U.S – The Food and Drug Administration (FDA) has issued a draft guidance for industry entitled “The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry”.

The draft guidance, when finalized, will provide answers to frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program.

It is intended to assist accreditation bodies’, third-party certification bodies’ and eligible entities’ understanding of the regulation and program requirements.

The final rule for Accredited Third-Party Certification was issued in 2015 under the FDA Food Safety Modernization Act (FSMA).

The rule establishes a voluntary program, known as the Accredited Third-Party Certification Program, also referred to as the Third-Party Program or TPP, in which the FDA recognizes accreditation bodies that have the responsibility of accrediting third-party certification bodies.

The accredited third-party certification bodies conduct food safety audits and certify that eligible foreign food entities and food produced by such entities, meet the applicable food safety requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.

An eligible entity is a foreign entity in the U.S. import food supply chain that undergoes a food safety audit conducted by an accredited certification body under the Accredited Third-Party Certification Program.

A “facility certification” will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which allows for expedited review and entry of foods from importers in the program.

To participate in VQIP, one should import foods from facilities audited and certified by accredited CBs under TPP.

The certification will also come in handy where the FDA requires, in specific circumstances, that a food offered for import be accompanied by certification or other assurances that the food complies with applicable FD&C Act requirements.

The TPP regulation is part of FSMA’s paradigm shift toward a modern, preventive, and risk[1]based approach to food safety. It establishes requirements for the competence and independence of CBs who are accredited to conduct foreign food safety audits to examine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations.

The program requirements help ensure the integrity of the TPP certificates that are used for the purposes of VQIP and the safety of imported food subject to import certification.

FDA maintains oversight and management of TPP through routine monitoring and periodic assessments of the participating

Comments can be submitted in writing or electronically within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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