Food Safety:

Federal Oversight of Shellfish Safety Needs Improvement

GAO-01-702: Published: Jul 9, 2001. Publicly Released: Jul 19, 2001.

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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.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: According to FDA, it is unlikely that they will ever develop an automated data system to capture the results of inspections of processing plants and patrols of growing waters due to resources constraints.

    Recommendation: To better ensure the safety of domestic and imported shellfish consumed in the United States, the Commissioner of the Food and Drug Administration should adopt a risk-based approach to overseeing states' and foreign countries' shellfish safety programs that include a standardized, automated system to capture the results of states' and foreign countries' inspections of processing plant and patrols of growing water.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: FDA has designed a risk-based approach to reviewing states' shellfish safety programs and incorporated it into their fiscal year 2003 to 2005, compliance program, which FDA's shellfish specialists use to evaluate state programs. Risk factors have been identified for each of the three program elements, and based on a scoring system for the factors a total risk score of high, medium, or low is computed for each program element. These risk designations determine the frequency that FDA evaluates that program element, with high risk elements receiving more frequent reviews. Regarding the second part of this recommendation, FDA does not believe its program could be improved by testing shellfish meats for contaminants and does not plan to implement this part of the recommendation.

    Recommendation: To better ensure the safety of domestic and imported shellfish consumed in the United States, the Commissioner of the Food and Drug Administration should adopt a risk-based approach to overseeing states' and foreign countries' shellfish safety programs that include baseline data, such as the results of regular shellfish microbial tests, to assess over time the effectiveness of states' and foreign countries' shellfish safety programs, including Hazard Analysis Critical Control Point programs.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: FDA and the Interstate Shellfish Sanitation Conference (ISSC) have developed and implemented a detailed plan to develop the necessary post-harvest treatment capacity to treat shellfish to kill the Vibrio vulnificus bacteria if other measures are not adequate to reach the ISSC's illness reduction goals.

    Recommendation: To better ensure the safety of domestic and imported shellfish consumed in the United States, the Commissioner of the Food and Drug Administration should work with ISSC to prepare and implement a detailed plan for developing adequate post-harvest treatment capacity to help achieve ISSC's goals for reducing illnesses.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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