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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 1213); 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

Toxic Substances Control Act
Title/Section Purpose Activities
Title I Control of Toxic Substances
source: Toxic Substance Control Act.
4 Chemical testing Test rules must show that the chemical "may present an unreasonable risk" or that "substantial" exposure may exist.
5 New chemical notices Premanufacture Notification (PMN) must be filed at least 90 days prior to manufacture or processing of a new chemical. No test data are required at this stage. If the chemical will pose an unreasonable risk, EPA must act. If it "may" pose an unreasonable risk, EPA can impose temporary controls or restrictions until data are developed.
6 Regulation of hazardous chemical substances and mixtures EPA can take action against chemicals that pose an unreasonable risk to health or the environment. Actions includebanning or restricting production, processing, distribution, use and requiring warning labels.
6(e) Regulation of polychlorinated biphenyls Phased out the manufacture and certain uses of PCBs, as well as PCB import and export.
8 Industry reporting of chemical data Directs manufacturers and processors to maintain records and provide data to the EPA as required. Such data can include chemical identity, categories of use, production levels, by-products, existing data on adverse health and environmental effects, and the number of workers exposed.
9 TSCA's relationship to other laws Requires that EPA make referrals to other agencies when it determines there is an unreasonable risk under a statute administered by that other agency. The other agency must move to promulgate a regulation or publish a notice of why no action is needed. Directs the EPA to use other laws it administers to protect against unreasonable risks, unless it determines that it is in the public's interest to regulate under TSCA.
12/13 Chemical export and import provisions Require notices to other nations when controlled chemicals are exported. Controls import of chemicals into US commerce.
14 Disclosure of chemical data Authorizes EPA to release chemical information obtained under TSCA. Protects confidential business information from disclosure.
Title II Asbestos Hazard Emergency Response Measurement, assessment and monitoring of asbestos hazards in buildings. Operations and maintenance of buildings to prevent asbestos hazards. Response measures. Laboratory accreditation. State asbestos programs. Worker protection.
Title III Indoor Radon Abatement Radon construction standards. State radon programs. Public information. Radon in schools.
Title IV Lead Exposure Reduction Identification of dangerous levels of lead in homes. Training and certification of lead inspectors and abatement workers for homes. Methods for lead abatement and measurement. State lead programs. Public information.

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 casesasbestosthe 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 statutes4,4-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.

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Toxic Substances Control Act (1976)

Toxic Substances Control Act (1976)

William V. Luneburg


Excerpt from the Toxic Substances Control Act

It is the policy of the United States that ... adequate authority should exist to regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment, and to take action with respect to chemical substances and mixtures which are imminent hazards.


Prior to 1970, federal regulation of harmful chemical substances was not extensive. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), for example, was limited in its health and environmental focus, and federal legislation that protected against environmental contamination and the health hazards caused thereby was similarly of modest ambition. However, with increasing evidence of an "environmental" crisis and of the risks posed by industrial pollution and exposure to modern chemicals, and with state governments unable or unwilling to aggressively come to grips with the perceived threats, Congress had no choice but to fill the regulatory vacuum. In quick succession, it passed the Clean Air Act (1970), the Clean Water Act (1972), and the Federal Environmental Pesticide Control Act (FEPCA, 1972), to name a few of the statutory responses.

Characteristic of many of these regulatory schemes was 1) a concentration on one medium (for example, air or water) through which harmful contaminants might reach the environment, thereby leaving other media for harm to be regulated by other statutes or entirely unregulated; 2) a focus less on directly changing manufacturing processes and more on controlling the quantity and quality of waste streams produced; 3) to accept the installation of the best pollution control technology as adequate even if that technology did not eliminate adverse impacts on the environment; and finally, 4) to intervene at the point where environmental harm was already occurring. Two of the prominent gaps in regulatory coverage were illustrated by polychlorinated biphenyls (PCBs) found in river sediment that could contaminate fish, and chlorofluorocarbons (CFCs) used as spray-can propellants and refrigerants that were destroying the stratospheric ozone layer, which protects against harmful ultraviolet radiation.

While FEPCA focused on the pre-marketing review of chemicals to avoid unreasonable environmental effects before they could occur, it dealt with only a small part of the universe of chemicals, that is, those that were used as pesticides. And that universe is a large one indeed: at least five million chemicals are known, with 250,000 new chemical compounds produced each year, thousands of which enter the commercial marketplace over the space of a few years.

PROVISIONS OF THE TOXIC SUBSTANCES CONTROL ACT

When it enacted the Toxic Substances Control Act (TSCA) (P.L. 94-469, 90 Stat. 2003) in 1976, Congress intended that the statute fill significant regulatory gaps that threatened not only public health but the natural environment. The TSCA could be utilized as the ideal pollution prevention statute. After all, review of a chemical or compound before it reaches the market and before it is used in manufacturing and elsewhere could, theoretically, insure that the health and environmental risks presented by it are both understood before harm can be inflicted and minimized throughout the lifecycle of the chemical as it is manufactured, used, and disposed of.

The touchstone of TSCA is its focus on identifying and eliminating "unreasonable risk[s] of injury to health or the environment." In other words, this is not a statute that demands a total elimination of all adverse effects. Rather, Congress intended that the U.S. Environmental Protection Agency (EPA), the agency responsible for TSCA implementation, balance the risks created by a chemical or compound against its potential benefits. For example, a particular chemical used in a manufacturing process might, if released into a river along with the rest of the manufacturer's waste stream, induce nausea in some swimmers ingesting the water even several miles downstream of the plant. But the chemical might also be the only one that could produce a particular type of drug proven effective in slowing the development of liver cancer. In these circumstances, TSCA might allow marketing of the chemical without significant restrictions on the basis that benefits of the chemical outweighed its costs.

