U.S. Department of Transportation Federal Aviation Administration
Advisory Circular Subject: Obtaining Foreign Design Approval / Acceptance of U.S. Products and Articles Date: 3/27/2013 Initiated by: AIR-40 AC 21-52 Change:
1. Purpose of this Advisory Circular (AC).
a. This AC provides guidance on obtaining a foreign design approval/acceptance of a U.S.
product or article approved under Title 14 of the Code of Federal regulations (14 CFR) part 21.
Its purpose is to provide information and offer guidance that will help obtain foreign design approval/acceptance.
b. This AC is not mandatory and does not constitute a regulation, however if an aviation safety agreement exists for the country or jurisdiction of interest, you must adhere to the agreement.
2. Applicability. This AC applies to any person who holds or will hold a U.S. type certificate (TC), supplemental type certificate (STC), or technical standard order (TSO) authorization and seeks approval/acceptance from a foreign Civil Aviation Authority (CAA).
Note: Most CAAs accept Parts Manufacturer Approval (PMA) as modification and replacement articles under the FAA system.
3. Terminology Review.
a. Foreign Design Approval. A foreign design approval is an approval given to the applicant by a CAA. It is a separate approval from an FAA approval. This would give the applicant the privileges and responsibilities associated with those authorities’ approval.
b. Bilateral Agreement. A bilateral agreement is an agreement for the promotion of aviation safety between the U.S. and the government of a foreign country or jurisdiction. Currently there are three types of aviation safety agreements applicable to the Aircraft Certification Service (AIR) -- Bilateral Airworthiness Agreements (BAA), Bilateral Aviation Safety Agreements (BASA), and an Aviation Safety Agreement in place between the United States and the European Union.
(1) These agreements are based on a high degree of mutual confidence in technical competency and regulatory capability of the CAA. BAAs are being replaced by BASAs which are more comprehensive in scope and more detailed in process.
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(2) Most BASAs are comprised of an executive agreement and one or more implementation procedures. The executive agreement is:
a) to facilitate acceptance by each authority of the other authority’s
(i) airworthiness approvals and environmental testing and approval of civil aeronautical products, and
(ii) qualification evaluations of flight simulators;
b) to facilitate acceptance by the authority of the approvals and monitoring of maintenance and alteration or modification facilities, maintenance personnel, flight crew members, aviation training establishments, and flight operations of the other authority; and
c) to provide for cooperation in sustaining an equivalent level of safety and environmental objectives with respect to aviation safety.
(3) The implementing procedures for these aviation safety agreements are between authorities, and therefore the applicant should work through the FAA if activities occur with the bilateral country or jurisdiction’s CAA. For example, all agreements have requirements for data that should be contained in an application to be submitted to a CAA to obtain their approval/acceptance. Only the applicant can supply the necessary information so it is important that the applicant review the agreement in place with the country or jurisdiction of interest. On some projects, the FAA may allow direct contact between the CAA and applicant. When this occurs, the applicant is responsible for providing details of all communication between the applicant and the CAA to the FAA (e.g., the applicant would cc the FAA point of contact on email correspondence).
(4) Every bilateral agreement is available on the FAA website at:
http://www.faa.gov/aircraft/air_cert/international/bilateral_agreements/baa_basa_listing/
c. Bilateral Airworthiness Agreement. BAAs are executive agreements concluded prior to 1996 through an exchange of diplomatic notes between the U.S. Department of State and its foreign counterpart based on FAA technical recommendations. We no longer enter into any new BAAs. We use BASAs instead. Along those same lines, the FAA developed working procedures known as Schedule of Implementation Procedures (SIP). These are older procedures which are being replaced with Implementation Procedures for Airworthiness (IPA) as described in paragraph 3e below.
d. Bilateral Aviation Safety Agreement. BASAs provide for bilateral facilitation and cooperation in a variety of aviation areas, including maintenance, aircraft certification, flight operations, and environmental certification. This agreement allows for creation of working level documents such as the Implementation Procedures for Airworthiness.
e. Implementation Procedures for Airworthiness (IPA).
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(1) The IPA is a procedural document authorized by the BASA Executive Agreement for design approval, design changes, production activities, export airworthiness approvals, postdesign approval activities including continued operational safety, and technical assistance between authorities. The IPA defines the civil aeronautical products and articles eligible for import and export between the United States and counterpart BASA signatory country or jurisdiction. It defines the interface requirements and activities between the authorities for the import, export, and continued support of those civil aeronautical products.
Note: In 2011, the FAA and EASA, as the technical agents for the United States and European Union respectively, signed the Technical Implementation Procedures (TIP) under the Aviation Safety Agreement. The TIP is similar to an IPA, but has slightly different structure because EASA represents multiple European Union countries.
