What Does it Mean if a Component has “a Negligible Safety Effect on the Product”? And Does it Change the Documentation Requirements?

September 6, 2022 by Leave a comment

Has your aircraft or engine manufacturer designated certain parts as having “a negligible safety effect on the product.” What does this mean? And what sort of documentation should you expect on these parts?

A European rule permits manufacturers to designate certain parts that do not need production approval and do not need EASA Form 1. This is not a novel concept – we have the same rule in the United States. Under the FAA regulations, these components are called “Commercial Parts.” 14 C.F.R. §§ 21.1(b)(3), 21.50(c). 

For roughly 15 years, FAA rules have permitted manufacturers to designate parts as “commercial” by demonstrating two facts:

  • The failure of the commercial part, as installed in the product, would not degrade the level of safety of the product; and
  • The part is produced only under the commercial part manufacturer’s specification and marked only with the commercial part manufacturer’s markings

After making an engineering demonstration to show these facts, the design approval holder would then publish the commercial parts in a list that was an element of the Instructions for Continued Airworthiness (ICA).

Very few design approval holders (DAHs) have chosen to take advantage of this opportunity. There are legal liability reasons for being cautious about this, but in addition to increased legal liability, this would also mean that the DAH lose quality control of the transaction. Many production approval holders (PAHs) would prefer to offer direct ship authority to suppliers (or rely on other traditional legal constructs like ‘licensed PMA’) so that the manufacturer (DAH/PAH) can continue to control the quality assurance as well as having contractual provisions limiting the DAH/PAH’s liability in the event of an issue.

I wrote about this EASA proposal in December 2019:

No EASA Form 1 for Certain EU Parts?

ASA raised a number of concerns when this was proposed.  A few of these concerns were addressed by EASA but not all of them.

The new EASA rule requires the design-approval holder to identify the parts as having “a negligible safety effect on the product.”  This is comparable to the United States’ “commercial parts” rule (14 C.F.R. §§ 21.1(b)(3), 21.50(c)).  So the first problem that we can see with this rule is that the same DAHs who did not designate parts in response to the US rule change are probably not going to designate parts now that EASA has added a comparable rule. 

Right now my biggest concern is that this rule-change will not be useful to most of the industry because of a lack of participation among the DAHs.  The fact that it may not be useful means that any safety-negatives associated with the rule are particularly bitter pills.

The rule change creates new complexity in the system, by permitting parts that previously used the EASA Form 1 to be sold under certificates of conformity, instead. The existing variety of certificates of conformity for standard parts has already created confusion in the industry. Distributors are an important link in the chain of commerce, and they play a vital role in scrutinizing documentation to detect and address problems before those problems can be passed on to an installer.

The rule change creates an opportunity for counterfeit parts to enter the system, because the exempted parts are described only in the ICAs.  Distributors typically do not have access to the ICAs.  This means that distributors will not be able to distinguish a part that is exempt under 21.307(b)(3) from one that is fraudulently claimed to be exempt; and the industry could lose the ability to easily read the new C of Cs for parts that were previously subject to EASA Form 1 but now are being moved to C of Cs.  Fraud is already difficult enough to detect, but the regulatory authorities may no longer have jurisdiction over frauds that do not rely on regulatory authority documentation (like the EASA Form 1), which will diminish some of the front-line response opportunities.

One way to help industry mitigate risks would be for the rule to require publication of the list of “negligible safety parts” (“commercial parts” in the FAA system) to anyone in the industry. This would permit distributors to be able to see who is eligible to produce such parts. When they receive a questionable certificate of conformity for a “negligible safety” part, they would be able to review the list of qualified producers to identify whether that producer was authorized to produce “negligible safety” parts.

The new EASA rule is a manufacturing rule; so how does it intersect with repair station obligations? As we all know, EASA 145.A.42 requires the repair station to obtain an EASA Form 1 or equivalent with each received part. The repair station rules were updated to include an exception for parts that are on one of these “negligible safety” parts lists. Commission Implementing Regulation 2021/700 (EU), Annex II (26 March 2021). Such parts will NOT need an EASA Form 1 or equivalent under the published exception.

Distributors should be especially careful with parts from Europe that are alleged to be subject to the “negligible safety parts” standard. Where possible, reach out to the DAH/PAH and obtain a copy of its “negligible safety parts” list so you can confirm that the European supplier is permitted to produce parts without a Production Organization Approval (POA) and without issuing an EASA Form One.

Also, distributors will want to carefully watch the bilateral agreements to assess when these sorts of parts will be permitted. The current version of the US-EU Technical Implementation Agreement is the April 2019 version, and that version requires EASA form 1 for all parts accepted into the United States. There is an exception for standard parts but there is not yet an exception for “negligible safety parts.” Because these parts woudl not have EASA FOrm 1 (and would appear to be ineligible for such a tag) they would not be eligible for import into the United States under the US-EU agreements. In summary, this means that such parts could be eligible for installation under EASA rules but they would not be eligible for import and installation under FAA rules (e.g. on FAA-registered aircraft) unless the DAH also compiled a commercial parts list under FAA rules.

