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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No EASA Form 1 for Certain EU Parts?

December 19, 2019 by 1 Comment

EASA has published the comment respond document (CRD) and Opinion for its rule concerning “Installation of parts and appliances that are released without an EASA Form 1 or equivalent.”

ASA has been talking about this proposal a lot, so many of our members are already familiar with the proposal.  It would allow the design approval holder (DAH) to classify articles, and to permit certain articles to be exempted from the regulations (so that the regulator would have no production oversight over the article).  This would be performed in the context of preparation of the ICAs, as a privilege of the design approval holder.  The reason for classifying articles is to define a class of articles that do not need production approval, and that do not need EASA Form 1.

The DAH could choose to classify parts into two categories.  The categories would be distinguished based on the safety effect of the article as installed on the aircraft

  • Category One would reflect the norm, under which articles are produced under production organization approval (POA) and bear an EASA Form 1. This will be the default in cases where the manufacturer does not classify articles.
  • Category Two would reflect articles with a negligible safety effect. The regulators would not regulate the production of such parts.  Such articles would not require EASA Form 1 to be received by a Part 145 organization.  This would allow the DAH to de-regulate an article.

Classifying parts into category two would be a voluntary activity.  The DAH would determine the safety effect and would publish the list of category two parts in the instructions for continuing airworthiness (ICA).

The proposed language in the regulation that EASA is proposing to the European Commission for the rules would state:

“1. An organisation responsible for the manufacture of products, parts and appliances shall demonstrate its capability in accordance with the provisions of Annex I (Part 21). This demonstration of capability is not required for the parts or appliances that an organisation manufactures which, in accordance with the provisions of Annex I (Part21), are eligible for installation in a type-certified product without the need to be accompanied by an authorised release certificate (i.e. EASA Form 1).’;”

Corollary language in the annex, section 21.A.307, would explain thatit is not necessary to obtain production approval for:

“a part or appliance for which the consequences of a non-conformity with its approved design data has a negligible safety effect on the product and which is identified as such by the holder of the design approval in the instructions for continued airworthiness. In order to determine the safety effects of a non-conforming part or appliance, the design approval holder may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part or appliance on the product;”

This language would provide a regulatory (“hard law”) basis for the EASA proposal.

The proposed rule still has problems.  ASA pointed out in comments that the ICA is typically not made available to distributors, and therefore it could become impossible for distributors to know the compliance obligations for articles, due to the fact that it would be impossible for distributors to know whether the articles were placed into category one or category two.  If a third party produced the parts under a claim that they were category two, then this claim would not be verifiable because the verification data would not be publicly available (thus a manufacturer could fabricate unapproved parts, erroneously call them category two, and introduce them into the system without EASA Form 1; and a distributor would have no way to verify whether the articles are category 1 or 2).  This opens to the door to introduction of unapproved parts, and undermines the systems that distributors have used to help protect air carriers from bad parts.

EASA has also discussed possibly using CS-STAN to identify articles that are considered to have ‘negligible safety effect’ and which can, therefore, be installed without an EASA Form 1.  This would be for articles that EASA feels generally have a negligible safety effect.

In comments, Rolls Royce Deutschland, the FAA, MARPA and ASA all suggested that this might be inconsistent with state duties under ICAO norms.  ASA suggested that the proposal might be inconsistent with European obligations under the Chicago Convention, Annex 8, Part II, section 2.2.1.

There is a possibility that this rule may change nothing,.  A comparable rule in the U.S., the commercial parts rule, was ill-formed and did not get used the way it was expected to be used.  So too, this new EASA rule might not be used and the industry may find itself unchanged after this rule.

 

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Commercial Parts – What Are They?

September 18, 2011 by Leave a comment

Lately we’ve had a number of questions about commercial parts.  Industry members want to know what are they, and how do the new commercial parts rules affect the marketplace?

The definition of commercial parts can be found at 14 C.F.R. 21.1(b)(3).  They are defined as anypart that is identified as a commercial part by a design approval holder.  To understand how to define such parts, though, a design approval holder must go to the defining criteria found in section 21.50(c) (discussed below).

The 2009 change (which become fully effective in April 2011) to the regulations modifieded the FAA’s standard for when a person needs to get a PMA or other production approval for the fabrication of a part.

Previously, the test was whether the manufacturer knew at the time of production that the part was going to end up on a type certificated aircraft. This standard was tested and established in the Pacific Sky case in 1993:

“The most reasonable interpretation of the regulation is that Complainant must show that Respondent knew or should have known that it was substantially certain that the parts produced by Respondent without a Parts Manufacturer
Approval would be installed on type-certificated products.”  In the Matter of Pacific Sky Supply, FAA Order No. 93-19; Docket No. CP91NM0319 (June 10, 1993).

That case goes on to explain that:

This is a somewhat more difficult burden to meet than Complainant’s reasonably likely standard. It more appropriately balances the equities involved — the FAA’s duty to promote aviation safety n8 by controlling the spread of unapproved parts, and the producer’s right to produce parts without FAA approval when it is insufficiently probable that the parts will find their way into type-certificated aircraft.  In the Matter of Pacific Sky Supply, FAA Order No. 93-19; Docket No. CP91NM0319 (June 10, 1993).

The 2009 change alters the language to reflect the proposal that the FAA Administrator rejected in 1993.  The new language of 14 C.F.R. 21.9 states that:

If a person knows, or should know, that a replacement or modification article is reasonably likely to be installed on a type-certificated product, the person may not produce that article unless it is ….

This section then goes on to list certain categories of parts that are considered acceptable under this provision.  Commercial parts are listed as one of the categories of acceptable parts – they reflect an exclusion from the general requirement to obtain production approval.  See 14 C.F.R. 21.9(a)(4).

An important element of this new rule is that the prior industry understanding of the term “commercial parts” – meaning parts that are not designed for use in aviation but that are chosen by the installer for installation, is no longer the definition used by the FAA.  Under the old standard, the installer was responsible for assuring airworthiness at the time of installation.  While the installer still bears this regulatory obligation (to assure airworthiness at the time of installation), commercial parts will be parts that have been previously subjected to engineering analysis by a FAA design approval holder, so the burden on the installer to confirm airworthiness would be theoretically decreased.

We say “theoretically decreased” because as of this time, we are not aware of any design approval holder that is designating commercial parts. We have been informally surveying design approval holders for over two years and the results have remained the same – none of the design approval holders intend to designate commercial parts.

The commercial parts category was conceived as a “safety valve” to permit the FAA to work with design approval holders in order to continue to have a category of parts that are used in aviation but that are not subject to direct FAA production approval.  Instead of that category being defined by the producer’s intent, it would be explicitly defined by an application made by a design approval holder and approved by the FAA.  However, the utility of that category is obviously undermined if it is not used, and the change in the regulatory standards identifying which parts need to be approved by the FAA becomes more pronounced – and has a more noticeable affect on the industry – when the regulatory change is not buffered by a use of the “commercial parts” designation.

A discussion of the protocol for identifying commercial parts can be found at 14 C.F.R. 21.50(c).  Essesntially, a design approval holder may submit a request to the FAA seeking FAA approval of a commercial parts list.  The request must be substantiated with engineering data to show that:

  1. “The failure of the commercial part, as installed in the product, would not degrade the level of safety of the product;”
  2. “The part is produced only under the commercial part manufacturer’s specification and marked only with the commercial part manufacturer’s markings;” and
  3. “Any other data necessary for the FAA to approve the List.” – under this provision the FAA may attempt to impose any other requirement at will.

The FAA has also published an advisory circular about commercial parts that provides additional guidance.

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