The FDA has responded that while it has devoted essentially the same number of staff to annual evaluations in each state that produces shellfish, regardless of the amount that state produces, it has not moved to risk-based assessments its shellfish safety programs. In part, the current approach, the FDA reports, is in place in part because shellfish producing states wanted uniform oversight. The agency admits that it could collect better data, but it believes that it is impossible to directly assess the effectiveness of shellfish safety efforts currently because of problems in accurately measuring shellfish-related pathogens and illness. The agency maintains that it does not know what data and collection methods would be most effective.
The GAO has recommended that the FDA examine two strategies for reducing Vibrio vulnificus exposure and illnesses. One, the agency could mandate refrigeration of the shellfish shortly after harvest. Or, two, the agency could impose phased-in requirements for post-harvest treatment. The FDA responded that it does not know if refrigeration will produced the desired effect. While a recent FDA study has demonstrated that immediate refrigeration maintains "at harvest" levels of bacteria, it does not know if this will reduce illnesses, as it does not know what level of Vibrio vulnificus causes injury. Additionally, the GAO noted that other drawbacks associated with implementing refrigeration requirements include added costs associated with equipment and labor and increased consumer costs.
Turning to post-harvest treatment, the GAO report indicated that three treatment processes are currently available. However, the report did indicate that potential disadvantages associated with requiring post-harvest treatment include a potential decrease in demand associated with lack of consumer in eating processed shellfish and the potential shutdown of certain processing facilities due to a lack of resources and an inability to maintain related equipment.
The FDA has indicated that it will only impose these types of requirements if the consumer education program does not meet its goal by 2008. Other proposed alternative controls include closing growing areas or diverting raw oysters for shucking rather than raw consumption.
All thirty U.S. states that harvest and or process shellfish commercially participate in the ISSC, and four foreign nations-Canada, Chile, South Korea, and New Zealand-have signed agreements with the U.S. government to abide by the NSSP provisions. Countries not agreeing to follow NSSP provisions are currently prohibited from importing raw shellfish into the United States. Currently, the ISSC classifies growing areas, imposing restrictions where contamination dangers are greatest; patrols shellfish growing areas to prevent harvests in restricted areas; inspects shellfish processing plants and issues annual certificates for producers; and operates laboratories to test growing waters and shellfish meats.
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