Advisory Circular
Subject: Transition Document for 14 CFR Parts 1, 21, 43, and 45 Date: 10/16/09 Initiated by: AIR-200 AC No: 21-42
1. Purpose.
a. This advisory circular (AC) provides information about Title 14, Code of Federal Regulations (14 CFR), part 21, Certification Procedures for Products, Articles, and Parts (part 21). The intent of this AC is to briefly describe the following changes and to facilitate the transition from the former part 21 rule to the new part 21 rule published in the Federal Register under docket number FAA-2006-25877-0114. The summary information in this AC is not a substitute for the text of the adopted CFRs, and persons subject to those rules should refer to the cited CFRs for exact compliance requirements.
Also, while this AC summarizes some of the reasons for the rule changes, the complete description of the intent of these changes can be found in the Federal Register preamble for the rule.
(1) This AC provides information concerning changes to the following parts as they relate to the revised part 21 rule: 14 CFR part 1, Definitions and Abbreviations;
14 CFR part 43, Maintenance, Preventive Maintenance, Rebuilding, and Alteration;
and 14 CFR part 45, Identification and Registration Marking.
(2) This AC provides information for both an applicant for and a holder of a production approval, and refers to both as a PAH. This information includes instructions on how to develop and maintain their quality system.
b. This AC is not mandatory and does not constitute a regulation. This AC describes an acceptable means, but not the only means, to comply with these requirements.
However, if you use the means described in the AC, you must follow it in all important respects.
2. Audience. This AC affects PAHs seeking information concerning the new requirements of part 21 and their impact on certification procedures for products, articles, and parts.
3. Effective Date. This AC is effective 180 days after publication of Production and Airworthiness Approvals, Part Marking, and Miscellaneous Amendments; Final Rule in the Federal Register under docket number FAA-2006-25877-0114.
4. Compliance Dates for the New Parts 1, 21, 43, and 45 Rules.
a. The rule becomes effective 180 days after publication in the Federal Register. The compliance date for part 1, part 21 (subparts H, I, L, and N), and part 45 (§§ 45.11 and
45.13) rules is 180 days after publication of the final rule in the Federal Register. Within this AC, each of these sections has been labeled in bold, “180-day compliance requirement.”
b. The compliance date for all other amendments to the rule is 18 months after publication of the final rule in the Federal Register.
c. PAHs are not required to comply with the new rules until they become effective. It is, however, acceptable if a PAH is currently in compliance with the existing rule and coincidentally also meets the requirements of the new rule.
d. It is also acceptable for a PAH to comply, before the compliance date, with portions of the new rule that do not compromise their compliance to the existing rule.
Once the compliance dates arrive, the PAH must be compliant with the new rule as discussed in the final rule preamble under section II C, Compliance Dates. To clarify further—
(1) Under new subparts G, K, and O (§§ 21.137, 21.307, and 21.607, respectively), quality system requirements are standardized for all PAHs. These new sections require that the quality system be described in writing and include elements specified in paragraphs (a) through (n) of those sections.
(2) Under new subparts G, K, and O (§§ 21.138, 21.308, and 21.608, respectively), the requirement for quality manuals is also standardized for all PAHs. These sections require PAHs to provide a manual describing their quality system for FAA approval.
Because current subparts G (Production Certificates) and O (Technical Standard Order Authorizations) require an “approved” quality system, a number of PAHs already have “approved” quality data and procedure documents. This however, is not the case for parts manufacturer approvals (PMA) operating under current subpart K, Approval of Materials, Parts, Processes, and Appliances. Current subpart K PMAs operate under a fabrication inspection system (FIS) and their manuals have been “accepted” by the FAA, rather than “approved.”
