FDA issues Laboratory Accreditation final rule required under FSMA

The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF).¹ This regulation was mandated by the FDA Food Safety Modernization Act (FSMA).  The LAAF rule will require use of certain laboratories, which must be accredited in a manner set out by the rule (LAAF-accredited laboratories), in a limited number of situations that generally relate to food with food safety concerns – specifically, foods with identified or suspected food safety problems, including certain food imports.  Thus, the rule is limited in scope and does not apply to all food testing (e.g., routine environmental and product testing).  When use of an accredited laboratory is required under this rule, the laboratory must send testing results directly to FDA.

Notably, the rule adopts a new procedure called a “directed food laboratory order” that will allow FDA to require use of an LAAF-accredited laboratory to address an identified or suspected food safety problem in certain circumstances that FDA says will be “rare.”  Industry comments on the proposed rule urged the agency not to adopt such a requirement (previously referred to as a “food testing order”), arguing the provision raised significant legal and policy concerns.

The rule will take effect in a stepwise fashion, as there must be sufficient LAAF-accredited laboratory capacity in place before food testing by such laboratories can be required.  FDA must first recognize accreditation bodies and then, in turn, laboratories can choose to apply to the recognized accreditation bodies for LAAF-accreditation.  After the program attains sufficient laboratory capacity, FDA will publish a notice in the Federal Register giving 6 months’ notice that owners and consignees would be required to use LAAF-accredited laboratories for the testing covered by the rule. 

This memorandum provides an overview of the key aspects of the final rule, with a focus on the impacts on food manufacturers and importers.  

Background

Section 202 of FSMA requires FDA to establish a program for testing food by accredited laboratories, whereby FDA-recognized accreditation bodies would accredit laboratories that must be used to perform certain food testing and must provide those testing results directly to FDA. ² The law provides that accredited laboratories must be used whenever designated food testing is conducted:

• “By or on behalf of an owner or consignee—
  • in response to a specific testing requirement under [the FFDCA] or implementing regulations, when applied to address an identified or suspected food safety problem; and
  • as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or
• on behalf of an owner or consignee—
  • in support of admission of an article of food under [FFDCA] section 801(a); and
  • under an Import Alert that requires successful consecutive tests.”³ 

The law also includes provisions on issues such as establishing model laboratory standards and establishing a public registry of accreditation bodies and accredited labs.

FDA issued a Proposed Rule in November 2019 and accepted comments through July 2020.⁴ FDA received approximately 70 comments on the proposal. The key provisions of the final rule will be codified at 21 CFR Part 1, Subpart R (§ 1.1101 et seq.).

Overview of the Final Rule

Accreditation Bodies, the Laboratory Accreditation Process, and Requirements for LAAF-Accredited Laboratories

FDA will recognize accreditation bodies for the LAAF program, which then will accredit laboratories to the standards established in the final rule.  These LAAF-accredited laboratories will be authorized to conduct certain food testing, as explained below.  The program structure is portrayed in the following diagram:

The rule contains eligibility requirements for accreditation bodies to qualify for FDA recognition and requirements that accreditation bodies must meet once recognized, such as requirements related to assessing and overseeing laboratories, conflicts of interest, reporting, and  records.  Likewise, the rule contains eligibility requirements for laboratories to qualify for LAAF accreditation by a recognized accreditation body and requirements that laboratories must meet once LAAF-accredited, such as those related to conflicts of interest, methods of analysis, reporting, and records.  This rule also contains procedures FDA will follow to recognize accreditation bodies under this program and procedures for accreditation bodies to follow to LAAF-accredit laboratories under this program.  Additionally, the rule contains regulatory procedures and requirements relating to FDA’s oversight of recognized accreditation bodies and LAAF-accredited laboratories.

Participation by laboratories is voluntary.  However, if laboratories wish to conduct the food testing covered by this rule, they will need to apply to a recognized accreditation body and satisfy the standards established by the rule.  ISO/IEC 17025:2017 is a baseline requirement for laboratories that wish to conduct food testing under this regulation.  FDA declined to provide modified requirements for specialized laboratories. 

