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FDA Finalizes FSMA Third-Party Certification User Fee Program
Thursday, December 15, 2016
  • In November 2015, the FDA announced a final rule regarding the “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” which established a voluntary program to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. As our readership is well aware, this final rule is one of several that implement the FDA Food Safety Modernization Act (FSMA). As also covered on this blog earlier this week, FDA issued final guidance for industry containing recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under this voluntary third-party certification program.

  • On December 14, 2016, the FDA published a final rule to establish a user fee program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program. FDA also announced the fiscal year 2017 application fee for accreditation bodies that wish to be recognized in the third-party certification program ($35,100). The fee is effective January 13, 2017, and will remain in effect through September 30, 2017.

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