FSMA Update - FDA Sets FY 2013 Fees for Facility and Importer Reinspections, Recall Noncompliance
FDA Sets FY 2013 Fees for Facility and Importer Reinspections, Recall Noncompliance Pursuant To FSMA § 107
Thank you for attending the Food Safety Modernization Act (FSMA) seminar sponsored by the Japan External Trade Organization (JETRO). This advisory is a regular series of communications from Sandler, Travis & Rosenberg that will keep you updated on key developments related to this important law.
The Food and Drug Administration announced Aug.1 its fiscal year 2013 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections. Fees for these services will be assessed at the rate of $221 per hour if domestic travel is required and $289 per hour if foreign travel is required. However, the FDA indicates that these fees will not be assessed until certain additional steps are completed. Comments on these fees are being accepted through Oct. 31 and will be considered in the FDA’s implementation of these fees.
Under the FDA Food Safety Modernization Act § 107 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 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 by the FDA 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.
The fee for import reinspection will generally be assessed in the following situations: (1) reconditioning of imported food to bring it into compliance, (2) importer request for admission of an article that has been detained , (3) request for removal from an import alert for detention without physical examination, and (4) destruction of food that has been refused admission.
Fees Delayed Pending Resolution of Outstanding Issues. In recognition of the fact that these fees could present a hardship for small businesses, the FDA is developing a guidance document to outline the process through which firms may request a reduction of fees. The FDA states that it does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.
The FDA is also in the process of considering various issues associated with the assessment and collection of importer reinspection fees. Recognizing the particular complexities involved in these issues, the FDA states that it is not in a position to assess importer reinspection fees until it has resolved these issues and will not assess importer reinspection fees until it notifies the public.
However, the fee rates set forth above will be used to determine any importer reinspection fees assessed in FY 2013.
For more information on this issue or any FDA matters, please contact Edgar J. Asebey-Birkholm, Esq. at (305) 894-1012 or via email at Easebey@strtrade.com