A decade after the Food Safety Modernization Act (FSMA) was signed into law, the FDA’s final rule on Laboratory Accreditation for Analyses of Foods (LAAF) for a laboratory accreditation program for the testing of food in certain circumstances is becoming a reality.
Under the LAAF program, the Food and Drug Administration will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule, referred to as LAAF-accredited laboratories.
Earlier this week, FDA announced that the final rule specifies eligibility requirements that ABs and laboratories wishing to participate in the program will need to satisfy, as well as procedures for how the FDA will manage and oversee the program. In certain circumstances, owners and consignees will be required to use a LAAF-accredited laboratory for food testing.
The FDA will maintain an online public registry listing recognized accredited bodies and LAAF-accredited laboratories.
The establishment of the LAAF program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories.
According to FDA, the LAAF final rule applies to accreditation bodies and food testing laboratories that wish to participate in the program. Participation is entirely voluntary. In certain circumstances, owners and consignees will be required to use LAAF-accredited laboratories to conduct food testing.
Under the rule, food testing, including environmental testing, is only required to be conducted by a LAAF-accredited laboratory under certain specified circumstances. For the purposes of the rule, “food” has the same definition as in section 201(f) of the Federal Food, Drug, and Cosmetic Act. It includes articles used for food or drink for man or other animals, except that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
After the LAAF final rule is fully implemented, owners and consignees will be required to use a LAAF-accredited laboratory for food testing:
The FDA’s leaders say the agency will take “a stepwise” approach to the implementation of the LAAF program. The agency intends to announce in early 2022 what accreditation bodies may apply for recognition. Once the FDA has recognized a sufficient number of accreditation bodies, the agency will announce that laboratories may apply to the recognized accreditation bodies for LAAF-accreditation.
When there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees six months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing. The agency 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.
FDA outlines the structure of the LAAF program here.
Meanwhile, the EAS Consulting Group reports that the LAAF program will:
- support removal of a food from an import alert through successful consecutive testing requirements;
- 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;
- be 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);
- be 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
- conduct in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order
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