(2) A typical IPA has information in the following areas:
a) General information. A high-level explanation of how the FAA and the CAA will work together and recognize each other’s findings. It promotes using the other’s determinations in approving design of products/articles to the maximum extent possible to help reduce redundant evaluation of the same design of the product or article. Production and surveillance is another area discussed in typical IPAs.
b) Scope of agreement. A high-level explanation of the foreign products and articles the U.S. will accept for import from the CAA. It also explains the U.S. products and articles the CAA will accept for import into their country or jurisdiction. It covers both new and used products and articles.
c) Initial design approval/acceptance procedures. A detailed explanation of the procedures for attaining FAA and CAA approvals. This section explains the steps that should be met to obtain design approval from either the FAA or CAA.
d) Follow-on design approval/acceptance procedures. A detailed explanation of the procedures for attaining FAA and CAA design approvals. This section also explains how changes needed for continued airworthiness are processed in addition to the procedures for approving or accepting repair data.
e) Production procedures. An explanation of the recognition the FAA and CAA have for each other’s production approval holders (PAH) or equivalent manufacturing entities.
Neither the FAA nor the CAA approve the other’s PAHs, but agree to maintain oversight of their respective PAHs including suppliers.
f) Export/import of individual products and articles procedures. A detailed explanation of the conditions for exporting/importing individual products and articles from one regulatory system to another, including the appropriate export form to use.
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g) Technical assistance and special arrangements. A general explanation on how the FAA and the CAA can arrange technical assistance on specific projects or establish special arrangements for situations that are unique and not addressed elsewhere in the IPA.
f. International Civil Aviation Organization (ICAO). ICAO is a specialized agency of the United Nations created to promote the global interoperability in the development of national aviation regulations. ICAO serves as the forum for cooperation in all fields of civil aviation among its 191 Member States. It sets forth definitions, standards and recommended practices necessary for aviation safety, security, efficiency and regularity, as well as for aviation environmental protection. These definitions, standards and recommended practices provide the framework for international civil aviation.
(1) Our bilateral agreements are developed to be consistent with the ICAO framework.
The following definitions developed within ICAO are used in the bilateral agreements:
a) State of Design: the State having jurisdiction over the organization responsible for the type design.
Note: Per 14 CFR 21.1(b)(7) State of Design means the country or jurisdiction having regulatory authority over the organization responsible for the design and continued airworthiness of a civil aeronautical product or article.
b) State of Manufacture: the State having jurisdiction over the organization responsible for the final assembly of the aircraft.
Note: Per 14 CFR 21.1(b)(8) State of Manufacture means the country or jurisdiction having regulatory authority over the organization responsible for the production and airworthiness of a civil aeronautical product or article.
c) State of Registry: the State on whose registry the aircraft is entered.
d) State of the Operator: the State in which the aircraft operator’s principal place of business is located, or if there is no place of business, the operator’s residence.
(2) The terms are based on the State’s authority and responsibility which can often cross geographic boundaries. Here are three examples:
a) The State of Design is responsible for communicating any mandatory continuing airworthiness information to any States that have the affected aircraft on its registry. The State of Registry is then responsible for assessing this information and determining the appropriate action for its fleet.
b) Many U.S. PAHs have suppliers located in foreign countries or jurisdictions. The supplier is operating under the FAA-issued production approval given to the U.S. PAH. The
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5 State of Manufacture in this example is the United States. So when the foreign supplier physically ships a part to the United States, the State of Manufacture (i.e., the United States) does not change.
c) When a CAA assumes responsibility for an aircraft under the State of Registry, the CAA will either issue its own certificate of airworthiness (C of A) or validate the C of A issued by the previous State of Registry of the aircraft. In either case, the CAA of the new State of Registry is ensuring that it is complying with ICAO Annex 8 paragraph 4.2.3 dated 11/18/2010.
g. Product. Product means an aircraft, aircraft engine, or propeller. The definition is per 14 CFR 21.1(b)(5).
h. Article. Article means a material, part, component, process, or appliance. The definition is per 14 CFR 21.1(b)(2).
4. Foreign Design Approval with and without a Bilateral Agreement.
a. Countries or jurisdictions with a bilateral agreement. A country or jurisdiction may have regulations that require an agreement to be in place before they can issue their design approval/acceptance and import U.S. products and articles. A bilateral partner importing U.S.
products may perform some level of evaluation (e.g., validation) before issuing its own approval.
Once approved by the CAA, respective U.S. products/articles may be exported to the CAA jurisdiction. The operators within that country or jurisdiction can then import the product or article.
