Chemical companies can claim certain  information, such as data disclosing chemical processes, as confidential  business information. EPA Lacks Sufficient Data to Ensure That Potential Health and Environmental Risks of New Chemicals Are Identified

While TSCA authorizes EPA to promulgate rules requiring chemical  companies to conduct tests on chemicals and submit the resulting data to  EPA, TSCA does not require chemical companies to test new chemicals for  their toxicity and exposures before they are submitted for EPA’s review  and, according to EPA officials, chemical companies typically do not  voluntarily perform such testing. However, use  of the models can present weaknesses in an assessment because models do  not always accurately determine the chemicals’ properties and the full  extent of their adverse effects, especially with regard to their general  health effects. Nevertheless, EPA believes that the models are useful as  basic screening tools where actual test data on health and environmental  effects information is not available from chemical companies. 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. EPA Does Not Routinely Assess Existing Chemicals, Has Limited Information on Their Health and Environmental Risks, and Has Issued Few Regulations Controlling Such Chemicals

TSCA authorizes but does not specifically require EPA to review the risks  of existing chemicals. While chemical industry organizations have said that  they will voluntarily provide a basic set of test data on certain  high-production-volume chemicals that are not part of the HPV Challenge  Program, it is unclear that their efforts will produce information sufficient  for EPA to make determinations of a chemical’s risk to human health or the  environment or provide the information in a timely manner. For example, on the basis of a study performed by the  state of Illinois with the cooperation of chemical companies and EPA,  Illinois regulators found that toxicity information submitted under TSCA  was useful in identifying chemical substances that should be included in  contingency plans in order to alert emergency response and planning  personnel to the presence of highly toxic substances at facilities. Matters for Congressional Consideration

To improve EPA’s ability to assess the health and environmental risks of  chemicals, the Congress should consider amending TSCA to  provide explicit authority for EPA to enter into enforceable consent  agreements under which chemical companies are required to conduct  testing;   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; and  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. Recommendations for Executive Action

To improve EPA’s management of its chemical review program, we  recommend the EPA Administrator  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;  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;  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; and  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. Scope and Methodology

Our objectives were to review the Environmental Protection Agency’s  (EPA) efforts to (1) control the risks of new chemicals not yet in  commerce, (2) assess existing chemicals used in commerce, and (3)  publicly disclose information provided by chemical companies under the  Toxic Substances Control Act (TSCA). PCBs are toxic and very persistent in the  environment. The agency determined  these chemicals would pose an unreasonable risk to human health or the  environment.
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, 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.

What GAO Found

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.