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FDA Issues Guidance on FSMA Third-Party Certification Program and Finalizes User Fees

The U.S. Food and Drug Administration (FDA) recently issued a guidance document that recommends standards for accrediting third-party certification bodies under the Food Safety Modernization Act (FSMA) third-party certification program. Accredited third-parties may conduct food safety audits and issue food and/or facility certifications. These certifications will be required for participation in FSMA’s Voluntary Qualified Importer Program (VQIP). In addition, when FDA has determined that an imported food may pose a safety risk, the Agency may require a certification as a condition for admitting the food into the United States.

FDA also published a final rule on December 14, 2016, to establish a user fee program for the work it performs with respect to the third-party certification program. On the same day, FDA announced the fiscal year (FY) 2017 user fees for the third-party accreditation program.

The first-time application fee for accreditation bodies seeking direct accreditation from FDA will be $35,100 for FY 2017. These fees will be effective from January 13, 2017 through September 30, 2017. In future years, the third-party certification program will also assess other application and annual fees. While FDA will not collect these fees in FY 2017, the Agency estimated what the following fees would be based on FY 2017 hourly rates:

  • Renewal application fee for recognized accreditation body—$18,855
  • Initial application fee for certification body seeking direct-accreditation from FDA—$35,100
  • Renewal application fee for directly-accredited certification body—$26,460
  • Annual fee for recognized accreditation body—$1,579
  • Annual fee for certification body directly-accredited by FDA—$20,208
  • Annual fee for accredited certification body—$1,974

For more information on the third-party certification program, see the article, FDA Publishes Final Rule on FSMA Third-Party Accreditation Program, and for more information on VQIP, see FDA Issues Final Guidance for Voluntary Qualified Importer Program Under FSMA.)