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Document 52019PC0122

Proposal for a COUNCIL DECISION on the position to be taken by the European Union within the Bilateral Oversight Board under the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, concerning the addition of an Annex 4 to the Agreement

COM/2019/122 final

Brussels, 7.3.2019

COM(2019) 122 final

2019/0067(NLE)

Proposal for a

COUNCIL DECISION

on the position to be taken by the European Union within the Bilateral Oversight Board under the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, concerning the addition of an Annex 4 to the Agreement


EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

Reasons for and objectives of the proposal

In 2008, the European Union and the United States of America signed an agreement on cooperation in the regulation of civil aviation safety (hereinafter referred to as 'the Agreement'). The scope of the Agreement, which entered into force on 1 May 2011, was initially limited to airworthiness and environmental testing, approval and monitoring of aeronautical products as well as approval and monitoring of maintenance facilities. The scope of the Agreement was subsequently extended to personnel licensing and training, operation of aircraft, and air traffic services and air traffic management. 1 That extension was effectuated by an amendment signed on 13 December 2017 and is provisionally applied since that date.

Taking into account the extended scope of the Agreement, the Commission, assisted by the European Union Aviation Safety Agency (EASA) developed together with the U.S. Federal Aviation Administration (FAA) a new Annex 4 to the Agreement on monitoring of Flight Simulation Training Devices (FSTD), to reduce redundant regulatory oversight of FSTDs in the Union and the U.S.

The scope of the proposed new FSTD Annex covers recurrent evaluations of Full Flight Simulators (FFS) for aeroplanes.

At present there are 131 active EASA certificates for FFS located in the United States and 34 active FAA certificates for FFS located in EU Member States (UK: 17, The Netherlands: 3, France: 13 and Denmark: 1). Each of these devices holds a double certificate: EASA and FAA certificate in case of devices located in US, and FAA certificate and certificate from a national aviation authority or, in certain cases, EASA in case of devices located in EU Member States.

In order to maintain the validity of their certificates, each of those simulators must be re-evaluated on a periodic basis. This results in double auditing of each of the device, which is causing unnecessary administrative burden, additional costs for a second re-evaluation and is reducing the availability of the devices for training of pilots. For example, in 2017, EASA conducted 132 recurrent evaluations of FFS located in the US. On the other hand in 2017, the FAA conducted 34 recurrent evaluations of FFS located in EU Member States. The FFS is not available for training during the authority evaluation.

Under the proposed new FSTD Annex, the conduct of the recurrent evaluations will be simplified. EASA will rely on the FAA for the recurrent evaluations of the devices located in the US, and the FAA will rely on the national aviation authorities or, in certain cases, EASA for the recurrent evaluation of devices located in EU Member States. This will allow to avoid duplication of audits and as a result will provide cost and productivity savings for the EASA, FAA and industry. FAA estimates that in 2017 it has charged about 170.000 USD to operators of FFS located in EU Member States to recover the costs of on-site recurrent evaluations conducted in Europe. On the EU side in 2017 EASA has charged over 1.1 million EURO to operators of FFS located in the US to recover the travel costs associated with recurrent evaluations conducted in US (in addition to charges for working hours performed on site in US during the evaluations).

Consistency with existing policy provisions in the policy area

The cooperation between the EU and the United States of America on aviation safety is part of the Aviation Strategy for Europe. The proposed new FSTD Annex is consistent with the general objectives of the Agreement on the regulation of civil aviation safety between the EU and the U.S., which is to ensure a high level of civil aviation safety worldwide and to minimise economic burdens on the aviation industry and operators from redundant regulatory oversight.

Consistency with other Union policies

The Agreement serves a fundamental objective of the external aviation policy of the Union by enhancing civil aviation safety and facilitate trade and investment in aeronautical products. The new FSTD Annex is consistent with the overall aviation policy of the Union by promoting mutual acceptance of certificates and technical findings with key international partners and making more efficient use of resources available at EU and Member State level.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

Legal basis

Treaty on the Functioning of the European Union, in particular Article 100(2) in conjunction with Article 218(9) thereof.    Subsidiarity (for non-exclusive competence)

Not applicable.

Proportionality

Not applicable.

Choice of the instrument

To add a new Annex to the Agreement is the most efficient instrument to achieve the goal of allowing efficient reciprocal acceptance of findings of compliance and documentation for Flight Simulation Training Devices (FSTD).

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

Ex-post evaluations/fitness checks of existing legislation

Not applicable.

Stakeholder consultations

EU Member States in which FFS (that are certified by the FAA) are located have been involved in the confidence building exercise conducted by EASA and the FAA in 2013 in preparation on establishing this new Annex.

