FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods

FDA has issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program, as required by the Food Safety Modernization Act (FSMA).

Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit food testing laboratories to standards established in the final rule (referred to as LAAF-accredited laboratories). The final rule outlines eligibility requirements that ABs and laboratories will need to satisfy to participate in the program, as well as procedures for how FDA will manage and oversee the program.

Currently, food testing, including environmental testing, is largely completed by private laboratories that may conform to a variety of standards and be subject to various levels of oversight. Once the LAAF program is fully implemented, only LAAF-accredited laboratories will be able to conduct food testing in certain circumstances that are defined in the final rule.

The LAAF program will cover food testing:

• 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;
• Required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
• Required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
• Conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.

Timeline for Laboratory Accreditation

FDA intends to announce in early 2022 that ABs may apply for recognition. Once FDA has recognized a sufficient number of organizations, 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 six months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing.