The functions oJ and debates about the various environmental laws and regulations are discussed f r o m the regulator’s viewpoint
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John B. Ritch, Jr. Office of Toxic Substances U S . EPA Washington, D.C. 20460 Nearly a decade has passed since the first Earth Day, May 1, 1970, a day which marked the beginning of a major national effort to combat pollution. Since then certain gains have been realized: More than 85% of the plants and factories that are major potential sources of air and water pollution have “cleaned up their act,” and are now complying with anti-pollution laws. Rivers from the St. John’s in Florida to the Willamette in Oregon are being reclaimed from the blight of pollution. The stretch of the Potomac that borders Washington has improved to the point at which it is now home to as many as 60 species of fish. Vast areas of scenic New England that once were afflicted by a noxious combination of sulfur dioxides, particulates, and other forms of pollution now meet most federal health standards for air quality. Even the tough fight to curb the environmental damage done by the automobile has shown results. EPA’s latest figures show that carbon monoxide levels have been cut by 20%. True, smog levels held steady between 1972 and 1977-but that is in the face of a 30%jump in vehicle-miles traveled during that five-year period.
cost of protecting the public health from chemicals may be too high. One question now being asked is: “Has environmental regulation gone too far?” Another is: “How is the cost-benefit balance shaping up for this mass of legislation?” Opponents of regulatiorl accuse these laws, among other things, of eliminating jobs, or reducing productivity, of diverting capital investment, and of impeding innovation. Regulations are also alleged to be a cause of inflation.
Problems, despite progress While not many would argue with the proposition that the national cleanup effort in the environment is making great gains, there are indications that these efforts have not been so successful in the area of human health. For example, Marvin Schneiderman of the National Cancer Institute told a Senate subcommittee on health on March 5 of this year that the number of cases of some major types of cancers are increasing rapidly, although there is a slight leveling-off trend in cancer incidence as a whole. Moreover, cancer risks posed by organic substances in drinking water are thought by scientists at the University of California a t Berkeley, and Caltech, to have been grossly underestimated. Even with these problems, progress has been substantial. T o achieve the success so far attained, a veritable mass of new legislation aimed a t protecting human health and the environment has been enacted. But these regulations have come in for much strident criticism lately. Both government and industry contend that the This article not subject to
U S . Copyright. Published 1979 American Chemical Society
Those favoring regulation see the issue quite differently. T o them, industry is constantly “crying wolf’ in its protestations. They generally maintain that the benefits derived from regulations exceed the cost, and that, in fact, stricter regulation is needed in many areas.
Landmarks and guideposts Obviously, it is very difficult to agree on the basic issue of the value of living and working in a smog-free environment versus the high cost of environmental regulation. Unfortunately, as long as there is no agreement on what resources society should devote to pursuing such goals, and as long as the true role of environmental regulations remains unclear, the current confrontation approach to regulation will continue. Nevertheless, despite the gains and the arguments, continuing newspaper headlines cause much concern about chemical substances. This concern was measured in a recent ABC News Harris Survey which reported that 29% of Americans believe that the government is doing about the right amount, and is moving at the right speed to clean up chemical hazards; while 5% think that the government is going too fast, and 51% think that movement should move faster. So amid the uproar of this confrontation and consternation, a look at the situation, from the regulator’s viewpoint, is in order. There are some landmarks as to where things stand, and some guideposts as to which way to go; and there is, believe it or not, some light at the end of the tunnel. Why was TSCA needed? First, all would almost certainly agree that the problems of pollution did not develop in just one decade. They have not been, and will not be eliminated in just one decade. In the nine years since EPA was created, however, one thing is clear: The major source of environmental and health pollution has come into sharp focustoxic chemicals. I n these past nine years, Congress has tried to give the agency the tools to deal with problems by passing six major federal laws which assigned EPA the responsibility to protect public health and the environment from hazards of toxic chemical substances, both as products, and as unintended by-products and wastes of a highly industrialized society. It should be noted that the common theme in all of these acts is to protect the public health and the environment from some form of chemical substance hazard. Volume 13, Number 8, August 1979
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With all of the other laws, why was TSCA needed? This very question, or some aspect of it caused much of the five-year debate in Congress that preceded TSCA’s final enactment in October 1976. In the end, Congress and the President concluded-with the support of an extraordinarily broadbased coalition of industry, labor, environmental, consumer, and other groups-that enactment of TSCA was necessary to fill a number of significant gaps that existed in the other Federal toxic-related laws. TSCA’s purpose One of the major concepts-and one of the major distinctions-underlying TSCA is that the public interest requires EPA to have the capacity to act before harmful substances threaten human health or the environment. The other laws, Congress found, largely enable the government to take action only after widespread exposure, and possibly serious harm has occurred. Also, a little study makes it apparent that with the exception of FIFRA, the Pesticide Act, the other Acts deal mainly with by-products or waste products, whereas TSCA deals with deliberately manufactured chemical substances. With TSCA, every facet of the chemical industry-product development, testing, manufacturing, processing, distribution, use and disposal-is subject to federal regulation. Now, EPA has the authority to gather information on chemicals, to identify harmful substances, and to control those substances whose risks outweigh their benefits to society and the economy. And because the Act treats importers of chemical substances as if they were domestic manufacturers, it also expands EPA’s responsibilities into certain aspects of the multi-billion-dollar international chemical trade. The next question one might ask is: “If toxic substances comprise such an area of concern, why has it taken so long to implement the law?” The answer to why it is taking a long time to implement TSCA fully lies in problems presented by the Act itself. A balancing act During TSCA’s development, two opposing schools of thought contended. Supporters pointed to the growing evidence that widespread exposure to toxic substances is taking a heavy toll on the quality of public health and the environment. Opponents voiced the strong concerns of an industry that, for the first time, would be subject to broad-based federal regulation, and 924
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feared that this regulation would seriously curtail or stymie innovation. To set a balance between the need to prevent unreasonable chemical risks, and the continuing need for an economically strong and technologically innovative chemical industry, is a tough job. The stakes are high. Perhaps, then, the question could be, not why it took five years of debate to get TSCA enacted, but how did TSCA get enacted at all? The answer to that question is that TSCA was enacted with the help of the chemical industry which worked with the Congress, as Congress attempted to do a balancing act between the interests affected by TSCA.
