FDA Announces $224-$325/Hour Fees for Import & Facility Reinspections, Etc.
The Food and Drug Administration is announcing the fiscal year 2012 fee rates for certain import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, all of which are mandated in the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act (FSMA).
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FDA has also issued new frequently asked questions on the fees available here.
To Charge $224/hour for Domestic Services, $325/hour if Foreign Travel Required
The FY 2012 rates for the subject fees are as follows: $224 an hour if no foreign travel is required, and $3251 an hour if foreign travel is required.
Fees Effective from October 1, Seeking Comments to Help with FY 2013
The fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. FDA is accepting comments to this document through October 31, 2011. The agency intends to consider such comments, as well as experience and additional data gained in implementing these user fees in FY 2012, when it implements the user fees for FY 2013.
Only Apply if Non-Compliance Results in Import or Facility Reinspections, FDA-Run Recalls
According to FDA’s notice and FAQ, the fees will only be charged to parties in the food and feed industry whose non-compliance results in the following activities:
Import reinspections -- follow up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that found a problem materially related to food safety requirements. The reinspection must be conducted specifically to determine that compliance has been achieved.
FDA states that the hourly fees described above will be charged in at least the following four specific circumstances related to import reinspections:
- Reconditioning of imported food - For reconditioning, the entity that is responsible for the reconditioning is responsible for paying the fee. The request for reconditioning can only be made by the owner or consignee of the food (21 CFR 1.95). If ownership changes, the new owner will be responsible for the reconditioning if that new owner executes a bond and obtains a new authorization (21 CFR 1.96(d)).
- Importer seeking admission of an article that has been detained - The entity that introduces evidence regarding admissibility is responsible for paying this fee. This is the owner or consignee of the food that is being imported or offered for import. (Section 801(a) of the FD&C Act; 21 CFR 1.83(b) and 1.94(a).)
- Entity requesting removal from an Import Alert for Detention without Physical Examination - FDA considers the entity that requests removal of the food from the Import Alert to be the importer subject to the examination and, thus, responsible for paying this fee.
- Destruction of food that has been refused admission. FDA considers the entity that destroys the product under FDA or CBP supervision to be the importer subject to the examination and, thus, responsible for paying this fee.
Facility reinspections -- follow up inspections conducted by FDA subsequent to a previous inspection that found a violation materially related to food safety requirements. 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.
1Three weeks after publication, FDA issued a notice stating that the correct FY 2012 fee when FDA foreign travel is required for facility and importer reinspections and for failures to comply with a recall order is $325 an hour, not $335.
(See ITT's Online Archives or 07/29/11 news, 11072013, for BP summary of related FDA notice seeking comment on the burden of FSMA fees on small business.)
FDA contact - Amy Waltrip (301) 796-8811, email: Amy.Waltrip@fda.hhs.gov
(FR Pub 08/01/11)