from the base, therefore travelling time is a big issue when planning the rosters. In addition to flying, HEMS pilots in Finland are required to participate the medical care situation and shall therefore be able to speak Finnish. This is limiting factor to increase the pool of sufficiently experienced pilots from abroad. In addition the government funding of HEMS is based on the fixed cost of 10 year agreement between the operator and HEMS service provider. There has been no accidents or incidents in HEMS operations during the term of the national FTL regulation. There are less than 10 fatigue related reports per year in HEMS in the whole Finland. Finnish HEMS operations have good reporting culture in a just culture environment.

response Please see the answer to comment # 54

comment 1499 comment by: ADAC Luftrettung gGmbH

Es wird von best practice gesprochen, jedoch werden die Erfahrungswerte nicht berücksichtigt. In Europa gibt es eine FTL, die sogar speziell für HEMS angepasst wurde. Dies basiert auf einer wissentschaftlichen Studie der DLR (German Aerospace Center) aus 1996. Diese Studie wurde in keinster Weise berücksichtigt, obwohl sie die einzige, existierende Studie zum Zeitpunkt der RMT war. Zwischenzeitlich haben die Norweger, Italiener und Deutschen jeweils eine Studie zu dem Thema durchgeführt. Man sollte die Erkenntnisse nun auch für das CRD nutzen und wirklich auf wissentschaftlicher Basis eine akzeptable Verordnung verfassen.

response Please see the answer to comment # 54

comment 1318 comment by: Elilombarda

Attachment #43

The attached file is a copy of the comments inserted into the CRD, for a better reading.

response Please see the answer to comment # 54

comment 1502 comment by: LPR

Attachment #46

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 62 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1520 comment by: Air Ambulance Services of Norway

Comments on NPA 2017-17 General The Air Ambulance Services of Norway (Luftambulansetjenesten HF, shortened LAT HF) is the government agency responsible for all air ambulance (AEMS and HEMS) in Norway. The service is funded by the Government. LAT HF signs contracts valid for 6-11 years with civilian AOC-holders to operate our 13 HEMS-bases and 7 AEMS-bases. They are all on 24/7 duty, and perform about 20 000 air ambulance- and HEMS missions per year. Norway has today one of the most modern and advanced air ambulance services in the world. With the new contracts starting in 2018 (HEMS) and 2019 (AEMS) we will have brand new aircraft (9) and helicopters (17) with the highest safety standards available, combined with requirements regarding flight crew training, fatigue risk management system, simulators, dispatch services and all aspects of the service that well exceeds the EASA and national legislation demands. The service is well functioning and regarded as very safe at today’s level, and this was also the conclusion in a national study of 2014 which compared safety and risks in different parts of Norwegian domestic helicopter operations. The HEMS service was described to be at the same high safety level as offshore helicopter operations in Norway (Bye, R.J., Seljelid, J., Heide; B., Lillehammer, G. Aasprang, B., Antonsen, S. Vinnem, J.E., Bø, B. (2013) Sikkerhetststudie innlandshelikopter - Hovedrapport. [Safety study inland helicopters – main report]). Our AEMS service is based on the present EASA regulations. Our comments to the NPA are primarily based on the suggested changes to the HEMS regulations, which are regulated on a national level today. Comments Intended harmonization EASA has described the extreme variety of HEMS services performed in their member states (mix of day and night services, IFR, NVG, single/two pilot operations, SAR and so on). LAT HF finds that a continued legislation by the national aviation authority is the best way to ensure a safe and proper HEMS operation in each member state. This will also cover the specific needs of each country as the HEMS service is an integrated part of the national specialist health service, as it is in Norway. If an EASA FTL is imposed for HEMS services, it will end up with almost all operators applying for an Individual Flight Time Specification Scheme (IFTSS), based on their Fatigue Risk Management Systems. This will, contrary to the intentions of the NPA, not lead to a level playing field. It will favor the operators in service in i.e. Norway, as they can participate in the next tender process offering a number of crews based on their IFTSS. It will be almost impossible for other contenders to compete with, as they have no such IFTSS and probably must offer a much higher number of crews. This will favour operators that

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 63 of 585

An agency of the European Union

are well established in future competitions in an unfair way. This undermines the idea behind the EU-wide rules for public procurement and the rules of competition. The HEMS operation in Norway is a national service, and less than 0.5 % of the HEMS missions performed per year are to neighboring countries. LAT HF considers that the best way to ensure a level playing field will be to continue to have a national HEMS regulation. This will ensure that all operators can participate in future tender processes based on the public and known national regulations (as opposed to competing with the present operators who probably have an IFTSS, unwilling to share all the details). Intended increase in safety The HEMS service is characterized by a low number of flight hours per crew per year. In Norway the average crew member has about 200 flight hours per year. This is considered low from a flight safety aspect, given the extreme variety of missions and qualifications the crews are required to hold). Today the crews can, based on national legislation, count a 24- hour duty on base as less than 24 hours (on average 16 hours) towards the annual 2000 hour limit. If the NPA is passed this will no longer be possible, and can cause a need to increase the number of crews by as much as 44 % to meet the requirements in the NPA. This will end up in the same number of flight hours divided by a substantially higher number of crews, ending up in a critically low number of flight hours per crew per year. The fixed wing air ambulance operation in Norway produces about 10 000 flight hours a year distributed on 9 aircraft. A high number of the flights are into short fields, with steep approaches during night time in the winter. The national authorities require the operator to give the crew special training and recency to operate into these special category airfields. With current flight time limitation it is hard for the operator to keep the crew current at all times. With the proposed limitations more pilots will be needed to deliver 24/7 service. This will lead to less flying per pilot, decreased regularity and in the end decreased level of safety. LAT HF finds the suggested change to be the largest identified risk towards flight safety in our service today. If the NPA is passed, we strongly suggest that operators will be granted an IFTSS (based on their FRMS) that allows them to continue with 24-hour duty periods, but counting as less than 24 hours towards the annual 2000 hour limit. Costs As described above; the suggested FTL can end up in a need for up to 44 % more crews. Next to the helicopters, the crews are the most expensive part of the service (salaries, training and pensions). The number of missions will not increase by the increase of crews. LAT HF will need to buy more helicopters, fly several thousand training hours in helicopters and simulators to partly compensate for the drop in annual flight hours per crew. Without going into detail; - the potential increase in costs for the Norwegian service could be more than 10 million Euro per year. Summary The NPA states that the “proposed changes are expected to improve safety….. and ensure harmonisation across the EU”, furthermore to “ensure a level playing field and improved safety”. In the NPA EMS Safety Risk Assessment (4.1.4.1) it is acknowledged that fatigue is at a very low occurrence, and that “the controls that have been in place to manage fatigue in European EMS have generally been effective”.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 64 of 585

An agency of the European Union

The NPA describes the safety, social and economic impacts of the suggested FTL (based on option 0, 1 and 2). LAT HF would emphasize the major safety risk an increase in crews could cause, in addition to a tremendous increase in costs. Based on the: - reduced ability for operators to participate on a level playing field, - flight safety risks associated with the need for more crews and - substantial increase in costs The Air Ambulance Services of Norway (LAT HF) can only recommend Option 0 for HEMS (No policy change). The other options will lead to one or more of the consequences listed above, without any positive effects to our service. Kind regards, Øyvind Juell Managing director (CEO) Air Ambulance Services of Norway

response Please see the answer to comment # 54

comment 771 comment by: Yorkshire Air Ambulance

Comments submitted hereafter reflect not only the position of the Yorkshire Air Ambulance, but broadly reflect the views of the British Helicopter Association, a trade body supporting all UK HEMS operators and affliated to the European Helicopter Association. From the outset, harmonising an FTL for these two disparate activities (air ambulance with aeroplances and HEMS with helicopters) was always likely to be challenging. The BHA suggest that a separate FTL needs to be developed for both activities, and offers to work alongside both the EHA and EASA to achieve this goal.

response Please see the answer to comment # 54.

comment 171 comment by: Marc Rothenhäusler

Durch eine Neuregelung der Flight Time Limitiation versuchen sie eine Vereinheitlichung zu erreichen, jedoch sind in jedem Land die unterschiedlichsten Gegebenheiten hinsichtlich der medizinischen Versorgung gegeben. Der größte Anteil an Hems Einsätzen in Europa werden in Deutschland geflogen, jedoch wird von Ihnen Deutschland nicht ausreichend berücksichtigt. Die Deutsche Luftrettung ist in Deutschland nicht wie in anderen Ländern als Ergänzung zum bodengebunden Rettungsdienst zu sehen, sondern fester Bestandteil des Rettungsdienstes, was auch in den Rettungsdienstgesetzen der einzelnen Bundesländern so geregelt ist! Die von Ihnen angestrebten Ziele würden einen massiven Einschnitt in die medizinische Versorgung in Notfällen für die Bevölkerung bedeuten.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 65 of 585

An agency of the European Union

Sie ziehen wissenschaftliche Studien heran mit denen sie argumentieren die Flugsicherheit erhöhen zu müssen. Jedoch fehlen hier die Quellen der Studien. Ich bitte sie diese zu nennen.

response Please see the answer to comment # 54.

comment 525 comment by: ADAC Luftrettung gGmbH

According to the document, the objective of this NPA is to develop a harmonized set of FTL rules across the European Union. The “main market” Germany with almost half of all HEMS missions flown in Europe is not taken into account enough. In Germany HEMS is an integral part of the rescue system that is also deep seated in national law concerning rescue. It is not add on service to regular rescue services like in most of the other European countries. This condition is misjudged completely by EASA. The planned rules according to this NPA would have severe negative impact on the German rescue system. EASA expects to improve flight safety by using scientific principles. Nevertheless there is no evidence of any scientific studies providing these principles especially for HEMS operation. We expect some more explanatory details on this issue.

response Please see the answer to comment # 54.

comment 547 comment by: Rüdiger Neu

Durch die avisierte Regelung soll laut EASA eine Harmonisierung der FTL in Europa erreicht werden. Dabei wird jedoch der „Hauptmarkt“ Deutschland mit fast der Hälfte aller in Europa geflogenen HEMS Einsätze nicht ausreichend berücksichtigt. In Deutschland handelt es sich bei HEMS um einen festen Bestandteil der Bevölkerungsvorsorge, der so auch in den jeweiligen Rettungsdienstgesetzen verankert ist. Es geht hierbei nicht nur, wie in den meisten anderen Ländern, um eine Ergänzung des bodengebundenen Rettungsdienstes. Diesen Umstand verkennt die EASA gänzlich. Die avisierten Regelungen hätten ganz erhebliche negative Auswirkungen auf die Notfallversorgung in Deutschland. Für die Erhöhung der Flugsicherheit werden angebliche wissenschaftliche Prinzipien angeführt, jedoch findet man keinen Hinweis auf welche wissenschaftlichen Studien sich bezogen wird. Hier erwarten wir deutlich mehr Transparenz.

response Please see the answer to comment # 54.

comment 582 comment by: NOLAS

EASA has acknowledged that, and this is indeed clearly stated in the NPA, there are no indications that the existing FTL requirements for HEMS, which is under national authority approvals, poses a flight safety problem. We do understand that it does not mean that

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 66 of 585

An agency of the European Union

there are operations that could be run in a better/safer way course. However, presently this means that the goal is merely to harmonize and standardize the regulations. It is our point of view that the NPA, as far as HEMS goes, has been conceived using a general lack of supporting data, an incomplete pre‐RIA report by DNV and very few (relevant) or outdated scientific publications concerning fatigue in HEMS. This has led to an NPA that is quite redundant to ensure that it covers all aspects of risk of fatigue in all European HEMS operation. The new FTL requirements for HEMS as envisioned in the NPA, will not meet most operators requirements and to continue their operation, which in the vast majority of cases is run in a safe manner with regards to fatigue, they will have to use the Regulation (EC) No 216/2008 Article 14‐6 or 22-2 flexibility provision and apply for an Individual Flight Time Specification Scheme (i.e. Option 1 – Flexible approach). This would certainly be the case for our operation (Our operation is 24/7 with a crew that has, in general, a 7/14/7/21 roster for pilots and a 7/21 roster for HEMS technical crew members in an operating environment characterized by a low number of missions per day). So, while we do agree fully with the principles of the objective of the NPA, we believe that harmonization and standardization will not be achieved and cannot be achieved in an industry that operates in such a contextual way in such a vast area as Europe. The European HEMS operating patterns are highly diversified (not only between countries, but also within countries) and have been developed and matured over a long period of time. The diversified operating patterns are necessary to perform safe and affordable HEMS operations in very different operating environments and in accordance with different requirements. Harmonizing and standardizing might not be the way to go unless the harmonization and standardization is at a framework level where the actual details are left up to the national authorities. While we believe that “Option 0 – No policy change” would work quite well for most Member States, we do recognize that “Option 1 – Flexible approach” could have the benefit of forcing the operators to demonstrate a safe operation. This will be quite costly and not practicable for many small operators, however and would also at the end lead to significant barriers of entry. “Option 2 – Fully prescriptive approach” would, as stated in the NPA, have a “Positive low benefits” for safety pertaining to the risk of fatigue, but we doubt it. For many operators/member states the envisioned safety benefits to guard against fatigue could be nullified due to the extra amount of commuting, which is itself causing extra stress and fatigue, that would be introduced. Furthermore, the regulation would have a negative impact on the service in way too many other cases. It will have a negative impact on social aspects for the “customers” (i.e. the patients) due to a lowered availability of the service), the public and the crew members. For the operation in Norway (a period of 6 + 2 + 2 years commencing 1.6.2018), Option 2 would incur an estimated cost of 250 million NOK (25 660 000 €) per year if the intention would be to maintain the same level of service and safety standard (amount to be verified by our customer). HEMS in Norway, while a CAT operation, is a public service matter and this cost increase would have to be carried by our customer and public funding. This cost increase, without adding any measurable safety benefit for the operation, is not acceptable. The alternative is a substantial reduction of the overall level of safety and/or service, but this is a scenario that cannot be accepted

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 67 of 585

An agency of the European Union

either. Additionally, the risk of fatigue will potentially increase, in many cases, due to heavy commuting. Other factors negative for flight safety would be introduced as well. These negative factors would include accepting lowered standards (due to difficulties in recruiting suitably experienced, qualified crew members with the proper attitude) and a lack of recency (the same amount of missions would have to be flown by a substantially higher number of crew members. In conclusion, NLA believes that that EASA has been given an impossible task under the present circumstances and that at least for the time being, the only suitable solution for HEMS FTL is “Option 0 – No policy change” as it will have a neutral safety impact, if operations remain predominantly in the Member State that issues the Air Operator Certificate. A new NPA specific for HEMS FTL should be developed and we are happy to assist, in any capacity, for all HEMS FTL matters pertaining to Scandinavian operations. As the regulations envisaged in the NPA is so far off from our operating concept and pattern, we can only provide constructive comments on principles and major issues.

response Please see the answer to comment # 54.

comment 760 comment by: DRF-Luftrettung

HEMS Operators very often perform their tasks in the field of public health insurances. Economic changes and social impacts lead to increased wages which will not always be covered by the health system. We therefore assume that many HEMS operators will have to use the flexibility provisions. This will jeopardies all efforts of harmonization. Instead of 31 national regulations we will end up with 360 individually based Flight time specification schemes. According to article 2 of the basic regulation, this NPA is therefore not valuable to provide

a level playing field for all actors in the common European aviation market and to facilitate

free movements of persons and services

response Please see the answer to comment # 54.

comment 792 comment by: Yorkshire Air Ambulance

The BHA welcomes any attempt by EASA to provide a level playing field in the scope of a HEMS FTL, but the current NPA falls short of achieving this objective. Feedback from real- world experience was quite limited, and probably not comprehensive enough to cover all eventualities. Equally, by EASA's own admission, the scientific evidence is patchy and provides few obvious criteria to nessitate significant changes to National FTLs. Overall, the BHA position will be to support EASA by adopting Option 1 - Flexible Approach. However, further industry consultation must take place to deliver substantial alterations to this NPA,

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 68 of 585

An agency of the European Union

otherwise operators will be forced to apply for individual FTSS and thus the common purpose of a uniform FTL will be lost.

response Please see the answer to comment # 54.

comment 1326 comment by: Civil Aviation Authority of Norway

General comment: We recognize the efforts that has been made to develop this rulemaking proposal. We generally support the proposal with regard to ATXO, AEMS and single pilot operations. On HEMS operations we recognize the difficulties for establishing common European rules due to the nature of these air services and the variety of how HEMS is regulated in the different EU and EFTA states. Due to the demography and the topographical characteristics in Norway, HEMS services is widely used as the only practical means for emergency medical transport. HEMS bases are spread out across the country, and the operation is typically characterized by stand-by duty which is performed by crew who lives in other parts of the country, and a relatively low number of flights during each duty period. If the proposed HEMS FTL rules were to be applied to this operation, many of the highly negative effects recognized by EASA in the impact assessment would apply. If this proposal is adopted we therefore expect that we have to exclude most of our HEMS base from applying the regulation by using the proposed amendment to Article 8. In that respect we support the "Option 1 - flexible approach" which has been taken with regard to regulating FTL for HEMS. The disadvantage of this approach is however a lack of harmonization of FTL requirements across Europe. Additionally, if the possibility for establishing individual FTL schemes will be widely used (something we suspect will be the case), this will put considerable workload and cost on operators, NAAs and on EASA. The possible economic benefits an efficiency gains resulting from harmonized rules, such as creating a common market for such services and a level playing field, will then risk failing. We therefore ask EASA to consider if the proposal regarding HEMS FTL rules is sufficiently mature to be put forward. In our view the "Option 0 –no policy change" is preferable for HEMS FTL until a proposal which is better adapted to the specific nature of HEMS operations can be put forward.

response Please see the answer to comment # 54.

comment 1416 comment by: FinnHEMS Oy

-Aircrew members will not benefit because more aircrew must be hired => less flighthours for crews

response Please see the answer to comment # 54.

comment 3 comment by: DHV e.V.

Extension submission of comments NPA 2017-17

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 69 of 585

An agency of the European Union

NPA 2017-17 „Flight Time Limitations for commercial air transport operations of emergency medical services…” has been published on October 27th. The deadline for submission of comments is 31 January 2018. Our members, ADAC Luftrettung and DRF Luftrettung, the two biggest HEMS operator in Germany carried out a scientific study this summer. The study is make in cooperation with the German Aerospace Center (DLR) and compares the actual duty schemes with future shift duty schemes. The results of the study are expected by the beginning of February 2018. These results will enable us to give adequate and scientific based comments on the NPA. Theerefore we apply for an extension of the submission of comments until 31 March 2018.

response Comments response period was extended until 31 March 2018.

1. About this NPA p. 3-4

2.1. Why we need to change the rules issue/rationale p. 5-6

comment 91 comment by: B. Wagner

Die aufgeführten Datenquellen decken nicht den HEMS Bereich ab. Einzige Quelle mit HEMS Bezug ist Samel et al, 2004. Diese Studie kommt allerdings nicht zu neuen oder besseren Erkenntnissen, als bereits in der 2. DVLuft BO festgelegt sind. Keine Veranlassung, von den bestehenden Regelungen überhaupt abzuweichen, ausser zur europaweiten Harmonisierung. Dies wird jedoch aufgrund der völlig unterschiedlich aufgestellten nationalen Rettungsdienststrukturen nicht gelingen können und dazu führen, dass es eine Vielzahl nationaler Ausnahmen geben wird.

response Please see the answer to comment # 54.

comment 1419 comment by: FinnHEMS Oy

There seems to be very few relevant data sources reverting to HEMS.

response Please see the answer to comment # 54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 70 of 585

An agency of the European Union

comment 172 comment by: Marc Rothenhäusler

Der tägliche Ablauf von Hems Einsätzen findet überwiegend unter VFR - Bedingungen.

Zwischen den Einsätzen finden oft längere Pausen statt auf Station mit der Möglichkeit

Ruhezeit einzuhalten. Dazu kommt, dass selbst an Einsatzstellen keine Arbeit des Piloten

notwendig ist, wir natürlich nicht Ruhen können aber nicht aktiv und anstrengend

arbeiten sondern einfach nur warten, bis die Besatzung zurückkommt. Einen Vergleich

mit Flächenpiloten zu ziehen ist vollkommen nicht möglich, welche unter Umständen

stundenlang im Cockpit verbringen.

Hubschraubern ist es auch möglich in den meisten Fällen einer Notsituation eine

sofortige Landung durchzuführen.

Daher komme ich zu der Meinung, dass eine Verschärfung der Flight Time Limitation und

Vereinheitlichung der Regeelung für den Flächenflugbetrieb und den Hems Flugebtrieb

nicht richtig ist!

response Please see the answer to comment # 54.

comment 220 comment by: ADAC Luftrettung gGmbH

Im HEMS Flugbetrieb entstehen teilweise lange Pausen zwischen Einsätzen. Unter

anderem deshalb ist die Belastung eines Airline-Piloten nicht direkt mit einem HEMS-

Piloten vergleichbar, und entsprechende Studien sind nicht zwangsläufig übertragbar.

response Please see the answer to comment # 54.

comment 248 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): 2.1 Para 11 HEMS is mostly on-demand VFR operations and (long) breaks at home base. Therefor the work load cannot be compared to the work load of a fixed wing crew that often lasts for several hours. Additionally if emergency conditions occur in a helicopter an emergency landing is possible almost everywhere. That’s why it makes no sense to adopt rules developed by use of scientific studies performed in fixed wing operations.

response Please see the answer to comment # 54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 71 of 585

An agency of the European Union

comment 377

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

Art 5 para 1 second sentence TEU provides: „The use of Union competences is governed by the principles of subsidiarity and proportionality. Art 5 para 3 TEU provides "Under the principle of subsidiarity, in areas which do not fall within its exclusive competence, the Union shall act only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level." The NPA in question is related to a regulatory subject which does not fall within the exclusive competence of the EU but rather within the shared competence in transport matters (Art 2 para 2 in conjunction with Art 4 para 2 lit g and Art 100 para 2 TFEU), since the Basic Regulation 216/2008 is based on Art 80 EC (now Art 100 TFEU) and the NPA in question will at the end of the rulemaking process form the base for an implementing regulation. According to its wording the principle of subsidiarity calls for two requirements: A test of comparative efficiency, looking at the capacity of Member States for problem- solving, which must be negative in outcome, and a test of added value in EU regulation, which must be positive in outcome. EASA observes in the NPA that HEMS operations usually remain within the territory of the Member State in which they are conducted. EASA has neither demonstrated why national regulation cannot adequately guarantee the safety of such operations, nor has it shown any added value in EU regulation. Hence, EU regulation on the subject would clearly violate the principle of subsidiarity, and any such implementing regulation would be null and void according to Art 263 TFEU.

response Not accepted. HEMS operations are already regulated by EU Regulation 965/2012. The

only element of HEMS that is still under national regulation is FTL. According to your

logic, that Regulation has been violating the principle of subsidiarity since 2012. In fact,

EU Regulation 965/2012 effectively applies from 2014 by EU Member States and

European operators and individual crew members, without any legal action being

brought against it on that ground.

comment 378

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

In some countries of the European Union HEMS is considered to be a service in public interest which leads to the conclusion that financing such systems is part of the public healthcare system. HEMS therefore is based on contracts between state authorities on the one hand and HEMS operators on the other. These contracts are the result of call for tenders and a following bidding process and have a certain agreed duration. This system of contracts (involving federal governments, district governments and social security institutions) is very complex, well-balanced, fragile but working.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 72 of 585

An agency of the European Union

Changing the facts which have an impact to the cost to which an operator is able to render its services would require to change these contracts if the changes of facts are above a certain threshold. Since the rules proposed in the NPA would result in an increase of the pilot's and HEMS-CM's headcount of about 40% of FTE the changes to be expected are very well above any such threshold. Having in mind the complexity of the negotiations for these contracts in the past and fearing that new contracts will not be in place before the new rules enter into force, we believe that these rules might endanger a very important piece of the public healthcare system and therefore the life and Health of the public. Considering on the one hand the fact that there is literally no positive impact on aviation safety to be expected and on the other hand the potential negative effects for the public, we are strongly concerned that the rules exceed what is necessary to achieve the objectives of the Treaties of the European Union and therefore infringe Article 5 para 4 TEU and – since the NPA is supposed to result in a Commission Regulation – the Protocol on the Application of the Principles of Subsidiarity and Proportionality. Any such implementing regulation would be null and void according to Art 263 TFEU. Considering the aim of the NPA to level the playing field amongst European HEMS operators EASA does obviously not realize that HEMS primarily is a national (domestic) type of operation; cross-border HEMS missions are less than 5% of all HEMS missions flown in Austria. Also from this point of view the idea of a level playing field is on the one hand not necessary (again subsidiarity and proportionality) and on the other hand not within the scope of EASA (E A SAFETY A) since it is not safety critical at all.

response Please see the answer to comment # 377 and # 54.

comment 414 comment by: UFH French Helicopters Association

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that: • An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2 missions i.e 4 flights) • Unknown landing sites o In France, 75% of the flights are performed between 2 hospitals’ helipads duly mapped • Daily duty period of 15h or 16h are quoted o In France, such duration of duty period are not performed in the national territory (French scheduled effective operational FDP are lasting 12h) The fatigue risk generated by the HEMS activity in France must therefore be properly assessed: • It is mostly a local transport activity (the average HEMS leg for SNEH is less than 50NM or less than 25 minutes of flight timei), which is most often performed between 2 well known HEMS operating bases. • In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i • The annual rest periods are ranged between 199 days and 220 days per yeari

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 73 of 585

An agency of the European Union

Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified. This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17. Generally speaking, FNAM would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety

response Please see the answer to comment # 54.

comment 446 comment by: Hélicoptères de France

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that:

• An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2 missions i.e 4 flights)

• Unknown landing sites o In France, 75% of the flights are performed between 2 hospitals’ helipads duly mapped

• Daily duty period of 15h or 16h are quoted o In France, such duration of duty period are not performed in the national territory (French scheduled effective operational FDP are lasting 12h) The fatigue risk generated by the HEMS activity in France must therefore be properly assessed:

• It is mostly a local transport activity (the average HEMS leg for SNEH is less than 50NM or less than 25 minutes of flight timei), which is most often performed between 2 well known HEMS operating bases.

• In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i

• The annual rest periods are ranged between 199 days and 220 days per yeari Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 74 of 585

An agency of the European Union

This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17. Generally speaking, Hélicoptères de France would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety (cf. attachment “synthèse SNEH”).

response Please see the answer to comment # 54.

comment 458 comment by: FNAM/SNEH

Attachment #49

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that:

• An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2

missions i.e 4 flights) • Unknown landing sites

o In France, 75% of the flights are performed between 2 hospitals’ helipads duly mapped

• Daily duty period of 15h or 16h are quoted o In France, such duration of duty period are not performed in the national

territory (French scheduled effective operational FDP are lasting 12h)

The fatigue risk generated by the HEMS activity in France must therefore be properly assessed:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 75 of 585

An agency of the European Union

• In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i

• The annual rest periods are ranged between 199 days and 220 days per yeari

Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified. This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17. Generally speaking, FNAM and SNEH would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety (cf. attachment “synthèse SNEH”).

response Please see the answer to comment # 54.

comment 523 comment by: ADAC Luftrettung gGmbH

This new regulation aims to increase flight safety on cone hand and harmonization of the natonal regulations on the other hand. But harmonization does not make sence in this context, when different requirements of member states are not considered.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 76 of 585

An agency of the European Union

With the 2. DVLuftBO § 22-23 of the German FTL regulation, there is a well proven FTL regulation exspecially for HEMS in force for years, that is based on a scientific studie and takes into account the special circumstances in our country our environment. HEMS is mostly on-demand VFR operations and (long) breaks at home base. Therefor the work load cannot be compared to the work load of a fixed wing crew that often lasts for several hours. Additionally if emergency conditions occur in a helicopter an emergency landing is possible almost everywhere. That’s why it makes no sense to adopt rules developed by use of scientific studies performed in fixed wing operations.

response Please see the answer to comment # 54.

comment 548 comment by: Rüdiger Neu

HEMS ist meist geprägt durch VFR-Flugbetrieb und (lange) Pausen auf der Station. Somit ist die Belastung gegenüber einem Flächenflugbetrieb mit mehreren zusammenhängenden Stunden Cockpit-Arbeit nicht vergleichbar. Ebenso ist in besonderen Notlagen eine schnelle Landung mit einem Hubschrauber meist überall möglich. Somit kann eine Verschärfung der Regelungen, sowie die Anwendung wissenschaftlicher Studien im Flächenflugbetrieb nicht für HEMS herangezogen werden.

response Please see the answer to comment # 54.

comment 638 comment by: Oya Vendée Hélicoptères

Attachment #50

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that:

• An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2 missions

i.e 4 flights) • Unknown landing sites • In France, 75% of the flights are performed between 2 hospitals’ helipads duly

mapped • Daily duty period of 15h or 16h are quoted

o In France, such duration of duty period are not performed in the national territory (French scheduled effective operational FDP are lasting 12h)

The fatigue risk generated by the HEMS activity in France must therefore be properly assessed:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 77 of 585

An agency of the European Union

• It is mostly a local transport activity (the average HEMS leg for OYA is less than 50NM or less than 25 minutes of flight timei), which is most often performed between 2 well known HEMS operating bases.

• In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i

• The annual rest periods are ranged between 199 days and 220 days per year

Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified. This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17. Generally speaking, OYA would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety (cf. attachment “synthèse SNEH”).

response Please see the answer to comment # 54.

comment 901 comment by: MBH SAMU

Attachment #51

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 78 of 585

An agency of the European Union

• An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2 missions

i.e 4 flights) • Unknown landing sites • In France, 75% of the flights are performed between 2 hospitals’ helipads duly

mapped • Daily duty period of 15h or 16h are quoted

o In France, such duration of duty period are not performed in the national territory (French scheduled effective operational FDP are lasting 12h)

The fatigue risk generated by the HEMS activity in France must therefore be properly assessed:

• It is mostly a local transport activity (the average HEMS leg for MBH is less than 50NM or less than 25 minutes of flight timei), which is most often performed between 2 well known HEMS operating bases.

• In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i

• The annual rest periods are ranged between 199 days and 220 days per year

Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified. This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17. Generally speaking, MBH would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 79 of 585

An agency of the European Union

reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety (cf. attachment “synthèse SNEH”).

response Please see the answer to comment # 54.

comment 1179 comment by: SAF

Attachment #52

The operational justifications expressed in this chapter n°2 of the NPA do not correspond to operating conditions of the HEMS encountered on the French national territory. Indeed, it is stated that:

• An activity of up to 20 flights over a period of a few hours o This level of activity is unknown in France (in average less than 2 missions

i.e 4 flights) • Unknown landing sites • In France, 75% of the flights are performed between 2 hospitals’ helipads duly

mapped • Daily duty period of 15h or 16h are quoted

o In France, such duration of duty period are not performed in the national territory (French scheduled effective operational FDP are lasting 12h)

The fatigue risk generated by the HEMS activity in France must therefore be properly assessed:

• It is mostly a local transport activity (the average HEMS leg for SAF is less than 50NM or less than 25 minutes of flight timei), which is most often performed between 2 well known HEMS operating bases.

• In average, the total flight time per FDP (in France, FDPs are currently scheduled at 12h excluding the pre-flight) is ranged between 30 min and 1h30i

• The annual rest periods are ranged between 199 days and 220 days per year

Considering the same fatigue evaluation than for CAT.A FTL rules does not seem justified. This is reinforced by the impact study presented in chapter 4 of the NPA 2017-17.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 80 of 585

An agency of the European Union

Generally speaking, SAF would welcome a new RIA better reflecting the reality of the operations. Besides fatigue, this NPA will lead, for single pilot + 1 TCM operations, to double the crews for H12/24 operational readiness and to increase by 50% the crew for H24 operational readiness. As a consequence, the NPA’s proposed dispositions will lead to diminish the flight safety due to a lack of practical recent experience for pilots. Indeed, if these proposed requirements are implemented, the pilots would fly 1.5 times to half-time less. As a consequence, only 50% to 66% of the flight times flown by a given pilot nowadays would be performed by this same pilot if applying this NPA. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. At the moment in France, crews are flying between 80 to 140 flight hours in average per year which is already low for a professional pilot activity. With the new proposed requirements of the NPA, pilots would only be able to fly between 40 to 90 flight hours per year which barely corresponds to an aeroclub activity. The pilots activity level could thus reach less than 5 hours of flight per month on a 24H/24 HEMS operating base resulting in a loss of skills which is detrimental to flight safety (cf. attachment “synthèse SNEH”).

response Please see the answer to comment # 54.

comment 173 comment by: Marc Rothenhäusler

Eine Vereinheitlichung des Hems Flugbetriebs europaweit ist meines Erachtens nicht tragbar, da die Luftrettung in den einzelnen Ländern unterschiedlichst eingesetzt wird und einen unterschiedlichen Stellenwert in der Patientenversorgung hat. So ist die Luftrettung in Deutschland in der notärztlichen Versorgung der Bevölkerung gar nicht mehr weg zu denken, wohingegen in anderen Ländern das Hauptaugenemrk auf dem sekundären Transport von Patienten liegt!

response Please see the answer to comment # 54.

comment 249 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): 2.2 In European countries, HEMS operation as part of the complete rescue system varies depending on geographical conditions and existing ground based services. With these prerequisites a harmonization in this special field of operation is neither reasonable nor

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 81 of 585

An agency of the European Union

desirable. In Germany for instance, use of helicopters is an integral part of patient care, especially acute care. Other countries focus more on subordinated patient transport.

response Please see the answer to comment # 54.

2.2. What we want to achieve - objectives p. 6

comment 309 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): “The specific objective of this proposal is to establish an improved and proportionate Europe-wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices.” Comment: Exactly what scientific knowledge does this refer to? The scientific studies this NPA is based on are inconclusive, not fully relevant or dated when it pertains to HEMS. With reference to this, who decides what “best practices” are?

response Please see the answer to comment # 54

comment 358 comment by: European Helicopter Association (EHA)

BHA (UK) "The specific objective of this proposal is to establish an improved and proportionate Europe-wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices". Comments: By scientific knowledge, does this refer to the study by FRMSc, which only looked at a very small sample (<20) of air taxi pilots, using their own commercial algorithms such at SAFE? 'Best practices' is a pejorative term and probably shouldn't be used. Who has sufficient authority to decide what "best practice" is for everyone?

response Please see the answer to comment # 54

comment 526 comment by: ADAC Luftrettung gGmbH

In European countries, HEMS operation as part of the complete rescue system varies depending on geographical conditions and existing ground based services. With these

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 82 of 585

An agency of the European Union

prerequisites a harmonization in this special field of operation is neither reasonable nor desirable. In Germany for instance, use of helicopters is an integral part of patient care, especially acute care. Other countries focus more on subordinated patient transport.

response Please see the answer to comment # 54

comment 549 comment by: Rüdiger Neu

Da dem HEMS-Betrieb in den europäischen Ländern ein jeweils unterschiedlicher Stellenwert im Rahmen der Notfallversorgung zukommt und insofern auch die geographischen Gegebenheiten und die medizinische Versorgung unterschiedlich sind, ist eine einheitliche Regelung in diesem speziellen Anwendungsgebiet überhaupt nicht möglich und auch nicht wünschenswert. In Deutschland ist der Einsatz von Hubschraubern beispielsweise fester Bestandteil der notärztlichen Versorgung der Bevölkerung, insbesondere in der Akutmedizin. In anderen Ländern liegt z.B. der nachgeordnete Patiententransport im Fokus.

response Please see the answer to comment # 54.

comment 584 comment by: NOLAS

“The specific objective of this proposal is to establish an improved and proportionate Europe- wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices.” Comment: Exactly what scientific knowledge does this refer to? The scientific studies this NPA is based on are inconclusive, not fully relevant or dated when it pertains to HEMS. With reference to this, who decides what “best practices” are?

response Please see the answer to comment # 54

comment 741 comment by: DRF-Luftrettung

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 83 of 585

An agency of the European Union

General We welcome the intention of the EASA to further enhance the safety of air operations by means of extensions to Regulation (EU) 965/2012 relating to flight time limitations. We are pleased to use the opportunity to comment on the EASA legislative proposals for the safe implementation of HEMS flight operations. We consider it reasonable to adapt the legal situation on FTL throughout all member states in order to strengthen the acceptance of the air rescue service throughout Europe and the aviation safety awareness within the crews. Talking about the development of the NPA 2017-17, one main goal of the EASA was the harmonization of the FTL all over the member states. The conclusion of the EASA to follow a flexible approach is neither appropriate to achieve this goal nor is the justification for option 1 comprehensive. To many factors leading to the conclusion have to be questioned. With nearly 90.000 HEMS Mission each year the German HEMS Operators fly more than 40% of the HEMS Missions counted by all 27 member states and the four associates. We therefore consider ourselves to be competent enough, to look at the new proposals from the German sight of view. Harmonization issues HEMS Operators very often perform their tasks in the field of public health insurances. Economic changes and social impacts lead to increased wages which will not always be covered by the health system. We therefore assume that many HEMS operators will have to use the flexibility provisions. This will jeopardies all efforts of harmonization. Instead of 31 national regulations we will end up with 360 individually based Flight time specification schemes. According to article 2 of the basic regulation, this NPA is therefore not valuable to provide a level playing field for all actors in the common European aviation market and to facilitate free movements of persons and services. Studies and best practice The specific objective of this proposal is to establish an improved and proportionate Europe-wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices. We have to question very critically the scientific studies and knowledges which have been used. In attachment 2 of the NPA we find some references to studies, which are not aviation based but relate to truck drivers, oil rig workers and railroad drivers which examine fatigue in the field of ground based transportation companies, automobile factories and more. Here we see one large field, where the data is not appropriate to be compared with the HEMS service. Working as employer in a factory always means, that from beginning of the shift until the late end there are no extended break times more than the national labor time regulations. Looking at the tables in Attachment 1 – data collection of EMS FTL provisions we have to state clear, that although the daily duty period may be up to 16 hours, the flight duty period is limited to a much lesser value. In practice this means, that if the HEMS Crew has to fly multiple missions a day, the flight duty time increases and the crew has to quit the service before the duty period is expired. On the other hand are flights at the end of the duty day only possible, when the crew had some hours rest in between. Fatigue in the HEMS Operation is therefore minimized due to early ends or several breaks in between and cannot be compared with scientific studies in other branches.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 84 of 585

An agency of the European Union

We would like to point out one more mentioned study, where data collection and conclusion do not fit the actual fatigue based evidences. The EASA takes the Study of Goodes from 2003 (Journal of safety research 2003) and states, that working hours more than 12 hours a day have a more than 5 time larger risk of fatigue related incidents. Goodes did not compare EMS but commercial American air traffic and used the so called Chi square to combine two totally different sets of statistic. His first set was the accident statistic from 1978 to 1999 with 55 accidents. His second setup was a set of the working hours from 10 aircraft carriers taken in one month in 1999. His conclusion was, that 5% of human factor accidents where related to pilots working more than 13 hours. The ratio taken from the working hours showed him, that in this specific one month period only 1% of the pilots worked more than 13 hours. Combining these both ratios he concluded, that the risk is more than 5 times higher than for the working shifts with less than 13 hours working time. Looking at this study, you can read, that Goodes is only writing about human error accidents, not fatigue related accidents. For human errors CRM is the relevant tool not FTL. We cannot see the reason, why the EASA takes statistics with values as old as nearly 40 years, to set up scenarios of fatigue related problems. In the list of the scientific studies we missed the only study for fatigue related flight time limitations of helicopter pilots in the HEMS services from the German center of aeronautics and space (DLR), which came 1996 to the conclusion, that duty periods up to 15:30 hrs are a reasonable compromise between the demands of the rescue service and flight safety. The study end with the sentence, that It could be used as a basis for harmonization at European level. This study was not used in the preparation of the NPA and we have heard rumors, that the results of the study where to old to be transferred to the modern demands of the HEMS Service. If this statement of the task group is verified, we have to ask about all the old studies (see Attachment 2 of the NPA) from the early 1990 to 2000 and why these have been used to create a scenario of safety risks in the field of HEMS Services all tough they do not cover HEMS Operations. Please remember, that since 1996 the German HEMS Operators have flown most likely more than 1.600.000 HEMS Missions with about 4.000.000 sectors without any fatigue related incident or accident. We think, that this fact is decisive to think about the German regulations as basis for a new harmonized EASA wide flight time specification. Comment to safety Impact Regarding the flexible Approach in comparison to the safety impact the EASA expects a positive low benefit. We do not agree with the manner, in which this conclusion was argued. The Attachment II stated in the period of 1971 to 2012 only three accidents, where fatigue was found as contributing factor. According to the EASA statement this is about 1.3% of all EMS occurrences from the ICAO ADFREP database. We have to question the data from the ADREP Database, because the EASA didn’t explain, if the 395 EMS related accidents where based on a world wide search or on a query only for the EU region. The number looks quite high compared to the data from the German federal bureau of aircraft accident investigation (BFU). In the period from 1989 to 2007 there have been only 14 fatal accidents related to HEMS operation in Germany. As stated in the beginning, German HEMS makes up nearly 40% of all HEMS Missions flown in the EASA member

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 85 of 585

An agency of the European Union

states. Therefore we consider the database as not relevant for the EASA kind of argumentation. Furthermore, if we compare the 3 accidents with the number of sectors flown in these 40 years (estimated more than 8 Mill), it is very clear, that fatigue is not a factor, where the safety of HEMS missions is jeopardized. Additionally the NPA states, that the current situation would remain acceptable, if HEMS operations were conducted predominantly in the Member State that issued the AOC. From the German side of view, there are isolated cross border missions, but these starts and ends always in the member state issuing the AOC. As shown in the beginning, HEMS is mainly government founded and assists the ground based national rescue system. We do not see the point in the argumentation of the EASA that this situation will change in the near future in terms of number of HEMS bases to be established across Europe and the number of services to be available cross-border. Also the next EASA statement regarding the safety aspects cannot be followed from our side of view. „Discrepancies between national FTL regimes might make it difficult for operators to conduct HEMS outside their principal home base.“ Our Opinion is that discrepancies between FTL regimes within the scope of the operators due to individual flight time schedules make it impossible to establish common rules for tenders and to give national ministries the chance to compare, which operator will have the best safety policy regarding fatigue. All together we came to the conclusion, that the new proposals will not enhance the flight safety and fatigue management and that the EASA conclusion has to be rethought with appropriate studies and the safety records from HEMS Missions in the last decade. The EASA itself made some presumptions like to consider, that option 1 may provide some low positive benefits. Within the scope of this highly difficult theme, considerations should not be used to argue about changing an existing, functioning and safe System of national flight time limitations. This is also more important, while the EASA will keep normal CAT Operations (i.E. passenger transport with one pilot) within the national scope. For germany this means, that with single pilot CAT the existing rules stay in place, while in HEMS operations with 2 pilots or one pilot and HEMS-TC way more restrictive rules apply. Ridiculous! Comment to social impact Regarding the flexible Approach in comparison to the social impact the EASA expects a neutral result. In fact, we estimate a negative outcome. In Summer 2017 the ADAC and the DRF started a scientific study with the German center of aeronautics and space (DLR). Unfortunately the scientific outcome will not be published by the DLR before the midst of march. From the point of view from the participating pilots we can already tell, that no one was fond working in a system with 2 shifts for rescue helicopters during the day time. Working in the rescue service will soon become unattractive, which leads to reduced safety due to the fact, that experienced pilots will join other services. The impact of the NPA is mainly, that the operators have to recruit and employ more pilots. The European market for experienced HEMS Pilots is more or less nonexistent. We are afraid, that this will lead to deterioration in flight safety. Assuming that there are not enough trained pilots, the operator have to reduce there common working schedule, which will lead to a deteoration in the provision of the HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 86 of 585

An agency of the European Union

operating hours. Furthermore this will have immediate effect to the number of HEMS missions, treated persons and patients transported. Thinking of need for relocation or more travelling time due to the FTL changes, also the work/life balance will deteriorate together with the social acceptance of the HEMS Business and the Crews involved. The DNR Study “Preliminary Analysis of Potential Regulatory Impacts – EMS” comes to the conclusion, that these task where relevant regarding possible social impacts. Being objective we cannot go conform with the EASA expectation of a neutral result. Instead we think, that the social impact has to be downgraded Comment to economic impact The EASA rule making group itself came to the conclusion, that the economical impact of option 1 – the flexible approach to a new regulation – has to be classified as medium negative. Here we cannot follow the argumentation in total. The difference between the fully prescriptive and the flexible approach is based on the fact, that in option 1 the operator will have the opportunity to set up individual flight time schemes as where in option 2 the operators stick to the new regulations and recruit new pilots. Option 2 is considered as highly negative. To avoid these highly negative impacts we assume, that nearly every HEMS operator will set up individual flight time schedules / schemes. The operators have to set up scientific based studies with a medical expertise. Due to the fact, that some operators have multiple HEMS operating bases with 24/7 h or bases only during daytime and these bases differs sometimes totally in the amount of flight times, duty times and mission complexity and also the daily missions flown, each base has to be evaluated separately. Worst case will be 360 individually based flight time schemes. According to regulation/EU) 216-2008 Article 22 Chapter (2)(c) the EASA has only 1 month for the assessment. The EASA estimates in the first year 11 derogations with about 800 hours for the evaluation. These figures do not match the current evaluations with up to 800 hours a single complex derogation flight time scheme. We do not see the EASA capable of handling the derogations in the given time frames of the basic regulation. The case study of the EASA came to the conclusion, to employ a forth pilot during the summer season. They did not mention, how this will fit into the regulations in cause 5 of the Council Directive 1999/70/EC of 28 June 1999 concerning the framework agreement on fixed-term work. To prevent abuse arising from the use of successive fixed-term employment contracts or relationships, the member states did set up regulations regarding: (a) objective reasons justifying the renewal of such contracts; (b) the maximum total duration of successive fixed-term employment contracts; (c) the number of renewals of such contracts. In Germany this means, if a pilot more is employed more than two times, he will automatically become a fixed-term employer. The impacts of these multiple short term employments have not been considered by the EASA. We therefore consider even the flexible approach (option 1) as highly negative. Conclusion

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 87 of 585

An agency of the European Union

Comparing the EASA conclusion

Safety Impact Social impact Economical impact

Option 1 Positive low benefit neutral Medium negative

With our conclusion

Safety Impact Social impact Economical impact

Option 1 neutral Medium negative Highly negative

we really have to question, if the NPA 2017-17 is appropriate to enhance the safety of HEMS operations. We would like the EASA to think about FTL from the operators and pilots view of sight. With the support of the competent operators, EASA should conduct a continuous monitoring over a period of minimum 5 years about the present provisions concerning flight and duty time limitations and rest requirements to get a updated evidence based judgement of the safety of the existing flight time regulations. Until the end of this evaluation the existing national regulations should stay in place.

response Please see the answer to comment # 54.

comment 1429 comment by: FinnHEMS Oy

"The specific objective of this proposal is to establish an improved and proportionate Europe‐ wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices.” COMMENT: Exactly what scientific knowledge does this refer to? The scientific studies this NPA is based on are mostly inconclusive, not fully relevant or out-dated when it concerns HEMS.

response Please see the answer to comment # 54

2.3. How we want to achieve it - overview of the proposals p. 6-7

comment 221 comment by: ADAC Luftrettung gGmbH

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 88 of 585

An agency of the European Union

Bei Anwendung einer "best practice" gem. Präambel müsste für den HEMS-Flugbetrieb die bisherige Regelung (2.DV LuftBO) sowie die deutsche Studie aus den 1990er Jahren berücksichtigt werden.

response Please see the answer to comment # 54.

comment 250 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): 2.3 According to this paragraph the NPA should take into account best practices in the field of HEMS operations. However neither the experience with 2.DVLuftBO nor the existing German study from the 90’s have been sufficiently considered. Here the rule making process of EASA seems to be inconsistent.

response Please see the answer to comment # 54.

comment 527 comment by: ADAC Luftrettung gGmbH

According to this paragraph the NPA should take into account best practices in the field of HEMS operations. However neither the experience with special German FTL regulation nor the existing German study from the 96’s have been sufficiently considered. Here the rule making process of EASA seems to be inconsistent.

response Please see the answer to comment # 54.

comment 550 comment by: Rüdiger Neu

Gemäß Präambel dieser NPA soll unter anderem die „best practice“ berücksichtigt werden, jedoch wurden sowohl die Erfahrungen der 2. DVLuftBO, als auch die existierende Studie aus Deutschland aus 1996 nicht hinreichend berücksichtigt. Hier widerspricht sich die EASA selbst.

response Please see the answer to comment # 54.

comment 761 comment by: DRF-Luftrettung

The specific objective of this proposal is to establish an improved and proportionate Europe-wide basis for regulating flight and duty times and rest periods for HEMS, based on scientific knowledge and established best practices.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 89 of 585

An agency of the European Union

We have to question very critically the scientific studies and knowledges which have been used. In attachment 2 of the NPA we find some references to studies, which are not aviation based but relate to truck drivers, oil rig workers and railroad drivers which examine fatigue in the field of ground based transportation companies, automobile factories and more. Here we see one large field, where the data is not appropriate to be compared with the HEMS service. Working as employer in a factory always means, that from beginning of the shift until the late end there are no extended break times more than the national labor time regulations. Looking at the tables in Attachment 1 – data collection of EMS FTL provisions we have to state clear, that although the daily duty period may be up to 16 hours, the flight duty period is limited to a much lesser value. In practice this means, that if the HEMS Crew has to fly multiple missions a day, the flight duty time increases and the crew has to quit the service before the duty period is expired. On the other hand are flights at the end of the duty day only possible, when the crew had some hours rest in between. Fatigue in the HEMS Operation is therefore minimized due to early ends or several breaks in between and cannot be compared with scientific studies in other branches. We would like to point out one more mentioned study, where data collection and conclusion do not fit the actual fatigue based evidences. The EASA takes the Study of Goodes from 2003 (Journal of safety research 2003) and states, that working hours more than 12 hours a day have a more than 5 time larger risk of fatigue related incidents. Goodes did not compare EMS but commercial American air traffic and used the so called Chi square to combine two totally different sets of statistic. His first set was the accident statistic from 1978 to 1999 with 55 accidents. His second setup was a set of the working hours from 10 aircraft carriers taken in one month in 1999. His conclusion was, that 5% of human factor accidents where related to pilots working more than 13 hours. The ratio taken from the working hours showed him, that in this specific one month period only 1% of the pilots worked more than 13 hours. Combining these both ratios he concluded, that the risk is more than 5 times higher than for the working shifts with less than 13 hours working time. Looking at this study, you can read, that Goodes is only writing about human error accidents, not fatigue related accidents. For human errors CRM is the relevant tool not FTL. We cannot see the reason, why the EASA takes statistics with values as old as nearly 40 years, to set up scenarios of fatigue related problems. In the list of the scientific studies we missed the only study for fatigue related flight time limitations of helicopter pilots in the HEMS services from the German center of aeronautics and space (DLR), which came 1996 to the conclusion, that duty periods up to 15:30 hrs are a reasonable compromise between the demands of the rescue service and flight safety. The study end with the sentence, that It could be used as a basis for harmonization at European level. This study was not used in the preparation of the NPA and we have heard rumors, that the results of the study where to old to be transferred to the modern demands of the HEMS Service. If this statement of the task group is verified, we have to ask about all the old studies (see Attachment 2 of the NPA) from the early 1990 to 2000 and why these have been used to create a scenario of safety risks in the field of HEMS Services all tough they do not cover HEMS Operations. Please remember, that since 1996 the German HEMS Operators have flown most likely more than 1.600.000 HEMS Missions with about 4.000.000 sectors without any fatigue related incident or accident.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 90 of 585

An agency of the European Union

We think, that this fact is decisive to think about the German regulations as basis for a new

harmonized EASA wide flight time specification.

response Please see the answer to comment # 54.

3.1. Draft cover regulation p. 8-9

comment 269 comment by: European Helicopter Association (EHA)

SHA (Switzerland) 3.1.1

Can you confirm that where alternative ground emergency medical services are not

possible or ineffective we are excluded from this regulation?

response Please see the answer to comment # 54.

comment 213 comment by: Frederique ARONICA Health s' Minsitry France

Attachments #53 #54

Development of FTL for commercial air transport operations of emergency medical services by aeroplanes and helicopters and Update and harmonisation of FTL for commercial air transport by aeroplane for air taxi operations and single-pilot operations taking into account operational experience and recent scientific evidence Affect rules : Regulation (EU) N° 965/2012 Article 8-Flight time limitations The rule “Article 8-Flight time limitations” : CAT operations with aeroplanes, including air taxi, single-pilot operations and emergency medical services, as well as CAT operations with helicopters for the purpose of emergency medical services, shall be subject to the requirements of Subpart FTL of Annex III. Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State. Impact assessment on French HEMS : This rule impacts the HEMS in French Guyana and in the Reunion island as we previously described in annex 2, where alternative ground emergency medical services are not possible or are ineffective.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 91 of 585

An agency of the European Union

French Guyana : It is impossible to go from Cayenne to Maripasoula in Amazonia by land, which gives particular importance to these air links (at least 1 hour 15 to join Cayenne- Maripasoula). Reunion island : Mafate is located in the central area of Reunion. No road serves the interior of the circus where 700 inhabitants live : access is only possible by footpaths or by helicopter. It is a hotspot for hiking tourism in Reunion Island. The isolation of Mafate, far from the roads, imposes a specific way of life and organization. Comments Article 8-Flight time limitations : The rule is amended as follows : France, as member state requests that French Guyana and Reunion are excluded from development of FTL for HEMS.

response Please see the answer to comment # 54.

comment 232 comment by: Federal Office of Civil Aviation (FOCA), Switzerland

Comment FOCA: The exclusion of HEMS operations conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State, is in contradiction to the principal of the Basic Regulation regarding the provision of a level playing field for all actors in the internal aviation market. Furthermore, as a consequence of it's application, numerous HEMS operating bases within alpine countries would be excluded and accordingly not regulated. In Switzerland, most HEMS operating bases are situated in a mountainous environment. FOCA suggests to amend Article 8 Flight Time limitations as below: Proposal FOCA:

‘Article 8 Flight time limitations 1. CAT operations with aeroplanes, including air taxi, single-pilot operations and emergency medical services, as well as CAT operations with helicopters for the purpose of emergency medical services, shall be subject to the requirements of Subpart FTL of Annex III. Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.

response Please see the answer to comment # 54.

comment 301 comment by: European Helicopter Association (EHA)

OEAMTC (Austria) Article YY Regulation (EU) No 965/2012 is amended as follows:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 92 of 585

An agency of the European Union

Article 8 is replaced by the following: […] Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State. COMMENT Who is responsible to decide or judge if an alternative ground emergency service is ineffective? It is not the competence of the competent authority. In case of catastrophic events or events with large impact on a certain region or its population there must be a provision within PART ORO.FTL to allow the operator to act out of this legal framework.

response Please see the answer to comment # 54.

comment 329 comment by: European Helicopter Association (EHA)

FNAM (France) #1 AGREEMENT The FNAM would like to thank the EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. #2 HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and state operators. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, the FNAM suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire :

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 93 of 585

An agency of the European Union

a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 379

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To Article 8: There is an exclusion of certain HEMS operations where ground based EMS are "not possible or ineffective". According to the rationals (page16 of the NPA) it will be up to the competent authority of a Member State to decide whether a certain operation is "not possible or ineffective". "Competent authority" in this context means the competent authority according to ORO.GEN.105, which is an aviation authority. It remains fully unclear how an aviation authority should judge the possibility or efficiency of a ground based EMS. This decision requires in-depth knowledge of organizing and administrating EMS which clearly is a domain of healthcare agencies and authorities and (even clearer) not of aviation authorities which do not have any competencies or knowledge in this area.

response Please see the answer to comment # 54

comment 415 comment by: UFH French Helicopters Association

AGREEMENT UFH would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, FNAM would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area. #2

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 94 of 585

An agency of the European Union

the organization and expenses about Health Care in each Memberstate is out of the scope of the European Union power, as are the labor regulations. UFH expectes hard difficulties to achieve a regulation that could match each individual State situation, HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, UFH supports the FNAM suggests to add a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 447 comment by: Hélicoptères de France

#1 AGREEMENT Hélicoptères de France would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 95 of 585

An agency of the European Union

This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, Hélicoptères de France would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area. #2 HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, Hélicoptères de France suggest adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 459 comment by: FNAM/SNEH

AGREEMENT FNAM and SNEH would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 96 of 585

An agency of the European Union

ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeuand overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, FNAM and SNEH would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area.

response Please see the answer to comment # 54.

comment 460 comment by: FNAM/SNEH

HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, FNAM and SNEH suggest adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 97 of 585

An agency of the European Union

comment 573 comment by: FinnHEMS Oy

Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” COMMENT: It could be easily argued that all ground EMS services are "ineffective" in comparison to airborne services, making this FTL is non-applicable.

response Please see the answer to comment # 54

comment 586 comment by: NOLAS

“Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Comment: This is highly relevant for operation serving remote areas, where also the mission rate is low. However, here it is important to emphasize that it is not always the location of the HEMS operating base that is relevant, but the actual area served. For example, a helicopter can be based in a city, while serving exclusively remote areas. Also, the wording “ineffective” should perhaps be reviewed as most medical personnel or operators could argue that the majority of road transport could be “ineffective” as compared to helicopter transport.

response Please see the answer to comment # 54

comment 639 comment by: Oya Vendée Hélicoptères

AGREEMENT OYA would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, OYA would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area.

response Please see the answer to comment # 54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 98 of 585

An agency of the European Union

comment 640 comment by: Oya Vendée Hélicoptères

HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, OYA suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 711 comment by: ÖAMTC Helicopter Air Rescue (Austria)

Article 8 Flight time limitations [...] Who is responsible to decide or judge if an ambulance system is ineffective? It is not the competence of the competent authority.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 99 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 766 comment by: AECA helicopteros.

Clarify the ‘operating area’ concept, using a CS or definitions page. Justification.- Being a concept that is left to the states definition, it is convenient to start from common criteria to avoid definitions that can be very diverse, making impossible the harmonization

response Please see the answer to comment # 54

comment 902 comment by: MBH SAMU

AGREEMENT MBH would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, MBH would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area.

response Please see the answer to comment # 54.

comment 903 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 100 of 585

An agency of the European Union

For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, MBH suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 908 comment by: AESA

New Article 8 of UE 965/2012 includes the statement “Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area where alternative ground emergency medical services are not possible or are ineffective…” In a general way, if helicopter is selected for an emergency medical operation, with its high associated cost, is because of ground service is not effective in that case or area. From this point of view, every HEMS operation could be excluded from new FTL. It would be necessary further explanation about this statement. Point 2 of Article 8 could include “CAT operations with helicopters, other than emergency medical services excluding those where alternative ground emergency are not possible or ineffective, and CAT operations …”. Otherwise, the exclusion of point 1 is not included.

response Please see the answer to comment # 54.

comment 1066 comment by: European Cockpit Association

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 101 of 585

An agency of the European Union

Commented text (page 8): Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State. ECA comment: ECA strongly opposes this new wording. Also, this proposal was never discussed in the Rulemaking Group. The proposed wording is providing for too much interpretation, since HEMS business itself is for rescuing people in areas, where other medical service is inappropriate. Either this rule is a safe and appropriate rule, then it should come into effect for every HEMS operation, or it is not safe and appropriate. Saving lives should never be a reason to endanger an aircraft, its occupants or people on the ground.

response Please see the answer to comment # 54.

comment 1180 comment by: SAF

AGREEMENT SAF would like to thank EASA for having excluded “emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.” Indeed, this is very useful in France since some HEMS operators have their HEMS base on an island (for instance on l’ile d’Yeu and overseas territories) and cannot be reached in an effective time and/or effective condition for the sake of the safe transportation of the patient by ground emergency medical services. This is also the case for French Guyana and the Reunion Island due to their landscape features. Additionally, SAF would like to point out that this exemption should also apply for mixed operations when a helicopter dedicated to EMS, and operated usually in an operating area where alternative ground emergency medical services are not possible or are ineffective, is brought to fly exceptionally in a non-exempted operating area.

response Please see the answer to comment # 54.

comment 1181 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 102 of 585

An agency of the European Union

shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, SAF suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : « Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile. » (ref CAC D 422-12)

response Please see the answer to comment # 54.

comment 1319 comment by: SAS

The amendment to 1. CAT operations appears to put into question the applicability of the whole NPA to the vast majority of HEMS operations in the UK. All UK HEMS operations are conducted in a specified local operating area, although alternative ground emergency medical services are possible, they are ineffective at delivering some of the services provided by HEMS aircraft. For example, HEMS aircraft often carry higher level medical personnel such as pre-hospital Doctors and specialist medical equipment not found on ground emergency services. In other situations it could be said that the ground medical services are ineffective at getting a patient to hospital in a suitable timeframe for the injuries or ailments with which they are suffering.

response Please see the answer to comment # 54

comment 1339 comment by: ENAC

Art.8 The new Art.8 excludes the applicability of the HEMS FTL requirements to HEMS operations that take place in areas where alternative ground services are not possible or ineffective.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 103 of 585

An agency of the European Union

It is not specified what requirements shall apply to those HEMS operators who perform medical services in those area. This lack of clear rules could lead to potential unsafe situations. Furthermore, since CAA has not control on every single HEMS mission, for the purpose of the oversight, it would be very difficult to verify compliance with the FTL limitations on HEMS operators because It would be impossible to verify if the operator flew in or out the established areas. This in consideration that the Italy has an extensive part of the territory where the ground service is impossible or ineffective (Sicilian and Tyrrhenian islands, Alps and Apennines mountains) For the above reasons ENAC proposes to stand by with the HEMS FTL rulemaking until further clarifications and exlude HEMS FTL from the NPA 2017-17.

response Please see the answer to comment # 54

comment 1363 comment by: Civil Aviation Authority of Norway

On Article 8: The possibility to exclude such HEMS services is supported and is considered necessary to avoid the highly negative impacts the proposed HEMS rules will have on these remote bases as highlighted in the impact assessment of this NPA.

response Please see the answer to comment # 54.

comment 1431

comment by: COPAC COLEGIO OFICIAL DE PILOTOS DE LA AVIACIÓN

COMERCIAL

En el “Article 8 Flight time limitations” se excluye la aplicación de esta NPA a algunas de las operaciones HEMS “Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State” ¿Cómo se aplicaría la norma para el caso de aeronaves que se encuentren en bases en áreas normales, pero que pueden atender servicios en dichas áreas donde servicios alternativos por tierra no son posibles o inefectivos?

response Please see the answer to comment # 54.

comment 1464

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

3.1 Article YY “1. CAT operations . . . Excluded are emergency medical service operations with helicopters conducted exclusively in an operating area, where alternative ground emergency medical services are not possible or are ineffective, as defined by the Member State.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 104 of 585

An agency of the European Union

Enhance the exclusion to be valid for HEMS operations mainly in an operating area where alternative ground emergency medical services are not possible, etc…. By changing in this manner, it would be possible to allow operators who usually operate in remote areas but on occasions do transports to more congested parts of the country.

response Please see the answer to comment # 54.

