FDA Issues Draft Guidance on Reconditioning Fish, Fishery Products by Segregation
The Food and Drug Administration issued a draft guidance document Sept. 16 outlining agency policies on reconditioning adulterated fish and fishery products by segregation. For imported and domestic fish that have 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 has not 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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“For the segregation of fish and fishery products adulterated due to pathogens (if applicable), unlawful drugs, scombrotoxin (histamine), and decomposition,” FDA recommends that the owner conduct “an investigation by or on behalf of the owner of the article that, based on a production-related rationale, supported by production records, identifies the cause of the adulteration and its restriction to only a portion of the article.” If such a root cause can be identified, the owner can offer “a segregation strategy based on that root cause, followed by relatively modest sampling and testing to confirm that the segregation was successful in isolating and removing the adulterated portion.”
Tables included in the draft guidance identify recommended sampling and testing rates to confirm successful segregation.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.
“When the root cause for the adulteration in an article has not or cannot be identified, you may consider segregation of the article on the basis of sampling and test results alone,” FDA said. The shipment may be partitioned based on product or production distinctions such as production date or manufacturing code, market form, raw material supplier, or some other attribute. “The portion(s) from which the original finding of adulteration was detected should be segregated as violative and should not be included in further sampling or testing,” FDA said. Sampling and testing rates for this method of segregation “may be substantial,” FDA said.
The sample also includes recommendations of information that should be included in a proposal to recondition adulterated fish and fishery products. Comments on the draft guidance are due Nov. 18, FDA said in a notice.