FDA Issues a Final Rule for Laboratory Accreditation for Analyses of Foods

On December 1, 2021, the FDA issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program, as required by the FDA’s Food Safety Modernization Act (FSMA). The rule will follow a stepwise approach by the FDA to implement the LAAF program. The FDA intends to announce in early 2022 that accreditation bodies can apply for recognition. Once an ample number of accreditation bodies have been identified by the FDA, they will disclose that laboratories can apply to the recognized accreditation bodies for LAAF- accreditation. Once there are enough LAAF- accredited laboratories for food testing, the FDA will issue a document in the Federal Register offering owners and consignees six months’ notice that they will be required to use a LAAF- accredited laboratory for food testing.

Under the LAAF program, the FDA will observe accreditation bodies that will accredit food testing laboratories to standards set in the final rule. The final rule details eligibility requirements that accreditation bodies and laboratories will need to meet in order to participate in the program and actions taken by the FDA to manage the program. In specific circumstances, it will be mandatory for owners and consignees to use a LAAF= accredited laboratory for food testing. The FDA will retain an online public registry listing those accredited bodies and LAAF- accredited laboratories.

The creation of the LAAF program is meant to advance the accuracy and dependency of food testing through the FDA set standards and management of laboratories involved in the program. Currently, majority of food testing is done by private laboratories that adhere to many standards and are monitored by multiple sources. The LAAF final rule will apply to accreditation bodies and food testing laboratories that choose to enroll in the program, so participation is voluntary.

The LAAF program will cover food testing:

  • enforced by existing FDA food safety regulations;
  • to support entry of imported foods detained at the border if violating the Federal Food, Drug, and Cosmetic Act;
  • to allow the FDA to require use of a LAAF- accredited laboratory to focus on identified or suspected food safety issues;
  • to assist removal of a food from an import alert through testing requirements;
  • conducted in connection with administrative processes.

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Picture Credit Susanne Kuehne

Posted on 9 December 2021