FDA Seeks Comment on Food Safety Fees for Facility Reinspections
On August 1, 2011, the U.S. Food and Drug Administration (FDA) posted a notice for public comment regarding food safety fees associated with facility reinspections. The passage of the Food Safety Modernization Act (FSMA) earlier this year granted the FDA authority to impose and collect fees from food producers when the Agency has to reinspect the facility for compliance with FDA regulations. The Federal Register notice seeks to “obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business.” The FDA will accept comments until October 17, 2011.
The FSMA was signed into law to enable the FDA to better protect public health by helping to ensure the safety and security of the food supply. The law provides the FDA with enforcement power intended to boost the rate of compliance with prevention- and risk-based food safety standards. The new section (32 U.S.C. 379j-31) of the Food, Drug, and Cosmetics Act (FDCA), “mandates that FDA assess and collect fees for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall orderand certain importer reinspections.”
In this Federal Register notice, the FDA is particularly interested in understanding how these costs may impact small business. In order to prepare for and develop guidelines in consideration of the burden of fee amounts on small businesses, the FDA will accept comments on the following questions:
- Is a fee reduction or other consideration for small business appropriate?
- How should small business be defined or recognized for the purpose of the proposed guidelines?
- If FDA considers reduced fee amounts in the proposed set of guidelines, what factors should FDA consider in establishing the amount by which fees could be reduced?
The fees associated with FDA reinspections will be based on an estimation of 100 percent of the costs of the FDAs expenses, such as the inspectors time at the facility, travel expenses, related administrative tasks, and laboratory analysis. The FDA plans to accept public comment on the cost of fees after the fees are established and published in the Federal Register later this year.
Fuerst Ittleman will continue to monitor the developments in the FDAs regulation of food facilities. For more information, please contact us at firstname.lastname@example.org.