USA -Fish and Fishery Products Hazards and Controls

FDA

This guidance represents the agency’s current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses

To help FDA effectively investigate, remove unsafe seafood products from the market, and develop new prevention strategies, the FDA relies on illness reporting from public health officials and healthcare providers.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
(240) 402-2300
SeafoodHACCP@fda.gov

This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies. The guidance will help consumers and the public generally to understand commercial seafood safety in terms of hazards and their controls. The guidance does not specifically address safe handling practices by consumers or by retail establishments, although many of the concepts contained in this guidance are applicable to both. This guidance is also intended to serve as a tool to be used by federal and state regulatory officials in the evaluation of HACCP plans for fish and fishery products.

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Introductory Video

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Seafood HACCP Video Series

The FDA has developed a Seafood HACCP Video Series, designed to help the seafood industry and federal and state regulators better understand specific concepts described in FDA’s Fish and Fishery Products Hazards and Controls Guidance. The series consists of 6 videos covering the following topics: Time-Temperature Indicators, Time and Temperature Controls during Unrefrigerated Processing, Secondary Processor Receiving and Storage Controls, Heat Process Validation, Primary Processor Scombrotoxin Controls – Overview and Testing at Receiving, and Primary Processor Scombrotoxin Controls – Harvest Vessel Records.


Download the Guidance

June 2022

This guidance represents the agency’s current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Note: This document was corrected on August 3, 2011. The Agency corrected a typographical error appearing in the April 2011 version of this document. The Agency corrected “15%” to “1.5%” so that the sentence in “Chapter 11: Aquaculture Drugs” now reads “Sodium sulfite Used in a 1.5% solution for 5 to 8 minutes to treat eggs in order to improve their hatchability.”

Errata: Corrections and Omissions (PDF – 67KB)

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