WASHINGTON—Earlier this month the U.S. Food and Drug Administration (FDA) announced plans to implement re-examination fees under the recently enacted FDA Food Safety Modernization Act (FSMA); however, the new fees may impose extra costs on importers and increase food prices, according to U.S. import consultancy FDA Imports.
Under the new law, FDA will collect a fee from importers for a re-inspection/re-examination of an imported food if there is any identified failure to comply with a requirement that is materially related to food safety. Beginning Oct. 2011, the new fee structure will create significant new layers of costs and fees for importers. At the core of the new process is the requirement that at least two examinations of a food must take place for FDA to assess the new imported food fees. U.S. importers will be charged $224 per hour (plus expenses) for any re-examinations; the expenses will be passed on to consumers, resulting in a dramatic increase to food costs.
In its Federal Register notice, FDA stated that a first examination occurs whenever it reviews information to determine a food's admissibility and that review results in an FDA detention for a violation related to food safety. Such a review includes the very few instances when FDA actually samples and tests imported food and conducts a facility inspection (e.g., of a foreign manufacturer or US importer) or a food label review.
However, FDA also includes in its first examination definition other tasks that do not involve an FDA examination of the food at all, such as reviewing sample results from a third party, reviewing any relevant epidemiological evidence, reviewing a third-party facility inspection report, and almost any activity related to an FDA import alert.
After FDA’s initial “examination", the importer must pay FDA for all costs associated with any further review conducted by FDA on the same imported food. These costs can even include expenses for examining future shipments of food (through FDA’s import alert program).
