FDA Finalizes FSMA Third-Party Certification User Fee Program

Constituent Update

December 13, 2016

The U.S. Food and Drug Administration today issued a final rule to establish a user fee program for a voluntary accreditation program under the FDA Food Safety Modernization Act.

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 established 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 final rule issued today, “Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program.” 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 agency also announced today the fiscal year 2017 fee rate for accreditation bodies applying to be recognized in the third-party certification program. The fee is effective (30 days after FR Publication Date), and will remain in effect through September 30, 2017.

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