FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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December 2, 2021


• Categories: Compliance, Food Labs, Food Manufacturing, FSMA

At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“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,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

• “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 will be published on the Federal Register on December 3.