3.1. ORO.FTL.100 p. 9

comment 270 comment by: European Helicopter Association (EHA)

SHA (Switzerland) 3.1.2

Regulation is applicable to CAT operations with helicopters / how is it intended to work

for operators like us flying daily under CAT, SPO, National. What will be applicable and

how?

response Please see the answer to comment # 54.

comment 330 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. The FNAM asks for a sound RIA to assess the economic and social impacts in addition to the flight safety impact.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 105 of 585

An agency of the European Union

comment 416 comment by: UFH French Helicopters Association

ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. FNAM thinks it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

comment 448 comment by: Hélicoptères de France

ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. Hélicoptères de France thinks it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

comment 461 comment by: FNAM/SNEH

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 106 of 585

An agency of the European Union

flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. FNAM and SNEH think it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

comment 641 comment by: Oya Vendée Hélicoptères

ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. OYA thinks it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

comment 904 comment by: MBH SAMU

ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. MBH thinks it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

comment 1182 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 107 of 585

An agency of the European Union

ISSUE In France, the technical crew member (TCM) who supports the pilot while ground or in- flight duties, does not have the same social regulatory framework than the pilots nor the cabin crew members. No European requirements for TCM are described in the Aircrew. They are all described in the AirOps and does not originate from the ICAO SARPs. Nevertheless, the scope of the FTL, through the proposal ORO.FTL.100 (‘HEMS crew members’) and the other proposals of this NPA, seems to place TCM and pilots at the same level. This will have impacts on the flight safety requirements for TCM, but it will also have an economic and social impact for operators and this aspect must not be neglected. SAF thinks it would be beneficial to further develop the economic and social impacts in the RIA in addition to the flight safety impact.

response Please see the answer to comment # 54

3.1. ORO.FTL.105 p. 9-10

comment 92 comment by: B. Wagner

(30) 'single-pilot operation' for HEMS muss auch die Möglichkeit einschliessen, dass der Pilot während einzelner Sektoren alleine an Bord sein darf, wenn der HEMS TC aus medizinischer Notwendigkeit den Arzt und den Patienten bodengebunden begleitet.

response Please see the answer to comment # 54

comment 107 comment by: UK CAA

Page No: 10 Paragraph No: ORO.FTL.105, (29) Definitions “EMS flight” Comment: The definition has been adapted from the HEMS definition but it is missing the requirement that the helicopter must be operating under a HEMS approval. This is an important reference within the HEMS definition and needs to be consistent within this definition. Justification: Clarity and consistency Proposed Text: “… or helicopter (operating under a HEMS approval) …”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 108 of 585

An agency of the European Union

response Please see the answer to comment # 54.

comment 271 comment by: European Helicopter Association (EHA)

SHA (Switzerland) 30

Single pilot ops: why HEMS Single pilot is defined with one pilot and one HEMS crew

member? This is not correct. A single pilot operation means one pilot only. This needs to

be amended.

response Please see the answer to comment # 54

comment 302 comment by: European Helicopter Association (EHA)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 109 of 585

An agency of the European Union

OEAMTC (Austria) ORO.FTL.105 Definitions For the purpose of this Subpart, the following definitions shall apply: […] (29) ‘EMS flight’ means a flight with an aeroplane (AEMS) or helicopter (HEMS) carrying out emergency medical service operations, the purpose of which is to facilitate emergency medical assistance, where immediate and rapid transportation is essential, by carrying at least one of the following: (a) medical personnel; (b) medical supplies (equipment, blood, organs, drugs); (c) ill or injured persons and other persons directly involved. A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight. COMMENT(S) With sector not defined for helicopters are the fights to the operating base before or after an HEMS flight considered part of that flight? If HEMS is not to be included in the definition then the definition must be changed to read: A sector flown to position an aircraft to the operating base before or after an AEMS flight is considered part of that flight ORO.FTL.105 Definitions For the purpose of this Subpart, the following definitions shall apply: […] (30) ‘single-pilot operation’ means, in the case of aeroplanes, an operation with one pilot or, in the case of HEMS, an operation with one pilot and one HEMS crew member. COMMENT(S) The HEMS concept of operating a mixed crew in which tasks are shared differs considerably from a true single pilot concept since cockpit workload is divided and monitoring is taking place. There are no credits for this sharing of workload in terms of FTL however the HEMS TCM must adhere to the FTL. Credits should be given for the mixed crew concept and be treated same as two-pilots.

response Please see the answer to comment # 54

comment 331 comment by: European Helicopter Association (EHA)

FNAM (France) #1 (5) “augmented flight crew” ADD an ON-BOARD REST DEFINITION ISSUE The FNAM thinks a clear and precise definition of on-board rest shall be provided.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 110 of 585

An agency of the European Union

The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby, especially for split duty. (cf. split duty and standby comments) Moreover, the FNAM doesn't understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest. #2 (24) ‘sector’ AGREEMENT The FNAM agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. The FNAM would like the Agency to keep this change - and the reason why - in mind when the EASA extends FTL to other CAT operations with helicopters. #3 (29) ‘EMS flight’ ISSUE According to the definition of a sector (§24) in ORO.FTL.105, the notion of sector is not applicable to HEMS operations. However, the notion of sector appears in the EMS flight definition (§29) although the EMS flight definition shall apply for HEMS operations. (Cf. comment #14.3) Besides, the helicopter by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the helicopter by itself, blood, organs, drugs);” Replace the sentence in §29: “A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.” by “A flight flown to position an aircraft to the operating base before or after an EMS flight is considered part of that emergency medical service.”

response Please see the answer to comment # 54

comment 360 comment by: European Helicopter Association (EHA)

BHA (UK) "'break’ means a period of time within an flight duty period, shorter than a rest period, counting as duty and during which a crew member is free of all tasks; " Comment: Poor definition. A break is a period when crew members are "free of all tasks," but a duty period ends when a crew members are "free of all duties." What's the difference?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 111 of 585

An agency of the European Union

"‘sector’ means the segment of an FDP between an aircraft aeroplane first moving for the purpose of taking off until it comes to rest after landing on the designated parking position." Comment: With change of text, this definition now excludes rotorcraft, contrary to the explanatory notes. "‘single-pilot operation’ means, in the case of aeroplanes, an operation with one pilot or, in the case of HEMS, an operation with one pilot and one HEMS crew member. " Comment: Agreed, but elsewhere in the document FDPs and fatigue levels are considered based on SP experience alone, and take no account of shared responsibilities.

response Please see the answer to comment # 54

comment 417 comment by: UFH French Helicopters Association

ADD an ON-BOARD REST DEFINITION ISSUE French stakeholders think that a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby. Moreover, we do not understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest. #2 (24) ‘sector’ AGREEMENT UFH agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. UFH supports the proposal of FNAM to the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters. #3 (29) ‘EMS flight’ ISSUE According to the definition of a sector (§24) in ORO.FTL.105, the notion of sector is not applicable to HEMS operations. However, the notion of sector appears in the EMS flight definition (§29) although the EMS flight definition shall apply for HEMS operations. (Cf. comment #14.3)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 112 of 585

An agency of the European Union

Besides, the helicopter by itself is part of the medical supplies which cannot be dissociated. Thus, it should be precise in the paragraph (29)(b). PROPOSAL Replace the paragraph (b) by the following: “(b) medical supplies (equipment including the helicopter by itself, blood, organs, drugs);” Replace the sentence in §29: “A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.” by “A flight flown to position an aircraft to the operating base before or after an EMS flight is considered part of that emergency medical service.”

response Please see the answer to comment # 54

comment 462 comment by: FNAM/SNEH

(5) “augmented flight crew” ADD an ON-BOARD REST DEFINITION ISSUE FNAM and SNEH think a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations.

This shall be applicable for split duty but also for standby. Moreover, FNAM and SNEH don’t understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest.

response Please see the answer to comment # 54

comment 463 comment by: FNAM/SNEH

(24) ‘sector’ AGREEMENT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 113 of 585

An agency of the European Union

FNAM and SNEH agree to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. FNAM and SNEH would like the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters.

response Please see the answer to comment # 54

comment 464 comment by: FNAM/SNEH

response Please see the answer to comment # 54

comment 574 comment by: FinnHEMS Oy

"Single-pilot operation" means something else than operations with one pilot and one HEMS-crew member.

response Please see the answer to comment # 54

comment 642 comment by: Oya Vendée Hélicoptères

(5) “augmented flight crew” ADD an ON-BOARD REST DEFINITION ISSUE OYA thinks a clear and precise definition of on-board rest shall be provided.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 114 of 585

An agency of the European Union

The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby. Moreover, OYA doesn't understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest.

response Please see the answer to comment # 54

comment 643 comment by: Oya Vendée Hélicoptères

(24) ‘sector’ AGREEMENT OYA agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. OYA would like the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters.

response Please see the answer to comment # 54

comment 644 comment by: Oya Vendée Hélicoptères

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 115 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 882 comment by: Stephanie Selim

Definition (24) ‘sector’ Technical comment – If the word « sector » only concerns aeroplanes, it should be deleted in all points where it still appears and could concern HEMS operations, as: - - the last sentence of definition n°29 which concerns AEMS and HEMS, and it could be replaced for example by the word « flight », - - ORO.FTL.110 i) - - in CS.FTL.3.205 b) (page 36).

response Please see the answer to comment # 54

comment 906 comment by: MBH SAMU

(5) “augmented flight crew” ADD an ON-BOARD REST DEFINITION ISSUE MBH thinks a clear and precise definition of on-board rest shall be provided. The notion is not easy to understand as it can be on the ground or in-flight and may lead to misunderstanding and subjective interpretations. This shall be applicable for split duty but also for standby. Moreover, MBH doesn't understand why the on-board rest is associated with the notion of augmented flight crew. Indeed, a non-augmented crew is able to have on-board rest since it can be taken on the ground. PROPOSAL Provide a clear and precise definition for on-board rest.

response Please see the answer to comment # 54

comment 907 comment by: MBH SAMU

(24) ‘sector’ AGREEMENT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 116 of 585

An agency of the European Union

MBH agrees to replace in the ‘sector’ definition ‘aircraft’ by ‘aeroplane’. The notion of ‘sector’ is therefore not defined anymore for helicopters and thus not applicable for HEMS operations. MBH would like the Agency to keep this change - and the reason why - in mind when EASA extends FTL to other CAT operations with helicopters.

response Please see the answer to comment # 54

comment 913 comment by: MBH SAMU

response Please see the answer to comment # 54

comment 919 comment by: AESA

Definition of “sector” has been changed replacing “aircraft” by “aeroplane” so helicopters are excluded from definition. Then, sector is used in CS.3 (e.g. in CS.3.205(b)). Since the meaning of "sector" usually is different for aeroplanes and helicopters, a definition of “sector” for helicopters should be added.

response Please see the answer to comment # 54

comment 919 comment by: AESA

Definition of “sector” has been changed replacing “aircraft” by “aeroplane” so helicopters are excluded from definition. Then, sector is used in CS.3 (e.g. in CS.3.205(b)).

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 117 of 585

An agency of the European Union

Since the meaning of "sector" usually is different for aeroplanes and helicopters, a definition of “sector” for helicopters should be added.

response Please see the answer to comment # 54

comment 1365 comment by: Civil Aviation Authority of Norway

On the definition of "single pilot operation": Annex V (Part SPA) to Reg. 965/2012 already uses the term "HEMS technical crew member". See also the definition of technical crew member in annex I to Reg. 965/2012. The terminology should be consistent if the term "HEMS crew member" refer to the same group of persons.

response Please see the answer to comment # 54

comment 1383 comment by: Swiss Air-Ambulance Rega

(No. 29) The definition has been adapted from the HEMS definition but it is missing the requirement that the helicopter must be operating under a HEMS approval. This is an important reference within the HEMS definition and needs to be consistent within this definition. Proposed amendment: “… or helicopter (operating under a HEMS approval) …”

response Please see the answer to comment # 54

comment 1393 comment by: European Helicopter Association (EHA)

Deutscher Hubschrauber Verband / DHV (Germany) Paragraph No: ORO.FTL.105, (13) Definitions “flight time” Comment: The word “total” is missing from this definition and should be included as per PART.FCL.010, Definition for Flight time: “for aeroplanes, touring motor gliders and powered-lift, it means the total time from the moment an aircraft first moves for the purpose of taking off until the moment it finally comes to rest at the end of the flight; for helicopters, it means the total time from the moment a helicopter’s rotor blades start turning until the moment the helicopter finally comes to rest at the end of the flight, and the rotor blades are stopped.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 118 of 585

An agency of the European Union

Justification: Consistency Proposed Text: Include the word “total” in the definition in line with the PART FCL definition. Paragraph No: ORO.FTL.105, (29) Definitions “EMS flight” Comment: The definition has been adapted from the HEMS definition but it is missing the requirement that the helicopter must be operating under a HEMS approval. This is an important reference within the HEMS definition and needs to be consistent within this definition. Justification: Clarity and consistency Proposed Text: “… or helicopter ( operating under a HEMS approval) …”

response Please see the answer to comment # 54

comment 1432

comment by: COPAC COLEGIO OFICIAL DE PILOTOS DE LA AVIACIÓN

COMERCIAL

Según ORO.FTL.105. (29), en la definición de EMS flight se indica entre otros “(…) by carring at least one of the following: (a) medical personel (…)”. Según esta definición, ¿todos aquellos servicios SAR que van dotados con personal médico pasarían a tratarse como HEMS? La pregunta viene motivada porque esta definición entra en conflicto con la definición SAR de la Normativa del Estado Miembro español.

response Please see the answer to comment # 54

comment 1454 comment by: Association of Air Ambulances

response Please see the answer to comment # 54

comment 1483 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 119 of 585

An agency of the European Union

Reasoning: New definitions ´active standby´, ‘active duty period (‘ADP’)’, ‘inactive duty period’ (‘IDP’)’ and 'relief crew' are essential to regulate active standby which differs from the current standby. Active standby is duty time, during which the pilots are immediately ready for HEMS tasks organised by the air operator. Active duty period (ADP) comprises of flying duty (FDP) and duty time used for other tasks, as requested by the operator. When there are no tasks, the duty time is counted as inactive duty. However, the inactive duty is not counted as a rest. The flight time and ADP during rolling 24 hour period are limited, and the maximum active duty can be maximum 72 hours see CS.FTL.3.207. Proposal: Add new definitions in ORO.FTL.105 as follows: (31) ´active standby´ means a duty period when the flight crew members are immediately prepared to start performing tasks. Active standby includes active duty and inactive duty. Active standby has to be planned in the duty roster. (32) ‘active duty period (‘ADP’)’ means FDP and all other tasks performed for the air operator which are not directly related to flying FDP, such as office work, aircraft inspections, loading, servicing or training organised by the air operator. (33) ‘inactive duty period (‘IDP’)’ means all other time than ADP during the active standby. The crew member must spent IDP in a place with facilities for washing and sleeping, such as a suitable accommodation in HEMS operating base or hotel room. IDP is not counted as a rest. (34) ´relief crew´ means HEMS crew member available to receive an assignment for an active standby, as required by the operator and as specified in the operations manual.

response Please see the answer to comment # 54

comment 140 comment by: CAA-NL

ORO.FTL.105 Definitions Comment: In the definition of ‘sector’ the requirement for helicopters is missing. With the replacement of aircraft by aeroplane the definition of sector is not applicable to helicopters anymore. Is it the intention not to apply this for helicopter operations and only relate to flight time? Also for helicopter operations the start and landing is the most intense part of the flight. When the duration of a typical heli-flight may be shorter it might be reasonable to take higher figures for the related use of sectors within the calculations for helicopter operations but not to delete this completely from the calculations of FDP max.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 120 of 585

An agency of the European Union

response Please see the answer to comment # 54

3.1. ORO.FTL.110 p. 10

comment 332 comment by: European Helicopter Association (EHA)

FNAM (France) #1 (i) AGREEMENT The paragraph (i) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times (FT) shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS) (Cf. comment #14.2) The FNAM fully agrees with the fact that FT cannot and shall not be scheduled before HEMS operations. Only FDP shall and can be scheduled. #2 (k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time is 25 minutes for HEMS, i.e 50 minutes back and force (1 mission)i: • Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP • Incertitude allowance over the FDP would thus not depend on the FT, but on the time spent grounded on the emergency site to take HEMS material (mostly, the patient, when stabilized and declared transportable by the medical staff) Thus, this provision seems irrelevant for HEMS. Therefore, the FNAM thinks an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations. Hence, the FNAM suggests applying the same allowance between scheduled and actual FDP than the one used for CAT, i.e 33%. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months. In HEMS operations,

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 121 of 585

An agency of the European Union

change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 33 % of the FDPs in any 3 months”.

response Please see the answer to comment # 54

comment 418 comment by: UFH French Helicopters Association

(i) AGREEMENT The paragraph (i) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times (FT) shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS) (Cf. comment #14.2) FNAM fully agrees with the fact that FT cannot and shall not be scheduled before HEMS operations. Only FDP shall and can be scheduled. #2 (k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for operators is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission)i: • Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP • Incertitude allowance over the FDP would thus not depend on the FT, but on the time spent grounded on the emergency site to take HEMS material (mostly, the patient, when stabilized and declared transportable by the medical staff) Thus, this provision seems irrelevant for HEMS. Therefore, we think an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54

comment 465 comment by: FNAM/SNEH

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 122 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 466 comment by: FNAM/SNEH

(k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for SNEH is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission):

• Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP

Thus, this provision seems irrelevant for HEMS. Therefore, FNAM and SNEH think an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54

comment 645 comment by: Oya Vendée Hélicoptères

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 123 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 646 comment by: Oya Vendée Hélicoptères

(k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for OYA is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission):

• Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP

Thus, this provision seems irrelevant for HEMS. Therefore, OYA thinks an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 124 of 585

An agency of the European Union

comment 767 comment by: AECA helicopteros.

(j) Delete ‘except for EMS operations’. (k) Delete all paragraph (k) Justification.- (j) Why the difference between CAT (33%) and EMS (10%)? (k) Reducing the percentage of enlargement reduces flexibility and, consequently, the capacity to respond. It shold be taken into account that we provide emergency services and reduce the flexibility to make it difficult to provide adequate services or even somes services could not be performed if is maintained the 10% of extension. In no case we are faced with scheduled services such as CAT, since you never know in advance when the event arises.

response Please see the answer to comment # 54

comment 914 comment by: MBH SAMU

response Please see the answer to comment # 54.

comment 916 comment by: MBH SAMU

(k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for MBH is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission):

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 125 of 585

An agency of the European Union

• Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP

Thus, this provision seems irrelevant for HEMS. Therefore, MBH thinks an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54.

comment 1187 comment by: SAF

response Please see the answer to comment # 54.

comment 1188 comment by: SAF

(k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 126 of 585

An agency of the European Union

The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed. The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for SAF is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission):

• Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP

Thus, this provision seems irrelevant for HEMS. Therefore, SAF thinks an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54.

comment 1265 comment by: Hélicoptères de France

#1 (i) AGREEMENT The paragraph (i) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times (FT) shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS) (Cf. comment #14.2) HDF fully agree with the fact that FT cannot and shall not be scheduled before HEMS operations. Only FDP shall and can be scheduled. #2 (k) ISSUE No RIA is given to reduce from 33% (general rules for CAT operations) to 10% (proposed for HEMS operations) the allowance between scheduled and actual FDP. The notion of scheduled FT is a non-sense for HEMS, where emergency destinations are hazardous but remain closeby. Thus, the hazard does not belong on determining flight time, but on when the last flight is performed.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 127 of 585

An agency of the European Union

The incertitude over max FDP is thus very low for mostly short helicopters legs, with no or low ATC constraints. In France, the average flight time for SNEH is 25 minutes for HEMS, i.e 50 minutes back and forth (1 mission)i:

• Incertitude allowance over the FT would thus be 2,5min, which is not significative and contrary to aeroplane CAT operations, has very low impact on the time of the end of the FDP NPA 2017-17 | HEMS Comments | FNAM & SNEH 14/57

• Incertitude allowance over the FDP would thus not depend on the FT, but on the time spent grounded on the emergency site to take HEMS material (mostly, the patient, when stabilized and declared transportable by the medical staff) Thus, this provision seems irrelevant for HEMS. Therefore, HDF thinks an allowance between scheduled and actual FDP of 10% is not appropriate for HEMS operations and should be suppressed. PROPOSAL: Replace the paragraph (k) by the following: “(k) in AEMS operations, change a schedule or adapt crew arrangements, if the actual operation exceeds the maximum FDP on any EMS operating base on more than 10 % of the FDPs in any 3 months.”

response Please see the answer to comment # 54.

3.1. ORO.FTL.120 p. 10

comment 222 comment by: ADAC Luftrettung gGmbH

Ein Unternehmen muss ein FRM durchführen wenn dies im Abschnitt "certification specification" gefordert ist. Da dies im Abschnitt FTL.3.235 nur bei "reduced rest" gefordert ist, ist bei Schichtbetrieb oder Einhaltung der vorgeschriebenen Ruhezeit dennoch ein FRM von Nöten?

response Please see the answer to comment # 54

comment 251 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) Fatigue Risk Management Question: the operator shall implement and maintain a FRM if required in certification specifications. This is only the case in CS FTL3.235 “reduced rest”. Is the assumption correct, that FRM is not necessary in case of regular rest periods like for instance a roster with only 8 hour FDP?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 128 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 361 comment by: European Helicopter Association (EHA)

BHA (UK) "ORO.FTL.120 Fatigue risk management (FRM) […] (b) The FRM established, implemented and maintained shall provide for a continuous improvement to the overall performance of the FRM and shall include: […] SECTION 2 Commercial Air Transport Operators […] " Comment: From the main FTL scheme, ORO.FTL.200 _ Home Base - would go here. Have the authors considered what impact this may have for TCMs?

response Please see the answer to comment # 54

comment 528 comment by: ADAC Luftrettung gGmbH

Question: the operator shall implement and maintain a FRM if required in certification specifications. This is only the case in CS FTL3.235 “reduced rest”. Is the assumption correct, that FRM is not necessary in case of regular rest periods like for instance a roster with only 8 hour FDP or the rest time after a FDP is greater than the FDP?

response Please see the answer to comment # 54

comment 551 comment by: Rüdiger Neu

Fragestellung: Das Unternehmen muss ein FRM haben und weiterführen, wenn dies im Abschnitt C&S certification specification gefordert wird. Dies ist nur im Abschnitt bei der CS FTL.3.235 „reduced rest“ gefordert. Ist es richtig, dass ein FRM bei einem Schichtbetrieb oder der Einhaltung der regulären Ruhezeiten dann nicht benötigt werden?

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 129 of 585

An agency of the European Union

comment 742 comment by: DRF-Luftrettung

response Please see the answer to comment # 54

comment 1384 comment by: Swiss Air-Ambulance Rega

Question: The operator must have and maintain an FRM if this is required in the CS section. This is only required in the section on “reduced rest” of CS FTL.3.235. Is it correct that an FRM is not necessary for shift operation or in adherence to regular rest times?

response Please see the answer to comment # 54

3.1. ORO.FTL.205 p. 10-13

comment 59 comment by: London's Air Ambulance

ORO.FTL.205(b) There is no mention in this paragraph of the FDP table for two-pilot HEMS which is at CS.FTL.3.205. Elsewhere in the amended IR there is reference to CS.FTL so it would be useful and aid clarity if a new paragraph ORO.FTL.205(b)(8) was adding: “In the case of two-pilot HEMS operations, the FDP limitation stated in CS.FTL.3(a) Table 1, are applicable.” It is our opinion that a definition of Multi-Pilot operation rather than Two-Pilot operations.

response Please see the answer to comment # 54.

comment 272 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Table 5

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 130 of 585

An agency of the European Union

Table 5 is defined with sectors but sectors are only for airplanes see article 29 page 10.

response Please see the answer to comment # 54

comment 273 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Flight time for each sector limited to 2 h without autopilot : this is discriminating for helicopter and shall be amended at least at 2h30 (fuel limit). Moreover, the article is confusing between EMS and HEMS.

response Please see the answer to comment # 54

comment 333 comment by: European Helicopter Association (EHA)

FNAM (France) #1(a)(1) ISSUE The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). The FNAM suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1). #2(b) GENERAL REMARK regarding the notion of a Daily FDP For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h. #3ISSUE The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, the FNAM would like to highlight that other cases (such as non-acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. The FNAM suggests suppressing the wording “without the use of extensions”. PROPOSAL Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7): “(b) Basic maximum daily FDP

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 131 of 585

An agency of the European Union

[…] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.” #4(c)AGREEMENT The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why the FNAM agrees not to add the notion of TCM in this paragraph. #5 (f) UNFORESEEN CIRCONSTANCES FOR HEMS ISSUE (Cf. comment #29.2) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and state operators. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, the FNAM suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12) #6 AMC1 ORO FTL 205 (f) ISSUE The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified it in the AMC. (Cf. comment #14.2)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 132 of 585

An agency of the European Union

PROPOSAL “(6) increased number of sectors, except for HEMS.”

response Please see the answer to comment # 54.

comment 362 comment by: European Helicopter Association (EHA)

BHA (UK) Table 5 Comment: Did this table really have to be so complicated, with time intervals of just fifteen minutes? I would challenge any scientist to prove that such small variations could ever make a demonstrable difference to flight safety. "(d1) Maximum daily FDP for acclimatised crew members in two-pilot air taxi and AEMS operations with the use of extensions without on-board rest " Comment: Unable to comment on air taxi and AEMS operations, because all feedback received was from HEMS operators.

response Please see the answer to comment # 54

comment 381

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

ORO.FTL.205(b)(7) and (f)(7) It is expected that most European HEMS operators will apply for deviations according to Article 22 Basic Regulation and flight time specification schemes according to ORO.FTL.125. Since this will lead to a deviation from the CS (but not from the Part- ORO.FTL itself!) it remains unclear what effect such a deviation might cause on the rule ORO.FTL.205(b)(7) and (f)(7) stating "…in accordance with the certification specification…". The possibility to obtain an approval for a deviation should be addressed in this rule.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 133 of 585

An agency of the European Union

comment 391 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Comment: Daily FDP shall be increased to 12h for unknown state of acclimatisation as long as you have no jetlag.

response Please see the answer to comment # 54

comment 419 comment by: UFH French Helicopters Association

(a)(1)ISSUE The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). FNAM suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1). #2(b) GENERAL REMARK regarding the notion of a Daily FDP For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h. #3 ISSUE The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, we would like to highlight that other cases (such as non-acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. We suggests suppressing the wording “without the use of extensions”. PROPOSAL Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7): “(b) Basic maximum daily FDP […] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.” #4(c) AGREEMENT The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why FNAM agrees not to add the notion of TCM in this paragraph. #5 (f) UNFORESEEN CIRCONSTANCES FOR HEMS ISSUE (Cf. comment #29.2) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 134 of 585

An agency of the European Union

State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, UFH supports FNAM suggestion to add a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12) #6 AMC1 ORO FTL 205 (f) ISSUE The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified it in the AMC. (Cf. comment #14.2) PROPOSAL “(6) increased number of sectors, except for HEMS.” (b) ISSUE In the paragraph (b), it is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #24, #25, #30.1, #39, #40) Therefore, UFH suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 135 of 585

An agency of the European Union

operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; and (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #30): (1) 110 duty hours in any 14 consecutive days, on the condition that: i. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.” #2 (d) ISSUE The definition of the mixed AEMS / HEMS operations is not precise and may lead to confusion. Indeed, it is not the philosophy of CAT operations to possess multiple type ratings for pilots especially aeroplane vs helicopter. The wording used is confusion and can be understood in different ways: • Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations We cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, UFH will see with EBAA and FNAM to give a French opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response Please see the answer to comment # 54

comment 467 comment by: FNAM/SNEH

(a)(1) ISSUE The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). FNAM and SNEH suggest clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1).

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 136 of 585

An agency of the European Union

comment 468 comment by: FNAM/SNEH

(b) GENERAL REMARK regarding the notion of a Daily FDP For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h.

response See the answer to comment # 54.

comment 469 comment by: FNAM/SNEH

ISSUE The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, FNAM and SNEH would like to highlight that other cases (such as non- acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. FNAM and SNEH suggest suppressing the wording “without the use of extensions”. PROPOSAL Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7): “(b) Basic maximum daily FDP […] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.”

response See the answer to comment # 54.

comment 470 comment by: FNAM/SNEH

(c) AGREEMENT The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why FNAM and SNEH agree not to add the notion of TCM in this paragraph.

response See the answer to comment # 54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 137 of 585

An agency of the European Union

comment 471 comment by: FNAM/SNEH

(f) UNFORESEEN CIRCONSTANCES FOR HEMS ISSUE (Cf. comment #491) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, FNAM and SNEH suggest adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12)

response See the answer to comment # 54.

comment 472 comment by: FNAM/SNEH

AMC1 ORO FTL 205 (f) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 138 of 585

An agency of the European Union

The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified in the AMC. (Cf. comment #463) PROPOSAL “(6) increased number of sectors, except for HEMS.”

response See the answer to comment # 54.

comment 647 comment by: Oya Vendée Hélicoptères

(a)(1) ISSUE The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). OYA suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1).

response See the answer to comment # 54.

comment 648 comment by: Oya Vendée Hélicoptères

response See the answer to comment # 54.

comment 649 comment by: Oya Vendée Hélicoptères

ISSUE The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, OYA would like to highlight that other cases (such as non-acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. OYA suggests suppressing the wording “without the use of extensions”. PROPOSAL Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7):

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 139 of 585

An agency of the European Union

“(b) Basic maximum daily FDP […] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.”

response See the answer to comment # 54.

comment 650 comment by: Oya Vendée Hélicoptères

(c) AGREEMENT The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why OYA agrees not to add the notion of TCM in this paragraph.

response See the answer to comment # 54.

comment 651 comment by: Oya Vendée Hélicoptères

(f) UNFORESEEN CIRCONSTANCES FOR HEMS ISSUE (Cf. comment #671) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, OYA suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire :

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 140 of 585

An agency of the European Union

response See the answer to comment # 54.

comment 652 comment by: Oya Vendée Hélicoptères

AMC1 ORO FTL 205 (f) ISSUE The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified in the AMC. (Cf. comment #643) PROPOSAL “(6) increased number of sectors, except for HEMS.”

response See the answer to comment # 54.

comment 812 comment by: Yorkshire Air Ambulance

From the main FTL scheme, ORO.FTL.200 - Home Base - goes above here. Have the authors considered what impact the impostion of a Home Base may have for TCMs, and how it might conflict with contractual obligations elsewhere?

response See the answer to comment #54.

comment 826 comment by: Yorkshire Air Ambulance

Did this table really have to be so complicated, with time intervals of just fifteen minutes? I would challenge any scientist to prove that such small variations could ever make a demonstrable difference to flight safety. Suggest it is redrafted to be more useable by both crews and operators.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 141 of 585

An agency of the European Union

response See the answer to comment #54.

comment 828 comment by: Yorkshire Air Ambulance

Unable to make useful comments on air taxi and AEMS operations, because all feedback received was from HEMS operators.

response See the answer to comment #54.

comment 917 comment by: MBH SAMU

(a)(1) ISSUE The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). MBH suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1).

response See the answer to comment #54.

comment 918 comment by: MBH SAMU

response See the answer to comment #54.

comment 920 comment by: MBH SAMU

ISSUE The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, MBH would like to highlight that other cases (such as non-acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. MBH suggests suppressing the wording “without the use of extensions”. PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 142 of 585

An agency of the European Union

Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7): “(b) Basic maximum daily FDP […] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.”

response See the answer to comment #54.

comment 921 comment by: MBH SAMU

(c) AGREEMENT The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why MBH agrees not to add the notion of TCM in this paragraph.

response See the answer to comment #54.

comment 922 comment by: MBH SAMU

(f) UNFORESEEN CIRCONSTANCES FOR HEMS ISSUE (Cf. comment #952) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, MBH suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » :

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 143 of 585

An agency of the European Union

“ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12)

response See the answer to comment #54.

comment 924 comment by: MBH SAMU

AMC1 ORO FTL 205 (f)ISSUE The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified in the AMC. (Cf. comment #907) PROPOSAL “(6) increased number of sectors, except for HEMS.”

response See the answer to comment #54.

comment 334 comment by: European Helicopter Association (EHA)

FNAM (France) #1 (b) ISSUE In the paragraph (b), it is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #24, #25, #30.1, #39, #40)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 144 of 585

An agency of the European Union

Therefore, the FNAM suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed either of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; and (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #30): (1) 110 duty hours in any 14 consecutive days, on the condition that: i. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.” #2 (d) ISSUE The definition of the mixed AEMS / HEMS operations is not precise and may lead to confusion. Indeed, it is not the philosophy of CAT operations to possess multiple type ratings for pilots especially aeroplane vs helicopter. The wording used is confusion and can be understood in different ways: • Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations The FNAM cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, the FNAM will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54.

comment 363 comment by: European Helicopter Association (EHA)

BHA (UK) "(a) (2)"

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 145 of 585

An agency of the European Union

These limits are more frequently used by F/W operators. In the UK, only 60 hours in 7 days and 200 hours in 28 days (CAP371) were applicable to helicopter operations, so this NPA has reduced (by 10 hours) a limit which has been permitted since 1975. Where is the evidence that this improves safety? "(b) (2)" See comments relating to this option in the CS section.

response See the answer to comment #54

comment 382

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To ORO.FTL.210(b)(2): It is expected that most European HEMS operators will apply for deviations according to Article 22 Basic Regulation and flight time specification schemes according to ORO.FTL.125. Since this will lead to a deviation from the CS (but not from the Part- ORO.FTL itself!) it remains unclear what effect such a deviation might cause on the rule ORO.FTL.210 (b)(2) stating "…in accordance with the certification specification…". The possibility to obtain an approval for a deviation should be addressed in this rule.

response See the answer to comment #54

comment 473

(b) ISSUE In the paragraph (b), it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the

implementing rule • Cherry-picking is allowed

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 146 of 585

An agency of the European Union

Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #496 to 501): (1) 110 duty hours in any 14 consecutive days, on the condition that: the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response See the answer to comment #54

comment 474 comment by: FNAM/SNEH

(d) ISSUE The definition of the mixed AEMS / HEMS operations is not precise and may lead to confusion. Indeed, it is not the philosophy of CAT operations to possess multiple type ratings for pilots especially aeroplane vs helicopter. The wording used is confusing and can be understood in different ways:

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 147 of 585

An agency of the European Union

FNAM and SNEH cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, FNAM and SNEH will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54

comment 653 comment by: Oya Vendée Hélicoptères

(b) ISSUE In the paragraph (b), it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the

implementing rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #657, #658, #676, #689, #690) Therefore, OYA suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and  

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 148 of 585

An agency of the European Union

3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.

OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #676 to 681): (1) 110 duty hours in any 14 consecutive days, on the condition that: the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response See the answer to comment #54

comment 654 comment by: Oya Vendée Hélicoptères

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

OYA cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, OYA will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54

comment 830 comment by: Yorkshire Air Ambulance

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 149 of 585

An agency of the European Union

the evidence that this improves safety? Also, 190 hours in 28 days unfairly penalises an equal time 4-on, 4-off roster, which results in 192 duty hours on the 28th day.

response Please see the answer to comment # 54

comment 923 comment by: AESA

Point (e)(1) refers to Table 1 in ORO.FTL.205(b)(1). That table doesn’t exist. It must be Table 2.

response See the answer to comment #54.

comment 926 comment by: MBH SAMU

(b) ISSUE In the paragraph (b), it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the

implementing rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #932, #933, #958, #975, #977) Therefore, MBH suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 150 of 585

An agency of the European Union

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #958 to 965): (1) 110 duty hours in any 14 consecutive days, on the condition that: the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response See the answer to comment #54.

comment 927 comment by: MBH SAMU

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

MBH cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, MBH will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54.

comment 1078 comment by: FNAM

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 151 of 585

An agency of the European Union

(c) ISSUE The definition of the mixed AEMS / HEMS operations is not precise and may lead to confusion. Indeed, it is not the philosophy of CAT operations to possess multiple type ratings for pilots especially aeroplane vs helicopter. The wording used is confusion and can be understood in different ways:

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

FNAM and EBAA France cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, FNAM and EBAA France will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations

response See the answer to comment #54.

comment 1081 comment by: FNAM

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

response See the answer to comment #54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 152 of 585

An agency of the European Union

comment 1099 comment by: European Cockpit Association

Commented text: ORO.FTL.210 The duty periods to which an individual crew member may be assigned in HEMS operations is established: (1) in accordance with (a); or (2) in accordance with the limits specified in the certifaction specifications applicable to HEMS operations. ECA comment: We strongly recommmend to add: but should never exceed (a) (3) 190 duty hours in any 28 consecutive days. If this cumulative time is kept including all times on alert, this is a huge improvement and a large step forwards to flight safety. This limit may not be possible to be by passed, even not by a CS/IFTSS.

response See the answer to comment #54.

comment 1199 comment by: SAF

(b ISSUE In the paragraph (b), it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the

implementing rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #1205, #1208, #1226, #1239, #1240) Therefore, SAF suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 153 of 585

An agency of the European Union

OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #1226 to 1231): (1) 110 duty hours in any 14 consecutive days, on the condition that: the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response See the answer to comment #54.

comment 1200 comment by: SAF

• Mixed AEMS / CAT operations • Mixed HEMS / CAT operations • Mixed AEMS / HEMS operations

SAF cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, SAF will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54.

comment 1268 comment by: Hélicoptères de France

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 154 of 585

An agency of the European Union

#1 (b) ISSUE In the paragraph (b), it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #24, #25, #30.1, #39, #40) Therefore, HDF suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL In ORO.FTL.210 (b) Suppress point (1) and (2) and only let: “The total duty periods to which an individual crew member may be assigned in HEMS operation is established in accordance with the certification specification applicable to HEMS operations.” In CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; and (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR OPTION 2 (taking into account the revisited version of the initial CS, explained in the comment #30): (1) 110 duty hours in any 14 consecutive days, on the condition that: i. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.” #2 (d) ISSUE The definition of the mixed AEMS / HEMS operations is not precise and may lead to confusion. Indeed, it is not the philosophy of CAT operations to possess multiple type ratings for pilots especially aeroplane vs helicopter. The wording used is confusing and can be understood in different ways:

• Mixed AEMS / CAT operations

• Mixed HEMS / CAT operations

• Mixed AEMS / HEMS operations

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 155 of 585

An agency of the European Union

HDF cannot comment this proposal since no definition of the mixed AEMS / HEMS operations has been written. When a clear definition of the mixed AEMS / HEMS operations is provided, HDF will give an opinion on the proposal. PROPOSAL Precise the definition of mixed AEMS / HEMS operations.

response See the answer to comment #54.

comment 1267 comment by: Hélicoptères de France

#1 The paragraph (a)(1) seems redundant with the prescriptions of the paragraph (b). HDF suggests clarifying the writing. PROPOSAL: Suppress the newly added paragraph (a)(1). #2 GENERAL REMARK regarding the notion of a Daily FDP For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h. #3 The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1). Besides, HDF would like to highlight that other cases (such as non-acclimatized crew, etc.) are not considered for HEMS by this regulation. Besides there is a need for extensions of the FDP in HEMS operations. HDF suggests suppressing the wording “without the use of extensions”. PROPOSAL Suppress the wording “without the use of extensions” newly added in the title (b) and in the content of the paragraph (b)(7): “(b) Basic maximum daily FDP […] (7) Flight time specification schemes in HEMS operations shall specify the maximum daily FDP for acclimatised crew members in accordance with the certification specification applicable to those operations.” #4 The paragraph (c) is not applicable for HEMS operations since only cabin crew are mentioned (not the TCM). None of the missions of the TCM is to prepare the flight, therefore, the notion of pre-flight is not applicable for TCM. That is why HDF agrees not to add the notion of TCM in this paragraph. #5 (f) UNFORESEEN CIRCONSTANCES FOR HEMS (Cf. comment #29.2) FORCE MAJEURE HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 156 of 585

An agency of the European Union

Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, HDF suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12) #6 AMC1 ORO FTL 205 (f) The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). To ensure consistency, the number of sectors in the paragraph (b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent with the ORO.FTL.105 (§24). It should be clarified in the AMC. (Cf. comment #14.2) PROPOSAL “(6) increased number of sectors, except for HEMS.”

response Please see the answer to comment # 54

comment 1332 comment by: ENAC

Point (c) It is not clear what “mixed AEMS/HEMS” operations means. Furthermore the text of point (c) would be easier to understand if it was written like point (a).

response See the answer to comment #54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 157 of 585

An agency of the European Union

comment 1190 comment by: SAF

(b) GENERAL REMARK regarding the notion of a Daily FDP

For small FT as currently operated in HEMS, it is possible to have multiple FDP within the

same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and

then a FDP from 20:30 to 22h.

response Please see the answer to comment # 54

comment 1191 comment by: SAF

The paragraph (b)(7) seems redundant with the prescriptions of the paragraph (a)(1).

Besides, SAF would like to highlight that other cases (such as non-acclimatized crew, etc.)

are not considered for HEMS by this regulation. Besides there is a need for extensions of

the FDP in HEMS operations. SAF suggests suppressing the wording “without the use of

extensions”.

PROPOSAL

Suppress the wording “without the use of extensions” newly added in the title (b) and in

the content of the paragraph (b)(7):

“(b) Basic maximum daily FDP

(7) Flight time specification schemes in HEMS operations shall specify the maximum daily

FDP for acclimatised crew members in accordance with the certification specification

applicable to those operations.”

response Please see the answer to comment # 54

comment 1194 comment by: SAF

(c)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 158 of 585

An agency of the European Union

AGREEMENT

The paragraph (c) is not applicable for HEMS operations since only cabin crew are

mentioned (not the TCM). None of the missions of the TCM is to prepare the flight,

therefore, the notion of pre-flight is not applicable for TCM. That is why SAF agrees not to

add the notion of TCM in this paragraph.

response Please see the answer to comment # 54

comment 1195 comment by: SAF

(f) UNFORESEEN CIRCONSTANCES FOR HEMS

ISSUE

(Cf. comment #1221)

FORCE MAJEURE

HEMS are deeply linked with national health, security and safety. HEMS depends on the

organization of the French healthcare system (the permanence and continuity of care

services is a public service & a sovereign prerogative), with groupings of medical

equipment and skills.

HEMS in France is both operated by private operators and the State.

State may charter private operators to operate HEMS operations on its behalf.

Current French regulation thus allows, by sovereign decision of the State, to grant

derogation for HEMS operations as far as national health, security or safety is involved.

Such a possibility shall remain for "Force majeure" and be introduced within the IR, in

respect of the sovereignty of each Member State facing major health crisis.

For example, in France, private operators of helicopters were chartered to ensure airlift

rotations during recent Millas train disaster on December, the 14th of 2017. Besides,

Helicopter Nuclear Response Team are partially delegated to a private operator.

Therefore, SAF suggests adding a specific paragraph in this implementing rule allowing

HEMS pilots to derogate from these requirements in case of Force Majeure as it is

already the case in the Current French National Regulation.

PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 159 of 585

An agency of the European Union

For illustrative purposes, in France the following article is applied in case of « Force

Majeure » :

“ Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions

suivantes :

1. Vols urgents, dont l'exécution immédiate est nécessaire :

a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour

réparer des accidents survenus soit au matériel, soit aux installations ;

b) Pour assurer le dépannage des aéronefs.

2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles

n'auraient pas permis d'effectuer dans les limites préétablies.

3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service

public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à

fixer par le ministre chargé de l'aviation civile.“ (Ref : CAC D422-12)

response Please see the answer to comment # 54

comment 1196 comment by: SAF

AMC1 ORO FTL 205 (f)

The paragraph (b)(6) of the AMC1 ORO.FTL.205(f) refers to sectors. Since the 'sector'

definition does not apply anymore for HEMS operations, flight times shall not be

scheduled before HEMS operations and are therefore unpredictable inside a given FDP

(by definition of HEMS). To ensure consistency, the number of sectors in the paragraph

(b)(6) of the AMC cannot be applied for HEMS operations. Otherwise it is not consistent

with the ORO.FTL.105 (§24). It should be clarified in the AMC. (Cf. comment #1184)

PROPOSAL

“(6) increased number of sectors, except for HEMS.”

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 160 of 585

An agency of the European Union

3.1. ORO.FTL.215 p. 10

comment 335 comment by: European Helicopter Association (EHA)

FNAM (France) (a) ISSUE The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #14.2) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

response See the answer to comment #54.

comment 475 comment by: FNAM/SNEH

(a) ISSUE The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #463) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

response See the answer to comment #54.

comment 655 comment by: Oya Vendée Hélicoptères

(a) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 161 of 585

An agency of the European Union

The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #643) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

response See the answer to comment #54.

comment 928 comment by: MBH SAMU

(a) ISSUE The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #907) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

response See the answer to comment #54.

comment 1201 comment by: SAF

(a) ISSUE The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #1184) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 162 of 585

An agency of the European Union

response See the answer to comment #54.

comment 1269 comment by: Hélicoptères de France

(a) ISSUE The paragraph (a) refers to 'sectors'. Since the 'sector' definition does not apply anymore for HEMS operations, flight times shall not be scheduled before HEMS operations and are therefore unpredictable inside a given FDP (by definition of HEMS). (Cf. comment #14.2) In that way, it is not clear whether the positioning requirement (a) is applicable to HEMS operations. PROPOSAL Rephrase as follows: “(a) Positioning after reporting but prior to operating shall be counted as FDP. For other CAT operations than HEMS, it shall not count as a sector;”

response See the answer to comment #54.

3.1. ORO.FTL.220 p. 14

comment 94 comment by: B. Wagner

zu (b): Es gibt keine wissenschaftlichen Grundlagen, die diesen Ansatz unterstützen. Ob und wie eine Pause zur FDP anzurechnen ist, sollte von den äusseren Umständen abhängen, in denen die Pausenzeit stattfindet. So kann man z.B. einen Ruheraum an einem Flughafen, der vielleicht von fremden Crews ebenso genutzt wird und der eventuell durch äussere Störfaktoren keine Ruhemöglichkeit bietet nicht mit einer HEMS Station vergleichen, die komfortable Ruheräume für jedes Crewmitglied bietet. Vorschlag für eine Änderung des Textes: "(b) the breaks on the ground shall count in full as FDP, except facilities provided to the crew member to rest are equipped as follows: one room per crew member, air condition, possibility to dim the light also during day time ... to be defined" Die Dienstzeit sollte davon unberührt weiter zählen. Oder man definiert unterschiedliche Kategorien von Ruheräumen (CAT A, B, C... facilities), die zu Unterschieden bei der Bewertung der Ruhezeiten führen: Hochwertige Unterkunft (CAT A) führt zu Unterbrechung der FDP im Fall einer Pause, CAT B wird zu 50% zur FDP gerechnet, CAT C zu 100%

response Please see the answer to comment # 54

ORO.FTL.220

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 163 of 585

An agency of the European Union

comment 95 comment by: B. Wagner

zu (c): mit dieser Einschränkung kann man Split duty im HEMS Bereich nicht nutzen, wenn es am nötigsten wäre, in den Monaten mit langen Dienstzeiten. Sinnvoller wäre eine Beschränkung auf z.B. maximal 3 oder 4 Tage in Folge.

response See the answer to comment #54.

comment 336 comment by: European Helicopter Association (EHA)

FNAM (France) (a) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks in split duty. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, the FNAM agrees and thanks the EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex-post that the break requirement has been fulfilled for pilots. Therefore, to ensure split duty is adapted to HEMS operations, the FNAM suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. Such a break may be monitored ex-post by the operator SMS, under the principle of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

response Please see the answer to comment # 54

comment 476 comment by: FNAM/SNEH

Attachments #57 #58 #59 #60

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 164 of 585

An agency of the European Union

it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, FNAM and SNEH agree and thanks EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex-post that the break requirement has been fulfilled for pilots. (Cf. attachments S1, S2, S3 and S4 illustrating this break issue) Therefore, to ensure split duty is adapted to HEMS operations, FNAM and SNEH suggest writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

response See the answer to comment #54.

comment 656 comment by: Oya Vendée Hélicoptères

Attachments #61 #62 #63 #64

(a) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks in split duty. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, OYA agrees and thanks EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex- post that the break requirement has been fulfilled for pilots. (Cf. attachments S1, S2, S3 and S4 illustrating this break issue) Therefore, to ensure split duty is adapted to HEMS operations, OYA suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 165 of 585

An agency of the European Union

response See the answer to comment #54.

comment 768 comment by: AECA helicopteros.

Questions needing answer in regulation:

• Does the application of this concept require an explicit notification to the pilot or is sufficient for him to remain in the base without functions?

• If notification is necessary, how is done? • Would it be necessary to notify the beginning and end of the break?

response See the answer to comment #54.

comment 929 comment by: MBH SAMU

Attachments #65 #66 #67 #68

(a) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks in split duty. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, MBH agrees and thanks EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex- post that the break requirement has been fulfilled for pilots. (Cf. attachments S1, S2, S3 and S4 illustrating this break issue) Therefore, to ensure split duty is adapted to HEMS operations, MBH suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

response See the answer to comment #54.

comment 1204 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 166 of 585

An agency of the European Union

Attachments #69 #70 #71 #72

(a) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks in split duty. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, SAF agrees and thanks EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex- post that the break requirement has been fulfilled for pilots. (Cf. attachments S1, S2, S3 and S4 illustrating this break issue) Therefore, to ensure split duty is adapted to HEMS operations, SAF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

response See the answer to comment #54.

comment 1270 comment by: Hélicoptères de France

(a) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks in split duty. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. Under these conditions, HDF agrees and thanks EASA for introducing the possibility of split duty for HEMS activities with unscheduled breaks. The operator should ensure ex- post that the break requirement has been fulfilled for pilots. (Cf. attachments S1, S2, S3 and S4 illustrating this break issue) Therefore, to ensure split duty is adapted to HEMS operations, HDF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 167 of 585

An agency of the European Union

operation. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. PROPOSAL Rephrase the paragraph (a) as follows: “(a) The operator ensures ex-post that at least one break of minimum 60 consecutive minutes if taken in a suitable accommodation, or at least 2 hours, if taken in accommodation”

response See the answer to comment #54.

3.1. ORO.FTL.225 Standby and duties at the airport p. 14-15

comment 89 comment by: AIR ZERMATT AG

• The NPA does not consider the case where crew members live close to the HEMS

operating base and may return to their home during rest periods and standby time. • Additional terminology “on-call-duty” should be implemented and defined as

follows: Time in which the crew member is permanently available on the order of the operator and is ready to fly. In doing so, the crew member stays at home or at another suitable location, which offers the opportunity for private activities and rest. On-call-duty can be counted as rest time.

• «On-call-duty» is counted as free time and hence shall be excluded from the overall duty time.

response See the answer to comment #54.

comment 180 comment by: ANSMUH

In the airplane field, the standby is used to allow the availability of one or more crews to substitute their colleagues or to provide for an off-schedule flight in case of contingent problems. There can be an airport standby and other than airport standby. The actual FTL Regulation and the NPA for air taxi define the duty periods based on the response time. In particular it is defined that the airport standby is considered in full as duty period (ORO.FTL.225(c)), but it does not say that the standby at the HEMS operating base is counted as duty period as well, but only when executing some duties (ORO.FTL.225(d)): (c) airport standby shall count in full as duty period for the purpose of points

ORO.FTL.210 (a) and (b) and ORO.FTL.235;

(d) any duty at the airport or at the HEMS operating base, as applicable, shall count in full

as duty period and the FDP shall count in full from the airport duty reporting time;

Airplane standby at the airport generally gives the pilot, once he is tasked, the needed time to plan for the flight and for all the ground necessities, thus allowing a response

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 168 of 585

An agency of the European Union

time from 30 minutes from take-off or above. Because of this readiness, and because he is waiting in an operating place (the airport), all the time spent in standby is counted as duty. On the other hand, for the HEMS pilot waiting for a flight in a HEMS base (i.e. an operating place like the airport standby but defined as "other than airport standby") it is left to the operator defining the amount of time to be counted as duty in its manuals. Currently in France standby is counted as duty time. If this NPA is applied there is a strong chance that social movements will appear very quickly to refuse it. Proposal: ORO.FTL.225 Standby and duties at the airport or at the HEMS operating base If an operator assigns crew members to standby or to any duty at the airport or at the HEMS operating base, the following shall apply in accordance with the certification specifications applicable to the type of operation: (a) standby and any duty at the airport or at the HEMS operating base, as applicable, shall be in the roster and the start and end time of standby shall be defined and notified in advance to the crew members concerned to provide them with the opportunity to plan adequate rest; (b) a crew member is considered on airport standby or on standby at the HEMS operating base from reporting at the reporting point until the end of the notified standby period; (c) airport standby or standby at the HEMS operating base shall count in full as duty period for the purpose of points ORO.FTL.210 (a) and (b) and ORO.FTL.235; (d) any duty at the airport or at the HEMS operating base, as applicable, shall count in full as duty period and the FDP shall count in full from the airport duty reporting time; (e) the operator shall provide accommodation to the crew member on airport standby or on standby at the HEMS operating base. (f) flight time specification schemes established in accordance with the certification specifications applicable to the type of operations shall specify the following elements: (1) the maximum duration of any standby; (2) the impact of the time spent on standby on the maximum FDP that may be assigned, taking into account facilities provided to the crew member to rest, and other relevant factors such as: – the need for immediate readiness of the crew member, – the interference of standby with sleep, and – sufficient notification to protect a sleep opportunity between the call for duty and the assigned FDP; (3) the minimum rest period following standby which does not lead to assignment of an FDP; (4) how time spent on standby other than airport standby shall be counted for the purpose of cumulative duty periods.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 169 of 585

An agency of the European Union

response See the answer to comment #54.

comment 937 comment by: AESA

Point (c) establish that airport standby count in full as duty, but it doesn’t mention that HEMS base standby count full as duty. Correct sentence must be “Airport standby or standby at the HEMS operating base shall count in full…”

response See the answer to comment #54.

comment 1316 comment by: Elilombarda

ORO.FTL.225 Standby and duties at the airport or at the HEMS operating base With regard to ‘Standby’ in HEMS operations, the following applies: 1. ORO.FTL.105 (25) - ‘standby’ 2. ORO.FTL.105 (26) - ‘airport standby’ 3. ORO.FTL.105 (27) - ‘other standby’ 4. ORO.FTL.225 Standby and duties at the airport or at the HEMS operating base (and related AMC/GM) 5. CS FTL.3.225 Standby and duties at the HEMS operating base Neither the ORO.FTL.225 nor the CS FTL.3.225 report minimum limits for the calculation of the HEMS duty time based on the response time or on the location where the crew shall wait. Typical HEMS duty daily shift is an uninterrupted duty of 8 to 14 hours (presently maximum 13 hours in Italy) where the crew is requested to take off in a time that varies from down to 5 minutes to up to 30 minutes from the time the mission is assigned. The crew shall remain in the base, close to the helicopter, and use the limited time available before take-off for planning purposes. Due to these HEMS operations peculiarities, the crew readiness is maximum, even if there are few or no flights at all during the day. For this reasons, it is not possible to consider the HEMS crew in ‘standby’ the same way it is intended for airplane airport standby, because the HEMS readiness is much more demanding. Based on these considerations, it is felt that HEMS crews cannot be considered in “standby” while waiting for a mission assignment “at HEMS operating base”, but they are in a full duty time. Moreover, the whole time shall be considered as FDP, because “ready to fly anytime”. Only standby outside the HEMS operating base (‘other standby’), i.e. when the crew is allowed to walk away from the operating base, can be counted partially as duty time. In this case, the minimum standby time shall be 90 minutes, in order to give the crew the necessary time to reach the base, plan for the flight, make the necessary phone calls and open and pre-flight the helicopter.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 170 of 585

An agency of the European Union

Suggested NPA amendment ORO.FTL.225 Standby and duties at the airport or at the HEMS operating base If an operator assigns crew members to standby or to any duty at the airport or at the HEMS operating base, the following shall apply in accordance with the certification specifications applicable to the type of operation: (…) (c) (c) airport standby shall count in full as duty period for the purpose of points ORO.FTL.210 (a) and (b) and ORO.FTL.235; (d) (d) standby at the HEMS operating base shall count in full as flight duty period (FDP) for the purpose of points ORO.FTL.210 (a) and (b) and ORO.FTL.235;

response See the answer to comment #54.

comment 1333 comment by: ENAC

Point (d) - To be consistent with previous point (c), the following phrase should be added to the text: “for the purpose of ORO.FTL.210”. - HEMS crew are usually standing by in the HEMS operating base ready to take off in few minutes. It is not clear if that status is considered “duty at the HEMS operating base” , where DP/FDP count from reporting, or “stand-by at the HEMS operating base” as in CS FTL.3.225.

response See the answer to comment #54.

comment 1338 comment by: ENAC

Neither the ORO.FTL.225 nor the CS FTL.3.225 report minimum limits for the calculation of the duty time based on the response time or on the location where the crew shall wait. Typical HEMS duty daily shift is an uninterrupted duty of 8 to 14 hours (presently maximum 13 hours in Italy) where the crew is requested to take off in a time that varies from down to 5 minutes to up to 30 minutes from the mission assignment. The crew shall remain in the base, close to the helicopter, and use the limited time available before take-off for planning purposes. Due to these HEMS operations peculiarities, the crew readiness is maximum, even if there are few or no flight at all during the day. For this reasons, it is not possible to consider the HEMS crew in ‘standby’, as intended for airplane airport standby, because the HEMS readiness is much more demanding. Based on these considerations, it is felt that HEMS crews cannot be considered in “standby at HEMS operating base” and, in any case, the whole time shall be considered as FDP, because “ready to fly anytime”. Only standby outside the HEMS operating base, i.e. when the crew is allowed to walk away from the operating base, can be counted partially as duty time. In this case the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 171 of 585

An agency of the European Union

minimum standby time shall be 90 minutes, in order to give the crew the necessary time to reach the base, plan for the flight, open and pre-flight the helicopter.

response See the answer to comment #54.

comment 1387 comment by: Swiss Air-Ambulance Rega

The NPA does not consider the case where crew members live close to the HEMS operating base and may return to their home during rest periods and standby time. Additional terminology “on-call-duty” should be implemented and defined. «On-call-duty» is counted as free time and hence shall be excluded from the overall duty time. Proposed amendment: Time in which the crew member is permanently available on the order of the operator and is ready to fly. In doing so, the crew member stays at home or at another suitable location, which offers the opportunity for private activities and rest. On-call-duty can be counted as rest time.

response See the answer to comment #54.