Note: Some countries will accept U.S. products and articles by issuing an acceptance letter rather than issuing a design approval.
Countries or jurisdictions that allow an acceptance process usually have regulations very similar to the U.S. and can generally complete the process quicker than countries or jurisdictions which perform a validation. There may be some special conditions or restrictions required by the importing authority as written in the bilateral agreement.
b. Countries or jurisdictions without a bilateral agreement. This does not preclude a U.S.
applicant from exporting to that non-bilateral country or jurisdiction provided all import requirements for that country or jurisdiction have been satisfied. The United States would support this export as part of our State of Design responsibilities. If an applicant seeks a foreign design approval from a non-bilateral country or jurisdiction, FAA may assist the applicant in the process. For export purposes, review AC 21-2 Complying with the Requirements of Importing Countries or Jurisdictions When Exporting U.S. Products, Articles, or Parts to gain an understanding of the process. If AC 21-2 still doesn’t cover your country or jurisdiction of interest, you may contact the geographic Aircraft Certification Office (ACO) to request AIR-40 assistance, if needed.
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5. Foreign Design Approval/Acceptance Process.
a. Below is a general process an applicant should follow to obtain foreign design approval/acceptance of its product or article.
(1) Read this AC to understand the basic process.
(2) Review the bilateral agreement (as applicable) for scope and application requirements. Each agreement explains which U.S. products and articles are eligible for export from the U.S. to that country or jurisdiction. Most countries or jurisdictions with which we have a bilateral agreement allow all U.S.-approved products and articles to be exported to that country or jurisdiction. The specific application requirements can differ among agreements. Therefore it is important to understand this AC and visit the international FAA web page(s) at http://www.faa.gov/aircraft/air_cert/international/ to gather all relevant information.
(3) Applicants may need to review CAA regulations and compare to FAA regulations.
In some cases, an applicant may need to know about any differences between the applicable U.S.
airworthiness requirements and the applicable CAA airworthiness requirements for the specific product. Environmental requirements should also be reviewed as they may be different between the United States and other countries or jurisdictions. Be sure to check each individual bilateral agreement to find out what airworthiness requirements should be met.
(4) Check CAA website for application forms and fees. Some CAAs, like EASA, require applicants to complete specific application forms depending on the type of design approval being sought. Some CAAs also charge a fee to process the application and will not begin to work the project until the fees have been paid and any prerequisite requirements are met. Check the international FAA web page(s) mentioned in paragraph 5a(2) above to find the applicable CAA website.
(5) All requests for design approval from a CAA are communicated between the FAA and CAA, unless agreed otherwise by the FAA and CAA. Submit the application to the geographic ACO. Regardless of which country or jurisdiction’s approval/acceptance desired or whether a country or jurisdiction has a bilateral agreement with the U.S. or not, send your request for the foreign design approval/acceptance to the geographic ACO. Check the bilateral agreement for the information that may be required to be sent to the CAA through the ACO and refer to paragraph 5b below for a general list.
(6) Support the familiarization meeting as required. The CAA may seek a meeting with the FAA and applicant to understand the product (or change to the product) prior to issuing a design approval/acceptance, in order to provide continued operational support. This meeting allows the CAA to determine the level of detail in its evaluation and to what extent it will rely on the FAA’s evaluation. If requested by the CAA, the applicant should plan to host and support a meeting to familiarize the CAA with the product (or change to the product). If the CAA has familiarity with the application based on previous involvement in a similar design/design change, the CAA may decide this meeting is not needed. See paragraph 6 for more information on familiarization.
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(7) Support technical meetings as required. Once the FAA and the CAA have established responsibilities for evaluations and findings, the applicant will need to support any technical meetings requested by the CAA.
(8) Support CAA evaluations as required. In addition to technical meetings, as the project progresses, the applicant may need to support other requests from the CAA in order for it to complete its evaluation and finding. This is typically done via telecom or email exchange and does not generally require a face-to-face meeting. CAA requests for information should be coordinated through the FAA. In some cases, an applicant can, with agreement from the FAA, provide information directly to the CAA. In such cases, the applicant must ensure the FAA is aware of all information being sent by the applicant to the CAA.
(9) The product/article may be subject to further data requirements if the FAA/CAA deems it necessary.
Note: Most IPAs do not require FAA approval to be issued before applying for CAA approval/acceptance. However, all IPAs require FAA approval to be issued before CAA will issue their approval/acceptance.
b. Recommended documents/data when requesting a foreign design approval/acceptance from a bilateral CAA. The following list of items is for reference and may not be all inclusive.
