FDA Increases Fees for Expedited Import Program, Importer and Facility Reinspections, Etc.
For more information on these fees and their associated programs, please contact Domenic Veneziano at (202) 734-3939.
Expedited Import Program
The Food and Drug Administration has established a fee of $17,000 (up from $16,681) for importers approved to participate in the Voluntary Qualified Importer Program for the fiscal year 2021 benefit period. Importers must pay this fee prior to Oct. 1 to begin receiving VQIP benefits 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 Domenic Veneziano at (202) 734-3939.
Food Facility and Importer Reinspection
The FDA has announced its fiscal year 2021 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 $263 per hour if domestic travel is required (up from $258 in FY 2020) and $310 per hour if foreign travel is required (up from $301). These fees will be effective as of Oct. 1, 2020, and remain in effect through Sept. 30, 2021.
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.
Accreditation of Third-Party Food Safety Auditors
The FDA has announced the following FY 2021 user fees associated with the third-party certification program authorized by FSMA.
- initial application fee for accreditation bodies seeking recognition: $42,320 (up from $41,328)
- annual fee for recognized accreditation bodies: $1,966 (up from $1,945)
- annual fee for certification bodies accredited by a recognized accreditation body: $2,458 (up from $2,432)
- initial application fee for certification body seeking direct accreditation from FDA: $42,320 (up from $41,328)
Under FSMA, third-party certification bodies (auditors) are accredited to conduct food safety audits of foreign food entities and certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. These audits and certifications will be used by importers seeking to establish eligibility for the VQIP and may also be required by the FDA as a condition of granting admission into the U.S. when certain food safety risks have been identified.
The FDA states that an accreditation body’s recognition will be suspended if the annual user fee is not submitted within 30 days of the due date and revoked if the fee is not submitted within 90 days. Similarly, a certification body’s accreditation will be suspended if the annual user fee is not paid within 30 days of the due date and withdrawn if the fee is not paid within 90 days.