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Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation April 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

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, 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.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  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.

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Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-3324.

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