Assessment of New Chemical Regulation Under the Toxic Substances Control Act

RCED-84-84: Published: Jun 15, 1984. Publicly Released: Jul 10, 1984.

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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.

Matter for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: Bills to amend the Toxic Substances Control Act were introduced by both requesting subcommittee chairmen, but these bills were not acted on by the full committees during the last session of Congress. Amendments to the act are not actively being considered, because legislative committees are giving priority to other environmental legislation.

    Matter: Congress may wish to provide EPA with additional authority to control changes in the manufacture and use of new chemicals that have undergone premanufacture review while data necessary for determining the chemical's health and environmental effects are being developed.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: Action is ongoing. EPA is doing this for selected new chemicals through increased use of significant new use rules. However, this does not result in follow-up on all or even most new chemicals.

    Recommendation: The Administrator, EPA, should establish monitoring procedures and reporting requirements for new chemicals that have undergone an EPA premanufacture notification review and have been added to the inventory of existing chemicals. Specifically, EPA should require: (1) premanufacture notification submitters to notify EPA of any significant changes in the manufacture and use of the substance described in their submission; and (2) subsequent manufacturers to notify EPA when they begin to manufacture the new substance and provide information on production volume and uses of the substance.

    Agency Affected: Environmental Protection Agency

  2. Status: Closed - Implemented

    Comments: EPA continues to consider the problem. It recognizes the problem, but has been unable to reach an agreement internally on an acceptable basis for distinguishing between these actions.

    Recommendation: To improve the enforceability of the new chemicals program, the Administrator, EPA, should revise the premanufacture notification regulations on what constitutes an exemption from the notification requirement by developing more specific criteria for distinguishing between research and development, test marketing, and commercial uses.

    Agency Affected: Environmental Protection Agency

  3. Status: Closed - Implemented

    Comments: EPA consolidated resources to carry out a centralized inspection program by the National Environmental Investigations Center and three EPA regional offices. The centralized program has resulted in a significant increase in inspection activity and in EPA meeting its inspection goals for fiscal year 1986.

    Recommendation: EPA should provide adequate inspection resources to achieve its inspection goals in the new chemicals program. If these resources are not available because of higher priority requirements, EPA should establish the additional needs of the program and provide such information to the appropriate congressional committees for their consideration.

    Agency Affected: Environmental Protection Agency


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