August 12, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update - FDA Seeks Comments on Accreditation of Third-Party Auditors/Certification Bodies (Input Requested by August 28, 2015)

On July 24, 2015, JPA members were notified that the Food and Drug Administration (FDA) had published a proposed rule and draft guidance related to the “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (Accreditation of Third-Party Auditors) as part of the Agency’s efforts to implement the provisions of the FDA Food Safety Modernization Act (FSMA).

As you may recall, in July 2013, the FDA issued a proposed rule regarding the accreditation of third-party auditors to provide for accreditation of third-party auditors and certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications. Under this program, in which participation is voluntary, FDA will recognize accreditation bodies, which will in turn accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food under specified programs.

Proposed Rule

The proposed rule establishes user fees for participation in the third-party accreditation program, and includes the following: “(1) Who would be subject to a user fee; (2) how user fees would be computed; (3) how FDA would notify the public about annual fee rates; (4) how the user fee would be collected; and (5) what the consequences would be for not paying a user fee.”

The FDA is seeking comment on a number of topics outlined in the proposed rule. For your convenience, the list of topics raised by the Agency and compiled by JPA staff is available here. The document is lengthy as background information is included for clarification purposes. If you believe JPA should submit comments to the FDA regarding this proposed rule, please provide your detailed input to Headquarters by the close of business on August 28, 2015. Comments related to the proposed rule must be submitted to the FDA by October 7, 2015.

Draft Guidance: Model Accreditation Standards

The FDA draft guidance, “Third-Party Auditor Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards” contains the Agency’s recommendations on third-party auditor/certification body qualifications, including recommendations based on provisions in the accreditation of third-party auditors/certification bodies proposed rule issued in July 2013. The draft guidance includes the following topics: (1) Definition, (2) Authority and responsibility, (3) Capacity and competence, (4) Conflicts of interest, (5) Quality Assurance, (6) Records, (7) Regulatory Audit Reports, and (8) Publicly accessible information and directory of certified clients and certification documents.

The FDA is accepting comments until October 7, 2015 on all aspects of the draft guidance. If you believe JPA should submit comments to the FDA regarding the draft guidance, please provide your detailed input to Headquarters by the close of business on August 28, 2015.

As always, please contact me with questions or comments.

Patricia Faison

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JPA Staff
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