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Shellfish and Death???--PART II


© Maggie Herman

GAO Study Results--Continued

With respect to FDA oversight, the GAO report indicated that data on the size and type of shellfish produced and consumed, public consumption patterns and rates, and state and foreign government compliance with safety requirements are available, but that the FDA is not using this data to determine risk factors and establish preventative measures. In particular, the GAO noted that while the FDA conducts annual evaluations, it does not use the data it collects on a state-by-state basis to identify deficiencies or respond to noncompliance with safety requirements experienced in certain states. Additionally, the GAO recommends that the FDA assist states in moving towards electronic data collection in order to use the data collected more efficiently.

In examining the FDA's future proposed strategies to reduce exposure to Vibrio vulnificus by focusing on consumer education, the GAO noted that the goal of these strategies is to focus on at-risk individuals in order to reduce deaths related to Vibrio vulnificus exposure. The FDA hopes to cut related fatalities by 60 percent by the year 2008. The GAO has questioned the efficacy of such efforts, citing the fact that this is the primary strategy currently employed, and Vibrio vulnificus fatalities have remained constant for nearly a decade.

In examining the issue of illness reduction through consumer education, the GAO report stated: "[I]t is unlikely that education alone will significantly reduce illnesses" by the target date of 2008. The report noted that a previous consumer education program was discontinued because its effectiveness could not be measured and the process was difficult for participating states to administer. Additionally, all of the states studied have laws requiring point of sale notification to consumers about the risks associated of Vibrio vulnificus. However, no longitudinal studies have been conducted measuring the effectiveness of the programs in changing consumer behavior. In one state, Texas, illnesses related to the bacteria actually increased after the introduction of the warnings.

The FDA's current efforts to detect shellfish contamination include inspections, but estimates indicate that the agency inspects as few as 5 percent of the shellfish processors in some states. The FDA contends that budget constraints prohibit more thorough review. Instead, the agency has relied for almost 20 years on the Interstate Shellfish Sanitation Conference (ISSC)-a group of state health officials-to set and carry out shellfish quality control policies. Specifically, the ISSC develops safe harvesting, processing, and distribution policies for both fresh and frozen shellfish. These policies are then incorporated into the National Shellfish Sanitation Program (NSSP) catalogue of safety procedures, also called model ordinances. The FDA oversees the ISSC by (1) conducting evaluations to ensure members comply with the NSSP provisions and (2) providing technical assistance.

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