FDA Sets FY 2020 Fees for Expedited Import Program, Facility/Importer Reinspections
Expedited Import Program Sets FY 2020 Fee
The Food and Drug Administration has established a fee of $16,681 for importers approved to participate in the Voluntary Qualified Importer Program for the fiscal year 2020 benefit period. Importers must pay this fee prior to Oct. 1 to be eligible to participate in VQIP for this period. The FDA states that it is not offering an adjusted fee for small businesses at this time.
VQIP is a voluntary fee-based program that provides expedited review and importation of human and animal foods for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign supplier are certified under the FDA’s accredited third-party certification program.
The FDA has said importers should have at least a three-year history of importing food into the U.S. and be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Program and the juice and/or seafood Hazard Analysis and Critical Control Points regulations, if required. However, VQIP requires that importers go one step further to establish additional controls over their supply chains; e.g., creating quality assurance programs, which include written policies and procedures regarding safety and security and show compliance with criteria related to transportation and food defense.
For more information about VQIP, please contact trade attorney Shelly Garg at (305) 894-1043.
Food Facility and Importer Reinspection Fees Set for FY 2020
The Food and Drug Administration has announced its fiscal year 2020 fees for certain domestic and foreign food facility reinspections, failures to comply with a recall order, and importer reinspections. Fees for these services will be assessed at $258 per hour if domestic travel is required (up from $253 in FY 2019) and $301 per hour if foreign travel is required (up from $282 in FY 2019). These fees will be effective as of Oct. 1, 2019, and remain in effect through Sept. 30, 2020.
It is possible, however, that the fees will not actually be assessed during all or part of this period. This is because the FDA (a) does not intend to issue invoices for reinspection or recall order fees until it publishes a guidance document on how small businesses may request a reduction of those fees given the “severe economic hardship” that paying them could cause, and (b) is still considering various issues associated with the assessment and collection of importer reinspection fees.
Under the Food Safety Modernization Act the FDA may assess a fee for a reinspection that is (a) conducted to determine whether corrective actions have been implemented and are effective and compliance has been achieved to the FDA’s satisfaction at a facility that manufactures, processes, packs, or holds food for consumption and (b) necessitated as a result of a previous inspection of the facility that had a final classification of “official action indicated” when the FDA determined that the non-compliance was materially related to food safety requirements of the Federal Food, Drug, and Cosmetic Act. This fee may be collected from the responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection.
The FDA is also authorized to assess fees for not complying with a recall order; e.g., not initiating a recall as ordered by the FDA, not conducting a recall in the manner specified in a recall order, or not providing the FDA with requested information regarding an FDA-ordered recall. Such fees are to be paid by the responsible party for a domestic facility and an importer who does not comply with a recall order.