Controlling Toxic Substances

In the past decade, the production of synthetic organic chemicals has more than tripled in volume. The number of new chemicals introduced into the economy has also increased greatly. To the 30,000 chemicals now in substantial use, several hundred new ones are being added each year.

This explosion in the use of chemicals reflects not only the power of postwar chemical technology, which now "synthesizes to order," but also the related economic benefits. At the same time, technological developments have given us the capacity to detect these chemicals at very low levels of concentration, which has made it possible to measure their pervasiveness and to gain some understanding of their effects on human health and the environment. Thus it has been shown that a number of these newly synthesized chemicals—perhaps on the order of 1 percent of them, according to the Council on Environmental Quality—are latently toxic and capable of causing cancer, mutation, and birth defects.

Achieving an acceptable level of safety throughout the commercial life of a synthetic chemical, from its production to its ultimate disposal, has therefore become an important aspect of environmental management. In this respect 1976 has been an important year. Far-reaching new legislation for the evaluation and control of synthetic chemicals in general was enacted, and considerable effort was devoted to understanding hazards from a number of specific chemicals. But many problems remain unanswered.

The new legislation. The Toxic Substances Control Act (TSCA) was passed during the last week of the 94th Congress. It was signed by the president in October and became effective on January 1, 1977. Legislation to control the discharge of chemical wastes into air or water already existed, as did legislation to regulate synthetic chemicals used in pesticides, drugs, and foods. However, there had been no regulation of most industrial chemicals and chemical products. The new legislation closed this gap.

The act represents two important advances in federal environmental legislation. It emphasizes the need to identify potential environmental dangers before a chemical substance becomes established in the economy. And it applies to all environmental media—air, water, and land—not to just one.

Enactment came five years after a toxic substances control bill was first introduced into Congress. It represents a hard-fought compromise between environmental and industrial forces.

What are the major provisions of the act?

• First, it establishes mechanisms for alerting the Environmental Protection Agency (EPA) to the existence of a risk or a potential risk during the manufacture, processing, distribution, or disposal of a chemical or mixture of chemicals. Substances already on the market will be reviewed by an expert committee that will identify those that appear to pose the highest risk. For new substances or new uses of existing substances, the prospective manufacturer or importer must submit information on the substance to the EPA before the manufacturing or the new use commences. If EPA suspects that risks may exist, or finds the information inadequate, it can request the manufacturer to undertake further tests to generate more information.
• Second, the act specifies the action to be taken when the chemical may not be sufficiently safe. While testing is under way, legal constraints can be imposed at any point in the substance's commercial life, from manufacturing to disposal. If, after adequate testing has been conducted, there is a reasonable basis to conclude that any part of the life of a substance "presents or will present unreasonable risk of injury to health or the environment," the risk can be reduced by imposing a variety of measures on the manufacturer or processor. These include: outright prohibition on the manufacture, limitations on the amounts produced and types of uses, and mandatory use of warning labels.
• Third, the act requires that data relating to the manufacturing and marketing of chemicals and information on environmental effects (including the observations from occupational exposure) be maintained by the manufacturer or importer and be available for inspection by EPA.

The new legislation, therefore, appears to give EPA broad powers to protect public health and the environment against chemical hazards. But implementing it will not be easy.

In assessing risk, the regulators will be faced with many uncertainties. The effects of chemicals that are encountered at very low concentrations are difficult to anticipate and subject to question. The problem of risk assessment will be greatly magnified by the large number of chemicals to be screened, by the current shortage of technical expertise and facilities within the regulatory agencies and industry, and by budgetary limitations. Moreover, the level of risk considered acceptable will also be subject to dispute. The act specifically requires that the probable detrimental effects of a chemical be compared with the costs to the "national economy, technological innovation, and smaller businesses" of restrictions on the chemical's commercial life. Techniques for such a comparison are far from well established and data are nonexistent. Thus, protracted legal battles can be anticipated.