RISK ASSESSMENT AND TSCA

Essential to the implementation of TSCA is what is called risk assessment. Such assessment poses a number of questions. Is there a scientific basis to conclude a particular substance causes or contributes to an adverse health effect (e.g., cancer)? At what level of exposure to the substance will these effects occur? And what is the extent of actual exposure of humans to the substance? The endpoint of analysis is a description of the nature and magnitude of human risk, including an estimate of the uncertainty that accompanies that conclusion. Such an assessment is crucial not only to TSCA decisionmaking, but also to regulatory action under other important statutory schemes for the protection of public health and the environment.

In order to carry out its purposes in enacting TSCA, Congress required the manufacturer of a new chemical or an existing chemical proposed for a new use give the EPA ninety days notice of intent to produce the substance in order for the EPA to determine whether or not the substance will create an unreasonable risk of injury. The EPA compiles a list of existing chemicals; if not on the list, a substance is considered a new chemical.

In order to determine if a new chemical proposed for manufacture creates unreasonable risks or if such risks are presented by a chemical currently being manufactured and used, the EPA may order companies that manufacture or propose to manufacture the substance test it for the adverse effects which might be produced. If the EPA believes there is a "reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture...presents or will present an unreasonable risk of injury to health or the environment," the agency may impose one or more requirements that vary in stringency from outright banning of the manufacture and use, to simple public notification of the risks involved. The EPA is directed to apply the "least burdensome requirements" that are "necessary to protect adequately against" the risk.

For a variety of reasons, despite what appear to be the ambitious goals and ample regulatory authority of the TSCA, it has never achieved its potential. For example, the EPA was sued and its action in regulating PCBs was overturned by a court on the basis that the agency did not regulate the chemicals stringently enough (Environmental Defense Fund, Inc. v. EPA, 1980). On the other hand, the agency's ban on the use of asbestos, the most draconian regulatory option available, was struck down for a variety of reasons, including inadequate and unreasonable cost/benefit analysis (Corrosion Proof Fittings v. EPA, 1991). Attempting to regulate thousands of chemicals and chemical compounds, which often present uncertain and difficult-to-identify risks, with neither too much nor too little stringency imposes huge costs on the EPA, whose resources for TSCA implementation have been limited. Given these circumstances, the relatively minor role the TSCA has filled to date in protecting public health and the environment should not come as a surprise, as disappointing as it may be to those who held high hopes for the statute when enacted.

See also: Comprehensive Environmental Response, Compensation, and Liability Act; Hazardous and Solid Waste Amendments of 1984.

BIBLIOGRAPHY

Breyer, Stephen G. Breaking the Vicious Circle: Toward Effective Risk Regulation. Cambridge, MA: Harvard University Press, 1993.

Lave, Lester B., and Arthur C. Upton, eds. Toxic Chemicals, Health, and the Environment. Baltimore, MD: Johns Hopkins University Press, 1987.

Ricci, Pacolo F., and Lawrence S. Molton. "Risk and Benefit in Environmental Law." Science 214 (1981): 10961100.

INTERNET RESOURCE

U.S. Environmental Protection Agency. <http://www.epa.gov/>.

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Toxic Substances Control Act (TSCA)

Toxic Substances Control Act (TSCA)


The Toxic Substances Control Act (TSCA), enacted by Congress in 1976, gives the U.S. Environmental Protection Agency (EPA) the responsibility for checking the relative safety of all chemical substances not already covered under other federal laws. The EPA can control or ban a chemical if it poses an unreasonable risk to human or environmental health. Manufacturers must give the EPA information about new chemicals before they are commercially produced or marketed. The EPA then reviews the information and can order further testing to determine, for instance, whether the substance is persistent, carcinogenic, or otherwise acutely toxic. The acute toxicity or short term poisoning effects of chemicals can be evaluated by the LD50 test that determines the lethal dose required to kill fifty percent of test animals, usually rats or mice. Microbial biotechnology products for use in industry have been subject to EPA review under TSCA since 1997. Over 70,000 chemicals were in use in the United States in 2002 according to the TSCA Chemical Substances Inventory.

Pesticides, and substances used in cosmetics, food, and drugs are regulated under other federal laws, but many chemicals, including polychlorinated biphenyls (PCBs), were not subject to review or regulation until TSCA was passed. Studies showing PCBs to be dangerous to human health were an impetus for TSCA. In 1977 the EPA outlawed PCBs and subsequently regulated their disposal with strict safety requirements.

Amendments to TSCA in 1986, 1988, and 1992 were aimed at reducing the health threats from asbestos, radon, and lead exposure. The amendments required the EPA to test schools and federal buildings for radon contamination and establish state programs for monitoring and reducing lead exposure levels. The Asbestos Hazard Emergency Response Amendment (AHERA) imposed stricter standards on the reduction of asbestos contamination in schools.

Any person or company not complying with TSCA can be fined or jailed. Many landlords have been fined and required to remove lead-based paint as a result of TSCA's enforcement. In 2002 two landlords were also sentenced to prison terms for noncompliance.

In Europe regulations for assessing the safety of new chemical substances were established in 1981 and for all existing chemicals in 1993. In 2001 the European Commission proposed a new policy called "Strategy for a Future Chemicals Policy" aimed at determining the environmental risk posed by thousands of chemicals that came on the European market before 1981.

see also Asbestos; Lead; Radon.

internet resources

EPA's New Chemical Program Web site. Available from http://www.epa.gov/opptintr.

European Commission Environment Web site. Available from http://www.europa.eu.int/comm.

Patricia Hemminger

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