Summary: Molluscan shellfish--oysters, clams, mussels, and scallops--cause more than 100,000 illnesses annually, according to the most recent available estimates made by the Food and Drug Administration (FDA). Unlike meat and most other seafood products, which are normally cooked before consumption, shellfish are often eaten raw, increasing the risk of illness. The severity of illnesses that occur from contaminated shellfish varies from mild gastrointestinal discomfort to death. The vibrio vulnificus (V. vulnificus) bacteria in shellfish, primarily raw oysters, have caused 275 reported illnesses and 143 deaths since 1989. FDA, state regulators, and shellfish industry representatives formed the Interstate Shellfish Sanitation Conference (ISSC) in 1982 to promote uniform shellfish policies for the safe harvesting, processing, and distribution of fresh and frozen shellfish. In 1997, FDA required processors of seafood, including shellfish, to implement Hazard Analysis Critical Control Point (HACCP) systems. Processors of raw molluscan shellfish must identify likely safety hazards establish controls to prevent or reduce contamination to acceptable levels. This report reviews (1) FDA's approach to oversight of state and foreign shellfish safety programs and (2) the ISSC's strategy for reducing the illnesses and deaths associated with V. vulnificus bacteria. GAO found several weaknesses in FDA's oversight of domestic and foreign safety programs. FDA does not use existing information, including shellfish production and illness data, to make risk-based decisions about which programs should receive the most oversight. FDA's ability to fully assess relative risk and allocate its limited oversight resources is limited by weaknesses in the compliance and effectiveness information it gathers on state and foreign country shellfish safety programs. FDA also lacks objective, measurable data on the effectiveness of HAACP requirements and other state and foreign country efforts to reduce the amount of bacteria in shellfish and associated illnesses. ISSC's efforts to reduce V. vulnificus-related illnesses and deaths have been ineffective. The ISSC is now developing a strategy to educate at-risk consumers, with a goal of reducing the number of shellfish-related illnesses and deaths by 60 percent by 2008.
