The U.S. Food and Drug Administration (FDA) has issued a draft guidance that provides answers to frequently asked questions about the Accredited Third-Party Certification Program (TPP) requirements. TPP is part of the Food Safety Modernization Act (FSMA). TPP recognizes the accreditation bodies that are responsible for certifying the groups that conduct third-party food safety audits and ensure that eligible foreign food entities operate in line with the Federal Food, Drug, and Cosmetic Act and with FDA regulations. The guidance is intended to help accreditation bodies, third-party certification bodies, and eligible entities understand TPP requirements.

The draft guidance includes information such as:

• Definitions applying to the TPP
• Circumstances that require certification under TPP
• Requirements for accreditation bodies seeking recognition under TPP
• Requirements for recognized accreditation bodies under TPP
• Requirements for certification bodies seeking accreditation from TPP-recognized accreditation bodies
• Requirements for accredited certification bodies under TPP
• Requirements for eligible entities under TPP
• General TPP requirements.

Comments on the draft guidance can be submitted within 90 days of its publication in the Federal Register at www.regulations.gov, using Docket No. FDA-2022-D-0370.