Fish and Fishery Products Hazards and Controls
Fourth Edition, June 2021
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
[email protected]
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.
Items Available
- Introductory Video
- Seafood HACCP Video Series
- Guidance Downloads NEW
- FDA and Seafood Labeling Learning Module
- FDA Seafood Sampling
Introductory Video
Transcript of Video | Help with Captions
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.
Time-Temperature Indicators (TTIs) discusses using TTIs to control growth and toxin production by Clostridium botulinum in refrigerated, reduced oxygen packaged seafood products. This video also includes discussions about the different types of C. botulinum, and controlling C. botulinum through the use of multiple barriers or freezing.
Time and Temperature Controls during Unrefrigerated Processing discusses how to control pathogen growth during unrefrigerated processing of raw ready-to-eat and cooked ready-to-eat seafood products. This video also includes discussions on evaluating time and temperature exposures during unrefrigerated processing and developing time-temperature profiles.
Secondary Processor Receiving and Storage Controls discusses receiving and storage controls for Secondary Processors to control scombrotoxin formation and pathogen growth in seafood products. This video also includes discussions on continuous temperature monitoring, and accuracy checks and calibration of temperature recording equipment.
Heat Process Validation discusses the general factors to consider when validating heat processes for seafood products. This video includes discussions on identifying the target pathogen, pathogen reduction, verifying pathogen reduction, and identifying the controls and critical limits to include in the HACCP plan to ensure a consistently safe product.
Primary Processor Scombrotoxin Controls – Overview and Testing at Receiving discusses the general strategies recommended by FDA for preventing scombrotoxin formation at the receiving critical control point. This video discusses how scombrotoxin is formed, the types of fish susceptible to scombrotoxin formation, monitoring internal temperatures, conducting sensory examinations, and histamine testing considerations.
Primary Processor Scombrotoxin Controls – Harvest Vessel Records discusses the Harvest Vessel Record control strategy recommended by FDA for preventing scombrotoxin formation at the receiving critical control point. This video discusses onboard chilling parameters for different harvest conditions, factors to consider when landing both live and dead fish, and the types of recorded observations, that when included on harvest vessel records, demonstrate that the fish were harvested, handled, and stored aboard the vessel in a manner that prevents scombrotoxin formation.
Transcript of Video | Help with Captions
Harvest Vessel Records Referenced in this Video: NEW
The following are copies of the harvest vessel records used in the Primary Processor Scombrotoxin Controls - Harvest Vessel Records video as a teaching aid and are best utilized in conjunction with the explanations in the video. They are illustrations to convey concepts of building an appropriate harvest vessel record form. Using these concepts, primary processors and fishermen should develop and tailor their own records to fit their specific fishery and harvesting operations.
Download the Guidance
June 2021
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)
Full Document Downloads
Download the full Fish and Fishery Products Hazards and Controls Guidance Full Document (PDF-5.24MB) June 2021 NEW
A Spanish translation of the FDA Fish and Fishery Products Hazards and Controls Guidance (Fourth Ed., April 2011) is now available for purchase or download at the Florida Sea Grant website. This website includes instructions for purchase from the University of Florida Bookstore. See Seafood and Seafood HACCP Publications for more information.
Individual Chapter Downloads
Introduction: Introduction and Discussion (PDF-638KB) June 2021 NEW
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-4.1MB) June 2021 NEW
Chapter 4: Pathogens From the Harvest Area (PDF-513KB)
Chapter 5: Parasites (PDF-425KB)
Chapter 6: Natural Toxins (PDF-710KB) August 2019
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-3MB) June 2021 NEW
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-567KB) August 2019
Chapter 20: Metal Inclusion (PDF-454KB)
Chapter 21: Glass Inclusion (PDF-447KB)
Appendix 1: Forms (PDF-371KB) June 2021 NEW
Appendix 2: Sample Product Flow Diagrams (PDF-263KB) June 2021 NEW
Appendix 3: Critical Control Point Decision Tree (PDF-360KB) June 2021 NEW
Appendix 4: Bacterial Pathogen Growth and Inactivation (PDF-734KB)
Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance (PDF-423KB) June 2021 NEW
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-201KB) June 2021 NEW
Appendix 9: Allergen Cross-Contact Prevention (PDF-337KB) August 2019
Appendix 10: Cleaning and Sanitation for the Control of Allergens (PDF-282KB) August 2019
Appendix 11: Approved Animal Drugs for Aquaculture Use (PDF-839KB) June 2021 NEW
Appendix 12: Unapproved Animal Drugs for Aquaculture (PDF-452KB) June 2021 NEW
Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60) (PDF-1.16MB) June 2021 NEW
Addendum 2: current Good Manufacturing Practices (cGMP) (PDF-741KB) June 2021 NEW
Learning Module
The module provides:
- an overview of the federal identity labeling requirements for seafood offered in interstate commerce;
- a list of the specific laws, regulations, guidance documents, and other materials pertinent to the proper labeling of seafood;
- a description of the FDA’s role in ensuring the proper labeling of seafood; and
- tips for identifying mislabeled seafood in the wholesale distribution chain or at the point of retail.
FDA and Seafood Labeling Part 1: This video describes the purpose of labeling; the role and authority of the FDA; and some possible reasons why seafood may be mislabeled.
FDA and Seafood Labeling Part 2: This video provides information on FDA’s specific laws, regulations, and guidance documents relevant to seafood labeling.
FDA and Seafood Labeling Part 3: This video illustrates FDA’s current work to discourage the mislabeling of seafood, and offers specific tips for regulators, retailers, and consumers in a combined effort to ensure proper seafood labeling.
Seafood Sampling
In recent years there have been reports of seafood in the U.S. being labeled with an incorrect market name. In response to these reports, the FDA began conducting DNA testing on fish that have a history of being misidentified, in an effort to determine the accuracy of the market names on their labels. Learn more on FDA DNA Testing at Wholesale Level to Evaluate Proper Labeling of Seafood Species.