FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods

Today, FDA published its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). Once effective, the Rule will require industry to ensure that certain types of food testing are conducted only by laboratories that are accredited by FDA-recognized accreditation bodies. The Rule establishes detailed eligibility, compliance, and oversight requirements for LAAF-accredited laboratories and FDA-recognized accreditation bodies. This is one of the major rules FDA was required to issue under the Food Safety Modernization Act (FSMA).

Who is covered by the Rule?

The Rule imposes requirements on three entities: accreditation bodies seeking to accredit laboratories under the Rule, laboratories seeking to conduct testing under the Rule, and the owners and consignees of foods subject to testing under the Rule.

• Accreditation Bodies: The Rule requires that accreditation bodies seeking to accredit laboratories under the Rule first obtain “recognition” from FDA. The Rule sets forth specific eligibility criteria for recognized accreditation bodies, procedures for obtaining and renewing recognition, and ongoing compliance and oversight requirements for recognized accreditation bodies. The Rule also specifies how recognized accreditation bodies must assess and oversee laboratories seeking LAAF accreditation.
• Laboratories: Only laboratories that receive accreditation from an FDA-recognized accreditation body will be permitted to conduct testing under the Rule. The Rule establishes eligibility criteria and ongoing compliance requirements for LAAF-accredited laboratories. Notably for industry, the Rule also requires that accredited laboratories send the results of all testing conducted under the Rule directly to FDA.
• Owners and Consignees: Owners and consignees of food products will be required to ensure that all testing covered by the Rule is conducted by an LAAF-accredited laboratory. To facilitate this, the Rule requires that FDA maintain an online public registry listing recognized accreditation bodies and LAAF-accredited laboratories.

Which types of food testing are covered by the Rule?

The Rule does not apply to all types of food testing. Instead, and as required by FSMA, the Rule applies only to testing performed under the following limited circumstances:

• To support removal of a food from an import alert through successful consecutive testing requirements;
• To support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
• When required by existing FDA food safety regulations that address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
• When conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order; and
• When required by a directed food laboratory order (discussed below).

Food testing conducted under other circumstances—including testing associated with Foreign Supplier Verification Programs and most verification testing conducted under FDA’s Preventative Controls Rule—is not covered by the Rule.

What are directed food laboratory orders and when will FDA issue such orders?

The Rule authorizes FDA to issue directed food laboratory orders when the agency deems testing appropriate to address “an identified or suspected food safety problem.”[1] Such orders must specify:

• The product or environment to be tested;
• Whether testing can occur at an accredited laboratory owned, operated, or controlled by the owner or consignee;
• The timeframe for the required testing; and
• The manner (i.e., methods) of the testing.

Directed food laboratory orders must contain all of the information FDA generally includes in regulatory hearing notices,[2] and owners and consignees may request a hearing in response to such orders.

During the rulemaking process, multiple stakeholders challenged FDA’s authority to require LAAF testing through directed food laboratory orders (which FDA called “food testing orders” in its proposed rule). But, in the preamble to the final rule, FDA takes the position that it has the statutory authority to issue such orders under narrow circumstances. FDA repeatedly clarifies, however, that it will only issue directed food laboratory orders in “rare situations” when the agency has “reason to question the accuracy or reliability of past or present test results, and an identified or suspected food safety problem exists.”[3] FDA provides the following examples of situations in which directed food laboratory orders may be 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.[4]

What should industry expect next?

While the Rule will be effective 60 days after publication, FDA will not require industry to begin conducting testing at LAAF-accredited laboratories on that date. Instead, FDA will take the following “stepwise” approach to implementing the Rule:[5]

• First, in early 2022, FDA will announce that accreditation bodies may apply for recognition.
• Second, after the agency recognizes a sufficient number of accreditation bodies, it will announce that laboratories may apply for LAAF-accreditation.
• Third, FDA will publish a notice in the Federal Register once there is sufficient LAAF-accredited laboratory capacity. Industry will have 6 months from the publication of the notice to begin using LAAF-accredited laboratories to conduct testing covered by the Rule. FDA has indicated that, if appropriate, it may take a phased approach to this stage of implementation, i.e., by issuing separate Federal Register notices for different types of tests if some testing categories achieve sufficient LAAF-accredited laboratory capacity before others.[6]

In the interim, industry stakeholders should familiarize themselves with the Rule and its potential implications, engage with FDA as necessary to clarify the Rule’s requirements, and take appropriate measures to facilitate future compliance with the Rule.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice: