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>.