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FDA ANNOUNCES AVAILABILITY OF VIBRIO PARAHAEMOLYTICUS RISK ASSESSMENT

The Food and Drug Administration (FDA) today announces the availability of a draft risk assessment report on the estimated public health risks associated with raw oysters containing pathogenic Vibrio parahaemolyticus. V. parahaemolyticus is a bacterial species that occurs naturally in oysters, and occasionally this organism causes illness in humans, following the consumption of raw oysters. Most often, illness caused by V. parahaemolyticus occurs as sporadic cases of self-limiting gastroenteritis, with symptoms such as diarrhea, vomiting, and abdominal cramps. In recent years, however, several outbreaks have been caused by V. parahaemolyticus, involving dozens to hundreds of consumers. Also, though rare, the organism can produce a life-threatening septicemia, especially in people having underlying medical conditions such as liver disease or immune disorders.

The draft risk assessment evaluated factors that affect the prevalence of V. parahaemolyticus in oysters before and after harvesting. It also estimated the impact of several preventive and intervention measures aimed at reducing the incidence of V. parahaemolyticus in oysters, including the Interstate Shellfish Sanitation Conference (ISSC) guidance of limiting viable V. parahaemolyticus to 10,000 or fewer cells per gram of seafood. The draft risk assessment attempted to address a number of specific questions, including how often V. parahaemolyticus bacteria occur in water and shellfish, the relationship of the level of V. parahaemolyticus ingested to the severity of illness, the differences in dose-response for consumers with different health conditions, and the influence of post-harvest handling on the numbers of V. parahaemolyticus in oysters.

The FDA began this risk assessment project in 1999 and has also held public meetings seeking scientific information and suggestions regarding the risk assessment project. Having completed the draft risk assessment, the FDA now is seeking comments on the technical aspects of this draft report in the following areas: (1) assumptions incorporated, (2) modeling approach, (3) data sets employed, and (4) transparency of the project and report. The FDA plans to review and evaluate all public comments and make modifications as appropriate.

Details of a public meeting will be published in the Federal Register at a later time. The draft risk assessment is available on FDA's website at: www.foodsafety.gov/~dms/fs-toc.html. The draft risk assessment also may be reviewed in the agency's Dockets Management Branch. Submit written comments by March 20, 2001 to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

This is a mirror of the page at http://www.fda.gov/bbs/topics/answers/2001/ANS01067.html

Draft Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Molluscan Shellfish