On December 1, 2021, the U.S. Food and Drug Administration (“FDA”) issued a final rule establishing the Laboratory Accreditation for Analyses of Food (“LAAF”) program.

FDA will utilize the LAAF program to recognize accreditation bodies that will accredit food testing laboratories to specified standards. The final rule outlines eligibility requirements for both accreditation bodies and laboratory facilities. The LAAF program will mark a major shift in food testing, which is currently handled by private laboratories with limited government oversight.

After the LAAF program is fully implemented, testing in LAAF-accredited facilities will be required if:

• 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 the 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.

The FDA’s press release states: “[t]he establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories.”