The Commission informed and consulted EU Member States about developing a new FSTD Annex in the Council’s Aviation Working Party though reports on the discussions in the Bilateral Oversight Board under the Agreement (to which EU Member States are invited to attend) and (b) in the context of the preparations for the Council Decision (EU) 2018/61 to enlarge the scope of the Agreement, including, among others, personnel licensing and training.

   Collection and use of expertise

When developing the new FSTD Annex the European Commission was assisted by EASA. EASA and FAA conducted a regulatory comparison between the EU and U.S. requirements for certification of FSTD. That comparison was finalised in 2014 and allowed to identify also the regulatory differences between the EU and U.S. systems, which are addressed by so called ‘special conditions’ which are laid down in the proposed FSTD Annex.

EASA also performed an assessment of the FAA’s National Simulator Programme (NSP) in order to establish confidence in the U.S. system for oversight of flight simulators. That assessment included an EASA visit to the NSP office located in Atlanta (August 2013), as well as observations of NSP evaluations of EASA certified simulators in Dallas (November 2013) and Miami (December 2013). The scope of the assessment was limited to recurrent evaluations of full flight simulators for aeroplanes, which corresponds to the scope of the proposed FSTD Annex.

On 2 July 2014, EASA together with the FAA reported to the Bilateral Oversight Board (BOB) established under the Agreement that the regulatory comparison as well as the confidence building exercises were successfully completed. That concluded the preparatory technical work for the development of the new FSTD Annex.

Impact assessment

Not applicable

Regulatory fitness and simplification

Not applicable

Fundamental rights

Not applicable

4.BUDGETARY IMPLICATIONS

No impact on the EU budget

5.OTHER ELEMENTS

Implementation plans and monitoring, evaluation and reporting arrangements

On the EU side, EASA will coordinate the implementation of the new FSTD Annex. The detailed procedures concerning the implementation will be defined in the Simulator Implementation Procedures (SIP), which are currently being finalised by the Technical Agents EASA and FAA (in time for the adoption of the new FSTD annex).

The monitoring of the implementation of the FSTD Annex will be performed in the first place by the FSTD Oversight Board (FOB) which will be accountable to the BOB established under the Agreement. The FOB will report to the BOB on a regular basis.

Explanatory documents (for directives)

Not applicable

Detailed explanation of the specific provisions of the proposal

Section 1 ‘Purpose and scope’

That section of the FSTD Annex explains the purpose of the Annex, which is reciprocal acceptance of findings of compliance and documentation, and the provision of technical assistance regarding recurrent evaluation and qualification of FFS.

The scope of the Annex covers recurrent evaluation and continuing qualification of FFS for airplanes that hold a qualification issued by the FAA and by EASA or an Aviation Authority of an EU Member State.

Section 2 ‘Definitions’

That section of the FSTD Annex defines some of the frequently used technical terms.

Section 3 ‘Joint Coordination Body’

That section establishes the FSTD Oversight Board (FOB), which will be accountable to the BOB and will be responsible for ensuring the effective implementation of the FSTD Annex. The FOB is co-chaired by the EASA and FAA Directors of Flight Standards. The main responsibilities of the FOB include:

a) Developing, approving, and revising the Simulator Implementation Procedures (SIP)

b) Sharing information on relevant safety issues and developing action plans to address them;

c) Ensuring the consistent application of the Annex;

d) Exchanging information on planned and ongoing rulemaking activities that could affect the basis and the scope of the Annex;

e) Sharing information on significant changes to the Parties’ FSTD qualification systems that could affect the basis and the scope of the Annex;

f) Resolving technical issues falling within the responsibilities of the Technical Agents and Aviation Authorities that cannot be solved at lower level; and

g) Proposing to the BOB amendments to the Annex

Section 4 ‘Implementation’

This section contains detailed conditions for mutual acceptance of evaluation reports between the Parties and for continuation of the FAA and EASA qualifications for FFS under the Agreement. The national aviation authorities of the Member States or, in certain cases, EASA will conduct the evaluations on behalf of the FAA for the devices located in the EU, and the FAA will conduct the evaluations on behalf of EASA for devices located in the US.

That section also contains provisions concerning follow up on evaluation report findings, provision of technical assistance in conducting special evaluations or obtaining and providing data and information upon request, as well as concerning exchange of information on revisions to laws, regulations, procedures, policy, or standards, that may affect the basis upon which the Annex is executed.

Section 5 ‘Communication and cooperation’

This section contains provisions on communication and exchange of information between the FAA, EASA and where applicable the aviation authorities of Member States. This includes provisions for the designation of contact points for the various technical aspects of the FSTD Annex, as well as information about exemptions and derogations granted to FFS.

Section 6 ‘Qualification requirements for the acceptance of findings of compliance’

This section contains the basic requirements for the authorities concerning effectiveness of their respective systems for the regulatory oversight of FSTD, including legal and regulatory structure, resources, training programmes, documentation and records, as well as internal policies, procedures and quality systems.

Furthermore, this section contains provisions concerning the initial and continued demonstration of the effectiveness of those systems, including provisions concerning participation of the Parties in each other’s quality audits and standardization activities, exchange of quality and standardisation reports and other relevant information, which may be necessary to maintain the continued confidence of the Parties in each other’s systems.

It is important to underline that authorities from all EU Member States can perform FFS evaluations on behalf of the FAA as long as they meet the requirements established under the Annex. It will be the responsibility of EASA to monitor that compliance as part of its routine standardisation activities.

Section 7 ‘Investigation and enforcement action’

This section contains provisions concerning cooperation on non-compliance investigations and the taking of enforcement actions. In accordance with the Agreement, both Parties retain the right to take enforcement actions against the operators of FSTDs that have FAA or EASA approvals.

Section 8 ‘Transfer provisions’

This section contains provisions defining the manner in which FFS that are at present under direct oversight of EASA will be handed over to the FAA, as well as the manner in which FFS that are at present under direct oversight of FAA will be handed over to national aviation authorities of EU Member States. At present there are four EU Member States where FFS with FAA approvals are located, that is United Kingdom, Denmark, France and the Netherlands.

The transfers shall take place within 18 months of the date of the entry into force of the Annex and will be synchronised with the dates of recurrent evaluations of the devices.

Section 9 ‘Fees’

The fees for the recurrent evaluations of the devices will be applied in accordance with Article 14 of the Agreement and in accordance with the applicable regulatory requirements, which on the EU side is Commission Regulation (EU) No 319/2014 of 27 March 2014 on the fees and charges levied by the European Aviation Safety Agency.

Appendix 1 ‘Special Conditions’

This Appendix contains the EU special conditions applicable to US based FFS as well as the FAA special conditions applicable to EU based FFS.

These special conditions are the additional regulatory requirements, which will need to be checked during the evaluation audits to account for the differences between the EU and US regulatory systems for flight simulators.

On the EU side, the responsibility for checking the compliance with the FAA special conditions will be with the national authorities of those Member States where the devices with the FAA certificates are located, or in certain circumstance with EASA if the FFS located in the EU is under the oversight of the Agency. The results of the special conditions check will be recorded in a “special conditions report” prepared by the authority after the evaluation.

Appendix 2 ‘Aviation Authority Actions’

This appendix contains the specific actions that the national aviation authorities of EU Member States will carry out when performing the recurrent evaluations of FFS on behalf of FAA. This includes scheduling the recurrent evaluation, preparing the performance of the evaluation, performing the evaluation and post evaluation activities, including the preparation of the evaluation report and special conditions report to be transmitted to the FAA.

2019/0067 (NLE)

Proposal for a

COUNCIL DECISION

on the position to be taken by the European Union within the Bilateral Oversight Board under the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, concerning the addition of an Annex 4 to the Agreement

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 100 (2) in conjunction with Article 218 (9) thereof,

 

Having regard to the proposal from the European Commission,

Whereas:

(1)The Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety ('the Agreement') entered into force on 1 May 2011 2 .

(2)One of the main aims of the Agreement is to improve the long-standing cooperative relationship between Europe and the United States to ensure a high level of civil aviation safety worldwide and to minimize economic burdens on the aviation industry and operators from redundant regulatory oversight.

(3)Amendment 1 3 of the Agreement expands the scope of Article 2.B of the Agreement to include, inter alia, personnel licensing and training.

(4)Article 5 of the Agreement, as amended, provides for the development of new Annexes to the Agreement for matters within the scope of the Agreement.

(5)(5) Both Technical Agents, i.e. the European Aviation Safety Agency for the EU and the Federal Aviation Administration for the U.S., have made the proposal to the Bilateral Oversight Board that it adopt a Decision to enact a new Annex 4 to the Agreement to cover the reciprocal acceptance of findings of compliance and documentation for Flight Simulation Training Devices (‘FSTD’).

(6)(6) Enacting the new Annex will generate savings for both Technical Agents and, at the same time, reduce costs for industry (FSTD operators) and subsequently, air carriers will profit from increased access to FSTD for their pilots.

(7)(7) Article 19.C of the Agreement provides for newly developed Annexes to enter into force upon a decision of the Bilateral Oversight Board established pursuant to Article 3 of the Agreement.

(8)(8) The new Annex 4 on Flight Simulation Training Devices should be approved on behalf of the European Union.

