Next Upcoming Seminar: Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar – April 4-5, 2018

Specializing in FDA Regulatory Matters

Have a Cup of Coffee and Pray – It’s the 20th Anniversary of the Seafood HACCP Rule

Newsletter Article

HACCP, of course, stands for Hazard Analysis Critical Control Point, is a highly effective preventive control system for foods and other commodities. “Have a cup of coffee and pray” was how one skeptical USDA union official described HACCP implementation in meat and poultry processing plants when it was implemented in the early 2000’s. It is an example of some of the reservations public health officials had as early as 1980. FDA implemented this systematic control system in seafood effective December 1997. Although controversial its implementation proved to be a tremendous success for the agency and public health in general.

First, let me provide a little history. In the early 1980’s there was a developing trend towards exercise and healthy eating. A nutritionist named Anne Fletcher published a highly popular book about the nutritional benefits from eating seafood entitled Eat Fish, Live Better. This book received a tremendous amount of attention in the media that spurred the consumption of seafood as part of a healthy lifestyle. However, the seafood industry at the time had some systemic quality control problems that allowed significant amounts of low-quality seafood on the market. Most of these quality problems were hygienic in nature and did not pose a food safety problem. However, it did cause concern in the media about seafood safety and the public began to believe that seafood was good nutritionally but not always safe.

Congress at the time also became concerned about seafood safety and offered various legislative bills for so-called mandatory inspection of seafood. Congress also provided money for a Model Seafood Surveillance Project whose mission was to determine what governmental regulations were needed to address these issues. NOAA Fisheries conducted the project and dozens of workshops with industry to garner feedback about what would address the issue of safety and would work best for them. The conclusion of that report was that implementation of mandatory HACCP was the best way forward. Circa 1990 President H.W. Bush ordered FDA and NOAA Fisheries’ Seafood Inspection Program to work together on a voluntary joint program to implement HACCP principles into the seafood industry and under President Bill Clinton, then FDA Commissioner Kessler decided that FDA would develop its own mandatory program for Seafood HACCP.

The resulting Seafood HACCP rule can be best understood and implemented by referencing the FDA drafted complex guidance document called the Fish and Fishery Products Hazard Guide (FFPHG). It is used worldwide as the, most authoritative, comprehensive guide to the science behind HACCP and FDA policies related to seafood.

While seafood HACCP regulations have been in place for 20 years, there is always work to do and vigilance to keep with regards to the safety of our food sources as the volume of seafood imported to the United States continues to increase. In 2009, 80 percent of the seafood in the U.S. food supply was imported, and by 2015, more than 90 percent was imported. A quick review of FDA warning letters at any point in time demonstrates this challenge, with as of this writing, six out of ten of the most recent FDA warning letters pertaining to seafood HACCP. Challenges such as implementing and verifying that seafood is processed, held and transported in sanitary conditions; that regular inspection records verify their safe handling, both before they reach US shores and when they are a domestically distributed are areas where FDA inspectors are working diligently.

Over the years the guidance and FDA policy thinking was refined and the regulation became a tremendous success. Seafood safety and quality improved, scientific thinking was imbued into the seafood industry through the FFPHG which promoted the health of consumers, consumers were less worried about safety issues and seafood HACCP became a template for the Food Safety Modernization Act of 2010 that would apply preventive control principles to the manufacturing of all food commodities. That’s quite an accomplishment. So let’s have a cup of coffee and praise the FDA for their fine work in improving food safety standards for seafood.