In the last several decades, Congress has passed various legislation to increase federal agencies’ abilities to identify and address the health and environmental risks associated with toxic chemicals and to address such risks. Some of these laws, such as the Clean Air Act; the Clean Water Act; the Federal Food, Drug and Cosmetic Act; and the Federal Insecticide, Fungicide, and Rodenticide Act authorize the control of hazardous chemicals in, among other things, the air, water, and soil and in food, drugs, and pesticides. Other laws, such as the Occupational Safety and Health Act and the Consumer Product Safety Act, can be used to protect workers and consumers from unsafe exposures to chemicals in the workplace and the home. Nonetheless, the Congress found that human beings and the environment were being exposed to a large number of chemicals and that some could pose an unreasonable risk of injury to health or the environment. In 1976, the Congress passed TSCA to provide EPA with the authority to obtain information on chemicals and regulate those substances that pose an unreasonable risk to human health or the environment. While other environmental and occupational health laws generally control only the release of chemicals in the environment, exposures in the workplace, or the disposal of chemicals, TSCA allows EPA to control the entire life cycle of chemicals from their production and distribution to their use and disposal. In October 2003, the European Commission presented a proposal for a new EU regulatory system for chemicals. REACH was proposed because the Commission believed that the current legislative framework for chemicals in the EU did not produce sufficient information about the effects of chemicals on human health and the environment. In addition, the risk assessment process was slow and resource-intensive and did not allow the regulatory system to work efficiently and effectively. Under REACH, authority exists to establish restrictions for any chemical that poses unacceptable risks and to require authorization for the use of chemicals identified as being of very high concern. These restrictions could include banning uses in certain products, banning uses by consumers, or even completely banning the chemical. Authorization will be granted if a given manufacturer can demonstrate that the risks from a given use of the chemical can be adequately controlled if a threshold can be determined for the chemical. Or, if no threshold can be determined, the manufacturer has to demonstrate that the socioeconomic benefits outweigh the risks associated with continued use and that there are no suitable alternatives or technologies available. In addition, a key aspect of REACH is that it places the burden on manufacturers, importers, and downstream users to ensure that they manufacture, place on the market, or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle. REACH was approved in December 2006 and went into effect in June 2007. To avoid overloading regulators and companies with the work arising from the registration process, full implementation of all the provisions of REACH will be phased in over an 11-year period (or by 2018). TSCA does not require companies to develop information for either new or existing chemicals, whereas REACH generally requires companies to submit and, in some circumstances, requires companies to develop such information for both kinds of chemicals. For new chemicals, TSCA requires companies to submit to EPA any available human health and environmental data, but companies do not have to develop additional information unless EPA requires additional test data through a test rule or other EPA action. For existing chemicals, companies do not have to develop such information unless EPA requires them to do so. In contrast, companies generally are required under REACH to provide and develop where needed the European Chemicals Agency with health and environmental data. The extent of such data depends on the annual production volume of the chemical. TSCA does not require chemical companies to test new chemicals for their effect on human health or the environment, but it requires companies to submit such information if it already exists when they submit a premanufacture notice (PMN) notifying EPA of their intent to manufacture a new chemical. This notice provides, among other things, certain information on the chemical’s intended uses and potential exposure. TSCA also requires chemical companies to submit data and other information on the physical/chemical properties, fate, or health and environmental effects of a chemical, which we refer to in this report as "hazard information," that the companies possesses or is reasonably ascertainable by them when they submit a PMN to EPA. In part because TSCA does not require chemical companies to develop hazard information before submitting a PMN, EPA employs several other approaches for assessing hazards, including using models that compare new chemicals with existing chemicals with similar molecular structures for which test data on health and environmental effects are available. In June 2005, we recommended that EPA develop a strategy for improving and validating the models that EPA uses to assess and predict the hazards of chemicals. EPA is currently devising such a strategy, according to