FDA Releases Draft Guidance on Use of Sampling for Seafood on Import Alert
The FDA on Feb. 9 released a draft guidance document on the use of sampling of fish and fishery products by importers and foreign manufacturers and processors to demonstrate the admissibility of goods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 import alert, or to have the goods removed from an import alert.
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The draft guidance includes recommendations on the number of samples that should be collected and tested and how to decide what portions of an affected shipment should be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 guidance applies to testing of fish and fishery products subject to import alert due to “the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition,” the FDA. “This guidance does not apply to seafood-related import alerts when sampling and testing is not relevant to securing release of individual shipments or removal from [detention without physical examination (DWPE)],” the agency said.
Comments on the draft guidance are due April 12.