Rationale for the implementing rules p. 15-18

comment 145 comment by: CAA-NL

Page 16, Rational number 3 Comment: This rational state that the definition of sector has been adapted to include helicopters. The opposite is proposed, by changing aircraft into aeroplane helicopters are excluded. See also remark related.

response See the answer to comment #54.

comment 275 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Point 8 the text allows some alleviations and if this is acceptable to the agency it shall be accepted for all HEMS operations and it shall be possible to continue to work under national regulation as they are best adapted.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 172 of 585

An agency of the European Union

response See the answer to comment #54.

comment 299 comment by: Federal Office of Civil Aviation (FOCA), Switzerland

Comment FOCA: Most transportations with helicopters are more effective/efficient than ground transportation. That's why the helicopter is used. Even within urban areas (towns, cities) the helicopter transport is often more effective/efficient than a transport by an ambulance. The argumentation within the "rationale for the IRs" (see p. 15-16 "(...) helicopters for the purpose of emergency medical services. It, however, excludes from the scope certain HEMS conducted exclusively in areas where an alternative ground transportation is not possible or is ineffective, to be defined by the competent authority of a Member State. This will allow a number of socially important operations to continue to exist, as any reduction in the duty and flight hours will further reduce the anyway low number of missions. Those impacts are expected to have a detrimental effect on pilots’ proficiency, costs for new recruitment and pilot training") will not only allow the continuation of a number of socially important operations, it will also justify the continuation of current national duty regulations, where scientific principles have not been used so far. Therefore, an exception from FTL shall only be applicable to HEMS operations conducted from a HEMS base located in a remote area. Remote areas may characterized by a low density of population, low density of motorway networks or long- distance transfers to metropolitan or urban centers (i.e. Lapland). Otherwise, most of the HEMS operations within the Alpine region may be excluded from more safe FTL regulations.

response See the answer to comment #54.

comment 311 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): “Article 8 ‘Flight time limitations’ of Regulation (EU) No 965/2012 is extended to now include air taxi, single-pilot and emergency medical service operations, with aeroplanes, as well as CAT operations with helicopters for the purpose of emergency medical services. It, however, excludes from the scope certain HEMS conducted exclusively in areas where an alternative ground transportation is not possible or is ineffective, to be defined by the competent authority of a Member State. This will allow a number of socially important operations to continue to exist, as any reduction in the duty and flight hours will further reduce the anyway low number of missions. Those impacts are expected to have a detrimental effect on pilots’ proficiency, costs for new recruitment and pilot training.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 173 of 585

An agency of the European Union

Comment: This is highly relevant for operation serving remote areas, where also the mission rate is low. However, here it is important to emphasize that it is not always the location of the HEMS operating base that is relevant, but the actual area served. For example, a helicopter can be based in a city, while serving exclusively remote areas. Also, the wording “ineffective” should perhaps be reviewed as most medical personnel or operators could argue that the majority of road transport could be “ineffective” as compared to helicopter transport. “1. ORO.FTL.100 is amended to also include HEMS crew members. HEMS operations, especially daily missions, are typically operated by mixed crews consisting of a pilot and a HEMS crew member who assists the PIC. This justifies the application of the same FTL regime to both.” Comment: As the HEMS technical crew member typically have the monitoring functions of a “pilot monitoring” this is sensible. However, it should be described how HEMS technical crew members, that are perhaps not working only for the operator providing the HEMS, should account for work or duty in other organizations or for other operators. “3. ORO.FTL.105 — the definitions of (13) ‘flight time’ and (24) ‘sector’ have been adapted to include both operations with aeroplanes and helicopters.” Comment: ‘sector’ is not applicable for helicopters.

response See the answer to comment #54.

comment 364 comment by: European Helicopter Association (EHA)

BHA (UK) "Article 8 Flight time limitations’ of Regulation (EU) No 965/2012 is extended to now include air taxi, single-pilot and emergency medical service operations, with aeroplanes, as well as CAT operations with helicopters for the purpose of emergency medical services. It, however, excludes from the scope certain HEMS conducted exclusively in areas where an alternative ground transportation is not possible or is ineffective, to be defined by the competent authority of a Member State. " Comment: See previous comment on poor choice of words. "1. ORO.FTL.100 is amended to also include HEMS crew members. HEMS operations, especially daily missions, are typically operated by mixed crews consisting of a pilot and a HEMS crew member who assists the PIC. This justifies the application of the same FTL regime to both. " Comment:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 174 of 585

An agency of the European Union

While explaining that TCMs should be included into an FTL scheme, there is no consideration given for the self-evident fact that TCMs will not actually be controlling/commanding an aircraft and, much like cabin crew, would be better served with some alleviations. Also, no attempt has been made to account for how TCMs should account for extra-curricular work they may conduct outside of the flight environment. "3. ORO.FTL.105 — the definitions of (13) ‘flight time’ and (24) ‘sector’ have been adapted to include both operations with aeroplanes and helicopters. " Comment: No it hasn't. "5. ORO.FTL.105 — a new definition (30) ‘single-pilot operation’ is included to avoid potential misinterpretation, especially as regards daily HEMS operations where a HEMS crew member is needed to assist the pilot." Comment: See previous comments. Although the NPA recognises the value of TCMs and brings them within the scope of an FTL scheme, no fatigue credit is given for SP + TCM in the HEMS role vs SP air-taxi/AEMS. "14. ORO.FTL.21 -Point (b) is replaced by new text providing HEMS operators with the flexibility to choose either the cumulative duty limits of scheduled and charter operations or those that are more adapted to the nature of HEMS operations. The cumulative duty periods in HEMS are governed by Member States’ national law, this flexibility will allow the continuation of national practices that are deemed to be safe; " Comment: I would dispute that it achieves this objective because, for example, the 'flexibility' described would not allow the continuation of UK national practices.

response See the answer to comment #54.

comment 588 comment by: NOLAS

“1. ORO.FTL.100 is amended to also include HEMS crew members. HEMS operations, especially daily missions, are typically operated by mixed crews consisting of a pilot and a HEMS crew member who assists the PIC. This justifies the application of the same FTL regime to both.” Comment: As the HEMS technical crew member typically have the monitoring functions of a “pilot monitoring” this is sensible. However, it should be described how HEMS technical crew members, that are perhaps not working only for the operator providing the HEMS, should account for work or duty in other organizations or for other operators.

response See the answer to comment #54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 175 of 585

An agency of the European Union

comment 589 comment by: NOLAS

“3. ORO.FTL.105 — the definitions of (13) ‘flight time’ and (24) ‘sector’ have been adapted to include both operations with aeroplanes and helicopters.” Comment: ‘sector’ is not applicable for helicopters.

response See the answer to comment #54.

comment 831 comment by: Yorkshire Air Ambulance

response See the answer to comment #54.

comment 832 comment by: Yorkshire Air Ambulance

See previous comments. Although the NPA recognises the value of TCMs and brings them within the scope of an FTL scheme, no fatigue credit is given for SP + TCM in the HEMS role vs SP air-taxi/AEMS.

response See the answer to comment #54.

comment 833 comment by: Yorkshire Air Ambulance

I would dispute that it achieves this objective because, for example, the 'flexibility' described would not allow the continuation of UK national practices.

response See the answer to comment #54.

comment 1111 comment by: European Cockpit Association

Commented text: Rationale for the implementing rules — Point (b) is replaced by new text providing HEMS operators with the flexibility to choose either the cumulative duty limits of scheduled and charter operations or those that are more adapted to the nature of HEMS operations. The cumulative duty periods in

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 176 of 585

An agency of the European Union

HEMS are governed by Member States’ national law, this flexibility will allow the continuation of national practices that are deemed to be safe; ECA comment: ECA recommends keeping the 2000h/y and 190h/28 day limit as an overall limit (implementing rule) and enable required flexibility by Member States national law

response See the answer to comment #54.

comment 1320 comment by: SAS

Clarificaton on the applicability of this extention to UK HEMS is required. Given the social importance of service is without question and often ground transportation would render any further medical intervention useless and ineffective.

response See the answer to comment #54.

comment 1462 comment by: European Cockpit Association

Commented provision: Cumulative flight times ECA expresses strong support for the lower cumulative limits in CS2 and point out that any relaxing of FDPs and other flexibilities beyond CAT FTLs are absolutely contingent on these limits staying as they are. Additionally, the workloads of the pilots examined in the FRMSc study which is used to justify this approach were significantly less than these limits on average. Proposal: We would therefore strongly recommend reduced cumulative duty limits as well. Positioning ECA expresses strong support for the new provisions on positioning in air taxi operations where positioning is very prevalent. Maintaining these provisions is absolutely necessary if the more permissive provisions elsewhere are to remain justified.

response See the answer to comment #54.

comment 587 comment by: NOLAS

“Article 8 ‘Flight time limitations’ of Regulation (EU) No 965/2012 is extended to now include air taxi, single-pilot and emergency medical service operations, with aeroplanes, as well as CAT operations with helicopters for the purpose of emergency medical services. It, however, excludes from the scope certain HEMS conducted exclusively in areas where an alternative ground transportation is not possible or is ineffective, to be defined by the competent authority of a Member State. This will allow a number of socially important operations to continue to exist, as any reduction in the duty and flight

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 177 of 585

An agency of the European Union

hours will further reduce the anyway low number of missions. Those impacts are expected to have a detrimental effect on pilots’ proficiency, costs for new recruitment and pilot training.” Comment: This is highly relevant for operation serving remote areas, where also the mission rate is low. However, here it is important to emphasize that it is not always the location of the HEMS operating base that is relevant, but the actual area served. For example, a helicopter can be based in a city, while serving exclusively remote areas. Also, the wording “ineffective” should perhaps be reviewed as most medical personnel or operators could argue that the majority of road transport could be “ineffective” as compared to helicopter transport.

response See the answer to comment #54.

comment 1340 comment by: Elilombarda

See comment to CS FTL.3.205 Flight duty period (FDP) — HEMS for rationale. Suggested NPA amendment ORO.FTL.235 Rest periods (...) Recurrent extended recovery rest periods Flight time specification schemes shall specify recurrent extended recovery rest periods to compensate for cumulative fatigue. The minimum recurrent extended recovery rest period shall be 36 hours, including 2 local nights, and in any case the time between the end of one recurrent extended recovery rest period and the start of the next extended recovery rest period shall not be more than 168 hours, or 336 hours for HEMS. The recurrent extended recovery rest period shall be increased to 2 local days twice every month.

response See the answer to comment #54.

comment 1420 comment by: Svensk Luftambulans

HEMS conducted exclusively in areas where an alternative ground transportation is not possible or is ineffective, Comment: This is highly relevant for operation serving remote areas, where also the mission rate is low. The wording “ineffective” must be clarified as there are areas with other means of transportations, but due to the sparsely population and large areas to be covered, Helicopter is the only alternate when it comes to time critical patients. Which guidelines have NAA on this?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 178 of 585

An agency of the European Union

response See the answer to comment #54.

comment 1285 comment by: Hélicoptères de France

(b) ISSUE: The paragraph (b) of this GM refers simultaneously to the ORO and the CS. The wording used: “using the appropriate table ORO.FTL.205 (b) or the certification specifications applicable to the type of operation” is very confusing especially the terms “or”. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #30.1, #40) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

comment 349 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE: The paragraph (b) of this GM refers simultaneously to the ORO and the CS. The wording used: “using the appropriate table ORO.FTL.205 (b) or the certification specifications applicable to the type of operation” is very confusing especially the terms “or”. It is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #30.1, #40) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 179 of 585

An agency of the European Union

applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

comment 510 comment by: FNAM/SNEH

(b) ISSUE: The paragraph (b) of this GM refers simultaneously to the ORO and the CS. The wording used: “using the appropriate table ORO.FTL.205 (b) or the certification specifications applicable to the type of operation” is very confusing especially the terms “or”. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #473, #477, #478, #496, #511) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

comment 689 comment by: Oya Vendée Hélicoptères

• All the CS.FTL.3 requirements shall be applicable "in block"

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 180 of 585

An agency of the European Union

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #653, #657, #658, #676, #690) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

comment 975 comment by: MBH SAMU

ISSUE: The paragraph (b) of this GM refers simultaneously to the ORO and the CS. The wording used: “using the appropriate table ORO.FTL.205 (b) or the certification specifications applicable to the type of operation” is very confusing especially the terms “or”. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #926, #932, #933, #958, #977) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 181 of 585

An agency of the European Union

comment 1239 comment by: SAF

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #1199, #1205, #1208, #1226, #1240) PROPOSAL: Rewrite to clarify as follows: “(b) The maximum daily FDP for acclimatised crew members is determined by using respectively tables of ORO.FTL.205(b) or of the relevant certification specifications applicable to the type of operations with the reference time of the point of departure. As soon as 48 hours have elapsed, the state of acclimatisation is derived from the time elapsed since reporting at reference time and the number of time zones crossed.”

response See the answer to comment #54.

comment 1286 comment by: Hélicoptères de France

ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #30.1, #39) PROPOSAL: Rewrite to clarify.

response See the answer to comment #54.

comment 350 comment by: European Helicopter Association (EHA)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 182 of 585

An agency of the European Union

FNAM (France) ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #30.1, #39) PROPOSAL: Rewrite to clarify.

response See the answer to comment #54.

comment 511 comment by: FNAM/SNEH

ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #473, #477, #478, #496, #510) PROPOSAL: Rewrite to clarify.

response See the answer to comment #54.

comment 690 comment by: Oya Vendée Hélicoptères

ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #653, #657, #658, #676, #689) PROPOSAL: Rewrite to clarify.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 183 of 585

An agency of the European Union

response See the answer to comment #54.

comment 977 comment by: MBH SAMU

ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #926, #932, #933, #958, #975) PROPOSAL: Rewrite to clarify.

response See the answer to comment #54.

comment 1240 comment by: SAF

ISSUE: This GM refers simultaneously to the ORO and the CS. It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #1199, #1205, #1208, #1226, #1239) PROPOSAL: Rewrite to clarify.

response See the answer to comment #54.

comment 1288 comment by: Hélicoptères de France

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 184 of 585

An agency of the European Union

"The workload and stress levels of single-pilots operations" wording omits that HEMS single-pilots are conducted by TWO technical crew members: one pilot and one TCM. They are not PEQ1 operations. The requirement for a TCM is justified by the fact that the TCM is deemed to be a mitigation measure and to enhance the safety of single-pilot + 1 TCM HEMS operations Therefore, TCM shall be quoted whenever taking into account workload and stress levels of singlepilots operations. PROPOSAL Supplement (c) by " (c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;"

response See the answer to comment #54.

comment 11 comment by: TG

Diese Faktoren sind so unglaublich unterschiedlich von HEMS-Base zu HEMS-Base, dass nur individuelle Lösungen (wie z. B. in Berlin) helfen. Die Hubschrauber sind zudem heute auch ohne Autopilot derart leicht zu fliegen, dass auch hier kein Unterschied zu machen ist. Das Wetter ist der einzige Faktor der unberechenbar ist und zu Spitzenstress führen kann - das aber äusserst selten! Auf einzelne "Großkampftage" folgen auch immer wieder Tage ohne Flug oder mit > 7 Stunden nichts-tun... Warum Fatigue? Hier muss der Mittelwert berücksichtigt werden und nicht ein Spitzenwert gekappt...

response See the answer to comment #54.

comment 352 comment by: European Helicopter Association (EHA)

FNAM (France) (c) ISSUE "The workload and stress levels of single-pilots operations" wording omits that HEMS single-pilots are conducted by TWO technical crew members: one pilot and one TCM. They are not PEQ1 operations. The requirement for a TCM is justified by the fact that the TCM is deemed to be a mitigation measure and to enhance the safety of single-pilot + 1 TCM HEMS operations Therefore, TCM shall be quoted whenever taking into account workload and stress levels of singlepilots operations. PROPOSAL Supplement (c) by " (c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;"

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 185 of 585

An agency of the European Union

response See the answer to comment #54.

comment 403 comment by: European Helicopter Association (EHA)

OEATMC (Austria): CS FTL.3.235 Rest periods — HEMS (a) Reduced rest in HEMS operations complies with the following: (1) The minimum rest period may be reduced to 10 hours, only if taken at the HEMS operating base with a suitable accommodation provided by the operator. COMMENT(S) The pilot living in vicinity of the base has to stay on the base? Even thought he would be at home within a couple of minutes?

response See the answer to comment #54.

comment 513 comment by: FNAM/SNEH

(c) ISSUE "The workload and stress levels of single-pilots operations" wording omits that HEMS single- pilots are conducted by TWO technical crew members: one pilot and one TCM. They are not PEQ1 operations. The requirement for a TCM is justified by the fact that the TCM is deemed to be a mitigation measure and to enhance the safety of single-pilot + 1 TCM HEMS operations Therefore, TCM shall be quoted whenever taking into account workload and stress levels of single-pilots operations. PROPOSAL Supplement (c) by " (c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;"

response See the answer to comment #54.

comment 692 comment by: Oya Vendée Hélicoptères

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 186 of 585

An agency of the European Union

PROPOSAL Supplement (c) by " (c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;

response See the answer to comment #54.

comment 734 comment by: ÖAMTC Helicopter Air Rescue (Austria)

AMC3 ORO.FLT.120 (b)(4)(d) [...] the permanent hands-on flying on aircraft not equipped with autopilot [...] Considering an average of 8min sector time possibly in alpine valleys, it creates more risk to focus on AP-Systems engagements versus flying hands on. Besides the distraction on focusing inside the aircraft, the fatigue aspect on 8min flight can be neglected.

response See the answer to comment #54.

comment 751 comment by: DRF-Luftrettung

(I) Helicopter flying is hands on flying due to the aero dynamical properties of the aircraft itself. This cannot account for any additional fatigue because it’s the usual way of flying for helicopter pilots. (II) According to the German Health and Safety regulations wearing a helmet is required for the safety of the crew. Your proposal now suggests, not to wear a helmet to reduce fatigue related risks.

response See the answer to comment #54.

comment 979 comment by: MBH SAMU

(c) ISSUE "The workload and stress levels of single-pilots operations" wording omits that HEMS single-pilots are conducted by TWO technical crew members: one pilot and one TCM. They are not PEQ1 operations. The requirement for a TCM is justified by the fact that the TCM is deemed to be a mitigation measure and to enhance the safety of single-pilot + 1 TCM HEMS operations Therefore, TCM shall be quoted whenever taking into account workload and stress levels of single-pilots operations. PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 187 of 585

An agency of the European Union

Supplement (c) by "(c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;

response See the answer to comment #54.

comment 1242 comment by: SAF

(c) ISSUE "The workload and stress levels of single-pilots operations" wording omits that HEMS single-pilots are conducted by TWO technical crew members: one pilot and one TCM. They are not PEQ1 operations. The requirement for a TCM is justified by the fact that the TCM is deemed to be a mitigation measure and to enhance the safety of single-pilot + 1 TCM HEMS operations Therefore, TCM shall be quoted whenever taking into account workload and stress levels of single-pilots operations. PROPOSAL Supplement (c) by "(c) The workload and stress levels of single-pilots operations, including the benefits of the presence of a TCM;

response See the answer to comment #54.

comment 1289 comment by: Hélicoptères de France

(b)(7)(a) ISSUE The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel […]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A,CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL HDF proposes to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, and all other involved personnel under the planned FRM; and”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 188 of 585

An agency of the European Union

response See the answer to comment #54.

comment 1357 comment by: European Cockpit Association

Commented text: AMC3 ORO.FTL.120(b)(4) Fatigue risk management (FRM) In addition to AMC1 ORO.FTL.120(b)(4), HEMS operators should also take into account hazards specific to HEMS operations, such as the following: ECA Comment: Any HEMS operation exeeding 12 hours of alertness/FDP should be under FRM - this should be an IR.

response See the answer to comment #54.

comment 353 comment by: European Helicopter Association (EHA)

FNAM (France) (b)(7)(a) ISSUE The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel […]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A, CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL The FNAM proposes to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, technical crew and all other involved personnel under the planned FRM; and”

response See the answer to comment #54.

comment 514 comment by: FNAM/SNEH

(b)(7)(a) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 189 of 585

An agency of the European Union

The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel[…]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A, CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL FNAM and SNEH propose to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, and all other involved personnel under the planned FRM; and”

response See the answer to comment #54.

comment 693 comment by: Oya Vendée Hélicoptères

(b)(7)(a) ISSUE The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel[…]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A, CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL OYA proposes to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, and all other involved personnel under the planned FRM; and”

response See the answer to comment #54.

comment 980 comment by: MBH SAMU

(b)(7)(a) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 190 of 585

An agency of the European Union

The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel[…]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A, CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL MBH proposes to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, and all other involved personnel under the planned FRM; and”

response See the answer to comment #54.

comment 1243 comment by: SAF

(b)(7)(a) ISSUE The Technical Crew Member has been added although he was already included thanks to the previous wording "and all other involved personnel[…]”. Since AMC1 ORO.FTL.120(b)(7) is a general CAT AMC which is applicable to all activities: CAT.A, CAT.HEMS, etc., operational specification shall not be added. The TCM is specific to HEMS operations and thus, it should not be quoted in the AMC1 ORO.FTL.120(b)(7). This additional wording seems confusing for other activities than HEMS and does not bring any additional safety enhancement. Reversely, HEMS are not concerned by cabin crew. PROPOSAL SAF proposes to let unchanged as regards to TCM and add a specification for cabin crew in (a): “(a) training programmes to ensure competency commensurate with the roles and responsibilities of management, flight crew, cabin crew whenever required, and all other involved personnel under the planned FRM; and”

response See the answer to comment #54.

comment 225 comment by: ANSMUH

Proposal following my comments to CS FTL.3.200 Home base — HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 191 of 585

An agency of the European Union

(b) By way of derogation from point (a), and in mutual agreement between the operator and the crew, the operator may assign the operator's principal place of business as crew member's HEMS home base. Proposal: GM1 ORO.FTL.200 Home base TRAVELLING TIME Crew members should consider making arrangements for temporary accommodation closer to their home base, if the travelling time from their residence to their home base usually exceeds 90 minutes. If the operator assign the operator's principal place of business as crew member's HEMS

home base, the operator must make the necessary to find a proper accomodation is

arranged in case the travelling time from their residence exceeds 90 minutes.

response See the answer to comment #54.

comment 30

Good morning, I read the proposal of 'EASA in question, specifically the part concerning the duty time and rest of the crews HEMS HELICOPTERS, Pilots and HEMS CREW MEMBER, personally I see no advantage neither in safety nor in the aspect of the rest, on the contrary, I think that in this way we add a factor of greater stress, because the "REST" in base does not allow to detach completely, as it happens now doing the 7 days, or in the case of technicians 15 days, in addition, this will entail a problem for all those who live far from the bases, which obviously can not return from their families, and this would create many problems that result in greater stress for the person, and therefore, a non- tranquility on the spot in work, (HF) in addition, the same companies will be taken to hire staff at the external bases with the consequences of the case. The figure of the MH will not be more polyvalent as now (MH and Technician) so it will still be necessary to present a technician on the base. I believe that right now exists the right relationship in terms of duty time and rest times, and that our reality is better than many others, in terms of safety, also considering our national territory, which can not be said to be an easy orography and therefore already in itself challenging under all the profiles. We can not pretend to equate what happens in fixed wing companies with the reality of helicopters, our work environment is always "HOSTILE", EASA should separate the two realities at least for what concerns the operational aspects. I would suggest to EASA, to leave the shifts as they are now, continuing to maintain the right compromise between work and life. Greeting Guido Luca Galante

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 192 of 585

An agency of the European Union

response See the answer to comment #54.

comment 354 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE Due to multiple Flight Times inside a unique FDP, the FNAM underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, the FNAM has suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, the FNAM suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #28.5 & #31.1) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 433 comment by: UFH French Helicopters Association

ISSUE Due to multiple flight times inside a unique FDP, UFH underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. (Cf. attachments S2, S3 and S4 illustrating the post flight issue) This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 193 of 585

An agency of the European Union

Therefore, FNAM has suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, UFH suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #28.5 & #31.1) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 515 comment by: FNAM/SNEH

Attachments #241 #242 #243

ISSUE Due to multiple flight times inside a unique FDP, FNAM and SNEH underline that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. (Cf. attachments S2, S3 and S4 illustrating the post flight issue) This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, FNAM and SNEH have suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, FNAM and SNEH suggest specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #486 & #502) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 194 of 585

An agency of the European Union

response See the answer to comment #54.

comment 694 comment by: Oya Vendée Hélicoptères

Attachments #244 #245 #246

ISSUE Due to multiple flight times inside a unique FDP, OYA underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. (Cf. attachments S2, S3 and S4 illustrating the post flight issue) This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, OYA has suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, OYA suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #666 & #682) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 982 comment by: MBH SAMU

Attachments #247 #248 #249

ISSUE Due to multiple flight times inside a unique FDP, MBH underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 195 of 585

An agency of the European Union

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. (Cf. attachments S2, S3 and S4 illustrating the post flight issue) This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, MBH has suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, MBH suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #944 & #966) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 1244 comment by: SAF

Attachments #250 #251 #252

ISSUE Due to multiple flight times inside a unique FDP, SAF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 196 of 585

An agency of the European Union

Therefore, SAF has suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, SAF suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #1216 & #1232) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 1291 comment by: Hélicoptères de France

ISSUE Due to multiple flight times inside a unique FDP, HDF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP

• Assuming the FDP ends with the last FT

• Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. (Cf. attachments S2, S3 and S4 illustrating the post flight issue) This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, FNAM and SNEH have suggested to clarify the use of the terms of "post flight" duties since they are confusing for HEMS. As a consequence, HDF suggests specifying the post-flight time within this AMC concerns the time for the duties just after the last FT of a FDP, if it is what is meant by the regulation for HEMS operations (Cf. comments #28.5 & #31.1) PROPOSAL “POST-FLIGHT DUTIES The operator should specify post-flight duty times immediately succeding the last flight journey (FT) within a given FDP taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response See the answer to comment #54.

comment 318 comment by: European Helicopter Association (EHA)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 197 of 585

An agency of the European Union

NORSK LUFTAMBULANSE AS (Norway): “44. AMC2 ORO.FTL.110(a) ‘PUBLICATION OF ROSTERED REST PERIODS IN AIR TAXI, AEMS AND HEMS OPERATIONS’ — a new AMC that requires pre-planning and publishing of extended recovery rest periods 7 days in advance. The 7-day advance is based on the consensus of the rulemaking group. The purpose of pre-planning is to allow crew members to manage their sleep periods and allow for an appropriate work-life balance, referring to being able to plan visits to administration, doctors, dentists etc.” Comment: We publish rosters minimum three months in advance (normally in January for the whole year). CAT rosters must be published over 14 days in advance. While it has no effect on us, what is the rationale behind having only 7 days for HEMS? As commuting is so common in HEMS, at least regulation for CAT rostering should be adhered to.

response See the answer to comment #54.

comment 372 comment by: European Helicopter Association (EHA)

BHA (UK) "44. AMC2 ORO.FTL.110(a) ‘PUBLICATION OF ROSTERED REST PERIODS IN AIR TAXI, AEMS AND HEMS OPERATIONS’ — a new AMC that requires pre-planning and publishing of extended recovery rest periods 7 days in advance. The 7-day advance is based on the consensus of the rulemaking group. The purpose of pre-planning is to allow crew members to manage their sleep periods and allow for an appropriate work-life balance, referring in particular to being able to plan visits to administration, doctors, dentists etc. " Comment: Unsure of the purpose of this? CAT rosters need to be published >14 days in advance, why should HEMS operations get alleviation?

response See the answer to comment #54.

comment 599 comment by: NOLAS

“44. AMC2 ORO.FTL.110(a) ‘PUBLICATION OF ROSTERED REST PERIODS IN AIR TAXI, AEMS AND HEMS OPERATIONS’ — a new AMC that requires pre-planning and publishing of extended recovery rest periods 7 days in advance. The 7-day advance is based on the consensus of the rulemaking group. The purpose of pre-planning is to allow crew members to manage their sleep periods and allow for an appropriate work-life balance, referring to being able to plan visits to administration, doctors, dentists etc.” Comment: We publish rosters minimum three months in advance (normally in January for the whole year). CAT rosters must be published over 14 days in advance. While it has no effect on us, what is the rationale behind having only 7 days for HEMS? As commuting is so common in HEMS, at least regulation for CAT rostering should be adhered to.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 198 of 585

An agency of the European Union

response See the answer to comment #54.

comment 848 comment by: Yorkshire Air Ambulance

CAT rosters need to be published >14 days in advance, why should HEMS operations get alleviation?

response See the answer to comment #54.

comment 691 comment by: Oya Vendée Hélicoptères

AGREEMENT 7-days prior notice for publishing rostered rest period in HEMS better suits the activity than the 14-days prior notice in CAT scheduled and charter operations. OYA agrees and would like to thank EASA for this proposal, also limited to extended recovery rest periods.

response See the answer to comment #54.

comment 1287 comment by: Hélicoptères de France

AGREEMENT 7-days prior notice for publishing rostered rest period in HEMS better suits the activity than the 14-days prior notice in CAT scheduled and charter operations. HDF agrees and would like to thank EASA for this proposal, also limited to extended recovery rest periods.

response See the answer to comment #54.

comment 512 comment by: FNAM/SNEH

AGREEMENT 7-days prior notice for publishing rostered rest period in HEMS better suits the activity than the 14-days prior notice in CAT scheduled and charter operations. FNAM and SNEH agree and would like to thank EASA for this proposal, also limited to extended recovery rest periods.

response See the answer to comment #54.

comment 978 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 199 of 585

An agency of the European Union

AGREEMENT 7-days prior notice for publishing rostered rest period in HEMS better suits the activity than the 14-days prior notice in CAT scheduled and charter operations. MBH agrees and would like to thank EASA for this proposal, also limited to extended recovery rest periods.

response See the answer to comment #54.

comment 1241 comment by: SAF

AGREEMENT 7-days prior notice for publishing rostered rest period in HEMS better suits the activity than the 14-days prior notice in CAT scheduled and charter operations. SAF agrees and would like to thank EASA for this proposal, also limited to extended recovery rest periods.

response See the answer to comment #54.

comment 539 comment by: ADAC Luftrettung gGmbH

Helicopter flying is hands on flying due to the aero dynamical properties of the aircraft itself. This cannot account for any additional fatigue because it’s the usual way of flying for helicopter pilots. According to DIN EN 13718-2 wearing a helmet is required.

response See the answer to comment #54.

comment 560 comment by: Rüdiger Neu

Hands on Flüge sind die normale Arbeitsweise eines Hubschrauberpiloten, somit kann dies keinen Faktor für Ermüdung darstellen. Eine Tragepflicht von Helmen wird durch weitere Rechtsvorschriften vorgeschrieben z.B. DIN EN 13718-2.

response See the answer to comment #54.

comment 729 comment by: ADAC

Hier bleibt es dem verantwortlichen Kapitän grundsätzlich selbst überlassen, Pausen zu machen. Dies ist Kapitänsentscheidung. Es müssen keine Einsätze geflogen werden, wenn der Kapitän müde oder erschöpft ist. Er kann selbständig Pausen anordnen. Dies ist im Handbuch so manifestiert.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 200 of 585

An agency of the European Union

response See the answer to comment #54.

comment 25 comment by: Johannes Brantz

Comment on Commuting The current commuting efforts of German HEMS pilots are very high, as your analysis also shows. With FTL you suggest that Flight Crews should move close to the HEMS operating base to avoid fatigue caused by a long commute. I do appreciate your effort that accounts for this fact. I would like to bring to your attention that I see a risk that this proposal will not reduce fatigue significantly for 2 reasons: 1. Flight crews will not get moving expenses reimbursed, so moving on there own expense imposes a economical risk This will lead to high threshold for individuals to actually move closer to there Home Base 2. The first reason exists because of the second reason: Many HEMS pilots want to or have to change there assigned HEMS Home Base for personal as well as economical reasons driven by the operator. This increases the economical risk created by reason #1 which in fact will not significantly reduce fatigue in my opinion

response See the answer to comment #54.

comment 260 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): This paragraph suggests to arrange for accommodation close to base for a crew member who is living more than 90 minutes away from his assigned home base. This is contradicting the fundamental right of free movement.

response See the answer to comment #54.

comment 355 comment by: European Helicopter Association (EHA)

FNAM (France) Standby Other than Airport Standby Notification #1 ISSUE The FNAM underlines that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. The FNAM suggests adding a precision in the title in the manner to differentiate the two GM.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 201 of 585

An agency of the European Union

PROPOSAL Replace the titles of these GM by the following: • GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A • GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

response See the answer to comment #54.

comment 516 comment by: FNAM/SNEH

Standby Other than Airport Standby Notification ISSUE FNAM and SNEH underline that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. FNAM and SNEH suggest adding a precision in the title in the manner to differentiate the two GM. PROPOSAL Replace the titles of these GM by the following:

• GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A

• GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

response See the answer to comment #54.

comment 541 comment by: ADAC Luftrettung gGmbH

This paragraph refers to an awake time of 18 hours which leaves some space for the rest of this regulation.

response See the answer to comment #54.

comment 695 comment by: Oya Vendée Hélicoptères

Standby Other than Airport Standby Notification ISSUE OYA underlines that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. OYA suggests adding a precision in the title in the manner to differentiate the two GM. PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 202 of 585

An agency of the European Union

Replace the titles of these GM by the following:

• GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A

• GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

response See the answer to comment #54.

comment 983 comment by: MBH SAMU

Standby Other than Airport Standby Notification ISSUE MBH underlines that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. MBH suggests adding a precision in the title in the manner to differentiate the two GM. PROPOSAL Replace the titles of these GM by the following:

• GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A

• GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

response See the answer to comment #54.

comment 1245 comment by: SAF

Standby Other than Airport Standby Notification ISSUE SAF underlines that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. SAF suggests adding a precision in the title in the manner to differentiate the two GM. PROPOSAL Replace the titles of these GM by the following:

• GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A

• GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 203 of 585

An agency of the European Union

response See the answer to comment #54.

comment 1292 comment by: Hélicoptères de France

Standby Other than Airport Standby Notification #1 ISSUE HDF underlines that there are two GM1 ORO.FTL.225. It can be confusing and may lead to misunderstanding. HDF suggests adding a precision in the title in the manner to differentiate the two GM. PROPOSAL Replace the titles of these GM by the following:

• GM1 ORO.FTL.225 (Standby other than airport standby notification) => GM1 ORO.FTL.225.A

• GM1 ORO.FTL.225 (Awake time) => GM1 ORO.FTL.225.B

response See the answer to comment #54.

comment 389

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To AMC2 ORO.FTL.110(a): It remains unclear what the difference between "rostered extended recovery rest period" and "recurrent extended recovery rest period" (ref. CS FTL 3.235) is supposed to be. If these two terms mean the same, we recommend to use the same term. If they are different use more descriptive wording to make clear what the terms really mean.

response See the answer to comment #54.

comment 122 comment by: UK CAA

Page No: 43 Paragraph No: AMC3 ORO.FTL.120(b)(4) Fatigue risk management (FRM) Comment: References to NVIS and the fatigue that is potentially generated through their use are included in GM1 SPA.NVIS.140 Information and Documentation which cites fatigue due to NVIS in several areas (3.2.2.2 and 3.2.1.4). This element should be specifically referenced in this list rather than included in the vague reference in (f) “helmet / survival suit”. Justification: Consistency of the application of the applicable requirements and the extent to which using NVIS could generate fatigue of the crew.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 204 of 585

An agency of the European Union

Proposed Text: Add “(g) The specific fatigue generated when wearing of NVIS.”

response See the answer to comment #54.

comment 395 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): AMC3 ORO.FTL.1208b)(4) Comment: Helicopter flying is hands on flying due to the aero dynamical properties of the aircraft itself. This cannot account for any additional fatigue because it’s the usual way of flying for helicopter pilots. According to DIN EN 13718-2 wearing a helmet is required.

response See the answer to comment #54.

comment 1405 comment by: Swiss Air-Ambulance Rega

References to NVIS and the fatigue that is potentially generated through their use are included in GM1 SPA.NVIS.140 Information and Documentation which cites fatigue due to NVIS in several areas (3.2.2.2 and 3.2.1.4). This element should be specifically referenced in this list rather than included in the vague reference in (f) “helmet / survival suit”. Proposed amendment: Add “(g) The specific fatigue generated when wearing of NVIS.”

response See the answer to comment #54.

comment 1358 comment by: European Cockpit Association

Commented text: GM1 ORO.FTL.200 Home base TRAVELLING TIME Crew members should consider making arrangements for temporary accommodation closer to their home base, if the travelling time from their residence to their home base usually exceeds 90 minutes. ECA Comment: National laws of members states often do not allow operators/employers to make living restrictions for their employees. In addition, this is unrealistic, because of CS FTL.3.200 where there is no restriction for the operator about changing the home base How often will the flight crew member have to change his living place? This becomes even less useful if a multiple HEMS base is assigned as home base; this restricts the possible living

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 205 of 585

An agency of the European Union

arrangements of the crew to an unacceptable level. If this is required/desired, then it has to be the operator’s responsibility, to arrange temporary accommodation.

response There is a misunderstanding about what home base is. Anyway, HEMS operations are

outside this proposal.

comment 1428 comment by: Bartosz Fibingier

AMC1 ORO.FTL.210(c)(f) and GM1 ORO.FTL.205(a)(1) could be published as one AMC.

response HEMS is not part of this proposal, therefore these texts have been removed.

comment 261 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): This paragraph refers to an awake time of 18 hours which leaves some space for the rest of this regulation.

response HEMS is not part of this proposal.

3.2. Draft certification specifications - CS.FTL.3 p. 34

comment 477 comment by: FNAM/SNEH

GENERAL ISSUE It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rules • Cherry-picking is allowed

The complexity of this proposal will lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #473, #478, #496, #510, #511) GENERAL PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 206 of 585

An agency of the European Union

Clarify the writing when there is a possibility of applying the CS requirements and / or the IR.

response See the answer to comment #54.

comment 530 comment by: ADAC Luftrettung gGmbH

For using Art. 22 and having a own certificatin specificatin there is the need for a scientific study, this makes the process expensive and for smaler operator impossible. If an operator has its own CS, it is almost impossible for an other operator to take over this base. Herewith it is a monopoly for the actuell operator and a fair market and an open compettition are not possible. If operator or states make there own CS, there will be again no harmonization like EASA wanted.

response See the answer to comment #54.

comment 657 comment by: Oya Vendée Hélicoptères

GENERAL ISSUE It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rules • Cherry-picking is allowed

The complexity of this proposal will lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #653, #658, #676, #689, #690) GENERAL PROPOSAL Clarify the writing when there is a possibility of applying the CS requirements and / or the IR.

response See the answer to comment #54.

comment 932 comment by: MBH SAMU

GENERAL ISSUE It is not explicit whether:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 207 of 585

An agency of the European Union

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rules • Cherry-picking is allowed

The complexity of this proposal will lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #926, #933, #958, #975, #977) GENERAL PROPOSAL Clarify the writing when there is a possibility of applying the CS requirements and / or the IR.

response See the answer to comment #54.

comment 1021 comment by: Stephanie Selim

General comment : As mentionned in the general comments of the NPA, DGAC requests for HEMS operations to be removed from this NPA and choses the option 0 described in the RIA (no policy change).. However, if this French position is not accepted, we provide hereafter detailed comments about proposed measures on HEMS in the HEMS part of the NPA.

response See the answer to comment #54.

comment 1205 comment by: SAF

GENERAL ISSUE It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rules • Cherry-picking is allowed

The complexity of this proposal will lead to misunderstanding and thus wrong application of the regulation.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 208 of 585

An agency of the European Union

(Cf. comments #1199, #1208, #1226, #1239, #1240) GENERAL PROPOSAL Clarify the writing when there is a possibility of applying the CS requirements and / or the IR.

response See the answer to comment #54.

comment 1271 comment by: Hélicoptères de France

GENERAL ISSUE It is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed The complexity of this proposal will lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #25, #30.1, #39, #40) GENERAL PROPOSAL Clarify the writing when there is a possibility of applying the CS requirements and / or the IR.

response See the answer to comment #54.

CS FTL.3.100 p. 34

comment 338 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE It is not explicit whether all the CS.FTL.3 requirements shall be applicable "in block" or if they should apply depending on what is said in the implementing rule or if it is possible to "cherry-pick". For instance, the ORO.FTL.210 (b)(2) lets the choice between applying DP max times from: • The IR: ORO.FTL.210 (a) • Or the HEMS CS.FTL (figures in table CS.FTL.3.210) The FNAM suggests rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #18.1, #24, #30.1, #39, #40) PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 209 of 585

An agency of the European Union

Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant)

response See the answer to comment #54.

comment 478 comment by: FNAM/SNEH

ISSUE It is not explicit whether all the CS.FTL.3 requirements shall be applicable "in block" or if they should apply depending on what is said in the implementing rule or if it is possible to "cherry-pick". For instance, the ORO.FTL.210 (b)(2) lets the choice between applying DP max times from:

• The IR: ORO.FTL.210 (a) • Or the HEMS CS.FTL (figures in table CS.FTL.3.210)

FNAM and SNEH suggest rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #473, #477, #496, #510, #511) PROPOSAL Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant).

response See the answer to comment #54.

comment 658 comment by: Oya Vendée Hélicoptères

• The IR: ORO.FTL.210 (a) • Or the HEMS CS.FTL (figures in table CS.FTL.3.210)

OYA suggests rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #653, #657, #676, #689, #690)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 210 of 585

An agency of the European Union

PROPOSAL Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant).

response See the answer to comment #54.

comment 933 comment by: MBH SAMU

• The IR: ORO.FTL.210 (a) • Or the HEMS CS.FTL (figures in table CS.FTL.3.210)

MBH suggests rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #926, #932, #958, #975, #977) PROPOSAL Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant).

response See the answer to comment #54.

comment 1208 comment by: SAF

• The IR: ORO.FTL.210 (a) • Or the HEMS CS.FTL (figures in table CS.FTL.3.210)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 211 of 585

An agency of the European Union

SAF suggests rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #1199, #1205, #1226, #1239, #1240) PROPOSAL Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant).

response See the answer to comment #54.

comment 1272 comment by: Hélicoptères de France

• The IR: ORO.FTL.210 (a)

• Or the HEMS CS.FTL (figures in table CS.FTL.3.210) HDF suggests rewriting and precising explicitly what and when the requirements of CS.FTL HEMS apply. (Cf. comments #18.1, #24, #30.1, #39, #40) PROPOSAL Rewrite: "A CAT operator shall apply the requirements of the following certification for each and every emergency medical service operations by helicopters (HEMS)" (if it is what is meant).

response See the answer to comment #54.

GM1 CS FTL.3.100 p. 34

comment 304 comment by: European Helicopter Association (EHA)

OEAMTC (Austria) GM1 CS FTL 3.100 Applicability To ensure regulatory continuity for the full duration of a HEMS flight, a HEMS flight may include positioning the helicopter after the patient is unloaded from the helicopter to enable it to return to the HEMS operating base for the next HEMS flight. COMMENT(S)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 212 of 585

An agency of the European Union

Why may only positioning to a HEMS operating base after a patient is unloaded from the helicopter be included in the HEMS flight? What is the difference with AEMS (reference ORO.FTL.105 Definitions (29) where a positioning to the operating base before and after an EMS flight are considered part of that flight? What happens if no patient is taken onboard at all (patient deceased or transported by ground emergency medical services) and why should this make a difference?

response See the answer to comment #54.

comment 339 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE The FNAM agrees on the fact post-positioning flights should also be considered as HEMS flight. However, the pre-positioning flights should also be considered as HEMS flights, to ensure continuity of the emergency service operations: for instance, helicopter going and taking medical staff / material from a third-place before flying to emergency site. Pre-positioning is nevertheless considered as part of the HEMS flight according to the IR ORO.FTL.105 (§29), but this is not stated in this GM and it may lead to misunderstanding. Furthermore, the HEMS payload shall not be limited to "patient" but extended to each and every kind of HEMS necessary material (medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved) This wording is not consistent with the EMS payload defined in ORO.FTL.105 (§29). (Cf. comments #14.3) In order to ensure consistency within this NPA, the FNAM suggests using the wording of the definition of an EMS flight payload ORO.FTL.105 (§29) in the GM1 CS FTL.3.100. PROPOSAL Replace the content of the GM1 CS FTL.3.100 by the following: “To ensure regulatory continuity for the full duration of a HEMS flight, a HEMS flight may include prepositioning and post-positioning the helicopter before and/or after the HEMS payload (medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved) is carried by the helicopter to enable it to operate the emergency medical service from the time it is launched till the helicopter returns at the HEMS operating base for the next HEMS flight.”

response See the answer to comment #54.

comment 420 comment by: UFH French Helicopters Association

Same as comment # 339

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 213 of 585

An agency of the European Union

response See the answer to comment #54.

comment 479 comment by: FNAM/SNEH

Same as comment # 339

response See the answer to comment #54.

comment 659 comment by: Oya Vendée Hélicoptères

Same as comment # 339

response See the answer to comment #54.

comment 781 comment by: AECA helicopteros.

Change GM1 CS FTL 3.100 into CS2 FTL.3.100 Justification.- Due to the importance of its content and for a better guarantee of the HEMS condition of the return flight.

response See the answer to comment #54.

comment 934 comment by: MBH SAMU

Same as comment # 339

response See the answer to comment #54.

comment 1088 comment by: Stephanie Selim

response See the answer to comment #54.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 214 of 585

An agency of the European Union

comment 1209 comment by: SAF

Same as comment # 339

response See the answer to comment #54.

comment 1273 comment by: Hélicoptères de France

Same as comment # 339

response Please see the answer to comment # 54

comment 1404 comment by: Swiss Air-Ambulance Rega

To ensure regulatory continuity for the full duration of a HEMS flight, a HEMS flight may include positioning the helicopter after the patient is unloaded from the helicopter to enable it to return to the HEMS operating base for the next HEMS flight.

response Please see the answer to comment # 54

CS FTL.3.200 p. 34

comment 4 comment by: TG

Die tatsächliche Belastung des Piloten auf dem Weg zur Arbeit ist nicht durch eine fixierte Ruhezeit abgedeckt. 72h/3N ist viel zu lang.

response Please see the answer to comment # 54

comment 97 comment by: B. Wagner

genauere Erläuterung erforderlich: Auf was bezieht sich der Term: "in case of change of home base..."? Trifft dies auf jeden Wechsel zwischen den unter (a) (2) zugewiesenen Stationen zu? Oder gilt das im Falle einer dauerhaften Versetzung nur einmalig? Oder betrifft es Piloten, die außerhalb ihrer nach (a) (1) zugewiesenen Station fallweise eingesetzt werden sollen?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 215 of 585

An agency of the European Union

Diese Einschränkung nimmt den Dienstplanern jegliche Flexibilität und ist nur durch unwirtschaftlich hohen Personalaufwand realisierbar. (Immer Personal im Standby halten, das mindestens die 72h Ruhezeit hatte) Ein Wechsel der Station innerhalb eines Standby Zeitraums würde erst nach 72h Ruhezeit möglich sein.

response Please see the answer to comment # 54

comment 118 comment by: UK CAA

Page No: 34 Paragraph No: CS FTL.3.200(a)(2) Home Base HEMS Comment: Further clarity on this requirement is needed as it could be misinterpreted as it is written. By referring to travelling time between any of the multiple HEMS operating bases, it could be interpreted that the 60 minutes was between any pairings of the HEMS operating bases rather than 60 minutes between all of them. The purpose is that the crew member can drive from any of the nominated HEMS operating bases to all of the other nominated multiple bases within 60 minutes. Justification: Clarity and to prevent excess build-up of fatigue prior to reporting at base. Proposed Text: Amend to read: “(2) multiple HEMS operating bases where the travelling time between all of the nominated bases does not exceed 60 minutes under normal operating conditions”.

response Please see the answer to comment # 54

comment 181 comment by: ANSMUH

CS FTL.3.200 Home. Base - HEMS (a) (2) Multiple HEMS operating bases. The asset that the NPA suggests is to have all (most) pilots have their residences in the operating base place. It's impossible in France, because most of the pilots are separated by more than 60 minutes from her/his operating base. This will have an economic and social impact on pilots who will be forced to take

acommodation within 60 minutes of the operating bases. They will face a high increase of

expenses, creating a problem in actual crew's contracts and remuneration.

Proposal: CS FTL.3.200 Home base — HEMS (a) The home base is assigned to each crew member with a high degree of permanence and may either be: (1) a single HEMS operating base; or

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 216 of 585

An agency of the European Union

(2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions. (b) By way of derogation from point (a), the operator may assign a different crew member's HEMS home base provided that, during duty periods, a proper accomodation is arranged in case the travelling time from their residence exceeds 90 minutes. (c) (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning or flight duty period.

response Please see the answer to comment # 54

comment 223 comment by: ADAC Luftrettung gGmbH

Was ist unter einer "change of home base" zu verstehen? Eine dauerhafte Versetzung an einen anderen Standort? Oder auch ein kurzfristiger temporärer Wechsel (Krankheitsvertretung) sowie wechselnde Stationen bei Springerpiloten?

response Please see the answer to comment # 54

comment 252 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) A crew member, either pilot or TC HEMS shall be assigned to one home base. In caseof more than one home base, traveling time between bases under normal circumstances shall be less than 1 hour. Question: Is it required to assign every crew member to a home base or to assign every base to a crew member? (b) In case of change of home base the recurrent extended recovery rest period is increased once to 72 hours including 3 local nights and travelling time counts as positioning or FDP. Question: What is the meaning of “change of home base” in this context? Long- termrelocation to another base or short-term temporary changes (e.g. caused by illness)or changing bases of reserve pilots.

response Please see the answer to comment # 54

comment 296 comment by: European Helicopter Association (EHA)

BABCOCK ITALY

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 217 of 585

An agency of the European Union

CS FTL 3.200 Home Base - HEMS GM1 ORO.FTL.200 Home base Travelling Time Why we want to change

The actual definition of Home base will reduce flexibility on rostering pilots and it will lead to a lack of crew on the not very populated areas resulting in an increasing of the HEMS cost. o What we propose CS FTL.3.200 Home base — HEMS (a) The home base is assigned to each crew member on the publication of rosters for a block of consecutive FDP with a high degree of permanence and may either be: (1) a single HEMS operating base; or (2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning or flight duty period. GM1 ORO.FTL.200 Home base TRAVELLING TIME Crew members should consider making arrangements in accord with the company, for temporary accommodation closer to their home base, if the travelling time from their residence to their home base usually exceeds 90 minutes.

response Please see the answer to comment # 54

comment 312 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): “(a) The home base is assigned to each crew member with a high degree of permanence and may either be: (1) a single HEMS operating base; or (2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions.” Comment: This is sensible, however, how should this be handled for crew members that are working for more than one organization or operator? Especially HEMS technical crew members are often working for more than one organization or more than one operator providing HEMS. Furthermore, while it is sensible to have a home base assigned, it may be too restrictive in cases where crew members need to have to maintain recency on two different type of helicopters. How often would an operator be able to switch permanent home base (not a temporary change as in (b))?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 218 of 585

An agency of the European Union

Would it be feasible to have home base decided upon publication of roster provided that the roster is published long time enough in advance? Furthermore, there is a need for clarification. The text as written could be interpreted as 60 minutes is between 60 minutes between all the HEMS operating bases in question or as 60 minutes between any two HEMS of them. We also wonder where the 60 minutes come from. In “48. GM1 ORO.FTL.200 ‘TRAVELLING TIME’” 90 minutes is used. Wouldn’t 90 minutes be as appropriate as 60 minutes?

response Please see the answer to comment # 54

comment 340 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE The FNAM would like to thank the EASA for introducing the possibility of multiple HEMS operatingbases corresponding to a home base. Indeed, in HEMS activity, multiple HEMS operating bases arefrequently used. The notion of home base for HEMS operators is very different from the one definedin CAT operations with aeroplanes. First, the proposal of a 60 minutes threshold to separate those 'multiple HEMS operating bases' is notconsistent with the 90 minutes threshold deemed to be safe and accepted between the residence ofthe crew and their home base. Then, in France, an HEMS operating base can either be a hospital (the pilot has a room / suitableaccommodation in the hospital) or for instance a drop zone at a summit of the slopes with an adjoiningdedicated room (suitable accommodation) for the pilot. The French multiple HEMS operating bases may be mostly used in the mountains. They can begeographically close. However, the time spent to reach another HEMS operating base by road can berather long. For instance, 60 minutes is far too short to reach another close hospital located in anothervalley or to reach the drop zone at the summit of the slopes. It is obvious that using a helicopter to reach this other HEMS operating base will decline considerablythis time spent. Thus, any home base change would imply a recurrent extended recovery rest increased to 72h PRIORto starting duty at the new base: • Even if moving from a HEMS operating base in a hospital to geographically nearby drop zoneat a summit • Even if there is no significant added travel time from the residence to the other HEMSoperating baseAs a consequence, 1/ If the possibility of multiple HEMS operating bases as a home base is to allow a given crew to workon different nearby HEMS operating bases / hospitals for France, the threshold of 60 minutes is notsufficient and should be extended to 90 min, which is by the way considered as acceptable for traveltime between residence and home base. 2/ If the possibility of changing home base is to allow to replace an ill crew from another base, thechange of home base should allow to warranty the continuity of the HEMS operations. In France, themost usual rostering is usually 7 days ON at home base / 7 days OFF. It would be simply impossible to replace a pilot by changing the home base by another for currentFrench 5 days ON / 2 days OFF.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 219 of 585

An agency of the European Union

The extended recovery rest period taken prior to starting duty may not allow the replacement of an illcrew from a base by another crew from another base as it will imply a 4-days delay. The FNAM suggests that the extension of the extended recovery rest period occurs on the extendedrecovery rest period following the change and not prior starting duty at the new home base. Otherwise,this provision will be inoperative in real life, since most of the operators will change of crew (replacingan ill crew) in 'back-to-back' without changing the home base. Moreover, for fatigue mitigation, it is already required that the haul between the former and the newhome base is considered as positioning or FDP. PROPOSAL Replace the content of this paragraph by the following: “(a) The home base is assigned to each crew member with a high degree of permanence and may (1) a single HEMS operating base; or (2) multiple HEMS operating bases if the travelling time between any of these HEMS operatingbases does not exceed 90 minutes under usual conditions. (b) In the case of a change of home base, the recurrent extended recovery rest period following thestarting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning or flightduty period.”

response Please see the answer to comment # 54

comment 366 comment by: European Helicopter Association (EHA)

BHA (UK) "CS FTL.3.200 Home base — HEMS (a) (1)" Comment: This is good, but see previous comments about TCMs. If they are employed by a third-party but engaged in HEMS activity, has consideration been given to the impact this arrangement may have on Home Base assignation?

response Please see the answer to comment # 54

comment 396 comment by: European Helicopter Association (EHA)

OEAMTC (Austria). CS FTL.3.200 Home base — HEMS […]

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 220 of 585

An agency of the European Union

(2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions. COMMENT(S) Why would travelling time between multiple HEMS operating bases be restricted to 60 minutesinstead of 90 minutes (reference GM1 CS FTL.1.200 Home base)? This seems rather arbitrary. Due toAustria’s geography most operating bases are separated more than 60 minutes travelling time (bycar), in fact most operating bases in Europe are separated more than 60 minutes travelling time (bycar). Crew usually travel the day before the first of (in our case 7) consecutive FDP and stay on or very near the HEMS operating base throughout these consecutive FDPs. Counting the travel time aspositioning because the definition of multiple bases is unusable this reduces the number ofconsecutive duties. CS FTL.3.200 Home base — HEMS […] (b) In the case of a change of home base, the recurrent extended recovery rest period prior tostarting duty at the new home base is increased once to 72 hours, including 3 local nights. Travellingtime between the former home base and the new home base is positioning or flight duty period. COMMENT(S) Unworkable if the travelling times in CS FTL.3.200 Home base — HEMS (a)(2) remain 60 minutes.

response Please see the answer to comment # 54

comment 397 comment by: European Helicopter Association (EHA)

OEAMTC (Austria). Page 34 and 26 COMMENT(S) CS FTL 3.205 Numbering is used for two chapters

response Please see the answer to comment # 54

comment 405 comment by: ANWB MAA

Why state a new limit of 60 minutes as there is already a travel limit of 90 minutes (ORO.FTL.200). Suggest to keep it 90 minutes for both

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 221 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 421 comment by: UFH French Helicopters Association

Same as comment # 340

response Please see the answer to comment # 54

comment 480 comment by: FNAM/SNEH

Same as comment # 3340.

response Please see the answer to comment # 54

comment 529 comment by: ADAC Luftrettung gGmbH

(a) A crew member, either pilot or TC HEMS shall be assigned to one home base. In case of more than one home base, traveling time between bases under normal circumstances shall be less than 1 hour. Question: Is it required to assign every crew member to a home base or to assign every base to a crew member? (b) In case of change of home base the recurrent extended recovery rest period is increased once to 72 hours including 3 local nights and travelling time counts as positioning or FDP. Question: What is the meaning of “change of home base” in this context? Long-term relocation to another base or short-term temporary changes (e.g. caused by illness) or changing bases of reserve pilots.

response Please see the answer to comment # 54

comment 552 comment by: Rüdiger Neu

(a) Ein Besatzungsmitglied, sowohl Pilot als auch HEMS TC, müssen einer Station zugeordnet sein. Sind es mehrere Stationen, muss die Reisezeit im Normalfall < 1 Stunde betragen. Fragestellung: Müssen jeder Station Besatzungsmitglieder zugeordnet werden oder muss jedem Besatzungsmitglied eine Station zugeordnet werden? Somit wäre der Einsatz der Flexpiloten stark eingeschränkt.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 222 of 585

An agency of the European Union

(b) Bei einem Wechsel der Heimatstation muss einmalig eine 72 stündige Ruhezeit (min. 3 Nächte) eingehalten werden und die Reisezeit zählt als Flugdienstzeit (FDP). Fragestellung: Ist mit „change of home base“ eine dauerhafte Versetzung an einen anderen Standort gemeint, oder soll dies auch für kurzfristige, temporäre Wechsel (z.B. Krankheitsvertretung) oder wechselnde Stationen der Flexpiloten (Spinger) gelten?

response Please see the answer to comment # 54

comment 581 comment by: FinnHEMS Oy

(a)(2) ...if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions. COMMENT: Finland is a sparsely populated country with long distances (up to 1000km) between crew homes and HEMS bases. It is necessary to increase the time requirement to be able to use pilots flexibly between two or three bases. SUGGESTION: Increase the amount of minutes to 240 minutes.

response Please see the answer to comment # 54

comment 660 comment by: Oya Vendée Hélicoptères

Same as comment # 340

response Please see the answer to comment # 54

comment 721 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FTL.3.200 (a) (2) "Multiple home bases" are irrelevant as across Europe there are hardly any bases within 60min reachable

response Please see the answer to comment # 54

comment 743 comment by: DRF-Luftrettung

Page 34 – CS.FTL.3.200 Home Base (a) A crew member, either pilot or TC HEMS shall be assigned to one home base. In case of more than one home base, traveling time between bases under normal circumstances shall be less than 1 hour.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 223 of 585

An agency of the European Union

Question: Is it required to assign every crew member to a home base or to assign every base to a crew member? (b) In case of change of home base the recurrent extended recovery rest period is increased once to 72 hours including 3 local nights and travelling time counts as positioning or FDP. Question: What is the meaning of “change of home base” in this context? Long-term relocation to another base or short-term temporary changes (e.g. caused by illness) or changing bases of reserve pilots.

response Please see the answer to comment # 54

comment 782 comment by: AECA helicopteros.

Question needing answer by regulation: In case of base change for emergency reasons, the pilot need specific training, regarding the new base?

response Please see the answer to comment # 54

comment 809 comment by: Babcock Mission Critical Services Limited

It could be understood that if you have a pilot assigned to one HEMS home base and you scheduled this pilot to one or several duties to another base, the operator must let him rest 72 hours with 3 local nights between the positioning and the first duty. We think it must only apply if you change the home base of the pilot as a permanent assignment, not as a result of, for example, if a pilot is sick and you need to roster immediately another pilot assigned to other home base. Revise “Home base” definition: CS FTL.2.200 Home base — air taxi and AEMS (a) The home base is any location assigned to the crew member with a high degree of permanence. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is considered Positioning in accordance with ORO.FTL.215. CS.FTL.3.200 Home Base – HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 224 of 585

An agency of the European Union

(a) The home base is any location assigned to the crew member with a high degree of permanence. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is considered Positioning in accordance with ORO.FTL.215 GM.CS.FTL.2/3.200 (a) Home Base In case of a touring pilot, their main place of residence may be considered as their home base. In this case fatigue protection is provided by all travelling to/from a HEMS operating base, as being considered as positioning within the FDP.

response Please see the answer to comment # 54

comment 836 comment by: Yorkshire Air Ambulance

This is good, but see previous comments about TCMs. If they are employed by a third- party but engaged in HEMS activity, has consideration been given to the impact this arrangement may have on Home Base assignation?

response Please see the answer to comment # 54

comment 898 comment by: Stephanie Selim

CS FTL.3.200 (a)(1)(2) : Technical comment – DGAC would like to thank EASA for introducing the possibility of multiple HEMS operating bases corresponding to a home base. Indeed, in HEMS activity, multiple HEMS operating bases are frequently used. The notion of home base for HEMS operators is very different from the one defined in CAT operations with aeroplanes. However, the French multiple HEMS operating bases may be mostly used in the mountains. They can be geographically close. However, the time spent to reach another HEMS operating base by road can be rather long. For instance, 60 minutes is far too short to reach another close hospital located in another valley or to reach the drop zone at the summit of the slopes. Consequently, the threshold of 60 minutes is not sufficient and should be extended to 120 min.

response Please see the answer to comment # 54

comment 899 comment by: Stephanie Selim

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 225 of 585

An agency of the European Union

CS FTL.3.200 (b) : Editorial comment – Wording similar to CS FTL.1.200 is suggested: “In the case of a change of home base, the first recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning.”

response Please see the answer to comment # 54

comment 935 comment by: MBH SAMU

Same as comment # 340

response Please see the answer to comment # 54

comment 1112 comment by: European Cockpit Association

Commented text: CS FTL.3.200 Home base — HEMS (a) The home base is assigned to each crew member with a high degree of permanence and may either be: ECA comment: "High degree of permanence" needs to be defined. It has to be prevented that this is used to avoid paying travelling allowances. Suggestion: "should not be changed more than two times within 365 days"

response Please see the answer to comment # 54

comment 1210 comment by: SAF

Same as comment # 340

response Please see the answer to comment # 54

comment 1274 comment by: Hélicoptères de France

Same as comment # 340

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 226 of 585

An agency of the European Union

comment 1300 comment by: Elilombarda

HOME BASE With regard to ‘home base’ in HEMS operations, the following applies: ORO.FTL.105 (14) - ‘home base’ ORO.FTL.200 Home base GM1 ORO.FTL.2004. CS FTL.3.200 Home base — HEMS CS FTL.3.200 Home base — HEMS Presently, some European countries are organised with 7/7 rosters and they allow crews to keep their residence and families away from the operating base. The crews travel to the assigned operating base, where a proper accommodation is available, in order to fulfil the roster and then they travel back to their residences for the recurrent extended recovery rest period. Existing contracts between crews and operators, and existing agreements with crews’ associations, reflect the resulting logistic and economic facts. HEMS bases are spread out in several places around the country, each with one helicopter and the minimum required personnel, i.e. few persons. Operators generally have several bases far away from their principal place of business. HEMS bases are likely to be changed (win/lose contracts by the operator), sometimes in very few years, so the operator and the personnel have to re-organise logistically. Some operators, especially small and medium operators, need to keep the crews proficient in more than one base in order to keep enough flexibility with logistical and operative necessities, like change of helicopter type, crews necessities (leave, unavailability, training, etc.), crew turnover (dismissed, hired, etc.), and so on. Moreover, the operator can have bases in very different flying environments (sea, mountain, big cities, heavy air traffic area). If the crew is forced to fly in only one base (and environment) for most of time, the operator will not be able to adequately substitute a missing crew in another base. This will eventually reduce flight safety. Crew flying opportunities can change dramatically from one HEMS base to another. There are operating bases with a high rate of daily flights, while others with very few hours of flight per month. Because of this, HEMS operators may elect to roster the crews in more than one base, in order to give the personnel the same flying and professional opportunities. While in an airplane carrier company most of crews are assigned on the same operating base (an airport), where they can be substituted in case of necessity, HEMS operating bases have a reduced number of minimum necessary crews per each base. Assigning a unique and defined home base to each crew in an operating base would limit the operator’s possibility to properly manage the various day-by-day necessities. In Italy, the crew’s home base is assigned at the operator’s principal place of business. The crews maintain their residence at their family place, unlinked from the possible operating base, and they travel from their own residence to the assigned operating base for the shift. At the end of the shift they return to their family residences. The rosters are defined by the Italian Authority of 7 days of shift, followed by 7 days of rest (recurrent extended recovery rest period), and it was allowed up to 14 days on and 14 days off. Travel expenses to/from

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 227 of 585

An agency of the European Union

operating bases, proper accommodation at the operating base area and daily allowances are on operator’s expenses. These reduced expenses are part of the crew’s actual salary purchasing power. Basic salaries, defined by trade union agreements, reflect this logistical and operative organisation. The ‘home base’, as proposed by the NPA, will definitely create an economical and organisational weak point for the crews, substantially reducing their overall income (increased expenses) and reducing the time spent with their families. This will very probably, induce social and economical tensions with the operators, crews discontent, increased stress levels (family, economical, etc.), potentially affecting the final safety of flight. It is suggested to allow the operator to assign the home base at his principal place of business. Suggested NPA amendment GM1 ORO.FTL.200 Home base TRAVELLING TIME Crew members should consider making arrangements for temporary accommodation closer to their home base, if the travelling time from their residence to their home base usually exceeds 90 minutes. CS FTL.3.200 Home base — HEMS

(a) The home base is assigned to each crew member at the operator’s main place of business with a high degree of permanence and may either be: (1) a single HEMS operating base; or (2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions. (b) In the case of a change of home base, the recurrent extended recovery rest period prior to starting duty at the new home base is increased once to 72 hours, including 3 local nights. Travelling time between the former home base and the new home base is positioning or flight duty period. IMPACT ANALYSIS Before suggested changes: SAFETY OPERATOR – NEUTRAL CREWS – NEGATIVE – Will increase tension with operators, and will introduce logistical and economical disadvantages for crews, increasing disappointment and stress. LOGISTIC

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 228 of 585

An agency of the European Union

OPERATOR – IMPROVED – Traveling and accommodation organisation are not due to the operators anymore. CREWS – NEGATIVE - Traveling and accommodation organisation are due to the crews. ECONOMIC OPERATOR – IMPROVED – Traveling, accommodation and daily allowance expenses are not due to the operator any more. CREWS – HIGLY NEGATIVE – Traveling and accommodation expenses are due to the crews. Daily allowance are not received by the crews any more. After suggested changes: SAFETY OPERATOR – NEUTRAL – No changes to present asset. CREWS – NEUTRAL – No changes to present asset. LOGISTIC OPERATOR – NEUTRAL - The operator will continue with the existing organisation. CREWS – NEUTRAL - The crew will continue with the existing organisation. ECONOMIC OPERATOR – NEUTRAL. The operator will continue with the existing organisation. CREWS – NEUTRAL. The crew will continue with the existing organisation.

response Please see the answer to comment # 54

comment 1321 comment by: SAS

The use of ‘Floater’ or ‘Touring’ pilots to fill shifts at different HEMS units to cover absences for sickness/training/currency, is essential to the smooth and continued operation of HEMS units. With the addition of this part of the NPA, if a pilot (or HEMS TCM) went absent at short notice it could lead to a HEMS aircraft being offline for 72hours. As required above to permit ‘a change of home base’. The only alternative would be to employ an extra pilot for every home base, this would be at great expense to charities and HEMS operators. More importantly, this would cause a reduction in the duty and flight hours of those pilots to a level that could have a detrimental effect on pilot’s proficiency.

response Please see the answer to comment # 54

comment 1336 comment by: ENAC

Same as comment # 1300

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 229 of 585

An agency of the European Union

comment 1388 comment by: Swiss Air-Ambulance Rega

Further clarity on this requirement is needed as it could be misinterpreted as it is written. By referring to travelling time between any of the multiple HEMS operating bases, it could be interpreted that the 60 minutes was between any pairings of the HEMS operating bases rather than 60 minutes between all of them. The purpose is that the crew member can drive from any of the nominated HEMS operating bases to all of the other nominated multiple bases within 60 minutes. Assignment of pilots A crew member, both pilot and HEMS TC, must be assigned to a base. If there are multiple bases, the travel time must be less than one hour. Question: Must crew members be assigned to each base or must a base be assigned to each crew member? In such a case, the use of stand-in pilots to ensure operational capability in the short term would be heavily limited. Change of home base In the event of a change of home base, a 72-hour resting period (min. three nights) must be observed once and the travel time is counted as flight duty period (FDP). Question: Does “change of home base” mean a permanent transfer to another location or is this supposed to apply also to short-term, temporary changes (e.g. sickness absence cover) or changing home bases of stand-in pilots Proposed amendment: (2) multiple HEMS operating bases where the travelling time between all of the nominated bases does not exceed 60 minutes under normal operating conditions. The travelling time shall be at least equal to the time to commute from home to the previsouly designated operating base.

response Please see the answer to comment # 54

comment 1436

comment by: COPAC COLEGIO OFICIAL DE PILOTOS DE LA AVIACIÓN

COMERCIAL

CS FTL.3.200 (b), ¿este apartado implica que si un piloto vuela habitualmente en una base, si se le traslada a otra base situada a 200 km, no puede producirse hasta 72 horas después de haber llegado a la nueva base? ¿En qué otros términos es aplicable este punto?

