	Background

The Toxic Substances Control Act was enacted in 1976 to provide EPA  with the authority, upon making certain determinations, to collect  information about the hazards posed by chemical substances and to take  action to control unreasonable risks by either preventing dangerous  chemicals from making their way into use or placing restrictions on those  already in commerce. This  structure places the burden on EPA to demonstrate a need for data on a  chemical’s toxicity rather than on a company to demonstrate that a  chemical is safe. As a result, EPA does not routinely assess the risks of the  roughly 80,000 industrial chemicals in use. However, EPA officials told us that it is time-consuming, costly, and  inefficient for the agency to use TSCA’s 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. We continue to believe  that providing EPA with more authority to obtain test data from  companies would enhance the effectiveness of TSCA. In contrast with TSCA’s provisions for obtaining information on  chemicals, we found that REACH, the legislation through which the  European Union has recently revised its chemical control policy, requires  chemical companies to develop more information than TSCA on the  effects of chemicals on human health and the environment. Regarding new chemicals, TSCA generally requires chemical companies to  notify EPA of their intent to manufacture or import new chemicals and to  provide any available test data. TSCA’s Regulatory Framework Impedes EPA’s Efforts to Control Toxic Chemicals

While TSCA authorizes EPA to issue regulations that may, among other  things, ban existing toxic chemicals or place limits on their production or  use, the statutory requirements EPA must meet to do so present a legal  threshold that has proven to be difficult for EPA. In addition, before regulating a chemical under section 6, the  EPA Administrator must consider and publish a statement regarding  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 banned or have limits  placed on their production or use. In fact, since Congress passed TSCA  nearly 33 years ago, EPA has issued regulations under the act to ban or  limit or restrict the production or use of only five existing chemicals or  chemical classes. Significantly, in 1991, EPA’s 1989 regulation broadly  banning asbestos was largely vacated by a federal appeals court decision  that cited EPA’s failure to meet statutory requirements. Asbestos, which refers to several minerals that typically separate into very  tiny fibers, is a known human carcinogen that can cause lung cancer and  other diseases if inhaled. Potential changes to TSCA include reducing the evidentiary burden that  EPA must meet to take regulatory action under the act by amending the  (1) unreasonable risk standard that EPA must meet to regulate existing  chemicals under section 6 of TSCA, (2) standard for judicial review that  currently requires a court to hold a TSCA rule unlawful and set it aside  unless it is supported by substantial evidence in the rulemaking record,  and (3) requirement that EPA choose the least burdensome regulatory  requirement. We have previously recommended that the Congress amend  TSCA to reduce the evidentiary burden that EPA must meet. For example, REACH is based on the  principle that chemical companies have the responsibility to demonstrate  that the chemicals they place in the market, distribute, or use do not  adversely affect human health or the environment, while TSCA generally  requires EPA to demonstrate that chemicals pose risks to human health or  the environment prior to controlling risks related to their production,  distribution, or use. While EPA may suspect that some  chemical companies’ confidentiality claims are unwarranted, the agency  does not have data on the number of inappropriate claims. According to  EPA, about 95 percent of premanufacture notices contain some  information that chemical companies claim as confidential. While both TSCA and REACH have provisions to protect information  claimed by chemical companies as confidential, REACH requires greater  public disclosure of certain information, such as basic chemical  properties. In previous reports, we recommended that the Congress consider  providing EPA additional authorities under TSCA to improve its ability to  make more chemical information publicly available. For example, in our  June 2005 report, we 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. Related GAO Products

High-Risk Series: An Update.
Why GAO Did This Study

Congress passed the Toxic Substances Control Act (TSCA) in 1976, authorizing the Environmental Protection Agency (EPA) to obtain information on the risks of industrial chemicals and to control those that EPA determines pose an unreasonable risk. However, EPA does not have sufficient chemical assessment information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks. In reports on TSCA, GAO has recommended statutory changes 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. The most important recommendations aimed at providing EPA with the information needed to support its assessments of industrial chemicals have not been implemented--a key factor leading GAO in January 2009 to add transforming EPA's process for assessing and controlling toxic chemicals to its list of high-risk areas warranting attention by Congress and the executive branch. This testimony, which is based on prior GAO work, addresses EPA's implementation of TSCA and options for (1) obtaining information on the risks posed by chemicals to human health and the environment, (2) controlling these risks, and (3) publicly disclosing information provided by chemical companies under TSCA.

What GAO Found

TSCA generally places the burden of obtaining data on existing chemicals on EPA, rather than on the companies that produce the chemicals. 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 roughly 80,000 industrial chemicals in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce annually for their toxicity, and companies generally do not voluntarily perform such testing. Further, the procedures EPA must follow in obtaining test data from companies can take years to complete. In contrast, the European Union's chemical control legislation generally places the burden on companies to provide health effects data on the chemicals they produce. Giving EPA more authority to obtain data from the companies producing chemicals, as GAO has in the past recommended that Congress consider, remains a viable option for improving the effectiveness of TSCA. While TSCA authorizes EPA to issue regulations that may, among other things, ban existing toxic chemicals or place limits on their production or use, the statutory requirements EPA must meet present a legal threshold that has proven difficult for EPA and discourages the agency from using these authorities. For example, EPA must demonstrate "unreasonable risk," which EPA believes requires it to conduct extensive cost-benefit analyses to ban or limit chemical production. Since 1976, EPA has issued regulations to control only five existing chemicals determined to present an unreasonable risk. Further, its 1989 regulation phasing out most uses of asbestos was 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 has previously recommended that Congress amend TSCA to reduce the evidentiary burden EPA must meet to control toxic substances and continues to believe such change warrants consideration. EPA has a limited ability to provide the public with information on chemical production and risk because of TSCA's prohibitions on the disclosure of confidential business information. 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. State environmental agencies and others have said that information claimed as confidential would help them in such activities as developing contingency plans to alert emergency response personnel to the presence of highly toxic substances at manufacturing facilities. The European Union's chemical control legislation generally provides greater public access to the chemical information it receives, and GAO has previously recommended that Congress consider providing EPA additional authorities to make more chemical information publicly available.