Problems in Protecting Consumers From Illegally Harvested Shellfish (Clams, Mussels, and Oysters)

In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) administration of the National Shellfish Sanitation Program, focusing on whether: (1) FDA has adequate legal authority to enforce federal standards designed to ensure the safety and quality of shellfish; (2) FDA is effective in regulating the shellfish industry; or (3) a stronger or different federal role is needed to regulate shellfish.

GAO found that, although FDA, state enforcement authorities, and the shellfish industry have been working to improve the sanitary quality of shellfish shipped in interstate commerce, problems still need to be overcome. These problems are as follows: (1) the National Shellfish Sanitation Program is voluntary, and FDA cannot ensure that members are adhering to program requirements; (2) according to state officials, law enforcement agencies do not have sufficient staff or equipment to adequately enforce shellfish program requirements or patrol areas closed to shellfish harvesting; (3) fines assessed by the courts for illegal harvesting have generally been so low that they have had little deterrent effect; (4) some growing areas and surrounding properties have not been adequately inspected; and (5) contaminated shellfish often cannot be traced back to the growing areas from which they were harvested and the persons who harvested them. GAO also determined that there are different alternatives for regulating the shellfish industry, including: (1) leaving regulatory authority with the states and allowing FDA to continue to function in an advisory capacity; (2) granting specific regulatory authority to FDA to administer the shellfish program; and (3) forming a cooperative relationship among the states, FDA, and the shellfish industry in which each party has a voice in the direction and regulation of shellfish and specific duties and responsibilities.