The U.S. Food and Drug Administration has opened an application portal for accreditation bodies interested in participating in the Laboratory Accreditation for Analyses of Foods (LAAF) program.
Under the LAAF program, the FDA will recognize accreditation bodies that will accredit food testing laboratories to standards established in the final rule on Laboratory Accreditation for Analyses of Foods, referred to as LAAF-accredited laboratories.
The final rule, issued by the FDA on in December 2021, established the LAAF program and outlined eligibility requirements that accreditation bodies and laboratories wishing to participate in the program will need to satisfy. The final rule also describes the procedures for how the FDA will manage and oversee the program. The FDA will maintain an online public registry of recognized accredited bodies and LAAF-accredited laboratories.
Eligibility requirements for an accreditation body seeking FDA recognition include being a full member of the International Laboratory Accreditation Cooperative (ILAC) and a signatory to the ILAC mutual recognition agreement (MRA) with demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025:2017”.
Interested accreditation bodies can apply through the portal.
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.
When the LAAF final rule is fully implemented, owners and consignees will be required to use a LAAF-accredited laboratory for food testing in the following instances:
- 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.
For additional information:
- LAAF User Guide
- LAAF Fact Sheet
- FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
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