Toxic Substances Control Act (1976)

The Toxic Substances Control Act (TSCA), enacted in 1976, is a key law for regulating toxic substances in the United States. The Act authorizes the Environmental Protection Agency (EPA) to study the health and environmental effects of chemicals already on the market and new chemicals proposed for commercial manufacture. If the EPA finds these health and environmental effects to pose unreasonable risks, it can regulate, or even ban, the chemical(s) under consideration.

The initiative to regulate toxic substances began in the early 1970s. In 1971, the Council on Environmental Quality produced a report on toxic substances. It concluded that existing health and environmental laws were not adequately regulating such substances. The report recommended that a new comprehensive law to deal with toxic substances be enacted. Among the problem substances that had helped to focus national concern on toxic substances were asbestos , chlorofluorocarbons (CFCs), Kepone (a pesticide ), mercury , polychlorinated biphenyl (PCB)s, and vinyl chloride . Research proved that these substances caused significant health and environmental problems, yet they were unregulated.

Congressional debate on regulating toxic substances began in 1971. The Senate passed bills in 1972 and 1973 that were strongly supported by environmentalists and labor, but the House approach to the issue was more limited and had the support of the chemical industry. The key difference between the two approaches was how much pre-market review would be required before new chemicals could be introduced and marketed. Although none of the key stakeholders, the chemical industry, environmentalists, or labor, was entirely happy with the compromise bill of 1976, all three groups supported it.

The approach adopted in TSCA is pre-market notification, rather than the more rigorous pre-market testing that is required before new drugs are introduced on the market. When a new chemical is to be manufactured, or an existing chemical is to be used in a substantially different way, the manufacturer of the chemical must provide the EPA with pre-manufacture notification data at least 90 days before the chemical is to be commercially produced. The EPA then examines this data and determines if regulation is necessary for the new chemical or new use of an existing chemical. The agency can require additional testing by manufacturers if it deems the existing data insufficient. Until such data is available, the EPA has the option to ban or limit the manufacture, distribution, use, or disposal of the chemical. For new chemicals or new applications of existing chemicals, producers must demonstrate that the chemicals do not pose unreasonable risks to humans or the environment . The EPA can act quickly and with limited burden to prevent such new chemicals from being produced or distributed.

Between July 1979, when TSCA went into effect for new chemicals, and April 2002, the EPA received 23,486 new chemical notices. The agency determined that no action was necessary for nearly 90% of these chemicals. Of the 2,702 chemicals that required further action, 917 were never produced commercially due to EPA concerns. The remaining 1,785 chemicals were controlled through formal actions or negotiated agreements.

As of mid-2002, there were nearly 75,000 chemicals within the purview of TSCA (including 5,000 new chemicals introduced in the past decade). Although the law requires that the EPA examine each of these chemicals for its potential health and environmental risk, the volume of chemicals and lack of EPA resources has made such a task virtually impossible. Through 2000, the agency had examined almost 700 existing chemicals. Of the compounds on this list, the EPA determined that 370 chemicals required no further action. This was due to the fact that the chemical was no longer being manufactured, it was under study by another federal agency or industry, adequate data on the chemical existed, or exposure to the chemical was limited. The EPA has issued rules to regulate 112 of these chemicals. The remaining chemicals are in various stages of testing and review.

TSCA created an Interagency Testing Committee (ITC) to help the EPA set priorities. The ITC designates which existing chemicals should be examined first. Once designated by the ITC, the EPA has one year to study the chemical and issue a ruling. The agency initially had difficulty meeting this one-year limit. In fact, the EPA was sued over its failure to meet the deadline and worked under a court schedule to test these identified chemicals. The record of the EPA has improved but the agency still struggles to meet deadlines imposed by ITC due to budgetary and personnel shortages.

The EPA also identifies specific chemicals already in use for review. Unlike the policy with new chemicals, the EPA must demonstrate that existing chemicals warrant toxicity testing. Furthermore, if the EPA desires to regulate the chemical once it has been tested, it must pursue another complex course of action. By design, the regulation of existing chemicals is a lengthy and complicated process.

There are several options available to the EPA if it concludes that a new or existing chemical presents "an unreasonable risk of injury to health or the environment." The EPA can: 1) prohibit the manufacture of the chemical by applying a rule or obtaining a court injunction; 2) limit the amount of the chemical produced or the concentration at which the chemical is used; 3) impose a ban or limit uses of the chemical; 4) regulate the disposal of the chemical; 5) require public notification of its use; and 6) require labeling and record keeping for the chemical. The EPA is required to use the least burdensome of these regulatory approaches for chemicals already in use.

There are several other important components to TSCA. First, the law requires strict reporting and record keeping by the manufacturers and processors of the chemicals regulated under the law. In addition to keeping track of the chemicals, these records also include data on environmental and health effects. Second, TSCA is one of the few federal environmental laws that require environmental and health benefits to be balanced by economic and societal costs in the regulatory process. The act states that toxic substances should only be regulated when an unreasonable risk to people or the environment is present. Although "unreasonable risk" is not clearly defined in the language of the act, it does incorporate a concern for balancing costs and benefits.

Third, PCBs were singled out in the TSCA legislation. Although the manufacture of PCBs was prohibited by 1979, fewer than 1% of all PCBs in use up to that time were phased out. Despite the ban, a significant PCB problem still remains. One major problem is how to process the millions of pounds of PCBs abandoned by firms that went bankrupt in the 1980s. There is also concern about the safety of disposing of PCBs. Environmentalists argued that PCB treatment required new legislation. In response, the EPA decided to issue stricter regulation under the TSCA to ensure the safe the transportation and final disposal of PCBs.

