Transforming EPA's Process for Assessing and Controlling Toxic Chemicals

Why It's High Risk

EPA's Process for Toxic Chemicals

The Environmental Protection Agency’s (EPA) ability to effectively implement its mission of protecting public health and the environment is critically dependent on credible and timely assessments of the risks posed by chemicals. Such assessments are the cornerstone of scientifically sound environmental decisions, policies, and regulations under a variety of statutes, such as the Safe Drinking Water Act, the Toxic Substances Control Act (TSCA), and the Clean Air Act. EPA conducts assessments of chemicals under its Integrated Risk Information System (IRIS) program and is authorized under TSCA to obtain information on the risks of chemicals and control those it determines pose an unreasonable risk. Because EPA had not developed sufficient chemical assessment information under these programs to limit public exposure to many chemicals that may pose substantial health risks, GAO added this issue to the High-Risk List in 2009.

^ Back to topWhat We Found

IRIS. EPA’s IRIS database provides the basic information the agency needs to determine whether it should establish controls to, for example, protect the public from exposure to toxic chemicals in the air, in water, and at hazardous waste sites.

• In March 2008, GAO reported that the viability of the IRIS program was at risk because EPA had been unable to complete timely, credible chemical assessments—including those of chemicals of greatest concern, such as formaldehyde and dioxin, which have been in progress for 13 and 19 years, respectively. In addition, EPA had been unable to decrease its long-standing backlog of ongoing assessments or to keep its existing assessments current.
• In May 2009, EPA revised its IRIS assessment process. If implemented effectively, these assessment reforms represent significant improvements and will be largely responsive to GAO’s 2008 recommendations. They will restore EPA’s control of the process and increase its transparency, among other things.
• For example, under the prior process, interagency reviews were required and managed by the Office of Management and Budget (OMB), and EPA was not allowed to proceed with assessments at various stages until OMB agreed that EPA had sufficiently responded to interagency comments. In contrast, under the reforms, EPA is to manage the entire assessment process, and all written comments on draft assessments provided during the interagency process are to be part of the public record.
• It is too soon to determine whether the reforms will be effective, but EPA has made some progress in addressing its assessment backlog. GAO is currently reviewing EPA’s implementation of the revised process.

TSCA. GAO has also reported that EPA’s assessments of industrial chemicals under TSCA provide limited information on health and environmental risks.

• In contrast to the approach taken by the European Union—which generally places the burden on companies to provide data on the chemicals they produce and to address the risks they pose to human health and the environment—TSCA generally places the burden on EPA to obtain information about the roughly 80,000 chemicals already on the U.S. market.
• TSCA also requires EPA to demonstrate that certain health or environmental risks are likely before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the industrial chemicals already in use. For the approximately 700 new chemicals introduced into commerce annually, chemical companies are required to provide EPA with certain information in premanufacture notices, and EPA can ban or limit the use of these chemicals if the information is inadequate. Although 85 percent of the notices lack any health or safety test data, EPA does not often use its authority to obtain more information.
• Subsequent to GAO’s reports, EPA has taken some steps to begin to address some of these issues. For example, using its existing authorities, EPA has initiated actions on such chemicals as mercury and lead to, for example, ban or phase out their use in certain products. However, most such actions are in the early stages of development. Regarding statutory changes, the EPA Administrator has expressed support for TSCA reforms and developed principles for addressing them.

^ Back to topWhat Needs to Be Done

The EPA Administrator needs to continue to demonstrate a strong commitment to and support of the IRIS program and its TSCA initiatives. Specifically, EPA needs to ensure that its 2009 IRIS reforms are implemented effectively and that the program can routinely provide timely and credible assessments. Regarding TSCA, GAO has recommended both statutory and regulatory changes to, among other things, provide EPA with additional authorities to obtain health and safety information from the chemical industry and to shift more of the burden to chemical companies for demonstrating the safety of their chemicals. Congress and EPA need to act on these important issues.

^ Back to topKey Reports

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EPA Chemical Assessments

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High-Risk Series

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Chemical Assessments

Toxic Chemicals

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