FDA Updates Guidance for Seafood Safety (4th edition)

(April 27, 2011)—The fourth edition of the Hazards and Controls Guide, as it is known by industry, has been published by the FDA. This updates the last version, originally published in 2001.

FDA Auditors will use this guidance to determine compliance and will expect processors to adopt controls to address hazards as identified in the Fish and Fishery Products Hazards and Controls Guidance.

Of course, it comes with this familiar statement:

“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.”

The document is intended to help seafood processors create and carry out their Hazard Analysis and Critical Control Point (HACCP) plans. While it does not specifically describe safe handling practices for consumers, grocery stores or restaurants, many of the concepts would be useful.

In the news release, FDA said key changes in the new edition include:

  • Updated post-harvest treatment for pathogenic bacteria in shellfish -- including Vibrio vulnificus and Vibrio parahaemolyticus;
  • Revised time and temperature recommendations to better control for scombrotoxin (histamine) formation and pathogenic bacteria;
  • Information on regulations and tolerance levels that have changed since the previous edition was published;
  • Hazard information on species of seafood new to the U.S. market;
  • More detailed descriptions of the potential illnesses and injuries related to seafood.

The FDA has put togther an introductory video that goes through the updates / changes in a 35 minute presentation. They are preparing several more 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. 

A printable version of the guide, in .pdf format, and the video are available here.

A bound copy of the guidance can be ordered online at www.ifasbooks.com or by calling the Florida Sea Grant, IFAS-Extension bookstore at the University of Florida at 1-800-226-1764.

You can email questions about the new 4th edition of the Fish and Fishery Products Hazards and Control Guidance by sending your questions to seafoodhaccp@fda.gov.


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