§379j–31 Authority to Collect and Use Fees

Summary

The Secretary must charge fees each year starting in fiscal year 2010 to pay for certain FDA food-safety work. Fees cover four things: reinspections of domestic facilities and reinspections of imports, FDA work on recalls when a company or importer does not follow a recall order, and the voluntary qualified importer program. The fees must equal the Secretary’s estimate of 100% of the costs for each of those activities in the year. The Secretary must publish the fee amounts in the Federal Register at least 60 days before each fiscal year and must say how and when fees will be paid. If a fee is unpaid 30 days after it is due, it will be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31. The law limits how fees are set and used. Fees collected for one purpose can only pay that same purpose. The Secretary must include credits if prior-year fees were overestimated. The Secretary must publish small-business fee guidelines within 180 days after January 4, 2011, take public comments, and change small-business fees only through notice-and-comment rulemaking. For the first five fiscal years after January 4, 2011, the importer program fee may include a surcharge to recoup start-up costs. Fees must be refunded for any fiscal year unless non-fee FDA food-safety appropriations meet or exceed fiscal year 2009 appropriations multiplied by an adjustment factor based on the Consumer Price Index (12-month change ending June 30, never negative, compounded each year). The Secretary may not collect more than $20,000,000 in fees for recall-related costs or more than $25,000,000 combined for the reinspection-related fees for domestic facilities and importers, except fees may still be charged to new facilities or importers that become subject after the cap is reached. The Secretary must report to Congress within 120 days after each fee year about fees collected and who paid them. Fees are collected and spent only as provided in appropriations Acts and may be used to pay FDA staff and contractors doing the work.