Chemical Regulation:

Observations on Improving the Toxic Substances Control Act

GAO-10-292T: Published: Dec 2, 2009. Publicly Released: Dec 2, 2009.

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The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to obtain information on the risks of chemicals and to control those that it determines to pose an unreasonable risk. EPA also conducts assessments of chemicals under its Integrated Risk Information System (IRIS) program. Nonetheless, EPA does not have sufficient information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. The Government Accountability Office (GAO) has recommended statutory changes to TSCA 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. GAO has also recommended that EPA adopt a streamlined, more transparent IRIS assessment process to address significant productivity and credibility issues. Problems with TSCA and IRIS led GAO to add transforming EPA's processes for assessing and controlling toxic chemicals to its list of high-risk areas warranting attention by Congress and the executive branch This testimony, based on prior GAO work, addresses EPA's implementation of TSCA and IRIS and options for (1) obtaining more information on chemical risks, (2) controlling these risks, and (3) sharing more of the information collected under TSCA.

EPA lacks adequate scientific information on the toxicity of many chemicals. One major reason is that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing. Furthermore, the procedures EPA must follow to obtain test data from companies can take years. Regarding IRIS, in 2008, GAO reported that this significant chemical assessment program--which provides EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals--is at serious risk of becoming obsolete because the agency has not been able to complete timely, credible assessments. In May 2009, EPA announced reforms to its IRIS assessment process, citing GAO's conclusions and its high-risk designation. Overall, GAO believes that, if the reforms are effectively implemented, they will address GAO's recommendations and provide a sound framework for conducting IRIS assessments. However, given the number of obstacles that can impede the progress of IRIS assessments, the viability of this program will depend on effective and sustained management. While TSCA authorizes EPA to ban, limit, or otherwise regulate existing toxic chemicals, EPA must meet a high legal threshold, which has proven difficult. For example, EPA must demonstrate "unreasonable risk" to ban or limit chemical production, which EPA believes requires it to conduct extensive cost-benefit analyses that can take many years to complete. Since 1976, EPA has issued regulations to control only five existing chemicals. Furthermore, its 1989 regulation phasing out most uses of asbestos was largely vacated by a federal appeals court in 1991 because it was not based on "substantial evidence." In contrast, the European Union and a number of other countries have largely banned asbestos, a known human carcinogen that can cause lung cancer and other diseases. GAO previously suggested that Congress amend TSCA to reduce the evidentiary burden EPA must meet to control toxic substances and continues to believe such change warrants consideration. Because of TSCA's prohibitions on the disclosure of confidential business information, EPA has limited ability to share information on chemical production and risk. According to EPA officials, about 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential. Evaluating the appropriateness of confidentiality claims is time- and resource-intensive, and EPA does not challenge most claims. GAO previously suggested that Congress, among other things, consider amending TSCA to authorize EPA to share the confidential business information that chemical companies provide to EPA with states.

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