FDA Says Fees in Food Safety Act Insufficient, Congress Needs to Ensure Funding
In statements about the benefits of the newly enacted Food Safety Modernization Act (FSMA), Food and Drug Administration Commissioner Hamburg has noted that the fee resources in the legislation are insufficient and that Congress will need to do its part to ensure FDA has the resources it needs to meet the new requirements.
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(See ITT’s Online Archives or 01/05/11 news, 11010517, for BP summary of the President signing the bill into law on January 4, 2011.)
FDA Looking to Congress to Ensure It Has What Is Needed
Commissioner Hamburg states, “Now, the task falls to the FDA to carry out the direction we’ve been given. We are hard at work planning how we will put this law into effect. As we look to make the improvements called for in the legislation, we must ask ourselves many questions. What resources do we already have? What resources will we need? Where will those resources come from? Already we know that the legislation did not include sufficient fee resources to cover the costs of the new requirements. In that, we will look to Congress to work with us to ensure that FDA has what’s needed to achieve our shared food safety and food defense goals.”
Act Has New Fees for Qualified Importer Program, Reinspection, Recalls
Under the FSMA, for fiscal year 2010 and each subsequent fiscal year, FDA will be required to assess and collect fees as follows:
- Qualified importer program - each importer participating in the voluntary “qualified importer program” will be required to pay an annual fee to cover the administrative costs of the program. (For the first five fiscal years after enactment, this fee will have to include a reasonable surcharge that provides a recoupment of the costs expended by FDA to establish and implement the program):
- Reinspections - each importer subject to reinspection will have to pay a fee in order to cover reinspection-related costs and each domestic food facility (which includes any importer food facilities located in the U.S.) and the U.S. agent for each foreign facility subject to a reinspection will have to pay a fee to cover reinspection-related costs for each year; and
- Recalls -- the responsible party for a domestic facility and importers who do not comply with a mandatory FDA recall in a fiscal year will have to pay a fee to cover food recall activities associated with that order, including technical assistance, follow-up effectiveness checks, and public notifications.
(See ITT’s Online Archives or 01/04/11 news, 11010426, for comprehensive summary of the bill, including details about the qualified importer program, FDA’s new mandatory recall authority, the new fees, etc.)
Other Commissioner Hamburg statements, dated 01/03/11 and 12/23/10, available here and here.