United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2001-07-09 monographic deposited born digital 53 p. GA 1.13:GAO-01-702 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-702 P0b002ee180391fad f:d01702 DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-01-702 machine generated eng fdlp REPORT GAOREPORTS-GAO-01-702 GAO-01-702 Contaminated foods Data collection Food inspection Importing Health hazards Safety standards Product safety Federal/state relations Shellfish State programs Safety regulation FSIS Hazard Analysis and Critical Control Point System Other Written Product A01127 Molluscan shellfish--oysters, clams, mussels, and scallops--cause over 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 frequently eaten raw, heightening 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 been the cause of 275 reported illnesses resulting in 143 deaths since 1989, according to FDA. In 1982, FDA, state regulators, and shellfish industry representatives formed the Interstate Shellfish Sanitation Conference (ISSC) to promote uniform shellfish policies for the safe harvesting, processing, and distribution of fresh and frozen shellfish. In December 1997, FDA required processors of seafood, including shellfish, to implement Hazard Analysis Critical Control Point (HACCP) systems. Processors of raw molluscan shellfish are required to identify safety hazards that are reasonably likely to occur and to 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 that several weaknesses exist in FDA's approach to 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 does not have objective, measureable 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. Despite various actions, the ISSC's efforts to reduce V. vulnificus-related illnesses and deaths have not been effective. The ISSC is now developing a strategy that would rely primarily on educating at-risk consumers to reach the goal of reducing the number of V. vulnificus-related illnesses and deaths by 60 percent by 2008. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-702/html/GAOREPORTS-GAO-01-702.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-702/pdf/GAOREPORTS-GAO-01-702.pdf GAO-01-702 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-702 Other Written Product GAO-01-702; Food Safety: Federal Oversight of Shellfish Safety Needs Improvement; Contaminated foods Data collection Food inspection Importing Health hazards Safety standards Product safety Federal/state relations Shellfish State programs Safety regulation FSIS Hazard Analysis and Critical Control Point System