Assessment of New Chemical Regulation Under the Toxic Substances Control Act

Pursuant to a congressional request, GAO reviewed: (1) the Environmental Protection Agency's (EPA) program for protecting health and the environment from the risks of new chemicals; (2) enforcement of program requirements by EPA; and (3) the differences between the EPA program and the new chemicals notification program adopted by the European Economic Community (EEC) and the potential impact of these differences on international trade.

EPA performs premanufacture reviews to assess the potential risks of new chemicals. GAO found that EPA reviews are limited in scope and their assessment of risks are frequently made with considerable uncertainty as to the toxicity of the chemicals being reviewed. EPA is required to provide enforcement inspections to ensure that: (1) new chemical notifications are being submitted; (2) EPA-imposed control actions are implemented by chemical manufacturers; and (3) data required to be submitted are reliable. GAO found that not all of the planned inspections were performed because inspection resources were being diverted to other enforcement activities. In addition, GAO found that the United States and EEC have pursued different approaches to chemicals regulation. While the American system is designed to protect against chemical risks without creating economic barriers to technological innovation, the European program is designed to avoid trade barriers that might arise if the nations of EEC did not standardize their reporting requirements. The EEC program involves a notification system, with risk assessment and control decisions left primarily to member nations. Under the EEC program: (1) a standardized set of tests is required for new chemicals; (2) any chemical not on the established chemical inventory must be pretested; and (3) additional testing is required when the quantity of a new chemical being marketed reaches specified levels. GAO believes that it is too early to tell whether international trade might be affected by the differences in the two systems.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Hugh J. Wessinger Team: General Accounting Office: Resources, Community, and Economic Development Division Phone: (202) 275-5489