Home > Major Acts of Congress > 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.