Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers April 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory AffairsCenter for Food Safety and Applied Nutrition
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) added section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d), which directs the U.S. Food and Drug Administration (FDA or Agency) to establish a program for accreditation of third-party certification bodies to conduct food safety audits and to certify that eligible foreign food entities (including registered foreign food facilities) and food produced by such entities meet applicable FDA requirements for purposes of sections 801(q) (21 U.S.C. 381(q)) and 806 (21 U.S.C. 384b) of the FD&C Act. On November 27, 2015, FDA issued the final rule, Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (also referred to as the TPP regulation) (80 FR 74569; 21 CFR Part 1, Subpart M).
This guidance answers frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) established in 21 CFR Part 1, Subpart M (21 CFR 1.600-1.695, 21 CFR 1.700-1.725). This guidance intends to assist the accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the TPP regulation and program requirements.
In this guidance, the pronouns “you” and “your” are used to refer to the accreditation bodies, certification bodies, or eligible entities, as applicable, applying to, or participating in the Third-Party Program. The pronouns “we” and “our” are used to refer to the FDA.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
- 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 (PDF: 6MB)
- Certification Body Electronic Portal User Instructions (PDF: 6.48MB)
- Key Facts About the Program (PDF: 79KB)
- Public Registry of Recognized Accreditation Bodies
- Public Registry of Accredited Third-Party Certification Bodies
- User Fees
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0370.