New Citizen Petition Asks FDA to Revoke Notice of FSMA User FeesNovember 4, 2011
By Susan J. Matthees –
The American Council of Independent Laboratories (“ACIL”), the Association of Food Industries, and the Cheese Importers Association of America, Inc. recently petitioned FDA to revoke or partially revoke its Federal Register notice announcing Food Safety Modernization Act (“FSMA”) user fees amounts because the fees were allegedly calculated in a manner contrary to the method specified in the FSMA, do not provide small business burden relief as required by the FSMA, and will be imposed on activities not authorized for fees under the FSMA.
Section 107 of the FSMA gives FDA the authority to collect user fees from, among others, the responsible party for each domestic facility and US agent for each foreign facility subject to reinspection to cover reinspection-related costs, the responsible party for a domestic facility and an importer that does not comply with a recall order, and importers subject to a reinspection to cover reinspection fees. This summer, FDA announced fee rates that became effective on October 1 (FDA will not invoice until January 1, 2012). FDA determined the fees by calculating an average hourly rate for an FDA employee. This hourly rate would be used as the basis to calculate fees for all activities that trigger a fee.
The petitioners argue that the FSMA requires FDA to calculate a unique amount for each activity that triggers a user fee. For example, petitioners state that FDA failed to calculate the hourly cost of reinspection-related activities for a facility (including by type or level of reinspection), activities associated with failure to comply with a recall (including recall activities performed by FDA, technical assistance, follow-up effectiveness checks, and public notifications), administrative activities to support the voluntary qualified importer program, and reinspection-related activities associated with food imports. In particular, the petitioners argue that FDA did not calculate the hourly cost of reinspection-related activities, activities associated with failure to comply with a recall order, administrative activities in support of the voluntary qualified importer program, and reinspection-related activities associated with food imports. The petitioners ask that FDA revoke the notice in its entirety because of this method of calculating fees.
In the alternative, the petitioners ask that FDA revoke the portions of the notice that relate to the imposition of fees on small businesses. The FSMA directed FDA to publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small businesses by July 4, 2011. Instead, on August 1, 2011, FDA opened a docket for comments on what burden the fees impose on small businesses and whether and how these burdens should be alleviated. The docket remains open until November 30, 2011. The petitioners argue that the FSMA is clear that the FDA must develop guidelines, and FDA’s approach is contrary to the FSMA.
Finally, the petitioners ask that FDA revoke the portions of the notice that would impose fees on activities related to food imports in the absence of prior identification of noncompliance materially related to a food safety requirement of the FDC Act. FDC Act § 801 permits FDA to detain an imported food on the appearance of noncompliance. The FSMA, however, states that with respect to food importers, reimportation fees can be assessed only after an examination “identified noncompliance materially related to a food safety requirement.” The petitioner argues that as drafted, FDA could assess fees on an importer on the basis of a detention of the food for the appearance of noncompliance, but under the FSMA, the fees can only be assessed if the food is actually shown to be noncompliant.