FDA announces FSMA-related user, reinspection and recall fees
By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) recently announced fiscal year 2022 fees associated with reinspecting facilities and importers, overseeing mandatory recalls, and participating in the agency’s third-party certification and voluntary qualified importer programs (VQIP).
The Food Safety Modernization Act (FSMA) provided FDA with authority to assess and collect fees to compensate the agency for 100 percent of its costs associated with reinspecting facilities and importers, and conducting mandatory recalls. FDA’s authority to assess and collect such fees extends to facilities and importers that handle human food, animal feed, pet food and grains and oilseeds. In addition, FSMA authorized FDA to collect users fees for entities that participate in the agency’s accredited third-party certification and voluntary qualified importer programs.
Reinspection and Recall Fees: FDA has authority to assess reinspection fees to determine whether adequate corrective actions have been implemented and compliance achieved at facilities and importers in response to a previous inspection which had a final classification of Official Action Indicated (OAI) conducted by or on behalf of FDA, when FDA determined the non-compliance was materially related to food safety requirements of the Federal Food Drug and Cosmetic Act (FD&C Act). Importantly, FDA does not consider non-compliance that is materially related to a food safety requirement to include circumstances where the non-compliance is of a technical nature and not food safety related (e.g., failure to comply with a food standard or incorrect font size on a food label). FDA states that determining when non-compliance is materially related to a food safety requirement of the FD&C Act may depend on the facts of a particular situation. Further, FDA intends to issue guidance to provide additional information about the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement.
Pertaining to recalls, FDA has authority to assess fees to cover activities performed by the agency when a facility or importer does not comply voluntarily with a food recall order issued by FDA. Not complying with a recall order may include: 1) not initiating a recall as ordered by FDA; 2) not conducting the recall in the manner specified by FDA in the recall order; or 3) not providing FDA with requested information regarding the recall, as ordered by the agency.
For fiscal year 2022, FDA’s announcement sets the hourly, per person, reinspection and recall rates at $277 if domestic travel is required and $330 if foreign travel is required. In comparison, FDA’s current fees are $263 for domestic travel and $310 for foreign travel. The fiscal year 2022 fees are effective Oct. 1, 2021 through Sept. 30, 2022.
Significantly, FSMA directed FDA to develop guidelines in consideration of the burden of reinspection and recall fees on small businesses. Such guidance remains under development, and FDA states in its notice that the agency does not intend to issue invoices for reinspection or recall order fees until the agency has published a guidance document to outline the process through which firms may request a reduction in fees.
In addition, FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees. As such, FDA states that fee rates set for fiscal year 2022 will be used should any importer reinspection fees be assessed.
Accredited Third-Party Certification Program Fees: FDA’s rule for the Accredited Third-Party Certification Program as mandated by FSMA was finalized in November 2015. The rule established a voluntary program in which FDA recognizes “accreditation bodies” that may accredit third-party “certification bodies.” The rule’s requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program. The accredited certification bodies may conduct food safety audits and issue certifications of foreign food facilities. FDA maintains a public registry of accredited certification bodies that have been recognized through the program.
FDA’s Third-Party Certification Program specifies two uses for certifications issued under the program:
• Certifications may be used by importers to help establish eligibility for participation in the FDA’s Voluntary Qualified Import Program (VQIP), which offers expedited review entry of food.
• To prevent potentially harmful food from reaching U.S. consumers, FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.
FDA’s announcement details the fiscal year 2022 fee rates for accreditation and certification bodies interested in voluntarily participating in the agency’s program.
VQIP Fees: VQIP is a voluntary fee-based program established by FDA as mandated by FSMA that provides expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains.
To participate, importers are to meet certain eligibility requirements, which include ensuring that the facilities of their foreign supplier are certified by a certification body that has been accredited through the FDA’s Accredited Third-Party Certification Program.
FDA’s announcement sets user fees for VQIP that will be effective on Aug. 1, 2021 and support program participation through Sept. 30, 2022. Approved VQIP applicants are to pay the user fee before Oct. 1, 2021 to participate in the program for the 2022 fiscal year.