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.

Additional Materials:

Contact:

John B. Stephenson
(202) 512-6225
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

EPA's reviews of new chemicals provide limited assurance that health and environmental risks are identified before the chemicals enter commerce. Chemical companies are not required by TSCA, absent a test rule, to test new chemicals before they are submitted for EPA's review, and companies generally do not voluntarily perform such testing. Given limited test data, EPA predicts new chemicals' toxicity by using models that compare the new chemicals with chemicals of similar molecular structures that have previously been tested. However, the use of the models does not ensure that chemicals' risks are fully assessed before they enter commerce because the models are not always accurate in predicting chemical properties and toxicity, especially in connection with general health effects. Nevertheless, given the lack of test data and health and safety information available to the agency, EPA believes the models are generally useful as screening tools for identifying potentially harmful chemicals and, in conjunction with other information, such as the anticipated potential uses and exposures of the new chemicals, provide a reasonable basis for reviewing new chemicals. The agency recognizes, however, that obtaining additional information would improve the predictive capabilities of its models. EPA does not routinely assess the risks of all existing chemicals and EPA faces challenges in obtaining the information necessary to do so. TSCA's authorities for collecting data on existing chemicals do not facilitate EPA's review process because they generally place the costly and time-consuming burden of obtaining data on EPA. Partly because of a lack of information on existing chemicals, EPA, in partnership with industry and environmental groups, initiated the High Production Volume (HPV) Challenge Program in 1998, under which chemical companies began voluntarily providing information on the basic properties of chemicals produced in large amounts. It is unclear whether the program will produce sufficient information for EPA to determine chemicals' risks to human health and the environment. EPA has limited ability to publicly share the information it receives from chemical companies under TSCA. TSCA prohibits the disclosure of confidential business information, and chemical companies claim much of the data submitted as confidential. While EPA has the authority to evaluate the appropriateness of these confidentiality claims, EPA states that it does not have the resources to challenge large numbers of claims. State environmental agencies and others are interested in obtaining confidential business information for use in various activities, such as developing contingency plans to alert emergency response personnel of the presence of highly toxic substances at manufacturing facilities. Chemical companies recently have expressed interest in working with EPA to identify ways to enable other organizations to use the information given the adoption of appropriate safeguards.

Matters for Congressional Consideration

  1. Status: Closed - Implemented

    Comments: 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.

    Matter: 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.

  2. Status: Closed - Implemented

    Comments: 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.

    Matter: 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.

  3. Status: Closed - Implemented

    Comments: 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.

    Matter: 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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Environmental Protection Agency

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Environmental Protection Agency

  3. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Environmental Protection Agency

  4. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Environmental Protection Agency

 

Explore the full database of GAO's Open Recommendations »

Sep 12, 2014

Sep 9, 2014

Aug 11, 2014

Jul 28, 2014

Jul 16, 2014

Jul 15, 2014

Jul 9, 2014

Jun 30, 2014

Jun 16, 2014

May 22, 2014

Looking for more? Browse all our products here