September 2019

This guidance is intended to clarify steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, this document provides guidance for reconditioning by:

1. 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,2 along with sampling and testing to confirm that the segregation was successful; or
2. segregation based on the results of statistically significant sampling and testing. Here the sampling and testing forms the basis for the segregation.

This guidance does not supersede Compliance Policy Guide Sec. 160.700, Reconditioning of Foods Adulterated Under 402(a)(4) (Ref. 1). Nor does this guidance apply in situations where reconditioning is proposed by means other than segregation, such as by cooking or conversion to animal feed. Also, segregation alone may not be a reliable or acceptable means of reconditioning adulterated fish and fishery products that are adulterated under section 402(a)(4) of the FD&C Act.

Our guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidance documents means that something is suggested or recommended, but not required. Throughout this guidance the terms "you" and "your" refer to persons or establishments that are owners of fish and fishery products, or their representatives, interested in bringing adulterated products into compliance with the FD&C Act by means of segregating non-violative product from adulterated product.

(As used in this guidance, the term article refers to the quantity of food deemed by us to be adulterated.)

Download the Draft Guidance

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Related Information

• Seafood Guidance Documents & Regulatory Information
• More on Seafood from FDA