Fourth, TSCA contained provisions for private citizens, as opposed to the U.S. government, to file lawsuits. Under the TSCA rules, private citizens could sue companies for violation of the law. They could also sue the EPA for failure to implement TSCA in a timely manner. Fifth, certain materials are not covered by TSCA. These include ammunition and firearms; nuclear materials; tobacco ; and chemicals used exclusively in cosmetics, drugs, food and food additives , and pesticides. These substances are regulated by other laws.

Although the authorization of TSCA expired in 1983 and Congress has not acted to re-authorize the law, it has continued to fund the program. The scope of the law was expanded in 1986 by an amendment requiring asbestos hazards to be reduced in schools, and in 1988 by an amendment providing grants and technical assistance to state programs that reduce indoor radon and assigning the regulation of genetically engineered organisms to TSCA. A 1990 amendment required accreditation of persons who inspect for asbestos-containing material in school, public, and commercial buildings, while the Residential Lead-Based Paint Hazard Reduction Act of 1992 introduced new requirements for the reduction of hazards associated with the inspection and abatement of lead-based paints. Reauthorization legislation has been introduced in the past decade. However, it has never gotten beyond consideration by congressional committees. Many experts attribute this trend to Republican control of congress since 1994.

Evaluations of the law have revealed three chief problems. First, the amount of data generated on chemicals is less than expected. A 1984 study by the National Academy of Sciences reported that only 4% of the major chemicals in the TSCA inventory had studies showing data on possible chronic toxicity. Toxicity data was absent for 78% of the chemicals produced at over 1 million lb (454,000 kg) per year and for 76% of chemicals that were produced at less than 1 million lb per year. The lack of data is thought to be due to early uncertainty over how the EPA would implement the law and the requirement that any regulation must follow rule-making procedures. Such rule-making procedures are slow and costly; the procedures associated with implementing the rules can sometimes cost more than the actual toxicity testing.

Second, in terms of existing chemicals, as of 2002, a total of 50 have been banned in the United States. Most of these are pesticides. A notable EPA action was the ban on the use of chlorofluorocarbons (CFCs) as aerosol propellants . This occurred in March 1978. Part of the reason for a lack of action may be due to the costs involved in implementing such a complex regulatory program. It is also difficult to determine unreasonable risk in light of inadequate data and more general uncertainties. Third, most pre-market notifications for new chemicals are not accompanied by test data. Rather, the EPA identifies potentially harmful chemicals by comparing the new chemical to existing chemicals for which data exists. If the EPA were to require more data for most new chemicals, in many cases the new chemicals might not be produced since the test costs would exceed the expected profit.

The chemical industry and environmentalists have reached conflicting conclusions about the TSCA legislation. The chemical industry has argued that the EPA has required more testing than is scientifically needed and that the regulatory approach for new chemicals is overly burdensome. Environmentalists have criticized the EPA for its slow progress in examining existing chemicals, for requiring no health data for new chemicals, and for withholding much of the data for new chemicals to comply with the desire for confidentiality requested by chemical manufacturers.

See also Chronic effects; Radioactive waste; Risk analysis

[L. Fleming Fallon Jr., M.D., Dr.P.H. ]

RESOURCES

BOOKS

Kreith, F. Handbook of Solid Waste Management. New York: McGraw Hill, 2002.

McDougall, F. R. Integrated Solid Waste Management: A Life Cycle Inventory. 2nd ed. Oxford, U.K.: Blackwell, 2001.

Meyers, R. A., D. K. Dittrick. The Wiley Encyclopedia of Environmental Pollution and Cleanup. New York: Wiley, 1999.

Pearson, Eric. Environmental and Natural Resources Law. Albany, NY: Matthew Bender & Company, 2001.

Thomas-Hope, E. Solid Waste Management. Kingston, Jamaica: University Press of the West Indies, 2000.

PERIODICALS

Gori, G. B. "The Costly Illusion of Regulating Unknowable Risks." Regulatory Toxicology and Pharmacology 34, no. 3 (2001): 205–212.

Landrigan, P. J. "Risk Assessment for Children and other Sensitive Populations." Annals of New York Academy of Science 865 (1999): 1–9.

Lee, C. C., G. L. Huffman, Y. L. Mao. "Regulatory Framework for the Thermal Treatment of Various Waste Streams." Journal of Hazardous Materials 76, no. 1 (2000): 13–22.

OTHER

U.S. Department of Energy. EH-41 Environmental Law Summary: Toxic Substances Control Act. April 1997 [cited July 2002]. <http://tis.eh.doe.gov/oepa/law_sum/TSCA.HTM>.

U.S. Department of Energy. DOE Environmental Guidance - Toxic Substances Control Act. March 1998 [cited July 2002]. <http://tis.eh.doe.gov/oepa/guidance/tsca.htm>.

U.S. Environmental Protection Agency. <http://www.epa.gov/region5/defs/html/tsca.htm> and <http://www.epa.gov/opptintr/biotech/> and <http://es.epa.gov/oeca/main/strategy/tsca.html> and <http://www.epa.gov/oppfead1/international/us-unlist.htm>.

U.S. Department of the Interior. Toxic Substances Control Act of 1986. <http://www.usbr.gov/laws/tsca.html>.

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.

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): 1096–1100.

INTERNET RESOURCE

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

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