FDA issues final rule for lab accreditation

December 9, 2021

The FDA issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act. Under the LAAF program, the FDA will recognize accreditation bodies (ABs) that will accredit food testing laboratories to standards in the final rule (LAAF-accredited laboratories). The final rule outlines eligibility requirements for ABs and laboratories and procedures FDA will use to oversee the program.

Currently, food testing, including environmental testing, is completed by private laboratories that conform to various standards and are 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.

What does this mean for egg producers? Once the rule is implemented, all egg testing required by the Egg Safety Rule due to a positive environmental sample must be conducted by an accredited laboratory. FDA will take approximately six months to identify the accreditation bodies and then publish a notice in the federal register. Once the laboratories are accredited, all egg testing must be conducted by laboratories recognized by the accrediting bodies. The entire process, prior to implementing the rule, will take FDA around one year.

The final rule does not exclude the food testing order included in the proposed rule for other foods but does rename it; the enforcement tool is referred to as a directed food laboratory order in the final rule. The rule preamble explains why this enforcement tool was maintained in the final rule despite stakeholder opposition and states the agency anticipates the tool will rarely be used. FDA will host stakeholder meetings after stakeholder review.

UEP staff and consultants will provide updates as the rule moves forward.