FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry

  • As previously covered on this blog, on November 27, 2015, FDA finalized the rule, “Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications,” also referred to as the Third-Party Program (TPP).  As required under the Food Safety Modernization Act (FSMA), this rule established the framework for the accreditation of “third-party certification bodies” (CBs) to conduct food safety audits and issue facility and food certifications to eligible entities.  Upon recognition by FDA, “Accreditation bodies” (ABs) may assess and accredit CBs that meet the TPP program requirements.  Accredited CBs may conduct consultative and/or regulatory food safety audits of eligible entities that produce food for humans or animals.
  • On April 28, 2022, FDA made available a new draft guidance titled, “The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.”  When finalized, this draft guidance will answer frequently asked questions (FAQs) about the requirements of the Accredited Third-Party Certification Program as follows:
    • Definitions of terms: consultative audits, regulatory audits, audit agent, and days;
    • Circumstances requiring certification: (1) “Facility certification” is required for eligible entities to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), and (2) “Food certification” is required by FDA under certain circumstances to provide assurance that the food meets applicable food safety requirements;
    • Requirements for ABs seeking recognition from FDA: (1) Eligibility, (2) How to Apply, (3) the 11 Scopes of Recognition (Acidified Foods, Dietary Supplements, Infant Formula, Juice Hazard Analysis and Critical Control Points (HACCP), Low-Acid Canned Foods (LACF), Medicated Feed Current Good Manufacturing Practices (CGMPs), Preventive Controls for Animal Food, Preventive Controls for Human Food, Produce Safety, Seafood HACCP, and Shell Eggs), and (4) how the scopes of recognition correspond with legal and regulatory food safety requirements;
    • Requirements for recognized ABs: (1) Information for developing criteria for evaluating food safety audits, (2) Factors to consider in determining the appropriate number of onsite audits to observe prior to accrediting a CB, (3) Reports and notifications that must be submitted to FDA, (4) Application to FDA for recognition of additional scopes of recognition, (5) Conditions for accepting payment from a CB for accreditation services, (6) Conflict of interest protections and documentation requirements involving an AB employee serving as an audit agent for a CB that the AB has accredited under the TPP, (7) Consideration of financial interests of spouses and children of a recognized AB’s officers, employees, and agents involved in accreditation activities, (8) Records to be maintained for fee payments and reimbursement of direct costs, and (9) Notification by FDA to a recognized AB of FDA’s response when a CB accredited by the AB requests a waiver for the 13-month limit for audit agents conducting regulatory audits.
    • Requirements for CBs seeking accreditation from recognized ABs: (1) Eligibility, (2) How to apply, (3) the 11 Scopes of accreditation, (4) how the scopes of accreditation correspond with legal and regulatory food safety requirements (including a table describing the scopes of recognition and accreditation), (5) Further information on audit criteria for CBs (including the possibility of additional food safety requirements beyond those for which FDA has developed templates), (6) How a CB could demonstrate capability to meet the requirements for accreditation if the CB has not previously issued certifications based on food safety programs, and (7) Explanation that onsite audits conducted prior to the CB’s accreditation cannot serve as the basis for issuing a food or facility certification;
    • Requirements for accredited CBs conducting observed onsite audits and food safety audits: (1) Restrictions on the same CB conducting both consultative audits and regulatory audits for the same eligible entity, (2) Conduct of a regulatory audit without announcement during an identified 30-day timeframe; (3) Auditing and certifying eligible entities outside the countries of the CB, (4) Who makes the determination and issues certificates, (5) Determining what to assess as part of a food safety audit, (6) Circumstances for issuing a certificate for food that was not directly observed during the onsite examination of a regulatory audit, (7) Prohibition on providing a certificate for a scope that is not part of the CB’s accreditation, and (8) Evaluation for a new scope while the accredited CB’s AB is onsite conducting monitoring activities for an already-accredited scope;
    • Reports and notifications that an accredited CB must submit to FDA: (1) Regulatory Audit Report (RAR), Self-assessments, serious risk to public health, and withdrawing or suspending a food or facility certification, (2) Name(s) that must appear in food or facility certificate information submitted to FDA, (3) Timing for submission of a RAR and when FDA considers the RAR to be complete, (4) Required data elements for a RAR, (5) Change of address for an eligible entity, (6) Adequate information about observed processes and foods, (7) Role of FDA product codes provided to FDA in the certification information in FDA’s Unified Registration and Listing System (FURLS), and (8) Notification when a condition of public health significance is identified during a non-TPP audit;
    • Conflict of interest requirements for accredited CBs: A written program to protect against conflicts related to the financial interests of spouses and children younger than 18;
    • Requirements for eligible entities: (1) Certification of an eligible entity (such as a farm) that is not required to register as a food facility, and (2) Non-issuance of certificates to eligible entities that are not in compliance with applicable U.S. food safety requirements including FDA’s food facility registration requirements.
    • General requirements for the TPP: (1) Public registries of the recognized ABs and accredited CBs, (2) User fees for participation, and (3) Inclusion of a logo or mark of conformity to indicate certification and restations on use of FDA’s name;
    • TPP and other FSMA requirements: (1) Relation to VQIP, (2) Use of TPP audits to meet requirements of the Foreign Supplier Verification Program (FSVP) and Preventive Controls regulations, and (3) Conflict of interest requirements when an FDA-recognized AB is also a FSVP importer.
  • FDA has requested that comments on the new TPP guidance be submitted to Docket No. FDA-2022-D-0370 by July 28, 2022.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com if you are interested in submitting comments on the new draft guidance or if you have any questions about FSMA or the Accredited Third-Party Certification Program.