The agency will publish online a publicly-available registry of recognized accreditation bodies and LAAF-accredited laboratories, including the scope of LAAF-accreditation for each.  LAAF-accredited laboratories can be located inside or outside of the United States.  Additionally, in-house laboratories are eligible to become LAAF-accredited.

Notably, while LAAF-accredited laboratories are required to submit their results directly to FDA, there is no requirement for them to concurrently provide the results to the owner or consignee of the food.  Therefore, industry and LAAF-accredited laboratories will need to make their own arrangements to share testing results.

Scope of Food Testing that Must Be Conducted Under the LAAF Program

Who Is Covered by the Rule

The rule applies to certain testing conducted “by or on behalf of an owner or consignee.”  The phrase “owner or consignee” is defined as “any person with an ownership or consignment interest in the food product or environment that is the subject of food testing conducted under [the several situations when the regulation applies].” 

Comments on the proposed rule requested clarification regarding which owners and consignees will be covered by the final rule, as there could be multiple owners and consignees in the context of imported food.  FDA responded in the preamble that although multiple parties could be considered owners and/or consignees of imported food, “there is generally only one importer of record for each entry” and “at the end of the day the importer of record remains the party ultimately responsible for the compliance of that entry and therefore is ultimately responsible for amassing any testimonial evidence (e.g., test results and associated analytical documentation) in support of admission of the food.” 

Testing Required to Be Conducted by LAAF-Accredited Laboratories

The rule applies only in certain circumstances related to testing of human and animal food and the food growing or manufacturing environment (e.g., environmental testing).  Specifically, the LAAF program covers food testing:

• In response to existing explicit testing requirements in the FDA regulations regarding sprouts⁵, shell eggs⁶, and bottled drinking water⁷;

• As required by FDA in a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain circumstances (as discussed in further detail below);

• To address an identified or suspected food safety problem and presented to FDA in connection with certain administrative processes – specifically, as part of evidence for a hearing prior to the issuance of a mandatory recall order, as part of the corrective action plan after a food facility’s registration has been suspended, and in connection with an appeal of an administrative detention order;

• To support admission of an imported food detained at the border because it is or appears to be adulterated or misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA); and

• To support removal of a food from an import alert through successful consecutive testing requirements.

When food testing is required under this regulation, analysis of samples must be conducted by a laboratory that is LAAF-accredited for the appropriate analytical method by a recognized accreditation body under this rule.

FDA emphasizes in the preamble that the final rule does not cover routine environmental testing (absent issuance of a directed food laboratory order).  Thus, routine testing under a Food Safety Plan is not required to be conducted by a LAAF-accredited laboratory.  FDA also confirms that these requirements do not apply to testing conducted in connection with the Foreign Supplier Verification Programs (FSVP) regulation.

Sampling Requirements

The final rule requires that the sample be collected by a person qualified by training or experience to do so, but the owner or consignee may select any sampler or sampling firm it likes, as long as the entity or person is qualified and will provide the documentation required under the final rule.  FDA does not establish a requirement for samplers to be accredited, instead establishing oversight provisions in the regulations.  The rule provides that certain sample-related information must be developed or obtained by the LAAF-accredited laboratory and submitted with the testing results, including written documentation of the sampler’s applicable qualifications by training and experience, the written sampling plan used to conduct the sampling, and a written sample collection report for each sample collected.

Additionally, the rule establishes limited for-cause circumstances when FDA may require advance notice of sampling, which must be submitted to FDA at least 48 hours before each of the next 10 occasions that the sampling firm will collect a sample that the LAAF-accredited laboratory will analyze under this regulation.  FDA also has flexibility to determine that a different amount of time is appropriate, ranging from 24 hours to 7 business days in advance.  Likewise, FDA can shift the number of occasions from a minimum of 1 to a maximum of 20.  When considering whether to require advance notice of sampling, FDA explains in the preamble that the agency will take into consideration such factors as the type of product, its shelf life, timing requirements of the test method, and the public health context for the testing.