(3) Under the new rule, the required approved quality manual will be the vehicle through which all PAHs describe their quality system elements. The quality system elements required by new § 21.137, § 21.307, or § 21.607 do not conflict with the existing rule. In fact many PAHs already have systems in place that address most or all of these elements.
e. PAHs who chose to comply early with the new rule may implement the requirements of new § 21.137, § 21.307, or § 21.607 before the 18-month compliance date, as long as they continue to operate in compliance with the existing rule. For instance, production certificate (PC) holders and technical standard order (TSO) authorization holders who have an “approved” quality manual under the existing rule would simply determine what changes to their existing quality manual are necessary to comply with the new rule and then submit those changes as updates to that quality manual. Moreover, a PMA who operates under a FIS rather than a quality system would simply submit updates to its FIS in accordance with the existing rule. All PAHs are required to submit their updates under the existing rule and to follow the current change submission criteria or standing agreement they may have with the FAA.
f. These same PAHs may simultaneously document these updates in their revised or newly created quality manual, which are require to be provided to the FAA for approval under the new §§ 21.138, 21.308, and 21.608 before the compliance date of the new rule.
This transition is further discussed under paragraph 5 of this AC. A proactive approach will greatly facilitate a PAH’s transition to the new rule requirements discussed below in paragraph 5.
g. You should contact your local Manufacturing Inspection District Office (MIDO) if you need further clarification regarding these compliance dates.
5. PAH Transition. As a PAH, you should—
a. Review your current quality system and note the differences between your existing system and the new quality system requirements. You should strive to do this as soon as possible once the final rule has been published in the Federal Register.
b. Revise your quality manual to address the requirements that will make your quality system compliant with the new rule. PAHs who do not have an approved quality manual are required by §§ 21.138, 21.308, or 21.608 to create one. PAHs are required to revise or create a new quality manual before the 18-month compliance date and provide that manual to the FAA for approval. In addition to the quality system elements required by new §§ 21.137, 21.307, and 21.607 you are encouraged to also include the following in your quality manual:
(1) A process to report failures, malfunctions, and defects as required by 21.3.
(2) A process to amend the organiza tion description document as required by new subparts G, K, and O §§ 21.146, 21.316, or 21.616.
(3) A process to immediately notify the FAA in writing of changes to the quality system that may affect the inspection, conformity, or airworthiness of its product or article as required by new subparts G, K, and O §§ 21.150, 21.320, and 21.620.
c. Provide the FAA with an organization description document before the 18-month compliance date, as required by §§ 21.135, 21.305, or 21.605.
d. Work with your certificate managing office to achieve and finalize your transition efforts. Contact your managing office as soon as possible to coordinate the submittal and review of your revised or new quality manual and your organization description document. In addition, the following should be kept in mind:
(1) To facilitate the timely review and approval of your quality manual, the FAA recommends that you submit your manual and organization description document well in advance of the 18-month compliance date. Coordinate with your managing office to determine which delivery method and media type will best accommodate the submission and review of your quality manual. Facsimile and email are permissible for the organization description document, provided a hardcopy follows.
(2) You may not operate under your revised or new quality manual (that has been created for the purpose of compliance with the new rule) until it has been approved by the FAA and reaches its effective date. As discussed above in paragraph 4, you may operate under your revised approved or accepted quality manual when following the current change submission criteria or any standing agreement that you may have with the FAA.
(3) A quality manual developed for the new part 21 rule may be approved before the effective date of the rule, provided the effective date of the manual is 04/16/2011 (18- month compliance date or later). The FAA will strive to review and approve all submitted manuals by the 18-month compliance date.
(4) Manuals submitted too near the compliance date could result in some manuals not being approved until after the compliance date. If you do not meet the requirements of § 21.135, § 21.305, or § 21.605 and § 21.138, § 21.308, or § 21.608 by the 18-month compliance date, your organization could be identified for immediate certificate management activity and possible enforcement action.
e. Prepare for your scheduled certificate management activity. During this activity the FAA will determine your actual compliance by evaluating your current quality system and your revised or new quality manual against the new part 21 rule.
f. Review the information concerning PAHs found in AC 21-43, Production Under 14 CFR Part 21, Subparts F, G, K, and O.
