FDA Allows More Comments on Draft Guidance on Sampling for Seafood on Import Alert
The FDA will allow more time for comments on a draft guidance it issued in February on the use of sampling of fish and fishery products by importers and foreign manufacturers and processors to demonstrate the admissibility of goods subject to an import alert, or to have the goods removed from an import alert (see 2402090066). The agency said it will now allow comments by June 25, after receiving a request that it extend the deadline for comments, which was originally April 12.
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The draft guidance includes recommendations on the number of samples that should be collected and tested and how to decide what portions of an affected shipment should be sampled. It also includes information on analytical methods that may be used, as well as what evidence should be included in a submission to release fish or fisheries products detained under an import alert, and what types of evidence may be used when requesting removal of a fish or fishery product or manufacturer from an import alert.
The National Fisheries Institute requested the extension. "After a cursory glance, we have determined that the costs to industry and the agency to implement the increased sampling proposed in the guidance will be substantial," it said in request to FDA. "Additional time will be necessary to provide a more concrete estimate of the added costs -- both dollars and man power -- that would be incurred to comply with the increased sampling as proposed in the guidance."