FDA announces FSMA-related fees for FY 2016.
- The FDA Food Safety Modernization Act (FSMA) authorizes FDA to collect fees associated with domestic and foreign facility reinspections, recall order noncompliance, and reinspections of importers. Regarding facility reinspection, FDA plans to assess a fee where it reinspects a facility to evaluate corrective actions taken in the wake of a prior inspection that revealed noncompliance materially related to food safety requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Regarding recall noncompliance, FDA plans to assess a fee where a firm fails to initiate or implement a recall in a manner consistent with the Agency’s order. FDA has not yet determined how it will assess fees related to importer reinspection.
- FDA has announced the fiscal year (FY) 2016 fee rates applicable to the activities above based on its estimate of 100% of the costs associated with each activity for the year. Fees will be assessed based on the number of direct hours spent on reinspections or on taking action in response to a firm’s failure to comply with a recall order. The hourly fee rates for FY 2016 are $221 (where domestic travel is required) and $315 (where foreign travel is required).
- To date, FDA has not yet assessed any fees under the circumstances described above. In a FSMA FAQ, FDA has indicated that it “does not intend to issues invoices for reinspection or recall order fees” until it has published guidance on various issues related to the assessment of fees (e.g., the types of noncompliance that will trigger fees, fee reduction procedures for small businesses, issues related to importer reinspections). Although FDA has not yet begun to collect fees under FSMA, and the Agency has not yet exercised its mandatory recall authority, FSMA implementation is well underway and major rules are due to be published in the very near future. In the meantime, the food industry should remain aware of FDA’s authority to assess fees under certain circumstances and should stay tuned for Agency guidance and future developments in this area.