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December 1, 2021
Dear International Colleague,
Today, the U.S. Food and Drug Administration (FDA) issued a final rule establishing a laboratory accreditation program for the testing of food, including circumstances applying to imports, bottled drinking water, shell eggs, and sprouts.
The Laboratory Accreditation for Analyses of Foods (LAAF) program was required by the FDA Food Safety Modernization Act (FSMA).
Under the LAAF program, the 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).
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 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 final rule outlines the eligibility requirements that ABs and laboratories must satisfy to participate in the program, as well as procedures for how the FDA will manage and oversee the program.
The LAAF program will improve the accuracy and reliability of certain food testing through the use of uniform standards and enhanced oversight of participating laboratories and thus improve the FDA’s capacity to protect U.S. consumers from unsafe food.
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