6. Global Amendments. A global amendment replaces one term or phrase with another throughout an entire document. In addition to the specific revisions discussed in paragraphs 8 through 25 of this AC, the following global amendments were made to the part 21 rule:
a. Remove the phrase “Federal Aviation Regulations.” The rule follows Federal Register direction not to use this generic reference in the regulations, and thus replace “Federal Aviation Regulations” and its abbreviation “FAR” with more specific references such as “this subchapter,” “this title,” “14 CFR,” or “49 U.S.C.”
b. Apply the definition of “article” in new § 21.1(b)(2) throughout part 21. “Article” simplifies regulatory language when referring to materials, parts, components, processes, or appliances.
c. Add the phrase “or jurisdiction” to existing references to agreements between the United States and other countries, clarifying that these agreements are not always with other countries.
d. Define and globally apply the terms “State of Design” and “State of Manufacture.”
e. Apply new part 1 abbreviations for PMA and TSO to new parts 21 and 45. The rule uses longstanding and widely understood abbreviations to simplify the language of the regulations.
f. Replace the phrase “quality control system” with “quality system.” The term “quality control” commonly refers to a specific discipline within the broader discipline of quality. The new rule clarifies that part 21 quality requirements apply to the PAH’s entire organization.
g. Remove references to FAA form numbers. Since FAA form numbers are subject to change, the FAA does not consider it appropriate to refer to such numbers in the regulations. Form numbers will be more appropriately controlled through agency directives.
h. Replace the word “Administrator” with “FAA.” The new rule uses simple, clear language.
i. Replace the word “shall” with the word “must.”
j. Replace the masculine pronouns “he” and “his” with gender-neutral terms. The new rule uses plain language.
7. Part 1, Definitions and Abbreviations. (180-day compliance requirement)
a. Section 1.1, General definitions. The rule changes the definition of “approved” by removing the word “Administrator” and replacing it with the abbreviation “FAA.” It expands the definition to include “any person to whom the FAA has delegated its 5
authority in the matter concerned, or approved under the provisions of a bilateral agreement between the United States and a foreign country or jurisdiction.” The intent of this rule is to clarify that data approved by a foreign authority within the scope of an applicable bilateral agreement does not require further FAA approval. Furthermore, the term “jurisdiction” applies to entities, such as the European Union (EU), that are not countries.
b. Section 1.2, Abbreviations and symbols. The rule revises this section by adding the abbreviations for PMA and TSO in alphabetical order.
8. Part 21, Subpart A, General.
a. Section 21.1, Applicability and definitions. The new rule revises this section’s heading to include the word “definitions” in order to reflect the section’s content more clearly. It also revises the list of definitions for part 21. Additional paragraphs in this section are revised as described in the following table:
Paragraph Revision
21.1(a)(1) Provides procedural requirements for issuing and changing the following types of approvals or certificates that part 21 addresses:
• Design approvals
• Production approvals
• Airworthiness certificates
• Airworthiness approvals
21.1(a)(2) Imposes procedural requirements on applicants for (in addition to holders of) any approvals or certificates specified in § 21.1(a)(1).
21.1(b) Provides in paragraphs (b)(1) through (b)(8) definitions for the following terms applicable to part 21:
• Airworthiness approval
• Article
• Commercial part
• Design approval
• Product
• Production approval
• State of Design
• State of Manufacture 6
b. Section 21.2, Falsification of applications, reports, or records. Paragraphs in this section are revised as described in the following table:
Paragraph Revision
21.2(a)(1) and (a)(2) Adds that a “misleading statement” may be treated as seriously as a fraudulent or intentionally false statement. In addition, § 21.2 (a)(2) now encompasses “any record or report that is required to be kept, made, or used to show compliance with any requirement of this part.”