(9)(9) Article 4 (3) of Council Decision 2011/719/EU of 7 March 2011 concerning the conclusion of the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety provides, in accordance with Article 218 (9) of the Treaty on the Functioning of the European Union, that the Council, acting by a qualified majority, on a proposal from the Commission, shall establish the position to be taken by the Union in the Bilateral Oversight Board with respect to the adoption of additional Annexes in accordance with Article 3.C.7 and Article 19.C of the Agreement.

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken by the European Union within the Bilateral Oversight Board, under Articles 3 and 19 of the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, with regard to the adoption of a Bilateral Oversight Board Decision adopting Annex 4 of the Agreement, shall be based on draft Decision 0011 of the Bilateral Oversight Board, attached to this Decision.

Article 2

The Director responsible for Aviation in the Directorate General for Mobility and Transport, as co-Chair and the Union's representative on the Bilateral Oversight Board, is hereby empowered to sign Decision 0011 of the Bilateral Oversight Board.

Article 3

After its adoption, the Decision of the Bilateral Oversight Board shall be published in the Official Journal of the European Union.

Article 5

This Decision is addressed to the Commission.

Done at Brussels,

   For the Council

   The President

(1)    COUNCIL DECISION (EU) 2018/61 of 21 March 2017
(2)    OJ L 291, 09/11/2011, p. 3-44
(3)    OJ L 11, 16/01/2018, p. 3-5
Top

Brussels, 7.3.2019

COM(2019) 122 final

ANNEX

to the

Proposal for a
COUNCIL DECISION


on the position to be taken by the European Union within the Bilateral Oversight Board under the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, concerning adding Annex 4 to the Agreement


BILATERAL OVERSIGHT BOARD

FOR THE AGREEMENT

BETWEEN

THE UNITED STATES OF AMERICA

AND THE EUROPEAN UNION

ON COOPERATION IN THE REGULATION OF CIVIL AVIATION SAFETY

RECORD OF DECISION

DECISION N˚ 0011

Noting that Amendment 1 to the Agreement between the United States of America and the European Community on Cooperation in the Regulation of Civil Aviation Safety (the “Agreement”) expands the scope of Article 2.B of the Agreement to include, inter alia, personnel licensing and training;

Further noting that Article 5 of the Agreement, as amended, provides for the development of new Annexes to the Agreement for matters within the scope of the Agreement, which are then, pursuant to Article 19.C, brought into force upon a decision of the Bilateral Oversight Board (“BOB”) established pursuant to Article 3;,

The BOB hereby decides as follows:

1.To adopt Annex 4 (Flight Simulation Training Devices) to the Agreement, as attached to this Decision.

2.Annex 4 (Flight Simulation Training Devices) to the Agreement shall enter into force on the date of the last signature below.

For the Bilateral Oversight Board:

FEDERAL AVIATION ADMINISTRATION

DEPARTMENT OF TRANSPORTATION

UNITED STATES OF AMERICA

EUROPEAN COMMISSION

EUROPEAN UNION

BY:

BY:

TITLE:

Associate Administrator for Aviation Safety

TITLE:

Director, Aviation

Directorate-General for Mobility and Transport, European Commission

DATE:

DATE:

PLACE:

Washington, DC

PLACE:

Brussels, Belgium

Top

Brussels, 7.3.2019

COM(2019) 122 final

ANNEX

to the

Proposal for a
COUNCIL DECISION


on the position to be taken by the European Union within the Bilateral Oversight Board under the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety, concerning adding Annex 4 to the Agreement


ANNEX 4

FLIGHT SIMULATION TRAINING DEVICES

1.PURPOSE & SCOPE

1.1.The Parties have assessed each other's standards, rules, practices, and procedures relating to the recurrent evaluation and continuing qualification of Full Flight Simulators (FFS) for airplanes and concluded that they are sufficiently compatible to permit acceptance of each other’s approvals and findings. This Annex covers the reciprocal acceptance of findings of compliance and documentation, and the provision of technical assistance regarding recurrent evaluation and qualification of FFS. Nothing in this Annex shall be construed to limit the authority of a Party to act in accordance with Article 15 of the Agreement.

1.2.The scope of this Annex covers recurrent evaluation and continuing qualification of level C, CG, D and DG FFS for airplanes that hold a qualification issued by the Federal Aviation Administration (FAA) and by the European Aviation Safety Agency (EASA) or an Aviation Authority, as applicable. This scope may be extended through an amendment to this Annex pursuant to a decision of the Bilateral Oversight Board (BOB) taken in accordance with Article 19.B of the Agreement.

1.3.The extension of the scope of this Annex shall take place following the necessary confidence building process conducted by the Technical Agents.

1.4.The scope of this Annex does not cover Flight Simulation Training Devices (FSTD) that are located outside the scope of applicability specified in Article 12 of the Agreement.