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 230 of 585

An agency of the European Union

comment 1468

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

“(a)(1) a single HEMS operating base;” The HEMS operating base should also be valid for rest facilities close to the base. The conditions for close at the HEMS operating base could be defined as a maximum traveling time to the HEMS operating base.

response Please see the answer to comment # 54

CS FTL.3.205 p. 34-36

comment 1 comment by: Kevin Hogan

autopilot is typically one word: https://en.oxforddictionaries.com/definition/autopilot Also, in section 4.1.4.1, database is usually one word: https://en.oxforddictionaries.com/definition/database

response Please see the answer to comment # 54

comment 64 comment by: London's Air Ambulance

response Please see the answer to comment # 54

comment 88 comment by: AIR ZERMATT AG

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 231 of 585

An agency of the European Union

The conditions should be adapted to the following: (1) Continuous FT is limited in all cases to 7 hours per day. Exceptionally, the flight time on one day per calendar month may not exceed 8 hours. (2) For FDPs of over 12 hours to a max of 14 hours, the operator ensures at least one break of minimum 120 consecutive minutes (split duty) […] (3) To be removed in order to reduce complexity. (4) Ok. Table 2: Should be deleted in order to reduce complexity and the flight time values in table 2 should be adapted as follows (no matter with or without autopilot): (1) 60 flight hours in 14 days; (2) 110 flight hours in 28 days; (3) 280 flight hours in three calendar months; (4) 900 flight hours per calendar year.

response Please see the answer to comment # 54

comment 98 comment by: B. Wagner

zu (a) (1) + (2): Die Anforderung einer festen, sichergestellten Pause ist nicht rettungsdiensttauglich. Alarmierungen sind nicht planbar, dementsprechend auch nicht die Pausen. Grundsätzlich wäre es im Sinne der Crews, nicht den ganzen Tag über ihre Zeiten mitkalkulieren zu müssen, die auch noch unterschiedlich für single pilot und two-pilot operations sind. Damit steigt gegen Ende der Schicht bei Alarmierung die Arbeitsbelastung der Crew, weil zusätzliches Augenmerk auf die maximal mögliche FDP und Blockzeit gelegt werden muss. Gegen Ende einer Schicht sollte aber die Aufmerksamkeit der Crew zu 100% im Cockpit sein und nicht durch äussere Faktoren zusätzlich gemindert werden. Dies führt zu einer erhöhten Arbeitsbelastung bei gleichzeitig geminderter Situational Awareness und damit zu Einschränkungen in der Flugsicherheit.

response Please see the answer to comment # 54

comment 100 comment by: B. Wagner

Attachment #85

zu Table 2: welche wissenschaftlichen Grundlagen führen zu den Unterscheidungen der maximal möglichen Blockzeiten mit und ohne Autopilot?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 232 of 585

An agency of the European Union

Die in der NPA zitierten Studien beziehen sich zum größten Teil auf AEMS, ATXO. HEMS wurde nicht betrachtet. Es gibt aktuelle Studien zum Thema automatisiertes Fahren, die eher darauf hinweisen, dass eine hochgradige Automatisierung eine schnelle Ermüdung fördert. Siehe Anhang Die Begrenzung der maximal möglichen Flugzeit ohne Autopilot für single pilot operation auf weniger als 05:00 stellt eine deutliche Einschränkung für den HEMS Betrieb in Deutschland dar und lässt sich auch nicht rechtfertigen, wenn parallel dazu in der CAT Fliegerei viel längere Zeiten möglich sind.

response Please see the answer to comment # 54

comment 101 comment by: B. Wagner

zu (c): Welche wissenschaftliche Grundlage rechtfertigt die Unterscheidung zwischen Ruhezeit auf der HEMS Station im Vergleich zu Ruhezeit daheim, wenn die Entfernung zwischen Daheim und Station z.B. weniger als 30 Minuten beträgt? Entweder von der Länge der Anreise abhängig definieren oder streichen

response Please see the answer to comment # 54

comment 102 comment by: B. Wagner

zu (d): Startet die 4 Tage Periode bereits mit der Anreise am Tag zuvor (falls erforderlich, da man ja nach (c) gezwungen ist, auf der Station zu übernachten, wenn man die verlängerten FDP nutzen möchte)? Was passiert, wenn mit Split duty oder Kommandantenentscheid der Dienst auf mehr als 14:00h verlängert werden muss? Muss der Pilot dann am nächsten Tag ersetzt werden oder kann er die 4 Tage Periode weiter arbeiten? Hier sind weitere Erläuterungen notwendig. Sollte der Pilot ersetzt werden müssen, fällt diese Entscheidung eventuell so spät am Abend, dass kein Ersatz mehr informiert werden kann, ohne dessen Anspruch auf 8 Stunden ungestörte Ruhe gemäß 230 (e) zu stören. Diese beiden Punkte widersprechen sich in besagtem Fall und führen auf jeden Fall zu einer Missachtung der FTL Regelungen.

response Please see the answer to comment # 54

comment 119 comment by: UK CAA

Page No: 34/35

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 233 of 585

An agency of the European Union

Paragraph No: CS FTL.3.205(a)(1) and (b)(2) Flight duty period (FDP) - HEMS Comment: The requirement for the operator to ensure that there is at least one break is supported. However, it is unclear that this should be planned within the FDP rather than retrospectively achieved. For this break to be meaningful within the times likely for sleep it needs to be planned, recognising that there may need to be flexibility on the day. Justification: Clarity of the application of the requirement. Proposed Text: “… the operator plans and ensures at least one break….”

response Please see the answer to comment # 54

comment 120 comment by: UK CAA

Page No: 34/35 Paragraph No: CS FTL.3.205(a)(1) and (b)(2) Flight duty period (FDP) - HEMS Comment: There needs to be specific AMC material developed to support training and awareness of the use of breaks within duties at times where the crew member is encouraged to sleep. This is to ensure that all those involved (crew members and those involved in planning the flights) understand and provide the necessary support for the crew to be fit to operate the flight. EASA is requested to develop specific training requirements and guidance material to ensure that crew and the operators understand how to: identify the times likely for sleep; the best use of the opportunities to sleep; how to manage sleep inertia issues; and, the impact of the commercial pressures of the operation. Justification: Time pressures and the emergency nature of callouts at short notice, especially as part of a block of long duties, may mean crew members commencing a flight whilst suffering from sleep inertia.

response Please see the answer to comment # 54

comment 174 comment by: Marc Rothenhäusler

Die nach ORO.FTL.105 Nr. 12 definierte Flugdienstzeit ist nicht kompatibel zum HEMS Betrieb. Im Hems Betrieb wartet das Team auf der jeweiligen Station auf einen Einsatzalarm. Es ist schlicht und ergfreifend überhaupt nicht absehbar, wann der erste Einsatz beginnt, zu genüge kommt es vor, dass mehrere Stunden vergehn bis der erste Einsatz stattfindet. Dies muss Berücksichtigt werden, da sonst die Flugdienstzeit beinahe gleich wäre wie die Dienstzeit, was eine massive Herabsetzung zum heutigen Betrieb darstellt! Hierzu muss wie bisher auch eine Unterbrechung der Flugdienstzeit bei Pausen größer 60 Minuten beibehlaten werden.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 234 of 585

An agency of the European Union

Desweiteren werden die Flugzeiten ohne Autopilot deutlich zu gering angesetzt, im Vergleich mit der Arbeitsfliegerei wo auf die Hilfe des Autopiloten komplett verzichtet wird.

response Please see the answer to comment # 54

comment 175 comment by: Marc Rothenhäusler

In der Festlegung der maximalen Flugzeit ist eine zu geringe Stundenzahl festgesetzt worden. Im Betrieb von 1 Pilot + Autopilot sollten die gleichen Zeiten gelten als im Zweimanncockpit. Da die Unterstützung eines Autopiloten mit der eines weiteren zu vregleichen ist! Zeiten könnten sein Ein Pilot Ohne AP = 5h maximale Flugzeit / ein Pilot + AP = 7h max. Flugzeit

response Please see the answer to comment # 54

comment 176 comment by: Marc Rothenhäusler

Welche Fluzeitenbeschränkunge sind bei der CAT bzw. Arbeitsfliegeri festgesetzt? In diesen Bereichen müssetn dann ja noch geringere Werte angesetzt werden, da die Belastung eine höhere ist! Wieso wird eine max. Flugzeit abhängig gemacht vom Dienstbeginn, hier wird im CAT - Bereich auch nicht unr

response Please see the answer to comment # 54

comment 182 comment by: ANSMUH

It is felt that the "standby" section of the CS for HEMS operations is not sufficiently defined and articulated. As presently defined in the NPA, the operator is allowed to use the standby tool in order to systematically assign rosters at the operating base with long periods of standby without counting those as full duty periods, in case no flight is requested during the daily shift. As a result, the personnel could undergo long periods at the operator's disposal with little time counted as duty. This is particularly true in operating bases where the actual number of assigned missions are low and there can be a consistent part of the day without flights. In particular, night shifts are likely to end with few mission assignments. If the operator defines the shift as 2 hours for bureaucratic paperwork (20:00-22:00) and 10 hours of standby for take-off within 30 minutes from call (22:00- 08:00), in case of no flight requests the pilot will end up with a 12-hours availability in an operative environment (inside the operating base), but with only 2 hours of recorded duty time. This kind of roster can became a regular everyday planning, permitting continuous personnel availability with very little duty period, thus influencing the duty, rest and recurrent extended

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 235 of 585

An agency of the European Union

recovery rest periods. This will also influence the count of the 2000 hours of working time as per Council Directive 2000/79/EC. This is why we consider that the concept of FDP on HEMS is not in adequacy with the HEMS world, especialy in France and other country in Europe. Presently, some European countries, like in France, are organised with 7/7 rosters, and they allow crews to keep their residence and families away from the operating base. The crews travel to the assigned operating base, where a proper accommodation is available, in order to fulfil the roster and then they travel back to their residences for the recurrent extended recovery rest period. Existing contracts between crews and operators, and existing agreements with crews’ associations, reflect the resulting logistic and economic facts. If it is requested that the home base be assigned at a specific operating base it will have a negative impact on crew’s family and economic aspects. In France there are 3 types of HEMS duty period: - H12: start of HEMS standby 8am, and end at 8pm, with or without mission assignments.(10 % of French HEMS Base) - H24: The HEMS standby is divided by 2 H12. First H12: Start of HEMS standby: 8am, and end at 8pm. Second H12 with another crew start at 8pm and end at 8am. With or without mission assignments. (50% of French HEMS Base) - H14: start of HEMS standby 8am, and end at 10pm (40% of French HEMS Base) with or without mission assignments. CS FTL.3.205 Flight duty period (FDP) — HEMS A specific HEMS FDP should be defined according to the following definition:

A HEMS FDP is any time during which a person operates in an aircraft as a member of its crew,

and starts when a crew member is required by an operator to commence a HEMS standby and

ends when the crew member is free from the HEMS standby. The HEMS FDP includes standby at

the operating base, post and pre-flight duties, flights, and all types of duties, without exceeding

the maximum daily HEMS FDP specified in CS FTL.3.205(a) or (b) and not exceeding 14 hours.

CS FTL 3.205 (b) (2) The minimum of 1 hour break of FDP over 10 hours, and 2 hours on 14 hours FDP's.

Unaceptable for the French State, and other country in Europe.

This is unacceptable to stop the HEMS during these periods. The French State is currently paying

for a continuous service. It's not feasible to use additional pilots to be on standby or reserve

during these periods to have a continuous service.

Economic and social impact: Strong for France.

CS FTL 3.205 (d) (e)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 236 of 585

An agency of the European Union

The operator may assign a block of up to 4 consecutive FDPs of more than 12 hours, but less

than 14 hours.

In France, HEMS shifts are 7D ON and 7D OFF. We consider 4/4 too short, especially if you have

to travel to the base from a distance.

If the pilot's residence is away from the operating base (most of the pilots in France), then a 4/4

shift will hardly allow him to go back home.

Consequences: The crew must move from his/hers own residence to the operating base,

because the shifts could became too tight (4/4) to be convenient to go back to her actual

residence and family place. It will have an strong economic, social, and family impact.

The French social and employer partners have signed the Annex 2 of the collective convention of

the HEMS , wich regulates the periods of duty, rest, maximum hours of flight, etc.... The NPAs

want to replace this convention. The risk is a strong social movement in France if these CS FTL

3.205 (d) (e) is validated.

Since 1987 there no has been HEMS accident in France. Since July 18, 2003 annex 2 of the pilots collective convention is valid without major incidents. Contacts with pilots, HEMS crew members, HEMS organisations and aviation associations indicate that this kind of roster is well accepted by all personnel and that generally the stress build up during the 7-day-shift is well managed by them. Generally, stress comes from fatigue, especially when facing intense flying days. In order to overcome this issue a possible barrier would be the reduction of the FDP in those days when a flying hour’s limit is exceeded – i.e. “If the ‘maximum daily FT – (minus) 2h’ is exceeded, on that day the maximum FDP is reduced to maximum 12 hours”. Security impact: No. We don't see a security gain for France. The current mode of operation

regulated by annex 2 of the collective convention has proven by no HEMS accident since its

application.

Social Impact: Strong for the life of the crews.

Economic impact: Strong for the operationality of the French HEMS.

Proposal: CS FTL.3.205 HEMS Flight duty period (HEMS FDP) Definition:

A HEMS FDP is any time during which a person operates in an aircraft as a member of its crew,

and starts when a crew member is required by an operator to commence a HEMS standby and

ends when the crew member is free from this HEMS standby. The HEMS FDP includes standby at

the operating base, post and pre-flight duties, flights, and all types of duties, without exceeding

the maximum daily HEMS FDP specified in CS FTL.3.205(a) or (b) and not exceeding 14 hours.

CS FTL.3.205 Flight duty period (FDP) — HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 237 of 585

An agency of the European Union

Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatised crew members in HEMS operations is established as follows: (a) For two-pilot HEMS operations, the basic maximum daily FDP and the maximum flight time within that FDP are established in accordance with Table 1 and comply with the following conditions: (1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; (2) The time for breaks constitutes 50 % of the time over 12 hours and excludes the necessary time for post- and pre-flight duties; and (1) If the maximum daily flight (FT), in accordance with the table 1, minus 2 hours on that day, the maximum FDP is reduced to maximum 12 hours. (2) (3) The operator specifies in the operations manual a minimum of 30 minutes for the first pre-flight duties performed at the beginning of the FDP and a minimum of 15 minutes for post- flight duties for every flight returning to the HEMS operating base. (b) For single-pilot HEMS operations, the basic maximum daily FDP and the maximum FT within that FDP are limited in accordance with Table 2, and comply with all the following conditions: (1) Continuous FT is limited in all cases to 4 hours with autopilot and to 2 hours without autopilot; (2) For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; (3) The time for breaks constitutes 50 % of the time over 10 hours and excludes the necessary time for post- and pre-flight duties; (2) If the maximum daily flight (FT), in accordance with the table 2, minus 2 hours on that day, the maximum FDP is reduced to maximum 12 hours. (3) (4) The operator specifies in the operations manual, a minimum of 30 minutes for the first pre-flight duties performed at the beginning of the FDP and a minimum of 15 minutes for post- flight duties for every flight returning to the HEMS operating base. (c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630– 0729. (d) The operator may assign a block of up to 4 7 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: (1) the rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 84 hours including 4 local nights.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 238 of 585

An agency of the European Union

comment 216 comment by: Frederique ARONICA Health s' Minsitry France

Attachments #86 #87 #88

Impact assessment “CS-FTL.3.205 Flight duty period (FDP) – HEMS”on French HEMS : All HEMS operations are single pilot with TCM (table single-pilot HEMS operations). French HeliSMUR have fluctuating hours of permanence due to different periods aeronautical of activity (day-night), noise abatment and seasonal flows of tourism activity from 6.00 am to 10.00 am (Amiens HeliSMUR base open at 9:30 am from 9:30 pm). (1) The introduction of a reference time rule based on the time of taking duty is a real source of confusion for crew members, medical team, and operators. As previously notified, pilots of the HEMS have an average flight duration of 1h30 per day with significant standby times. A HEMS pilot in France has an activity of 90 hours per year. Reducing duty time will increase the number of pilots needed to guarantee the same HEMS activity. This measure poses several difficulties, the first one being the lack of experienced pilots on the labor market, and the second one the reduction of flying time per pilot, which creates a new risk concerning the maintenance of skills. In several case, an HEMS could pick up a patient in a hospital to bring it to a third hospital. This mission called “triangulars” in France is common. Sometimes HEMS crew upload patient ou add fuel with rotor running. In these cases, pilots could not either achieve the return way without the patient, or worse, the availability for HEMS operations would be compromised until the end of the flight duty period of the pilot. The postponement for HEMS activity to favour state helicopters is not always possible. The increase of crews to anticipate this risk of availability would be a source of significant additional expenses. As we have mentioned, pilots HEMS fly only 90 hours a year so there was no report significant fatigue by the crews. (1). In case of the continuous FT limited to 4 hours with autopilot and to 2 hours without autopilot, this rule impacts Cayenne HeliSMUR base (French Guyana). Every year, the rule would be exceeded because we totalise in 2015, 2016 and 2017 an average of 3 days will an activity longer than 6 hours. So France, as member state requests that French Guyana and as Reunion are excluded from development of FTL for HEMS (Art. 8). (2 & 3). After, the rule imposes for single-pilot a break after 10 hours of FDP to prevent risk fatigue for the crew. However, setting the time of the break in the day, does not take into account that the crew might need to take this break before the 10 th hour of FDP at his request, or blocks the possibility to reconcile the break with a period of inactivity (due to bad meteorologicals conditions). In addition, it does not allow the pooling of crews, when tit enables to continue to assure the HEMS activity thanks to the mobilisation of multiples teams Finally, the accommodation type described as simple “accommodation” instead of “suitable accomadation” as defined in ORO FTL 105 would be sufficient for a crew of 2 people needing a break of one hour.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 239 of 585

An agency of the European Union

Case 1 : Application of FTL : a break after 10 hours for single-pilot with same number of crew : A break after 10 hours of FDP involves a suspension activity on each base of HEMS french hospital (H12 / H14 or H24). Hospital activity is not predictable, especialy emergency medical services. A break during FDP does not allow to cover an emergency mission. This is not acceptable because given the loss of luck for the population to access emergency medical help. An other HEMS s’organisation must be define by France. Case 2 : Application of FTL a break after 10 hours for single-pilot with same service ability The preliminary work of companies indicates the need to recruit 50% of crew for a H24 activity and to double all crews in case of H12 & H14 activity.

- First impact : France has not enough ressources on crew to be conforme to FTL a break after 10 hours for single-pilot.

- Second impact : Add crew involves new cost. The impacts of CS-FTL.3.205 Flight duty period are estimated for France at 15 millions of euros each year (French market is close to 80 millions of euros a year) The new regulation will have a huge economic impact on public expenses of the French State and ultimately on the participation of the population in the HEMS service. (4) The rule imposes a minimum of 30 minutes for the first pre-flight duties performed at the beginning of the FDP. This measure hight impacts the availability of crews to perform HEMS operations. Feedback indicate that 20 minutes are sufficient to prepare the first flight and this organization does not question the prerogatives of the captain who is the only one to decide on the mission and the time of takeoff. Unforeseen circumstances in flight operations- Commander‘s discretion in HEMS under ORO FTL 205 (f). The rule “Unforeseen circumstances in flight operations” : The conditions to modify the limits on flight duty, duty and rest periods by the commander in the case of unforeseen circumstances in HEMS flight operations which occur at or after the reporting time, or at the end of the FDP, comply with the following : (a) The maximum basic daily FDP may be increased for HEMS by up to 1 hour for single- pilot operation or by up to 2 hours for two-pilot operation. (b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off on the final sector, the allowed increase may only be exceeded to transport the patient. (c) If commander discretion is used in any HEMS operating base more than 10 % of the total FDP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted. Impact assessment “CS-FTL.3.205 Flight duty period (FDP) – HEMS” on French HEMS : The operating range of HeliSMUR is 12 hours for 16 bases, 14 hours for 15 bases and 24 hours for 18 bases. If, on these bases, the rule introduce an interruption of the HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 240 of 585

An agency of the European Union

permanence of 1 hour for 15 bases, 2 hours for 14 bases and 2 hours for 17 bases, the consequences would be : * The impact of this measure if we guarantee the same level of operation emergency access SMUH is to recruit about 240 pilots and TCM for all HEMS bases. This measure would represent an additional expense of 15 million euros per year that would be difficult to commit for the State. *In the event that the increase in the number of pilots and TCM to carry out the activity would not be feasible for reasons of unavailable humans resources or funding, the reduction in the disponibility of HEMS helicopter would be considerable. The reduction in the capacity of access of HEMS is estimated with a loss of 1 825 hours or 152 days of avaibility for operations emergency medical service.This situation is difficult to envisage given the increased risk of loss of opportunity for the population. The rule opposes the return of the medical team because the patient isn’t on board and creates a risk related to the unavailability of the doctor for another HEMS so the operations HEMS would be interrupted. This also results in a loss of luck for other wounded patients who would require an operation of emergency service HEMS. This case occurs when the crew is engaged in an operation HEMS outside the hospital, for example a car accident in an isolated area and far from the base. If the injured dies on site, it’s not possible in France to bring back a body on board. So, if the return sector flight is greater than the captain‘s discretion, the crew and the medical team would be blocked without the possibility to come back to the base. In this situation, the operations HEMS would be interrupted again. Comments “CS-FTL.3.205 Flight duty period (FDP) – HEMS” : The maximum daily FDP in hours, single-pilot HEMS operation, could be put at 4 hours whatever the start of FDP. This rule could be transitory and lasts,for 5 years after the publication of FTL regulation. Thus, operators engaged in public procurement contracts with hospitals, have time to adapt and have helicopters with PA. We request that wathever the flights the crew could be flight out the presence of a patient on board, which allows the return of the crews and the medical team and the helicopter on the hospital headquarters of the activity HEMS. So availability for HEMS operations will be guarantee. We request that in compliance with aeronautical safety, pilots have all the updated data for the pre-flight tasks, and that the pre-flight time in early FDP is at least 20 minutes instead of 30 minutes. The captain remains the onely one to decide the moment of the mission. We request that the rule lightened as long as no event related to the crew fatigue was reported in HEMS operation. The proposed amendment is for a break time adjustment of 25% over 12 hours. The break should not be scheduled at a fixed time during the HEMS activity in accomodation as defined in ORO.FTL.105. instead of suitable accommodation. And, given the low daily activity of the HEMS in France, in case of pilot inactivity of at least one hour, this time can be likened to the daily break imposed by the regulations.

comment 224 comment by: ADAC Luftrettung gGmbH

CS.FTL.205(a) Wie kann eine "likelihood of sleep" objektiv Festgestellt werden? Dieser Passus kann so nicht erhalten bleiben.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 241 of 585

An agency of the European Union

Abs. (a) (2) Wann beginnt die FDP? Übergabezeiten FDP oder DT? Die Definition der FDP geht davon aus, dass ein Besatzungsmitglied das einen Dienst antritt einen Flugabschnitt oder mehrere Flugabschnitte zeitnah durchführt. Dies ist für den HEMS Betrieb nicht zutreffend, da für die HEMS Crew der erste Einsatz oft erst Stunden nach Dienstantritt ausgelöst wird. Es ist folglich bei Dienstantritt garnicht absehbar wann der erste Flugabschnitt beginnt. Dies muss bei der Definition der FDP berücksichtigt werden, da sonst im HEMS Betrieb die FDP=DP wäre, was eine erhebliche Einschränkung für HEMS-Betreiber ggü. den jetzigen Regularien darstellen würde. Pausen von min. 1h könnten z.B. die FDP unterbrechen. Da keine wissenschaftliche Studie zum HEMS-Betrieb genannt wird stellt sich die Frage auf welcher Grundlage die Zeiten der Table 1 und 2 festgelegt wurden? Eine max FT für den SP Betrieb ohne AP von teilweise 3 Stunden ist im Vergleich zur Arbeitsfliegerei, bei der ebenfalls selten ein AP vorhanden ist/genutzt werden kann, inakzeptabel. CS.FTL.205(b) Table 2 Ein Flug mit einem Piloten und AP muss mindestens genausoviel FT ermöglichen wie ein Flug mit 2 Piloten. Sinnvoll erscheinen 5h ohne AP und 7h FT mit AP. Warum soll bei HEMS eine FT auf Grund des Dienstbeginns angepasst werden, während dies bei CAT nicht durchgeführt wird? CS.FTL.205(d) Beinhalten die 4 FDPs die Reisezeiten gem CS.FTL.3.200(b)?

response Please see the answer to comment # 54

comment 253 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS.FTL.205 (a) Maximum basic daily FDP in two-pilot HEMS operations according to table 1. For FDPs over 12hours the operator ensures at least one break of minimum 60 minutes at times that ensurelikelihood of sleep. Question: What is the definition of the term “ensures likelihood of sleep” in practice? Thiscompletely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore it must be deleted from the regulation completely. Para. a2: The time for breaks constitutes 50% of the time over 12 hours. Question: Is time for breaks calculated by adding all break times but only one of them needs tobe more than 60 minutes? Question: When does FDP start / is handover FDP or DT? The definition of FDP according to ORO.FTL.105 (12) is based on the assumption that a crewmember reports for duty that includes one or more sectors. This definition doesn’t fit to HEMSoperations. One basic principle of HEMS is that the crew awaits an incoming alert at the home base. Therefor when reporting for duty it is not sure if or when a

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 242 of 585

An agency of the European Union

mission alert and thus a sectorwill occur. Frequently the first mission takes place several hours after reporting without anysectors in between. This fact needs to be considered in the definition of FDP for HEMS, otherwiseFDP and duty period are almost the same in HEMS operations. Compared to the current systemthis would pose a massive constraint for operators. Possible solution: Breaks of more than 60 minutes between sectors interrupt FDP. Remark on table 1 and 2: What’s the origin of the times? What data is used to define them? There is no evidence of anyscientific study of HEMS operation that could lead to such definitions. Especially maximum flighttimes for single pilot operation without autopilot (e.g. 03:00 hours) are much too restrictive. Thesetime limitations are unacceptable particularly in comparison with other CAT helicopter operations that take place completely without autopilot. CS.FTL.205 (b) Maximum basic daily FDP in single-pilot HEMS operations according to table 2. For FDPs over10 hours the operator ensures at least one break of minimum 60 minutes at times that ensurelikelihood of sleep. Question: What is the definition of the term “ensures likelihood of sleep” in practice? Thiscompletely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore, it must be deleted from the regulation completely. Para. b3: The time for breaks constitutes 50% of the time over 10 hours. Question: Is time for breaks calculated by adding all break times but only one of them needs tobe more than 60 minutes? Table 2: Maximum flight time limits are unacceptable, too low and presented without any datajustification. Possible solution after more than 40 years of HEMS operation: Single pilot without autopilot: max. 5 h, single pilot with autopilot: max. 7 h. Question: What limits are planned for CAT operations such as logging or other aerial work? Theyare flying most of their flights without autopilot, so their flight time limits must be even morerestrictive than in HEMS. If not, this would be a disadvantage for HEMS operators. The dependency between time of reporting for duty and maximum allowable flight time is notforeseen in CAT operations and therefor poses another disadvantage for HEMS operators.

response Please see the answer to comment # 54

comment 277 comment by: European Helicopter Association (EHA)

SHA (Switzerland) CS FTL 3.205 (b Sectors are defined for airplane so why do have limitations for sector s?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 243 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 280 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.205 (a) (3) Problem: HEMS Service is unpredictable and after returning to the base the next alert may start after 3 or 4 minutes. Nobody can grant this 15 min period without interfering with the rescue order. Solution: Minimum of 15 minutes for post flight duties at the end of the day

response Please see the answer to comment # 54

comment 284 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.205 Table 1 Problem: Standardized schedules should give for day and night pilots the same FDP at HEMS- bases with 24 / 7 working times. This is not possible for the maximum FDP of 12 hours, because we need at least an overlapping period of 30 min for the pre-flight checks Solution: Alter the max. FDP between 1400 and 0629 to read 12:30! This allows for evenly spread schedules i.e.: Shift 1 from 0630 to 1900 Shift 2 from 1830 to 0700

response Please see the answer to comment # 54

comment 285 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg):

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 244 of 585

An agency of the European Union

CS FTL 3.205 (d) As soon as the FDP is between 12 and 14 hours long a block of consecutive FDPs is limited to 4 days. The rest period preceding the first FDP is at least 36 hours including two local nights, the current system requires only 24 hours in advance. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights, the current system allows for 48 hours. Question: Is travelling time in accordance with CS.FTL.3.200 (b) part of these 4 FDPs? If this is the case it will reduce the time on base of each pilot during times with more than 12 hours FDP to 2-3 days. The use of reserve pilots for only 2 consecutive days would pose an economicburden to the operator. Question: What happens on 24h bases in case of a single exceedance of the 12 hour FDP? Willthe length of the duty block be automatically be shortened to 4 days instead of 7 as scheduled? This would lead to an additional limit regarding these bases, because they will have to changetheir current attractive 7 day blocks to 4 day blocks. This is expected to further reduce theattractivity of 24 h bases for pilots especially when they don’t live close to their home base. Split duty is not accounted for in this paragraph. Or is this paragraph not relevant for split duty? Using split duty would allow for FDP of more than 14 hours. Currently there is no further regulation provided for FDP of more than 14 hours.

response Please see the answer to comment # 54

comment 295 comment by: European Helicopter Association (EHA)

BABCOCK ITALY CS FTL 3.205 Table 2 -Why we want to change As it is the table 2 for single-pilot HEMS operations it will disrupt the actual roster of 7 days on 7 days off, increasing enormously the operational HEMS cost for the companies and for the National Health Care Systems.-What we propose We propose to add a point e) allowing a block of max 7 consecutive FDP of 13 hours. This will be in accordance at the max FDP of 110 hours per 14 days (13 hours x7 days =91 hours) and it will assure adaily rest of 11 hours at the HEMS home base. The rest period preceding the first FDP and the rest period provided after completion of a series of FDP isproportional augmented compare to the point d) in order to assure a max FDP of 91 hours in a 14 days period as acompensation. “(e) The operator may assign a block of up to 7 consecutive FDPs of more than 12 hours, up to 13 hours, if thefollowing conditions are met: (1) the rest period preceding the first FDP is at least 48 hours including 3 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 96 hours including 4 localnights.“

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 245 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 297 comment by: European Helicopter Association (EHA)

BABCOCK ITALY CS FTL 3.205 Table 2 (c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630– o Why we want to change We are not the owners of our Hems operating base and we can’t provide an arrangement for the crew but we provide comfortable hotels accommodation close to the base with the same amount of hours in term of sleep opportunities. o What we propose CS FTL.3.205 Flight duty period (FDP) — HEMS Table 2 (c) If the rest period before reporting for the FDP is taken at the HEMS operating base or at a suitable accommodation close to the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–

response Please see the answer to comment # 54

comment 300 comment by: European Helicopter Association (EHA)

BABCOCK ITALY CS FTL 3.205 Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatised crew members in HEMS operations is established as follows: (a) For two-pilot HEMS operations, the basic maximum daily FDP and the maximum flight time within that FDP are established in accordance with Table 1 and comply with the following conditions: o Why we want to change There are no reason to consider the HCM max FDP as the single pilot, they could be compare to the two-pilot HEMS operations. o What we propose CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 246 of 585

An agency of the European Union

The maximum basic daily FDP without the use of extensions for acclimatised crew members in HEMS operations is established as follows: (a) For two-pilot HEMS operations and in any case for the HEMS Crew Members, the basic maximum daily FDP and the maximum flight time within that FDP are established in accordance with Table 1 and comply with the following conditions: (...)

response Please see the answer to comment # 54

comment 313 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway) “Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) (1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base;” Comment: The concept of breaks for HEMS operations is not useable and should be handled differently by using a concept of “maximum active time” and “passive time” when calculating duty time. CAT.GEN.MPA.100(e)(1) already put the responsibility on commanders not to fly when fatigued. Furthermore, as the text is written, one could interpret this break would be in addition to the specific duration for a meal opportunity described in ORO.FTL.240 – Nutrition, which would be unnecessary. Furthermore, the concept of breaks is very unclear, especially regarding how this should be planned. Shall the break or breaks be pre-planned or may they have been achieved retrospectively? As mentioned in the comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 36 and CS FTL.3.210 Flight times and duty periods — HEMS, NPA p 75 below prescribing breaks is not a practicable solution and the concept of breaks is very unclear, especially regarding how this should be planned. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. Refer to explanation in comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 36 and CS FTL.3.210 Flight times and duty periods — HEMS, NPA p 75 below. (c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–0729. Comment: While our HEMS operating bases include suitable accommodation, there is not enough accommodation to cater for crew that are to report for duty. Furthermore, many HEMS operating bases in Europe does not have suitable accommodation at the base, but close by. This should be reflected. Suitable accommodation close to the HEMS operating base should be acceptable. (d) The operator may assign a block of up to 4 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 247 of 585

An agency of the European Union

(1) the rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights. Comment: While not fully relevant for us, we note that this will make it impossible to have operation with a roster that includes 7 days on and then a long period off (1, 2 or 3 weeks) which is a common practice in HEMS operations. The increased number of commutes would increase both fatigue and incur substantial costs on the national health care systems.

response Please see the answer to comment # 54

comment 314 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): “Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) (2) For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base;” Comment: In Norway 12+ hours Single Pilot HEMS has been common practice for close to 40 years without any incidents relating to fatigue. If the flight duty period is of a reasonable length, it is the number of duty periods that induced fatigue, not the length of the flight duty period. Crews involved in HEMS operation typically have ample time for rest and food intake. Prescribing breaks is not a practicable solution.

response Please see the answer to comment # 54

comment 367 comment by: European Helicopter Association (EHA)

BHA (UK) "CS FTL.3.205 Flight duty period (FDP) — HEMS (a)(1)" Comments: The concept of breaks for HEMS operations is unnecessary because CAT.GEN.MPA.100(e)(1) already places an obligation on commanders not to fly when fatigued. An appropriate statement to this effect would be better justified. Also, the text indicates such breaks are in addition to operators providing a specific duration for a meal opportunity, as described at ORO.FTL.240 - Nutrition. The requirement for breaks in suitable accommodation will have a significant negative impact for delivery of a HEMS service. "(2)"

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 248 of 585

An agency of the European Union

Comment: By my calculations, this means a one-hour break every 14-hour FDP. "(3)" Comment: Specifying fifteen-minute post-flight duties after every flight returning to the HEMS operating base is completely unacceptable. What is the rationale for introducing such a limit? For most HEMS units doing several missions every day, this could result in an additional hour of aircraft unavailability. Curiously, the text only specifies a HEMS operating base, and not if the aircraft pre-positions elsewhere? "(b)(2)" Comments: In the UK, 12-hour SP HEMS shifts have been commonplace for many years, without any fatigue-related incidents. Cumulative duty periods induce tiredness, not the length of a single FDP (within reason). HEMS pilots have plenty of time in a normal shift to rest, and achieve comfort and food breaks. Introducing a prescriptive break is punitive and antithesis to the HEMS philosophy. The introduction of a one-hour break in an FDP>10 hours is contradicted by the rationale text in para. 34 which states: "Basic maximum FDPs of more than 12 hours are possible only if crew members can benefit from at least one break of at least 60 consecutive minutes."

response Please see the answer to comment # 54

comment 387

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

In the first of the two CSs FTL 3.205(c) (page 36) a reference must be made not only to Table 1 but also to Table 2.

response Please see the answer to comment # 54

comment 398 comment by: European Helicopter Association (EHA)

OEAMTC (Austria): CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMSoperations is established as follows: […]

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 249 of 585

An agency of the European Union

(b) For single-pilot HEMS operations, the basic maximum daily FDP and the maximum FT within thatFDP are limited in accordance with Table 2, and comply with all the following conditions:(..) COMMENT(S) The concept of operating a mixed crew in which tasks are shared differs considerably from a truesingle pilot concept since cockpit workload is divided and monitoring is taking place. There are nocredits for this sharing of workload in terms of FTL however the HEMS TCM must adhere to the FTL. Credits should be given for the mixed crew concept and be treated same as two-pilots. CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMSoperations is established as follows: […] (b) For single-pilot HEMS operations, the basic maximum daily FDP and the maximum FT within thatFDP are limited in accordance with Table 2, and comply with all the following conditions: (1) Continuous FT is limited in all cases to 4 hours with autopilot and to 2 hours without autopilot; COMMENT(S) We appreciate considering autopilot systems as a support for the flight crew. But in view of the factthat AP systems create a complex work environment we do not understand that not having an APreduces allowable flight time up to 2 (!!!) hours per day (This reduction seems not to be an evidencedbased approach). An average leg in the air rescue throughout Austria is just above 8 minutes. In mostmissions this puts the use of AP systems in question. CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMSoperations is established as follows: […] (b) For single-pilot HEMS operations, the basic maximum daily FDP and the maximum FT within thatFDP are limited in accordance with Table 2, and comply with all the following conditions: […] (2) For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; COMMENT(S) The concept of a 60 consecutive minutes break must be clarified to be 60 consecutive minutes onbase without activities (no preflight, no flying or other duties, no post flight). These 60 consecutiveminutes must not be planned, nor shall they lead to unavailability and may be assignedretrospectively.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 250 of 585

An agency of the European Union

According to most contracts with state authorities in Austria it is a requirement to be airborne withina few minutes (max. 4min) after receiving an emergency dispatch call. The following mission ormissions have an undetermined duration. Therefore it is not possible to schedule predeterminedbreaks during a shift without taking the helicopter out of service. Besides the fact that this would bean infringement of existing contracts with state authorities (guaranteed hours of service) this would also cause an unacceptable burden to healthcare for potential patients (i.e. the total population of a certain region). An alleged but not verifiable benefit for flight safety (in terms of fatigue only) wouldcause a tremendous negative and disproportional effect to the public. In the Austrian duty roster allowing up to 15.5h FDP per day retrospective analysis of 12.000 dutydays in the last two years shows there are only 0.21% of the duties which did not have at least one 80consecutive minutes break (accounting for a 15 minutes post flight plus 60 minutes break plus 5minute margin). CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMSoperations is established as follows: […] (b) For single-pilot HEMS operations, the basic maximum daily FDP and the maximum FT within thatFDP are limited in accordance with Table 2, and comply with all the following conditions: […] (4) The operator specifies in the operations manual, a minimum of 30 minutes for the first pre-flight duties performed at the beginning of the FDP and a minimum of 15 minutes for post-flight duties for every flight returning to the HEMS operating base. COMMENT(S) A post flight is required for every flight returning to the base? Meaning for six flights returning tobase 1.5 hours post flight are required? Does this means during this 15 minute periods no newmissions may be accepted? It should be possible to react to a new mission within the 15 minutespost flight period or only one such period should be required at the end of the FDP.

response Please see the answer to comment # 54

comment 406 comment by: ANWB MAA

We didn't see any evidence the AP will have any effect on the fatigue of the crew in high density areas. In those areas in the Netherlands the average flight time is around 10 minutes including take-off and landing. Using an AP in this short flight will not make any sense. The article doesn't state any guidelines in the use of the AP - so having an AP seems to be relevant, but using it not: is this the influence of the helicopter industry who prefer to sell more expensive AP machines? Additional costs for the Netherlands will be 26 million euros to replace the helicopters by those with an AP

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 251 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 422 comment by: UFH French Helicopters Association

#3 CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM ISSUE We highlight the too restrictive limitation of total flight time for the single-pilot + TCM operations(b)(1). Indeed, the proposal constrains the continuous flight time for single- pilot + TCM operations: • with autopilot at 4 hours • without autopilot at 2 hours Some rescues and patient transportation, like severe burned patients, will not be possible with the 2hours limitation without the autopilot. Indeed, these flights can be a haul from Lyon to Paris whichlasts more than 2h and they are necessary because the transport by road is not considered sufficientlyeffective considering the patient’s condition. These flights are usually flown with lighter helicopter without autopilot because they can fly longerdistances (4h30 of autonomy) than heavy helicopters. These flights are usually scheduled from a knownhelipad in a hospital to another known helipad in another hospital and correspond more to the scopeof commercial sanitary flights not yet defined by EASA than the HEMS scope. In addition, it is usual to keep the engine running (the rotor blades are still turning while loading thehelicopter between two legs or three legs in case of a triangular mission, i.e the single-pilot + TCM takeofffrom the home base, pick up a patient at a given hospital to finally bring him at the plannedhospital). Thus, according to the definition of a Flight Time in ORO.FTL.105(13), these two legs areconsidered as a unique flight time. In that way, the limitation of 2 hours for an equipage with a singlepilot+ TCM is too restrictive. Moreover, in HEMS, a single-pilot does not fly alone, he is assisted by a Technical Crew Member (whichis a recent additional EASA requirement). In that way, the risk of fatigue is lower since the TCM isassisting the pilot in non-piloting tasks and is contributing to the safety of the flight. De facto, single pilot HEMS operations are in fact 2 technical crews operations (1 pilot + 1 TCM). By parallelism, no suchtotal flight time limitation has been defined for 2 technical crews operations (2 pilots). No RIA is given to justify this proposal. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additionalpilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. Thisrepresents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such amassive recruitment would not be achievable and would thus result in a significant reduction in thequality of the French Healthcare system. Considering the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations)and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopterand no flight standard for 2 pilots operations), the sum of the previous constraints leads to theimpossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This willnot have a major impact on the fatigue of the pilots since most of the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 252 of 585

An agency of the European Union

HEMS flights have a unit flighttime ranged around 25 minutes for SNEH, i.e 50 minutes back and forth (1 mission)i and this extensionof the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, FNAM suggests usingthe possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot underthe principles of a FRM. Thus, we agree with the proposal of FNAM for single-pilot + TCM without autopilot to: • Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM Otherwise, it would be beneficial to further develop the RIA basing it on experience and safety recordson this subject, in order to better assess the economic and social impacts in addition to the flight safetyimpact. PROPOSAL Replace the paragraph (b)(1) by the following: “(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 3 hours withoutautopilot. These limitations can be increased by 1 hour under the principles of a FRM;” (a)(1)(a)(2) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times areunpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besidesthe wording “break” should be rethought to make it easy to understand that this period is a timeallowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, theopportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break witha maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break witha maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flownhours There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue riskmanagement. Therefore, under the above risk analysis and under a monitoring following the principles of a fatiguerisk management, FNAM suggests writing clearly in the regulation that in HEMS, breaks do not have tobe scheduled before the operation. (Cf. comment #30.3) PROPOSAL Rephrase the paragraph (a)(1) as follows: “(1) For FDP over 12 hours, the operator ensures ex-post that at least one break of minimum 60consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood ofsleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 253 of 585

An agency of the European Union

(a3) and (b4) ISSUE UFH agrees a minimum time shall be taken to ensure the safety of the flight: • Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible tomaximize operational availability and response time. In that way, in France, the contractual time forthe National Health Authorities between the launch of a HEMS flight and the effective take-off is 7minutes. Indeed, when a patient needs essential life- saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance ofsurvival due to EASA proposition of having a minimum preflight time of 30 minutes at the beginning ofthe FDP. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within thefirst 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment in the FNAM comments) Whatever the number of life that would not have been saved during these 30 minutes, no loss wouldbe politically and socially acceptable. With the same philosophy, the proposed requirement of having a minimum post flight period of 15minutes at each HEMS operating base returns will reduce the chance of survival by 8 minutes for thenext patient in case of close consecutive missions. To illustrate those two issues, let’s take the example of 2 unpredicted HEMS operations within thesame FDP: • 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes(mission back and forth) o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been done • Further operations: no preflight required as far as preflight is already done This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDPbefore the first flight time and no preflight requirement for the following flight time though it occurs 4hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, FNAM underlines that the definition of postflight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP. • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after thelast effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending onthe end of the last FT. This definition does not correspond to the definition of the proposal which defines a post-flight aftereach flight time returning to HEMS operating base within the same FDP. Therefore, FNAM suggestssuppressing the post flight duties since they are confusing and replacing it by a proportionate pre-flighttime before any take-off from the HEMS operating base. For French HEMS services, the suitable accommodation is nearby the helicopter. According to French experience, the effective time for preparing a new flight is 7 minutes. This reduction from 15 minutes to this current value of 7 minutes for pre-flight time before any takeofffrom the HEMS operating base will not impact the level of safety, otherwise it would be beneficialto further develop the RIA in order to base it on experience and safety records on this subject. On the other hand, FNAM agrees these requirements do not apply for the Technical Crew Membersince TCM function does not include the flight preparation.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 254 of 585

An agency of the European Union

(Cf. comment #44)In consequence, the proposal does not demonstrate safety improvement in all cases, in particular whenseveral flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if theemergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, we propose: • To reduce the minimum duration of initial preflight from 30 minutes to 15 minutes (inclusionof the helicopter checks); this proposal does not affect the cammander’s prerogatives sincehe remains the one to make the final decision regarding the take-off time • To dissociate from the above the time for the operational preparation of further individualflight time • To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base” • To set the minimum duration of “operational pre-flight at the HEMS operating base” at 7minutes instead of 15 minutes for the post-flight between 2 FT at the HEMS operating base PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) The operator specifies in the operations manual a minimum of 15 minutes for the initialpre-flight duties performed at the beginning of the FDP and a minimum of 7 minutes foroperational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) The operator specifies in the operations manual a minimum of 15 minutes for the initialpre-flight duties performed by the pilot at the beginning of the FDP and a minimum of 7 minutes foroperational pre-flight duties performed by the pilot before each flight taking-off from the HEMSoperating base. Pre-flights duties do not apply to TCM.” #6 (c) ISSUE UFH highlights that the proposition in point (c) shall apply for both: • Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2 Indeed, the proposed mitigation is met in both operations by offering suitable accommodation atHEMS operating base (Cf. point (b)(2) and (a)(1)): the rest and mitigated resulting fatigue are the samethus the alleviation shall be the same. PROPOSAL Replace paragraph(c) by the following: “If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits ofTable 1 for two-pilots operations and Table 2 for single-pilot operations, for reporting times between0730-0959 also apply for reporting times between 0630-0729.” Table 2 ISSUE would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones: • FDP starting between 06:30-06-59 => maximum total flight time = 3:30 • FDP starting between 12:00-13:59 => maximum total flight time = 3:30

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 255 of 585

An agency of the European Union

• FDP starting between 4:00-06:29 => maximum total flight time = 3:00 There is no regulation in France on this subject for HEMS operations, with no reported inherent safetyissue through experience. A further developed RIA based on experience and safety records on this subject would be beneficial,in order to assess the economic and social impacts in addition to the flight safety impact. In CAT provisions, when the operator has implemented a FRM, it is considered as a valuable mitigationto allow for the FDP to be increased by 1hour, in some cases. Thus, in the same philosophy than for CAT operations, FNAM proposes to increase all total flight timelimitations by 1 hour under the principles of a FRM. PROPOSAL Add the following sentence below the Table 2: “The maximum Flight Time in Table 2 can be increased by 1 hour under the principles of a FRM” #8 MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readinessissues) (d) ISSUE On the one hand, UFH underlines the French regulation historically proposes several rostering cyclesfor HEMS operations that are currently used with an excellent safety track record demonstrated byexperience: • 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the NationalHealth Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hoursOFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), anHEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure theyfollow their engagement with hospitals. Thus, all HEMS operators will have to schedule: • More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according toCS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM.Moreover, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 minfor SNEH)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitableaccommodation at the HEMS operating base, thus pilots can have breaks in comfortable placesbetween two flight times. These pilots have to have their rest at the HEMS operating base which isconsidered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is consideredas a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering inFrance on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working athome base and then 7 days of rest at home which can be at 500

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 256 of 585

An agency of the European Union

kilometers from home base. Therefore,most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which willbe limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shallbe met: (1) The rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) The rest period provided after completion of the series of consecutive FDPs is at least 60 hoursincluding 3 local nights. A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principlesof a FRM."

response Please see the answer to comment # 54

comment 481 comment by: FNAM/SNEH

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. FNAM and SNEH suggest adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)”

response Please see the answer to comment # 54

comment 482 comment by: FNAM/SNEH

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) REMARK For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 257 of 585

An agency of the European Union

comment 483 comment by: FNAM/SNEH

Attachment #89

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM (Cf. attachment S4 illustrating this continuous flight time limitation in single-pilot + TCM issue) (b)(1) ISSUE FNAM and SNEH highlight the too restrictive limitation of total flight time for the single- pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations:

• with autopilot at 4 hours • without autopilot at 2 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 258 of 585

An agency of the European Union

the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations) and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopter and no flight standard for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for SNEH, i.e 50 minutes back and forth (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, FNAM and SNEH suggest using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, FNAM and SNEH propose for single-pilot + TCM without autopilot to:

• Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM

Otherwise, it would be beneficial to further develop the RIA basing it on experience and safety records on this subject, in order to better assess the economic and social impacts in addition to the flight safety impact. PROPOSAL Replace the paragraph (b)(1) by the following: “(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 3 hours without autopilot. These limitations can be increased by 1 hour under the principles of a FRM;”

response Please see the answer to comment # 54

comment 484 comment by: FNAM/SNEH

BREAK PERIODS for two-pilots HEMS operations (a)(1)(a)(2) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 259 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

response Please see the answer to comment # 54

comment 485 comment by: FNAM/SNEH

Attachments #90 #91 #92 #93

Same comment as # 484.

response Please see the answer to comment # 54

comment 486 comment by: FNAM/SNEH

Attachments #94 #95 #96 #97 #98

PRE AND POST FLIGHT MINIMUM TIME (Cf. attachments S1, S2, S3 and S4 illustrating this pre and post flight minimum time issue) (a3) and (b4) ISSUE FNAM and SNEH agree a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 260 of 585

An agency of the European Union

Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum preflight time of 30 minutes at the beginning of the FDP. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. With the same philosophy, the proposed requirement of having a minimum post flight period of 15 minutes at each HEMS operating base returns will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. To illustrate those two issues, let’s take the example of 2 unpredicted HEMS operations within the same FDP:

• 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth)

o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been

done • Further operations: no preflight required as far as preflight is already done

This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, FNAM and SNEH underline that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 261 of 585

An agency of the European Union

For French HEMS services, the suitable accommodation is nearby the helicopter. On the other hand, FNAM and SNEH agree these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #513) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, FNAM and SNEH propose:

• To suppress the minimum duration of initial preflight of 30 minutes and to replace it by “a sufficient time determined by the operator and specified in the operating manual”; this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time

• To dissociate from the above the time for the operational preparation of further individual flight time

• To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base”

• To suppress the minimum duration of “operational pre-flight at the HEMS operating base” at and to replace it by “a sufficient time determined by the operator and specified in the operating manual”instead of the proposed required 15 minutes for the post-flight between 2 FT at the HEMS operating base

(Cf. comment #502) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base. Pre-flights duties do not apply to TCM.”. Pre-flights duties do not apply to TCM.”

response Please see the answer to comment # 54

comment 487 comment by: FNAM/SNEH

(c)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 262 of 585

An agency of the European Union

ISSUE FNAM and SNEH highlight that the proposition in point (c) shall apply for both:

• Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2

Indeed, the proposed mitigation is met in both operations by offering suitable accommodation at HEMS operating base (Cf. point (b)(2) and (a)(1)): the rest and mitigated resulting fatigue are the same thus the alleviation shall be the same. PROPOSAL Replace paragraph(c) by the following: “If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for two-pilots operations and Table 2 for single-pilot operations, for reporting times between 0730-0959 also apply for reporting times between 0630-0729.”

response Please see the answer to comment # 54

comment 488 comment by: FNAM/SNEH

Attachments #99 #100 #101 #102

SINGLE-PILOT + TCM TOTAL FT LIMITATION (Cf. attachments S1, S2, S3 and S4 illustrating this total flight time limitation issue) Table 2 ISSUE FNAM and SNEH would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones:

• FDP starting between 06:30-06-59 => maximum total flight time = 3:30 • FDP starting between 12:00-13:59 => maximum total flight time = 3:30 • FDP starting between 4:00-06:29 => maximum total flight time = 3:00

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 263 of 585

An agency of the European Union

Thus, in the same philosophy than for CAT operations, FNAM and SNEH propose to increase all total flight time limitations by 1 hour under the principles of a FRM. PROPOSAL Add the following sentence below the Table 2: “The maximum Flight Time in Table 2 can be increased by 1 hour under the principles of a FRM”

response Please see the answer to comment # 54

comment 489 comment by: FNAM/SNEH

Attachments #103 #104 #105 #106

MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues) (d) ISSUE On the one hand, FNAM and SNEH underline the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #486), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM

Moreover, FNAM and SNEH highlight that, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 264 of 585

An agency of the European Union

(with an average leg of 25 min for SNEH)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the HEMS operating base, thus pilots can have breaks in comfortable places between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met:

1. The rest period preceding the first FDP is at least 36 hours including 2 local nights; and

2. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights.

A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 532 comment by: ADAC Luftrettung gGmbH

Maximum basic daily FDP in two-pilot HEMS operations according to table 1. For FDPs over 12 hours the operator ensures at least one break of minimum 60 minutes at times that ensure likelihood of sleep. Question: What is the definition of the term “ensures likelihood of sleep” in practice? This completely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore it must be deleted from the regulation completely. Para. a2: The time for breaks constitutes 50% of the time over 12 hours. Question: Is time for breaks calculated by adding all break times but only one of them needs to be more than 60 minutes? Question: When does FDP start / is handover FDP or DT?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 265 of 585

An agency of the European Union

The definition of FDP according to ORO.FTL.105 (12) is based on the assumption that a crew member reports for duty that includes one or more sectors. This definition doesn’t fit to HEMS operations. One basic principle of HEMS is that the crew awaits an incoming alert at the home base. Therefor when reporting for duty it is not sure if or when a mission alert and thus a sector will occur. Frequently the first mission takes place several hours after reporting without any sectors in between. This fact needs to be considered in the definition of FDP for HEMS, otherwise FDP and duty period are almost the same in HEMS operations. Compared to the current system this would pose a massive constraint for operators. Possible solution: Breaks of more than 60 minutes between sectors interrupt FDP. Remark on table 1 and 2: What’s the origin of the times? What data is used to define them? There is no evidence of any scientific study of HEMS operation that could lead to such definitions. Especially maximum flight times for single pilot operation without autopilot (e.g. 03:00 hours) are much too restrictive. These time limitations are unacceptable particularly in comparison with other CAT helicopter operations that take place completely without autopilot. Maximum basic daily FDP in single-pilot HEMS operations according to table 2. For FDPs over 10 hours the operator ensures at least one break of minimum 60 minutes at times that ensure likelihood of sleep. Question: What is the definition of the term “ensures likelihood of sleep” in practice? This completely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore, it must be deleted from the regulation completely. Para. b3: The time for breaks constitutes 50% of the time over 10 hours. Question: Is time for breaks calculated by adding all break times but only one of them needs to be more than 60 minutes? Table 2: Maximum flight time limits are unacceptable, too low and presented without any data justification. Possible solution after more than 40 years of HEMS operation: Single pilot without autopilot: max. 5 h, single pilot with autopilot: max. 7 h. Question: What limits are planned for CAT operations such as logging or other aerial work? They are flying most of their flights without autopilot, so their flight time limits must be even more restrictive than in HEMS. If not, this would be a disadvantage for HEMS operators. The dependency between time of reporting for duty and maximum allowable flight time is not foreseen in CAT operations and therefor poses another disadvantage for HEMS operators. As soon as the FDP is between 12 and 14 hours long a block of consecutive FDPs is limited to 4 days. The rest period preceding the first FDP is at least 36 hours including two local nights, the current system requires only 24 hours in advance. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights, the current system allows for 48 hours. Question: Is travelling time in accordance with CS.FTL.3.200 (b) part of these 4 FDPs?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 266 of 585

An agency of the European Union

If this is the case it will reduce the time on base of each pilot during times with more than 12 hours FDP to 2-3 days. The use of reserve pilots for only 2 consecutive days would pose an economic burden to the operator. Question: What happens on 24h bases in case of a single exceedance of the 12 hour FDP? Will the length of the duty block be automatically be shortened to 4 days instead of 7 as scheduled? This would lead to an additional limit regarding these bases, because they will have to change their current attractive 7 day blocks to 4 day blocks. This is expected to further reduce the attractivity of 24 h bases for pilots especially when they don’t live close to their home base. Split duty is not accounted for in this paragraph. Or is this paragraph not relevant for split duty? Using split duty would allow for FDP of more than 14 hours. Currently there is no further regulation provided for FDP of more than 14 hours.

response Please see the answer to comment # 54

comment 553 comment by: Rüdiger Neu

Maximale Flugdienstzeit (FDP) bei 2-Piloten siehe Tabelle 1. Werden die 12 Stunden überschritten, muss mindestens eine zusammenhängende Stunde (> 60 Minuten) Pause an der Station eingehalten werden, mit der Wahrscheinlichkeit schlafen zu können. Fragestellung: Wie ist eine Wahrscheinlichkeit in der Praxis zu bewerten (time that ensure likelihood of sleep)? Dies ist absolut unpraktikabel, dieser Passus muss gestrichen werden. Abs. a2: Die Summe der Pausen muss 50% der Zeit sein, die mehr als 12 Stunden beinhalten. Fragestellung: Berechnet sich die Pausenzeit der Summe aller Pausen, jedoch muss nur eine der Pausen > 60 Minuten sein? Fragestellung: Wann beginnt FDP / Übergabezeiten FDP oder DT? Die Definition der FDP nach ORO.FTL.105 Nr. 12 stellt darauf ab, dass der Dienst, zu dem sich das Besatzungsmitglied meldet, einen Flugabschnitt oder eine Abfolge von Flugabschnitten beinhaltet. Diese Definition passt für HEMS-Betrieb nicht. HEMS ist davon gekennzeichnet, dass die Besatzung an der home base auf die Alarmierung zu einem Einsatz wartet. Insofern ist bei der Anmeldung noch gar nicht absehbar, ob bzw. wann ein Flugabschnitt stattfindet. Es kommt regelmäßig vor, dass der erste Einsatz erst mehrere Stunden nach Anmeldung erfolgt. Dies muss im Rahmen der Definition Berücksichtigung finden, sonst wäre die FDP im Rahmen von HEMS-Betrieb nahezu deckungsgleich mit der Dienstzeit (duty period), was eine erhebliche Einschränkung der Betreiber im Gegensatz zum heutigen System darstellen würde. Eine mögliche Lösung wäre hier, dass Pausen zwischen einzelnen Einsätzen, die mindestens 60 zusammenhängende Minuten dauern, die FDP unterbrechen. Anmerkung zu Table 1 und 2: woher kommen dieses Zeiten? Aufgrund welcher Datengrundlage wurde dies festgelegt? Es ist keine wissenschaftliche Studie zum HEMS- Betrieb ersichtlich oder genannt, die diese willkürlich festgelegten Zeiten belegt? Im Übrigen sind die maximalen Flugzeiten ohne Autopilot (Max FT without autopilot) insbesondere im Single-Pilot-Betrieb mit teilweise nur drei Stunden deutlich zu knapp

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 267 of 585

An agency of the European Union

bemessen. Insbesondere im Vergleich zur Arbeitsfliegerei, die stets ohne Autopilot stattfindet, sind die hier festgelegten Zeiten geradezu inakzeptabel. Maximale Flugdienstzeit (FDP) bei einem Piloten siehe Tabelle 2. Werden die 10 Stunden überschritten, muss mindestens eine zusammenhängende Stunde (> 60 Minuten) Pause an der Station eingehalten werden, mit der Wahrscheinlichkeit schlafen zu können. Fragestellung: Wie ist eine Wahrscheinlichkeit zu bewerten (time that ensure likelihood of sleep? Dies ist absolut unpraktikabel, dieser Passus muss gestrichen werden. Abs. b3 Die Summe der Pausen muss 50% der Zeit sein, die mehr als 10 Stunden beinhalten. Fragestellung: Die Pausenzeit errechnet sich aus der Summe aller Pausen, jedoch muss nur eine der Pausen > 60 Minuten sein? Table2: Die festgelegten max. Flugzeiten sind nicht akzeptabel, sind zu gering und entbehren jeglicher Grundlage. Zumindest sollten beim Betrieb mit einem Piloten und Autopilot (AP) die gleichen Flugstunden möglich sein, wie bei zwei Piloten. Der AP unterstützt das manuelle Fliegen genauso wie ein weiterer Pilot. Empfehlung: Ein Pilot ohne AP max. 5h, ein Pilot mit AP 7h. Fragestellung: Wo liegen die Flugzeitenbeschränkungen bei CAT und der Arbeitsfliegerei? Werden dort noch geringere Flugzeiten festgelegt? Eine Abhängigkeit zwischen dem Dienstbeginn und der max. Flugzeit ist ebenfalls nicht akzeptabel, wird auch nicht bei CAT unterschieden. Dies wäre eine unzulässige Ungleichbehandlung.

response Please see the answer to comment # 54

comment 580 comment by: FinnHEMS Oy

(a)(3) ...and a minimum of 15 minutes for post-flight duties for every flight returning to the HEMS operating base. COMMENT: A post flight duty cannot be required for every flight returning to the base. This means that during this 15 minute period no new missions cannot be accepted? It should be possible to react to a new mission directly after returning to the base.

response Please see the answer to comment # 54

comment 590 comment by: NOLAS

“(a) The home base is assigned to each crew member with a high degree of permanence and may either be: (1) a single HEMS operating base; or (2) multiple HEMS operating bases if the travelling time between any of these HEMS operating bases does not exceed 60 minutes under usual conditions.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 268 of 585

An agency of the European Union

Comment: This is sensible, however, how should this be handled for crew members that are working for more than one organization or operator? Especially HEMS technical crew members are often working for more than one organization or more than one operator providing HEMS. Furthermore, while it is sensible to have a home base assigned, it may be too restrictive in cases where crew members need to have to maintain recency on two different type of helicopters. How often would an operator be able to switch permanent home base (not a temporary change as in (b))? Would it be feasible to have home base decided upon publication of roster provided that the roster is published long time enough in advance? Furthermore, there is a need for clarification. The text as written could be interpreted as 60 minutes is between 60 minutes between all the HEMS operating bases in question or as 60 minutes between any two HEMS of them. We also wonder where the 60 minutes come from. In “48. GM1 ORO.FTL.200 ‘TRAVELLING TIME’” 90 minutes is used. Wouldn’t 90 minutes be as appropriate as 60 minutes?

response Please see the answer to comment # 54

comment 591 comment by: NOLAS

“Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) (1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base;” Comment: The concept of breaks for HEMS operations is not useable and should be handled differently by using a concept of “maximum active time” and “passive time” when calculating duty time. CAT.GEN.MPA.100(e)(1) already put the responsibility on commanders not to fly when fatigued. Furthermore, as the text is written, one could interpret this break would be in addition to the specific duration for a meal opportunity described in ORO.FTL.240 – Nutrition, which would be unnecessary. Furthermore, the concept of breaks is very unclear, especially regarding how this should be planned. Shall the break or breaks be pre-planned or may they have been achieved retrospectively? As mentioned in the comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 36 and CS FTL.3.210 Flight times and duty periods — HEMS, NPA p 75 below prescribing breaks is not a practicable solution and the concept of breaks is very unclear, especially regarding how this should be planned. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. Refer to explanation in comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 36 and CS FTL.3.210 Flight times and duty periods — HEMS, NPA p 75 below.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 269 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 592 comment by: NOLAS

(c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–0729. Comment: While our HEMS operating bases include suitable accommodation, there is not enough accommodation to cater for crew that are to report for duty. Furthermore, many HEMS operating bases in Europe does not have suitable accommodation at the base, but close by. This should be reflected. Suitable accommodation close to the HEMS operating base should be acceptable.

response Please see the answer to comment # 54

comment 593 comment by: NOLAS

(d) The operator may assign a block of up to 4 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: (1) the rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights. Comment: While not fully relevant for us, we note that this will make it impossible to have operation with a roster that includes 7 days on and then a long period off (1, 2 or 3 weeks) which is a common practice in HEMS operations. The increased number of commutes would increase both fatigue and incur substantial costs on the national health care systems.

response Please see the answer to comment # 54

comment 594 comment by: NOLAS

“Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) (2) For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base;” Comment: In Norway 12+ hours Single Pilot HEMS has been common practice for close to 40 years without any incidents relating to fatigue. If the flight duty period is of a reasonable length, it is the number of duty periods that induced fatigue, not the length of the flight

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 270 of 585

An agency of the European Union

duty period. Crews involved in HEMS operation typically have ample time for rest and food intake. Prescribing breaks is not a practicable solution.

response Please see the answer to comment # 54

comment 661 comment by: Oya Vendée Hélicoptères

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. OYA suggests adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)”

response Please see the answer to comment # 54

comment 662 comment by: Oya Vendée Hélicoptères

response Please see the answer to comment # 54

comment 663 comment by: Oya Vendée Hélicoptères

Attachment #107

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM (Cf. attachment S4 illustrating this continuous flight time limitation in single-pilot + TCM issue) (b)(1) ISSUE OYA highlights the too restrictive limitation of total flight time for the single-pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 271 of 585

An agency of the European Union

• with autopilot at 4 hours • without autopilot at 2 hours

Some rescues and patient transportation, like severe burned patients, will not be possible with the 2 hours limitation without the autopilot. Indeed, these flights can be a haul from Lyon to Paris which lasts more than 2h and they are necessary because the transport by road is not considered sufficiently effective considering the patient’s condition. These flights are usually flown with lighter helicopter without autopilot because they can fly longer distances (4h30 of autonomy) than heavy helicopters. These flights are usually scheduled from a known helipad in a hospital to another known helipad in another hospital and correspond more to the scope of commercial sanitary flights not yet defined by EASA than the HEMS scope. In addition, it is usual to keep the engine running (the rotor blades are still turning while loading the helicopter between two legs or three legs in case of a triangular mission, i.e the single-pilot + TCM take-off from the home base, pick up a patient at a given hospital to finally bring him at the planned hospital). Thus, according to the definition of a Flight Time in ORO.FTL.105(13), these two legs are considered as a unique flight time. In that way, the limitation of 2 hours for an equipage with a single-pilot + TCM is too restrictive. Moreover, in HEMS, a single-pilot does not fly alone, he is assisted by a Technical Crew Member (which is a recent additional EASA requirement). In that way, the risk of fatigue is lower since the TCM is assisting the pilot in non-piloting tasks and is contributing to the safety of the flight. De facto, single-pilot HEMS operations are in fact 2 technical crews operations (1 pilot + 1 TCM). By parallelism, no such total flight time limitation has been defined for 2 technical crews operations (2 pilots). No RIA is given to justify this proposal. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. Considering the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations) and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopter and no flight standard for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for OYA, i.e 50 minutes back and forth (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, OYA suggests using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, OYA proposes for single-pilot + TCM without autopilot to:

• Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 272 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 664 comment by: Oya Vendée Hélicoptères

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 273 of 585

An agency of the European Union

“(1) For FDP over 12 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.”

response Please see the answer to comment # 54

comment 665 comment by: Oya Vendée Hélicoptères

Attachments #108 #109 #110 #111

BREAK PERIODS for single-pilot + TCM HEMS operations Cf. attachments S1, S2, S3 and S4 illustrating this break issue (b)(2)(b)(3) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 274 of 585

An agency of the European Union

“(2) For FDP over 10 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.”

response Please see the answer to comment # 54

comment 666 comment by: Oya Vendée Hélicoptères

Attachments #112 #113 #114 #115 #116

PRE AND POST FLIGHT MINIMUM TIME (Cf. attachments S1, S2, S3 and S4 illustrating this pre and post flight minimum time issue) (a3) and (b4) ISSUE OYA agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

• 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth)

o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been done

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 275 of 585

An agency of the European Union

• Further operations: no preflight required as far as preflight is already done

This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, OYA underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after

the last effective FT

Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. This definition does not correspond to the definition of the proposal which defines a post-flight after each flight time returning to HEMS operating base within the same FDP. Therefore, OYA suggests suppressing the post flight duties since they are confusing and replacing it by a proportionate pre-flight time before any take-off from the HEMS operating base. For French HEMS services, the suitable accommodation is nearby the helicopter. On the other hand, OYA agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #692) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, OYA proposes:

• To dissociate from the above the time for the operational preparation of further individual flight time

• To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 276 of 585

An agency of the European Union

(Cf. comment #682) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base. Pre- flights duties do not apply to TCM.”. Pre-flights duties do not apply to TCM.”

response Please see the answer to comment # 54

comment 667 comment by: Oya Vendée Hélicoptères

• Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 277 of 585

An agency of the European Union

comment 668 comment by: Oya Vendée Hélicoptères

Attachments #117 #118 #119 #120

SINGLE-PILOT + TCM TOTAL FT LIMITATION (Cf. attachments S1, S2, S3 and S4 illustrating this total flight time limitation issue) Table 2 ISSUE OYA would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones:

response Please see the answer to comment # 54

comment 669 comment by: Oya Vendée Hélicoptères

Attachments #121 #122 #123 #124

MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues) (d) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 278 of 585

An agency of the European Union

On the one hand, OYA underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #666), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM

Moreover, OYA highlights that, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 min for OYA)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the HEMS operating base, thus pilots can have breaks in comfortable places between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 279 of 585

An agency of the European Union

1. The rest period preceding the first FDP is at least 36 hours including 2 local nights; and

2. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights.