Providing the items listed below should be sufficient for most projects, however check with the country or jurisdiction specific bilateral agreement to verify. Provide the following typically recommended items with the application to the FAA for CAA design approvals/acceptances:
(1) A statement of the applicable U.S. design certification standards (the CAA should provide differences to U.S. regulations). Include type certificate data sheet (TCDS) if available.
(2) A description of all novel or unusual design features which might necessitate issuance of special conditions.
(3) All exemptions or equivalent level of safety findings granted by the FAA.
(4) The amendment level of the CAA airworthiness and environmental standards that the CAA requires, if applicable.
(5) The applicant’s requested date for issuance of the approval/acceptance.
(6) Available information on specific foreign customers of the country or jurisdiction to which application is made including delivery schedule. It may be helpful to include content produced in the applied to country or jurisdiction (e.g. major components from the country or jurisdiction to which application is made) of the product.
(7) Available information that the product/article will be imported into the country or jurisdiction from which an approval/acceptance is sought.
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(8) Instructions for Continued Airworthiness if available at time of application, otherwise to be provided when it becomes available.
c. In addition to all the items mentioned above, an applicant will need to provide (as applicable) the following items to the geographic ACO (and ACO may send per the bilateral agreement) for each foreign design approval requested from a bilateral CAA:
(1) TC for an aircraft (In addition to paragraph 5b above), CAA may require an applicant to have continued operational safety and type design change procedures in place before a type validation/acceptance approval is issued
a) Three-view drawing (exterior configuration).
b) General interior arrangement configuration drawings.
c) Master drawing list or Type Design Definition document or equivalent documentation.
d) Master equipment list.
e) Aircraft Flight Manual (including the Configuration Deviation List, if applicable).
f) Certification compliance (e.g., checklist).
(2) TC for an aircraft engine (In addition to paragraph 5b above)
a) Cross-section arrangement drawing.
b) Master drawing list or Type Design Definition document.
c) Operating manual.
d) Installation manual.
e) Certification compliance (checklist).
(3) TC for a propeller (In addition to paragraph 5b above)
a) General arrangement drawings and model description.
b) Master drawing list or Type Design Definition document.
c) Installation manual.
d) Operating manual.
e) Certification compliance (checklist).
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(4) STC for an aircraft, engine, or propeller (In addition to paragraph 5b above)
a) A description of the change, together with the make and model of the product.
b) The classification as Basic or Non Basic STC (if applicable, i.e. EASA).
c) Certification compliance checklist to the CAA design certification standards.
d) Aircraft Flight Manual supplement.
e) Master documentation list.
f) Master drawing list or Type Design Definition document.
g) Installation instructions.
h) Maintenance/Repair manual supplements.
i) Weight and Balance data.
j) Include any model exclusions listed on the STC to be validated (if necessary).
(5) TSO approval/acceptance for an article (In addition to paragraph 5b above)
a) A copy of the TSO authorization issued by the FAA for the article in question.
b) A statement from the applicant that the article meets the TSO, or the applicable performance standard (including any other performance standard prescribed to provide an equivalent level of safety) issued by the CAA.
c) A copy of the information and data required in the TSO issued by the CAA (if required by the bilateral agreement).
d) Operating manual.
e) Installation manual.
f) If applicable, a request for deviation to the TSO issued by the CAA with information and data to support that compensating factors or features exists to establish an equivalent level of safety to the TSO.
g) If a bilateral document addresses non-TSO functions, provide the information requested in that document.
6. Familiarization and Validation.
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a. Familiarization. Familiarization is the process by which the CAA of the country or jurisdiction importing the product/article becomes knowledgeable to the extent necessary for them to meet their ICAO State of Registry responsibilities and any bilateral agreement requirements. Because the CAA manages the product/article in an airworthy condition, the CAA needs to have an understanding of the product/article design to the degree necessary to accomplish this responsibility.
b. Validation. Validation is the process used between authorities to recognize the exporting authority’s findings to the importing authority’s airworthiness regulations for the product/article being approved. The intent of validation is to identify the regulatory equivalencies and differences between the two authorities, accept the exporting authority’s findings for the equivalencies, and maximize acceptance of the exporting authority to make findings for the differences. At times the importing authority may retain their right to make their own findings in some areas. Validation should maximize the instances where the importing authority uses the exporting authority to act on their behalf.
c. Differences between familiarization and validation. The goals of familiarization and validation are quite different even though the process by which they are accomplished generally overlap. As explained above, to accomplish their ICAO continued operational safety obligations, a CAA needs sufficient familiarity with the product/article. This knowledge and information may be less extensive than the knowledge, information, and data necessary to validate a product/article. The level of familiarity and validation varies from each country or jurisdiction and therefore the specific bilateral agreement must be checked.
