From the Experts: New Fish and Fisheries Guidance Includes Numerous Additions and Changes

In keeping with food safety improvements of the supply chain from source to consumer, FDA published the fourth edition of the Fish and Fisheries Hazards and Control Guidance in April replacing the 2001 third edition. FDA implemented it without prior public comment "because the Agency determined that prior public comment was not feasible or appropriate" (76 FR 23823), FDA said, adding, "The Agency made this determination because the updated information in the guidance significantly enhances the seafood industry's ability to protect the public health and provides important recommendations for conducting a hazard analysis and implementing a HACCP plan."

For those of us who supply, receive, or sell/distribute seafood products, this manual is the regulatory guidance for our HACCP plan(s), a defining component of our food safety programs. Also available is a video on some of the changes. The guide, comment submission instructions, video and transcript, and more information are available at: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide.

Key personnel for HACCP plans may be required to be trained in seafood HACCP in accordance with 21 CFR 123.10, for which information and training can also be found online (http://seafood.ucdavis.edu/seafoodhaccp.html). Two programs are also available from the National Seafood HACCP Alliance and the U.S. Department of Commerce, National Marine Fisheries Service, including a fourth edition Fish and Fisheries Hazards and Control Guidance; fifth edition Hazard Analysis and Critical Control Point Training Curriculum; and first edition Seafood HACCP Alliance manual (and courses) entitled Sanitation Control Procedures for Processing Fish and Fisheries Products.

On November 9, the FDA Center for Food Safety and Applied Nutrition (CFSAN) released a Letter to Industry—Guide Implementation stating that FDA is already using the information in the fourth edition of the guidance to evaluate HACCP plans for fish and fishery products. So, if seafood HACCP is required for your or your suppliers' products, it is important to become compliant now and ensure that you and your suppliers have this new information fully integrated. (See www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/ucm279442.htm.)

We must educate ourselves in the hazards and controls guidance as it pertains to our seafood products. Knowledge, understanding, regulatory compliance, and food science are essential to this country's food safety and our developing, processing, storing, and supplying of the many seafood products.

While the "most significant and broad change to the 4th edition guide is how it is formatted," many of the chapters include key changes, with control strategies often followed by HACCP plan examples.

In an update session, the Seafood HACCP Alliance stated that the new guide is expected to remain in electronic format so it can be progressively updated based on new science, experience, and commercial developments. The guidance is "intended to assist processors of fish and fishery products in the development of their HACCP plans. Processors of fish and fishery products will find information in this guidance that will help them formulate control strategies."

The new guidance has a great deal to discover and utilize, but a few key notes are:

• Chapter 3: Potential Species-Related and Process-Related Hazards. More aquaculture species included; some hazards per species and species per hazards changed.

• Chapter 5: Parasites. Information added on parasites and what is required for parasitic infection prevention.

• Chapter 7: Scombrotoxin (Histamine) Formation. Time and temperature controls and strategies for preventing poisoning of scombroid fish (such as tunas, mahi mahi, bluefish, sardines, mackerel, amberjack, and abalone). Because monitoring of the CCP is very critical to food safety, temperature critical limits are included in this and other chapters. In the guide, it is also very important to understand the differences and application of accuracy checks and calibration for thermometers for CCP verification.

• Chapter 11: Aquaculture Drugs. It is imporant to know your supply chain and the weaknesses in this vital area. Study the regulations for unapproved drugs (e.g. antibiotics) and the regulations on approved aquaculture drug use.

• Chapter 13: Clostridium botulinum Toxin Formation. Includes information on risks of C. botulinum for seafood in reduced oxygen packaging (ROP), strategies for prevention, and proper handling and the layers of food safety barriers that may be needed.

• Chapter 19: Undeclared Major Food Allergens and Certain Food Intolerances Causing Substances and Prohibited Food and Color Additives. Information and strategies on finished product labeling verification for undeclared food allergens and sulfiting agents.

At times in our programs and protocols, processors and receivers may need to determine proven building blocks of preventive design through hazard analysis and risk assessments, then rebuild existing programs in the manner prescribed by science and regulation. Layering new information on top of outdated systems that may have been developed from tradition and "the way we always did it" may not be accurate or safe.

It has been said that insanity is doing what we always did and expecting a different result. The guidance is intended to make a positive difference in our food supply when it is followed correctly and interwoven into researched and proven programs. Read and understand the material, as the examples may not be applicable in all situations. It is best to thoroughly and continuously research various resources through regulations, science, academia and industry.