FDA Foreign Facility Re-Inspection Fees Still on Hold, Lower Priority for Agency, Report Says
FDA implementation of fees for follow-up inspections of foreign food facilities continues to be a low priority for the agency, and FDA will continue to concentrate on higher priority rulemakings instead, a March 19 report issued by the Government Accountability Office said. Those higher priority rules include FDA’s laboratory accreditation and food traceability rules proposed by FDA in 2019 and 2020, respectively, FDA officials said, according to the report.
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Required by the Food Safety Modernization Act and first announced in 2011 (see 11080114), the fees were immediately delayed until after FDA could issue a guidance document on how small businesses can request fee reductions (see 11100412 and 12073133). The fees run from over $200 to more than $300 per hour, depending on where the inspection occurs, and FDA says the full cost could cause “severe economic hardship on small businesses,” the report said.
Nearly a decade later, FDA still has yet to issue that guidance, and the report did not indicate that the guidance is imminent. “When FDA is able to devote more staff resources to the development of the guidance, the agency intends to conduct stakeholder outreach to explain the fees, how they would be collected, and how firms could request a fee reduction on the basis of their individual circumstances, according to agency officials,” it said.
The update on foreign facility registration fees came in an appendix to a lengthier report on FDA warning letters. The report found that, though FDA policy is to conduct follow-up inspections after issuing a warning letter, that goal was only met 11% of the time for warning letters issued on imported seafood during the period January 2014-March 2019. For 44% of warning letters issued on imported seafood during that period, FDA still has conducted no follow-up inspection at all, the report said.
GAO recommended that FDA establish a process to monitor its warning letters and whether it is following key procedures. It also said FDA should develop performance goals and measures to assess whether warning letters are effective in ensuring the safety of imported seafood. FDA agreed with both recommendations.