21.2(b) Defines consequences for committing prohibited actions that occur before a certificate or approval is issued. Paragraph (b) expands the consequences for committing prohibited actions to include denying issuance of any certificate or approval under this part. This change clarifies the FAA’s right to deny issuance of certificates or approvals when the prohibited actions occur before the FAA issues the certificate or approval.
c. Section 21.3, Reporting of failures, malfunctions, and defects. Paragraphs in this section are revised as described in the following table:
Paragraph Revision
21.3(d)(2) Clarifies that approvals, not type certificates (TC), are issued under proposed § 21.621.
21.3(e)(3) Replaces specific product and article marking requirements with a reference to the new part 45 where these marking requirements are defined. The FAA’s intent is to—
• Consolidate marking requirements into part 45, and
• Expand reporting requirements to include all applicable product and article marking information required by part 45. This will enhance the FAA’s ability to respond to service difficulty reports.
21.3(f) Expands reporting requirements to all PAHs.
d. Section 21.5, Airplane or rotorcraft flight manual. The rule revises this section to incorporate global language amendments listed in paragraph 6 of this AC.
Section 21.5 has been expanded to now apply to the holders of amended type certificates.
e. Section 21.8, Approval of articles. The rule relocates the requirements of former § 21.305, Approval of materials, parts, processes, and appliances, to the new § 21.8 in subpart A. We also deleted the text of the second and third sentences of former § 21.305(b) because it was advisory in nature. Former § 21.305(b) referenced AC 20-110 7
and how to obtain copies of that AC. The requirements of former § 21.305 are directed to all persons and more appropriately belong in a general subpart. Finally, the relocation allows subpart K to address PMA requirements only.
f. Section 21.9, Replacement and modification articles. The rule relocates the requirements of former §21.303, Replacement and modification parts, to the new § 21.9 in subpart A. Paragraphs in this section are revised as described in the following table:
Paragraph Revision
21.9(a) Amends subpart A by relocating former § 21.303(a) and (b) from subpart K and combining the information into one paragraph under new § 21.9(a). The intent of this change is to—
• Provide a more appropriate location for this requirement. This requirement is directed to all persons and more appropriately belongs in a general subpart instead of subpart K. This requirement also allows the FAA to limit subpart K to PMA requirements only; and
• Amend relocated paragraph §21.303(a) to prohibit a person (who knows or should know that a replacement or modification article is reasonably likely to be installed on a type-certificated product) from producing that article unless they do so in accordance with the requirements established in § 21.9(a)(1) through (6).
21.9(a)(4) Adds a new category called “commercial parts” for use as replacement and modification articles as defined in § 21.1(b).
21.9(a)(6) Adds an exception for replacement or modification articles produced and installed on a product or article under revised part 43.
21.9(b) Prohibits a person, who produces a replacement or modification article for sale, from representing that article as suitable for installation on a type-certificated product, except under the provisions of proposed § 21.9(a)(1) and (a)(2).
21.9(c) Adds the provision for surplus U.S. Armed Forces articles used on certificated U.S. Armed Forces surplus aircraft.
9. Part 21, Subpart B, Type Certificates.
a. Section 21.15, Application for type certificate. The rule amends § 21.15(a) by replacing “Aircraft Certification Office” with “aircraft certification office.” The intent of this change is meant generically to include other offices that are not titled Aircraft Certification Office, such as the Engine Certification Office and, for import products, the Standards Staff of an FAA directorate.
b. Section 21.20, Compliance with applicable requirements. The rule amends subpart B by creating the new § 21.20. This section requires an applicant for a TC (including amended or supplemental type certificates (STC)) to show compliance with all applicable requirements, and to provide the FAA the means by which such compliance has been shown. Under § 21.20 an applicant for a production approval is required to provide a statement certifying that it has complied with the applicable requirements of this section. The intent of this change is to emphasize that it is the applicant, not the FAA, who is responsible for satisfying all applicable requirements.
c. Section 21.21, Issue of type certificate: normal, utility, acrobatic, commuter, and transport category aircraft; manned free balloons; special classes of aircraft;
aircraft engines; propellers. The rule revises this section to incorporate the global language amendments listed in paragraph 6 of this AC.
d. Section 21.27, Issue of type certificate: surplus aircraft of the Armed Forces.
