Evaluating the appropriateness of  confidentiality claims is time- and resource-intensive, and EPA does not  challenge most claims. EPA uses risk assessments developed with IRIS toxicity data  to determine whether the identified health risks warrant regulatory or  other actions. EPA Lacks Adequate Information on Potential Health and Environmental Risks of Chemicals

EPA lacks adequate scientific information on the toxicity of many  chemicals that are or may be found in the environment. For existing  chemicals, TSCA generally places the burden of obtaining data on EPA,  rather than on the companies that produce the chemicals. This approach  requires that EPA 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 more than 83,000  commercial chemicals in use. for new chemicals that, for various reasons, never  In addition to TSCA, EPA assesses chemicals under its IRIS program reported in March 2008 that this key program was at serious risk of  becoming obsolete because the agency has not been able to keep its  existing assessments current; decrease its backlog of 70 assessments complete assessments of key chemicals of concern, such as dioxin,  formaldehyde, and trichloroethylene (TCE). As a result, we recommended that EPA adopt a streamlined, more transparent assessment process. As a result, we included the IRIS  program along with TSCA in our high-risk designation on assessing and  controlling toxic chemicals. We reviewed EPA’s  reforms and testified that overall, if implemented effectively, these  reforms will address our recommendations and provide a sound  framework for conducting IRIS assessments and significantly improve the  IRIS process. Overall, the viability of the IRIS program will depend on effective and sustained management, given the number of factors that can  impede the progress of IRIS assessments—even one delay can have a  domino effect, requiring the process to essentially be repeated to  incorporate changing science. As we have previously stated, we believe  th contribute to EPA’s failure to complete timely IRIS assessments. TSCA’s Regulatory Framework Impedes EPA’s Efforts to Control Risks Posed by Chemicals

While TSCA authorizes EPA to issue regulations that may ban, limit, or  otherwise regulate the production or use of existing toxic chemicals, EPA  must meet a high legal threshold, which has proven to be difficult. In addition, before regulating a chemical under  section 6, the EPA Administrator must consider and publish a statement  regarding the following:  the effects of the chemical on human health and the magnitude of human  exposure to the chemical;  the effects of the chemical on the environment and the magnitude of the  environment’s exposure to the chemical;  the benefits of the chemical for various uses and the availability of  substitutes for those uses; and  the reasonably ascertainable economic consequences of the rule, after  consideration of the effect on the national economy, small business,  technological innovation, the environment, and public health. EPA has had difficulty demonstrating that harmful chemicals pose an  unreasonable risk and consequently should be regulated. In fact, since  Congress passed TSCA in 1976—over 33 years ago—EPA has issued TSCA  regulations on only five existing chemicals or chemical classes. In 1991,  one of these regulations—the 1989 regulation banning most uses of  asbestos—was largely vacated by a federal appeals court decision that  cited EPA’s failure to meet statutory requirements. In contrast to the  United States, the European Union and a number of other countries have  banned all, or almost all, asbestos and asbestos-containing products. Asbestos is a known human carcinogen that can cause lung cancer and  other diseases if inhaled. TSCA Limits EPA’s Ability to Share Information

TSCA’ s confidential business information provisions limit EPA’s ability to  make the information that it collects under the act available to outside  entities if chemical companies designate such information as confidential  business information. According to  EPA officials, about 95 percent of premanufacture notices contain some  information that chemical companies claim as confidential. In our June 2005 report, we suggested that Congress consider amending  TSCA to authorize EPA to share the confidential business information that  chemical companies provide to EPA with states and foreign  governments. In our previous reports on TSC have recommended both statutory and regulatory changes to (1)  strengthen EPA’s authority to obtain additional information from the  chemical industry, (2) shift more of the burden to chemical companies for demonstrating the safety of their chemicals, and (3) enhance the public’s understanding of the risks of chemicals to which they may be exposed,  among other things. Chemical Regulation: Options for Enhancing the Effectiveness of the  Toxic Substances Control Act. Chemical Assessments: EPA’s New Assessment Process Will Further  Limit the Productivity and Credibility of Its Integrated Risk  Information System.
Why GAO Did This Study

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.

What GAO Found

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.