FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.

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 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.

The draft guidance, when finalized, will provide answers to frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program, and is intended to assist accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the regulation and program requirements.

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electronically within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments at Regulations.gov, using Docket No. FDA-2022-D-0370.

Additional information:

Federal Register Notice

Accredited Third-Party Certification Program

Apply to become an Accreditation Body (Select “Create New Account” and then select the appropriate box under FSMA)

Accreditation Body Electronic Portal User Instructions

Certification Body Electronic Portal User Instructions

Key Facts About the Program

Public Registry of Recognized Accreditation Bodies

Public Registry of Accredited Third-Party Certification Bodies

User Fees