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FDA Establishes User Fee Program to Fund Accreditation of Third-Party Food Safety Auditors

Wednesday, December 14, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule establishing a user fee program for a voluntary accreditation program under the Food Safety Modernization Act.

This program accredits third-party certification bodies (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. These audits and certifications will be used by importers seeking to establish eligibility for the Voluntary Qualified Importer Program and may also be required by the FDA as a condition of granting admission into the U.S. when certain food safety risks have been identified.

The final rule allows the FDA to assess fees for the work it performs to establish and administer the third-party certification program. The only one of these fees that will be assessed in fiscal year 2017 (specifically, for the period Jan. 13 through Sept. 30, 2017), will be the $35,100 initial application fee for certification bodies seeking direct accreditation.

For transparency and planning purposes the FDA has provided the following estimate of what the following additional fees could have been for FY 2017.

- $18,855 renewal application fee for recognized accreditation bodies

- $26,460 renewal application fee for directly accredited certification bodies

- $1,579 annual fee for recognized accreditation bodies

- $20,208 annual fee for certification bodies directly accredited by the FDA

- $1,974 annual fee for accredited certification bodies

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