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U.S. Department of Health and Human Services

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Letter to Interstate Shellfish Sanitation Conference

October 16, 2009

Dear ISSC Member:

This letter is to inform you that the U.S. Food and Drug Administration (FDA) intends to reformulate its policy on the control of Vibrio vulnificus in raw molluscan shellfish (shellfish) as it relates to the “Seafood HACCP Regulation,” 21 CFR Parts 123 and 1240. When completed, the policy change is expected to be reflected in the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition,” which is currently under development at FDA. FDA is providing this information to you today because we believe it is relevant to deliberations at the upcoming biennial meeting of the Interstate Shellfish Sanitation Conference (ISSC).

The efforts of the ISSC over the past decade have been instrumental in identifying those conditions under which contamination with this pathogen constitutes a hazard that is reasonably likely to occur. In this same period, industry, academia, and government, with the support of the ISSC, have developed technologies that can largely eliminate this hazard while preserving the sensory qualities of raw product. These technologies, collectively called Post Harvest Processing (PHP), include individual quick freezing (IQF) with frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation. The shellfish industry in the Gulf of Mexico region has indicated that PHP product now accounts for about 15% of its production of half-shell oysters and that the capacity exists to treat all half-shell oysters harvested from the Gulf of Mexico. Present PHP capacity likely is much lower in other regions of the country.

The Seafood HACCP Regulation requires that preventive measures for hazards that are reasonably likely to occur be sufficient to “prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” In light of the availability of demonstrably effective and feasible PHP methods, and the failure of other measures to achieve the purpose of the HACCP regulation, we believe application of PHP, or other equally effective controls, is the appropriate preventive measure under the regulation for the control of V. vulnificus in shellfish when the hazard is reasonably likely to occur. We do not believe measures that reduce, but fall well short of eliminating the hazard, such as improvements in refrigeration, are sufficient to meet the purpose of the regulation, especially given the availability of PHP technologies. These considerations will inform our future implementation of the Seafood HACCP Regulation, with the intent that implementation of PHP or equivalent measures would be achieved for the control of V. vulnificus by the beginning of the risk season in 2011.

Improving food safety by fostering implementation of preventive controls to prevent foodborne illness is a priority for the leadership of FDA. In acting on these responsibilities, FDA will continue to seek the advice and support of all interested parties, including the ISSC. In particular, we seek dialogue with the ISSC and industry with respect to (1) the availability of alternatives to PHP that are equally effective in reducing the risk associated with V. vulnificus, (2) ways in which the impact on small business can be mitigated, and (3) how best to address other hazards that affect the safety of shellfish.

It is our hope as well that the deliberations at the biennial meeting can consider ISSC strategies for the mandatory implementation, within the ISSC framework, of PHP for the control of V. vulnificus when the hazard is reasonably likely to occur.




Donald W. Kraemer, Ph.D.
Deputy Director
Office of Food Safety
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration