FDA Food Safety Modernization Act (FSMA) and associated fees
Dear valued customer,
The Federal Food, Drug and Cosmetic (FD&C) Act, as amended by the FDA Food Safety Modernization Act (FSMA) (P.L. 111-353), authorizes FDA to collect and use fees to cover 100 percent of FDA’s costs for: certain reinspections of domestic and foreign facilities; and certain food and feed recall activities beginning in the current fiscal year (FY) and each subsequent fiscal year. For more detailed information on fee setting for the reinspection and recall user fees for the current FY rates and to obtain answers to frequently asked questions about FSMA, please go to FSMA Fees(http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm). We have provided some of the FAQs for your convenience:
Will there be a fee associated with FDA inspections?
There is no fee for an initial FDA inspection. FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems
What are the FY 2015 fees?
The rates are as follows: $217 an hour if no foreign travel is required and $305 an hour if foreign travel is required.
When do the FY 2015 fees go into effect?
The fees are effective October 1, 2014, and will remain in effect through September 30, 2015. As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.
Who is affected by these fees?
Only those parties in the food and feed industry whose non-compliance results in the following activities:
· Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
· Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
· Importer reinspections — follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.
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