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U.S. Department of Health and Human Services


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Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition

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You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

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

April 2011


Items Available:


Introductory Video on Fish and Fishery Products Hazards and Controls Guidance, 4th Edition  

Transcript of Video   |   Help with Captions


Future Projects

FDA is preparing several informational videos to supplement the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance. These videos will discuss topic areas such as harvest vessel records, primary and secondary processing considerations, time-temperature indicators, heat process validation, and time and temperature considerations. More information will be provided soon.


Table of Contents

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) NEW

Fish and Fishery Products Hazards and Controls Guidance Full Document (PDF-4.7MB)
Introduction: Introduction and Discussion (PDF-379 KB)
Chapter 1:General Information (PDF-302KB)
Chapter 2:Conducting a Hazard Analysis and Developing a HACCP Plan (PDF-398KB)
Chapter 3:Potential Species-Related and Process-Related Hazards (PDF-2.5MB)
Chapter 4:Pathogens From the Harvest Area (PDF-513KB)
Chapter 5:Parasites (PDF-425KB)
Chapter 6:Natural Toxins (PDF-495KB)
Chapter 7:Scombrotoxin (Histamine) Formation (PDF-812KB)
Chapter 8:Other Decomposition-Related Hazards (PDF-295KB)
Chapter 9:Environmental Chemical Contaminants and Pesticides (PDF-785KB)
Chapter 10:Methylmercury (PDF-273KB)
Chapter 11:Aquaculture Drugs (PDF-711KB)
Chapter 12:Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse (PDF-775KB)
Chapter 13:Clostridium botulinum Toxin Formation (PDF-889KB)
Chapter 14:Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying (PDF-479KB)
Chapter 15:Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes (PDF-408KB)
Chapter 16:Pathogenic Bacteria Survival Through Cooking or Pasteurization (PDF-506KB)
Chapter 17:Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics (PDF-495KB)
Chapter 18:Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes (PDF-439KB)
Chapter 19:Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives (PDF-834KB)
Chapter 20:Metal Inclusion (PDF-454KB)
Chapter 21:Glass Inclusion (PDF-447KB)
Appendix 1:Forms (PDF-342KB)
Appendix 2:Sample Product Flow Diagrams (PDF-289KB)
Appendix 3:Critical Control Point Decision Tree (PDF-309KB)
Appendix 4:Bacterial Pathogen Growth and Inactivation (PDF-734KB)
Appendix 5:FDA and EPA Safety Levels in Regulations and Guidance (PDF-346KB)
Appendix 6:Japanese and Hawaiian Vernacular Names for Fish Eaten Raw (PDF-561KB)
Appendix 7:Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts (PDF-310KB)
Appendix 8:Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products (PDF-405KB)