The regulation provides that sampling must be conducted after the food has arrived in the United States, unless the owner or consignee has written approval from FDA that a sample taken prior to arrival is or would be a representative sample of the food offered for import into the United States.  FDA will make this determination on a case-by-case basis. 

Directed Food Laboratory Orders

As noted above, one of the situations when use of an LAAF-accredited laboratory is required is when FDA issues a “directed food laboratory order.”  This is a new regulatory enforcement tool that FDA is establishing based on its interpretation of the legal authority provided by the FFDCA.  The proposed rule included a similar provision, which was called a “food testing order.”  FDA changed the name because the term “directed food laboratory order” “more accurately reflect[s] the order and its impact.”  The preamble to the final rule responds to industry comments opposing the orders and asserting that FDA lacks the statutory authority to issue such orders, explaining the agency’s conclusion that this requirement has adequate legal support. 

The regulation provides as follows:

• “FDA may require the owner or consignee to conduct food testing, or to have food testing conducted on their behalf, under [the LAAF regulation] to address an identified or suspected food safety problem, as FDA deems appropriate.” 

• “The directed food laboratory order will specify the food product or environment to be tested; whether the food testing may be conducted using a LAAF-accredited laboratory that is owner, operated, or controlled by the owner or consignee; the timeframe in which the food testing must be conducted; and the manner of the food testing, such as the methods that must be used.”

• An affected owner or consignee may request a regulatory hearing on a directed food laboratory order no later than 3 business days after the order was issued.  The request for the regulatory hearing must include a written appeal that corresponds to the bases for FDA’s determinations described in the directed food laboratory order, together with any supporting information.  The regulations include additional provisions regarding such hearings.

The preamble includes an extensive discussion regarding directed food laboratory orders and provides the following additional information regarding this tool:

• Issuance: 
  • Who Can Issue a Directed Food Laboratory Order? FDA declined to specify who within FDA has authority to issue a directed food laboratory testing order.  In the preamble, FDA said that it agrees that the authority “would not be delegated to FDA investigators or State inspectors, [but] decline[s] to make the issuance of a directed food laboratory order a non-delegable function of the FDA Commissioner.”  The preamble states that the agency intends to limit the delegation of authority to issue a directed food laboratory order “to FDA officials with the appropriate level of responsibility.”

• How Is a Directed Food Laboratory Order Issued?  FDA intends to provide the “most legally responsible person at the firm that day with written notice of a directed food laboratory order, generally via email.”  The agency will make “every attempt” to call to inform the firm of the order prior to its arrival.  For imports, FDA “would generally deliver the written notice to the importer of record.”

• Duration:  The preamble explains that generally “a directed food laboratory order would last until [FDA has] adequate assurances that the underlying known or suspected food safety problem has been resolved. . . . However, details regarding the duration and termination of a directed food laboratory order will be contingent on the specific facts and circumstances of the order, which will vary greatly.”  Some orders may initially define the timeframe and testing frequency, but the agency will determine these matters on a case-by-case basis.  Regarding termination of an order, FDA says that the agency “expect[s] to be in dialogue with the entity subject to the order and intend[s] to take their feedback into consideration.”

• “Identified or Suspected Food Safety Problem”:  As noted above, the trigger for issuing a directed food laboratory order is that it would “address an identified or suspected food safety problem, as FDA deems appropriate.”  The agency declined to define the phrase “identified or suspected food safety problem” and declined to adopt a “serious adverse health consequences or death to humans or animals” (SAHCODHA)⁸ standard or to tie the requirement to a “reasonable belief that the food is violative,” as requested by comments.  However, FDA did discuss the intended scope of this phrase at length in the preamble.