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UK and EU Ink Aviation Manufacturing Deal, Formalizing Acceptance of New Parts

May 17, 2021 by Leave a comment

Today, the UK CAA and EU’s EASA signed a Technical Implementation Procedure (TIP).

The purpose of the TIP is to establish the rules for UK and EU acceptance of articles and products produced under the production authority of the other authority. There are correlative agreements regarding design approvals issued by each authority, and the acceptance of each by the other.

This TIP will be important because it affects parts transactions involving third parties. For example, if a US-based distributor has Airbus parts in its US inventory, and those parts were produced under (and tagged under) the authority of EASA, then the sale of those parts for installation on a UK-registered aircraft will be subject to the UK-EASA TIP.

Under the Agreement, the importing authority will expect the following documentation to accompany aircraft parts:

  • For import into the EASA system: an Authorized Release Certificate (CAA Form 1) issued by an authorized UK CAA production organization approval holder [in other words, a UK CAA Form 1 properly signed on the left side]
  • For import into the UK CAA system: an Authorized Release Certificate (EASA Form 1) issued by (a) a production organization approval holder authorized to engage in such activity by an EASA Member State, or (b) a production organization approval holder authorized to engage in such activity by EASA [in other words, an EASA Form 1 properly signed on the left side]

One interesting point is a requirement that instructions for continued airworthiness and other maintenance manuals must be provided for articles to be acceptable for import into each authority. The language specifically states:

“The following documentation will be provided as a condition of acceptance of the civil aeronautical product being imported … ICA and maintenance manuals which include airworthiness limitation sections”

Technical Implementation Procedures for Airworthiness and Environmental Certification Between The Civil Aviation Authority of the United Kingdom And The European Union Aviation Safety Agency, section 6.5.1 (May 17, 2021)

The TIP does not address maintained parts. The authorities are expected to conclude a separate set of procedures for acceptance of maintenance.

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Mutual Acceptance of European and US TSOA Components is on the Horizon

July 1, 2015 by Leave a comment

The US and Europe are investigating how to accomplish mutual acceptance of TSOAs and ETSOAs. This could be a huge advance for the aviation community, that could save both industry and government resources.  It also would be great for US parts distributors handling TSOA articles, because it would make it easier to sell these articles into both markets.

The current US-EU Bilateral Airworthiness Safety Agreement (BASA) Technical Implementation Procedures (TIP) allows the FAA and EASA to each issue a TSOA/ETSOA in reliance on certain assurances by the other authority, following certain validation processes by the second authority.  The way that it works is that an authorization holder on one side of the Atlantic applies through its own airworthiness authority for the corollary approval on the other side of the Atlantic.  The application is reviewed by the first airworthiness authority and then forwarded to the second authority for validation.  Once the validation is granted, the article would be marked for both approvals.

But what if you didn’t need two approvals and two markings?  What if you could get one authorization from one authority and it was good for sales into both jurisdictions (US and EU)?

The authorities have announced a plan to mutually accept technical standard order articles from the other jurisdiction. Under this plan the validation process would no longer be necessary (saving both applicant and authority resources). This is a sign that the FAA and EASA have progressed to a point of mutual trust in the TSO authorization process.

The mutual acceptance will not happen overnight. It is part of a lengthy process that began with TSO-ETSO harmonization, and that has involved significant coordination among the authorities. But once it is complete it means that receiving inspectors and installers will have to get used to the idea that approved TSO parts are coming from both the US and Europe, without the intermediate step of validation.

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Language on the 8130-3 Tag: “This PMA part is not a critical component”

July 30, 2014 by Leave a comment

An ASA member recently asked whether a DAR would be permitted to write “This PMA part is not a critical component,” on the domestic 8130-3 tag for a PMA component.

Many of you will recognize this as the language requested by the EU on export 8130-3 tags that accompany FAA-PMA parts that are not critical components.

Does this sort of language have value in a domestic 8130-3 tag?  It might.  When a Maintenance DAR (DAR-T) produces an export 8130-3 tag for a non-critical PMA part that is destined for an EU member nation, the DAR-T may add language verifying that the PMA part is not a critical component.  The DAR-T may need some basis to make this non-critical decision, though.

The determination of whether a PMA part is critical is made by the design approval holder (the FAA-PMA holder) and confirmed as part of the FAA approval.  See Order 8130.21H Section 4.4(c).  The PMA holder is thus in a prime position to inform the first DAR to issue an 8130-3 tag about whether the part is critical.  Adding the language “This PMA part is not a critical component,” on the domestic 8130-3 tag may support efficient issue of future export tags for the same article, when a later decision to export is made.

