	EPA Has Limited Information on the Health and Environmental Risks of Existing Chemicals and Has Issued Few Regulations Controlling Such Chemicals

Because chemical companies are generally not required to develop and  submit toxicity information to EPA, when the agency decides to review  existing chemicals, it generally has only limited information on the risks  that the chemicals pose to human health and the environment. EPA has used its authority to require testing for  fewer than 200 of the 62,000 chemicals in commerce when EPA began  reviewing chemicals under TSCA in 1979. This program is intended to provide basic data on the  characteristics of about 2,800 chemicals produced in excess of 1 million  pounds a year. For example, there are currently over 200 high-production- volume chemicals for which chemical companies have not agreed to  provide the minimal test data that EPA believes are needed to initially  assess their risks. However, EPA officials told us that it is time-consuming, costly, and  inefficient for the agency to use a two-step process of (1) issuing rules  under TSCA (which can take months or years to develop) to obtain  exposure data or available test data that the chemical industry does not  voluntarily provide to EPA and then (2) issuing additional rules requiring  companies to perform specific tests necessary to ensure the safety of the  chemicals tested. Since the Congress enacted TSCA in 1976, EPA has issued  regulations under the act to ban or limit the production or restrict the use  of only five existing chemicals or chemical classes. According to EPA, the lack of information on  existing chemicals and the relative difficulty of requiring testing under  TSCA on the scale that would be necessary for the thousands of chemicals  produced at high volumes, has led EPA, in cooperation with chemical  companies, environmental groups, and other interested parties, to  implement a voluntary program to obtain test data on high-production- volume chemicals from chemical companies. In the absence of chemical test  data, EPA largely relies on scientific models that do not always accurately  determine chemicals’ properties or the full extent of their adverse effects. This method, also referred to as the nearest analogue  approach, involves using models to compare new chemicals with  chemicals with similar molecular structures for which test data on health  and environmental effects are available. That is, according to EPA officials, the majority of new  chemicals submitted for review can be screened out as not requiring  further review because (1) EPA determines on the basis of its screening  models that a chemical has low potential to harm human health or the  environment or (2) on the basis of other information, such as the  anticipated uses, exposures, and releases of the chemicals, only limited  potential risks to people and the environment are expected. EPA Reviews of New Chemicals Have Resulted in Some Control Actions

When EPA’s assessment of a new chemical identifies health and safety  problems, EPA can issue a proposed rule to prevent chemical companies  from manufacturing or distributing the chemical in commerce, or to  otherwise restrict the chemical’s production or use, if the agency believes  the new chemical may present an unreasonable risk before EPA can  regulate the chemical under the relevant provisions of TSCA. Despite  limitations in the information available on new chemicals, EPA’s reviews  have resulted in some action being taken to reduce the risks of over 3,600  new chemicals that chemical companies have submitted for review. EPA’s Ability to Share Data Collected Under TSCA Is Limited

EPA’s ability to make publicly available the information that it collects  under TSCA is limited. We also  recommended that the Congress consider amending TSCA to authorize  EPA to share with the states and foreign governments the confidential  business information that chemical companies provide to EPA, subject to  regulations to be established by EPA in consultation with the chemical  industry and other interested parties that would set forth the procedures  to be followed by all recipients of the information in order to protect the  information from unauthorized disclosures. EPA did not disagree with the  report’s findings and is in the process of implementing several of our  recommendations. However, the  fundamental and historical problems the agency has experienced with  utilizing its authorities under TSCA continue to limit EPA’s ability to  manage its chemical review program and assess chemical risks. Moreover, EPA’s  ability to provide the public with information on chemical production and  risks is hampered by the strict confidential business information  provisions of TSCA.
Why GAO Did This Study

Chemicals play an important role in everyday life, but some may be harmful to human health and the environment. Chemicals are used to produce items widely used throughout society, such as cleansers and plastics as well as industrial solvents and additives. However, some chemicals, such as lead and mercury, are highly toxic at certain doses and need to be regulated because of health and safety concerns. In 1976, the Congress passed the Toxic Substances Control Act (TSCA) to authorize the Environmental Protection Agency (EPA) to control chemicals that pose an unreasonable risk to human health or the environment. This testimony is based on GAO's June 2005 report, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (GAO-05-458). GAO's report describes EPA's efforts to (1) assess chemicals used in commerce, (2) control the use of chemicals not yet in commerce, and (3) publicly disclose information provided by chemical companies under TSCA. GAO recommended that the Congress consider providing EPA additional authorities under TSCA to improve EPA's ability to assess chemical risks, and that the EPA Administrator take several actions to improve EPA's management of its chemical review program. EPA did not disagree with our findings and is currently implementing some of our recommendations.

What GAO Found

EPA's authority under TSCA to obtain the data needed to assess existing chemicals does not facilitate its review process because the costly and time-consuming burden of obtaining the data is on EPA, rather than chemical companies. Consequently, EPA has used its authorities to require testing of fewer than 200 of the 62,000 chemicals in commerce when EPA began reviewing chemicals under TSCA in 1979. To obtain more data on existing chemicals, EPA implemented its High Production Volume Challenge Program, under which chemical companies voluntarily provide test data on about 2,800 chemicals produced or imported in amounts of 1 million pounds or more a year. While the purpose of the program is laudable, several problems remain, including that the chemical industry has not agreed to provide test data for over 200 chemicals with high production volumes. Moreover, after obtaining test data, EPA is required under TSCA's provisions to determine that a chemical poses an unreasonable risk before EPA can act to regulate its production or use. EPA officials say the act's legal standards for demonstrating unreasonable risk are so high that they have generally discouraged EPA from using its authorities to ban or restrict the manufacture or use of existing chemicals. Since Congress enacted TSCA in 1976, EPA has issued regulations to ban or limit the production of only five existing chemicals or groups of chemicals. EPA's reviews of new chemicals provide only limited assurance that health and environmental risks are identified because TSCA does not require companies to test chemicals before they notify EPA of their intent to manufacture the chemicals. Because of a general lack of data on new chemicals, EPA has developed methods to predict their potential exposure and toxicity levels by using scientific models to compare the new chemicals with chemicals that have similar molecular structures and for which toxicity information is available. However, the use of these models can be problematic because the models are not always accurate in predicting chemical properties and EPA's evaluation of general health effects of the chemicals is contingent upon the availability of information on chemicals with similar molecular structures. Additionally, the estimates of a chemical's production volume and anticipated uses, which EPA uses to assess exposure, can change substantially after EPA completes its review. Despite these limitations, EPA's reviews have resulted in some action being taken to reduce the risks of over 3,600 new chemicals. EPA's ability to provide the public with information on chemical production and risk is generally limited by the confidential business information provisions of TSCA. As a result, state agencies and foreign governments interested in obtaining this data for important purposes are denied access to the information. Recently, chemical companies have expressed interest in working with EPA to identify ways of enabling the agency to share confidential information with other organizations, provided that appropriate safeguards are adopted to prevent the unauthorized use of the information.