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FDA Finalizes Guidance on Reconditioning Fish, Fishery Products by Segregation

FDA recently finalized a new guidance document on agency policies on reconditioning adulterated fish and fishery products by segregation. For imported and domestic fish that have been found to be adulterated, the owner of the fish may segregate the adulterated portion of a shipment based on a “production-related rationale” based on production records. If the root cause hasn't been identified and the adulterated portion can’t be segregated based on production records, then a more burdensome segregation by means of sampling and testing is also available, FDA said.

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Tables included in the guidance identify recommended sampling and testing rates to confirm successful segregation. Those rates vary based on the type of adulteration found. If adulteration is found in any sample unit from any portion of the segregated article presented as non-violative, “we would most likely find the reconditioning to be unsuccessful,” FDA said. The guidance also includes recommendations of information that should be included in a proposal to recondition adulterated fish and fishery products.