FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
December 1, 2021
Today, the U.S. Food and Drug Administration (FDA) issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as 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). 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 the 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 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 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.
For More Information