(1) The following list shows the type of information that is typically needed to support product familiarization (provided it is noted in the bilateral with the country or jurisdiction):
a) Three-dimensional, cut-away, and general cross section drawings.
b) Aircraft flight manual.
c) Operating manuals.
d) Maintenance manuals.
e) Service bulletins (as necessary).
(2) The following list shows the type of information and data that, in addition to the information listed above for product familiarization is typically needed to support product validation (provided it is noted in the bilateral agreement with that country or jurisdiction):
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a) Test plans and reports for the agreed-to compliance data necessary to support retained compliance findings by the CAA.
b) Analysis and computations for the agreed-to compliance data necessary to support retained compliance findings by the CAA.
c) Higher level drawings necessary to support the above listed items.
Note: In order to preserve and protect the applicant’s intellectual property and proprietary data, only the documentation necessary to show compliance to the areas retained by the CAA need be submitted and should only be used by the CAA for validation purposes. This data is not as extensive as the data package that is needed to define the type design of the product.
7. Responsibilities during Foreign Design Approval/Acceptance Process.
a. Applicants are strongly encouraged to submit their application to the FAA per this AC and for a country or jurisdiction with which we have a bilateral agreement, applicants must submit their application per the bilateral agreement with the CAA. Those countries or jurisdictions without a bilateral agreement, applicants are stronlgy encouraged to provide a courtesy copy to the FAA when communicating with the non-bilateral CAA. Applicants also need to ensure they address all CAA requirements, pay any applicable fees (possibly upfront), respond to CAA questions in a timely manner, and support a familiarization or technical meeting if asked.
b. The FAA will work in accordance with the respective bilateral agreement and any supporting policy and guidance material (i.e., FAA orders, notices, AC 21-2, or other policies).
Typically the ACO will have the responsibility to forward the application to the CAA. This includes ensuring the available data included in the package are as specified in the bilateral agreement, providing a cover letter for transmittal to the CAA, and sending the package to the CAA. The FAA will work in a liaison role to help facilitate the process for both the applicant and CAA.
c. The CAA is expected to uphold its responsibilities according to ICAO, our bilateral agreement (if applicable), and its internal regulations. This includes notifying the applicant (through the FAA):
(1) that the application package has been received.
(2) of any deficiencies in the application (including non-technical issues such as paying fees).
(3) of any additional certification requirements, such as additional technical conditions.
(4) of an anticipated date to decide on approval/acceptance.
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(5) of the issuance of the approval/acceptance when all requirements have been met by the applicant and FAA.
d. For more information on the responsibilities for different products/articles, please visit the FAA website at http://www.faa.gov/aircraft/air_cert/international/ and click on the bilateral agreements listing and select the country or jurisdiction. Then select the obtaining certification approvalfrom this country link.
8. Tips to Efficiently Achieve Foreign Design Approval/Acceptance.
a. A familiarization meeting can be the best tool an applicant, the FAA, and the CAA have to ensure a project gets off to a good start, is managed appropriately, and leads to a timely approval/acceptance. A presentation is generally the preferred method to begin the process of obtaining an approval/acceptance from the CAA. It is recommended that the following elements be included in the presentation:
(1) General description with photos or illustrations.
(2) List of the FAA certification basis.
(3) A proposed schedule for completion of the project including expected date for issuance of the foreign design approval/acceptance. Verify with the FAA and the CAA that they can support the schedule. If additional approval/acceptance is anticipated from the CAA in the future, show them the proposed schedule.
(4) Contact information for the project manager.
(5) For STCs, focus on the change that needs approval/acceptance - do not review the entire product design again. The intent is to prevent spending time or resources on elements of the project that have already been approved.
(6) Evidence of prior FAA approval or, for concurrent projects, the date when you expect the FAA approval to be issued.
b. Clear communication of validation project expectations should be explained at the familiarization meeting. Make sure that all questions are answered to the greatest extent possible before leaving the meeting. If any issues are unclear, don’t hesitate to ask more questions. Also, make an effort prior to leaving the meeting to ensure all the CAAs questions are answered.
Projects may run into problems because the applicant, the FAA, and the CAA left a meeting with different understandings of the same issue, although they believed they were in agreement at the time. Be aware of cultural differences and the potential use of translators to help communication during the meeting.
c. Circulate meeting minutes or list that summarizes all discussions and actions to the FAA and CAA. Ask each authority to review and provide a written response acknowledging the minutes and commenting as appropriate. If any comments require further action, work quickly