Although there is no language to this respect in the codified provisions of the regulation, the agency explains that the use of directed food laboratory orders will be tied to situations when FDA has “reason to question the accuracy or reliability of past or present test results.”  The preamble suggests that this intent is captured through the codified phrase “as FDA deems appropriate.”  The agency provides the following examples of situations when it believes a directed food laboratory order would be useful and appropriate:

• “Following a for-cause inspection of a human food firm with a documented history of falsified laboratory reports, after the Agency’s receipt of information from an employee informant indicating that the firm continued to provide false or misleading certificates of analysis to conceal the production of adulterated human food;

• Following a recall by an animal food firm because the firm’s laboratory historically used an inappropriate method and reported results that differed from FDA laboratory results; and

• If FDA laboratories have on multiple occasions obtained positive pathogen results on food products in past years that conflict with the company’s contract laboratory’s results. Given a pattern of past ineffective monitoring by the company, coupled with the public health risk, on the next positive finding by FDA that leads to a voluntary recall for pathogen adulteration in this company’s food products, FDA might issue a directed food laboratory order.”

At the same time, it is important to note the preamble discussion explaining that “follow up testing in response to routine environmental testing results that indicate the presence of a pathogen or indicator organism in the food production environment may qualify as testing that addresses an identified or suspected food safety problem, and therefore could warrant issuance of a directed food laboratory order, depending on the circumstances.”  The agency goes on to state:

“We have also determined that routine verification testing that occurs pursuant to a preventive controls food safety plan . . . does not address an identified or suspected food safety problem . . . .  however, followup testing in response to routine verification test results indicating the presence of a pathogen or indicator organism in either a food product or the food production environment may qualify as testing that addresses an identified or suspected food safety problem, depending on the circumstances. We affirm the statement we made in the proposed rule that, depending on the circumstances, a positive indicator organism test would not necessarily constitute a suspected food safety problem; for example, a single positive Listeria spp. on a food contact surface in a facility would not necessarily constitute a suspected food safety problem. However, when a routine verification test of a food product indicates the presence of a pathogen, in many circumstances we would conclude that there is at least a suspicion of a food safety problem. For example, the presence of Salmonella in nuts indicates a suspicion of a food safety problem, but the presence of Bacillus cereus in tree nuts is not likely to indicate a food safety problem, since the organism cannot grow to the high numbers needed to cause illness due to the low water activity of tree nuts. Additionally, in many circumstances a routine environmental monitoring test result indicating the presence of a pathogen in a facility producing a ready-to-eat product could be classified at least as a suspected food safety problem.”

Thus, it is important to be aware that follow up testing that addresses an identified or suspected food safety problem under the Preventive Controls regulations (or any other FDA food safety regulation) could be the subject of a directed food laboratory order.

• Transparency:  Directed food laboratory orders may be included on an FDA website such as the data dashboard, so that other entities in the supply chain can be aware of their existence as they research and evaluate suppliers.  Information about the orders also generally would be subject to FOIA, with the usual limitations on disclosure of information due to FOIA exemptions.

• Limited Use:  There are several statements in the preamble explaining FDA’s intent that “it will be uncommon for [the agency] to issue a directed food laboratory order.”  The agency says that this tool will be applied “in particularized circumstances,” “rarely used,” and is not expected “to apply broadly or frequently.”

Implementation

FDA will take a stepwise approach to implementation of the LAAF program.  The agency intends to announce in early 2022 that accreditation bodies may apply for recognition.  Once the FDA has recognized a sufficient number of accreditation bodies, the agency will announce that laboratories may apply to the recognized accreditation bodies for LAAF-accreditation. 

When there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees 6 months’ notice that they will be required to use an LAAF-accredited laboratory for such food testing.  The agency may publish more than one Federal Register document as LAAF-accredited laboratory capacity is attained for various types of food testing described in the final rule.  The agency also explains in the preamble that if sufficient laboratory capacity is not reached for a particular category or subcategory of tests, then the immediate result would be that FDA would not require owners and consignees to use a LAAF-accredited laboratory to conduct those particular tests.

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We will continue to closely follow FDA’s implementation and enforcement of FSMA.  If you have any questions, please contact us.

References

Authored by Maile J. Gradison, Elizabeth Barr Fawell.