The rule revises this section to incorporate global language amendments listed in paragraph 6 of this AC.
e. Section 21.29, Issue of type certificate: import products. The rule revises this section to incorporate global language amendments listed in paragraph 6 of this AC.
f. Section 21.33, Inspection and tests. The rule revises this section to incorporate global language amendments listed in paragraph 6 of this AC.
g. Section 21.45, Privileges. The rule amends paragraph (b) in order to correct a typographical error. The words “or certified” are changed to “on certificated.” Also, the words “§§21.133 through 21.163” found in paragraph (c) have been replaced with “subpart G of this part.”
h. Section 21.47, Transferability.
(1) The rule revises this section to change the timing requirement regarding the notification for TC transfers in cases where the State of Design remains the same. The rule also revises this section to change the timing requirement for TC licensing agreements. Before this rule, the FAA required each holder of an FAA TC to notify the FAA within 30 days after the transfer of a certificate or execution or termination of a licensing agreement. The FAA now requires notification before the transfer or before executing or terminating a licensing agreement. This will provide the FAA with adequate time to coordinate between affected offices and to inform the prospective applicant of its responsibilities under this subchapter.
(2) This section is also revised to require a holder of a FAA TC to notify the FAA of a transfer in cases where the State of Design is changing before the transfer occurs.
Transferring a TC where the State of Design is changing requires FAA coordination with the aviation authority of the prospective State of Design. This is necessary to identify the detailed requirements in support of the transfer and to reduce any burden on the FAA for managing the certificate. This change is intended to provide the FAA with adequate time 9
to coordinate with the aviation authority of a prospective State of Design to support and execute a TC transfer. This coordination is consistent with the applicable International Civil Aviation Organization (ICAO) airworthiness manual.
i. Section 21.50, Instructions for continued airworthiness and manufacturer’s maintenance manuals having airworthiness limitations sections.
(1) This rule revises § 21.50 to require a design approval holder to submit to the FAA a list of parts it has designated as commercial pursuant to the provisions of § 21.50(c).
(2) The FAA may find that a part will be designated as a commercial part if the design approval holder (1) provides data to the FAA showing that the failure of the commercial part, as installed in the product, would not degrade the level of safety of the product; (2) shows the part is produced only under the commercial part manufacturer’s specification and marked with only the commercial part manufacturer’s markings;
and (3) provides any other data the FAA requires to approve the Commercial Parts List.
j. Section 21.53, Statement of conformity. The rule amends this section by revising paragraph (a) to remove “(FAA Form 317).” This form is obsolete and has been replaced by FAA Form 8130-9. The removal of FAA form numbers from the rule is discussed under paragraph 6 of this AC. In addition, paragraph (a) has been amended to improve clarity by removing the words “conforms to the type design therefore” and replacing them with “conforms to its type design.”
10. Part 21, Subpart C, Provisional Type Certificates.
a. Section 21.73, Eligibility. The rule amends this section by replacing the words “Any manufacturer of aircraft manufactured in a foreign country with which the United States has an agreement” in paragraph (b) with “Any manufacturer of aircraft in a State of Manufacture subject to the provisions of an agreement with the United States.”
The intent of this change is to improve the clarity of the text.
b. Section 21.75, Application. The rule revises this section to remove detailed requirements related to where an applicant is required to submit an application for a provisional type certificate and instead requires submission to the appropriate aircraft certification office. The intent of this change is to provide flexibility to the FAA in managing the provisional type certification process. The new rule enables more efficient and effective use of FAA resources and is consistent with the open application process used for other design approvals.
