FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Food Safety Mondernization Act, which established a voluntary program to accredit third-party certification bodies, or 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. The final rule provides for a reimbursement, or 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 will notify the public of the fee schedule annually. The fee notice will be made publicly available prior to the beginning of the fiscal year for which the fees apply, except for the first fiscal year in which this regulation is effective. Each new fee schedule will be adjusted for inflation and improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year.