A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 712 comment by: ÖAMTC Helicopter Air Rescue (Austria)

Bearing in mind a circadian rhythm, reporting times after BCMT cannot be considered as abnormal working time. Most percentage of the working population starts work in the early morning which constitutes a biological high. The limitation off flight time implies anyway periods of times with low work load. Nevertheless the complex calculation scheme might stress a flight crew even more. Applying this scheme would force the crews to turn down missions during a normal working day in order to implement up to 3 hours of break, this has as a result a negative impact of the availability of the service. In the contrary to EASAs original intention of creating a system with more rest period, this system actually allows less free time. E.g. the operator has to apply a 4 by 4 days roster as otherwise it wouldn’t work out with the required local nights. Unfortunately this would mean that an employee would have duty on a minimum of 4 consecutive weekends. Highly negative social impact (just as a social thought this would mean that a relation with a non-aviation related partner, the couple wouldn’t meet for a month) Considering that flight crews might not live in the vicinity of the base, this means during a four day off period two days are used for traveling to and from the base only two days are left. If positioning is part of duty time this would limit the period to the maximum of two days with one day of positioning upfront and one day of positioning after the duty. Pilot’s duties are more than the actual HEMS duties. All kinds of tactical trainings on the bases, CRM classes, pilots meetings, trainings for other crewmembers, simulator checks can with this system not be done anymore. Flight crew members are challenged enough to preserve the service. Additional HR costs ranging from 30-45% across Europe would be the result as well as way less proficiency of pilots due to less flight time in probably the same amount and thus a growing safety risk. This is killing the HEMS philosophy!

response Please see the answer to comment # 54

comment 713 comment by: ÖAMTC Helicopter Air Rescue (Austria)

Table 2 Maximum FT with autopilot We appreciate considering autopilot systems as a support for the flight crew. But in view of the fact that AP systems create a complex work environment we do not understand that not using the AP reduces average flight time up to 2 (!!!) hours per day (This reduction

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 280 of 585

An agency of the European Union

seems not to be an evidenced based approach). An average leg in the air rescue throughout Austria is just above 8min. In most missions this puts the use of AP systems in question (also bear in mind that this means flights through valleys).

response Please see the answer to comment # 54

comment 715 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT 3.205(b) This means that crew will be tempted to turn down missions in the last hour of duty, because for a flight to a trauma center taking more than an hour, crews would be condemned to remain on ground on the hospital (and not being able to return to their homebase). This would mean: 1.) That there is no helicopter available for this specific region anymore 2.) The hospital’s landing site is blocked for at least another 10 hours (affecting the capacity of the hospital and therefore affecting the health care of third patients) 3.) Following multiple other effects like the fact that the helicopter cannot be protected against adverse weather conditions on the hospital site, no adequate protection can be provided

response Please see the answer to comment # 54

comment 716 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FTL.3.205(b)(2) [...] FDPs over 10 hours, the operator ensures at least one brak of minimum 60 consecutive minutes [...] Analyzing over 12.000 duty days in the last two years there are only 0,21% of the days which had not 80 consecutive minutes of break (60min + post flight duties). These numbers are for the Austrian duty roster currently allowing up to 15.5h FDP per day.

response Please see the answer to comment # 54

comment 717 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FTL.3.205(b)(4) [...] and a minimum of 15 minutes for post-flight duties for every flight [...]

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 281 of 585

An agency of the European Union

For every flight? Meaning for six flights post flight duties would require 1,5 hours. Bear in mind that there might be consecutive missions. Post flight duties always require the same amount of time, no matter how many legs. Does this means during this 15min period no new missions may be accepted?

response Please see the answer to comment # 54

comment 718 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FTL.3.205 (b)(2) HEMS is a non-projectable operation throughout a shift. We do not know when we are dispatched or to which kind of missions. Any mission could turn out way longer, weather might change or patient status requires different attention so planning a 60 minute break ahead would not consider the possible fatal impact on a patient compared to a very manageable low advantage for pilot’s fatigue.

response Please see the answer to comment # 54

comment 719 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FTL.3.205 (c) Shouldn`t this include table 2?

response Please see the answer to comment # 54

comment 723 comment by: ADAC

Es ist von vorne herein nie vorhersehbar, wie lange ein Einsatz dauert - daher ist diese Regelung praxisfremd. HEMS-Operation beinhaltet für den Piloten zudem viele Pausen, auch vor Ort, während denen er sich nicht an Bord befindet oder konzentrieren muss. Es ist anders als in der Linienfliegerei über dem Atlantic, wo ein Pilot nicht "Weg" kann. Die Regelung steht im Konflikt mit einer effiziente Einsatzdurchführung und Patientenversorgung.

response Please see the answer to comment # 54

comment 744 comment by: DRF-Luftrettung

(I) Maximum basic daily FDP in two-pilot HEMS operations according to table 1. For FDPs over12hours the operator ensures at least one break of minimum 60 minutes at times that ensure likelihood of sleep.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 282 of 585

An agency of the European Union

Question: What is the definition of the term “ensures likelihood of sleep” in practice? This completely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore it must be deleted from the regulation completely. (II) The time for breaks constitutes 50% of the time over 12 hours. Question: Is time for breaks calculated by adding all break times but only one of them needs to be more than 60 minutes? Question: When does FDP start / is handover FDP or DT? (III) The definition of FDP according to ORO.FTL.105 (12) is based on the assumption that a crew member reports for duty that includes one or more sectors. This definition doesn’t fit to HEMS operations. One basic principle of HEMS is that the crew awaits an incoming alert at the home base. Therefor when reporting for duty it is not sure if or when a mission alert and thus a sector will occur. Frequently the first mission takes place several hours after reporting without any sectors in between. This fact needs to be considered in the definition of FDP for HEMS, otherwise FDP and duty period are almost the same in HEMS operations. Compared to the current system this would pose a massive constraint for operators. Possible solution: Breaks of more than 60 minutes between sectors interrupt FDP. (IV) Remark on table 1 and 2: What’s the origin of the times? What data is used to define them? There is no evidence of any scientific study of HEMS operation that could lead to such definitions. Especially maximum flight times for single pilot operation without autopilot (e.g. 03:00 hours) are much too restrictive. These time limitations are unacceptable particularly in comparison with other CAT helicopter operations that take place completely without autopilot

response Please see the answer to comment # 54

comment 745 comment by: DRF-Luftrettung

(I) Maximum basic daily FDP in single-pilot HEMS operations according to table 2. For FDPs over 10 hours the operator ensures at least one break of minimum 60 minutes at times that ensure likelihood of sleep. Question: What is the definition of the term “ensures likelihood of sleep” in practice? This completely contradicts the idea of availability times for rescue missions and is useless in HEMS. Therefore, it must be deleted from the regulation completely. (II) he time for breaks constitutes 50% of the time over 10 hours.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 283 of 585

An agency of the European Union

Question: Is time for breaks calculated by adding all break times but only one of them needs to be more than 60 minutes? (III)Table 2: Maximum flight time limits are unacceptable, too low and presented without any data justification. Possible solution after more than 40 years of HEMS operation: Single pilot without autopilot: max. 5 h, single pilot with autopilot: max. 7 h. (IV) Question: What limits are planned for CAT operations such as logging or other aerial work? They are flying most of their flights without autopilot, so their flight time limits must be even more restrictive than in HEMS. If not, this would be a disadvantage for HEMS operators. The dependency between time of reporting for duty and maximum allowable flight time is not foreseen in CAT operations and therefor poses another disadvantage for HEMS operators.

response Please see the answer to comment # 54

comment 753 comment by: DRF-Luftrettung

HEMS Service is unpredictable and after returning to the base the next alert may start after 3 or 4 minutes. Nobody can grant this 15 min period without interfering with the rescue order. Solution: Minimum of 15 minutes for post flight duties at the end of the day

response Please see the answer to comment # 54

comment 756 comment by: DRF-Luftrettung

For FDP of 14 hours the time of break has to be 2 hours (50% of the time over 10 hours) but only one has to be consecutive. That means, that any period (i.e 6 x10 minutes) fits into this scheme. The administrative implementation is very exaggerated Solution: Delete sub paragraph 3 in total

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 284 of 585

An agency of the European Union

comment 783 comment by: AECA helicopteros.

Regarding the 60 minutes break, is a generic knowledge enough for the pilot or should there be an explicit communication of the start of this break at every opportunity? (page 34) 1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base;

response Please see the answer to comment # 54

comment 784 comment by: AECA helicopteros.

1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; Question needing answer by regulation In case of emergency this break could be interrupted to assign duties?

response Please see the answer to comment # 54

comment 785 comment by: AECA helicopteros.

Tables 1 y 2.- Column "Start of FDP at reference time" Change first and last line, as follows: Sunset-06:59 … 12:00-16.59 17.00- Sunset Justification.- The proposed classification of the time period is probably valid in the north and center of Europe, but it does not make sense in southern Europe, where 14:00 may be the period of maximum activity with more than 7 hours of light per day ahead in some months of the year. Our proposal is that an adaptation should be allowed to each State, according to its geographical situation.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 285 of 585

An agency of the European Union

comment 790 comment by: AECA helicopteros.

Table 1 and 2 Column.- Maximum FT without autopilot Proposal.- Delete column in both tables. Justification.- Table 1.- "Acclimatised crew members in two pilots HEMS operations", we think that the fact of not carrying an autopilot should not affect the maximum FT since tasks are shared. And in any case, the proposed reduction between 22% and 28% of the hours in the case of having an autopilot, will be unacceptable, putting at risk the adequate provision of the services. Justification.- Table 2.- "Acclimatised crew members in single pilot HEMS operations", The exaggerated reduction of the proposed FDP time could make the emergency service useless. It would be necessary to stop the activity in some cases, for example, at 3:00 hours, in times of possible maximum activity. As we told in a previous comment at 14.00h in southern Europe, we are in a period of maximum activity with more than 7 hours of light ahead. For example, in Spain, during the months of April to August, most of the days the sunset is above 21.00 hours. Or it would be necessary to schedule three or more crews to carry out the service and that does not seem feasible.

response Please see the answer to comment # 54

comment 791 comment by: AECA helicopteros.

CS FTL.3.205. Table 1 and table 2.- In casethat our previous comment (790) was not accepted, change as follows Proposed text: Change “autopilot” to “long term attitude retention system (force-trim) Justification. The maximum flight time for acclimatised crew members (helicopters) limits depend on whether the helicopter has (or hasn´t) “autopilot”. The definition of autopilot differs from each manufacturer, getting confused about what is the component needed to fulfil (or don´t fulfil) the requirement to fly up to one or other limit. We understand that the motivation to limit the maximum flight time is the fatigue cause in case the helicopter requires a pilot to fly all the time hands-on with any kind of system installed which provides a long term attitude retention system for pitch and roll. Common known to have a force trim system which requires an “autopilot” connected

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 286 of 585

An agency of the European Union

comment 818 comment by: Babcock Mission Critical Services Limited

The proposed requirement to have a 60-minute break during the FDP is not compatible with the provision of emergency service operations, where by their nature it is not possible to predict when the emergency will occur. How does EASA propose the service is maintained? By the use of additional pilots?

response Please see the answer to comment # 54

comment 819 comment by: Babcock Mission Critical Services Limited

Maximum basic daily FDP in hours — Acclimatised crew members in single-pilot HEMS operations As it is the table 2 for single-pilot HEMS operations it will disrupt the existing roster of 7 days on 7 days off, increasing enormously the operational HEMS cost for the companies and for the National Health Care Systems. We propose to add a point e) allowing a block of max 7 consecutive FDP of 13 hours. This will be in accordance at the max FDP of 110 hours per 14 days (13 hours x 7 days =91 hours) and it will assure a daily rest of 11 hours at the HEMS home base. The rest period preceding the first FDP and the rest period provided after completion of a series of FDP is proportional augmented compare to the point d) in order to assure a max FDP of 91 hours in a 14 days period as a compensation. "(e) The operator may assign a block of up to 7 consecutive FDPs of more than 12 hours, up to 13 hours, if the following conditions are met: (1) the rest period preceding the first FDP is at least 48 hours including 3 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 96 hours including 4 local nights. "

response Please see the answer to comment # 54

comment 821 comment by: Babcock Mission Critical Services Limited

What we (do/)don't agree with; (c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–0729.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 287 of 585

An agency of the European Union

o Why we (do/)don't agree with it; We are not the owners of our HEMS operating base and we can't provide an arrangement for the crew but we provide comfortable hotels accommodation close to the base with the same amount of hours in term of sleep opportunities. o What we suggest as an alternative CS FTL.3.205 Flight duty period (FDP) (a) If the rest period before reporting for the FDP is taken at the HEMS operating base or at a suitable accommodation close to the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–0729.

response Please see the answer to comment # 54

comment 827 comment by: Babcock Mission Critical Services Limited

response Please see the answer to comment # 54

comment 834 comment by: Babcock Mission Critical Services Limited

EASA does not appear to consider the positive impact of the HCM in single pilot operations, we believe such operations would be comparable to two-pilot HEMS operations. Hence we suggest the following changes: CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatised crew members in HEMS operations is established as follows:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 288 of 585

An agency of the European Union

(a) For two-pilot HEMS operations and single pilot operations with a HEMS Crew Member, the basic maximum daily FDP and the maximum flight time within that FDP are established in accordance with Table 1 and comply with the following conditions

response Please see the answer to comment # 54

comment 837 comment by: Yorkshire Air Ambulance

The concept of breaks for HEMS operations is unnecessary because CAT.GEN.MPA.100(e)(1) already places an obligation on commanders not to fly when fatigued. An appropriate statement to this effect would be better justified. Also, the text indicates such breaks are in addition to operators providing a specific duration for a meal opportunity, as described at ORO.FTL.240 - Nutrition.

response Please see the answer to comment # 54

comment 838 comment by: Yorkshire Air Ambulance

The requirement for breaks in suitable accommodation will have a significant negative impact for delivery of a HEMS service.

response Please see the answer to comment # 54

comment 839 comment by: Yorkshire Air Ambulance

By my calculations, this means a one-hour break every 14-hour FDP.

response Please see the answer to comment # 54

comment 840 comment by: Yorkshire Air Ambulance

Specifying fifteen-minute post-flight duties after every flight returning to the HEMS operating base is completely unacceptable. What is the rationale for introducing such a limit? For most HEMS units doing several missions every day, this could result in an additional hour of aircraft unavailability. Curiously, the text only specifies a HEMS operating base, and not if the aircraft pre-positions elsewhere?

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 289 of 585

An agency of the European Union

comment 841 comment by: Yorkshire Air Ambulance

In the UK, 12-hour SP HEMS shifts have been commonplace for many years, without any fatigue-related incidents. Cumulative duty periods induce tiredness, not the length of a single FDP (within reason). HEMS pilots have plenty of time in a normal shift to rest, and achieve comfort and food breaks. Introducing a prescriptive break is punitive and antithesis to the HEMS philosophy.

response Please see the answer to comment # 54

comment 842 comment by: Yorkshire Air Ambulance

The introduction of a one-hour break in an FDP>10 hours is contradicted by the rationale text in para. 34 which states: "Basic maximum FDPs of more than 12 hours are possible only if crew members can benefit from at least one break of at least 60 consecutive minutes."

response Please see the answer to comment # 54

comment 936 comment by: MBH SAMU

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. MBH suggests adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)”

response Please see the answer to comment # 54

comment 938 comment by: MBH SAMU

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 290 of 585

An agency of the European Union

comment 939 comment by: MBH SAMU

Attachment #125

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM (Cf. attachment S4 illustrating this continuous flight time limitation in single-pilot + TCM issue) (b)(1) ISSUE MBH highlights the too restrictive limitation of total flight time for the single-pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations:

• with autopilot at 4 hours • without autopilot at 2 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 291 of 585

An agency of the European Union

Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. Considering the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations) and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopter and no flight standard for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for MBH, i.e 50 minutes back and forth (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, MBH suggests using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, MBH proposes for single-pilot + TCM without autopilot to:

• Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM

response Please see the answer to comment # 54

comment 940 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 292 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

response Please see the answer to comment # 54

comment 941 comment by: MBH SAMU

Attachments #126 #127 #128 #129

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 293 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, MBH suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #960) PROPOSAL Rephrase the paragraph (b)(2) as follows: “(2) For FDP over 10 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.”

response Please see the answer to comment # 54

comment 944 comment by: MBH SAMU

Attachments #130 #131 #132 #133 #134

PRE AND POST FLIGHT MINIMUM TIME (Cf. attachments S1, S2, S3 and S4 illustrating this pre and post flight minimum time issue) (a3) and (b4) ISSUE MBH agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 294 of 585

An agency of the European Union

contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum preflight time of 30 minutes at the beginning of the FDP. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. With the same philosophy, the proposed requirement of having a minimum post flight period of 15 minutes at each HEMS operating base returns will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. To illustrate those two issues, let’s take the example of 2 unpredicted HEMS operations within the same FDP:

• 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth)

o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been

done • Further operations: no preflight required as far as preflight is already done

This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, MBH underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 295 of 585

An agency of the European Union

On the other hand, MBH agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #979) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, MBH proposes:

• To dissociate from the above the time for the operational preparation of further individual flight time

• To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base”

(Cf. comment #966) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base. Pre-flights duties do not apply to TCM.”. Pre-flights duties do not apply to TCM.”

response Please see the answer to comment # 54

comment 945 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 296 of 585

An agency of the European Union

MBH highlights that the proposition in point (c) shall apply for both:

• Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2

response Please see the answer to comment # 54

comment 947 comment by: MBH SAMU

Attachments #135 #136 #137 #138

SINGLE-PILOT + TCM TOTAL FT LIMITATION (Cf. attachments S1, S2, S3 and S4 illustrating this total flight time limitation issue) Table 2 ISSUE MBH would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 297 of 585

An agency of the European Union

PROPOSAL Add the following sentence below the Table 2: “The maximum Flight Time in Table 2 can be increased by 1 hour under the principles of a FRM”

response Please see the answer to comment # 54

comment 950 comment by: MBH SAMU

Attachments #139 #140 #141 #142

MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues) (d) ISSUE On the one hand, MBH underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #944), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM

Moreover, MBH highlights that, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 min for MBH)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the HEMS operating base, thus

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 298 of 585

An agency of the European Union

pilots can have breaks in comfortable places between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met:

1. The rest period preceding the first FDP is at least 36 hours including 2 local nights; and

2. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights.

A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 984 comment by: AESA

Break included in CS FTL.3.205(a)(1) for FDPs over 12 hours, must be rostered in advance by the operator with start and finish time?

response Please see the answer to comment # 54

comment 1008 comment by: Stephanie Selim

(b) and Table 2 Technical comment (basic FDP) – As previously notified, the pilots of the HEMS have mean flight duration of 1h30 per day with significant waiting times. A HEMS pilot in France has an activity of 90 hours per year. Reducing FDP depending on hours of start of FDP will increase the number of pilots needed to guarantee the same HEMS activity. For example, the Bordeaux HeliSMUR begins at 10 am and has a 14 hours vacation. This won’t be possible anymore with this NPA with only one pilot. This measure causes several difficulties, the first one being the lack of

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 299 of 585

An agency of the European Union

experienced pilots on the labor market, and the second one the reduction of flying time per pilot, which creates a new risk that is the maintenance of skills. We want to mention again that, in single-pilot HEMS operations, the pilot is not alone anymore and is assisted by a TCM. In that way, the risk of fatigue is lower. Hence, his FDP should not be considered as if he was alone. We ask for, at least, a FDP of 14 hours when the FDP starts at 10.

response Please see the answer to comment # 54

comment 1009 comment by: Stephanie Selim

(b) and Table 2 Technical comment (FT with and without autopilot) – Without autopilot, the proposal leads to 3 hours of maximum FT by night and only 2 continuous FT hours. This proposal may result in big difficulties for some pathologies as highly burn victims because few hospitals are specialised in that kind of pathologies and 2 hours to pick the victim, bring him/her to the specialised centre and come back with the medical team and the helicopter in order to be available for further missions is not possible in 2 hours in all cases. Indeed, these flights can be a haul from Lyon to Paris which lasts more than 2h and they are necessary because the transport by road is not considered sufficiently effective considering the patient’s condition. And if an additional flight has to be made during the period when the flight time is limited to 3 hours, this next mission will not be possible either. Moreover, in several cases, a HEMS flight could pick up a patient in a hospital to bring him/her to a third hospital. This mission call “triangulars” in France is common. These flights are usually flown with lighter helicopter without autopilot because they can fly longer distances (4h30 of autonomy) than heavy helicopters. They usually occur from a known helipad in a hospital to another known helipad in another hospital In addition, it is usual to keep the engine running (the rotor blades are still turning while loading the helicopter between two legs or three legs in case of a triangular mission, i.e the single-pilot + TCM take off from the home base, pick up a patient at a given hospital to finally bring him at the planned hospital). Thus, according to the definition of a Flight Time in ORO.FTL.105(13), these two legs are considered as a unique flight time. In that way, the limitation of 2 hours for an equipage with a singlepilot + TCM is too restrictive. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for SNEH, i.e 50 minutes back and forth (1 mission) and this extension of the continuous flight time limitation will be used for a few and very specific missions.

response Please see the answer to comment # 54

comment 1010 comment by: Stephanie Selim

(b)(2) and (3) Technical comment (breaks) – This proposal has ABSOLUTELY to be deleted. The break can not be scheluled, except if we accept to waive the helicopter for 1 hour,

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 300 of 585

An agency of the European Union

taking the risk that a patient has to be transported at that moment, which is obviously impossible. Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours There is always a room for such a 1h break in an accommodation at HEMS operating base.

response Please see the answer to comment # 54

comment 1011 comment by: Stephanie Selim

(b)(4) Technical comment (pre and post flight duty) – Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there is almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to this proposition of having a minimum pre-flight time of 30 minutes at the beginning of the FDP. Moreover, this requirement is a problem regarding the organisation of HEMS operations in France. This pre-flight duty, when carried out, launches the start of the FDP which will cause difficulties with the values of maximum FDP proposed in this NPA, especially considering that FT are low in France, as exposed. Thus, we ask for the deletion of this requirement which has no equivalent in other types of operations (pre-flight duty exists but does not have a minimum duration).

response Please see the answer to comment # 54

comment 1012 comment by: Stephanie Selim

(d) Technical comment (4 FDP of more than 12h) – With this proposal, the usual French rostering 7 days ON at home base / 7 days OFF could not be respected anymore, both for 14h vacations, and for the current 12h vacations if our proposal to delete the minimum duration of pre and post-flight duties is not accepted as it will lead to 12h45 of vacation (or hiring new pilots). Yet, this model has proven its efficiency in terms of safety, fatigue and quality of life for crews. Indeed, the total amount of flight times for pilots is quite low, a lot of time can be spent for rest, and the working pace of 7 days ON / 7 days OFF does not appear more tiring

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 301 of 585

An agency of the European Union

(due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 min/30 mn) in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Furthermore, no demonstration or RIA is given to justify the point (d).

response Please see the answer to comment # 54

comment 1114 comment by: European Cockpit Association

Commented text: CS FTL.3.205 Flight duty period (FDP) — HEMS (1) For FDPs of over 12 hours, the operator ensures at least one break of minimum 60 consecutive minutes or more within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; ECA Comment: The Rulemaking Group agreed on minimum break times before to be counted for any kind of reduction of 1 hour - comparable to the min of 90 minutes of in-flight-rest – a break which is lasting less than 1 hour doesn’t assure recovering from fatigue, but since suitable accommodation is more relaxing than in-flight-rest 60 min is from ECA’s point of view appropriate. This wording is unclear, because the interpretation is possible, that "only one" break must be at least 60 minutes. In addition, the Rulemaking Group agreed, that active time of the dual pilot flight crew is limited to 12 hours within a possible longer duty time. ECA strongly recommends, that this limit of 12h of active time is not exceeded.

response Please see the answer to comment # 54

comment 1115 comment by: European Cockpit Association

Commented text: CS FTL.3.205 Flight duty period (FDP) — HEMS (2) The time for breaks constitutes 50 % of the time over 12 hours and excludes the necessary time for post- and pre-flight duties; and ECA comment: Agreed by the Rulemaking Group: the total break time must be at least equal to the time over the limiting hours; The time for breaks excludes the necessary time for post- and pre- flight duties; leads to lower limits, more prolongation - from ECA point of view more practicable, clearer and safer approach.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 302 of 585

An agency of the European Union

comment 1117 comment by: European Cockpit Association

Commented text: CS FTL.3.205 Flight duty period (FDP) — HEMS (2) For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; ECA comment: The Rulemaking Group agreed on minimum break times before to be counted for any kind of reduction of 1 hour – a break which is lasting less than 1-hour doesn`t assure recovering from fatigue. This wording is unclear, because the interpretation is possible, that "only one" break has to be at least 60 minutes. In addition, the Rulemaking Group agreed, that active time of the single pilot flight crew is limited to 10 hours within a possible longer duty time. ECA strongly recommends, that this limit of 10h of active time is not exceeded.

response Please see the answer to comment # 54

comment 1118 comment by: European Cockpit Association

Commented text: (3) The time for breaks constitutes 50 % of the time over 10 hours and excludes the necessary time for post- and pre-flight duties; ECA comment: Agreed by the Rulemaking Group: the total break time has to be at least equal to the time over the limiting hours; The time for breaks excludes the necessary time for post- and pre-flight duties; leads to lower limits, more prolongation - from ECA point of view more practicable, clearer and safer approach.

response Please see the answer to comment # 54

comment 1167 comment by: NHV Group

Paragraph No: CS FTL.3.205 Flight duty period (FDP) - HEMS Subparagraph (b), point (4). Comment: Limitation given in point (4) does not reflect impact the complexity of mission or flight rules type on minimum time for pre-flight and post-flight duties. Justification: Option to reduce these figures or flexibility in applying these limits depending on complexity of mission and type of flight rules shall be allowed to the HEMS operators. Proposed text: (4) The operator specifies in the operations manual, a minimum time for the first pre-flight duties performed at the beginning of the FDP and a minimum of time for post-flight duties for every flight returning to the HEMS operating base.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 303 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1211 comment by: SAF

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. SAF suggests adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)”

response Please see the answer to comment # 54

comment 1212 comment by: SAF

response Please see the answer to comment # 54

comment 1213 comment by: SAF

Attachment #143

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 304 of 585

An agency of the European Union

(Cf. attachment S4 illustrating this continuous flight time limitation in single-pilot + TCM issue) (b)(1) ISSUE SAF highlights the too restrictive limitation of total flight time for the single-pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations:

• with autopilot at 4 hours • without autopilot at 2 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 305 of 585

An agency of the European Union

for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for SAF, i.e 50 minutes back and forth (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, SAF suggests using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, SAF proposes for single-pilot + TCM without autopilot to:

• Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM

Otherwise, it would be beneficial to further develop the RIA basing it on experience and safety records on this subject, in order to better assess the economic and social impacts in addition to the flight safety impact. PROPOSAL Replace the paragraph (b)(1) by the following: “(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 3 hours without autopilot. These limitations can be increased by 1 hour under the principles of a FRM;”

response Please see the answer to comment # 54

comment 1214 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 306 of 585

An agency of the European Union

Indeed, given the following aspects (Table 1 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

response Please see the answer to comment # 54

comment 1215 comment by: SAF

Attachments #144 #145 #146 #147

BREAK PERIODS for single-pilot + TCM HEMS operations Cf. attachments S1, S2, S3 and S4 illustrating this break issue (b)(2)(b)(3) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 307 of 585

An agency of the European Union

Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, SAF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #1228) PROPOSAL Rephrase the paragraph (b)(2) as follows: “(2) For FDP over 10 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.”

response Please see the answer to comment # 54

comment 1216 comment by: SAF

Attachments #148 #149 #150 #151 #152

PRE AND POST FLIGHT MINIMUM TIME

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 308 of 585

An agency of the European Union

(Cf. attachments S1, S2, S3 and S4 illustrating this pre and post flight minimum time issue) (a3) and (b4) ISSUE SAF agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

• 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth)

o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been

done • Further operations: no preflight required as far as preflight is already done

This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, SAF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 309 of 585

An agency of the European Union

• Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT

Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. This definition does not correspond to the definition of the proposal which defines a post- flight after each flight time returning to HEMS operating base within the same FDP. Therefore, SAF suggests suppressing the post flight duties since they are confusing and replacing it by a proportionate pre-flight time before any take-off from the HEMS operating base. For French HEMS services, the suitable accommodation is nearby the helicopter. On the other hand, SAF agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #1242) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, SAF proposes:

• To dissociate from the above the time for the operational preparation of further individual flight time

• To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base”

(Cf. comment #1232) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base.”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 310 of 585

An agency of the European Union

“(b) […] (4) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base. Pre-flights duties do not apply to TCM.”. Pre-flights duties do not apply to TCM.”

response Please see the answer to comment # 54

comment 1217 comment by: SAF

• Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2

response Please see the answer to comment # 54

comment 1218 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 311 of 585

An agency of the European Union

Attachments #153 #154 #155 #156

SINGLE-PILOT + TCM TOTAL FT LIMITATION (Cf. attachments S1, S2, S3 and S4 illustrating this total flight time limitation issue) Table 2 ISSUE SAF would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones:

response Please see the answer to comment # 54

comment 1219 comment by: SAF

Attachments #157 #158 #159 #160

MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 312 of 585

An agency of the European Union

(Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues) (d) ISSUE On the one hand, SAF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #1216), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM

Moreover, SAF highlights that, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 min for SAF)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the HEMS operating base, thus pilots can have breaks in comfortable places between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 313 of 585

An agency of the European Union

for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met:

1. The rest period preceding the first FDP is at least 36 hours including 2 local nights; and

2. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights.

A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 1275 comment by: Hélicoptères de France

CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) #1 There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. HDF suggests adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)” #2 REMARK For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h. #3 CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM (Cf. attachment S4 illustrating this continuous flight time limitation in single-pilot + TCM issue) (b)(1) ISSUE HDF highlights the too restrictive limitation of total flight time for the single-pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 314 of 585

An agency of the European Union

• with autopilot at 4 hours

• without autopilot at 2 hours Some rescues and patient transportation, like severe burned patients, will not be possible with the 2 hours limitation without the autopilot. Indeed, these flights can be a haul from Lyon to Paris which lasts more than 2h and they are necessary because the transport by road is not considered sufficiently effective considering the patient’s condition. These flights are usually flown with lighter helicopter without autopilot because they can fly longer distances (4h30 of autonomy) than heavy helicopters. These flights are usually scheduled from a known helipad in a hospital to another known helipad in another hospital and correspond more to the scope of commercial sanitary flights not yet defined by EASA than the HEMS scope. In addition, it is usual to keep the engine running (the rotor blades are still turning while loading the helicopter between two legs or three legs in case of a triangular mission, i.e the single-pilot + TCM takeoff from the home base, pick up a patient at a given hospital to finally bring him at the planned hospital). Thus, according to the definition of a Flight Time in ORO.FTL.105(13), these two legs are considered as a unique flight time. In that way, the limitation of 2 hours for an equipage with a singlepilot + TCM is too restrictive. Moreover, in HEMS, a single-pilot does not fly alone, he is assisted by a Technical Crew Member (which is a recent additional EASA requirement). In that way, the risk of fatigue is lower since the TCM is assisting the pilot in non-piloting tasks and is contributing to the safety of the flight. De facto, single pilot HEMS operations are in fact 2 technical crews operations (1 pilot + 1 TCM). By parallelism, no such total flight time limitation has been defined for 2 technical crews operations (2 pilots). No RIA is given to justify this proposal. Besides, HEMS pilots are scarce resources in France, and this NPA would lead to hire 120 additional pilots and 120 additional TCM in order to offer the same quality of HEMS activity in France. This represents an additional cost of 20% for the whole French HEMS State Budget. It is likely that such a massive recruitment would not be achievable and would thus result in a significant reduction in the quality of the French Healthcare system. Considering the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations) and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopter

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 315 of 585

An agency of the European Union

and no flight standard for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes for SNEH, i.e 50 minutes back and forth (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, HDF suggests using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, HDF proposes for single-pilot + TCM without autopilot to:

• Have an augmentation of this limitation to 3 hours

• Increase the limitation to 4 hours under the principles of a FRM Otherwise, it would be beneficial to further develop the RIA basing it on experience and safety records on this subject, in order to better assess the economic and social impacts in addition to the flight safety impact. PROPOSAL Replace the paragraph (b)(1) by the following: “(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 3 hours without autopilot. These limitations can be increased by 1 hour under the principles of a FRM;” #4.1 BREAK PERIODS for two-pilots HEMS operations (a)(1)(a)(2) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 316 of 585

An agency of the European Union

a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no- flown hours There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, HDF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #30.3) PROPOSAL Rephrase the paragraph (a)(1) as follows: “(1) For FDP over 12 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.” #4.2 BREAK PERIODS for single-pilot + TCM HEMS operations Cf. attachments S1, S2, S3 and S4 illustrating this break issue (b)(2)(b)(3) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 317 of 585

An agency of the European Union

HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, HDF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #30.3) PROPOSAL Rephrase the paragraph (b)(2) as follows: “(2) For FDP over 10 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.” #5 PRE AND POST FLIGHT MINIMUM TIME (Cf. attachments S1, S2, S3 and S4 illustrating this pre and post flight minimum time issue) (a3) and (b4) ISSUE HDF agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 318 of 585

An agency of the European Union

same FDP:

• 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth) o This requires a 30-minutes preflight then a 15-minute post flight

• 2nd launch at 12h00: no preflight required because the preflight has already been done

• Further operations: no preflight required as far as preflight is already done This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple flight times inside a unique FDP, HDF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP

• Assuming the FDP ends with the last FT

• Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. This definition does not correspond to the definition of the proposal which defines a post- flight after each flight time returning to HEMS operating base within the same FDP. Therefore, HDF suggests suppressing the post flight duties since they are confusing and replacing it by a proportionate pre-flight time before any take-off from the HEMS operating base. For French HEMS services, the suitable accommodation is nearby the helicopter. On the other hand, HDF agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #44) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple rotations. Thus, HDF proposes:

• To suppress the minimum duration of initial preflight of 30 minutes and to replace it by “a sufficient time determined by the operator and specified in the operating manual”; this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time

• To dissociate from the above the time for the operational preparation of further individual flight time

• To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 319 of 585

An agency of the European Union

• To suppress the minimum duration of “operational pre-flight at the HEMS operating base” at and to replace it by “a sufficient time determined by the operator and specified in the operating manual” instead of the proposed required 15 minutes for the post-flight between 2 FT at the HEMS operating base (Cf. comment #31.1) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) A sufficient time is determined by the operator and specified in the operating manual for the initial pre-flight duties performed at the beginning of the FDP and for operational pre-flight duties before each flight taking-off from the HEMS operating base. Pre-flights duties do not apply to TCM.”. Pre-flights duties do not apply to TCM.” #6 (c) ISSUE HDF highlights that the proposition in point (c) shall apply for both:

• Two-pilots operations: Table 1; and

• Single-pilot + 1 TCM operations: Table 2 Indeed, the proposed mitigation is met in both operations by offering suitable accommodation at HEMS operating base (Cf. point (b)(2) and (a)(1)): the rest and mitigated resulting fatigue are the same thus the alleviation shall be the same. PROPOSAL Replace paragraph(c) by the following: “If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for two-pilots operations and Table 2 for single-pilot operations, for reporting times between 0730-0959 also apply for reporting times between 0630-0729.” #7 SINGLE-PILOT + TCM TOTAL FT LIMITATION (Cf. attachments S1, S2, S3 and S4 illustrating this total flight time limitation issue) Table 2 ISSUE HDF would like to highlight that the total flight time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones:

• FDP starting between 06:30-06-59 => maximum total flight time = 3:30

• FDP starting between 12:00-13:59 => maximum total flight time = 3:30

• FDP starting between 4:00-06:29 => maximum total flight time = 3:00

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 320 of 585

An agency of the European Union

There is no regulation in France on this subject for HEMS operations, with no reported inherent safety issue through experience. A further developed RIA based on experience and safety records on this subject would be beneficial, in order to assess the economic and social impacts in addition to the flight safety impact. In CAT provisions, when the operator has implemented a FRM, it is considered as a valuable mitigation to allow for the FDP to be increased by 1hour, in some cases. Thus, in the same philosophy than for CAT operations, HDF proposes to increase all total flight time limitations by 1 hour under the principles of a FRM. PROPOSAL Add the following sentence below the Table 2: “The maximum Flight Time in Table 2 can be increased by 1 hour under the principles of a FRM” #8 MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues) (d) ISSUE On the one hand, HDF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours

• 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

• 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift

• Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM Moreover, HDFH highlights that, due to short and continuous flight times with a total flight time limited per Table 2 and which are in average 1h30 per 12 hours of shifts (with an average leg of 25 min for SNEH)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the HEMS operating base, thus pilots can have breaks in comfortable places

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 321 of 585

An agency of the European Union

between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met: (1) The rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights. A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 1306 comment by: Elilombarda

CS FTL.3.205 Flight duty period (FDP) — HEMS With regard to ‘Duty Period’, ‘Flight Duty Period (FDP)’ and ‘Rest Periods’ in HEMS operations, the following applies: ORO.FTL.105 (11) - ‘duty period’ ORO.FTL.105 (12) - ‘flight duty period (‘FDP’)’ ORO.FTL.205 Flight duty period (FDP) (and related AMC/GM) ORO.FTL.210 Flight times and duty periods (and related AMC/GM) ORO.FTL.235 Rest periods (and related AMC/GM) CS FTL.3.205 Flight duty period (FDP) (and related AMC/GM) CS FTL.3.210 Flight times and duty periods (and related AMC/GM) CS FTL.3.235 Rest periods (and related AMC/GM)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 322 of 585

An agency of the European Union

Some European countries have been organised for several years in 7/7 rosters, with up to 13/14 hours of daily FDP, also in night duties. Italy has been organised in 7/7 and also 14/14 rosters with up to 13 hours of duty time and FDP. Contacts with pilots, HEMS crew members, HEMS organisations and aviation associations indicate that this kind of roster is well accepted by all personnel and that generally the stress build up during the 7 or 14 day-shift is well managed by them. In Italy, HEMS rosters are organised in 7/7 with a maximum of 13 hours of duty and FDP time. Italy was organised in 14/14 days rosters for many years. This organisation has been introduced by national Authority (ENAC), and operators, pilots and aviation associations have considered this safe for crew’s possible stress build up and required rest necessities. Generally, stress comes from fatigue, especially when facing intense flying days. A possible barrier to this kind of stress can be by reducing the maximum allowed FDP in those days where the flying time is going to reach the maximum allowed for the day. For example, in a two-pilot HEMS duty day with a FDP of 14 hours, the maximum allowed daily flight time is 9:00 hours. If the crew reaches, during that day, a flight time of 7:00 hours (2 hours before the maximum allowed daily FT), then the maximum FDP in that day will be reduced to maximum 12:00 hours, so the crew can have an increased rest time on the rest of the day. Breaks do not seem to be an efficient solution for two main reasons:

1. The emergency service will be disrupted in a time frame where a mission is likely to be requested (i.e. “at times that ensure likelihood of sleep” - ref. ‘CS FTL.3.205(a)(1) - in a daily shift means between 14:00-16:00). This means that the emergency service will be suspended (no helicopter intervention, for example, on car accidents or heart strokes), or that the operator shall provide for a substitute crew during break periods.

2. The crew member shall remain in the base (i.e. “at the HEMS operating base” - ref. ‘CS FTL.3.205(a)(1)) which would partly reduce the rest effect. Breaks and the related rest not always comes from sleep, but sometimes it comes from "mentally breaking" with the operative environment, thus phisically temporarly walk away from the stressing environment.

(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 2 hours

without autopilot;

For FDPs of over 10 hours, the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base; (3) (3) The time for breaks constitutes 50 % of the time over 10 hours and excludes the necessary time for post- and pre-flight duties; If the crew reaches a flight time of 2 hours before the maximum allowed daily flight time, as reported in table 2, the maximum FDP on that day is reduced to maximum 12:00 hours.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 323 of 585

An agency of the European Union

The operator specifies in the operations manual, a minimum of 30 minutes for the first pre- flight duties performed at the beginning of the FDP and a minimum of 15 minutes for post- flight duties for every flight returning to the HEMS operating base.

(…) The operator may assign a block of up to 4 7 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: the rest period preceding the first FDP is at least 36 hours including 2 local nights; and the rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights.

response Please see the answer to comment # 54

comment 1322 comment by: SAS

The majority of single pilot HEMS operations in the UK operate a 12hr FDP. It would be uncommon to not have a break of 60 minutes at least once in a shift, but to specify a break through-out which the flight crew could not be disturbed threatens the availability of the operation. HEMS is an environment where minutes can literally be the difference between life and death for the patient. GM1 SPA.HEMS.100 – ‘The HEMS Philosophy’ states that HEMS flights are able to accept ‘potential risk … to a level proportionate to the task’. This enforced break would be undermining this HEMS philosophy.

response Please see the answer to comment # 54

comment 1323 comment by: SAS

Post-flight duties on returning to a HEMS operating base are often minimal. The very nature of HEMS operations leads to extended periods of time waiting, either at HEMS operating sites or a hospitals. It is possible to complete the post-flight duties for each sector at the end of that sector. This renders the stipulation of ‘a minimum of 15 minutes for post-flight duties for every flight returning to base’ pointless. On the contrary it has the potential to severely affect the effectiveness of an operation. A HEMS crew may only attend 2 jobs in a day, it is perfectly conceivable that these tasking could be within 15min of one another. As stated previously, this is an environment where minutes can literally be the difference between life and death and the patient. With this in mind, this restriction seems both unnecessary and inappropriate.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 324 of 585

An agency of the European Union

comment 1337 comment by: ENAC

ENAC received the following comment from HEMS operators: Breaks do not seem to be an efficient solution for two main reasons: 1) The emergency service will be disrupted in a time frame where a mission is likely to be requested (i.e. “at times that ensure likelihood of sleep” - ref. ‘CS FTL.3.205(a)(1) - in a daily shift means between 14:00-16:00). This means that the emergency service will be suspended (no helicopter intervention, for example, on car accidents or heart strokes), or that the operator shall provide for a substitute crew during break periods. 2) The crew member shall remain in the base (i.e. “at the HEMS operating base” - ref. ‘CS FTL.3.205(a)(1)) which would partly reduce the rest effect.

response Please see the answer to comment # 54

comment 1342 comment by: European Cockpit Association

Commented text: CS FTL.3.205 Flight duty period (FDP) — HEMS The conditions to modify the limits on flight duty, duty and rest periods by the commander in the case of unforeseen circumstances in HEMS flight operations which occur at or after the reporting time, or at the end of the FDP, comply with the following: ECA Comment: ECA appreciates this approach; this is a major achievement/improvement against fatigue and should be remained in at least the CS.

response Please see the answer to comment # 54

comment 1344 comment by: European Cockpit Association

General Comment: If the commanders discretion is used, the following min rest period - if this is a reduced rest - has to be extended by the amount of the extension of the FDP due to the commanders discretion.

response Please see the answer to comment # 54

comment 1390 comment by: Swiss Air-Ambulance Rega

CS.FTL.3.205(a) Here, the table establishes “Maximum Flight Duty Period (FDP) for two-pilot operations” according to Table 1. If 12 hours are exceeded, at least one break of an uninterrupted hour

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 325 of 585

An agency of the European Union

at the base must be guaranteed, as “time that ensures likelihood of sleep”. The assessment of this likelihood in practice is likely to be extremely difficult and not comparable. Hence, this specification lacks practicability and relevance, and the passage should be deleted. CS.FTL.3.205(a)(2) The total breaks must constitute 50% of the time over 12 hours. Question: The break time is the total of all breaks, but only one of the breaks must be > 60 minutes? Question: When does FDP/handover time FDP or DT start? The definition of FDP according to ORO.FTL.105 No 12 states that the duty the crew member reports for contains a sector or a series of sectors. This definition does not work for HEMS operation. HEMS is characterised by the fact that the crew at the home base waits for a mission alert. In this regard, when reporting for duty, it is not foreseeable whether and when a sector will be flown. It is regularly the case that the first mission occurs several hours after reporting for duty. This must be taken into consideration in the definition, otherwise the FDP in the scope of HEMS operation would be nearly identical to the duty period, which would impose substantial limitations on the operator as compared to today’s system. One possible solution here would be that breaks between missions that last at least 60 consecutive minutes interrupt the FDP. Comment on Tables 1 and 2: Where do these times come from? What is the underlying data? No scientific study on HEMS operation, which confirms these apparently arbitrarily established times, is evident or mentioned. CS.FTL.3.205(b) Maximum flight duty period (FDP) for one pilot, see Table 2. If 10 hours are exceeded, at least one break of an uninterrupted hour (> 60 minutes) at the base must be guaranteed, as “time that ensures likelihood of sleep”. Question: How should likelihood be assessed (time that ensures likelihood of sleep)? This is completely impractical; this passage is to be deleted. Para. b3: The total breaks must constitute 50% of the time over 10 hours. Question: The break time is calculated as the total of all breaks, but only one of the breaks must be > 60 minutes. Table 2: The established maximum flight times are unacceptable, too short and are totally unfounded. As a minimum, the same flight hours should be possible for operation with one pilot and autopilot (AP) as with two pilots. The AP supports manual flying just as another pilot does. Recommendation: A pilot without AP max. 5 hours, a pilot with AP 7 hours. Question: What are the flight time limitations for CAT and aerial work? Will even shorter flight times be established for these? Dependency between the start of duty and the max. flight time is also unacceptable, and no distinction is made for CAT either. This would represent an inadmissible unequal treatment. The concept of operating a mixed crew, in which tasks are shared, differs considerably from a true single pilot concept since cockpit workload is divided and monitoring is taking place. There are no credits for this sharing of workload in terms of FTL however the HEMS TCM must adhere to the FTL. Credits should be given for the mixed crew concept and be treated same as two-pilots.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 326 of 585

An agency of the European Union

Proposed amendment: (1) Continuous FT is limited in all cases to 7 hours per day. Exceptionally, the flight time on one day per calendar month may not exceed 8 hours. (2) For FDPs of over 12 hours to a max of 14 hours, the operator ensures at least one break of minimum 120 consecutive minutes (split duty) plus a total of 60 minutes during the daytime […] (3) To be removed in order to reduce complexity. (4) Ok. Table 2: Should be deleted in order to reduce complexity and the flight time values in table 2 should be adapted as follows (A pilot without AP max. 5 hours, a pilot with AP 7 hours.): (1) 60 flight hours in 14 days; (2) 110 flight hours in 28 days; (3) 280 flight hours in three calendar months; (4) 900 flight hours per calendar year. CS.FTL.3.205(b)(2) There needs to be specific AMC material developed to support training and awareness of the use of breaks within duties at times where the crew member is encouraged to sleep. This is to ensure that all those involved (crew members and those involved in planning the flights) understand and provide the necessary support for the crew to be fit to operate the flight. EASA is requested to develop specific training requirements and guidance material to ensure that crew and the operators understand how to: identify the times likely for sleep; the best use of the opportunities to sleep; how to manage sleep inertia issues; and, the impact of the commercial pressures of the operation. CS.FTL.3.205(d) If an FDP is between 12 and 14 hours, the duty period is limited to 4 consecutive days. This must be preceded by a rest period of 36 hours (2 nights); previously, only 24 hours were required. It must be followed by a rest period of 60 hours (3 nights); previously, this was 48 hours. Question: Is the travel time according to CS.FTL.3.200 (b) part of the 4 FDPs? If it was conceived in this way, pilots can only be used on 2 to 3 days if the FDP > 12 hours; this makes the use of flex-time pilots, etc. unprofitable in these times. Question: In the event of a 24-hour base, will the FDP be limited to four days if the 12 hours are exceeded once? This means that planning is limited to just four days. Until now, the 7- day duty cycle has been the appealing part of shift duty at a 24-hour base. This would lead to a further loss of acceptance among pilots. Rega's HEMS FDP is max. 5 d on a mountain base and max. 2 d on a midland base. The expected days of duty shall be based on the expected mission per day, taking seasonal variations into account. Split duty is not taken into account in this section. Or is this section not relevant for spilt duty? With spilt duty, FDPs of more than 14 hours would be possible. The consequences of this on planning are not defined.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 327 of 585

An agency of the European Union

comment 1421 comment by: Svensk Luftambulans

Comment: The concept of breaks for HEMS operations is not useable and should be handled differently. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”.

response Please see the answer to comment # 54

comment 1422 comment by: Svensk Luftambulans

Comment: While our HEMS operating bases include suitable accommodation, there is not enough accommodation to cater for crew that are to report for duty.

response Please see the answer to comment # 54

comment 1423 comment by: Svensk Luftambulans

Comment: In Sweden 12+ hours has been common practice for close to 20 years without any incidents relating to fatigue. If the flight duty period is of a reasonable length, it is the number of duty periods that induced fatigue, not the length of the flight duty period. Crews involved in HEMS operation typically have ample time for rest and food intake. Prescribing breaks is not a practical solution.

response Please see the answer to comment # 54

comment 1424 comment by: Svensk Luftambulans

Comment: An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. Passive time is calculated as 50% towards the total Flight Duty Time. Active time is calculated as 100% towards the total Flight Duty Time.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 328 of 585

An agency of the European Union

comment 1437

comment by: COPAC COLEGIO OFICIAL DE PILOTOS DE LA AVIACIÓN

COMERCIAL

CS FTL.3.205, se habla de “break”, además de otros puntos en los que también se hace referencia a estos mismos “break”. ¿Cómo se determina un break? Es decir, ¿se ha de notificar al operador que asigna las misiones que durante un mínimo de 60 minutos no se le puede asignar misión? ¿O no es necesaria la notificación y simplemente la confirmación de que durante dichos 60 minutos mínimo se ha podido descansar?

response Please see the answer to comment # 54

comment 1456 comment by: Association of Air Ambulances

CS.FTL.3.205 states that for two-pilot HEMS operations, the FDP limitation data in table 1 is applicable, and hence applicable to LAA HEMS operations. Subparagraph (a)(3) states that the operations manual shall specify a minimum of 30 minutes for pre-flight duties and 15 minutes for post flight duties “for every flight returning to the HEMS operating base.” For a short sector HEMS operation like London's Air Ambulance where the average sector duration is historically 6 minutes the imposition of the 15 minute post flight duty embargo for every flight returning to the HEMS operating base is a major operational limitation. This needs to be clarified as previously the 15 minutes of post flight duty period was applied after the last flight of the duty day. Just taking a brief look at the returned SRPs, this would have delayed at least 4 responses that I found in one month alone. I think we might have to argue this (a9(3) a minimum of 15 minutes post flight duties for every flight returning to teh HEMS operating base is considered very restrictive and could impact operational service, particularly in the summer A one hour discretion over our current operating system is a reduction in capability There is no guidance surrounding travel arrangements for touring/travelling pilots

response Please see the answer to comment # 54

comment 1487 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Reasoning: Paragraph describes 24 to 72 hours of active standby. FDP or other work required by operator may be associated with this active standby. The safety mitigating action is based on the fact that during active standby the pilot is active only short times. In

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 329 of 585

An agency of the European Union

Finland the average ADP is only 3,5 hours within rolling 24 hour period. In addition, maximum flight time and ADP during the rolling 24 hours are limited. For this reason, active standby operation ensures an adequate rest to the crew members. Most of the HEMS operations take place in day time, in Finland approximately 15% of HEMS tasks take place during the night. Proposal: Add new paragraph CS FTL.3.207 after CS FTL.3.205 as follows: CS FTL.3.207 Active duty period (ADP) in active standby – HEMS By way of derogation from CS FTL.3.205, the flight and duty time limitations given below shall apply to active standby in helicopter emergency medical service (HEMS) operations: (a) For two-pilot (table 1) and single-pilot (table 2) HEMS operations, the basic maximum daily ADP and the maximum flight time FT within that ADP are established in accordance with tables and comply with the following conditions: (1) The active standby is considered to begin when the individual crew member reports for duty, and finishes when crew member stops being on active standby or hands the standby duties over to another person. (2) Maximum ADP in rolling 24 hour period, for acclimatized crew members are established in accordance with Table 1 and 2:

Table 1 Maximum basic daily ADP in hours — Acclimatised crew members in two-pilot HEMS operations

Active standby period

Maximum ADP in rolling 24 hour period

Maximum flight time FT

with autopilot in rolling 24 hour period

Maximum flight time FT without autopilot in

rolling 24 hour period

24:00 12:00 08:00 06:00

48:00 11:00 07:30 05:30

72:00 10:00 07:00 05:00

Table 2 Maximum basic daily ADP in hours — Acclimatised crew members in single-pilot HEMS operations

Active standby period

Maximum ADP in rolling 24 hour period

Maximum flight time FT

with autopilot in rolling 24 hour period

Maximum flight time FT without autopilot in

rolling 24 hour period

24:00 12:00 06:00 04:00

48:00 11:00 05:30 03:30

72:00 10:00 05:00 03:00

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 330 of 585

An agency of the European Union

response Please see the answer to comment # 54

CS FTL.3.205 p. 36

comment 5 comment by: TG

Die FDP Zeiten lassen sich nicht immer vorhersehen - große Spielräume sind zum Benefit von Patient, Crew und Hubschrauber nötig. Es kann nicht sein, dass eine Crew länger mit der Suche nach Parkmöglichkeiten und Absicherung des Hubschraubers beschäftigt ist als mit einem vielleicht 30-minütigen Flug zur Home-Base. 60h/3N ist viel zu lang vor dem Dienst - kein Benefit.

response Please see the answer to comment # 54

comment 6 comment by: TG

Die Berechnung der Folgen von "unforeseen Circumstances" ist erheblich zu kompliziert und für die Dienstplanung und Erfüllung des EMS Auftrages nicht praktikabel.

response Please see the answer to comment # 54

comment 24 comment by: Johannes Brantz

60 Minutes guaranteed break at the Home Base This is a real plus to manage fatigue, HEMS crews have a high motivation to help patients. Therefore decisions to accept another mission are likely to be made even though the crew would need a break. The guaranteed break helps crews to avoid fatigue. Commander’s discretion

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 331 of 585

An agency of the European Union

Some extensions of Flight Duty Times are accounted for in the FTL by commander’s discretion. I would like to bring to your intention that a successful HEMS Mission is the result of an excellent team work. Therefore I would agree that decisions about extensions should be team decision instead of commander’s discretion.

response Please see the answer to comment # 54

comment 60 comment by: London's Air Ambulance

response Please see the answer to comment # 54

comment 65 comment by: London's Air Ambulance

CS FTL.3.205(b) permits the allowed increase to the FDP to be extended if the unforeseen circumstance (HEMS call) occurs just before take-off on the final sector, but only to transport the patient. If a medical decision is made not to transport the patient by air, this could result in a helicopter being stranded until a rested crew can arrive at the HEMS site to relieve the duty crew. This should be amended to allow either the transport of the patient or an non-HEMS flight to the overnight base. This contradicts ORO.FTL.105 (29) A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.

response Please see the answer to comment # 54

comment 184 comment by: ANSMUH

CS FTL 3.205 FDP (a) The maximum basic daily FDP may be increased for HEMS by up to 1 hour for single- pilot operation or by up to 2 hours for two-pilot operation. Actually in France it's possible for an H12 operating base to have a commander's dicretion of 2 hours. For H14, it's impossible to have this commander's discretion, because the minimum rest period is 10 hours.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 332 of 585

An agency of the European Union

We want to keep this possibility of 2 hours commander's discretion without restriction of number of pilot. The ideal would be to keep the French system with the obligation of a minimum of 10 hours of rest. (b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take- off on the final sector, the allowed increase may only be exceeded to transport the patient. In France all operating base are located on hospitals. Imagine that for unforeseen circumstances we must go beyond the commander's discretion because the patient must be transported to another hospital than the operating base. Problem: What do we do with the medical team who must return to the operating base after the patient transportation ? How does the crew to find suitable accomodation, if they have to stop taking off an come back to the operating base ? Our proposal would be to give the opportunity to go back to the operating base, provided that it is a minimum of 10 hours of rest after. This is what is happening in France. Proposal: CS FTL.3.205 Flight duty period (FDP) — HEMS Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) The conditions to modify the limits on flight duty, duty and rest periods by the commander in the case of unforeseen circumstances in HEMS flight operations which occur at or after the reporting time, or at the end of the FDP, comply with the following: (a) The maximum basic daily FDP may be increased for HEMS by up to 2 1 hours not exceeding 14 hours FDP for single-pilot operation or by up to 2 hours for two-pilot operation. (b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take- off on the final sector, the allowed increase may only be exceeded to go back to the HEMS operating base transport the patient. In that case, the rest period shall be at least 10 hours. (c) If commander discretion is used in any HEMS operating base more than 10 % of the total FDP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 333 of 585

An agency of the European Union

comment 276 comment by: European Helicopter Association (EHA)

SHA (Switzerland) Table 2

The maximum time without autopilot is a nonsense and no difference shall be

applicable. They are not such limitations in SPO or CAT and pilots flies often in more

demanding work (sling load).

response Please see the answer to comment # 54

comment 281 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.205 (b) (2) & (3) Problem: For FDP of 14 hours the time of break has to be 2 hours (50% of the time over 10 hours) but only one has to be consecutive. That means, that any period (i.e 6 x10 minutes) fits into this scheme. The administrative implementation is very exaggerated Solution: Delete sub paragraph 3 in total

response Please see the answer to comment # 54

comment 315 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): Comment: (the same comment is placed on page 37 for CS FTL 3.210) NLA presently operates in a system that have one crew on duty for 24/7 for one complete week in a 7 ON/14 OFF/7 ON/21 off for flight crew members and 7 ON / 21 OFF for HEMS technical crew members. As our FRM and sicentific studies has shown, this is apparently conducted in a safe manner and we intend to seek an IFTSS. Having said that, having two crews manning one helicopter for a 24 hour period is quite common pracice in Europe and as we see it, this will no longer be practicable. For HEMS operating base conducting 24/7 operations:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 334 of 585

An agency of the European Union

When operating in compliance with CS FTL.3.205 Flight duty period (FDP) — HEMS and CS FTL.3.210 Flight times and duty periods — HEMS, there is not enough overlap to ensure continuity of the service if only two crews (a “day” and “night” crew) are used to cover a 24-hour period. With two crews, the maximum of 14 hours and 12 hours FDP limits respectively gives only a maximum of 1 hour overlap in each end. This does not give enough time to dispatch on, and complete a, HEMS mission. Note that this is even if not one single HEMS mission has taken place during the FDP prior to the alarm. Should an alarm come in shortly (for example 1:30 to 1 hour) before overlap, the mission will have to be postponed until the new crew has commenced their FDP. Alternatively, three crews must be used for every 24-hour period to keep one HEMS operating base operational 24/7. 1:30 to 1 hour before the overlap is just an example. The period necessary to complete a mission is quite contextual and sufficient time is up for discussion, but the question needs to be addressed. Furthermore, as mentioned in the comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 35 above, prescribing breaks is not a practicable solution and the concept of breaks is very unclear, especially regarding how this should be planned. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. This could look like the following example: “Passive time” is all the time spent on a HEMS duty period that is not considered to be active time, relaxing, free of all duties except standing by to receive an alarm. “Active time” is all the time spent pre- and post-flight activities, operation of the helicopter, HEMS missions, rapid response vehicle missions, training, checking, administrative work, meetings, attending a course, simulator, travel etc. While passive time is the time the crew members are relaxing, the fatigue level is a direct consequence of the circadian rhythm and therefore it is of outmost importance, as far as practicable, to maintain a normal sleep pattern. Passive time is calculated as 50% towards the total Flight Duty Time. Active time is calculated as 100% towards the total Flight Duty Time. If reaching any Flight time or Active time limit, the crew member shall go off Active duty. HEMS:

• Duties such as pre-flight inspection, fuel checks, equipment check, etc. shall be logged as active time;

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 335 of 585

An agency of the European Union

• Active time is triggered by an alarm and is defined from time of alarm to minimum 1 hour after block-on time. If the time for post flight duties takes more than 1 hour, actual time shall be logged as active time.

