FDA published the final rule "Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program" and the final guidance "Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards" under the FDA Food Safety Modernization Act ("FSMA").
In November 2015, the FDA announced the final rule "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications," which establishes a voluntary program to accredit third-party certification bodies, or auditors, to conduct food safety audits of foreign food entities and certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. The new final rule provides for a reimbursement, or user-fee, program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program. The final guidance contains FDA recommendations and describes the standards for accreditation of third-party certification bodies as required by FSMA under the voluntary third-party certification program. The FDA issued a draft version of this guidance in July 2015. In establishing the model standards, FDA refers specifically to International Organization for Standardization ("IOS")/International Electrotechnical Commission ("IEC") recommendations.
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