FDA sets FY 2021 FSMA fees for import, third-party audits
The Food and Drug Administration has set fiscal year 2021 fees for inspection relating to imports and third-party audits under the Food Safety Modernization Act.
The fees cover the Voluntary Qualified Importer Program from Oct. 1 this year to Sept. 30, 2021, according to a news release.
The fees for both programs cover businesses of all sizes; links to the Federal Register entries contain equations showing how the agency calculated the fees.
VQIP
The VQIP is a fee-based program that expedites the review and importation of foods from importers who “achieve and maintain a high level of control over the safety and security of their supply chains,” according to the release.
The FY 2021 VQIP user fee is set at $17,000, according to the Federal Register notice on the fee.
That takes into account average times to complete the process:
- 36 hours to review a new VQIP application;
- 28 hours to review a returning VQIP application;
- 16 hours for on-site performance evaluation for a domestic importer; and
- 34 hours for on-site evaluation of foreign importer; and
- Assorted maintenance of information technology costs.
Third Party Audits
The Accredited Third-Party Certification Program is a voluntary program in which the FDA recognizes “accreditation bodies” than can accredit third party “certification bodies.” The certification bodies can then conduct food safety audits and issue certifications of foreign food facilities, according to the release.
According to the Federal Register, the FY 2021 user fees for the Third-Party Certification Program is:
- Initial Application Fee for Accreditation Body Seeking Recognition: $42,320;
- Annual Fee for Recognized Accreditation Body: $1,966;
- Annual Fee for Accredited Certification Body: $2,458; and
- Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA: $42,320.
Related stories:
FDA to launch online portal for importers
FDA: Voluntary importer program will benefit importers and agency
