FDA announced the Food Safety Modernization Act (FSMA) domestic and foreign facility reinspection, recall and importer reinspection fee rates for Fiscal Year (FY) 2015, in an August 1, 2014 Federal Register notice. Section 107 of FSMA added section 743 to the FD&C Act giving FDA the authority to assess and collect fees from the responsible parties of domestic and U.S. Agents of foreign facilities requiring reinspections; domestic facilities and an importer who do not comply with a recall order and importers subject to reinspections. The FSMA Fee Schedule for FY 2015:
- Hourly rate if domestic travel is required $217 and
- Hourly rate if foreign travel is required $305
These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.
These fees will be assessed for the reinspection to evaluate if a firm has taken the appropriate corrective actions from the prior inspection in where “Official Action Indicated” (OAI) was indicated. The responsible party for each domestic facility and the U.S. agent for the foreign facility will be required to pay the reinspection fees. The fees will be based on the number of hours spent on the reinspection. This will include time to conduct the physical inspection preparation for the reinspection, travel time, report writing, collecting and analyzing samples, etc. to ensure the facility is compliant.
In addition FDA will be assessing fees for non-compliance with a recall order to cover food recalls. Non-compliance may include: not initiating a recall as ordered by FDA and/or not performing the recall in a manner specified by FDA recall order and/or not providing FDA with requested information regarding the recall order. The responsible parties for a domestic facility and an importer who does not comply with the recall will be responsible for paying the assessed fees. These fees will be assessed on the direct number of hours spent on the FDA taking action in response to the firm’s failure to comply with the recall order.
FDA will be invoicing the responsible parties for paying the fees after the Agency has completed the work for which the invoice is based and payment will be required within 90 days in U.S currency by check, bank draft or U.S. postal money order.
Also, FDA is developing guidance documents to outline the new processes for requesting a reduction of fees for the reinspection and recalls and the agency’s process for assessment and collection of fees from importers.