U.S – The Food and Drug Administration (FDA) has 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, 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, and 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
It will also cover tests required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem and by a directed food laboratory order.
This final rule will allow FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances.
The program will also include testing conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.
Step-wise approach in implementation
The establishment of the LAAF program will improve 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.
The LAAF final rule is entirely voluntary hence applies to accreditation bodies and food testing laboratories that wish to participate in the program. In certain circumstances owners and consignees will be required to use LAAF-accredited laboratories to conduct food testing.
FDA will take a step-wise approach to implementation of the LAAF program. The recognition process will kick off in 2022 starting with accreditation bodies, followed by laboratories.
Once there are adequate LAAF-accredited laboratories to manage the scope of testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees 6 months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing.
FDA may issue more than one Federal Register document as LAAF-accredited laboratory capacity is attained for various types of food testing described in the final rule.