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Advocacy Article

Regulatory Alert: Food and Drug Administration: Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications

On July 29, 2013, the Food and Drug Administration (FDA) published in the Federal Register its proposed rule on Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications as established by the 2011 FDA Food Safety Modernization Act (FSMA). 78 Fed. Reg. 45781, July 29, 2013.  This proposed rule establishes a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and their foods.  This voluntary program is for foreign facilities and foods only.  FSMA does not require FDA to establish a domestic audit program.

This proposal also contains requirements relating to monitoring and oversight of participating accreditation bodies and auditors at every level.  These include procedures that FDA will follow when removing an auditor or an accreditation body from the program, for good cause.  Having comprehensive oversight of a credible and reliable program for third-party audits and certifications of foreign food facilities will help FDA prevent potentially harmful food from reaching U.S. consumers.

 The comment deadline is November 26, 2013.

  •  Advocacy contact: Linwood Rayford at 202-205-6533
  • The proposed rule and a Fact Sheet highlighting a quick summary of the key provisions of this proposed rule can be found at:  http://www.fda.gov/fsma.