Draft–Not for Implementation
- Available in PDF (343KB)
- Federal Register Notice for this Guidance
- Docket Number FDA-2011-N-0146 for commenting, comment period on the draft closes October 7, 2015
- Constituent Update: New Tools Would Advance Efforts to Ensure the Safety of Imported Foods
- FSMA Proposed Rule on Accreditation of Third-Party Auditors
- FSMA Proposed Rule on User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
This guidance is being distributed for comment purposes only.
You should submit comments and suggestions regarding this draft document within 75 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition’s Office of Compliance at 240-402-3708.
U.S. Department of Health and Human Services
Food and Drug Administration
The FDA Food Safety Modernization Act (FSMA), enacted January 4, 2011, added Section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d). Section 808 of the FD&C Act directs FDA to establish a program for the recognition of accreditation bodies that accredit third-party auditors/certification bodies to conduct food safety audits to assess compliance with the provisions of the FD&C Act and to issue food and/or facility certifications that FDA may use in certain circumstances to facilitate the entry of foods presented for import. Section 808(b)(2) of the FD&C Act requires FDA to develop Model Accreditation Standards that recognized accreditation bodies shall use to qualify third-party auditors/certification bodies for accreditation, and in so doing, to look to existing standards for certification bodies (as of the date of enactment of FSMA) to avoid unnecessary duplication of efforts and costs.
FDA’s standard-setting activities also are guided by the National Technology Transfer and Advancement Act of 1995 (NTTAA), which directs federal agencies to use voluntary consensus standards in lieu of government-unique standards, except where inconsistent with law or otherwise impractical. In developing this draft guidance, FDA considered several voluntary consensus standards for their relevance to the qualifications of third-party auditors/certification bodies that would certify foreign food facilities and/or their foods for conformance with the requirements of the FD&C Act. FDA also sought to identify the standards most commonly used by stakeholders (e.g., other governments, public and private accreditation bodies, the food industry, and the international standards community) in qualifying third-party auditors/certification bodies for conducting food safety audits. As a result, FDA was guided in developing this draft Model Accreditation Standards guidance document by International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) ISO/IEC 17021: Conformity Assessment – Requirements for bodies providing audit and certification management systems (2011) (“ISO/IEC 17021:2011”).
This draft guidance, if finalized, will constitute the model accreditation standards referred to in section 808(b)(2) of the FD&C Act. In instances where this draft guidance provides different or more specific recommendations than are contained in the ISO/IEC 17021:2011, or conflicts with ISO/IEC 17021:2011, the recommendations of this guidance apply.
This draft guidance document is issued as a companion to the proposed rule “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (“the proposed rule”). This draft guidance document contains FDA recommendations on third-party auditor/certification body qualifications, including recommendations based on relevant provisions in the proposed rule. When finalized, the Model Accreditation Standards will serve as a companion guidance document to the final rule. It will include FDA’s final recommendations on third-party auditor/certification body qualifications and will incorporate relevant requirements from the final rule, as permitted in FDA final guidance documents.
The complete guidance is available in PDF (343KB).
1 The proposed rule “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” was published in the Federal Register on July 29, 2013 (78 FR 45782).
2 In this draft guidance sections of the proposed rule are referred to as “proposed [x].”