Domestic Food Facilities, U.S. Agents, and Importers: Get Ready for FSMA FeesJuly 31, 2011
By Ricardo Carvajal –
FDA announced fee rates for reinspections of domestic and foreign facilities, importer reinspections, and noncompliance with a recall order – all authorized by the Food Safety Modernization Act ("FSMA"). The fees kick in on October 1, 2011. The hourly fee rate is $224 ($335 if foreign travel is required). FDA can be expected to collect fees under the following circumstances:
- Reinspection after a previous inspection that was classified as Official Action Indicated (meaning that significant objectionable conditions or practices were found and regulatory action is warranted to address non-compliance), and where non-compliance was materially related to food safety requirements (meaning the food is adulterated under FDC Act § 402 or misbranded under § 403(w)). For domestic facilities, fees will be collected from the responsible party (the person who submitted the food facility registration required under § 415). For foreign facilities, fees will be collected from the U.S. agent. The fee will be based on the number of hours FDA spends on the reinspection. Those hours could add up quickly, given that FDA can include time spent on physical surveillance, travel, preparation of reports, and sample analysis.
- Import reinspection/reexamination after a refusal under § 801(a) (including refusal pursuant to an import alert for detention without physical examination) that is materially related to food safety requirements. Fees will be collected from the importer. The fee will be based on the time spent on the activity in question (e.g., evaluation of a request for, and supervision of, reconditioning; review of evidence regarding admissibility, under some circumstances; evaluation of a request for removal from import alert, under some circumstances).
- Recall activities performed by FDA as the result of noncompliance with a recall order. The fee will be collected from the person who received the recall order, which would be the responsible party (in the case of domestic facilities) or the importer. Again, the hours could add up quickly, considering the time spent on audit checks, inspections, and monitoring of disposition, among other things.
For the first year, there will be no formal mechanism for fee reductions for small business because FSMA requires notice and comment rulemaking to implement such fee adjustments. In the interim, to help develop proposed guidelines, FDA published a separate notice requesting comment on the burdens imposed by the fees on small business, and whether FDA should alleviate those burdens. FDA will also “consider waiving in limited cases some or all of an invoice fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.”