The burden of demonstrating the safety of a product is placed in principle on the manufacturer, but many administrative decisions of the EPA can be challenged by the manufacturers in court. One of the main problems is likely to be the generation and validation of toxicity data. The act places the primary responsibility for the development of information on industry. However, there is some doubt about how effective this provision will be because of the possibility that a company's own data will be used against it. The case of dieldrin is a good example. Under pesticide regulations, Shell developed data which, together with Public Health Service data, implied that since the mid-1950s the general population has absorbed concentrations of dieldrin equal to those causing a 30-percent increase in liver cancer in a strain of mice. Although Shell argued for registration, it was Shell's own data that led to the cancellation of dieldrin and aldrin. A central question for the future is whether the fines and other provisions in the law will be an adequate incentive for industry to develop evidence that may incriminate its product. The success of the act will therefore depend considerably on the astuteness of its administration, the cooperativeness of industry, and the efficiency of the judiciary.

To deal with chemicals as they become waste flows in the economy, Congress passed the Resource Conservation and Recovery Act of 1976. This act establishes a permit system to control the treatment, storage, and disposal of hazardous waste. Although it has received little attention, it could be a sleeper with wide regulatory significance because of its broad definitions of disposal and hazard.

PCBs and other hazards. One of the spurs to the enactment of toxic substances legislation was public concern with reports of widespread hazards from chemicals. The dispersion throughout the environment of polychlorinated biphenyls (PCBs), used in electrical equipment, was receiving considerable attention as the year began. PCBs have been recognized as an environmental contaminant since 1966. Their production in the United States has their sharply reduced since 1970 and their uses voluntarily restricted to so-called closed systems. It was believed that the problem was overcome until mid-1975 when unexpectedly widespread contamination of PCBs was found in the general population. The compounds were detected in tap water and agricultural watersheds. Levels in some fish exceeded the government safety limit, and the concentration of PCBs in mothers' milk was at the same level that had found to cause mental retardation in chimpanzees. Additional testing in 1976 added to the knowledge of reproductive and carcinogenic effects. The only U.S. manufacturer, Monsanto, confirmed it will cease producing and marketing PCBs for any use by October 1977, and at least one major electrical manufacturer said that it will not use PCBs as transformer fluids by the end of 1976. Industry has been developing apparently safer substitutes, but imports of PCBs into the United States have continued, accompanied by some uses other than in closed systems.

Somewhat belatedly, EPA proposed standards in 1976 under the Federal Water Pollution Control Act (FWPCA) to limit discharges from manufacturers of PCBs. In September, the General Electric Company agreed to pay $3 million toward the cost of cleaning up in the Hudson River and $1 million toward associated research, all matched by the licensee of the earlier discharges, New York State.

A subsidiary section of the Toxic Substances Control Act is devoted specifically to the control of PCBs. Restrictions on the uses and disposal of PCBs are to be imposed within a year; within two years, manufacture in the United States must cease; and within three years, processing and distribution must cease unless they are demonstrably safe or there exist no adequate substitutes for PCBs. Protecting the public against the dangers of PCBs currently in the environment, however, is virtually impossible.

While PCBs were a long recognized hazard, a new potential threat arose from other synthetic chemicals—fluorocarbons used as spray can propellants—which were found to be a possible threat to ozone in the stratosphere. The management of the fluorocarbon issue is of considerable significance, not only for its own importance but also because it may be the forerunner of similar problems in the future. In March 1976, the Interagency Task Force on Inadvertent Modification of the Stratosphere released a report suggesting that, in the future, such modification may occur from the massive use of nitrogenous fertilizers and the increasing release of such chemicals as brominated compounds, carbon monoxide, and chlorinated compounds other than fluorocarbons. Because this concern is highly speculative, further research into the area has been urged.

