21 U.S.C. § 379j–31 — Authority to collect and use fees

(a) In general. (1) Purpose and authority. Starting with fiscal year 2010, the FDA must charge and collect fees from: (A) whoever is responsible for a domestic food facility, or the U.S. agent for a foreign facility, that gets reinspected that year, to cover the reinspection costs; (B) the responsible party at a domestic facility, or an importer, who doesn't comply with a recall order, to cover the FDA's recall-related work such as technical help, follow-up checks, and public notices; (C) each importer in the Voluntary Qualified Importer Program, to cover that program's administrative costs; and (D) each importer who gets reinspected that year, to cover reinspection costs. (2) Definitions. "Reinspection" means a follow-up inspection or import examination done specifically to check whether a facility or importer has fixed a food-safety problem found in an earlier inspection. "Reinspection-related costs" means all expenses of arranging, conducting, and evaluating reinspections, plus the cost of assessing and collecting the fee itself. "Responsible party" has the meaning given elsewhere in this title. (b) Establishment of fees. (1) Each year, the FDA must set these fees using the method below and publish them in the Federal Register at least 60 days before the fiscal year starts. (2) Method. Each fee category — reinspections, ignored recalls, the importer program, and importer reinspections — is set to cover 100% of the FDA's estimated costs for that category that year. In setting the importer-program fee, the FDA must account for how many importers signed up to join, and for the first 5 years after January 4, 2011 it must add a surcharge to recover the program's original startup costs. In setting reinspection fees, the FDA must credit back any amount it overestimated the year before, and may consider other adjustments as needed. Within 180 days of January 4, 2011, the FDA had to propose, with public comment, guidelines addressing the burden of these fees on small businesses, possibly including reduced fees for them; the FDA can only change the small-business fee schedule later through formal notice-and-comment rulemaking. (3) Use of fees. Fees collected for each category may only be spent on that category's costs. (c) Limitations. (1) Fees must be refunded for any year after FY2010 unless Congress's non-fee food-safety funding for that year is at least equal to FY2009's non-fee funding, increased by the inflation factor described below. (2) If the FDA skips fees for part of a year because of (1), but conditions later improve that same year, it can resume collecting fees at the normal rate, regardless of the usual due dates. (3) Adjustment factor. This is the percentage change in the national Consumer Price Index over the 12 months ending the previous June 30 (never counted as negative), added on a compounding basis to all the adjustments made since fiscal year 2009. (4) Caps. The FDA can't collect more than $20,000,000 a year in ignored-recall fees, or more than $25,000,000 combined per year in reinspection fees from domestic facilities and importers. If a facility or importer becomes newly subject to a fee after the relevant cap has already been reached, the FDA may still collect a fee from that facility or importer. (d) Crediting and availability of fees. Fees can only be spent up to what Congress allows in appropriations laws, but they stay available until spent. The FDA may transfer money between its salaries-and-expenses accounts as needed, and any transferred funds may be spent only on FDA staff and contractors doing food-safety-fee-related work. (e) Collection of fees. (1) The FDA must state in its Federal Register notice how and when these fees will be collected. (2) If a fee isn't paid within 30 days of its due date, it's treated as a debt owed to the U.S. government, handled under the federal debt-collection law. (f) Annual report to Congress. Within 120 days after each fee-collection fiscal year, the FDA must report to the Senate HELP Committee and House Energy and Commerce Committee, describing the fees assessed and collected and summarizing who paid them and what kind of business they're in. (g) Authorization of appropriations. For fiscal year 2010 and every year after, Congress is authorized to fund these fees at the total amount calculated under (b), as adjusted or otherwise affected under the rest of this section.