2.DEFINITIONS

2.1.For the purposes of this Annex, the following definitions apply, in addition to those definitions found in the Agreement:

(a)“FFS Qualification Level” means the level of compliance based on the technical

capability of the FFS as determined by an evaluation of the FFS against the established technical evaluation criteria as defined in the applicable requirements. FFS are categorised as level A, B, C, D. Additionally, some EU qualified devices hold qualification level AG, BG, CG, DG under Grandfather Rights.

(b)“Finding” means a verification whether the FSTD is in compliance or non-compliance with the applicable requirements and which shall be recorded as results/discrepancies in the evaluation report compiled by the FAA, EASA, or an Aviation Authority, as applicable.

(c)“Flight Simulation Training Device” (FSTD) means:

(I)For the European Union, a training device which is, in the case of airplanes, a full flight simulator (FFS), a flight training device (FTD), a flight and navigation procedures trainer (FNPT), or a basic instrument training device (BITD).

(II)For the United States, a training device which is, in the case of airplanes, a full flight simulator (FFS) or a flight training device (FTD).

(d)“Full Flight Simulator” (FFS) means a full-size replica of a specific type or make, model and series of aircraft flight deck/cockpit, including the assemblage of all equipment and computer programmes necessary to represent the aircraft in ground and flight operations, a visual system providing an out-of-the-flight deck/cockpit view, and a force cueing motion system.

(e)“FSTD Evaluation” means the measure of the FSTD against the established technical criteria for the respective level leading to a FSTD qualification.

(f)“FSTD Operator” identifies the organization directly responsible to EASA or an Aviation Authority, as applicable, for requesting and maintaining the qualification of a particular FSTD and which has to comply with Part-ORA requirements of Regulation (EU) No 1178/2011.

(g) “FSTD Sponsor” identifies the organization directly responsible to FAA for requesting and maintaining the qualification of a particular FSTD and which has to comply with Title 14 of the United States Code of Federal Regulations, part 60 (hereinafter referred to as part 60) requirements.

(h)“Grandfather Rights” means:

(I)For the United States, the right of an FSTD operator/sponsor to retain the qualified level granted under a previous advisory circular.

(II)For the European Union, the right of an FSTD operator/sponsor to retain the qualified level granted under a previous regulation. It also means the right for an FSTD user to retain the training, testing and checking credits that were gained under that previous regulation.

(i)“Master Qualification Test Guide” (MQTG) is the authority-approved Qualification Test Guide (QTG) that incorporates the results of tests witnessed by the FAA, EASA, or Aviation Authority, as applicable. The MQTG serves as a reference for future evaluations.

(j)“Qualification Test Guide” (QTG) means a document used to demonstrate that performance and handling qualities are within prescribed limits with those of the aircraft and that all applicable requirements have been met.

(k)“Special Conditions” means those requirements that have been found, based on a comparison of the respective regulatory systems related to evaluation and qualification of FFS, not to be common to both systems and which are significant enough to be addressed in this Annex.

3.JOINT COORDINATION BODY

3.1.Composition

3.1.1.The joint coordination body called the FSTD Oversight Board (FOB), accountable to the Bilateral Oversight Board, is hereby established under the joint leadership of the EASA Flight Standards Director and the FAA Executive Director of Flight Standards. The FOB shall include FSTD experts from each Technical Agent.

3.1.2.The joint leadership may invite additional participants to the FOB to facilitate the fulfilment of the objectives of this Annex.

3.2.Mandate

3.2.1.The FOB shall meet at least once a year to ensure the effective functioning and implementation of this Annex. The FOB functions include:

(a)Developing, approving, and revising the Technical Implementation Procedures - Simulator (TIP-S) for FFS evaluation and qualification, including cooperation, assistance, exchange of information, and continued confidence activities to be used for the processes covered by this Annex;

(b)Sharing information on relevant safety issues and developing action plans to address them;

(c)Ensuring the consistent application of this Annex;

(d)Exchanging information on planned and ongoing rulemaking activities that could affect the basis and the scope of the Annex;

(e)Sharing information on significant changes to the Parties’ FSTD qualification systems that could affect the basis and the scope of the Annex;

(f)Resolving technical issues falling within the responsibilities of the Technical Agents and Aviation Authorities that cannot be solved at lower level; and

(g)Proposing to the BOB amendments to this Annex.

3.2.2.The FOB shall report unresolved issues to the BOB and ensure the implementation of decisions adopted by the BOB regarding this Annex.

4.IMPLEMENTATION

4.1.The Technical Agents shall, for monitoring purposes, establish and maintain a Master List of FFSs whose qualification falls within the scope of this Annex. The procedures to establish and maintain this Master List shall be detailed in the TIP-S.