Rapid response vehicle operation:

• Between 10:00 and 22:59, Active time is triggered by an alarm and is defined from time of alarm to the time the mission is completed and equipment etc. is re- supplied and prepared and as a minimum 15 minutes; and

• Between 23:00 and 09:59, Active time is triggered by an alarm and is defined from time of alarm to minimum 1 hour after returning at the base. If the time for post mission duties takes more than 1-hour, actual time shall be logged as active time.

For HEMS and rapid response vehicle operation:

• If there are less than two hours between on-block and the time of a new alarm, the entire time between on-block and the time of a new alarm counts as Active time.

Other operations (pre-flight, ferry flight, test flight, training flight, etc.):

• Active time is triggered when reporting for duty or commencing preparations and ends minimum 30 minutes after block-on time;

• Related duties such as pre-flight inspection, fuel checks, equipment check, flights registration etc., are not counted separately. This is considered included in the minimum 30 minutes after block-on time; and

• If the time for post flight duties takes more than 30 minutes, actual time shall be logged as Active time.

With a system like this, perhaps a maximum Flight Duty Period of 16 hours could be introduced for a “day crew” with a maximum of 10 or 12 hours total active and passive time. For a “night crew”, a maximum of 12 or even 14 hours maximum Flight Duty Period could be used with a maximum of 10 hours of total active time. This system would also allow for sufficient overlap in case of missions just prior to a crew/shift change.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 336 of 585

An agency of the European Union

comment 317 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): ”Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) (a) The maximum basic daily FDP may be increased for HEMS by up to 1 hour for single- pilot operation or by up to 2 hours for two-pilot operation.” Comment: Unforeseen circumstances would typically include only longer time at HEMS operating site or weather. Unforeseen should also should include catastrophic events. “(b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take- off on the final sector, the allowed increase may only be exceeded to transport the patient.” Comment: This is too restrictive. After delivering the patient, the crew should be allowed to return to the HEMS operating base (perhaps under the condition that there is suitable accommodation where the crew can rest). Otherwise, the consequence could be that the crew is stuck at a hospital without practical possibility to get rest. Furthermore, the helicopter will also be stuck at a hospital without crew to fly it. On most hospital landing sites, the helicopter would block the helipad for the duration of the stay (i.e. no other helicopters would be able to use the helipad) and in many circumstances also take occupy hospital security personnel. In addition, it is not necessary the case that the relieving crew have a practicable chance to travel from the HEMS operating base to the hospital where the helicopter is parked is parked. “(c) If commander discretion is used in any HEMS operating base more than 10 % of the total FDP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted. Comment: While sensible, the should be re-worked to make it easier to understand.

response Please see the answer to comment # 54

comment 341 comment by: European Helicopter Association (EHA)

FNAM (France) CS FTL.3.205 Maximum basic daily FDP in HEMS under ORO.FTL.205 (b)(7) #1

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 337 of 585

An agency of the European Union

There are two CS FTL.3.205 (with exactly the same title), which introduces complexity, uncertainty and may lead to misunderstanding. The FNAM suggests adding precisions in the title of this paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205 (b)(7)” #2 REMARK For small FT as currently operated in HEMS, it is possible to have multiple FDP within the same day. For instance: One FDP from 07:00 to 8:30 followed by a 12h rest period and then a FDP from 20:30 to 22h. #3 CONTINUOUS FLIGHT TIME LIMITATION IN SINGLE-PILOT + TCM (b)(1) ISSUE The FNAM highlights the too restrictive limitation of total flight time for the single-pilot + TCM operations (b)(1). Indeed, the proposal constrains the continuous flight time for single-pilot + TCM operations: • with autopilot at 4 hours • without autopilot at 2 hours Some rescues and patient transportation, like severe burned patients, will not be possible with the 2 hours limitation without the autopilot. Indeed, these flights can be a haul from Lyon to Paris which lasts more than 2h and they are necessary because the transport by road is not considered sufficiently effective considering the patient’s condition. These flights are usually flown with lighter helicopter without autopilot because they can fly longer distances (4h30 of autonomy) than heavy helicopters. These flights are usually scheduled from a known helipad in a hospital to another known helipad in another hospital and correspond more to the scope of commercial sanitary flights not yet defined by the EASA than the HEMS scope. In addition, it is usual to keep the engine running (the rotor blades are still turning while loading the helicopter between two legs). Thus, according to the definition of a Flight Time in ORO.FTL.105(13), these two legs are considered as a unique flight time. In that way, the limitation of 2 hours for an equipage with a single-pilot + TCM is too restrictive. Moreover, in HEMS, a single-pilot does not fly alone, he is assisted by a Technical Crew Member (which is a recent additional EASA requirement). In that way, the risk of fatigue is lower since the TCM is

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 338 of 585

An agency of the European Union

assisting the pilot in non-piloting tasks and is contributing to the safety of the flight. De facto, single pilot HEMS operations are in fact 2 technical crews operations (1 pilot + 1 TCM). By parallelism, no such total flight time limitation has been defined for 2 technical crews operations (2 pilots). No RIA is given to justify this proposal. Considering the limited range of heavy helicopter with autopilot, the lack of ATPL(H) pilots in France (for acting as commander for 2 pilots HEMS operations) and considering the fleet currently assigned to hospitals in France (with single-pilot certified helicopter and no flight standard for 2 pilots operations), the sum of the previous constraints leads to the impossibility to transport this kind of patient by road or air. It is necessary to increase the limitation of continuous flight time described in this paragraph. This will not have a major impact on the fatigue of the pilots since most of the HEMS flights have a unit flight time ranged around 25 minutes, i.e 50 minutes back and force (1 mission)i and this extension of the continuous flight time limitation will be used for a few and very specific missions. However, in order to ensure it does not have an impact on the fatigue of the crew member, the FNAM suggests using the possibility of having a 4 hours continuous flight time for single-pilots + TCM without autopilot under the principles of a FRM. Thus, the FNAM proposes to for single-pilot + TCM without autopilot: • Have an augmentation of this limitation to 3 hours • Increase the limitation to 4 hours under the principles of a FRM Otherwise, a sound RIA based on experience and safety records on this subject appears to be necessary, in order to assess the economic and social impacts in addition to the flight safety impact. PROPOSAL Replace the paragraph (b)(1) by the following: “(1) Continuous FT is limited in all cases to 4 hours with autopilot and to 3 hours without autopilot. These limitations can be increased by 1 hour under the principles of a FRM;” #4.1 BREAK PERIODS for two-pilots HEMS operations (a)(1)(a)(2) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 339 of 585

An agency of the European Union

opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no- flown hours There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principle of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, the FNAM suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #30.3) PROPOSAL Rephrase the paragraph (a)(1) as follows: “(1) For FDP over 12 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.” #4.2 BREAK PERIODS for single-pilot + TCM HEMS operations (b)(2)(b)(3) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 340 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no- flown hours There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principle of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, the FNAM suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comment #30.3) PROPOSAL Rephrase the paragraph (b)(2) as follows: “(2) For FDP over 10 hours, the operator ensures ex-post that at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep and provides suitable accommodation for the purpose of breaks at the HEMS operating base. Fatigue risk management principles may be applied to monitor this break.” #5 PRE AND POST FLIGHT MINIMUM TIME (a3) and (b4) ISSUE The FNAM agrees a minimum time shall be taken to ensure the safety of the flight: • Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information. Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of an HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to the EASA proposition of having a minimum preflight time of 30 minutes at the beginning of the FDP. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. With the same philosophy, the proposed requirement of having a minimum post flight period of 15

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 341 of 585

An agency of the European Union

minutes at each HEMS operating base returns will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. To illustrate those two issues, let’s take the example of 2 unpredicted HEMS operations within the same FDP: • 1st launch at the start of the FDP, at 8h00 with a mission with 2 flight times of 10 minutes (mission back and forth) o This requires a 30-minutes preflight then a 15-minute post flight • 2nd launch at 12h00: no preflight required because the preflight has already been done • Further operations: no preflight required as far as preflight is already done This example highlights the lack of efficiency of having a long pre-flight at the beginning of the FDP before the first flight time and no preflight requirement for the following flight time though it occurs 4 hours after the initial checks. Moreover, due to multiple Flight Times inside a unique FDP, the FNAM underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT Thus, for HEMS operations, it is not clear if the post-flight does belong or not to the FDP depending on the end of the last FT. This definition does not correspond to the definition of the proposal which defines a post- flight after each flight time returning to HEMS operating base within the same FDP. Therefore, the FNAM suggests suppressing the post flight duties since they are confusing and replacing it by a proportionate pre-flight time before any take-off from the HEMS operating base. For French HEMS services, the suitable accommodation is nearby the helicopter. According to French experiences, the effective time for preparing a new flight is 7 minutes. This reduction from 15 minutes to this current value of 7 minutes for pre-flight time before any takeoff from the HEMS operating base will not impact the level of safety, otherwise a sound RIA based on experience and safety records on this subject would be appreciated. On the other hand, the FNAM agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #44) In consequence, the proposal does not demonstrate safety improvement in all cases, in particular when several flight times are allocated in the same FDP and suppress life opportunity for the 1st patient if the emergency occurs in the first 30 minutes of the FDP and the next ones in case of airlift multiple

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 342 of 585

An agency of the European Union

rotations. Thus, FNAM proposes: • To reduce the minimum duration of initial preflight from 30 minutes to 15 minutes (inclusion of the helicopter checks) • To dissociate from the above the time for the operational preparation of further individual flight time • To replace the notion of “post-flight” by “operational pre-flight at the HEMS operating base” • To set the minimum duration of “operational pre-flight at the HEMS operating base” at 7 minutes instead of 15 minutes for the post-flight between 2 FT at the HEMS operating base (Cf. comment #31.1) PROPOSAL Replace the paragraph (a)(3) and (b)(4) by the following: “(a) […] (3) The operator specifies in the operations manual a minimum of 15 minutes for the initial pre-flight duties performed at the beginning of the FDP and a minimum of 7 minutes for post-flight operational pre-flight duties before each flight taking-off from the HEMS operating base.” “(b) […] (4) The operator specifies in the operations manual a minimum of 15 minutes for the initial pre-flight duties performed by the pilot at the beginning of the FDP and a minimum of 7 minutes for post-flight operational pre-flight duties performed by the pilot before each flight taking-off from the HEMS operating base. Pre-flights duties do not apply to TCM.” #6 (c) ISSUE The FNAM highlights that the proposition in point (c) shall apply for both: • Two-pilots operations: Table 1; and • Single-pilot + 1 TCM operations: Table 2 Indeed, the proposed mitigation is met in both operations by offering suitable accommodation at HEMS operating base (Cf. point (b)(2) and (a)(1)): the rest and mitigated resulting fatigue are the same and the alleviation shall be the same. PROPOSAL Replace paragraph(c) by the following: “If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for two-pilots operations and Table 2 for single-pilot operations, for reporting times between 0730-0959 also apply for reporting times between 0630-0729.” #7 SINGLE-PILOT + TCM TOTAL FT LIMITATION Table 2 ISSUE The FNAM would like to highlight that the total Flight Time limitation for single-pilot + TCM operations without the use of autopilot are too restrictive especially the following ones: • FDP starting between 06:30-06-59 => maximum total flight time = 3:30

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 343 of 585

An agency of the European Union

• FDP starting between 12:00-13:59 => maximum total flight time = 3:30 • FDP starting between 4:00-06:29 => maximum total flight time = 3:00 There is no regulation in France on this subject for HEMS operations, with no reported inherent safety issue through experience. A sound RIA based on experience and safety records on this subject appears to be necessary, in order to assess the economic and social impacts in addition to the flight safety impact. In CAT provisions, when the operator has implemented a FRM, it is considered as a valuable mitigation to allow for the FDP for pilots to be increased by 1hour, in some cases. Thus, in the same philosophy than for CAT operations, the FNAM proposes to increase all total flight time limitations by 1 hour under the principles of a FRM. PROPOSAL Add the following sentence below the Table 2: “The maximum Flight Time in Table 2 can be increased by 1 hour under the principles of a FRM” #8 MITIGATION AFTER A BLOCK OF UP TO 4 CONSECUTIVE FDP OF MORE THAN 12 HOURS (d) ISSUE On the one hand, the FNAM underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience: • 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule: • More than 12h FDP for each and every vacation • Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM Moreover, the FNAM highlights that, due to short and continuous flight times with a total time limited per Table 2 and which are in average 1h30 per 12 hours of vacations (with an average leg of 25 min)i in France, the fatigue will not be an issue for FDP ranged from 12h up to 14h. Indeed, according to the requirements (a)(1) and (b)(2), all HEMS organizations shall provide suitable accommodation at the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 344 of 585

An agency of the European Union

HEMS operating base, thus pilots can have breaks in comfortable places between two flight times. These pilots have to have their rest at the HEMS operating base which is considered as a mitigation measure. This is also a safety improvement because the rest is at the HEMS operating base which is considered as a mitigation measure. Furthermore, no demonstration nor RIA is given to justify the point (d), while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. On the other hand, most of the French pilots are "faux-basés", meaning they spend 7 days working at home base and then 7 days of rest at home which can be at 500 kilometers from home base. Therefore, most of French HEMS pilots prefer the cycle 7 days ON / 7 days OFF for their quality of life which will be limited by the requirement (d). Nevertheless, the provisions of (d) implies at least 4 days ON per 3 days OFF, which appears counterproductive for social issues and crew quality of life. PROPOSAL Replace paragraph (d) by the following: "If an operator assigns two or more consecutive FDPs of more than 12h, the following conditions shall be met: (1) The rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights. A block of more than 4 consecutive FDPs of more than 12hours can be scheduled under the principles of a FRM."

response Please see the answer to comment # 54

comment 342 comment by: European Helicopter Association (EHA)

FNAM (France) CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) #1 ISSUE There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. The FNAM suggests adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 345 of 585

An agency of the European Union

PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)” #2 ISSUE - FORCE MAJEURE (Cf. comment #17.5) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and state operators. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, the FNAM suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12) #3 + scenario commander’s discretion attached (a) ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for single-pilot + TCM HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 346 of 585

An agency of the European Union

operations. The FNAM wonders how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for single-pilot + TCM HEMS operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by single-pilot + TCM HEMS operations in case of emergency for the patient. To illustrate this issue, the FNAM attached a scenario taken from real HEMS operator planning where the commander’s discretion (single-pilot + TCM) exceeds 1 hour (in that case, the commander’s discretion is of 1h50). Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France. Thus, the FNAM suggests a 2 hours commander’s discretion for both 1 pilot +TCM and two- pilots operations. PROPOSAL Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.” #4 (b) ISSUE The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, the FNAM suggests replacing the term of sector by the notion of flight time. (Cf. comment #14.2) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, the FNAM suggests replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination OR ANY OTHER HELIPAD OR DROP ZONE. If unforeseen circumstances occur just before take-off on the final flight time,

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 347 of 585

An agency of the European Union

the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter) #5 (b) ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of HEMS, which encompasses the following HEMS payload (medical personnel, medical supplies such as equipment, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the HEMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why the FNAM suggests replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport the MEDICAL PERSONNEL, MEDICAL SUPPLIES SUCH AS EQUIPMENT INCLUDING THE HELICOPTER, BLOOD, ORGANS OR DRUGS, ILL OR INJURED PERSONS AND OTHER PERSONS DIRECTLY INVOLVED.” #6 (c) ISSUE The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing. Therefore, in order to make the reading easier, the FNAM suggests not repeating the same ideas in different paragraphs of this NPA. PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 348 of 585

An agency of the European Union

Suppress the paragraph (c) of this CS

response Please see the answer to comment # 54

comment 368 comment by: European Helicopter Association (EHA)

BHA (UK) "CS FTL.3.205 Flight duty period (FDP) — HEMS (a)" Comment: This should include an exemption for exceptional circumstances in the national interests, or force majeure. "(b)" Comment: This seems unduly prescriptive? "(c)" Comment: Very sensible, but not well-defined.

response Please see the answer to comment # 54

comment 384

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

This CS exists twice with the same name which clearly should be avoided to make precise references to the rules.

response Please see the answer to comment # 54

comment 385

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

response Please see the answer to comment # 54

comment 386

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 349 of 585

An agency of the European Union

In the second of the two CSs FTL 3.205(c) (page 36 last para) an exceedance of a total FDP causes the operator to review and adapt the scheduling with respect to a HEMS operating base. We have to stress that this rule neglects the fact that FDP is something personal (related to a certain pilot) and not related to a certain HEMS operating base. So it does not make any sense to review and adapt the scheduling and crew resources of a certain HEMS operating base if the exceedance of the (personal) FDP was caused for example due to the shifts on other HEMS operating bases.

response Please see the answer to comment # 54

comment 394 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (c) commander discretion Comment: Extension of max FDP by 2 hours (2-pilot crew), 1 hour (single pilot) only to finish either the last flight or the last flight with patient. In addition use of this extension is limited to 10 % of all FDPs of the last 3 months. Compared to the current regulation, this is more limiting due to the exclusive use in relation to the last flight and the transport of the patient to a hospital. The use of the same numbering in two different CS paragraphs is puzzling – max FDP. Implementing this limit seems not reasonable because this can only happen in one mission. It can only occur during summer months (long days) and would only lead to changes during summer. To collect data for this statistic would pose additional work to the crews since they will have to produce the input. This additional work will be required exatly at that times, where the work load is already high namely at the end of long FDPs.

response Please see the answer to comment # 54

comment 399 comment by: European Helicopter Association (EHA)

OAEMTC (Austria): CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMS operations is established as follows: […] Table 2

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 350 of 585

An agency of the European Union

COMMENT: Complex table with FDP reductions to a maximum of 14 hrs. Day HEMS FDP typically starts at sunrise but no earlier than 06:00hrs LT. Bearing in mind a circadian rhythm, reporting times after BCMT cannot be considered as abnormal working time. Most percentage of the working population starts work in the early morning which constitutes a biological high. The limitation off light time implies anyway periods of times with lower workloads. This regulation would force us to hire and train more crew (40%) to cover our contracts. In summer 2 shift duties would be required and would reduce the exposure of pilots and HEMS TCM (i.e. missions per pilot/HEMS TCM). What is the added value for flight safety when looking at the whole rather than only at fatigue? CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205(b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMS operations is established as follows: […] (c) If the rest period before reporting for the FDP is taken at the HEMS operating base, the limits of Table 1 for reporting times between 0730-0959 also apply for reporting times between 0630–0729. COMMENT(S) The alleviation is given only for table 1 which is applicable to two pilots only. Shouldn`t this also refer to table 2 to make it applicable to the single pilot operation also? CS FTL.3.205 Flight duty period (FDP) — HEMS Maximum basic daily FDP in HEMS operations under ORO.FTL.205 (b)(7) The maximum basic daily FDP without the use of extensions for acclimatized crew members in HEMS operations is established as follows: […] (d) The operator may assign a block of up to 4 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: (..) COMMENTS(S) A maximum of 4 consecutive duties will lead to an increase of travelling of 78% in terms of cost, kilometers covered and time compared to our current roster. The number of days which crew is off and without travel will decrease accordingly from approximately 169 to 137. This has a negative

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 351 of 585

An agency of the European Union

impact on actual extended recovery periods and turns time off into travelling time. We don’t see any benefit in terms of fatigue reduction. Crews will have to work in consecutive weekends as a consequence. CS FTL.3.205 Flight duty period (FDP) — HEMS (must be renumbered) Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) […] (b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off on the final sector, the allowed increase may only be exceeded to transport the patient. COMMENT(S) De text contains the word sector which is not defined for HEMS, see ORO.FTL.105 Definitions (29). This probably means that crew will be tempted to turn down missions in the last hour of duty, because for a mission taking more than one hour, crews will be condemned to remain on ground at the hospital. This could mean: • Missions are turned down early; • The mission might end in the field if no patient is to be transported; • In case a patient has to be transported the hospital’s landing site is blocked for at least another 10 hours (affecting the capacity of the hospital and therefore affecting the health care of third patients); • Following multiple other effects because the helicopter cannot be protected against adverse weather conditions on most of the hospital landing sites; • Crew would need to seek accommodation locally. i.e. all ends up at the wrong place and likely the crew is to become more fatigued then when returning to base. CS FTL.3.205 Flight duty period (FDP) — HEMS (must be renumbered) Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) […] (c) If commander discretion is used in any HEMS operating base more than 10 % of the total FDP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted. COMMENT(S)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 352 of 585

An agency of the European Union

This 10% are probably meant for a base and not FDP, as the FDP would count for an individual person. The total scheduled duties on a base for a three months period equals up to 1267h therefore 10% are 126,7h. As there is 1 additional hour only at commanders discretion allowed, this rule cannot apply in a single pilot operation within a 90-days period. If something else is intended consider revising the text.

response Please see the answer to comment # 54

comment 407 comment by: ANWB MAA

The distinguish between a 2 pilot operation and single pilot operation doesn't match the new insight of EASA on the operation with a HEMS Crew Member as stated in the proposal where the HCM is seen as a relevant member of the crew concept when received adequate training (draft NPA on HEMS DVE).

response Please see the answer to comment # 54

comment 408 comment by: ANWB MAA

Request to add the sector to fly back to the HEMS station. It's not feasible to have a helicopter at a hospital without any relieve crew

response Please see the answer to comment # 54

comment 424 comment by: UFH French Helicopters Association

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) #1 ISSUE There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. We suggest adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 353 of 585

An agency of the European Union

PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)” #2 ISSUE - FORCE MAJEURE (Cf. comment #17.5) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, UFHsuggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12) #3 + scenario commander’s discretion attached (Cf. attachment S2 illustrating this lack of commander’s discretion issue) (a)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 354 of 585

An agency of the European Union

ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for single-pilot + TCM HEMS operations. UFH wonders how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for single-pilot + TCM HEMS operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by single-pilot + TCM HEMS operations in case of emergency for the patient. In France, 3%i of flights saving lives would be impossible with a commander’s discretion capped to 1 hour (cf. SNEH illustrative Table in attachment). To illustrate this issue, UFH attached a scenario taken from real HEMS operator planning where the commander’s discretion (single-pilot + TCM) exceeds 1 hour (in that case, the commander’s discretion is of 1h50). Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France. Thus, we suggest a 2 hours commander’s discretion for both 1 pilot +TCM and two-pilots operations. PROPOSAL Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.” #4 (b) ISSUE The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, UFH suggests replacing the term of sector by the notion of flight time. (Cf. comment #14.2) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, we suggest replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 355 of 585

An agency of the European Union

exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination OR ANY OTHER HELIPAD OR DROP ZONE. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter) #5 (b) ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of HEMS, which encompasses the following HEMS payload (medical personnel, medical supplies such as equipment, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the HEMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why UFH suggests replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport the MEDICAL PERSONNEL, MEDICAL SUPPLIES SUCH AS EQUIPMENT INCLUDING THE HELICOPTER, BLOOD, ORGANS OR DRUGS, ILL OR INJURED PERSONS AND OTHER PERSONS DIRECTLY INVOLVED.” #6 (c) ISSUE The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 356 of 585

An agency of the European Union

Therefore, in order to make the reading easier, we suggest not repeating the same ideas in different paragraphs of this NPA. PROPOSAL Suppress the paragraph (c) of this CS.

response Please see the answer to comment # 54

comment 490 comment by: FNAM/SNEH

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. FNAM and SNEH suggest adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)”

response Please see the answer to comment # 54

comment 491 comment by: FNAM/SNEH

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE - FORCE MAJEURE (Cf. comment #471) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 357 of 585

An agency of the European Union

Therefore, FNAM and SNEH suggest adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12)

response Please see the answer to comment # 54

comment 492 comment by: FNAM/SNEH

Attachments #164 #165

(Cf. attachment S2 illustrating this lack of commander’s discretion issue) (a) ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for single-pilot + TCM HEMS operations. FNAM and SNEH wonder how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for single-pilot + TCM HEMS operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by single-pilot + TCM HEMS operations in case of emergency for the patient. In France, 3%iof flights saving lives would be impossible with a commander’s discretion capped to 1 hour (cf. SNEH illustrative Table in attachment). To illustrate this issue, FNAM and SNEH attached a scenario taken from real HEMS operator planning where the commander’s discretion (single-pilot + TCM) exceeds 1 hour (in that case, the commander’s discretion is of 1h50). Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 358 of 585

An agency of the European Union

Thus, FNAM and SNEH suggest a 2 hours commander’s discretion for both 1 pilot +TCM and two-pilots operations. PROPOSAL Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.”

response Please see the answer to comment # 54

comment 493 comment by: FNAM/SNEH

(b) ISSUE The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, FNAM and SNEH suggest replacing the term of sector by the notion of flight time. (Cf. comment #463) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, FNAM and SNEH suggest replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter)

response Please see the answer to comment # 54

comment 494 comment by: FNAM/SNEH

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 359 of 585

An agency of the European Union

to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why FNAM and SNEH suggest replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport themedical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved.”

response Please see the answer to comment # 54

comment 495 comment by: FNAM/SNEH

(c) ISSUE The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing. Therefore, in order to make the reading easier, FNAM and SNEH suggest not repeating the same ideas in different paragraphs of this NPA. PROPOSAL Suppress the paragraph (c) of this CS.

response Please see the answer to comment # 54

comment 533 comment by: ADAC Luftrettung gGmbH

Extension of max FDP by 2 hours (2-pilot crew), 1 hour (single pilot) only to finish either the last flight or the last flight with patient. In addition use of this extension is limited to 10 % of all FDPs of the last 3 months. Compared to the current regulation, this is more limiting due to the exclusive use in relation to the last flight and the transport of the patient to a hospital. The use of the same numbering in two different CS paragraphs is puzzling – max FDP. Implementing this limit seems not reasonable because this can only happen in one mission. It can only occur during summer months (long days) and would only lead to changes during summer.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 360 of 585

An agency of the European Union

To collect data for this statistic would pose additional work to the crews since they will have to produce the input. This additional work will be required exactly at that times, where the work load is already high namely at the end of long FDPs.

response Please see the answer to comment # 54

comment 554 comment by: Rüdiger Neu

Sobald eine FDP zwischen 12 - 14 Stunden liegt, ist die Dienstperiode auf 4 aufeinanderfolgende Tagen begrenzt. Davor müssen 36 Stunden (2 Nächte) Ruhezeit enthalten, bisher waren hier nur 24 Stunden gefordert. Im Anschluss muss eine Ruhezeit von 60 Stunden (3 Nächte), bisher waren es 48 Stunden. Fragestellung: Gehört die Reisezeit gem. CS.FTL.3.200 (b) zu den 4 FDPs? Falls dies so gedacht wäre, könnten Piloten bei FDP > 12 Stunden nur noch an 2-3 Tagen eingesetzt werden, dies macht den Einsatz von Flexpiloten etc. in diesen Zeiten unrentabel. Fragestellung: Wird bei einer 24h-Station wird beim einmaligen Überschreiten der 12h FDP auf vier Tage limitiert? Eine Planbarkeit ist somit nur noch beschränkt auf vier Tage möglich. Bisher war beim Schichtdienst auf einer 24h-Station ein Dienstrhythmus von 7 Tagen das Attraktive. Dies würde zu weiterem Akzeptanzverlust bei den Piloten führen. Split duty wird in diesem Abschnitt nicht berücksichtigt. Oder ist dieser Abschnitt nicht für Split duty relevant? Verlängerung der max. FDP um 2 Stunden (2-Mann-Besatzung), 1 Stunde (1 PiC) nur für die Beendigung des letzten Fluges oder für den Flug mit Patient. Außerdem ist die Nutzung des Kommandantenentscheids limitiert auf 10% der gesamten FDP der letzten 3 Monate. Dieser Passus ist nicht vergleichbar mit dem bisherigen, er dient nur dazu einen Flug zu beenden oder den Patient noch ins Krankenhaus zu bringen. Verwirrend ist die gleiche CS Bezeichnung, wie für die max. FDP. Eine Limitierung innerhalb der 3 Monate ist unrealistisch, da dies nur bei einem Einsatz passieren kann. Außerdem könnte es nur im Sommer vorkommen und würde dann nur für diesen zu Dienstplanänderung führen. Die Auswertung der 10% Regelung würde einen Mehraufwand für die Besatzungen bedeuten, der genau zu den Zeiten gemacht werden muss, wenn die Belastung für die Besatzungen am größten ist, nämlich an den langen Sommertagen.

response Please see the answer to comment # 54

comment 595 comment by: NOLAS

Comment: NLA presently operates in a system that have one crew on duty for 24/7 for one complete week in a 7 ON/14 OFF/7 ON/21 off for flight crew members and 7 ON / 21 OFF for HEMS technical crew members. As our FRM and sicentific studies has shown, this is apparently

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 361 of 585

An agency of the European Union

conducted in a safe manner and we intend to seek an IFTSS. Having said that, having two crews manning one helicopter for a 24 hour period is quite common pracice in Europe and as we see it, this will no longer be practicable. For HEMS operating base conducting 24/7 operations: When operating in compliance with CS FTL.3.205 Flight duty period (FDP) — HEMS and CS FTL.3.210 Flight times and duty periods — HEMS, there is not enough overlap to ensure continuity of the service if only two crews (a “day” and “night” crew) are used to cover a 24-hour period. With two crews, the maximum of 14 hours and 12 hours FDP limits respectively gives only a maximum of 1 hour overlap in each end. This does not give enough time to dispatch on, and complete a, HEMS mission. Note that this is even if not one single HEMS mission has taken place during the FDP prior to the alarm. Should an alarm come in shortly (for example 1:30 to 1 hour) before overlap, the mission will have to be postponed until the new crew has commenced their FDP. Alternatively, three crews must be used for every 24-hour period to keep one HEMS operating base operational 24/7. 1:30 to 1 hour before the overlap is just an example. The period necessary to complete a mission is quite contextual and sufficient time is up for discussion, but the question needs to be addressed. Furthermore, as mentioned in the comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 35 above, prescribing breaks is not a practicable solution and the concept of breaks is very unclear, especially regarding how this should be planned. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. This could look like the following example: “Passive time” is all the time spent on a HEMS duty period that is not considered to be active time, relaxing, free of all duties except standing by to receive an alarm. “Active time” is all the time spent pre- and post-flight activities, operation of the helicopter, HEMS missions, rapid response vehicle missions, training, checking, administrative work, meetings, attending a course, simulator, travel etc. While passive time is the time the crew members are relaxing, the fatigue level is a direct consequence of the circadian rhythm and therefore it is of outmost importance, as far as practicable, to maintain a normal sleep pattern. Passive time is calculated as 50% towards the total Flight Duty Time. Active time is calculated as 100% towards the total Flight Duty Time. If reaching any Flight time or Active time limit, the crew member shall go off Active duty. HEMS:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 362 of 585

An agency of the European Union

• Duties such as pre-flight inspection, fuel checks, equipment check, etc. shall be logged as active time;

Rapid response vehicle operation:

For HEMS and rapid response vehicle operation:

• If there are less than two hours between on-block and the time of a new alarm, the entire time between on-block and the time of a new alarm counts as Active time.

Other operations (pre-flight, ferry flight, test flight, training flight, etc.):

• Active time is triggered when reporting for duty or commencing preparations and ends minimum 30 minutes after block-on time;

• If the time for post flight duties takes more than 30 minutes, actual time shall be logged as Active time.

response Please see the answer to comment # 54

comment 596 comment by: NOLAS

”Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 363 of 585

An agency of the European Union

(a) The maximum basic daily FDP may be increased for HEMS by up to 1 hour for single- pilot operation or by up to 2 hours for two-pilot operation.” Comment: Unforeseen circumstances would typically include only longer time at HEMS operating site or weather. Unforeseen should also should include catastrophic events.

response Please see the answer to comment # 54

comment 597 comment by: NOLAS

“(b) If on the final sector within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take- off on the final sector, the allowed increase may only be exceeded to transport the patient.” Comment: This is too restrictive. After delivering the patient, the crew should be allowed to return to the HEMS operating base (perhaps under the condition that there is suitable accommodation where the crew can rest). Otherwise, the consequence could be that the crew is stuck at a hospital without practical possibility to get rest. Furthermore, the helicopter will also be stuck at a hospital without crew to fly it. On most hospital landing sites, the helicopter would block the helipad for the duration of the stay (i.e. no other helicopters would be able to use the helipad) and in many circumstances also take occupy hospital security personnel. In addition, it is not necessary the case that the relieving crew have a practicable chance to travel from the HEMS operating base to the hospital where the helicopter is parked is parked.

response Please see the answer to comment # 54

comment 598 comment by: NOLAS

“(c) If commander discretion is used in any HEMS operating base more than 10 % of the total FDP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted. Comment: While sensible, the should be re-worked to make it easier to understand.

response Please see the answer to comment # 54

comment 670 comment by: Oya Vendée Hélicoptères

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 364 of 585

An agency of the European Union

There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. OYA suggests adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)”

response Please see the answer to comment # 54

comment 671 comment by: Oya Vendée Hélicoptères

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE - FORCE MAJEURE (Cf. comment #651) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, OYA suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 365 of 585

An agency of the European Union

3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12)

response Please see the answer to comment # 54

comment 672 comment by: Oya Vendée Hélicoptères

Attachments #166 #167

(Cf. attachment S2 illustrating this lack of commander’s discretion issue) (a) ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for single-pilot + TCM HEMS operations. OYA wonders how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for single-pilot + TCM HEMS operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by single-pilot + TCM HEMS operations in case of emergency for the patient. In France, 3%iof flights saving lives would be impossible with a commander’s discretion capped to 1 hour (cf. SNEH illustrative Table in attachment). To illustrate this issue, OYA attached a scenario taken from real HEMS operator planning where the commander’s discretion (single-pilot + TCM) exceeds 1 hour (in that case, the commander’s discretion is of 1h50). Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France. Thus, OYA suggests a 2 hours commander’s discretion for both 1 pilot +TCM and two-pilots operations. PROPOSAL Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.”

response Please see the answer to comment # 54

comment 673 comment by: Oya Vendée Hélicoptères

(b) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 366 of 585

An agency of the European Union

The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, OYA suggests replacing the term of sector by the notion of flight time. (Cf. comment #643) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, OYA suggests replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter)

response Please see the answer to comment # 54

comment 674 comment by: Oya Vendée Hélicoptères

(b) ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of HEMS, which encompasses the following HEMS payload (medical personnel, medical supplies such as equipment, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the HEMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why OYA suggests replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport themedical personnel, medical supplies such as equipment including

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 367 of 585

An agency of the European Union

the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved.”

response Please see the answer to comment # 54

comment 675 comment by: Oya Vendée Hélicoptères

(c) ISSUE The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing. Therefore, in order to make the reading easier, OYA suggests not repeating the same ideas in different paragraphs of this NPA. PROPOSAL Suppress the paragraph (c) of this CS.

response Please see the answer to comment # 54

comment 720 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.205 (a) (c) [...] is used in any HEMS operating base more than 10% of the total FDP [...] This 10% are probably meant for a base and not FDP, as the FDP would count for an individual person. The total flight duty period for three months for a base equals up to 1260h therefore 10% are 126,7h. As there is 1 additional hour only at commanders discretion allowed, this rule cannot apply in a single pilot operation within a 90-days period.

response Please see the answer to comment # 54

comment 746 comment by: DRF-Luftrettung

(I) As soon as the FDP is between 12 and 14 hours long a block of consecutive FDPs is limited to 4 days. The rest period preceding the first FDP is at least 36 hours including two local nights, the current system requires only 24 hours in advance. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights, the current system allows for 48 hours.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 368 of 585

An agency of the European Union

Question: Is travelling time in accordance with CS.FTL.3.200 (b) part of these 4 FDPs? If this is the case it will reduce the time on base of each pilot during times with more than 12 hours FDP to 2-3 days. The use of reserve pilots for only 2 consecutive days would pose an economic burden to the operator. Question: What happens on 24h bases in case of a single exceedance of the 12 hour FDP? Will the length of the duty block be automatically be shortened to 4 days instead of 7 as scheduled? This would lead to an additional limit regarding these bases, because they will have to change their current attractive 7 day blocks to 4 day blocks. This is expected to further reduce the attractivity of 24 h bases for pilots especially when they don’t live close to their home base. Split duty is not accounted for in this paragraph. Or is this paragraph not relevant for split duty? Using split duty would allow for FDP of more than 14 hours. Currently there is no further regulation provided for FDP of more than 14 hours.

response Please see the answer to comment # 54

comment 747 comment by: DRF-Luftrettung

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 369 of 585

An agency of the European Union

comment 754 comment by: DRF-Luftrettung

Standardized schedules should give for day and night pilots the same FDP at HEMS- bases with 24 / 7 working times. This is not possible for the maximum FDP of 12 hours, because we need at least an overlapping period of 30 min for the pre-flight checks Solution: Alter the max. FDP between 1400 and 0629 to read 12:30! This allows for evenly spread schedules i.e.: Shift 1 from 0630 to 1900 Shift 2 from 1830 to 0700

response Please see the answer to comment # 54

comment 755 comment by: DRF-Luftrettung

As soon as the FDP is between 12 and 14 hours long a block of consecutive FDPs is limited to 4 days. The rest period preceding the first FDP is at least 36 hours including two local nights, the current system requires only 24 hours in advance. The rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights, the current system allows for 48 hours. Question: Is travelling time in accordance with CS.FTL.3.200 (b) part of these 4 FDPs? If this is the case it will reduce the time on base of each pilot during times with more than 12 hours FDP to 2-3 days. The use of reserve pilots for only 2 consecutive days would pose an economic burden to the operator. Question: What happens on 24h bases in case of a single exceedance of the 12 hour FDP? Will the length of the duty block be automatically be shortened to 4 days instead of 7 as scheduled? This would lead to an additional limit regarding these bases, because they will have to change their current attractive 7 day blocks to 4 day blocks. This is expected to further reduce the attractivity of 24 h bases for pilots especially when they don’t live close to their home base. Split duty is not accounted for in this paragraph. Or is this paragraph not relevant for split duty? Using split duty would allow for FDP of more than 14 hours. Currently there is no further regulation provided for FDP of more than 14 hours.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 370 of 585

An agency of the European Union

comment 786 comment by: AECA helicopteros.

d) The operator may assign a block of up to 4 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: (1) the rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights. Question needing answer by regulation. This principle should be applied only in the case of 4 consecutive FDPs or also in the case of 2 or 3?

response Please see the answer to comment # 54

comment 823 comment by: Babcock Mission Critical Services Limited

We don't agree with : If on the final sector within the FDP Because : as per revised definition proposed page 10 of the NPA (ORO.FTL.105 (24) ), "sector" is to be used only for aeroplanes, so it should not be used in a paragraph dedicated to HEMS to avoid any confusion with the applicability of some other paragraphs. We suggest the term “flight” is used, in place of “sector”, in all requirements relating to helicopter operations. The meaning of the term “flight” is implied by the definition of “flight time” at ORO.FTL.105 Definitions: (13) ‘flight time’ means, …, and for helicopters, the time from the moment a helicopter’s rotor blades start turning until the moment the helicopter finally comes to rest at the end of the flight, and the rotor blades are stopped.

response Please see the answer to comment # 54

comment 843 comment by: Yorkshire Air Ambulance

This should include an exemption for exceptional circumstances in the national interests, or force majeure.

response Please see the answer to comment # 54

comment 844 comment by: Yorkshire Air Ambulance

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 371 of 585

An agency of the European Union

Why is the aircraft not allowed to return to its HEMS operating base? This seems unduly prescriptive, and will introduce more problems for operators and crews regarding fatigue (ie. recovering flight crew by land transfers).

response Please see the answer to comment # 54

comment 951 comment by: MBH SAMU

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. MBH suggests adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)”

response Please see the answer to comment # 54

comment 952 comment by: MBH SAMU

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE - FORCE MAJEURE (Cf. comment #922) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, MBH suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 372 of 585

An agency of the European Union

PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » : “Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12)

response Please see the answer to comment # 54

comment 953 comment by: MBH SAMU

Attachments #168 #169

(Cf. attachment S2 illustrating this lack of commander’s discretion issue) (a) ISSUE The paragraph (a) of this CS proposes a 1 hour commander’s discretion for single-pilot + TCM HEMS operations. MBH wonders how this value has been chosen by the Agency since there is no justification within the RIA regarding this matter. Currently in France, the regulation allows a 2 hours commander’s discretion, including for single-pilot + TCM HEMS operations, with no reported inherent safety issue through experience. This 2 hours commander’s discretion is frequently used by single-pilot + TCM HEMS operations in case of emergency for the patient. In France, 3%iof flights saving lives would be impossible with a commander’s discretion capped to 1 hour (cf. SNEH illustrative Table in attachment). To illustrate this issue, MBH attached a scenario taken from real HEMS operator planning where the commander’s discretion (single-pilot + TCM) exceeds 1 hour (in that case, the commander’s discretion is of 1h50). Safety record and experience show such an allowance demonstrates a high level of safety, with no accident occurrence when the commander’s discretion exceeds 1 hour. For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France. Thus, MBH suggests a 2 hours commander’s discretion for both 1 pilot +TCM and two-pilots operations. PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 373 of 585

An agency of the European Union

Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.”

response Please see the answer to comment # 54

comment 954 comment by: MBH SAMU

(b) ISSUE The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, MBH suggests replacing the term of sector by the notion of flight time. (Cf. comment #907) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, MBH suggests replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter)

response Please see the answer to comment # 54

comment 955 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 374 of 585

An agency of the European Union

The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why MBH suggests replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport themedical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved.”

response Please see the answer to comment # 54

comment 956 comment by: MBH SAMU

(c) ISSUE The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing. Therefore, in order to make the reading easier, MBH suggests not repeating the same ideas in different paragraphs of this NPA. PROPOSAL Suppress the paragraph (c) of this CS.

response Please see the answer to comment # 54

comment 991 comment by: AESA

Point (a) allows increasing the maximum basic daily FDP up to 1 hour, but it doesn’t allow to increase the maximum flight time. Is it correct?

response Please see the answer to comment # 54

comment 1000 comment by: B. Wagner

zu (a): eine zeitliche Beschränkung während eines Einsatzes ist nicht praxistauglich. Besser wäre eine Formulierung, die es der Besatzung erlaubt, einen bereits begonnenen Einsatz so schnell wie möglich im Sinne des Patienten zu Ende zu fliegen.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 375 of 585

An agency of the European Union

zu (b): Das Ziel sollte immer sein, den Hubschrauber zur Homebase zu überführen, da nur dort die Infrastruktur sowohl für den Schutz der Maschine als auch für die Ruhemöglichkeiten der Besatzung zur Verfügung stehen. Eine Übernachtung z.B. am Zielkrankenhaus hat eine Vielzahl von flugsicherheitsgefährdenden Auswirkungen, u.a. mangelhafte Absicherung der Maschine, Blockierung eines Nachtlandeplatzes für andere Maschinen, fehlende Ruhemöglichkeiten für die Crew (aus Erfahrung ist mit organisatorischem Aufwand von mehr als einer Stunde im Idealfall zu rechnen, bis die Besatzung tatsächlich eine Ruhemöglichkeit organisiert hat; in dünn besiedelten Regionen kann es deutlich länger dauern bis zu einem geeigneten Hotel o.ä.), Wettereinflüsse auf die im freien geparkte Maschine usw. zu (c): Dieser Punkt ist näher zu definieren. So ist nicht ersichtlich, wie diese 10% ermittelt werden sollen. Zusätzliche Daten zu ermitteln, um solche Statistiken zu füttern bedeutet immer Mehraufwand für die betroffenen Besatzungen. Dies ist speziell an den Tagen, an denen die Crews das erlaubte Limit im Dienst ausschöpfen nicht akzeptabel.

response Please see the answer to comment # 54

comment 1013 comment by: Stephanie Selim

(a)(b) Technical comment (commander’s discretion, unforeseen circumstances) – First comment: The word « sector » is mentioned on b): should be replaced by « flight ».

response Please see the answer to comment # 54

comment 1014 comment by: Stephanie Selim

(a)(b) Technical comment (commander’s discretion, unforeseen circumstances) – Second comment: We do not understand why, if « unforeseen circumstances occur just before take-off on the final sector, the allowed increase may only be exceeded to transport the patient ». Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the HEMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies… If pilots cannot come back to the HEMS base with the helicopter and medical staff (but without patient on board), the helicopter won’t be available for the next mission of the next pilot neither medical staff for another operation etc… The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. This is why DGAC propose the following amendment: “If unforeseen circumstances occur just before take-off for the final flight sector, the allowed increase may only be exceeded

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 376 of 585

An agency of the European Union

where immediate and rapid transportation is essential as defined in ORO.FTL.105 ‘EMS fight’ to transport the patient.”

response Please see the answer to comment # 54

comment 1016 comment by: Stephanie Selim

(a)(b) Technical comment (commander’s discretion, unforeseen circumstances) – Third comment: Moreover, we ask for a 2 hours commander’s discretion instead of 1, including for single-pilot. This 2 hours commander’s discretion is frequently used by single-pilot in HEMS operations in France in case of emergency for the patient. Moreover, regulation already requires for safety reason an additional crew member for single-pilot HEMS operations, the TCM. Therefore, single-pliot HEMS operations are not PEQ1operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander's dicretion should be 2 hours for both two-pilots ans 1 pilot + 1 TCM.

response Please see the answer to comment # 54

comment 1017 comment by: Stephanie Selim

(a)(b) Technical comment (commander’s discretion, unforeseen circumstances) – Fourth comment: DGAC wonders if the words « alternate aerodrome » in (b) are appropriate for HEMS. We suggest « operating site ».

response Please see the answer to comment # 54

comment 1018 comment by: Stephanie Selim

(c) Technical comment (commander’s discretion, unforeseen circumstances) – We wonder if that requirement makes sense for HEMS operations which are unpredictable by definition. And we wonder why it is asked for 10 % of FDP in any 3 months. HEMS in France is characterized by a small number of flight hours, and statistics may be significantly modified by a very limited number of events. Moreover, since ORO.FTL.205(f)(4) and (5) should apply (refers to the technical comment on ORO.FTL.205(f)(7)), Authorities will be informed of recurrent important FDP or rest modifications. Therefore, we ask for the deletion of that point.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 377 of 585

An agency of the European Union

comment 1169 comment by: NHV Group

Attachment #170

Paragraph No: CS FTL.3.205 Flight duty period (FDP) - HEMS Subparagraph (d) Comment: FOM should have freedom in defining number of consecutive FDP blocks taking into account pilot/TCM personal needs. Justification: Block of 4 consecutive FDPs are inducing more interruption to the HEMS crews than blocks of 7 consecutive FDPs. Also, more frequent blocks of smaller number of consecutive FDPs are increasing the accumulation of commuting time and stress induced fatigue of pilots. Pilot mission familiarisation is less frequent with higher number of consecutive FDP blocks. In particular NHV company case, limiting number of consecutive FDPs to 4 (from current 7) will have detrimental effects for the HEMS helicopter pilots, working in Northern France. - NHV’s HEMS helicopter pilots working in Northern France live in general in Southern part of France. The decrease of the duration of the shifts will lead to more travelling time from home to base station and vice versa. It will be a increase of 57% more travelling time. - This increase of travelling time, together with the distance between home and work area, has a great impact on the private life of our HEMS helicopter pilots working in Northern France. The families can spend less time together. - These pilots live in Southern France because of their human wellbeing. They feel integrated in this region, the families have their social environment over there, children are going to school/college and partners have their own career path to follow. Moving with their families to the North of France is in their opinion no option because of their wellbeing. - An increase of 57% travelling time on yearly basis (from ca. 41 travel days a year to ca. 72 days a year) Evidence #1: HEMS crew members prefer longer stable periods as provided in blocks of 7 consecutive FDPs. "Company survey among its HEMS crew members." Evidence #2: Results of the survey indicate that social and personal needs of pilots do have an effect, though indirectly, on pilots' perceptions of their flight performance. This effect is generally felt through deficits in concentration and energy that result from pilots’ needs to resolve the conflict between personal requirements and professional demands. Work schedules impact this situation by the demands they place on pilot work time and the amount of off-duty time provided. If the schedule provides adequate rest, in addition to sufficient personal time to pursue individual interests, the conflict of personal and professional demands is minimized. If not, the pilots are caught on the horns of a major dilemma. The energy involved in resolving this may easily result in a lack of concentration at work, thus increasing one's personal accident liability and the potential for a fatal outcome. [Cauthorne, C. V., Fedorowicz, R. J. "Sociological impacts of work/rest schedules on pilots, and their perceptions of performance" Hospital Aviation, https://doi.org/10.1016/S0740-8315(86)80195-4] Evidence #3: Distressing shifts are related to delayed sleep onset, workload is related to impaired sleep quality, and distressing shifts are positively related to perseverative cognition, perseverative cognition delayed sleep onset and mediated the association between distressing shifts and sleep onset latency. [Radstaak, M. et al "Work Stressors, Perseverative Cognition and Objective Sleep Quality: A Longitudinal Study among Dutch

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 378 of 585

An agency of the European Union

Helicopter Emergency Medical Service (HEMS) Pilots" Journal of Occupational Health, https://doi.org/10.1539/joh.14-0118-OA] Evidence #4: "An Investigation of Pilot Fatigue in Helicopter Emergency Medical Services" - This study found some evidence of a statistically significant positive relationship between HEMS pilot night shift respondent BFI (Brief Fatigue Inventory) scores and experience as an HEMS pilot, while controlling for consecutive HEMS pilot night shifts and age. A 1-way analysis of variance suggested that the effect of experience as an HEMS pilot on HEMS pilot night shift respondent BFI scores was statistically significant. [Nix, S. "An Investigation of Pilot Fatigue in Helicopter Emergency Medical Services" Air Medical Journal, https://doi.org/10.1016/j.amj.2013.04.001] Proposed text: (d) The operator may assign a block of up to 7 consecutive FDPs of more than 12 hours, but less than 14 hours, if the following conditions are met: (1) the rest period preceding the first FDP is at least 36 hours including 2 local nights; and (2) the rest period provided after completion of the series of consecutive FDPs is at least 60 hours including 3 local nights, or equal to the number of preceding duty days whichever is greatest.

response Please see the answer to comment # 54

comment 1171 comment by: NHV Group

Paragraph No: CS FTL.3.205 Flight duty period (FDP) - HEMS Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) Comment: Exceptional circumstances in HEMS missions might require pilot to either extend FDP or reduce rest period. Justification: Proposition is to move commander's discretion into reducing the rest period or extending FDP, depending on medical complexity of ongoing HEMS mission. Evidence #1: If on-duty rest on both day and night shifts is allowed, notable differences arose between on-duty work and rest patterns for pilots and medical team members. Shorter shifts limit on-duty rest. [Frakes, M. A., "Shift length and on-duty rest patterns in rotor-wing air medical programs" Air Medical Journal, https://doi.org/10.1016/j.amj.2004.08.027] Proposed text: (a) The maximum daily rest period may be decreased for HEMS by up to 1 hour for single-pilot operation or by up to 2 hours for two-pilot operation, or FDP may be extended for HEMS by up to 1 hour for single-pilot operation or by up to 2 hours for two- pilot operation.

response Please see the answer to comment # 54

comment 1220 comment by: SAF

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 379 of 585

An agency of the European Union

There are two CS FTL.3.205, which introduces complexity, uncertainty and may lead to misunderstanding. SAF suggests adding precisions within the titles of the paragraph in order to quickly make the link with the ORO paragraph involved. PROPOSAL Replace the title of this CS by: “CS FTL.3.205(f)”

response Please see the answer to comment # 54

comment 1221 comment by: SAF

CS FTL.3.205 UNFORESEEN CIRCONSTANCES FOR HEMS under ORO FTL 205(f) ISSUE - FORCE MAJEURE (Cf. comment #1195) HEMS are deeply linked with national health, security and safety. HEMS depends on the organization of the French healthcare system (the permanence and continuity of care services is a public service & a sovereign prerogative), with groupings of medical equipment and skills. HEMS in France is both operated by private operators and the State. State may charter private operators to operate HEMS operations on its behalf. Current French regulation thus allows, by sovereign decision of the State, to grant derogation for HEMS operations as far as national health, security or safety is involved. Such a possibility shall remain for "Force majeure" and be introduced within the IR, in respect of the sovereignty of each Member State facing major health crisis. For example, in France, private operators of helicopters were chartered to ensure airlift rotations during recent Millas train disaster on December, the 14th of 2017. Besides, Helicopter Nuclear Response Team are partially delegated to a private operator. Therefore, SAF suggests adding a specific paragraph in this implementing rule allowing HEMS pilots to derogate from these requirements in case of Force Majeure as it is already the case in the Current French National Regulation. PROPOSAL For illustrative purposes, in France the following article is applied in case of « Force Majeure » :

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 380 of 585

An agency of the European Union

“Il peut être dérogé aux limitations mentionnées à la présente section dans les conditions suivantes : 1. Vols urgents, dont l'exécution immédiate est nécessaire : a) Pour prévenir des accidents imminents et organiser des mesures de sauvetage, ou pour réparer des accidents survenus soit au matériel, soit aux installations ; b) Pour assurer le dépannage des aéronefs. 2. Pour assurer l'achèvement d'une période de vol que des circonstances exceptionnelles n'auraient pas permis d'effectuer dans les limites préétablies. 3. Vols exécutés dans l'intérêt de la sûreté ou de la défense nationale ou d'un service public sur ordre du Gouvernement constatant la nécessité de la dérogation ; la limite est à fixer par le ministre chargé de l'aviation civile.“ (ref CAC D 422-12)

response Please see the answer to comment # 54

comment 1222 comment by: SAF

Attachments #171 #172

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 381 of 585

An agency of the European Union

For safety reasons, regulation already requires an additional crew member for HEMS, the TCM. Therefore, single-pilot HEMS operations are not PEQ1 operations but 1 single-pilot + 1 TCM contributing to the safety of the flight. As a consequence, commander’s discretion should be of 2h for both two-pilots and 1 pilot + 1 TCM, as preexisting in France. Thus, SAF suggests a 2 hours commander’s discretion for both 1 pilot +TCM and two-pilots operations. PROPOSAL Replace the content of the paragraph (a) by the following: “(a) The maximum basic daily FDP may be increased for HEMS by up to 2 hours.”

response Please see the answer to comment # 54

comment 1223 comment by: SAF

(b) ISSUE The paragraph (b) refers to ‘sector’. However, the notion of 'sector' is not anymore defined for helicopters (Cf. ORO.FTL.105 (§24)). Therefore, SAF suggests replacing the term of sector by the notion of flight time. (Cf. comment #1184) Besides, the wording ‘alternate aerodrome’ is used in the paragraph (b) but is not consistent with the activity of HEMS. Therefore, SAF suggests replacing this notion of alternate aerodrome by the notion of helipad or drop zone which better suits the activity of the HEMS. PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport *the patient*.” (Cf. comment hereafter)

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 382 of 585

An agency of the European Union

comment 1224 comment by: SAF

(b) ISSUE In the paragraph (b), the extension of the last flight time before take-off is limited to the case of the transportation of a patient. This is not consistent with the definition of HEMS, which encompasses the following HEMS payload (medical personnel, medical supplies such as equipment, blood, organs or drugs, ill or injured persons and other persons directly involved). Life threatening emergency of a flight is not only conditioned by a patient onboard. It can deal with all the HEMS payload defined in ORO.FTL.105 (§29): medical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved. Indeed, it may be urgent for the medical staff to come back to the hospital, to ensure the medical material is available for another operation, etc. The extension of the last flight shall include all the content defined for HEMS payload, for the present or next HEMS operations requiring a quick return to the base without uselessly immobilizing critical material and staff, including the helicopter. That is why SAF suggests replacing the term patient used in the paragraph (b) by the HEMS payload defined in this NPA in the ORO.FTL.105 (§29). PROPOSAL Replace the paragraph (b) by the following: “(b) If on the final flight time within the FDP the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or any other helipad or drop zone. If unforeseen circumstances occur just before take-off on the final flight time, the allowed increase may only be exceeded to transport themedical personnel, medical supplies such as equipment including the helicopter, blood, organs or drugs, ill or injured persons and other persons directly involved.”

response Please see the answer to comment # 54

comment 1225 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 383 of 585

An agency of the European Union

The paragraph (c) is redundant with the ORO.FTL.110 (k). Both says exactly the same thing. Therefore, in order to make the reading easier, SAF suggests not repeating the same ideas in different paragraphs of this NPA. PROPOSAL Suppress the paragraph (c) of this CS.

response Please see the answer to comment # 54

comment 1392 comment by: Swiss Air-Ambulance Rega

CS.FTL.3.205 (FDP) Extension of the max. FDP by 2 hours (two-pilot crew), 1 hour (1 PiC) only for the completion of the last flight or for the flight with a patient. Moreover, the use of commander’s discretion is limited to 10% of the entire FDP from the past 3 months. This passage cannot be compared to the previous one; it only applies to the completion of a flight or for taking the patient to hospital. The same CS name as for the max. FDP is confusing. A limitation within 3 months is unrealistic, because the limit can be reached in just one mission. Furthermore, it could only occur in the summer and would then lead to duty plan changes just for this season. The evaluation of the 10% regulation would require the crews to perform extra work, which would have to be carried out precisely in times when the strain on the crews is at its highest level, that is, on long summer days. CS.FTL.3.205(b) (FDP) The text contains the word sector, which is not defined for HEMS. This probably means that crew will be tempted to turn down missions in the last hour of duty, because for a mission taking more more than one hour, crews will be condemned to remain on ground at the hospital. This could mean: Missions are turned down early; The mission might end in the field if no patient is to be transported; In case a patient has to be transported the hospital’s landing site is blocked for at least another10 hours (affecting the capacity of the hospital and therefore affecting the health care of thirdpatients); Following multiple other effects because the helicopter cannot be protected against adverseweather conditions on most of the hospital landing sites; Crew would need to seek accommodation locally. i.e. all ends up at the wrong place and likely the crew is to become more fatigued then when returning to base CS.FTL.3.205(c) (FDP) This 10% are probably meant for a base and not FDP, as the FDP would count for an individual person. The total flight duty period for three months for a base equals up to 1267h therefore 10% are 126,7h. As there is 1 additional hour only at commanders discretion allowed, this rule cannot apply in a single pilot operation within a 90-days period. If something else is intended consider revising the text.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 384 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1396 comment by: European Helicopter Association (EHA)

Deutscher Hubschrauber Verband / DHV (Germany) Comment: The German FTL allows HEMS operator to apply for specific FTL schedules allowing FDP in single pilot operation of up to 15:30 hours on max. four consecutive days, according to NPA, this will not longer be possible. Action requested: Please review and adjust accordingly.

response Please see the answer to comment # 54

comment 1457 comment by: Association of Air Ambulances

This does not read logically. It should be amended to read: “(c) If the total of Commander’s discretion used at any HEMS operating base is more than 10 % of the total FDP for a 3-month period, the future schedule of crew resource utilisation of that HEMS operating base is to be reviewed and amended.” CS FTL.3.205(b) permits the allowed increase to the FDP to be extended if the unforeseen circumstance (HEMS call) occurs just before take-off on the final sector, but only to transport the patient. If a medical decision is made not to transport the patient by air, this could result in a helicopter being stranded until a rested crew can arrive at the HEMS site to relieve the duty crew. This should be amended to allow either the transport of the patient or an non-HEMS flight to the overnight base. This contradicts ORO.FTL.105 (29) A sector flown to position an aircraft to the operating base before or after an EMS flight is considered part of that flight.

response Please see the answer to comment # 54

comment 1470

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

Add a new condition: After delivering the patient the crew should also be allowed to return to the HEMS base. Otherwise, the helicopter would risk blocking the helipad at the hospital.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 385 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1489 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Proposal: Add new paragraph CS FTL.3.208 after [second] CS FTL.3.205 as follows: CS FTL.3.208 Active duty period (ADP) in active standby — HEMS Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f) By way of derogation from CS FTL.3.205, the conditions to modify the limits on FT and ADP by the commander in the case of unforeseen circumstances in HEMS flight operations which occur during the active standby, comply with the following: (a) The maximum basic daily FT or ADP may be increased for HEMS by up to 1 hour for single-pilot operation or by up to 2 hours for two-pilot operation. (b) If on the final sector within the HEMS task the allowed increase under (a) is further exceeded because of unforeseen circumstances after take-off, the flight may continue to the planned destination or alternate aerodrome. If unforeseen circumstances occur just before take-off on the final sector, the allowed increase may only be exceeded to transport the patient. (c) If commander discretion is used in any HEMS operating base more than 10 % of the total ADP over a 3-month period, the schedule and crew resources of the HEMS operating base are reviewed and adapted.

response Please see the answer to comment # 54

CS FTL.3.210 p. 37

comment 7 comment by: TG

Jede Veränderung, die für die Piloten erhöhte Reise-Belastung zur Folge hat ist zu vermeiden. Die langen Schichtfolgen ergeben überhaupt erst genug Erholung und verkürzen die Zeit auf der Straße für den großen Teil der HEMS-Piloten erheblich.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 386 of 585

An agency of the European Union

comment 61 comment by: London's Air Ambulance

First paragraph should be amended to read: “...ORO.FTL.210(b) is not to exceed the following limits:”

response Please see the answer to comment # 54

comment 121 comment by: UK CAA

Page No: 37 Paragraph No: CS FTL.3.210 Flight times and duty periods - HEMS Comment: As per UK CAA comment for page 13, the insertion of “either of the following limits” implies an either / or meaning so that only one of the limits need to be applied. This would be an incorrect application and generates potential confusion. Justification: The correct application of this requirement. Proposed Text: Delete “either of” in all of the alphabetical bullet points, leaving the text at “shall not exceed the following limits” or change “either” to “any”.

response Please see the answer to comment # 54

comment 185 comment by: ANSMUH

CS FTL.3.210 Flight times and duty periods Duty periods in HEMS operations under ORO.FTL.210(b) The total duty periods to which an individual crew member in HEMS operations may be assigned under ORO.FTL.210(b) does not exceed either of the following limits: (1) 110 duty hours in any 14 consecutive days, on the condition that: i. the maximum daily FDP specified in CS FTL.3.205(a) or (b). If the maximum daily flight (FT) minus 2 hours on that day, the maximum FDP is reduced to maximum 12 hours. ii. the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep; iii. for each FDP of more than 12 hours, the total break time constitutes 50 % of the time above 12 hours; iv. the time for breaks excludes the necessary time for post- and pre-flight duties; Refers to my comments regarding CS FTL 3.205

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 387 of 585

An agency of the European Union

comment 255 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): a. 110 duty hours in 14 consecutive days b. 190 duty hours in 28 consecutive days Question: 1.i refers to max FDP of 14 hours. What would be the limit if this 14 hour limit was extended e.g. with commanders discretion or with split duty? 1.vi refers to ORO.FTL.235(d) which is not part of the NPA documentation. It would be really helpful for interested parties to have a complete set of documents instead of a cloze with empty spaces to be filled from different other documents. This paragraph introduces a setback compared to the current regulation where a maximum annual duty time in combination with 210 duty hours in consecutive 30 days was the limit. To avoid additional personnel and the ability of managing short notice illness of crews, the 14 days limit needs to be minimum 120 hours. Remark: It is not obvious how these limits are developed and what kind of data it is based on. Especially the 14 day/110 hour limit is too limiting and restricts the ability of crew planners to react to illness of crews on short notice.

response Please see the answer to comment # 54

comment 287 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.210 (1) TEXT: "110 duty hours in any consecutive days" Problem: It is not possible to set up normal schedules(i.e. 4 days on, 4 days off) with 1400 hours FDP, because this will give you 112 hours in 14 days Solution: Increase the duty hours to 120 duty hours in any 14 consecutive days

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 388 of 585

An agency of the European Union

comment 289 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.210 (1) & (2) TEXT: " (1) 110 duty hours; 14 hours FDP - rest period = 4 local nights" TEXT: " (2) 190 duty hours; 14 hours FDP - rest period = 3 local nights" Problem: We do not see the reason for different rest periods; even in schedules based on 190 hours duty, it may be necessary, to give two duty periods of 4 days with 14 hours FDP shortly one after the other Solution: Set the rest period to 3 local nights

response Please see the answer to comment # 54

comment 316 comment by: European Helicopter Association (EHA)

NORSK LUFTAMBULANSE AS (Norway): Comment: (the same comment is placed on page 36 for CS FTL 3.205) NLA presently operates in a system that have one crew on duty for 24/7 for one complete week in a 7 ON/14 OFF/7 ON/21 off for flight crew members and 7 ON / 21 OFF for HEMS technical crew members. As our FRM and sicentific studies has shown, this is apparently conducted in a safe manner and we intend to seek an IFTSS. Having said that, having two crews manning one helicopter for a 24 hour period is quite common pracice in Europe and as we see it, this will no longer be practicable. For HEMS operating base conducting 24/7 operations: When operating in compliance with CS FTL.3.205 Flight duty period (FDP) — HEMS and CS FTL.3.210 Flight times and duty periods — HEMS, there is not enough overlap to ensure continuity of the service if only two crews (a “day” and “night” crew) are used to cover a 24-hour period. With two crews, the maximum of 14 hours and 12 hours FDP limits respectively gives only a maximum of 1 hour overlap in each end. This does not give enough time to dispatch on, and complete a, HEMS mission. Note that this is even if not one single HEMS mission has taken place during the FDP prior to the alarm. Should an alarm come in shortly (for example 1:30 to 1 hour) before overlap, the mission will have to be postponed until the new crew has commenced their FDP. Alternatively,

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 389 of 585

An agency of the European Union

three crews must be used for every 24-hour period to keep one HEMS operating base operational 24/7. 1:30 to 1 hour before the overlap is just an example. The period necessary to complete a mission is quite contextual and sufficient time is up for discussion, but the question needs to be addressed. Furthermore, as mentioned in the comment to CS FTL.3.205 Flight duty period (FDP) — HEMS, NPA p 35 above, prescribing breaks is not a practicable solution and the concept of breaks is very unclear, especially regarding how this should be planned. An easier approach would be a concept comprising a maximum Duty Period with a maximum Flight Duty Period comprising “Passive time” and “Active time”. This could look like the following example: “Passive time” is all the time spent on a HEMS duty period that is not considered to be active time, relaxing, free of all duties except standing by to receive an alarm. “Active time” is all the time spent pre- and post-flight activities, operation of the helicopter, HEMS missions, rapid response vehicle missions, training, checking, administrative work, meetings, attending a course, simulator, travel etc. While passive time is the time the crew members are relaxing, the fatigue level is a direct consequence of the circadian rhythm and therefore it is of outmost importance, as far as practicable, to maintain a normal sleep pattern. Passive time is calculated as 50% towards the total Flight Duty Time. Active time is calculated as 100% towards the total Flight Duty Time. If reaching any Flight time or Active time limit, the crew member shall go off Active duty. HEMS:

• Duties such as pre-flight inspection, fuel checks, equipment check, etc. shall be logged as active time;

Rapid response vehicle operation:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 390 of 585

An agency of the European Union

For HEMS and rapid response vehicle operation:

• If there are less than two hours between on-block and the time of a new alarm, the entire time between on-block and the time of a new alarm counts as Active time.

