Background

The Food and Drug Administration has announced the following fiscal year 2020 user fees associated with the third-party certification program authorized by the Food Safety Modernization Act.

- initial application fee for accreditation bodies seeking recognition: $41,328 (up from $38,211)

- annual fee for recognized accreditation bodies: $1,945 (up from $1,775)

- annual fee for certification bodies accredited by a recognized accreditation body: $2,432 (up from $2,219)

- initial application fee for certification body seeking direct accreditation from FDA: $41,328 (up from $38,211)

Under FSMA, third-party certification bodies (auditors) are accredited 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 FDA states that an accreditation body’s recognition will be suspended if the annual user fee is not submitted within 30 days of the due date and revoked if the fee is not submitted within 90 days. Similarly, a certification body’s accreditation will be suspended if the annual user fee is not paid within 30 days of the due date and withdrawn if the fee is not paid within 90 days.

For more information on FSMA and food safety audits, please contact trade attorney Shelly Garg at (305) 894-1043.

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