4.2.FAA Continuing Qualification

4.2.1.The Parties agree that an FFS that:

(a)Holds a current qualification in accordance with the applicable EU qualification basis, and

(b)Complies with the conditions set forth in this Annex, including the FAA Special Conditions set forth in Appendix 1, notwithstanding part 60 Simulator Quality Management System requirements applicable to the FFS certificate holder,

shall be considered to meet the technical requirements for an FAA continuing qualification upon receipt, review and acceptance of the evaluation and special conditions reports issued by EASA or by an Aviation Authority, as applicable.

4.2.2.The competent Aviation Authorities shall carry out the actions defined in Appendix 2 of this Annex when acting on behalf of the FAA for the recurrent evaluation of each FFS covered under this Annex.

4.3.EASA Continuing Qualification

4.3.1.The Parties agree that an FFS that:

(a)Holds a current qualification by the FAA in accordance with the applicable U.S. qualification basis, and

(b)Complies with the conditions set forth in this Annex, including the EU Special Conditions set forth in Appendix 1, notwithstanding Part-ORA requirements applicable to the FSTD certificate holder,

shall be considered to meet the technical requirements for an EASA continuing qualification upon receipt, review and acceptance of the evaluation and special conditions reports issued by the FAA.

4.4.Mutual Acceptance of Evaluation Reports

4.4.1.Subject to the terms of this Annex, the Parties agree that the Technical Agents and the Aviation Authorities, as appropriate, shall provide to the Technical Agent of the other Party, FFS recurrent evaluation and special conditions reports. These reports shall include findings of compliance with the respective EU and U.S. requirements as the basis for issuance or continued validity of their respective FFS qualifications, as applicable.

4.5.Follow-up on Evaluation Report Findings

4.5.1.The FSTD operator/sponsor shall resolve findings with the Technical Agent or the Aviation Authority that conducted the evaluation unless otherwise instructed by the relevant Technical Agent for the cases defined in the TIP-S. In such cases, when an on-site visit is necessary to assess the closure of the finding, this on-site visit shall be conducted, as resources permit, by the Technical Agent or, where applicable, an Aviation Authority that conducted the evaluation.

4.6.When circumstances arise outside the scope of recurrent evaluations, each Party's Technical Agent, or where applicable an Aviation Authority, shall provide, as necessary, upon request and after mutual agreement, technical assistance in FFS evaluations to the other Party's Technical Agent, or where applicable to an Aviation Authority. The Technical Agents or an Aviation Authority may decline to provide such technical assistance due to lack of resource availability. Such areas of assistance may include, but are not limited to:

(a)Conducting and reporting on investigations upon request;

(b)Obtaining and providing data where requested; and

(c)Conducting a special evaluation of an FFS in the event of a relocation or a modification to the device.

4.7.In accordance with Article 15.B of the Agreement, the Technical Agents may conduct independent evaluations of devices in the event of specific safety concerns.

4.8.Revisions by either Party to its organizational structure, laws, regulations, procedures, policy, or standards, including those of the Technical Agents and Aviation Authorities, may affect the basis on which this Annex is executed. The Parties, through the Technical Agents and Aviation Authorities, as appropriate, shall advise one another of plans for such changes at the earliest possible opportunity, and discuss the extent to which such planned changes affect the basis of this Annex. If consultations pursuant to Article 15.C of the Agreement result in an agreement to amend this Annex, the Parties shall seek to ensure that such an amendment enters into force at the same time as, or as soon as possible thereafter, the entry into force or implementation of the change that prompted such amendment.

5.COMMUNICATION AND COOPERATION

5.1.The Technical Agents shall exchange and maintain a list of contact points for the various technical aspects of this Annex.

5.2.All communications, including technical documentation, between the Technical Agents, and where applicable the Aviation Authorities, shall be in the English language.

5.3.The format for all dates used in communications shall be DD MMM YYYY, e.g., “05 MAY 2014”.

5.4.The Technical Agents and the Aviation Authorities shall inform each other of exemptions and derogations granted to FFSs falling within the scope of this Annex.

5.5.Evaluation Instructions

The Technical Agents and the Aviation Authorities shall submit for review any special instructions or requests to be completed during an evaluation at least 30 calendar days prior to the evaluation.

6.QUALIFICATION REQUIREMENTS FOR THE ACCEPTANCE OF FINDINGS OF COMPLIANCE

6.1.Basic Requirements

6.1.1.Each Technical Agent and Aviation Authority, as applicable, shall demonstrate to the other Technical Agent the effectiveness of its respective system for the regulatory oversight of FSTD. In order to carry out evaluations of FFSs on each other’s behalf, the Technical Agents and the Aviation Authorities, as applicable, shall demonstrate effective and adequate:

(a)Legal and regulatory structure;

(b)Organizational structure;

(c)Resources, including sufficient qualified staff;

(d)Training programme for their technical staff;

(e)Internal policies, processes and procedures including a quality system;

(f)Documentation and records;

(g)Oversight programme; and

(h)Authority on regulated entities and devices.

