Skip to main content

FDA Publishes Final Rule on FSMA Third-Party Accreditation Program

The Food and Drug Administration (FDA) published its final rule on November 27, 2015, to implement a third-party accreditation program under the FDA Food Safety Modernization Act (FSMA). The rule establishes an FDA accreditation system to govern bodies that conduct food safety audits and issue certifications for facilities and food.

The final rule establishes a new, voluntary program for FDA to recognize accreditation bodies that in turn accredit third-party certification bodies to perform food safety audits and issue certifications for foreign food facilities and the foods they produce. Consistent with the Foreign Supplier Verification Program (FSVP) final rule that was published concurrently with this rule, the term “food” includes food-contact substances.* 

FDA has indicated that it may use certifications:  (1) as a condition of entry for certain foods that FDA has determined may pose a safety risk; and (2) to facilitate participation in the Voluntary Qualified Importer Program (VQIP) that will give importers expedited review and entry of imported food into the U.S.  The final rule is effective January 26, 2016, although ultimate implementation depends on when FDA finalizes its Model Accreditation Standards.

The final rule, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications, was published in the Federal Register (80 Fed. Reg. 74570 (Nov. 27, 2015)).


* Since the publication of this article, FDA announced in January 2018 that it would exercise enforcement discretion for food-contact substances with regard to FSVP requirements.