Is it permissible for the designee at the manufacturer’s facility to place this PMA “criticality statement” on the domestic 8130-3 tags that accompany the PMA parts?  Yes, because it is not prohibited.

Manufacturers typically rely on designees to issue its 8130-3 tags (such as a DMIR, DAR, or an organizational delegation known as an ODA). Each designee is required to follow the instructions in Order 8130.21 (latest revision, which is currently the “H” revision).

Originally, industry requested the “domestic 8130-3 tag” as a work-around to circumvent outdated rules that prevented anyone other than a manufacturer from requesting an export 8130-3 tag for a (“class III”) aircraft part. These outdated rules were impeding US exports and undermining safety (because the 8130-3 tag is used to distinguish known airworthy parts).  I know this history because I proposed the “domestic 8130-3 tag” to the FAA as just this sort of work-around, after FAA management explained that they could not modify the regulations in a timely fashion to support exporters.  As time went one, this tag quickly began to serve other uses (including documenting actual domestic shipments) and the FAA ultimately revised the regulations to permit any exporter to apply for an export 8130-3 tag for an aircraft part (which eliminated the original NEED for the tag as a work-around).

Critical Components and the EU Bilateral

The PMA “criticality statement” is something that is requested under the technical implementation procedures (TIPs) that accompany the US-EU bilateral aviation safety agreement (BASA). It is not intrinsically necessary for domestic shipments.

Under the US-EU TIP, a “Critical Component” is defined as:

“a part identified as critical by the design approval holder during the product type validation process, or otherwise by the exporting authority. Typically, such components include parts for which a replacement time, inspection interval, or related procedure is specified in the Airworthiness Limitations section or certification maintenance requirements of the manufacturer’s maintenance manual or Instructions for Continued Airworthiness.”

The TIP directs that PMA parts being exported from the United States to the European Union bear appropriate language in block 12 (the remarks block). For a PMA part which is not a critical component, the remarks block of the 8130-3 should state:

“This PMA part is not a critical component.”

But if the PMA part is a critical component, then there are two options for the language in the remarks block. In the first option, if the PMA holder also holds an EASA STC design approval which incorporates the PMA part into an EASA certified or validated product, then the language should say:

“Produced by the holder of the EASA STC number [INSERT THE FULL REFERENCE OF THE EASA STC INCORPORATING THE PMA].”

In the second option, if the PMA holder holds a licensing agreement from the TC or STC holder (giving the PMA holder the rights to use the TC/STC design for the PMA parts), then the
following statement should be written in the remarks block:

“Produced under licensing agreement from the holder of [INSERT TC or STC NUMBER].”

These are the only two options for exporting FAA-PMA critical components from the US to the EU.

Who Determines Whether a Component is Critical?

Section 4.4(c) of Order 8130.21H states that “The determination of a PMA article’s criticality, as required to be entered in Block 12 when exported, can only be determined by the actual design approval holder (that is, the FAA-PMA holder).” This is important language because certain parties (foreign governments and competitors) have attempted to gainsay the FAA-approved “critical part” decisions of the FAA-PMA holders. But this language is not meant to prevent a designee issuing an export 8130-3 tag from making a PMA “criticality statement” on the 8130-3 tag that is consistent with the determination of the design approval holder. Thus, any subsequent designee issuing an export 8130-3 tag for an FAA-PMA part may rely on the design approval holder’s determination as to whether the PMA part is a critical component.

Can We Place this Language in Block 12?

Block 12 is a free-form remarks block. The specific instructions of the block are that the block should state any information “necessary for the user or installer to determine the airworthiness of the product or article.” There is a list of examples in the FAA guidance, but this list is not exclusive. A replacement time, inspection interval, or related procedure specified in the Airworthiness Limitations section would certainly be necessary information, and the fact that there is no such limit (e.g. that the part is not critical) could likewise be useful to the installer. Thus, there seems to be no legal bar to adding this language to block 12 in a domestic 8130-3 tag (e.g. “This PMA part is not a critical component.”). When such text is added to the first domestic 8130-3 tag that is generated at the production approval holder’s facility, this would seem to be useful information that is preserved to support subsequent DARs who might later produce export airworthiness tags, which reflects additional value in the use of this language on a domestic 8130-3 tag.

Note that the language we are discussing, “This PMA part is not a critical component,” is not required language on a domestic tag.  Therefore, addition of this language to block 12 would be at the discretion of the designee, who is creating this tag.  Thus, the designee would be within his or her rights to refuse to add this specific text to a domestic 8130-3 tag, to the same extent that he or she would be permitted to do so. It is simply a matter of discretion.

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