Other operations (pre-flight, ferry flight, test flight, training flight, etc.):

• Active time is triggered when reporting for duty or commencing preparations and ends minimum 30 minutes after block-on time;

• If the time for post flight duties takes more than 30 minutes, actual time shall be logged as Active time.

response Please see the answer to comment # 54

comment 343 comment by: European Helicopter Association (EHA)

FNAM (France) #1 ISSUE In general, and in this paragraph, it is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 391 of 585

An agency of the European Union

In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #39, #40) Therefore, the FNAM suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments #2 (1)(i) ISSUE The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, the FNAM suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. Cf. consolidated proposal of writing at the end of below additional comments #3 (1)(ii) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. For Single-pilot + TCM operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 1 and 2 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 392 of 585

An agency of the European Union

a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no- flown hours There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. For Two-pilots operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no- flown hours. There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principle of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, the FNAM suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #28.4.1 and #28.4.2) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #28.4.1 and #28.4.2) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, the FNAM suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 393 of 585

An agency of the European Union

Cf. consolidated proposal of writing at the end of below additional comments #4 (1)(iii) and (iv) ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, the FNAM suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS. #5 (1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, the FNAM suggests withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS. #6 (1)(vi) ISSUE The FNAM wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. The FNAM underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience: • 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 394 of 585

An agency of the European Union

HEMS organization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule: • More than 12h FDP for each and every vacation • Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes i.e 50 minutes back and force for 1 mission in Francei). Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes i.e 50 minutes back and force for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. The FNAM suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a sound RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #36.1 et #36.2) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #1, #2, #3, #4, #5 and #6 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed either of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; and (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 395 of 585

An agency of the European Union

OPTION 2: (1) 110 duty hours in any 14 consecutive days, on the condition that: ii. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 369 comment by: European Helicopter Association (EHA)

BHA (UK) "CS FTL 3.210 Flight times and duty periods — HEMS (1) (ii)" Comment: Whatever the length of the individual FDP?

response Please see the answer to comment # 54

comment 388

comment by: Joachim J. Janezic (Institute for Austrian and International Aviation

law)

To CS FTL.3.210(1)(ii) and (iii): These two requirements are in fact redundant.

response Please see the answer to comment # 54

comment 400 comment by: European Helicopter Association (EHA)

OEATMC (Austria): CS FTL.3.210 Flight times and duty periods — HEMS Duty periods in HEMS operations under ORO.FTL.210(b) The total duty periods to which an individual crew member in HEMS operations may be assigned under ORO.FTL.210(b) does not exceed either of the following limits: (1) 110 duty hours in any 14 consecutive days, on the condition that: i. the maximum daily FDP specified in CS FTL.3.205(a) or (b) does not exceed 14 hours; and (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 396 of 585

An agency of the European Union

period. COMMENT(S) Apparently this is calculated ONLY for a 5-days ON/ 5-days OFF roster with 12 hour FDPs. If an organization needs a 4-days ON/4-days OFF roster with up to 14 hour FDPs it is not manageable with 110 hours in 14 days! It would require at least 115 hours in 14 days being the multiple of 4 times 14 and additional 3h of reserve. Following this line of thoughts, 190 hours in paragraph (2) is also not the multiple 14 times 14 and should be raised to 200 hours. An evaluation of third party damages of over 36.000 missions (108.000 flights) in the period of 2016 and 2017 concluded two peaks, one on Thursday which represents the starting day in our duty roster and one Saturday. Interestingly enough shows Wednesday (the last day of the 7 days roster) the lowest risk for damages. This correlates with a study made by employer’s mutual insurance associations in Germany and Switzerland (SUVA and BGW) which prove a high peak on the first day of duty. This NPA’s duty roster would almost double this count!

response Please see the answer to comment # 54

comment 427 comment by: UFH French Helicopters Association

#1 ISSUE In general, and in this paragraph, it is not explicit whether: • All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing rule • Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #39, #40) Therefore, we suggest listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 397 of 585

An agency of the European Union

in the CS. Cf. consolidated proposal of writing at the end of below additional comments #2 (1)(i) ISSUE The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these Tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. (1)(ii) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. For Single-pilot + TCM operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no- flown hours There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. For Two-pilots operations

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 398 of 585

An agency of the European Union

As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS): • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours • Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no- flown hours There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, we suggest writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #28.4.1 and #28.4.2) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #28.4.1 and #28.4.2) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. #4 (1)(iii) and (iv) ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 399 of 585

An agency of the European Union

why, FNAM suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS. #5 (1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, we suggest withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS. #6 (1)(vi) ISSUE French stakeholders wonder why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. We underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience: • 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule: • More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 400 of 585

An agency of the European Union

in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for French operators i.e 50 minutes back and forth for 1 mission in Francei). Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. We suggest keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #36.1 et #36.2) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #1, #2, #3, #4, #5 and #6 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days; (2) 110 duty hours in any 14 consecutive days; and (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR OPTION 2: (1) 110 duty hours in any 14 consecutive days, on the condition that: ii. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 401 of 585

An agency of the European Union

(2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 496 comment by: FNAM/SNEH

ISSUE In general, and in this paragraph, it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #473, #477, #478, #510, #511) Therefore, FNAM and SNEH suggest listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 497 comment by: FNAM/SNEH

(1)(i) ISSUE The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these Tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM and SNEH suggest withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 402 of 585

An agency of the European Union

Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 498 comment by: FNAM/SNEH

Attachments #173 #174 #175 #176

(Cf. attachments S1, S2, S3 and S4 illustrating break issue) (1)(ii) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. For Single-pilot + TCM operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base. For Two-pilots operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 403 of 585

An agency of the European Union

There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, FNAM and SNEH suggest writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #484 and #485) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #484 and #485) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM and SNEH suggest withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 499 comment by: FNAM/SNEH

(1)(iii) and (iv) ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM and SNEH suggest withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS.

response Please see the answer to comment # 54

comment 500 comment by: FNAM/SNEH

(1)(v) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 404 of 585

An agency of the European Union

The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, FNAM and SNEH suggest withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS.

response Please see the answer to comment # 54

comment 501 comment by: FNAM/SNEH

Attachments #177 #178 #179 #180

(1)(vi) ISSUE FNAM and SNEH wonder why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. FNAM and SNEH underline the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #486), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 405 of 585

An agency of the European Union

a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei).

Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. FNAM and SNEH suggest keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #507 et #508) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #496, #497, #498, #499, #500 and #501 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 406 of 585

An agency of the European Union

1. 110 duty hours in any 14 consecutive days, on the condition that: 1. the minimum recurrent extended recovery rest period required under

ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.

2. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 534 comment by: ADAC Luftrettung gGmbH

(1) 110 duty hours in 14 consecutive days (2) 190 duty hours in 28 consecutive days Question: 1.i refers to max FDP of 14 hours. What would be the limit if this 14 hour limit was extended e.g. with commanders discretion or with split duty? 1.vi refers to ORO.FTL.235(d) which is not part of the NPA documentation. It would be really helpful for interested parties to have a complete set of documents instead of a cloze with empty spaces to be filled from different other documents. This paragraph introduces a setback compared to the current regulation where a maximum annual duty time in combination with 210 duty hours in consecutive 30 days was the limit. To avoid additional personnel and the ability of managing short notice illness of crews, the 14 days limit needs to be minimum 120 hours. Remark: It is not obvious how these limits are developed and what kind of data it is based on. Especially the 14 day/110 hour limit is too limiting and restricts the ability of crew planners to react to illness of crews on short notice.

response Please see the answer to comment # 54

comment 555 comment by: Rüdiger Neu

a. Limit 110 Stunden Arbeitszeit innerhalb 14 aufeinanderfolgenden Tagen b. Limit 190 Stunden Arbeitszeit innerhalb 28 aufeinanderfolgenden Tagen Fragestellung: Bei 1.i. bezieht man sich auf eine maximale FDP von 14 Stunden. Würde mit dem Kommandantenentscheid oder Split duty die 14 Stunden Marke überschritten, was wäre dann das Limit? Bei 1.vi. bezieht man sich auf ORO.FTL.235 (d), dieser ist in den NPA Unterlagen nicht zu finden. Man sollte einen Entwurf mit allen notwendigen Bezugsquellen veröffentlichen und nicht mit einem Lückentext, bei dem man im Gesetzes Wust sich seine Quellen suchen muss.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 407 of 585

An agency of the European Union

Eine deutliche Verschlechterung der bisherigen Regelung in der die Jahresarbeitszeit geregelt war und eine maximale Flugdienstzeit von 210 Stunden innerhalb von 30 Tagen. Um einen vernünftigen Dienstplan zu gewährleisten muss das 14-Tage-Limit 120h betragen, damit ein Ausfallmanagement gewährleistet werden kann. Anmerkung: auch hier stellt sich die Frage, aufgrund welcher Datengrundlage diese Stunden festgelegt wurden. Insbesondere die 110h innerhalb von 14 Tagen sind zu knapp bemessen. Um kurzfristige Ausfälle (z.B. Krankheit) auffangen zu können, ist dieser Stundensatz auf 120h zu erhöhen.

response Please see the answer to comment # 54

comment 676 comment by: Oya Vendée Hélicoptères

ISSUE In general, and in this paragraph, it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #653, #657, #658, #689, #690) Therefore, OYA suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 677 comment by: Oya Vendée Hélicoptères

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 408 of 585

An agency of the European Union

specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, OYA suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 678 comment by: Oya Vendée Hélicoptères

Attachments #181 #182 #183 #184

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 409 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, OYA suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #664 and #665) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #664 and #665) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, OYA suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 679 comment by: Oya Vendée Hélicoptères

(1)(iii) and (iv) ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, OYA suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 410 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 680 comment by: Oya Vendée Hélicoptères

(1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, OYA suggests withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS.

response Please see the answer to comment # 54

comment 681 comment by: Oya Vendée Hélicoptères

Attachments #185 #186 #187 #188

(1)(vi) ISSUE OYA wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. OYA underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #666), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 411 of 585

An agency of the European Union

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for OYA i.e 50 minutes back and forth for 1 mission in Francei).

Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for OYA i.e 50 minutes back and forth for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. OYA suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #686 et #687) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #676, #677, #678, #679, #680 and #681 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 412 of 585

An agency of the European Union

1. 110 duty hours in any 14 consecutive days, on the condition that: 1. the minimum recurrent extended recovery rest period required under

ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.

2. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 722 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.210 (1) and (2) Apparently this is calculated for a 5/4 roster (5 days duty / 4 days off). If an organization needs a 4/4 days roster it is not manageable with 110h. It requires at least 115 hours being the multiple of 4 times 14 and additional 3h of reserve. Following this line of thoughts, 190h in paragraph (2) are also not the multiple 14 times 14.

response Please see the answer to comment # 54

comment 724 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.210 (1) and (2) [...] 110 duty hours in any 14 consecutive days [...] This might work for an airline but is not suitable for a HEMS operation. Rosters 4/4 (4 on / 4 off) are not possible due to traveling/positioning but 4/5 rosters (4 on / 5 off) leave the question about who is doing the 5th days duty. Applying this to a real duty roster in a HEMS operation it would increase the need for pilots and TCMs by 40%. This human resource is not available on the market and even young pilots cannot be brought to the required experience. At the same time the proficiency level of the flight crews drop by the same percentage.

response Please see the answer to comment # 54

comment 748 comment by: DRF-Luftrettung

Question: 1.i refers to max FDP of 14 hours. What would be the limit if this 14 hour limit was extended e.g. with commanders discretion or with split duty?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 413 of 585

An agency of the European Union

1.vi refers to ORO.FTL.235(d) which is not part of the NPA documentation. It would be really helpful for interested parties to have a complete set of documents instead of a cloze with empty spaces to be filled from different other documents. This paragraph introduces a setback compared to the current regulation where a maximum annual duty time in combination with 210 duty hours in consecutive 30 days was the limit. To avoid additional personnel and the ability of managing short notice illness of crews, the 14 days limit needs to be minimum 120 hours. Remark: It is not obvious how these limits are developed and what kind of data it is based on. Especially the 14 day/110 hour limit is too limiting and restricts the ability of crew planners to react to illness of crews on short notice.

response Please see the answer to comment # 54

comment 757 comment by: DRF-Luftrettung

TEXT: "110 duty hours in any consecutive days" Problem: It is not possible to set up normal schedules(i.e. 4 days on, 4 days off) with 1400 hours FDP, because this will give you 112 hours in 14 days Solution: Increase the duty hours to 120 duty hours in any 14 consecutive days

response Please see the answer to comment # 54

comment 758 comment by: DRF-Luftrettung

TEXT: " (1) 110 duty hours; 14 hours FDP - rest period = 4 local nights" TEXT: " (2) 190 duty hours; 14 hours FDP - rest period = 3 local nights" Problem: We do not see the reason for different rest periods; even in schedules based on 190 hours duty, it may be necessary, to give two duty periods of 4 days with 14 hours FDP shortly one after the other Solution: Set the rest period to 3 local nights

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 414 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 822 comment by: Babcock Mission Critical Services Limited

The reduction to 190 hours in 28 days restricts only a 4/4 roster. All other variations are permitted (1/1,2/2,3/3,5/5) 4/4 is an existing safe working model consisting of a block of 4 days on 4 days off, maintaining below 60 hours in 7 days. But with the problem of achieving 190 hours in 28 days. We request that the 190 hour limit is increased to 200 hours (as per current UK policy) to accommodate the existing safe 4/4 working model.

response Please see the answer to comment # 54

comment 958 comment by: MBH SAMU

ISSUE In general, and in this paragraph, it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #926, #932, #933, #975, #977) Therefore, MBH suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 415 of 585

An agency of the European Union

comment 959 comment by: MBH SAMU

(1)(i) ISSUE The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these Tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, MBH suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 960 comment by: MBH SAMU

Attachments #189 #190 #191 #192

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

There is always a room for such a break lasting between 2h and 1h in a suitable accommodation at HEMS operating base.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 416 of 585

An agency of the European Union

For Two-pilots operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a 1h hour break is warranted. Indeed, given the following aspects (Table 1 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, MBH suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #940 and #941) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #940 and #941) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, MBH suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 962 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 417 of 585

An agency of the European Union

dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, MBH suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS.

response Please see the answer to comment # 54

comment 964 comment by: MBH SAMU

(1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, MBH suggests withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS.

response Please see the answer to comment # 54

comment 965 comment by: MBH SAMU

Attachments #193 #194 #195 #196

(1)(vi) ISSUE MBH wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. MBH underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 418 of 585

An agency of the European Union

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #944), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for MBH i.e 50 minutes back and forth for 1 mission in Francei).

Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for MBH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. MBH suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #971 et #973) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #958, #959, #960, #962, #964, and #965 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 419 of 585

An agency of the European Union

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2:

1. 110 duty hours in any 14 consecutive days, on the condition that: 1. the minimum recurrent extended recovery rest period required under

ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.

2. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 994 comment by: AESA

Is it mandatory accomplishing with both, (1) and (2)? According the text, it seems that only is mandatory to accomplish with one of them. About point (1), what happen if not all the conditions from i to vi are accomplished? In that case could the pilot flight more than 110 hours in 14 consecutive days? Additionally, some of the conditions i to vi are included in the rules. For example, condition “i. the maximum daily FDP specified in CS FTL.3.205(a) or (b) does not exceed 14 hours”. The tables specified in CS FTL.3.205(a) or (b) doesn’t allow more than 14 hours in any case. About point (2), would be acceptable, for example, 120 duty hours in first 14 days and 70 hours in second 14 days if it is not practicable more spreading throughout the 28 days?

response Please see the answer to comment # 54

comment 1002 comment by: B. Wagner

Uneindeutig formuliert: müssen beide Unterpunkte (1) und (2) gleichzeitig erfüllt sein oder nur einer von beiden ("either ... or") zu (1):

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 420 of 585

An agency of the European Union

i. was passiert bei Überschreitung der 14h durch Commanders descretion oder split duty? Eine solche Überschreitung ist gemäß der entsprechenden Artikel im vorliegenden Entwurf möglich, die Folgen sind jedoch nicht definiert. ii. die vorgeplante Pause ist im Luftrettungsdienst nicht möglich, da weder Einsätze noch daraus resultierende Pausen im Vorhinein bekannt und planbar sind.

response Please see the answer to comment # 54

comment 1226 comment by: SAF

ISSUE In general, and in this paragraph, it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block" • The CS requirements should apply depending on what is said in the implementing

rule • Cherry-picking is allowed

Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #1199, #1205, #1208, #1239, #1240) Therefore, SAF suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 1227 comment by: SAF

(1)(i) ISSUE

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 421 of 585

An agency of the European Union

The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these Tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, SAF suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

response Please see the answer to comment # 54

comment 1228 comment by: SAF

Attachments #197 #198 #199 #200

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time without autopilot = 5 hours which means at least 7 to 9 no-flown hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 422 of 585

An agency of the European Union

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no-flown hours

There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, SAF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #1214 and #1215) PROPOSAL Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #1214 and #1215) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, SAF suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. Cf. consolidated proposal of writing at the end of below additional comments

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 423 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1229 comment by: SAF

(1)(iii) and (iv) ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, SAF suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS.

response Please see the answer to comment # 54

comment 1230 comment by: SAF

(1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, SAF suggests withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS.

response Please see the answer to comment # 54

comment 1231 comment by: SAF

Attachments #201 #202 #203 #204

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 424 of 585

An agency of the European Union

(1)(vi) ISSUE SAF wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. SAF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #1216), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SAF i.e 50 minutes back and forth for 1 mission in Francei).

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 425 of 585

An agency of the European Union

Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. SAF suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #1236 et #1237) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #1226, #1227, #1228, #1229, #1230 and #1231 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1:

1. 60 duty hours in any 7 consecutive days;  

2. 110 duty hours in any 14 consecutive days; and   3. 190 duty hours in any 28 consecutive days, spread as evenly as practicable

throughout that period.

OR OPTION 2:

1. 110 duty hours in any 14 consecutive days, on the condition that: 1. the minimum recurrent extended recovery rest period required under

ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.

2. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 426 of 585

An agency of the European Union

comment 1278 comment by: Hélicoptères de France

#1 ISSUE In general, and in this paragraph, it is not explicit whether:

• All the CS.FTL.3 requirements shall be applicable "in block"

• The CS requirements should apply depending on what is said in the implementing rule

• Cherry-picking is allowed Indeed, two options seem to be presented, one described in ORO.FTL.210 (a) and another in CS.3.210. In that way, the CS is a substitution of the IR, which is not the aim and the statute of a CS. The complexity of this proposal may lead to misunderstanding and thus wrong application of the regulation. (Cf. comments #18.1, #24, #25, #39, #40) Therefore, HDF suggests listing the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. PROPOSAL List the two options in the CS.FTL.3.210 instead of having one described in the IR and one in the CS. Cf. consolidated proposal of writing at the end of below additional comments #2 (1)(i) ISSUE The paragraph (1)(i) of this CS says that the maximum daily FDP does not exceed 14 hours. It is redundant with the provisions of the CS FTL.3.205 (a) Table 1 and (b) Table 2. Indeed, in these Tables, the maximum FDP is 14 hours. Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, the reference to the specific CS FTL.3.205(a) and (b) is not consistent, it is not useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, HDF suggests withdrawing the paragraph (1)(i) of this CS. PROPOSAL Withdraw the paragraph (1)(i) of this CS. Cf. consolidated proposal of writing at the end of below additional comments #3 (Cf. attachments S1, S2, S3 and S4 illustrating break issue) (1)(ii) ISSUE Flight times in HEMS are unpredictable inside a given FDP, by definition of HEMS. Since flight times are unpredictable and cannot be scheduled within a FDP, the same has to be applied for breaks. Besides

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 427 of 585

An agency of the European Union

the wording “break” should be rethought to make it easy to understand that this period is a time allowed for physiological needs, which is different from a rest period free of all duties, of at least 1 hour. For Single-pilot + TCM operations As a mitigation, it is obvious that due to the very low average reported flight time in HEMS, the opportunity for a break lasting between 2h and 1h is warranted. Indeed, given the following aspects (Table 2 of this CS):

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 10 hours for break with a maximum Total Flight Time with autopilot = 7 hours which means at least 5 to 7 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time with autopilot = 9 hours which means at least 3 to 5 no-flown hours

• Maximum FDP = Ranged between 14 hours and 12 hours and threshold at 12 hours for break with a maximum Total Flight Time without autopilot = 7 hours which means at least 5 to 7 no- flown hours There is always a room for such a 1h break in a suitable accommodation at HEMS operating base. Such a break may be monitored ex-post by the operator SMS, under the principles of the fatigue risk management. Therefore, under the above risk analysis and under a monitoring following the principles of a fatigue risk management, HDF suggests writing clearly in the regulation that in HEMS, breaks do not have to be scheduled before the operation. (Cf. comments #28.4.1 and #28.4.2) PROPOSAL

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 428 of 585

An agency of the European Union

Replace this paragraph of the NPA by the following: “(ii) The operator ensures ex-post at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep. This break can be monitored ex-post by the operator SMS, under the principle of the fatigue risk management.” But in fact CS.FTL.3.210(1)(ii) is strictly the same as CS.FTL.3.205(a)(2) and CS.FTL.3(b)(2). Those provisions already apply in all cases. (Cf. comment #28.4.1 and #28.4.2) Therefore, it is not consistent nor useful to repeat them in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, HDF suggests withdrawing the paragraph (1)(ii) of this CS. Withdraw the paragraph (1)(ii) of this CS. Cf. consolidated proposal of writing at the end of below additional comments #4 (1)(iii) and (iv) The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, HDF suggests withdrawing the paragraph (1)(v) of this CS. PROPOSAL Withdraw the paragraph (1)(v) of this CS. #6 (1)(vi) ISSUE HDF wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. HDF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours

• 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 429 of 585

An agency of the European Union

OFF. (Cf. attachments S1, S2, S3 and S4 illustrating the 12h operational readiness issue) According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift

• Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in ISSUE (1)(iii) and (iv) The paragraph (1)(iii) and (iv) of this CS is redundant with the provisions of the CS FTL.3.205 (a)(2) and (b)(3). It is therefore not consistent nor useful to repeat these dispositions in those paragraphs since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, HDF suggests withdrawing the paragraph (1)(iii) and (iv) of this CS. PROPOSAL Withdraw the paragraph (1)(iii) and (iv) of this CS. #5 (1)(v) ISSUE The paragraph (1)(v) of this CS says the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks. It is redundant with the provisions of the CS FTL.3.205 (a)(1) and (b)(2). Besides, the HEMS operators do not have any option to apply FDP requirements described in the CS. Therefore, it is not consistent nor useful to repeat it in this paragraph since it will be applied anyway. The actual writing may lead to misunderstanding. That is why, HDF suggests withdrawing the paragraph HDF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours

• 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 430 of 585

An agency of the European Union

According to the Agency requirement on the pre-flight and post-flight minimum times (Cf. #28.5), an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift

• Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, such a reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. HDF suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #36.1 et #36.2) PROPOSAL Replace the paragraph (1)(vi) by the following: “(1)(vi) the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM.” CONSOLIDATED PROPOSAL of #1, #2, #3, #4, #5 and #6 Replace the whole CS by the following: CS FTL.3.210: “The total duty periods to which an individual crew member may be assigned in HEMS operation shall not exceed any of the following limits: OPTION 1: (1) 60 duty hours in any 7 consecutive days;

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 431 of 585

An agency of the European Union

(2) 110 duty hours in any 14 consecutive days; and NPA 2017-17 | HEMS Comments | FNAM & SNEH 41/57 (3) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. OR OPTION 2: (1) 110 duty hours in any 14 consecutive days, on the condition that: ii. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights or 3 local nights under the principles of a FRM. (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.”

response Please see the answer to comment # 54

comment 1307 comment by: Elilombarda

CS FTL.3.210 Flight times and duty periods — HEMS See comment to CS FTL.3.205 Flight duty period (FDP) — HEMS for rationale. If the operator elects to plan rosters of 10/10 and up to 14/14, provided that an equal number of subsequent days of extended rest period is assigned to the crew, the point (a) cannot be applicable. Maximum duty time in 28 consecutive days, as in point (b), shall remain. The concept of prolonged duty periods followed by equal number of rest days period is not compatible with the sentence "spread as evenly as practicable throughout that period". Suggested NPA amendment CS FTL.3.210 Flight times and duty periods — HEMS Duty periods in HEMS operations under ORO.FTL.210(b) The total duty periods to which an individual crew member in HEMS operations may be assigned under ORO.FTL.210(b) does not exceed either of the following limits: 110 duty hours in any 14 consecutive days, on the condition that: the maximum daily FDP specified in CS FTL.3.205(a) or (b) does not exceed 14 hours; the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep; for each FDP of more than 12 hours, the total break time constitutes 50 % of the time above 12 hours; the time for breaks excludes the necessary time for post- and pre-flight duties;

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 432 of 585

An agency of the European Union

the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks; the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights. 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period. (3) in case of a block of more than 10 consecutive FDP, followed by an equal number of days of extended recovery rest period, point (a) is not applicable.

response Please see the answer to comment # 54

comment 1324 comment by: SAS

The English used in this paragraph does not appear to be correct. By saying ‘does not exceed either..’ it is stating that you must comply with both of them (and therefore, in part (1)ii) stating that every HEMS shift must have a break of minimum 60 minutes, regardless of the length of FDP). We believe the intention of the paragraph is to ensure that duty periods comply with either of the limits; (1) must not exceed 110 duty hours… (2) must not exceed 190 duty hours…

response Please see the answer to comment # 54

comment 1341 comment by: European Cockpit Association

response Please see the answer to comment # 54

comment 1346 comment by: European Cockpit Association

Commented text: CS FTL.3.210 Flight times and duty periods — HEMS

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 433 of 585

An agency of the European Union

(1) 110 duty hours in any 14 consecutive days, on the condition that: ECA Comment: This limit is not useful for the majority of HEMS operations in Europe, we suggest this to be GM

response Please see the answer to comment # 54

comment 1347 comment by: European Cockpit Association

Commented text: i. the maximum daily FDP specified in CS FTL.3.205(a) or (b) does not exceed 14 hours; ECA Comment: The rest in suitable accomodation is more relaxant than in flight rest, even in class 1 facilities; it is against the logic, that with in-flight-rest, the FDP can be extended to 16 hours, any HEMS FDP not, even if sufficient breaks in suitable accomodation are provided.

response Please see the answer to comment # 54

comment 1348 comment by: European Cockpit Association

Commented text: ii. the operator ensures at least one break of minimum 60 consecutive minutes within each FDP at the HEMS operating base at times that ensure likelihood of sleep; ECA Comment: The break time to be used for extension, can consist of more than one break, but any break used to extend duty/FDP has to be longer than one hour. Breaks of less than one hour do not assure required rest and recreation.

response Please see the answer to comment # 54

comment 1349 comment by: European Cockpit Association

Commented text: iii. for each FDP of more than 12 hours, the total break time constitutes 50 % of the time above 12 hours; ECA Comment: We believe that, a 10 hour (single pilot) an a 12 hour (dual pilot) operation per day is safe from the fatigue perspective - as long as sufficient break times are available, this time can be prolonged, by the amount of break time (>than 1 hour breaks) - we suggest a clearer, easier approach: Max. FDP is (up to - depending on reporting time) 10 hours single Pilot

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 434 of 585

An agency of the European Union

and 12 hours dual pilot. The FDP can be extended by the amount of break times of more than one hour breaks up to 16 hours (corresponding to in-flight-rest limit)

response Please see the answer to comment # 54

comment 1350 comment by: European Cockpit Association

Commented text: iv. the time for breaks excludes the necessary time for post- and pre-flight duties; ECA Comment: absolute condition for above

response Please see the answer to comment # 54

comment 1351 comment by: European Cockpit Association

Commented text: v. the operator provides suitable accommodation for crew members at the HEMS operating base for the purpose of breaks ECA Comment: absolute condition for above

response Please see the answer to comment # 54

comment 1352 comment by: European Cockpit Association

Commented text; vi. the minimum recurrent extended recovery rest period required under ORO.FTL.235(d) shall be increased to include 4 local nights. ECA Comment: not supported

response Please see the answer to comment # 54

comment 1353 comment by: European Cockpit Association

Commented text: (2) 190 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 435 of 585

An agency of the European Union

ECA Comment: It is necessary to take this number into the IR.

response Please see the answer to comment # 54

comment 1397 comment by: Swiss Air-Ambulance Rega

a. Limit 110 duty hours in any 14 consecutive days b. Limit 190 duty hours in any 28 consecutive days Question: Para. 1.i. refers to a maximum FDP of 14 hours. If the 14-hour mark was exceeded at the commander’s discretion or through split duty, what would be the limit then? Para. 1.vi. refers to ORO.FTL.235 (d), which is not found in the NPA documents. A draft with all the necessary reference sources should be published, not a text full of gaps, which leaves you to search for sources in the regulatory mess. A clear worsening of the previous regulation that established the annual working hours and a maximum flight duty period of 210 hours within 30 days. To ensure a reasonable duty plan, the 14-day limit must amount to 120 hours, so that absences can be managed reliably. Please note: here too, the question is raised as to what data these hours are based on. In particular, 110 hours within 14 days are assessed as too few. To be able to compensate for last-minute absences (e.g. illness), this must be increased to 120 hours. Apparently this is calculated ONLY for a 5-days ON/ 5-days OFF roster with 12 hour FDPs. If an organization needs a 4-days ON/4-days OFF roster with up to 14 hour FDPs it is not manageable with 110 hours in 14 days! It would require at least 115 hours in 14 days being the multiple of 4 times 14 and additional 3h of reserve. Following this line of thoughts, 190 hours in paragraph (2) is also not the multiple 14 times 14 and should be raised to 200 hours. An evaluation of third party damages of over 36.000 missions (108.000 flights) in the period of 2016 and 2017 concluded two peaks, one on Thursday which represents the starting day in our duty roster and one Saturday. Interestingly enough shows Wednesday (the last day of the 7 days roster) the lowest risk for damages. This correlates with a study made by employer’s mutual insurance associations in Germany and Switzerland (SUVA and BGW) which prove a high peak on the first day of duty. This NPA’s duty roster would almost double this count!

response Please see the answer to comment # 54

comment 1458 comment by: Association of Air Ambulances

First paragraph should be amended to read: “...ORO.FTL.210(b) is not to exceed the following limits:”

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 436 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1491 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Reasoning: Since all active standby is calculated as duty time, it is reasonable to consider only the 14 and 28 consecutive days limitations. As active standby is limited to 72 hours following 96 hours rest, the limitation for 7 consecutive days is unnecessary. Duty time of 28 consecutive days is limited to 175 hours, which allows up to 7 days of active standby. Seven extra hours allow unforeseen circumstances or other HEMS duty related to it. Proposal: Add new paragraph CS FTL.3.212 after CS FTL.3.210 as follows: CS FTL.3.212 Flight times and duty periods in active standby — HEMS By way of derogation from CS FTL.3.210, the total duty periods to which an individual crew member in active standby HEMS operations may be assigned under ORO.FTL.210(b)(2) does not exceed either of the following limits: (a) 120 duty hours in any 14 consecutive days. (b) 175 duty hours in any 28 consecutive days, spread as evenly as practicable throughout that period.

response Please see the answer to comment # 54

CS FTL.3.220 p. 37

comment 177 comment by: Marc Rothenhäusler

Anstatt Spilt Duty einzuführen, wäre eine Möglichkeit Hems folgendermaßen zu gestallten. Pausen größer 1h auf der Station unterbrechen die Flugdienstzeit. Maximale Dienstzeit beträgt 15:30h mit entsprechenden Pausen. Flugdienstzeit 10h darf jedoch wie bisher auch auf 12h "Kommandantenentscheid" ausgeweitet werden zur Versorgung von Patienten. Die Anzahl der Tage einer Dienstperiode im Sommer (Dienstzeit größer 14h) auf 3 Tage in Folge zu verkürzen mit 24h Ruhezeit vor der Dienstperiode und 48h Ruhezeit nach einer Periode. Eine Einschränkung der Dienstzeit sowie Flugdienstzeit würde zu einem Schichtdienst im Sommer führen, der vor allem für die Bestzungen ein größerer Stress wäre und mehr

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 437 of 585

An agency of the European Union

Arbeitstage mit sich ziehen würde wie Ruhezeiten und freie Tage. Viele Kollegen wohnen nicht stationsnah sondern pendeln. Viele ca 70% haben Anfahrtswege von über einer Stunde was bedeutet, dass man weniger Freizeit und Ruhezeit hat. Sowie ist es ein enormer Einschnitt in die Work-life-Balance von uns Piloten. Ein Schichtbetrieb wird zu einer Ausweitung der Einsatzzeit führen, was bedeutet dass morgens um 5 Einsatzbereitschaft gewährleistet werden muss. Was bedeutet, dass selbst Piloten die in der Nähe der Station um 3 Uhr aufstehen müssen um pünktlich den Frühdienst aufnehmen zu können. Gegen 14:30Uhr endet dann der Dienst. Der Spätdienst übernimmt gegen 14:30 Uhr und endet um 23 Uhr. Der Biorythmus wird dadurch völlig verschoben. Die Anzahl der Diensttage wird enorm zunehmen, was die Lebensqualität herabsetzt.

response Please see the answer to comment # 54

comment 186 comment by: ANSMUH

This concept is difficult to understand in France. The pilot is assigned in his/her operating

base for a standby (H12, or H14), and must be available for each mission.

If this concept of split duty is validated it will have a strong impact on the HEMS business

in France, without gain of security (No accident since 1987 in France), and with a strong

economic impact for the operators and hospitals.

This concept is still modeled on the practices of aircraft. It is not usable in HEMS.

Proposal: CS FTL.3.220 Split duty — HEMS The following applies in the case of split duty with one or more breaks on the ground in HEMS operations: (a) A break on the ground at the HEMS operating base is at least 60 consecutive minutes, if taken in a suitable accommodation, or at least 2 consecutive hours, if taken in accommodation. (b) If not taken at the HEMS operating base, the break on the ground has a minimum duration of 3 consecutive hours. (c) For any break of 6 hours or more or for a break that encroaches the window of circadian low (WOCL), suitable accommodation is provided; (d) Time allowed for post- and pre-flight duties and travelling is excluded from each break; the minimum total time for post- and pre-flight duties and travelling is 30 minutes or 15 minutes if at a HEMS operating base; the operator shall specify the actual times in its operations manual; (e) An operator may extend the basic maximum daily FDP specified in CS FTL.3.205 by up to 50 % of the combined duration of all breaks on the ground, with the exception of the time exceeding 6 hours or encroaching the WOCL if spent in other than suitable accommodation.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 438 of 585

An agency of the European Union

comment 234 comment by: Federal Office of Civil Aviation (FOCA), Switzerland

Comment FOCA: (b) ...a suitable accommodation has to be available.

response Please see the answer to comment # 54

comment 256 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) and (b) Breaks can be taken into account for split duty, when they are of the following length: >60 minutes when taken at home base, >2 hours in a place with accommodation or >3 hours in other places. (e) Max FDP can be extended by 50 % of the duration of the breaks. Question: Is this contradicting the max FDP of 14 hours as defined in above paragraphs? Remark: possible extensions by using split duty are well meant but not practicable. Calculation of possible FDP is complex due to all available options and must be made during the day on base taking into account all breaks of that day. Breaks can’t be planned in advance when the HEMS base is part of the national rescue system where availability times are defined and need to be covered by the base. To simplify this paragraph, we suggest to cancel the calculation of breaks and allow to stop counting FDP when breaks are longer than 60 minutes. Proposal text: CS FTL 3.220 Interruption FDP a. For HEMS operations only breaks of more than 60 minutes at the home base count as break. These breaks will interrupt FDP. b. Max FDP according table 1 and 2 remain valid c. Max duty time per day is limited to 16 h For example: Report for duty 06:30, max FDP 12:30h, three times break of 1 hour each, 15:30 h HEMS availability.

response Please see the answer to comment # 54

comment 344 comment by: European Helicopter Association (EHA)

FNAM (France)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 439 of 585

An agency of the European Union

#1 (d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (d) ISSUE The FNAM agrees a minimum time shall be taken to ensure the safety of the flight: • Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information. Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of an HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to the EASA proposition of having a minimum time for duties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in FNAM’s comment #28.5, the FNAM suggests reducing this 30 minutes value to a 15 minutes period to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. This reduction from 30 minutes to this current value of 15 minutes for duties performed by the pilots after and before flights and travelling will not impact the level of safety, otherwise a sound RIA based on experience and safety records on this subject would be appreciated. Moreover, due to multiple flight times inside a unique FDP, the FNAM underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT For French HEMS services, the suitable accommodation is nearby the helicopter, hence, there is no need for traveling time.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 440 of 585

An agency of the European Union

With the same philosophy, the proposed requirement of having a minimum time for duties performed by the pilots after and before flights of 15 minutes at the HEMS operating base will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. According to French experiences, the effective time for preparing a new flight is 7 minutes. This reduction from 15 minutes to this current value of 7 minutes for duties performed by the pilots after and before flights at the HEMS operating base will not impact the level of safety, otherwise a sound RIA based on experience and safety records on this subject would be appreciated. On the other hand, the FNAM agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #44) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, the FNAM suggests suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #28.5 to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #28.5) PROPOSAL Replace the paragraph (d) by the following: “(d) Time allowed for the duties performed by the pilots after and before flights and travelling is excluded from each break; such a minimum total time for the pilots is 15 minutes or 7 minutes at a HEMS operating base; the operator shall specify the actual times in its operations manual; a shorter time may be specified for the TCM, but not less than the actual travelling time;"

response Please see the answer to comment # 54

comment 428 comment by: UFH French Helicopters Association

#1 (d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME ISSUE UFH agrees a minimum time shall be taken to ensure the safety of the flight: • Before the 1st flight of the crew, by preparing the aircraft, and

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 441 of 585

An agency of the European Union

• After each flight, by reporting flight and aircraft information Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum time for duties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in our comment #28.5, we suggest reducing this 30 minutes value to a 15 minutes period to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. This reduction from 30 minutes to this current value of 15 minutes for duties performed by the pilots after and before flights and travelling will not impact the level of safety, otherwise it would be beneficial to further develop the RIA basing it on experience and safety records on this subject. Besides, this proposal does not affect the cammander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, we underline that the definition of post flight duty is non-consistent with the usual definition of post-flight: • Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT For French HEMS services, the suitable accommodation is nearby the helicopter, hence, there is no need for traveling time. With the same philosophy, the proposed requirement of having a minimum time for duties performed by the pilots after and before flights of 15 minutes at the HEMS operating base will reduce the chance

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 442 of 585

An agency of the European Union

of survival by 8 minutes for the next patient in case of close consecutive missions. According to French experience, the effective time for preparing a new flight is 7 minutes. This reduction from 15 minutes to this current value of 7 minutes for duties performed by the pilots after and before flights at the HEMS operating base will not impact the level of safety, otherwise it would be beneficial to further develop the RIA basing it on experience and safety records on this subject. (Cf. attachments S2 and S3 illustrating this issue of 15 min inoperative readiness) On the other hand, we agree these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #44) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP.

response Please see the answer to comment # 54

comment 502 comment by: FNAM/SNEH

Attachments #205 #206 #207 #208 #209

(d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (Cf. attachments S1, S2, S3 and S4 illustrating pre and post flight issues) (d) ISSUE FNAM and SNEH agree a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 443 of 585

An agency of the European Union

Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in FNAM and SNEH’s comment #486, FNAM and SNEH suggest suppressing this 30 minutes value and to add that “a sufficient time is determined by the operator and specified in the operating manual” to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. Besides, this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, FNAM and SNEH underline that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

For French HEMS services, the suitable accommodation is nearby the helicopter, hence, there is no need for traveling time. With the same philosophy, the proposed requirement of having a minimum time for duties performed by the pilots after and before flights of 15 minutes at the HEMS operating base will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. (Cf. attachments S2 and S3 illustrating this issue of 15 min inoperative readiness) On the other hand, FNAM and SNEH agree these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #513) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, FNAM and SNEH suggest suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #486to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #486)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 444 of 585

An agency of the European Union

PROPOSAL Replace the paragraph (d) by the following: “(d) Time allowed for the duties performed by the pilots after and before flights and travelling is excluded from each break; such a minimum total time is determined by the operator and specified in the operating manual; a shorter time may be specified for the TCM, but not less than the actual travelling time;"

response Please see the answer to comment # 54

comment 535 comment by: ADAC Luftrettung gGmbH

Question: Can breaks be taken into account for split duty, when they are of the following length: >60 minutes when taken at home base, >2 hours in a place with accommodation or >3 hours in other places? Max FDP can be extended by 50 % of the duration of the breaks. Question: Is this contradicting the max FDP of 14 hours as defined in above paragraphs? Remark: possible extensions by using split duty are well meant but not practicable. Calculation of possible FDP is complex due to all available options and must be made during the day on base taking into account all breaks of that day. Breaks can’t be planned in advance when the HEMS base is part of the national rescue system where availability times are defined and need to be covered by the base. To simplify this paragraph, we suggest to cancel the calculation of breaks and allow to stop counting FDP when breaks are longer than 60 minutes. Proposal text: CS FTL 3.220 Interruption FDP a. For HEMS operations only breaks of more than 60 minutes at the home base count as break. These breaks will interrupt FDP. b. Max FDP according table 1 and 2 remain valid c. Max duty time per day is limited to 16 h For example: Report for duty 06:30, max FDP 12:30h, three times break of 1 hour each, à 15:30h HEMS availability

response Please see the answer to comment # 54

comment 556 comment by: Rüdiger Neu

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 445 of 585

An agency of the European Union

Fragestellung: Gilt bei Split duty eine Zeit von > 60 Minuten an der Station, > 2 Stunden an einem Ort mit einer Unterkunft oder einem anderen Ort wenn > 3 Stunden, als Pause? Die max. FDP kann um 50% der Pausen verlängert werden. Dieser Punkt ist der wichtigste bei unseren Planungen und unserem weiteren Vorgehen. Da mit diesem Passus die max. Flugdienstzeit (FDP) deutlich über das heutige Maß angehoben werden kann. Der Wermutstropfen kommt jedoch später bei den verlängerten Ruhezeiten und beim Standby. Fragestellung: Steht dies im Widerspruch zu den oftmals beschriebenen max. 14 Stunden FDP, da nun doch die max. FDP verlängert werden kann? Anmerkung: die möglichen Erleichterungen durch die Anwendung von split duty sind gut gemeint, aber nicht praktikabel. Die Berechnung der möglichen Zeiten ist zu kompliziert, als dass dies in der Praxis von den Besatzungsmitgliedern auf den Stationen umgesetzt werden kann. Hinzu kommt, dass die Pausen aufgrund der Einbindung in den öffentlich- rechtlichen Rettungsdienst nicht in Voraus planbar sind. Zur Erleichterung wird angeregt, die komplizierte Berechnung zu streichen und stattdessen einen Passus einzupflegen, dass Pausen zwischen einzelnen Einsätzen, die mindestens 60 zusammenhängende Minuten dauern, die FDP unterbrechen. Alternative für HEMS anstelle split duty: CS FTL.3.220 Interruption FDP a. Für HEMS Operation gelten nur die Pausen >1h auf der Station mit entsprechender Unterkunft. Diese Pausen führen zu einer Unterbrechung der FDP b. Die max. FDP gem. Table 1 und Table 2 haben Bestand c. Die Dienstzeit pro Tag wird auf 16h limitiert Beispiel: Dienstbeginn 06:30, max. FDP 12:30h, drei Mal eine Stunde Pause, ergeben einen möglichen Einsatztag mit 15:30h Dienstzeit

response Please see the answer to comment # 54

comment 682 comment by: Oya Vendée Hélicoptères

Attachments #210 #211 #212 #213 #214

(d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (Cf. attachments S1, S2, S3 and S4 illustrating pre and post flight issues) (d) ISSUE OYA agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 446 of 585

An agency of the European Union

• After each flight, by reporting flight and aircraft information

Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum time forduties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in OYA’s comment #666, OYA suggests suppressing this 30 minutes value and to add that “a sufficient time is determined by the operator and specified in the operating manual” to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. Besides, this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, OYA underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 447 of 585

An agency of the European Union

Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, OYA suggests suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #666 to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #666) PROPOSAL Replace the paragraph (d) by the following: “(d) Time allowed for the duties performed by the pilots after and before flights and travelling is excluded from each break; such a minimum total time is determined by the operator and specified in the operating manual; a shorter time may be specified for the TCM, but not less than the actual travelling time;"

response Please see the answer to comment # 54

comment 725 comment by: ADAC

Pausen sind grundsätzlich nie planbar oder vorhersehbar, daher ist diese Regelung praxisfremd.

response Please see the answer to comment # 54

comment 726 comment by: ADAC

Aufgrund welcher Erfahrung/welchen Vorfalls/welcher Studie wird eine solche Regel erstellt ? HEMS Operation bietet genug Pausen, und wenn nicht kann der Kapitän diese jederzeit einfordern - unabhängig fest vorgegebener Zeiten sondern nach dem eigenen Befinden. Dies ist praxisrelevant, keine Vorgaben die die verschiedenen Biorhythmen und Pausenanforderungen verschiedener Piloten nicht erüllen können.

response Please see the answer to comment # 54

comment 749 comment by: DRF-Luftrettung

Max FDP can be extended by 50 % of the duration of the breaks. Question: Is this contradicting the max FDP of 14 hours as defined in above paragraphs?

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 448 of 585

An agency of the European Union

Remark: possible extensions by using split duty are well meant but not practicable. Calculation of possible FDP is complex due to all available options and must be made during the day on base taking into account all breaks of that day. Breaks can’t be planned in advance when the HEMS base is part of the national rescue system where availability times are defined and need to be covered by the base. To simplify this paragraph, we suggest to cancel the calculation of breaks and allow to stop counting FDP when breaks are longer than 60 minutes.

response Please see the answer to comment # 54

comment 966 comment by: MBH SAMU

Attachments #215 #216 #217 #218 #219

(d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (Cf. attachments S1, S2, S3 and S4 illustrating pre and post flight issues) (d) ISSUE MBH agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum time forduties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in MBH’s comment #644, MBH suggests suppressing this 30 minutes value and to add that “a sufficient time is determined by the operator and specified in the operating manual” to take into account the time for

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 449 of 585

An agency of the European Union

duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. Besides, this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, MBH underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

For French HEMS services, the suitable accommodation is nearby the helicopter, hence, there is no need for traveling time. With the same philosophy, the proposed requirement of having a minimum time for duties performed by the pilots after and before flights of 15 minutes at the HEMS operating base will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. (Cf. attachments S2 and S3 illustrating this issue of 15 min inoperative readiness) On the other hand, MBH agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #979) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, MBH suggests suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #944 to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #944) PROPOSAL Replace the paragraph (d) by the following: “(d) Time allowed for the duties performed by the pilots after and before flights and travelling is excluded from each break; such a minimum total time is determined by the operator and specified in the operating manual; a shorter time may be specified for the TCM, but not less than the actual travelling time;"

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 450 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 995 comment by: AESA

Are the breaks considered in CS FTL.3.220 split duty for extending the basic máximum daily FDP independent to break included in CS FTL.3.205 (a)(1) when FDP is over 12 hours? In other words, if the operator plans a FDP of 13 hours with breaks along de FDP including one of 60 min like prescribed in CS FTL.3.205(a)(1) because the FDP is over 12 hours, could it be used this break of 60 min to extend 30 min more the FDP?

response Please see the answer to comment # 54

comment 1015 comment by: B. Wagner

Das Konzept von Split duty entstammt wahrscheinlich der FTL Regelungen für Fixed wing operations. Eine Übertragung auf den HEMS Flugbetrieb ohne eine komplette inhaltliche Überarbeitung ist wenig sinnvoll. Grundsätzlich befindet sich die Besatzung während ihrer Bereitschaftszeit auf der Station, die in der Regel als "suitable accommodation" betrachtet werden kann. Damit sollten alle Zeiten auf Station, die nicht Flugzeit oder Nachbereitung eines Einsatzes sind, als Pause gerechnet werden dürfen. Die Idee hinter diesem Punkt liesse sich einfacher regeln, indem man FDP als die Zeit definiert, in der ein Einsatz durchgeführt, vor- oder nachbereitet wird oder andere Stationsarbeiten erledigt werden und der Rest der Bereitschaftszeit zählt nur zur Dienstzeit. Dann reicht die Definition von max FDP und max DP pro Tag aus und der Abschnitt split duty kann ersatzlos entfallen.

response Please see the answer to comment # 54

comment 1232 comment by: SAF

Attachments #220 #221 #222 #223 #224

(d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (Cf. attachments S1, S2, S3 and S4 illustrating pre and post flight issues) (d) ISSUE SAF agrees a minimum time shall be taken to ensure the safety of the flight:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 451 of 585

An agency of the European Union

• Before the 1st flight of the crew, by preparing the aircraft, and • After each flight, by reporting flight and aircraft information

Due to the life-threatening emergency operation in HEMS, these times shall be as short as possible to maximize operational availability and response time. In that way, in France, the contractual time for the National Health Authorities between the launch of a HEMS flight and the effective take-off is 7 minutes. Indeed, when a patient needs essential life-saving measures, after 30 minutes, there are almost no chance to save the life of the patient. Thus, the first patient of a FDP will have no chance of survival due to EASA proposition of having a minimum time forduties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in SAF’s comment #666, SAF suggests suppressing this 30 minutes value and to add that “a sufficient time is determined by the operator and specified in the operating manual” to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. Besides, this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, SAF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP • Assuming the FDP ends with the last FT • Though for HEMS operations FT are unpredictable and scheduled FDP may end

long after the last effective FT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 452 of 585

An agency of the European Union

On the other hand, SAF agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #1242) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, SAF suggests suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #1216 to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #1216) PROPOSAL Replace the paragraph (d) by the following: “(d) Time allowed for the duties performed by the pilots after and before flights and travelling is excluded from each break; such a minimum total time is determined by the operator and specified in the operating manual; a shorter time may be specified for the TCM, but not less than the actual travelling time;"

response Please see the answer to comment # 54

comment 1280 comment by: Hélicoptères de France

#1 (d) MINIMUM TIME FOR DUTIES PERFORMED BY THE PILOTS BEFORE AND AFTER FLIGHTS AND TRAVELLING TIME (Cf. attachments S1, S2, S3 and S4 illustrating pre and post flight issues) (d) ISSUE HDF agrees a minimum time shall be taken to ensure the safety of the flight:

• Before the 1st flight of the crew, by preparing the aircraft, and

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 453 of 585

An agency of the European Union

survival due to EASA proposition of having a minimum time for duties performed by the pilots after and before flights and travelling of 30 minutes. Moreover, French numbers underlines that 7%i of the HEMS take-off preformed within the first 30 minutes of the FDP. (Cf. SNEH illustrative Table in attachment) Whatever the number of life that would not have been saved during these 30 minutes, no loss would be politically and socially acceptable. To align the values with the initial preflight time and proportionate pre-flight time before any take-off from the HEMS operating base proposed in HDF’s comment #28.5, HDF suggests suppressing this 30 minutes value and to add that “a sufficient time is determined by the operator and specified in the operating manual” to take into account the time for duties performed by the pilots after and before flights and travelling time if not at the HEMS operating base. Besides, this proposal does not affect the commander’s prerogatives since he remains the one to make the final decision regarding the take-off time. Moreover, due to multiple flight times inside a unique FDP, HDF underlines that the definition of post flight duty is non-consistent with the usual definition of post-flight:

• Which starts at the end (of the last FT) of the FDP

• Assuming the FDP ends with the last FT

• Though for HEMS operations FT are unpredictable and scheduled FDP may end long after the last effective FT For French HEMS services, the suitable accommodation is nearby the helicopter, hence, there is no need for traveling time. With the same philosophy, the proposed requirement of having a minimum time for duties performed by the pilots after and before flights of 15 minutes at the HEMS operating base will reduce the chance of survival by 8 minutes for the next patient in case of close consecutive missions. (Cf. attachments S2 and S3 illustrating this issue of 15 min inoperative readiness) On the other hand, HDF agrees these requirements do not apply for the Technical Crew Member since TCM function does not include the flight preparation. (Cf. comment #44) Besides, for HEMS operations, the definition implicitly given (but never written) to post- flight seems not to be in accordance with the usual acceptance of a post-flight as given in the IR for the CAT operations other than HEMS: post-flight is a time after the last FT of a FDP, outside of the FDP. CS.FTL.3.205(a)(3) and (b)(4) only defines "post-flight" when returning to the HEMS operating base. Therefore, HDF suggests suppressing the post flight duties as written and to refer to the definition stated in the proposal of comment #28.5 to CS.FTL.3.205(a)(3) and (b)(4). (Cf. comment #28.5)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 454 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1354 comment by: European Cockpit Association

Commented text: CS FTL.3.220 The following applies in the case of split duty with one or more breaks on the ground in HEMS operations: ECA Comment: There is a need to clarify that being on alertness, with a notification time of less than 1 hour cannot be considered as a break for the use of split duty. Urgent need to clarify this point: Split Duty cannot be combined with rest periods at the base to extend FDP - similar to CS FTL.1.220 (f) "Split duty cannot be combined with in-flight rest" - which is similar

response Please see the answer to comment # 54

comment 1355 comment by: European Cockpit Association

Commented text: (b) If not taken at the HEMS operating base, the break on the ground has a minimum duration of 3 consecutive hours. ECA Comment: This may only be available if at least accomodation is provided

response Please see the answer to comment # 54

comment 1399 comment by: Swiss Air-Ambulance Rega

CS.FTL.3.220(a)(b) In the event of split duty, a period of > 60 minutes at the base, > 2 hours at a place with suitable accommodation, or > 3 hours in another place is considered a break. CS.FTL.3.220(e)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 455 of 585

An agency of the European Union

The max. FDP can be extended by 50% of the breaks. This point is the most important one in our plans and our further action. This is because as a result of this passage the max. flight duty period (FDP) can be increased much above today’s period. However, the “bitter pill” comes later in the form of the extended rest times and standby. Question: Does this contradict the frequently described max. 14-hour FDP, because the max. FDP can now be extended after all? Please note: The potential simplifications through the application of split duty are well- intentioned, but not practical. The calculation of the possible times is too complicated, as this has to be implementable in practice by crew members at bases. In addition, the breaks cannot be planned in advance due to the integration in the public emergency services. To make things easier, it is suggested to take out the complicated calculation and instead incorporate a passage stating that breaks between individual missions that last at least 60 consecutive minutes interrupt the FDP. Proposed amendment: CS FTL.3.220 Interruption FDP a. Only breaks >1 hour at the base with suitable accommodation apply to HEMS operations. These breaks interrupt the FDP. b. The max. FDPs acc. to Table 1 and Table 2 are maintained. c. The duty period per day is limited to 16 hours. Example: Start of duty 6:30 a.m., max. FDP 12.5 hours, three one-hour breaks result in a possible duty day of 15.5 hours.

response Please see the answer to comment # 54

comment 1493 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Proposal: Amend CS FTL.3.220 as follows: CS FTL.3.220 Split duty in continuous standby — HEMS -- (f) Split duty may not be used during active standby.

response Please see the answer to comment # 54

GM1 CS FTL.3.220(b) p. 37-38

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 456 of 585

An agency of the European Union

comment 345 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE (Cf. comment #31) Taking into account comment and proposal for CS.FTL.3.220(b), this referring GM is proposed to be amended to reflect the above suggested modifications. It would also clarify misunderstanding that this GM precising “Post-, pre-flight duty, travelling times and operational pre-flight duties" for the sake of Split duty may have on the same terms but different notions used in CS.FTL.3.205(a)(3) and (b)(4). PROPOSAL Replace the content of this GM by the following: “Duties performed by the pilots after and before flights and travelling The operator should specify: • Time allowed for duties performed by the pilots after and before flights; • Travelling times for the crews; operational pre-flight duties before each flight taking-off from the HEMS operating base and travelling times for HEMS taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response Please see the answer to comment # 54

comment 503 comment by: FNAM/SNEH

ISSUE (Cf. comment #502) Taking into account comment and proposal for CS.FTL.3.220(b), this referring GM is proposed to be amended to reflect the above suggested modifications. It would also clarify misunderstanding if this GM precising “Post-, pre-flight duty and travelling times” for the sake of split duty reuses the same terms (although the notions are different) used in CS.FTL.3.205(a)(3) and (b)(4).i.e “and operational pre-flight duties”. PROPOSAL Replace the content of this GM by the following: “Duties performed by the pilots after and before flights and travelling The operator should specify:

• Time allowed for duties performed by the pilots after and before flights;

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 457 of 585

An agency of the European Union

• Travelling times for the crews; operational pre-flight duties before each flight taking-off from the HEMS operating base and travelling times for HEMS

taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response Please see the answer to comment # 54

comment 683 comment by: Oya Vendée Hélicoptères

ISSUE (Cf. comment #682) Taking into account comment and proposal for CS.FTL.3.220(b), this referring GM is proposed to be amended to reflect the above suggested modifications. It would also clarify misunderstanding if this GM precising “Post-, pre-flight duty and travelling times” for the sake of split duty reuses the same terms (although the notions are different) used in CS.FTL.3.205(a)(3) and (b)(4).i.e “and operational pre-flight duties”. PROPOSAL Replace the content of this GM by the following: “Duties performed by the pilots after and before flights and travelling The operator should specify:

• Time allowed for duties performed by the pilots after and before flights; • Travelling times for the crews; operational pre-flight duties before each flight

taking-off from the HEMS operating base and travelling times for HEMS

taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response Please see the answer to comment # 54

comment 968 comment by: MBH SAMU

ISSUE (Cf. comment #966) Taking into account comment and proposal for CS.FTL.3.220(b), this referring GM is proposed to be amended to reflect the above suggested modifications. It would also clarify misunderstanding if this GM precising “Post-, pre-flight duty and travelling times” for the sake of split duty reuses the same terms (although the notions are different) used in CS.FTL.3.205(a)(3) and (b)(4).i.e “and operational pre-flight duties”.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 458 of 585

An agency of the European Union

PROPOSAL Replace the content of this GM by the following: “Duties performed by the pilots after and before flights and travelling The operator should specify:

• Time allowed for duties performed by the pilots after and before flights; • Travelling times for the crews; operational pre-flight duties before each flight

taking-off from the HEMS operating base and travelling times for HEMS

taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response Please see the answer to comment # 54

comment 1020 comment by: B. Wagner

Dieser Absatz widerspricht der Zielsetzung, die Regelungen europaweit zu harmonisieren. Wenn jeder Operator für sich diese Zeiten definieren kann, wird es zu Unterschieden kommen, die sich bei der Bewerbung auf ausgeschriebene Stationen als Wettbewerbsvor- oder nachteil erweisen können. Feste Vorgaben, die für alle verbindlich sind, sollten in GM vorgegeben werden. Abweichungen in begründeten Ausnahmefällen könnten trotzdem erlaubt werden, wenn sie von der EASA für die jeweilige Station und nicht für einen bestimmten Operator genehmigt werden.

response Please see the answer to comment # 54

comment 1233 comment by: SAF

ISSUE (Cf. comment #1232) Taking into account comment and proposal for CS.FTL.3.220(b), this referring GM is proposed to be amended to reflect the above suggested modifications. It would also clarify misunderstanding if this GM precising “Post-, pre-flight duty and travelling times” for the sake of split duty reuses the same terms (although the notions are different) used in CS.FTL.3.205(a)(3) and (b)(4).i.e “and operational pre-flight duties”.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 459 of 585

An agency of the European Union

PROPOSAL Replace the content of this GM by the following: “Duties performed by the pilots after and before flights and travelling The operator should specify:

• Time allowed for duties performed by the pilots after and before flights; • Travelling times for the crews; operational pre-flight duties before each flight

taking-off from the HEMS operating base and travelling times for HEMS taking into account the aircraft type, the type of operation and the condition of the airport, landing site or HEMS operating base, as applicable.”

response Please see the answer to comment # 54

CS FTL.3.225 p. 38

comment 62 comment by: London's Air Ambulance

First paragraph contains the word ‘may’. This implies that the paragraph is GM not IR, therefore optional. This is clearly not the intention. The wording of the paragraph needs to be amended to reflect the intention.

response Please see the answer to comment # 54

comment 187 comment by: ANSMUH

It is felt that the "standby" section of the CS for HEMS operations is not sufficiently defined and articulated. As presently defined in the NPA, the operator is allowed to use the standby tool in order to systematically assign rosters at the operating base with long periods of standby without counting those as full duty periods, in case no flight is requested during the daily shift. As a result, the personnel could undergo long periods at the operator's disposal with little time counted as duty. This is particularly true in operating bases where the actual number of assigned missions are low and there can be a consistent part of the day without flights. In particular, night shifts are likely to end with few mission assignments. If the operator defines the shift as 2 hours for bureaucratic paperwork (20:00-22:00) and 10 hours of standby for take-off within 30 minutes from call (22:00-08:00), in case of no flight requests the pilot will end up with a 12-hours availability in an operative environment (inside the operating base), but with only 2 hours of recorded duty time.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 460 of 585

An agency of the European Union

This kind of roster can became a regular everyday planning, permitting continuous personnel availability with very little duty period, thus influencing the duty, rest and recurrent extended recovery rest periods. This will also influence the count of the 2000 hours of working time as per Council Directive 2000/79/EC. We consider the standby as duty. The crew not being at rest is considered active, so this standby must be deducted from duty. See proposal ORO FTL 225. In France the crew is in standby at the HEMS operating base for 12 or 14 hours. During these 12 or 14 hours of standby the crew is limited of flying hours per day, month and year independently the time which he is assigned to a mission. It is then up to the crew to accept or not a mission depending on the time of release, without exceeding the maximum of 14 hours of duty per day. This is not the time of the beginning of a flight assignment which determines the duty time. If this proposal is applied it is likely to have strong social movements in France.

