In September 2019, we reported that FDA had issued a draft guidance for industry titled “Reconditioning of Fish and Fishery Products by Segregation.” On April 13, 2022, FDA issued its final guidance on the topic.

The guidance is intended to clarify the steps that owners or representatives of fish and fishery products can take to segregate non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The document provides guidance for the reconditioning of fish and fishery products by:

• segregation based on a production-related rationale, supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article, along with sampling and testing to confirm that the segregation was successful; or

• segregation based on the results of statistically significant sampling and testing, where the sampling and testing forms the basis for the segregation.

The guidance document emphasizes that proposals for reconditioning by segregation require sufficient evidence to demonstrate that the violative product can be reliably separated from the non-violative product. It provides transparency on the information sought by FDA for such proposals.

FDA will continue to accept comments on the guidance. Public comments can be submitted to www.regulations.gov using Docket ID: FDA-2019-D-3324.