On October 1, the Food and Drug Administration began to implement the fee provisions of the Food Safety Modernization Act. Under this provision, FDA has the authority to assess and collect fees from domestic facilities, importers and U.S. agents of foreign facilities subject to a re-inspection to cover re-inspection related costs. FDA may also collect fees to cover recall activity costs for domestic facilities and importers that do not comply with recall orders.
The agency recently released guidance to answer questions about the new fees and FDA's plans for implementation in 2012. The "Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act" discusses how the fees will be calculated, whether firms will receive fee estimates prior to re-inspection, whether companies can appeal and how much money the agency expects to collect. Processors should note that FDA does not have the authority to collect fees for inspections or re-inspections performed by state authorities.
According to the guidance, FDA will "begin the process of tracking, assessing and collecting" fees for initial facility inspections and recall orders beginning on or after October 1, 2011. Since the agency is still evaluating comments received in response to its August 1 Federal Register notice establishing fee rates for Fiscal Year 2012, it will not send out invoices until January 1, 2012.
IDFA and nine other food organizations last Friday requested an extension to the comment period for these fee rates, now October 31, and for the fee amounts on small business, now October 17. In a joint letter to FDA, the groups also asked for these issues to be combined into one set of comments with a new deadline of November 30.
"Consolidation in this instance will provide administrative efficiency to commenters and agency alike, with each interested party being able to submit one set of comments, and FDA being able to review and respond to those comments in a single FSMA fees determination," the letter said.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org.