• The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs.  See Sections 743(a)(1)(A), (B), and (D), respectively, of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Every year since Fiscal Year (FY) 2012, FDA has published the established rates for assessing fees for food facility reinspections, recall orders, and importer reinspections.  These FSMA authorized fees have not been collected, however, because guidelines mandated under Section 743(b)(2)(B)(iii) of the FD&C Act, for considering the burden of such fees on small businesses, are not yet available, and FDA is also still considering various issues associated with the assessment and collection of importer reinspection fees.  Additionally, guidance is also pending regarding the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement of the FD&C Act.  It is food safety related noncompliance issues that trigger a reinspection (subject to a fee assessment) to evaluate corrective actions.
  • In the July 25, 2019 Federal Register, FDA announced its FY 2020 rate of $240/hour, exclusive of travel, that will be assessed for FDA staff working on certain food facility reinspections, recall orders, and importer reinspections.  FDA’s rates where domestic travel or foreign travel are required are $258/hour and $301/hour, respectively, and are both increased as compared to the rates of $253/hour and $282/hour, respectively, for FY 2019, which ends September 30, 2019.  It does not appear as though any of these FSMA authorized fees will be collected for FY 2020 because FDA simultaneously announced (as it has in the past) that it does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees and that importer reinspection fee issues are still under consideration.