11. Part 21, Subpart D, Changes to Type Certificates. The rule revises § 21.97, Approval of major changes in type design, and the intent of this change is discussed under § 21.20 (paragraph 9b. of this AC). The rule revises § 21.97(a) to require an applicant for approval of a major change in type design to—
a. Show that the changed product complies with the applicable requirements of this subchapter,
b. Provide the FAA the means by which such compliance has been shown, and
c. Provide a statement certifying the applicant has complied with the applicable requirements.
12. Part 21, Subpart E, Supplemental Type Certificates.
a. Section 21.113, Requirement of supplemental type certificate. The rule amends this section to require submission of an application for an STC to the “appropriate aircraft certification office” instead of to the “Administrator.” The intent of this change is to provide flexibility to the FAA in managing the STC process. The rule enables more efficient and effective use of FAA resources and is consistent with the open application process used for other design approvals.
b. Section 21.117, Issue of supplemental type certificates. The rule amends § 21.117 by replacing the words “if he” in paragraph (a) with “if the FAA finds that the applicant.” The intent of this change is to clarify that issuance of an STC occurs only after the FAA makes a finding of compliance with the applicable regulations.
c. Section 21.119, Privileges. The rule amends § 21.119(c) to clarify that the holder of an STC may obtain a PC for a type design change approved by that STC. This may occur only if the STC holder meets the requirements of subpart G (Production Certificates) pertaining to the issuance of PCs. The intent of this change is to clarify that issuance of a PC occurs only after the FAA makes a finding of compliance in accordance with applicable regulations.
13. Part 21, Subpart F, Production Under Type Certificate Only.
a. Section 21.122, Location of or change to manufacturing facilities. The rule amends subpart F by adding a new § 21.122 and incorporating the requirements of current § 21.139.
(1) Section 21.122(a) clarifies and relieves requirements related to the location of manufacturing facilities for production under a TC. The FAA considered amending subpart F to clarify that it does not apply to manufacturing outside of the United States.
However, the FAA decided instead that we might allow manufacturing under a TC outside of the United States as long as it causes no undue burden on the FAA.
(2) Section 21.122(b) requires a TC holder to obtain FAA approval before making changes to the location of any of its manufacturing facilities.
(3) Section 21.122(c) requires a TC holder to immediately notify the FAA, in writing, of any changes to its manufacturing facility that may affect the inspection, conformity, or airworthiness of the TC holder’s products or articles thereof.
b. Section 21.123, Production under type certificate. The rule revises the introductory text of this section to include manufacturers of articles to clarify that the holder of a TC is authorized to manufacture articles for its type-certificated products.
This section has been further revised to—
(1) Remove language requiring technical data and drawings to be maintained at the place of manufacture, and replaces it with references to sections where that information is defined more thoroughly.
(2) Add paragraph (b) to require that a TC holder make each article available to the FAA for inspection. This is in addition to the existing requirement to make each product available.
(3) Change paragraph (c) to require each manufacturer of a product or article under a TC to maintain records of the completion of all inspections and tests for a specified period of time. These records will enable the TC holder to prove to the FAA that it has properly completed and documented all required inspections and tests to ensure compliance with this subpart.
(4) Increase the records retention requirement in paragraph (c) for persons producing under a TC, from 2 years to at least 5 years for products and articles manufactured under the approval. For critical components identified under § 45.15(c) of this chapter, the record retention requirement is at least 10 years. The beginning of the 5-year or 10-year retention for a given product or article would correspond to the manufacturing completion date for that product or article.
(5) Add paragraph (d) to require each manufacturer of a product or article manufactured under a TC to allow the FAA to make any inspection or test necessary to determine compliance with the subchapter. This includes any inspection or test at a supplier facility.
(6) Add paragraph (e) to require each manufacturer of a product manufactured under a TC to mark the product or any critical parts in accordance with part 45.
(7) Add paragraph (f), which requires each manufacturer of a product manufactured under a TC to identify any portion of that product (for example, subassemblies, component parts, or replacement articles) that leaves the manufacturer’s facility as FAA-approved with the manufacturer’s part number and name, trademark, symbol, or other FAA-approved manufacturer’s identification.