A U.S. Food and Drug Administration official on Saturday expressed the agency’s intent to change its policy regarding the use of post-harvest processing to control for Vibrio vulnificus in raw mollusks.
In a speech during the Interstate Shellfish Sanitation Conference’s (ISSC) biennial meeting in Manchester, N.H., Mike Taylor, FDA senior advisor to the commissioner, talked about FDA’s role in protecting nation’s food supply, its aspirations to partner with the states to build an integrated national food-safety system, and the steps necessary to address concerns regarding Vibrio vulnificus in raw oysters.
“We now believe that, under our HACCP (Hazard Analysis and Critical Control Point) rules, when raw oysters are harvested in waters and at times where V. vulnificus is reasonably likely to occur, the appropriate preventive measure is one of the available, validated post-harvest processing methods, or another control measure that can be validated to be equally effective,” said Taylor. “We base this belief on the availability of demonstrably effective post-harvest processing methods and the failure of other measures to achieve the purpose of the HACCP regulation.
“The ISSC and FDA have collaborated to identify scientifically where and when the hazard is reasonably likely to occur, such as in the Gulf Coast in the warm weather months, but we welcome further dialogue on this point as we develop our formal guidance,” he continued.
“On this, however, we are clear: We no longer believe that measures which reduce the hazard, but fall well short of eliminating it, such as improvements in refrigeration, are sufficient to meet the purpose of the regulation, given the severity of the hazard and the availability of post-harvest processing technologies.”
This policy change relates to 21 CFR Parts 123 and 1240 of “Seafood HACCP Regulation” and is expected to be reflected in the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition,” which the FDA is currently developing.
To read the rest of Taylor’s speech, click here.