agency officials. EPA receives approximately 1,500 new chemical notices each year, half of which are exemption requests, and has reviewed more than 45,000 from 1979 through 2005. PMNs include information such as specific chemical identity estimated maximum production volume for 12 months of production a description of how the chemical will be processed and used and estimates of how many workers may be exposed to the chemical. Additionally, EPA requires that the following information be submitted with a PMN: all existing health and environmental data in the possession of the submitter, parent company, or affiliates, and a description of any existing data known to or reasonably ascertainable by the submitter. EPA estimates that most PMNs do not include test data of any type, and only about 15 percent include health and safety data—such as acute toxicity or skin and eye irritation data. In some cases, EPA may determine during the review process that more data are needed for an analysis of a chemical’s potential risks and often will negotiate an agreement with the chemical company to conduct health hazard or environmental effects testing. According to EPA, more than 300 testing agreements have been issued since EPA began reviewing new chemicals in 1979. In some cases, however, the chemical company may voluntarily withdraw the PMN rather than incur the costs of hazard testing requested by EPA, or for other reasons. EPA does not maintain records as to how many PMNs chemical companies have withdrawn because of potential EPA action. While TSCA does not require chemical companies to develop information on the harmful effects of existing chemicals on human health or the environment, TSCA provides that EPA, by issuing a test rule, can require such information on a case-by-case basis. Before promulgating such a rule EPA must find, among other things, that current data are insufficient, testing is necessary, and that either (1) the chemical may present an unreasonable risk or (2) the chemical is or will be produced in substantial quantities and that there is or may be substantial human or environmental exposure to the chemical. EPA officials responsible for administering the act said that TSCA’s test rule provision and data-gathering authorities can be burdensome and too time consuming for EPA to administer. Because EPA has limited information on existing chemicals and the difficulty in promulgating test rules, EPA uses voluntary programs to help gather more data to assess risks on certain chemicals. While TSCA authorizes EPA to require testing of existing chemicals, the act does not authorize the agency to do so unless EPA first determines on the basis of risk or exposure information that the chemicals warrant such testing. TSCA provides EPA the authority to obtain hazard information needed to assess chemicals by issuing rules under Section 4 of TSCA requiring chemical companies to test to determine the health and environmental effects of chemicals and submit the test data to EPA. However, in order for EPA to issue a test rule, the agency must determine that a chemical (1) may present an unreasonable risk of injury to health or the environment or (2) is or will be produced in substantial quantities and (a) there is or may be significant or substantial human exposure to the chemical or (b) it enters or may reasonably be anticipated to enter the environment in substantial quantities. EPA must also determine that there are insufficient data to reasonably determine or predict the effects of the chemical on health or the environment and that testing is necessary to develop such data. Once EPA has made the required determination, the agency can issue a proposed rule for public comment, consider the comments it receives, and promulgate a final rule ordering chemical testing. OPPT officials responsible for implementing TSCA told us that finalizing rules under Section 4 of TSCA can take from 2 to 10 years and require the expenditure of substantial resources. EPA has used its authority to require testing for about 200 existing chemicals since the agency began reviewing chemicals under TSCA in 1979. EPA does not maintain estimates of the cost of implementing these rules. However, in our September 1994 report on TSCA, we noted that EPA officials told us that issuing a rule under Section 4 can cost up to a $234,000. Given the difficulties and cost of requiring testing, EPA could review substantially more chemicals in less time if it had authority to require chemical companies to conduct testing and provide test data on chemicals once they reach a substantial production volume. In June, 2005, we stated that Congress may wish to consider amending TSCA to provide EPA such authority. As an alternative to formal rule making, EPA asserts that Section 4 of TSCA provides EPA implied authority to enter into "enforceable consent agreements" with chemical companies that would require them to conduct testing when there is insufficient data available to assess a chemical’s risk. EPA uses enforceable consent agreements to accomplish testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. According to EPA, these agreements allow greater flexibility in the design of the testing program and negotiating these agreements is generally less costly and time consuming than promulgating test rules.