Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program
GAO-05-458
Published: Jun 13, 2005. Publicly Released: Jul 13, 2005.
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Highlights
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, including consumer products such as cleansers, paints, plastics, and fuels, 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. GAO reviewed EPA's efforts to (1) control the risks of new chemicals not yet in commerce, (2) assess the risks of existing chemicals used in commerce, and (3) publicly disclose information provided by chemical companies under TSCA.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| To improve EPA's ability to assess the health and environmental risks of chemicals, the Congress may wish to consider amending TSCA to provide explicit authority for EPA to enter into enforceable consent agreements under which chemical companies are required to conduct testing. | Congress introduced H.R. 6100 and S. 3040 in the 110th Congress to amend the Toxic Substances Control Act (TSCA) to significantly reshape U.S. chemical assessment and management. Sponsors cited GAO's work when releasing the bills and invited GAO to testify at hearings held by relevant committees in both houses on the subject of TSCA reform. The bills addressed GAO's concerns about the relative weaknesses of TSCA in controlling chemical risks that prompted the matters for consideration. Specifically, EPA would have greater authority to control chemicals if companies do not provide sufficient data to assess their safety. Currently, EPA has to promulgate test rules, which are time consuming and expensive, or ask companies to voluntary agree to testing through consent orders which may not stand up to court challenges. To address this, under the bill, chemical manufacturers would have been required to submit to EPA a statement that each chemical they manufacture or import meets the safety standard, or that there are insufficient data to determine whether that is the case, and all reasonably available information regarding chemical properties, uses, production volume, exposure, and fate. Based on all available information, EPA then would have been required to categorize all chemicals in commerce based on criteria relating to human exposure, known health effects, and persistence in the environment, and to identify high-priority chemicals. No new chemical would have been permitted to enter U.S. commerce unless EPA had found that the manufacturer had demonstrated conformance with the safety standard. If manufacturers failed to submit required statements or data for a chemical, or if the EPA Administrator determined that a chemical failed to meet the safety standard, then manufacture, importation, and distribution of that chemical in the United States would have been prohibited. | |
| To improve EPA's ability to assess the health and environmental risks of chemicals, the Congress may wish to consider amending TSCA to give EPA, in addition to its current authorities under section 4 of TSCA, the authority to require chemical substance manufacturers and processors to develop test data based on substantial production volume and the necessity for testing. | Congress introduced H.R. 6100 and S. 3040 in the 110th Congress to amend the Toxic Substances Control Act (TSCA) to significantly reshape U.S. chemical assessment and management. Sponsors cited GAO's work when releasing the bills and invited GAO to testify at hearings held by relevant committees in both houses on the subject of TSCA reform. The bills addressed GAO's concerns about the relative weaknesses of TSCA in controlling chemical risks that prompted the matters for consideration. Specifically, EPA would have greater authority to control chemicals if companies do not provide sufficient data to assess their safety. Chemical manufacturers would have been required to submit to EPA a statement that each chemical they manufacture or import meets the safety standard, or that there are insufficient data to determine whether that is the case, and all reasonably available information regarding chemical properties, uses, production volume, exposure, and fate. Based on all available information, EPA then would have been required to categorize all chemicals in commerce based on criteria relating to human exposure, known health effects, and persistence in the environment, and to identify high-priority chemicals. No new chemical would have been permitted to enter U.S. commerce unless EPA had found that the manufacturer had demonstrated conformance with the safety standard. If manufacturers failed to submit required statements or data for a chemical, or if the EPA Administrator determined that a chemical failed to meet the safety standard, then manufacture, importation, and distribution of that chemical in the United States would have been prohibited. | |
| To improve EPA's ability to assess the health and environmental risks of chemicals, the Congress may wish to 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. | Congress introduced H.R. 6100 and S. 3040 in the 110th Congress to amend the Toxic Substances Control Act (TSCA) to significantly reshape U.S. chemical assessment and management. Sponsors cited GAO's work when releasing the bills and invited GAO to testify at hearings held by relevant committees in both houses on the subject of TSCA reform. The bills addressed GAO's concerns about the relative weaknesses of TSCA in controlling chemical risks that prompted the matters for consideration. Specifically, EPA would have been authorized to share confidential business information upon request to a State, tribal, or municipal government. In order to facilitate sharing of information internationally, the act would also authorize EPA to consider information provided by foreign governments as confidential business information if the information is considered to be confidential business information by the officer or employee of the foreign government. Furthermore, the act requires companies to reassert claims of confidentiality after a certain time period, which would increase the amount of information that EPA could share with foreign governments. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Environmental Protection Agency | To improve EPA's management of its chemical review program, the EPA Administrator should develop and implement a methodology for using information collected through the HPV Challenge Program to prioritize chemicals for further review and to identify and obtain additional information needed to assess their risks. |
Since we issued our report and recommendation,EPA has implemented a process to use data it obtains under its High Production Volume (HPV)program to develop hazard characterizations for chemicals included under the HPV program. These characterizations are key to EPA's current efforts to prioritize chemicals in order to give regulatory priority to the most potentially harmful.
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| Environmental Protection Agency | To improve EPA's management of its chemical review program, the EPA Administrator should promulgate a rule under section 8 of TSCA requiring chemical companies to submit to EPA copies of any health and safety studies, as well as other information concerning the environmental and health effects of chemicals, that they submit to foreign governments on chemicals that the companies manufacture or process in, or import to, the United States. |
EPA is complying with the spirit of the recommendation. It is evaluating targeted approaches for collecting information submitted to foreign governments. These approaches are designed to minimize duplicate testing of chemicals, increase data collection as needed, and contribute to the management of chemicals.
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| Environmental Protection Agency | To improve EPA's management of its chemical review program, the EPA Administrator should develop a strategy for improving and validating, for regulatory purposes, the models that EPA uses to assess and predict the risks of chemicals and to inform regulatory decisions on the production, use, and disposal of the chemicals. |
EPA issued in March 2009 guidance for the development, evaluation, and application of environmental models used in assessing chemicals and predicting their risks to inform regulatory decisions. This guidance, titled "Guidance Document on the Development, Evaluation, and Application of Environmental Models," was developed by EPA's Council on Regulatory Environmental Modeling.
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| Environmental Protection Agency | To improve EPA's management of its chemical review program, the EPA Administrator should revise its regulations to require that companies reassert claims of confidentiality submitted to EPA under TSCA within a certain time period after the information is initially claimed as confidential. |
EPA is exploring ways to reduce the number of inappropriate and over-broad claims of confidentiality by companies that submit data to EPA. Actions may include rulemaking activities as well as policy changes governing the claims of confidentiality. For example, EPA recently acted to list 530 substances, previously treated as confidential on the public portion of the master inventory list of the Toxic Substances Control Act after confidential claims were not reasserted by companies that responded to EPA's rule requiring companies to update their information on chemicals reported to EPA.
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Topics
Chemical regulationChemicalsContingency plansEmergency responseEmergency response personnelEnvironmental lawEnvironmental monitoringFederal regulationsHealth hazardsProduct evaluationPublic healthSafety regulationToxic substances