We refuse this proposal. The maximum standby duration should be 14 hours as HEMS

PFD which includes standby, post and pre-flight duties, fligths, and all type of duties.

Proposal: CS FTL.3.225 Standby and duties at the HEMS operating base. The limits on flight duty, duty and rest periods in HEMS operations may be modified in accordance with the following: Standby at the HEMS operating base is defined as a standby with whenever, due to operative and logistic requirements, the crew is required to remain at the operating base during the standby period. Standby at the HEMS operating base should count in full as duty period: (a) When a standby at the HEMS operating base does not lead to the assignment of a FDP, standby at the HEMS operating base is followed by a rest period as specified in ORO.FTL.235. (b) Standby at the HEMS operating base should count in full as FDP. (a) The maximum duration of standby duty is 16 hours. (b) Standby is followed by a rest period in accordance with ORO.FTL.235. In case of consecutive standby duties not leading to an assignment of FDP, the applicable minimum rest period may be reduced to 8 hours, if the response time specified by the operator is 60 minutes or more. (c) Standby ceases when the crew member reports at the designated reporting point.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 461 of 585

An agency of the European Union

(d) If standby ceases within the first 6 hours of standby, the maximum FDP counts from reporting; (e) If standby ceases after the first 6 hours, the maximum FDP is reduced by the amount of standby time exceeding 6 hours except in case of split duty; or (f) Time on standby duty is not counted for the reduction of the maximum allowable FDP in the following cases: (1) if the standby starts between 23:00 and 07:00 and the crew member is not contacted by the operator during that period; (2) if the assigned FDP includes a break on the ground; and (3) the response time established by the operator allows the crew member to arrive from his/her place of rest to the designated reporting point within a reasonable time. (g) The response time is the time between the communication of a duty assignment and the reporting time and is reflected in the operator’s flight time specification scheme.

response Please see the answer to comment # 54

comment 257 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) Limit 16 hours. This means max allowable day with split duty is also limited to 16 hours?

response Please see the answer to comment # 54

comment 346 comment by: European Helicopter Association (EHA)

FNAM (France) #1 AGREEMENT The FNAM globally agrees with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life. For instance, for some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL (1) Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 462 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 401 comment by: European Helicopter Association (EHA)

OEATMC (Austria): CS FTL.3.225 Standby and duties at the HEMS operating base […] (b) Standby is followed by a rest period in accordance with ORO.FTL.235. In case of consecutive standby duties not leading to an assignment of FDP, the applicable minimum rest period may be reduced to 8 hours, if the response time specified by the operator is 60 minutes or more. COMMENT(S) This was apparently as well taken from scheduled fixed wing operations and does in no means apply to HEMS operations. The spirit of HEMS implies a quick response; therefore a response time of one hour surprises us. CS FTL.3.230 Reserve — HEMS […] (f) Minimum notification time for any duty is 10 hours that may include the 8-hour sleep opportunity under (e). COMMENT(S) Assuming a sick leave of a pilot in the morning - this rule prohibits the reserve pilot to fill the gap within 10h. Even if it is the home base and the reserve pilot is living a couple minutes away. With this rule it is basically not possible to continue service if someone gets sick throughout the day. This endangers the health of sick or injured people!

response Please see the answer to comment # 54

comment 504 comment by: FNAM/SNEH

AGREEMENT FNAM and SNEH globally agree with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 463 of 585

An agency of the European Union

For instance, some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

response Please see the answer to comment # 54

comment 536 comment by: ADAC Luftrettung gGmbH

Limit 16 hours. Question: Does this mean, that the max allowable day with split duty is also limited to 16 hours?

response Please see the answer to comment # 54

comment 557 comment by: Rüdiger Neu

Limit sind 16 Stunden. Fragestellung: Kann bei Split duty der Arbeitstag nur max. 16 Stunden betragen, da die Besatzung sich sonst im Standby befindet?

response Please see the answer to comment # 54

comment 684 comment by: Oya Vendée Hélicoptères

AGREEMENT OYA globally agrees with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life. For instance, some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 464 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 727 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.225 (b) [...] if the response time specified by the operator is 60 minutes or more [...] This was apparently as well taken from scheduled fixed wing operations and does in no means apply to HEMS operations. The spirit of HEMS implies a quick response; therefore a response time of one hour surprises us.

response Please see the answer to comment # 54

comment 787 comment by: AECA helicopteros.

Standby and duties at the HEMS operating base (a) The maximum duration of standby duty is 16 hours. Which criteria apply in the event that the standby period takes place at pilot´s home? Can in this case be extended up to 24 hours ?. There are no regulation for HEMS in case of Satnd by in any place other than operating base.

response Please see the answer to comment # 54

comment 969 comment by: MBH SAMU

AGREEMENT MBH globally agrees with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life. For instance, some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 465 of 585

An agency of the European Union

comment 997 comment by: AESA

Title seems to be wrong; point only includes standby, so the title should be “CS FTL.3.225 Standby”. It would be consistent with CS 1 and CS 2. In the body, it should be included different requirements for standby in HEMS operating base and for other than HEMS operating base, following the scheme used in CS 1 and CS 2. Requirements included (a) to (g) seems to be for standby in other than HEMS operating base, but rationale says that it is an adaptation from CS 1 airport standby. For example, response time is a concept from other than airport standby in CS 1.

response Please see the answer to comment # 54

comment 1028 comment by: B. Wagner

Auch hier gibt es zuviele mögliche Anwendungen, die zu unterschiedlicher Berechnung der maximal möglichen FDP führen. Das ist nicht praktikabel. Dieser Abschnitt ist in Deutschland dennoch akzeptabel, da dieses Dienstmodell derzeit keine Anwendung findet.

response Please see the answer to comment # 54

comment 1172 comment by: NHV Group

Paragraph No: CS FTL.3.225 Standby and duties at the HEMS operating base Comment: Response time is not taken into account when assessing impact of stress induced fatigue on flight crews during FDP and/or FT. Justification: Response time should reflect adversity level of current or forecasted meteo conditions & flight rules applicable to the mission planned to be flown. Rationale: prescriptive short response times after rest period during night duty can be critical to the pilot's ability to make necessary accommodation in the cockpit. Proposed text: (g) The response time is the time between the communication of a duty assignment and the rotor-start time and is reflected in the operator’s flight time specification scheme as a minimum response time allowing safety checks being performed by the pilot before take-off.

response Please see the answer to comment # 54

comment 1234 comment by: SAF

AGREEMENT

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 466 of 585

An agency of the European Union

SAF globally agrees with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life. For instance, some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

response Please see the answer to comment # 54

comment 1282 comment by: Hélicoptères de France

#1 AGREEMENT HDF globally agrees with these standby modalities. Nevertheless, the 8-hour sleep opportunity should have the flexibility to be adapted depending on the local conditions on rhythm of life. For instance, some overseas territories have not the same alignment between local time and effective sunrise / sunset. Thus an 8-hour sleep opportunity between 23h and 7h, local time, does not always correspond to the acclimatized circadian rhythm, expressed in local time. PROPOSAL (1) Allow to change 23:00 and 7:00 to another 8-hour sleep opportunity, adapted to the effective acclimatized circadian rhythm, expressed in local time (eg 0:00 to 8:00, 22:00 to 6:00, or 21:00 to 5:00 depending of the area of world considered)

response Please see the answer to comment # 54

comment 1317 comment by: Elilombarda

CS FTL.3.225 Standby and duties in at the HEMS operations operating base The limits on flight duty, duty and rest periods in HEMS operations are modified in accordance with the following:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 467 of 585

An agency of the European Union

Standby at the HEMS operating base Standby at the HEMS operating base is defined as a standby with a response time of less than 90 minutes or whenever, due to operative and logistic requirements, the crew is required to remain at the operating base during the standby period. Standby at the HEMS operating base should count in full as flight duty period (FDP). When a standby at the HEMS operating base does not lead to the assignment of a FDP, standby at the HEMS operating base is followed by a rest period as specified in ORO.FTL.235. If an assigned FDP starts during standby at the HEMS operating base, the following applies: the FDP counts from the start of the FDP. The maximum FDP is reduced by any time spent on standby in excess of 4 hours; the maximum combined duration of standby at the HEMS operating base and assigned FDP as specified in ORO.FTL.205(b) is 16 hours. Standby other than standby at the HEMS operating base: The maximum duration of standby other than airport standby is 16 hours; Standby other than standby at the HEMS operating base is followed by a rest period in accordance with ORO.FTL.235. In case of consecutive standby duties not leading to an assignment of FDP, the applicable minimum rest period may be reduced to 8 hours, if the response time specified by the operator is 60 minutes or more. the operator’s standby procedures are designed to avoid that the combination of standby and FDP leads to more than 18 consecutive hours awake time; Time spent on standby other than at the HEMS operating base counts as duty time for the purpose of CS.FTL.3.210, as follows: 25 % for standby duty with a response time of 120 minutes or more; 50 % for standby duty with a response time between 119 and 90 minutes; 100 % for standby duty with a response time of less than 90 minutes. standby ceases when the crew member reports at the designated reporting point; if standby ceases within the first 6 hours, the maximum FDP counts from reporting; if standby ceases after the first 6 hours, the maximum FDP is reduced by the amount of standby time exceeding 6 hours; if the FDP is extended due to split duty according to CS FTL.3.220, the 6 hours of points (6) and (7) are extended to 8 hours;

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 468 of 585

An agency of the European Union

Time on standby duty is not counted for the reduction of the maximum allowable FDP in the following cases: if the standby starts between 23:00 and 07:00 and the crew member is not contacted by the operator during that period; if the assigned FDP includes a break on the ground; and the response time established by the operator allows the crew member to arrive from his/her place of rest to the designated reporting point within a reasonable time. IMPACT ANALYSIS Before suggested changes: SAFETY OPERATOR – IMPROVED – Due to lack of regulation in HEMS standby, the operator may consider the crew in standby, with a reduced response time down to 30 minutes or 5 minutes, until a mission assignment, thus reducing the count of the crew’s duty time and related limits over the 14 and 30 days. CREWS – NEGATIVE – The count of the duty time and related rest and extended rest periods could be defined by the operator and possibly reduced. LOGISTIC OPERATOR – IMPROVED – In case the operator elects to partially count the standby at HEMS operating base as duty time, the total crews’ duty time will be reduced. CREWS – NEGATIVE – The crew is available to the operator’s needs with reduced count of duty time. ECONOMIC OPERATOR – NEUTRAL - It depends on the personal or collective contracts. CREWS – NEUTRAL – It depends on the personal or collective contracts. After suggested changes: SAFETY OPERATOR – NEUTRAL – Basically, it will not change today’s assets. CREWS – NEUTRAL – Basically, it will not change today’s assets. LOGISTIC OPERATOR – NEUTRAL – Basically, it will not change today’s assets. CREWS – NEUTRAL – Basically, it will not change today’s assets. ECONOMIC OPERATOR – NEUTRAL - It depends on the personal or collective contracts. CREWS – NEUTRAL – It depends on the personal or collective contracts.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 469 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1345 comment by: Babcock Mission Critical Services Limited

response Please see the answer to comment # 54

comment 1400 comment by: Swiss Air-Ambulance Rega

The limit is 16 hours. Thus, using split duty, the working day can amount to a max. of 16 hours because the crew is otherwise on standby.

response Please see the answer to comment # 54

comment 1438

comment by: COPAC COLEGIO OFICIAL DE PILOTOS DE LA AVIACIÓN

COMERCIAL

CS FTL.3.225 (f) (3) “the response time established by the operator allows the crew member to arrive from his/her place to rest to the designated reporting point within a reasonable time” ¿cuánto es un tiempo razonable? En el Estado Español, se deberá de modificar la forma de programar a las tripulaciones, basándose en esta nueva normativa, lo que sin duda traerá resistencias en las tripulaciones de vuelo. Actualmente, muchas de las tripulaciones no tienen su residencia habitual en las bases de trabajo, por lo que se intenta agrupar días de trabajo seguidos, y así permitir a las tripulaciones conciliar la vida familiar. Un modelo razonable es el de 7 ON/ 7 OFF. Sin embargo, este modelo va a ser difícilmente prorrogable en el momento en que se ponga en vigor esta norma, si se va a programaciones de 4 ON / 3OFF, esos tres días de descanso se convertirán en días de viaje a los respectivos lugares de residencia.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 470 of 585

An agency of the European Union

Uno de los motivos por los que no se mudan los tripulantes de vuelo junto a sus familias, es la falta de estabilidad laboral en este sector, castigado por concursos públicos que se asignan con muy poco tiempo hasta el momento en el que se inicia la operación, además de duraciones relativamente cortas que no dan ninguna garantía de futuro.

response Please see the answer to comment # 54

comment 1459 comment by: Association of Air Ambulances

response Please see the answer to comment # 54

comment 1495

comment by: Swedish Transport Agency, Civil Aviation Department

(Transportstyrelsen, Luftfartsavdelningen)

If EASA prefers to go forward with regulations according to Option 1 or 2, the Swedish Transport Agency has the following proposal: CS FTL.3.225 Standby and duties at the HEMS operating base (a) The maximum duration of standby duty is 16 hours Should be changed to 24 hours per day during a maximum of 7 consecutive days to be followed by a minimum of 7 day’s rest. Note: ORO.FTL.235 Rest Periods should be changed in line with this proposal.

response Please see the answer to comment # 54

comment 1496 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Proposal: Add new paragraph CS FTL.3.227 after CS FTL.3.225 as follows: CS FTL.3.227 IDP and ADP in active standby -HEMS By way of derogation from CS FTL.3.225, the limits on flight duty, duty and rest periods in active standby HEMS operations may be modified in accordance with the following: (a) The maximum rostered duration of active standby is 72 hours.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 471 of 585

An agency of the European Union

(b) For active standby in HEMS, the ADP is counted as starting when an alarm is received, or when air operator requires crew to start other tasks than flying. ADP is counted ending 30 minutes after the flight has ended, or when all duties related to the flight or to other tasks that have been carried out, whichever occurs later. (c) For active standby in HEMS, if the time between two ADPs is less than 1 hour, this time shall be counted as ADP.

response Please see the answer to comment # 54

CS FTL.3.230 p. 38-39

comment 8 comment by: TG

Mir ist nicht klar, ob Sie sich unsere Bereitschaftspläne angesehen haben und deren praktische Anwendung untersucht. Alle Piloten sind ausnahmslos einverstanden und sehen die persönlichen Vorteile des bestehenden Systems.

response Please see the answer to comment # 54

comment 188 comment by: ANSMUH

For airplanes, the same home base is shared by several crews, so in case of personnel unavailability, crews from the same home base can replace the colleagues. They regularly use the airport standby and the reserve personnel from the same home base to face operating problems. HEMS operating bases will have just the strict number of required crews to be rostered, because the other crews will have different rosters and home bases. In case of crew's unavailability a crew with the same home base is not automatically available. This proposal is modeled on what is done for aiplanes. It would be difficult to apply it to the French HEMS and other european country, especially for day/night bases. if this proposal is applied, it risks having a strong social movement in France. Proposal: CS FTL.3.230 Reserve HEMS The operator, when assigning duties to a crew member on reserve as provided for by ORO.FTL.230, complies with the following: (a) A crew member may be assigned to a maximum of 21 days on reserve per calendar year.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 472 of 585

An agency of the European Union

(b) Any FDP or standby duty, assigned after the reserve, counts from the reporting time. (c) Reserve times count for 50% of duty period do not count as duty period for the purpose of ORO.FTL.210(a) or (b) and ORO.FTL.235. (d) The operator specifies a number of consecutive reserve days within the limits of ORO.FTL.235(d). (e) To protect an 8-hour sleep opportunity in accordance with fatigue management principles, the operator rosters/pre-notifies for each reserve day a period of 8 hours during which a crew member on reserve cannot be contacted by the operator. (f) Minimum notification time for any duty is 10 hours that may include the 8-hour sleep opportunity under (e). (g) Reserve time does not count as recurrent extended recovery rest.

response Please see the answer to comment # 54

comment 258 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) max 21 days/year (b) FDP Counts from reporting time Question: Definition of reporting time? Does it start with arrival at base or with receiving the activation from reserve? (c) The operator needs to define an 8 hour period during reserve when the pilot must not be contacted (d) Reserve time doesn’t count for extended recurrent rest This can be accepted because if the pilot is not activated during reserve time he doesn’t need additional time for rest afterwards.

response Please see the answer to comment # 54

comment 292 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): CS FTL 3.230 Problem: Pilots in HEMS Service are on reserve, in case another pilot gets ill. Being 2 weeks at home in reserve without beeing activated has no impact on cumulative fatique. Being called all standard regulations apply. If there is a large distance to the HEMS base, he has to perform a 10 hour rest before starting service and because his travel counts as FDP, he can only perform 3 day shift.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 473 of 585

An agency of the European Union

We do not see any impact on cumulative fatique, if a pilot has more than 21 days in reserve Solution: Maximum of 4 periods with 7 days on reserve

response Please see the answer to comment # 54

comment 347 comment by: European Helicopter Association (EHA)

FNAM (France) ISSUE #1 (a) Réserve limitée à 21 jours, est-ce problématique ? => A discuter avec le SNEH. #2 REMARK (f) Due to the life-threatening mission and unexpected missions, the response time in the case of HEMS operation shall be really short to ensure, for example, the essential life-saving measures are offered to the patient as fast as possible. However, the EASA proposal allows a maximum notification time of 10 hours when the pilot is in reserve. In that way, the use of "reserve" for HEMS operation seems de facto limited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 409 comment by: ANWB MAA

In practice this will mean an operator (whose aim it will be to continue the HEMS operation as quick as possible) needs a standby crew on every station to replace an ill/not available pilot as 10 hours will be way too long to use the reserve pilot. Suggest to change this to less reaction time when notified in the morning (after 0700) and 8 hours if notified after 2200

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 474 of 585

An agency of the European Union

comment 430 comment by: UFH French Helicopters Association

REMARK (f) Due to the life-threatening mission and unexpected missions, the response time in the case of HEMS operation shall be really short to ensure, for example, the essential life-saving measures are offered to the patient as fast as possible. However, EASA proposal allows a maximum notification time of 10 hours when the pilot is in reserve. In that way, the use of "reserve" for HEMS operation seems de facto limited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 505 comment by: FNAM/SNEH

REMARK (f) Due to the life-threatening mission and unexpected missions, the response time in the case of HEMS operation shall be really short to ensure, for example, the essential life-saving measures are offered to the patient as fast as possible. However, EASA proposal allows a maximum notification time of 10 hours when the pilot is in reserve. In that way, the use of "reserve" for HEMS operation seems de facto limited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 537 comment by: ADAC Luftrettung gGmbH

(a) max 21 days/year (b) FDP Counts from reporting time Question: Definition of reporting time? Does it start with arrival at base or with receiving the activation from reserve? (c) The operator needs to define an 8 hour period during reserve when the pilot must not be contacted (d) Reserve time doesn’t count for extended recurrent rest This can be accepted because if the pilot is not activated during reserve time he doesn’t need additional time for rest afterwards.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 475 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 558 comment by: Rüdiger Neu

(a) Max. 21 Tage/Jahr (b) FDP in der Bereitschaft zählt ab der Reporting time Fragestellung: Wie ist die Reporting Time definiert, ist es der Zeitpunkt des Erhalts des Auftrags, Zeitpunkt Beginn des Auftrags (FDP / Standby)? (e) Das Unternehmen muss 8 Stunden innerhalb der Bereitschaft definieren, in der das Besatzungsmitglied nicht kontaktiert werden darf. (g) Bereitschaftszeit zählt nicht zur verlängerten Ruhezeit Dies ist akzeptabel, da wenn ein Pilot in der Bereitschaft nicht gerufen wird im Anschluss noch eine zusätzliche Phase, die Ruhezeit von bis zu 36 Stunden (unter den Voraussetzungen von CS FTL.3.205 (d) einhalten müsste.

response Please see the answer to comment # 54

comment 685 comment by: Oya Vendée Hélicoptères

REMARK (f) Due to the life-threatening mission and unexpected missions, the response time in the case of HEMS operation shall be really short to ensure, for example, the essential life-saving measures are offered to the patient as fast as possible. However, EASA proposal allows a maximum notification time of 10 hours when the pilot is in reserve. In that way, the use of "reserve" for HEMS operation seems de factolimited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 728 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.230 (f) [...] minimum notification time for any duty is 10 hours[...] Assuming a sick leave of a pilot on a HEMS duty in the morning - this rule prohibits the reserve pilot to fill the gap within 10h. Even though if it is the home base and the reserve pilot is living within a couple minutes. With this rule it is basically not possible to continue service if someone gets sick throughout the day. This endangers the health of sick or injured people!

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 476 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 759 comment by: DRF-Luftrettung

Problem: Pilots in HEMS Service are on reserve, in case another pilot gets ill. Being 2 weeks at home in reserve without being activated has no impact on cumulative fatique. Being called all standard regulations apply. If there is a large distance to the HEMS base, he has to perform a 10 hour rest before starting service and because his travel counts as FDP, he can only perform 3 day shift. We do not see any impact on cumulative fatique, if a pilot has more than 21 days in reserve Solution: Delete this limitation

response Please see the answer to comment # 54

comment 789 comment by: AECA helicopteros.

The operator, when assigning duties to a crew member on reserve as provided for by ORO.FTL.230, complies with the following: (a) A crew member may be assigned to a maximum of 21 days on reserve per calendar year. Proposal.- Delete (a) Justification.- For a small operator having, for example, 2 helicopters and 10 pilots can not cover one year of reserve, they would have 155 days a year without coverage.. The number of reserves that can be programmed should be left to the discretion of the operator.

response Please see the answer to comment # 54

comment 970 comment by: MBH SAMU

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 477 of 585

An agency of the European Union

In that way, the use of "reserve" for HEMS operation seems de factolimited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 992 comment by: Babcock Mission Critical Services Limited

We don´t agree of the maximum of 21 days per calendar year. We propose that the limitation should relate to the number of reporting times per calendar year, assuring rest times between a reserve time and a FDP. (Refer also to CS FTL.2.230 Reserve – Page 27) We consider that the limit is arbitrary and should not only apply to helicopter operations – CS.FTL.3.230 should be revised to replicate CS.FTL.2.230.

response Please see the answer to comment # 54

comment 998 comment by: AESA

Reserve is limited to 21 days per year due to pilots of HEMS tend to live far of their operating base. Since that is a very common situation affecting to crews of scheduled and air taxi operations (perhaps more than in HEMS), we think that it could be limited the total number of reserve per year for that operations, too.

response Please see the answer to comment # 54

comment 999 comment by: AESA

The expression “assigned after the reserve” in (b) is confusing. ¿Means it “after the reserve starts”, or “after the reserve finishes”?

response Please see the answer to comment # 54

comment 1094 comment by: B. Wagner

zu (a): Warum 21 Tage? Welche wissenschaftliche Grundlage liegt zugrunde? zu (b):

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 478 of 585

An agency of the European Union

Was ist die "reporting time"? Ankunft auf der jeweiligen Station oder Erhalt der Aktivierung? zu (f): nicht praktikabel. Sollte ein Pilot aus gesundheitlichen Gründen kurzfristig ersetzt werden, muss ich 10h vorher den Ersatz informieren? Dies wird in der Praxis zu Ausfällen in der vertraglich geforderten Bereitschaftszeit führen und eine Versorgungslücke für Patienten generieren. zu (g): Wenn in der Reserve keine Aktivierung erfolgt ist, hat der Besatzungsangehörige effektiv ausreichend Gelegenheit zur Ruhe. Deshalb ist diese geforderte Einschränkung nicht logisch.

response Please see the answer to comment # 54

comment 1173 comment by: NHV Group

Paragraph No: CS FTL.3.230 Reserve — HEMS Comment: Limiting the maximum number of days assigned to reserve, is related to the proposed limitation of maximum number of 4 consecutive FDP blocks, which in turn negatively affects quality of life for HEMS crew members is. Final effect of related limitation in number of consecutive FDPs induces more frequent exchange of reserve periods, and as such should be addressed. Justification: In case of the following work schedule: block of 7 consecutive FDP + block of 7 consecutive FDP + block of 14 days off-duty (in the last 7 days of off-duty block, flight crew is reserve flight crew), flight crews appreciate less frequent exchange of on-duty/off- duty periods, increasing their quality of life and flight performance. Evidence #1: Company survey among its HEMS crew members. Proposed text: (a) A crew member may be assigned to a maximum of 42 days on reserve per calendar year.

response Please see the answer to comment # 54

comment 1235 comment by: SAF

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 479 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1283 comment by: Hélicoptères de France

#1 REMARK (f) Due to the life-threatening mission and unexpected missions, the response time in the case of HEMS operation shall be really short to ensure, for example, the essential life-saving measures are offered to the patient as fast as possible. However, EASA proposal allows a maximum notification time of 10 hours when the pilot is in reserve. In that way, the use of "reserve" for HEMS operation seems de facto limited to non-urgent duties; for instance, to ensure a "reserve" crew can replaces an ill / not available crew at another operating base.

response Please see the answer to comment # 54

comment 1402 comment by: Swiss Air-Ambulance Rega

(a) Max. 21 days/year (b) FDP on reserve is counted from the reporting time Question: How is the reporting time defined; is it the point when an assignment is received, the start of an assignment (FDP/standby)? (e) The operator must define 8 hours within the reserve period during which a crew member cannot be contacted. (g) Reserve time does not count as extended rest time This is acceptable, because if a pilot on reserve is not called, there will be an additional phase after that, which would have to contain a rest time of up to 36 hours (under the requirements of CS FTL.3.205(d)).

response Please see the answer to comment # 54

comment 1497 comment by: Finnish Transport Safety Agency

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 480 of 585

An agency of the European Union

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Reasoning: When active standby is used, relief crew is required as a mitigating measure. The details of the system will be required in the operations manual. The intention is that relief crew is ready to be notified when the operator notices that duty times of the crew in active standby threaten to be exceeded. With this requirement the pressure on active crew would be decreased. It must be kept in mind that HEMS is a life-saving activity, and the pressure it creates for the crew should be taken into account. Proposal: Add new paragraph CS FTL.3.232 after CS FTL.3.230 as follows: CS FTL.3.232 Relief crew — HEMS (a) active standby can only be used if a system for alarming relief crew is described in operations manual. (b) the operator, when assigning duties to a relief crew member to back-up crew in active standby in HEMS operations, and as provided for by ORO.FTL.230, complies with the following: (1) a crew member may be assigned to a maximum of 21 days on as a relief crew member per calendar year. (2) the ADP of relief crew starts from alarm to HEMS base and ends 30 minutes after the flight has ended, or when all duties related to the flight or to other tasks that have been carried out, whichever occurs later.

response Please see the answer to comment # 54

GM1 CS.FTL.3.230(d) p. 39

comment 63 comment by: London's Air Ambulance

The use of the words “surrounding days” is poor use of English. You cannot ‘surround’ a sleep pattern with ‘days’. Consider amending to read: “…crew members should be able to maintain an established sleep pattern.”

response Please see the answer to comment # 54

comment 1284 comment by: Hélicoptères de France

#1 GENERAL AGREEMENT TO CS.FTL.3.235

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 481 of 585

An agency of the European Union

HDF thanks EASA for allowing flexibility to use reduced rest. HDF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours

• 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

• 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift

• Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). (Cf. comment #30.6) #2 (a)(3) ISSUE HDF wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 482 of 585

An agency of the European Union

Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. Therefore, HDF suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #30.6) PROPOSAL: Replace the paragraph (3) by the following: “(3) The recurrent extended recovery rest following a reduced rest period is increased to include 3 local nights.” #3 (b)(2) AGREEMENT HDF agrees to require the use of a FRM for using reduced rest and points out again to EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, HDF suggests proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 1356 comment by: European Cockpit Association

Commented text: Fatigue management principles means, in the context of a rostered 8-hour sleep opportunity, that crew members should be able to maintain a consistent sleep pattern with surrounding days. ECA Comment: Suggest different wording, to include all reductions below 12hrs. The min rest period may be reduced to 10 hours for max 3 times between two extended recovery rests; if the WOCL is included the rest period may be reduced to an 8 hour sleep opportunity taking any personal and duty needs into account, for one time between two extended recovery rests. Any rest period below 10hrs must be taken at the operation base with suitable accommodation. (This is in line with the recommendation of the RMG)

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 483 of 585

An agency of the European Union

comment 1460 comment by: Association of Air Ambulances

response Please see the answer to comment # 54

CS FTL.3.235 p. 39

comment 9 comment by: TG

Eine festgelegte Zeit von 10h "Rest" erhöht keineswegs die Erholung. Die nötige Zeit hängt ausschließlich von der tatsächlichen Belastung der Crew ab. Das REGA Modell - "Fliege und Ruhe wie Du es benötigst" schafft den besten Fatigue-Schutz.

response Please see the answer to comment # 54

comment 259 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): (a) Rest period can be reduced to 10 hours (currently in Germany 8:30h, based on a scientificstudy from DLR 1996). As soon as rest period is reduced a FRM is required. If rest periodis reduced, extended recurrent recovery rest is required afterwards including 4 nights(currently 3 nights and 48 hours). Reduced rest is defined as rest of less than the FDP infront, min. 12 hours at home base or 10 hours at other bases. (b) When changing from night duty to day duty, at least one night free of duty needs to beplanned. After more than 4 night duties, early start (05:00 – 05:59) or late landing (23:00-01:59) recurrent recovery rest period needs to include 3 nights. We need to insist on a further reduction of possible rest periods to allow for thecontinuation of the current duty roster. Experience from our own operation with 08:30hours rest and Austrian schedules with 08:00 hours rest and flight safety statistics fromthe past missing any fatigue related accident in HEMS should allow for a reduction of restperiod times. In addition, results from the ongoing DLR study will probably show, that thereis no major risk in reducing rest periods according to the implemented and provenregulations already in place in Germany for some years. The implementation of FRMseems to be unnecessary as well.

response Please see the answer to comment # 54

comment 348 comment by: European Helicopter Association (EHA)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 484 of 585

An agency of the European Union

FNAM (France) #1 GENERAL AGREEMENT TO CS.FTL.3.235 The FNAM thanks the EASA for allowing flexibility to use reduced rest. The FNAM underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience: • 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours • 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours Therefore, most hospitals / HEMS organizations have a contractual engagement with the NationalHealth Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hoursOFF.According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMSorganization will yet roster cycle with a FDP of 12h30 and a Duty Period of 12h45 to ensure they followtheir engagement with hospitals. Thus, all HEMS operators will have to schedule: • More than 12h FDP for each and every vacation • Reduced rest of more than 10h amongst a 11h15 available time for rest according to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. Morethan 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent ina suitable accommodation at the HEMS operating base, and the effective flight time are verylow (average of total flight time of 1h30 per FDP with an average leg of 25 minutes i.e 50 minutes back and force for 1 mission in Francei). (Cf. comment #30.6) #2 (a)(3) ISSUE The FNAM wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes i.e 50 minutes back and force for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has no reported inherent safety issue through experience. Therefore, the FNAM suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a sound RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #30.6) PROPOSAL: Replace the paragraph (3) by the following: “(3) The recurrent extended recovery rest following a reduced rest period is increased to include 3 local nights.” #3 (b)(2)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 485 of 585

An agency of the European Union

AGREEMENT The FNAM agrees to require the use of a FRM for using reduced rest and points out again to the EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, the FNAM suggests proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 370 comment by: European Helicopter Association (EHA)

BHA (UK) "CS FTL.3.235 Rest periods — HEMS (a)(1)" Comment: This is good, but throughout the FTL scheme, there is no mention of how an operator should manage Days Off. CAP371 provides some useful guidance, but this is not reflected by the NPA.

response Please see the answer to comment # 54

comment 402 comment by: European Helicopter Association (EHA)

response Please see the answer to comment # 54

comment 410 comment by: ANWB MAA

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 486 of 585

An agency of the European Union

As some people live close by and to fulfill the requirement of 8 hours sleep suggest to change in 8 hours rest excluding travelling

response Please see the answer to comment # 54

comment 432 comment by: UFH French Helicopters Association

Allowing flexibility to use reduced rest is most appreciated.

The French regulation historically proposes several rostering cycles for HEMS

operations that are currently used with an excellent safety track record demonstrated by

experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours

• 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

• 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours

Therefore, most hospitals / HEMS organizations have a contractual engagement with the

National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative

availability and 12 hours OFF.

Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational

readiness issues According to the Agency requirement on the pre-flight and post-flight

minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a

Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all

HEMS operators will have to schedule:

• More than 12h FDP for each and every shift

• Reduced rest of more than 10h amongst a 11h15 available time for rest according to

CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM.

More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they

are spent in a suitable accommodation at the HEMS operating base, and the effective

flight time are very low (average of total flight time of 1h30 per FDP with an average leg

of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei).

(a)(3)

ISSUE

We wonder why the minimum recurrent extended recovery rest period following a

reduced rest period is increased to include 4 local nights since no analysis has been made

in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations.

Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight

time: they are spent in a suitable accommodation at the HEMS operating base, and the

effective flight time are very low (average of total flight time of 1h30 per FDP with an

average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in

Francei).

Moreover, reduced rest is used under the principles of a FRM, that shall provide all other

mitigation measures as necessary.

Furthermore, no demonstration nor RIA is given to justify this value, while the current

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 487 of 585

An agency of the European Union

rostering in France on this subject for HEMS operations has not reported inherent safety

issue through experience.

Therefore, UFH suggests keeping the standard extended recovery rest period of 3 local

nights including when reduced rest occurs, under the principles of a FRM, unless a further

developed RIA and/or a scientific study justify the necessity of 4 local nights.

(Cf. comment #30.6)

PROPOSAL:

Replace the paragraph (3) by the following:

“(3) The recurrent extended recovery rest following a reduced rest period is increased to

include 3 local nights.”

(b)(2)

AGREEMENT

We agree to require the use of a FRM for using reduced rest and points out again to

EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority

of HEMS operators are SME, we agree with FNAM proposal to suggests proportionating

the measure and using reduced rest under the principles of a FRM.

PROPOSAL

Replace the paragraph (a)(3) by the following:

“(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 507 comment by: FNAM/SNEH

Attachments #225 #226 #227 #228

GENERAL AGREEMENT TO CS.FTL.3.235 FNAM and SNEH thank EASA for allowing flexibility to use reduced rest. FNAM and SNEH underline the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 488 of 585

An agency of the European Union

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei).

(Cf. comment #501)

response Please see the answer to comment # 54

comment 508 comment by: FNAM/SNEH

(a)(3) ISSUE FNAM and SNEH wonder why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SNEH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. Therefore, FNAM and SNEH suggest keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #501)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 489 of 585

An agency of the European Union

PROPOSAL: Replace the paragraph (3) by the following: “(3) The recurrent extended recovery rest following a reduced rest period is increased to include 3 local nights.”

response Please see the answer to comment # 54

comment 509 comment by: FNAM/SNEH

(b)(2) AGREEMENT FNAM and SNEH agree to require the use of a FRM for using reduced rest and points out again to EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, FNAM and SNEH suggest proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 538 comment by: ADAC Luftrettung gGmbH

a) Rest period can be reduced to 10 hours (currently in Germany 8:30h, based on a scientific study from DLR 1996). As soon as rest period is reduced a FRM is required. If rest period is reduced, extended recurrent recovery rest is required afterwards including 4 nights (currently 3 nights and 48 hours). Reduced rest is defined as rest of less than the FDP in front, min. 12 hours at home base or 10 hours at other bases. (b) When changing from night duty to day duty, at least one night free of duty needs to be planned. After more than 4 night duties, early start (05:00 – 05:59) or late landing (23:00 -01:59) recurrent recovery rest period needs to include 3 nights. We need to insist on a further reduction of possible rest periods to allow for the continuation of the current duty roster. Experience from our own operation with 08:30 hours rest and Austrian schedules with 08:00 hours rest and flight safety statistics from the past missing any fatigue related accident in HEMS should allow for a reduction of rest period times. In addition, results from the ongoing DLR study will probably show, that there is no major risk in reducing rest periods according to the implemented and proven regulations already in place in Germany for some years. The implementation of FRM seems to be unnecessary as well.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 490 of 585

An agency of the European Union

comment 559 comment by: Rüdiger Neu

(a) Ruhezeit darf auf 10 Stunden reduziert werden (bisher 8:30 Stunden). Sobald man die Ruhezeit reduziert wird ein FRM benötigt. Wird eine Ruhezeit reduziert, muss eine verlängerte Ruhezeit im Anschluss an die Dienstperiode von 4 Nächten (bisher 48 Stunden und 3 Nächte) eingehalten werden. Von einer reduzierten Ruhezeit spricht man, sobald diese kleiner ist als die vorangegangene FDP, min. 12 Stunden an der Heimatstation oder 10 Stunden an einer fremden Station. (b) Beim Übergang von Nacht- zu Tagdienst muss mindestens eine Nacht eingeplant werden. Bei mehr als 4 Nachtdiensten oder frühem Start (05:00 -05:59 Uhr) oder später Landung (23:00 – 01:59) muss die verlängerte Ruhezeit drei Nächte enthalten. Hier muss auf eine weitergehende Verkürzung der Ruhezeit gedrängt werden, damit ein Dienstmodell analog heute weiterhin möglich bleibt. Die Erfahrung aus unserem Flugbetrieb mit min. 8:30 Stunden und den Österreichern mit 8:00 Stunden Ruhezeit, sowie die fehlenden Flugunfälle in der Vergangenheit bezüglich Fatigue, sollten eine weitergehende Reduzierung belegen. Hier werden auch unser Studienergebnis weitere Erkenntnisse bringen und belegen, dass eine Reduzierung der Ruhezeit, wie sie in Deutschland seit Jahrzehnten praktiziert wird, keinen Einfluss auf die Sicherheit hat. Die Einführung eines FRM muss damit hier obsolet sein.

response Please see the answer to comment # 54

comment 686 comment by: Oya Vendée Hélicoptères

Attachments #229 #230 #231 #232

GENERAL AGREEMENT TO CS.FTL.3.235 OYA thanks EASA for allowing flexibility to use reduced rest. OYA underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 491 of 585

An agency of the European Union

Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for OYA i.e 50 minutes back and forth for 1 mission in Francei).

(Cf. comment #681)

response Please see the answer to comment # 54

comment 687 comment by: Oya Vendée Hélicoptères

(a)(3) ISSUE OYA wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for OYA i.e 50 minutes back and forth for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. Therefore, OYA suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #681) PROPOSAL: Replace the paragraph (3) by the following:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 492 of 585

An agency of the European Union

“(3) The recurrent extended recovery rest following a reduced rest period is increased to include 3 local nights.”

response Please see the answer to comment # 54

comment 688 comment by: Oya Vendée Hélicoptères

(b)(2) AGREEMENT OYA agrees to require the use of a FRM for using reduced rest and points out again to EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, OYA suggests proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 730 comment by: ÖAMTC Helicopter Air Rescue (Austria)

CS FLT.3.235 (a) [...] only if taken at the HEMS operating base [...] The pilot living in vicinity of the base has to stay on the base? Even thought he would be at home within a couple of minutes? (b) If you follow those regulations in a normal HEMS schedule, you won’t be able to work anymore (to many local nights necessary and to many restrictions which make a applicable roster planning impossible)

response Please see the answer to comment # 54

comment 750 comment by: DRF-Luftrettung

We need to insist on a further reduction of possible rest periods to allow for the continuation of the current duty roster. Experience from our own operation with 08:30 hours rest and Austrian schedules with 08:00 hours rest and flight safety statistics from the past missing any fatigue related accident in HEMS should allow for a reduction of rest period times. In addition, results from the ongoing DLR study will probably show, that there is no major risk in reducing rest periods according to the implemented and proven

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 493 of 585

An agency of the European Union

regulations already in place in Germany for some years. The implementation of FRM seems to be unnecessary as well.

response Please see the answer to comment # 54

comment 824 comment by: Babcock Mission Critical Services Limited

Clarification required on rest period at HEMS base. Nearby suitable and more appropriate accommodation needs to be defined within a distance/time of an operating base. Revise as follows: CS FTL.3.235 Rest periods — HEMS (a) Reduced rest in HEMS operations complies with the following: (1) The minimum rest period may be reduced to 10 hours, only if taken at suitable accommodation designated by the operator. (2) …

response Please see the answer to comment # 54

comment 845 comment by: Yorkshire Air Ambulance

Mandating rest periods is useful but, throughout the FTL scheme, there is no mention of how an operator should manage Days Off. CAP371 provides some useful guidance, but this is not reflected by the NPA.

response Please see the answer to comment # 54

comment 971 comment by: MBH SAMU

Attachments #233 #234 #235 #236

GENERAL AGREEMENT TO CS.FTL.3.235 MBH thanks EASA for allowing flexibility to use reduced rest.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 494 of 585

An agency of the European Union

MBH underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for MBH i.e 50 minutes back and forth for 1 mission in Francei).

(Cf. comment #965)

response Please see the answer to comment # 54

comment 973 comment by: MBH SAMU

(a)(3) ISSUE MBH wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 495 of 585

An agency of the European Union

effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for MBH i.e 50 minutes back and forth for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary. Furthermore, no demonstration nor RIA is given to justify this value, while the current rostering in France on this subject for HEMS operations has not reported inherent safety issue through experience. Therefore, MBH suggests keeping the standard extended recovery rest period of 3 local nights including when reduced rest occurs, under the principles of a FRM, unless a further developed RIA and/or a scientific study justify the necessity of 4 local nights. (Cf. comment #965) PROPOSAL: Replace the paragraph (3) by the following: “(3) The recurrent extended recovery rest following a reduced rest period is increased to include 3 local nights.”

response Please see the answer to comment # 54

comment 974 comment by: MBH SAMU

(b)(2) AGREEMENT MBH agrees to require the use of a FRM for using reduced rest and points out again to EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, MBH suggests proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 1113 comment by: B. Wagner

zu (a) (1): die Erfahrung mit bestehenden Systemen zeigt, dass für eine begrenzte Anzahl aufeinanderfolgender Tage eine Reduzierung der Ruhezeit auch auf acht Stunden ohne Probleme machbar ist. Speziell wenn die Crew adäquate Ruhemöglichkeiten auf der Station oder in der direkten Umgebung hat, reichen acht Stunden aus, um effektiv sieben Stunden am Stück und planbar zu schlafen, was für einen Erwachsenen als durchaus realistischer und ausreichender Wert betrachtet werden kann. Diese Annahme basiert auf

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 496 of 585

An agency of the European Union

jahrelanger praktischer Erfahrung und hat sich auch ohne Nachweis durch eine Studie bewährt. zu (a) (2): FRM ist eine zusätzliche Bürde für die Unternehmen. Besser wäre es, die Prinzipien eines FRM anzuwenden ohne den administrativen Aufwand der Implementierung eines solchen Systems auf jedes Unternehmen zu übertragen. Kleine Unternehmen haben keine Kapazitäten, dieses Erfordernis umzusetzen. zu (b) (2): Auch hier wird wieder ein hoher organisatorischer Aufwand gefordert, um die speziellen Fälle festzustellen und die Planung entsprechend anzupassen. Das führt eher zu Störungen in der Dienstplanung und damit Einbussen in der planbaren Freizeit und fördert dadurch das Risiko von Fatigue. Dies widerspricht der eigentlichen Zielsetzung des Entwurfs.

response Please see the answer to comment # 54

comment 1174 comment by: NHV Group

Paragraph No: CS FTL.3.235 Rest periods — HEMS Comment: To be aligned with change of provisions given under comments in CS FTL.3.205 Flight duty period (FDP) - HEMS Unforeseen circumstances in flight operations — commander’s discretion in HEMS under ORO.FTL.205(f), commander's discretion should allow reduction of the rest period instead of increase of the FDP as proposed in the NPA. Justification: Proposed text: 1) The minimum rest period may be reduced to 8 hours, only if taken at the HEMS operating base with a suitable accommodation provided by the operator.

response Please see the answer to comment # 54

comment 1236 comment by: SAF

Attachments #237 #238 #239 #240

GENERAL AGREEMENT TO CS.FTL.3.235 SAF thanks EASA for allowing flexibility to use reduced rest. SAF underlines the French regulation historically proposes several rostering cycles for HEMS operations that are currently used with an excellent safety track record demonstrated by experience:

• 7 days ON / 7 days OFF with a limitation of 14 hours of duties for 24 hours • 5 days ON / 2 days OFF with a limitation of 12 hours of duties for 24 hours

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 497 of 585

An agency of the European Union

• 12 days ON / 6 days OFF with a limitation of 12 hours of duties for 24 hours

Therefore, most hospitals / HEMS organizations have a contractual engagement with the National Health Authority over a rolling 24 hours period: 12 hours of HEMS operative availability and 12 hours OFF. Cf. attachments S1, S2, S3 and S4 illustrating the reduced rest and the 12h operational readiness issues According to the Agency requirement on the pre-flight and post-flight minimum times, an HEMS organization will yet roster cycles with a FDP of 12h30 and a Duty Period of 12h45 to ensure they follow their engagement with hospitals. Thus, all HEMS operators will have to schedule:

• More than 12h FDP for each and every shift • Reduced rest of more than 10h amongst a 11h15 available time for rest according

to CS.FTL.3.235 to reengage at the same time the day after, under the principles of a FRM. More than 12 hours FDP does not appear more tiring than less than 12 hours FDP: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SAF i.e 50 minutes back and forth for 1 mission in Francei).

(Cf. comment #1231)

response Please see the answer to comment # 54

comment 1237 comment by: SAF

(a)(3) ISSUE SAF wonders why the minimum recurrent extended recovery rest period following a reduced rest period is increased to include 4 local nights since no analysis has been made in the RIA. Besides, there is not such a requirement is for non-HEMS CAT operations. Reduced rest does not appear over tiring, as balanced to the nature of the FDP and flight time: they are spent in a suitable accommodation at the HEMS operating base, and the effective flight time are very low (average of total flight time of 1h30 per FDP with an average leg of 25 minutes for SAF i.e 50 minutes back and forth for 1 mission in Francei). Moreover, reduced rest is used under the principles of a FRM, that shall provide all other mitigation measures as necessary.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 498 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 1238 comment by: SAF

(b)(2) AGREEMENT SAF agrees to require the use of a FRM for using reduced rest and points out again to EASA the necessity to allow flexibility to use reduced rest. Nevertheless, as the majority of HEMS operators are SME, SAF suggests proportionating the measure and using reduced rest under the principles of a FRM. PROPOSAL Replace the paragraph (a)(3) by the following: “(3) Reduced rest is used under the principles of a FRM.”

response Please see the answer to comment # 54

comment 1312 comment by: Elilombarda

CS FTL.3.235 Rest periods — HEMS See comment to CS FTL.3.205 Flight duty period (FDP) — HEMS for rationale. It is suggested to allow rosters of 7/7 and up to 14/14, maintaining an equal number of extended rest period days as the preceding FDP block days. During the rest period, the crew can be tasked to perform training, checking and duties in a non-operative environment (not for an operative shift) as per the operator’s necessities, provided that adequate rest is granted after the end of the preceding shift and before the beginning of

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 499 of 585

An agency of the European Union

the subsequent shift. All training, checking and duties shall be counted as duty time for the maximum duty time in the 14 and 28 days. Point (a)(3) has been increased to "84 hours including 4 local nighs" which correspond to 3 full days of continuous rest after a shift. 2 full days, as indicated in the NPA are not enough for a complete rest after a full shift. Suggested NPA amendment CS FTL.3.235 Rest periods — HEMS Recurrent extended recovery rest periods The minimum recurrent extended recovery rest period should be at least of the same number of days and nights as the preceding duty or FDP period. The operator may assign duties, training and checking to a crew during the recurrent extended recovery rest period, provided that: the assigned duties are not in an operative context; the rest period preceding the first FDP is at least 36 hours including 2 local nights; the rest period provided after completion of the series of consecutive FDPs is at least 84 hours including 4 local nights; and all the assigned duties, training and checking are counted as duty time for the duty time limits defined in ‘CS FTL.3.210 Flight times and duty periods — HEMS’. Reduced rest in HEMS operations complies with the following: The minimum rest period may be reduced to 10 hours, only if taken at the HEMS operating base with a suitable accommodation provided by the operator. Reduced rest is used under FRM. The recurrent extended recovery rest following a reduced rest period is increased to include 4 local nights. Disruptive schedules When a transition from a late finish/night duty to an early start is planned at home base, the rest period between the 2 FDPs, includes 1 local night. For a crew member performing 4 or more night duties, early starts or late finishes between 2 extended recovery rest periods as defined by ORO.FTL.235(d), the second extended recovery rest period is extended to include 3 local nights.’ IMPACT ANALYSIS ON DUTY PERIOD, FLIGHT DUTY PERIOD and REST PERIODS Before suggested changes:

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 500 of 585

An agency of the European Union

SAFETY OPERATOR – NEGATIVE – In case the operator shall guarantee an uninterrupted HEMS service during the day (most of present contracts), he must organise for a substitute crew during brakes. CREWS – NEGATIVE – In case of 4/4 rosters the crew may not be able to rest at his residence and family place. If the crew’s local accommodation is at the HEMS operating base, he will not be able to use that accommodation due to the presence of the duty crew. ECONOMIC OPERATOR – IMPROVED – The operator shall not organise for a substitute crew during brakes. CREWS – IMPROVED – If the crew’s residence and family place is away from the operating base, the crew shall not manage for a local accommodation during extended rest periods. ECONOMIC OPERATOR – IMPROVED – The operator shall not renegotiate the HEMS contracts or provide for a substitute crew for breaks. CREWS – IMPROVED – The crew will reduce the travel and the local accommodation expenses.

response Please see the answer to comment # 54

comment 1403 comment by: Swiss Air-Ambulance Rega

(a) The rest period may be reduced to 10 hours (8.5 hours until now). Once the rest period is reduced, FRM is needed. If a rest period is reduced, an extended rest period of 4 nights (48 hours and 3 nights until now) must be observed after the duty period. A rest time is reduced once it is shorter than the preceding FDP, min. 12 hours at the home base or 10 hours at another base. (b) In the event of transition from night duty to day duty, at least one night must be planned in between. In the event of more than 4 nights of duty or an early start (5:00–5:59 a.m.) or late landing (11:00 p.m.–1:59 a.m.), the extended rest time must include three nights. Here, it is necessary to insist on a further reduction of the rest time so that a duty model similar to today’s continues to be possible. The experience gained from flight operations in Germany with min. 8.5 hours and in Austria with 8 hours of rest time, as well as the absence of aircraft accidents in the past resulting from fatigue should serve as evidence for a further reduction. Here, the ADAC and DRF study results will provide further information as well and demonstrate that a reduction in rest time, as practised in Germany for decades, has no impact on safety.

response Please see the answer to comment # 54

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 501 of 585

An agency of the European Union

comment 1498 comment by: Finnish Transport Safety Agency

In order to establish rolling 24 hour standby for HEMS, following amendments are proposed. Reasoning: Proposed rest periods are more restrictive than in the NPA for HEMS. This mitigates fatigue between the two active standby periods. Proposal: Add new paragraph CS FTL.3.237 after CS FTL.3.235 as follows: CS FTL.3.237 Rest periods in active standby — HEMS By way of derogation from CS FTL.3.235, the minimum rest periods in active standby are established in accordance with Table 1:

Table 1

Active standby - HEMS Minimum rest period after active standby

24:00 48:00

48:00 72:00

72:00 96:00

response Please see the answer to comment # 54

Rationale for CS-FTL.3 p. 39-41

comment 10 comment by: TG

zu 39.: Die erforderlich Schlafmenge ist äusserst individuell - mir reichen 5h pro Tag vollkommen aus und ich bin mit 54J. kerngesund. Das Prinzip "Melde dich zur Erholung ab wenn erforderlich auch vor dem Ende des regulären Dienstes" ist effektiver. Ich habe das bereits mehrfach angewandt - der Operator ist zufrieden damit. Das erhöht die Sicherheit wirklich.

response Please see the answer to comment # 54

comment 371 comment by: European Helicopter Association (EHA)

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 502 of 585

An agency of the European Union

BHA (UK) "(38)... CS FTL.3.230 is an adaptation of the CS-FTL.1 Reserve provisions, but for clarity includes some elements from the definition and the GM. The prescriptive limit of 21 days of reserve per crew member and per calendar year is based on the comparison of existing practices and the consensus of the rulemaking group. In the HEMS operating environment it is often found that crew members have considerable commuting distances between their residence and the HEMS operating base. " Comment: Seems to be a very arbitrary limit - why 21 days and not 28? "(39).. CS FTL.3.235 establishes reduced rest provisions that are tailored to the HEMS environment. The reduced rest periods in HEMS operations are provided on the HEMS operating base. That means, crew members do not spend any time on travelling between the HEMS operating base and the place of rest. Therefore, the minimum rest period at the HEMS operating base is set to 10 hours. This allows for an 8-hour sleep opportunity. The FDP following a reduced rest period does need to be reduced because the workload in HEMS is limited by limiting the number of flight hours per FDP and by prescribing a protected break(s) during the FDP. " Comment: This paragraph suggests that breaks for HEMS FDPS have been introduced as mitigation for reduced rest. The two elements should be kept separate.

response Please see the answer to comment # 54

comment 411 comment by: ANWB MAA

Ad 38. It states "often found" - often found but doesn't meet countries that have just short commuting distances

response Please see the answer to comment # 54

comment 732 comment by: ÖAMTC Helicopter Air Rescue (Austria)

34. CS FTL.3.205: 34. On and off duty times are interconnected in a roster. Less on duties create less off duties in a specific period. This leads to a significant higher travel activity. Applied to our operation we had the experience that this might lead up to 2,7 times of the time used for traveling. Therefore this diverts possible free time into travel activities of the pilots (as well as spending more time on the road).

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 503 of 585

An agency of the European Union

response Please see the answer to comment # 54

comment 733 comment by: ÖAMTC Helicopter Air Rescue (Austria)

34 CS FTL.3.205: [...] the maximum flight time for the maximum daytime FDP is limited to 7 hours with autopilot and 5 hours without autopilot[...] 34. We appreciate considering autopilot systems as a support for the flight crew. But in view of the fact that AP systems create a complex work environment we do not understand that not using the AP reduces average flight time up to 2 hours per day (This reduction might not have a scientific background and seems not to be an evidenced based approach)

response Please see the answer to comment # 54

comment 846 comment by: Yorkshire Air Ambulance

Seems to be a very arbitrary limit - why 21 days and not 28?

response Please see the answer to comment # 54

comment 847 comment by: Yorkshire Air Ambulance

This paragraph suggests that breaks for HEMS FDPS have been introduced as mitigation for reduced rest. The two elements should be kept separate.

response Please see the answer to comment # 54

Id. CRD table of comments, responses and resulting text – Impact Assessment (HEMS)

comment 262 comment by: European Helicopter Association (EHA)

ADAC (Germany), DRF (Germany) and LAR (Luxembourg): The contents have already been doubted and partially contradicted during RMT phase. Even associations have shown failures during the assessment, nevertheless these inputs have not been taken into regard by EASA. Time calculations and tables are not explained to interested parties and social impact on crews is not mentioned and accounted for at all.

European Union Aviation Safety Agency CRD 2 to NPA 2017-17

Individual comments and responses — HEMS

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 504 of 585

An agency of the European Union

This NPA when being transferred into regulation without change will lead to a requirement of additional pilots. In Germany there is not enough qualified personnel available on short notice and the training and qualification of available pilots will cost a large amount of money and take several years. The rise in costs could in the worst case even lead to a total collapse of the system implemented in Germany with unpredictable social impact concerning jobs of crew and reduction of quality in the rescue system.

response The impact assessment (IA) to NPA 2017-17 did not evaluate the impact of the proposed