Some environmentally toxic products have been regulated for several years such as atmospheric lead from the combustion of gasoline, which comes within the 1970 Amendments to the Clean Air Act. The legal battle over the potential danger to health from this source of lead was concluded in June 1976 when the Supreme Court rejected a request by the Ethyl Corporation to review the decision of the full bench of the D.C. Court of Appeals which upheld EPA's regulation ordering a phased reduction in the lead content of gasoline. The Supreme Court action confirms an important shift in the standard of proof for toxic substances. Generally speaking, the earlier standard was that "the best and (only convincing) proof . . . is what has happened in the past." The final standard is now more precautionary, requiring only a reasonable likelihood of future harm.

Drinking water and cancer. The importance of turning attention to multiple toxic waste products was emphasized during the year by a further demonstration of the association between the incidence of cancer in a population and the source of its drinking water. Repeating the type of study performed for Louisiana in 1974, an epidemiological investigation; in which RFF's Talbot Page participated, was undertaken for Ohio residents. Those whose drinking water came from Lake Erie and the Ohio River had a roughly 8 percent higher cancer death rate than residents who drank water from less polluted sources.
Scientists have identified about 360 organic chemicals in treated drinking water, some presumably the result of industrial waste, but others possibly a consequence of chlorination of the water supply. The identified chemicals represent only a small fraction of the organic component of drinking water—2 percent in the case of Louisiana Mississippi water. Furthermore, only a small fraction of the 360 identified chemicals have been tested for carcinogenic and other toxic potential. The problem of multiple chemical contaminants is clearly enormous and as yet barely defined. How it is to be dealt with and the part that the TSCA might play has still to be determined.

Regulating carcinogens. As a result of the prominent part that chemicals play in the economy, the criteria by which they are convicted of being carcinogenic to humans and the form of their sentence have become important issues. To help clarify these issues, EPA developed "formal interim procedures for cancer assessment," and the NCI issued "criteria for assessing that a chemical is a carcinogen." While differing in some aspects, both approaches agree that a chemical should be considered a possible cancer risk when it causes a statistically significant excess incidence, not only of malignant tumors, but also of benign tumors, either in humans or in animals.

The three agencies that are responsible for the control of chemicals each approach the regulation of carcinogens in a somewhat different way.

The Food and Drug Administration is required to prohibit the use of any food additive which is carcinogenic (the Delaney Amendment). Although it had employed the Delaney Amendment only rarely in the past nineteen years, the agency proposed in 1976 the withdrawal of the synthetic estrogen, DES, as a growth stimulant in food animals and of the widely used food coloring, Red Dye No. 2. It also rejected a request by manufacturers to allow the artificial sweeteners, cyclamates, back onto the market. All of these FDA decisions were based on the criterion of carcinogenic potential.

The Occupational Safety and Health Administration does not necessarily prohibit the use of carcinogens in the workplace, but it can require that exposure to them be limited to the extent that is "technologically feasible." A standard was issued for vinyl chloride on this basis in 1974.

Partly on evidence of carcinogenicity, EPA has banned five pesticides (except for certain uses). In addition, during 1976 manufacturers voluntarily cancelled four others—including mirex and kepone. Increasing attention is now being paid to the process of weighing the risks against the benefits of using a chemical.

But comprehensive laws themselves are not a protection against environmental disaster. TSCA's small budget of less than $10 million will severely limit the number of chemicals examined in 1977 to perhaps just two chemicals, PCBs and fluorocarbons. TSCA's budget will have to grow if the enormous backlog of chemicals is to be scrutinized. Moreover, there is the problem of institutional competence. Pollution of the James River at Hopewell, Virginia, by the release of kepone occurred as a result of the failure to enforce existing regulations on pesticides, not because of the lack of legislation. The difficulty of managing toxic substances was further underscored on July 10, 1976, one year after the kepone tragedy was first disclosed. In Seveso, Italy, error in design of equipment permitted a cloud containing an extremely toxic chemical, dioxin, to be vented upon the general population.

Although an important regulatory gap has been closed by the Toxic Substances Control Act, the problems of management and institutional competence remain. How can sufficient accountability be created for the control of chemicals that are sometimes potent at the parts-per-billion range, especially when there are risks thirty years latent, low probabilities, large numbers of chemicals, and great ignorance of the health effects? We are just beginning a new era in chemistry.