6.2.Initial Confidence

6.2.1.Each Technical Agent has demonstrated to the other Technical Agent the effectiveness of its respective system for the regulatory oversight of activities covered under this Annex through initial confidence building activities. The Technical Agents have also demonstrated to each other the effectiveness of their quality audits and standardization activities, including audits of Aviation Authorities, as referred to in paragraph 6.3.1.

 

6.2.2.The EU Technical Agent shall, before an Aviation Authority starts carrying out evaluations of FFS on behalf of the U.S. Technical Agent, conduct an assessment of that Aviation Authority in accordance with the provisions of the TIP-S.

6.3.Continued Confidence

6.3.1.The Technical Agents and the Aviation Authorities shall continue to demonstrate effective oversight, as detailed in paragraph 6.1.1 in accordance with the relevant provisions of the TIP-S developed and approved by the FOB.

(a)In particular, Technical Agents and, as applicable, Aviation Authorities shall:

I)Have the right to participate as observer: for EASA, to FAA quality audits and standardization meetings; for the FAA, to EASA standardization activities.

II)Ensure that FSTD operators/sponsors provide access to both Technical Agents for audits, evaluations and inspections, as applicable;

III)Make available the reports from audits, standardization and mutual inspections applicable to this Annex;

IV)Share relevant safety information and known limitations that may affect an Aviation Authority or Technical Agent’s capability to fully meet applicable international safety standards or any safety requirements established under the Agreement;

V)Make the appropriate personnel available to participate in audits and inspections applicable to this Annex;

VI)Make available FSTD operators’/sponsors’ records, including evaluation reports and Special Conditions reports;

VII)Provide interpretive assistance at the Aviation Authorities’ office during the review of FFS records and documentation that are recorded in its national language, where necessary; and

VIII)Assist each other in the closure of any findings from mutual inspections.

(b)The EU Technical Agent shall conduct supplemental standardization audits to ensure the Aviation Authority’s compliance with the terms of the Annex and, in particular, the FAA Special Conditions that are applicable to EU-based FFS, as specified in the TIP-S.

(c)    The Technical Agents shall notify each other at the earliest opportunity in the event that a Technical Agent or an Aviation Authority is not able to meet a requirement in paragraph 6.3.1. If either Technical Agent believes that technical competency is no longer adequate, the Technical Agents shall consult and propose an action plan, including any necessary corrective activities, in order to address deficiencies.

(d)    In the event that a Technical Agent or an Aviation Authority does not correct deficiencies within the timeframe specified in the action plan, either Technical Agent may refer the matter to the FOB.

(e)    When a Party intends to suspend acceptance of findings or qualifications made by a Technical Agent or Aviation Authority within the scope of this Annex, the Party shall promptly notify the other Party in accordance with Article 18.A of the Agreement.

7.INVESTIGATION AND ENFORCEMENT ACTION

7.1.The Parties retain the right to take enforcement actions against the operators/sponsors of FSTDs that have FAA or EASA approvals

7.2.In accordance with the provisions of Article 8 of the Agreement, each Party, through its Technical Agent and, where applicable, the Aviation Authorities, shall notify the other promptly of any investigation and subsequent closure actions for non-compliance within the scope of this Annex, when the non-compliance could result in a penalty, revocation, suspension or downgrade of the FFS qualification.

7.3.In the event of a revocation or suspension of an FFS qualification, the Technical Agent and, where applicable, an Aviation Authority shall notify the other Technical Agent of the revocation or suspension.

7.4.The above notifications shall be sent to the other Party's appropriate contact point.

8.TRANSFER PROVISIONS

8.1Recurrent evaluations for FFS whose qualifications were issued by the FAA under the provisions defined in the U.S. - UK Simulator Implementation Procedures (SIP) shall continue to be conducted until the transition of evaluation activities as defined in 8.2 has been completed. (The U.S. – UK SIP, which was agreed on December 20, 1995, was revised on October 6, 2005. It was concluded pursuant to the Agreement between the Government of the United States of America and the Government of the United Kingdom of Great Britain and Northern Ireland for Promotion of Aviation Safety, signed at London on December 12, 1995.)

8.2The Parties agree that the transfer of the FFS evaluations under this Annex shall be accomplished in accordance with the following transfer provisions:

(a)An Aviation Authority and the Technical Agents shall complete training of sufficient personnel regarding procedures relating to the Agreement, this Annex, and the EU and U.S. Special Conditions, as applicable, prior to the transfer.

