Toxic Substances Control Act

TOXIC SUBSTANCES CONTROL ACT

During the early part of the twentieth century there was a tremendous increase in the development of new synthetic chemicals, as well as a rise in industrial uses for older ones. By 1976 it was estimated that there were 60,000 chemical substances in commercial use in the United States. A need was identified for a comprehensive framework for the prevention of risks that might be posed by these chemicals. In response to this need, Congress enacted the Toxic Substances Control Act (TSCA) in 1976 (see Figure 1). The TSCA addressed three major policy goals:

• Those who manufacture and process chemical substances and mixtures should develop adequate data with respect to the effect of chemical substances and mixtures on health and the environment.
• The government should have adequate authority to regulate chemical substances and mixtures that present "an unreasonable risk of injury to health or the environment, and to take action with respect to chemical substances and mixtures that are imminent hazards."
• Government's authority over chemical substances and mixtures should be exercised "in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation" while assuring that such substances and mixtures do not present "an unreasonable risk of injury to health or the environment."

Further, Congress made clear its intent that the government "shall consider the environmental, economic, and social impact of any action the administrator takes or proposes to take."

In addition to general provisions related to chemicals and substances, the TSCA contained specific requirements to regulate polychlorinated biphenyls (PCBs). Over the years, TSCA was amended to specifically regulate asbestos (1986), Radon (1988), and lead (1992).

The TSCA contains a number of major provisions that provide the EPA with tools for assessment and control of chemicals used in commerce or proposed to be added to commerce. TSCA authorized a number of activities under the EPA Administration including the authority to issue chemical test rules (section 4); a requirement for a Premanufactive Notification PNM) to be filed at least 90 days prior to manufacture or processing of a new chemical (section 5); authority to regulate chemical risks (section 6); a requirement to report chemical data and information on adverse health and environmental effects (section 8); requirements related to export and import of chemicals (sections 12–13); and protection by EPA of confidential business information (section 14). These provisions broadly direct the EPA to assure that the public will be protected from "unreasonable risks" to health and the environment. Although the statute did not clearly define "unreasonable risk," since its enactment (through administrative and judicial actions) this has come to be interpreted as including aspects of both risk analysis, which analyzes the severity and magnitude of health and environmental effects, and economic analysis, which looks at the economic benefits of the use of the substance as well as the availability and costs of switching to alternatives. In the cases of PCBs, asbestos, radon, and lead, Congress saw fit to identify that unreasonable risks did indeed exist and gave the EPA very specific direction for how to address those risks.

Several aspects of TSCA's chemical regulatory regime have been studied extensively by the National Academy of Sciences, the Congressional Office of Technology Assessment, the General Accounting Office, and the EPA itself.

Generally, the regulation of existing chemicals under TSCA has been modest. The General Accounting Office concluded in 1994 that the EPA regulates few chemicals under TSCA section 6, listing only five (polychlorinated biphenyls, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium), and noting that the

Figure 1

act itself required the regulation of one of the five, PCBs. In only two cases, for PCBs and asbestos, did the EPA take a comprehensive approach to the regulation of chemicals, and in one of these cases—asbestos—the rule was essentially overturned by the courts. In 1994, the GAO found that of 23,971 premanufacture notices for new chemicals (PMNs) that had been reviewed, action to reduce risks was taken on only about 10 percent. No test data are required as part of a PMN submission. If the EPA determines that the chemical will pose an unreasonable risk, it must act within 90 days. There is also the option of imposing temporary controls or restrictions. Finally, the GAO found that the EPA had formally referred only four chemicals to other agencies for control under their statutes—4,4-methylene dianiline; 1,3-butadiene; glycol ethers; and dioxin in bleached wood pulp and papers used for food packaging.

Various studies have indicated that the informational provisions of TSCA have fallen short of expectations. The GAO pointed to the breadth of the confidential information protections and the significant costs to the EPA in assessing claims made by manufacturers under the law. Likewise, gathering of new information about chemicals under section 4 has been judged unproductive. Few test rules have been promulgated under Section 4, which requires that the EPA determine that a chemical "may present an unreasonable risk" or that "substantial" exposure may exist to justify imposition of a test rule. In recent years, industry has begun to voluntarily develop "screening level" test data for the high volume chemicals in U.S. commerce (those produced at least one million pounds per year).

LYNN R. GOLDMAN

(SEE ALSO: Asbestos; Chlorofluorocarbons; Dioxins; Environmental Determinants of Health; Environmental Movement; Environmental Protection Agency; Exposure Assessment; Lead; PCBs; Radon; Risk Assessment, Risk Management; Toxicology; Toxic Torts)

BIBLIOGRAPHY

Congress of the United States, Office of Technology Assessment (1995). Screening and Testing of Chemicals of Commerce. Background Paper. Washington, DC: Author.

National Research Council, Commission on Life Sciences (1984). Toxicology Testing: Strategies to Determine Needs and Priorities. Washington, DC: National Academy Press.

U.S. Environmental Protection Agency, Office of Prevention Pesticides and Toxic Substances (1998). Chemical Hazard Data Availability Study: What Do We Really Know about the Safety of High Production Volume Chemicals? EPA's 1998 Baseline of Hazard Information That Is Readily Available to the Public. Washington, DC.: Author.

U.S. General Accounting Office (1994). Toxic Substances Control Act: Legislative Changes Could Make the Act More Effective. Washington, DC: Author.