(b)Once a sufficient number of staff has completed the training, the Technical Agents shall transfer evaluation activities of qualified FFS to the Technical Agents or the Aviation Authorities, as applicable.

(c)The transfers shall take place within 18 months of the date of the entry into force of this Annex.

(d)The Technical Agents and the Aviation Authorities shall agree on a procedural plan and time schedule for:

I)Synchronising recurrent evaluations, and

II)Conducting all evaluations in accordance with this Annex.

9.FEES

9.1    Fees shall be applied in accordance with Article 14 of the Agreement and in accordance with applicable regulatory requirements.



Appendix 1

SPECIAL CONDITIONS

1.EU SPECIAL CONDITIONS APPLICABLE TO U.S.-BASED FULL FLIGHT SIMULATORS (FFS) IN THE AIRPLANE AIRCRAFT CATEGORY

1.1.The special conditions referred to in Section 4.3.1, as detailed in the TIP-S, are the following:

(a)The FSTD sponsor shall provide to the FAA the following:

I.Recurrent evaluation dossier;

II.Annual fly-out records;

III.Simulator safety features check records (ORA.FSTD.115 (b) Installations of Regulation (EU) 1178/2011); and

IV.Changes to the published EASA FSTD datasheet.

(b)The instructor operating station manual shall include operating instructions with EU standards.

(c)Instructor operating station settings and indications shall conform to the International System of Units (SI).

(d)At least one declared qualification European airport/airfield model featuring proper modelling and navigation/communication facilities shall be evaluated.

(e)Category I, II, or III (as applicable) instrument approaches and low visibility take-off operations shall be demonstrated at a European airport and with corresponding settings selectable from the instructor operating station.

(f)The FFS shall reflect the European configuration of the simulated airplane.

(g)A continuous, uninterrupted flight phase shall be conducted during the evaluation.

(h)All engine fits listed in the EASA FFS qualification certificate shall be evaluated during each evaluation.

(i)When several EASA FFS qualification certificates are issued for several avionics configuration of a single FFS, each configuration – with each engine fit if applicable – shall be evaluated during each evaluation.

(j)FFS-specific objective, functional and subjective tests as per applicable European requirements that are not covered by the applicable FAA FFS standard level of qualification shall be performed.

2.FAA SPECIAL CONDITIONS APPLICABLE TO EU BASED APPROVED FULL FLIGHT SIMULATORS (FFS) IN THE AIRPLANE AIRCRAFT CATEGORY

2.1.The special conditions referred to in Section 4.2.1, as detailed in the TIP-S, are the following:

(a)The FSTD operator shall:

I)Provide to the Aviation Authority or EASA, as applicable, evidence that FAA FSTD directives have been incorporated into the MQTG, and

II)Identify any changes to the published FAA FFS configuration list.

(b)The instructor operating station manual shall include operating instructions with U.S. standards.

(c)Instructor operating station settings and indications shall conform to the U.S. units of measurement.

(d)At least one declared qualification U.S. airport/airfield model featuring proper modelling and navigation/communication facilities shall be evaluated.

(e)Category I, II, or III (as applicable) instrument approaches shall be demonstrated at a U.S. airport and with corresponding settings selectable from the instructor operating station.

(f)The FFS shall reflect the U.S. configuration of the simulated airplane.

(g)All configurations listed in the FAA FFS qualification certificate shall be evaluated during each evaluation.

(h)A circling approach to a U.S. airport at the maximum demonstrated landing weight shall be conducted.

(i)FFS-specific objective, functional, and subjective tests as per applicable U.S. requirements that are not covered by the applicable European FFS standard level of qualification shall be performed.



Appendix 2

AVIATION AUTHORITY ACTIONS

The competent Aviation Authority acting on behalf of the FAA shall carry out the following actions for the recurrent evaluations of each FFS covered under this Annex, as detailed in the TIP-S:

1.Schedule the recurrent evaluation and provide the scheduled date for the evaluation to the FAA.

2.Perform evaluation preparation. The evaluating Aviation Authority inspector(s) shall:

(a)Identify the special conditions;

(b)Obtain the appropriate forms and checklists; and

(c)Identify any modifications that have occurred between recurrent evaluations.

3.Perform the evaluation, taking the special conditions and the relevant TIP-S provisions into account.

4.Perform post evaluation activities to include:

(a)Transmitting the following information/documents to the FAA within five working days following completion of the evaluation:

I.Evaluation report;

II.FFS configuration list; and

III.Special Conditions report.

(b)Performing the on-site visit referred to in paragraph 4.5.1. of this Annex.

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