But actually providing such a balance has much to do with why TSCA is so tough to implement. In its decisionmaking under TSCA, EPA must consider a wide range of social, scientific, legal, and economic issues. Also, the Act is written in such a way that it provides considerable room for EPA’s interpretation and discretion. Congress deliberately gave EPA flexibility to apply a variety of nonregulatory and regulatory options to control the problems posed by toxic chemical hazards in our society. These options can range from “jawboning” and voluntary guidelines, to limited regulation of handling, use, and labeling, or to outright banning of manufacturing and processing. With this much flexibility and discretion, given limited resources, and in light of the enormous number of potential targets for attention, EPA’s efforts to implement this law must be well-focused and deliberate. The increased flexibility of TSCA imposes increased responsibility. EPA must seek solutions that consider industry innovation and the national economy, as well as environmental protection.
This high degree of flexibility also causes much concern about possible overregulation. Thrusts of TSCA TSCA basically has two major thrusts: establishing an inventory of existing chemicals and selectively acting on those that appear to pose potential hazard devising a system to examine new chemicals before they reach the market place. This effort, in itself, has been a tremendous undertaking. In the fourmonth reporting period from January 1 to May 1, 1978, EPA received over 140 000 reporting forms from 7400 manufacturers and importers, which reported the 44 000 chemical substances now appearing in the initial inventory. Many of the reported chemical substances had never been previously identified by a Chemical Abstract Service (CAS) registry number, or by standardized nomenclature. Many substances were identified by generic names in order to protect their confidential or proprietary status. The four-volume base set will allow one to identify a substance by C A S Registry No., by chemical name, by common name, or by molecular structure. Two additional volumes also list trademarks or product names for substances, which were voluntarily reported. For a 210-day period, beginning June l , processors and users of chemical substances will have the opportunity to report any substances that they process or use, which have been omitted from this inventory. Then, the list can be corrected for the revised inventory which EPA expects to publish in the next year. Testing rules Another major effort is under way through the Interagency Testing Committee (ITC), formed in early 1977. This committee has provided four reports to the administrator, naming 33 chemicals and categories of chemicals, which are suspected of causing cancer, gene mutations, or birth defects, and which the committee has identified as requiring priority testing. In July of last year, EPA published a rule requiring all manufacturers and processors of the 10 chemicals listed in the first ITC report to submit lists or copies of any unpublished health and safety studies already performed on these ten chemicals. The agency is now reviewing the information submitted in response to that rule.
About three dozen chemicals and groups of chemicals currently are candidates for inclusion in rules requiring actual testing, including the first 21 recommended by the Interagency Testing Committee. The first testing rule will be proposed the end of this year, with a second testing rule scheduled for proposal in the first quarter of 1980. The first testing rule will probably call for health-effects testing of four chemicals and four categories of chemicals. The second rule is expected to require health-effects testing of two additional chemicals, and five categories of chemicals. These two rules would cover all the health-effects testing recommended by the ITC’s first report, plus some chemicals mentioned in subsequent reports. The first ITC report called for health-effects testing of alkyl epoxides; alkyl phthalates, mono- and dichlorinated benzenes; chlorinated paraffins; chloromethane; cresols; hexachloro1,3-butadiene; nitrobenzene; toluene; and xylenes ( E S & T ,November 1978; p 1246). However, these initial test rules are taking a long time to develop because of the time needed to evolve initial policies and procedures for evaluating chemicals, and for preparing test standards and corresponding data formats for chemical-specific findings. Future testing rules should require much less time to formulate. Proposed standards for testing of chemicals to determine whether they could produce tumors-that is, oncogenic effects-and other chronic effects, largely the same as those contained in EPA’s guidelines for pesticide testing-will be published very soon. So will the Proposed Good Laboratory Practice Standards for health effects testing. The Good Laboratory Practice Standards are virtually identical to those issued by the Food and Drug Administration. Other health-effects test standards under development include those for acute toxicity, subchronic toxicity, teratogenicity, mutagenicity, and reproductive effects. Test standards for ecological effects and chemical fate in the environment are also under development. Ecological effects testing will be designed to assess the potential impact of chemicals on aquatic and terrestrial ecosystems. Chemical fate testing will be designed to provide insights into mobility and persistence, so that one can assess exposures and identify populations at risk. After all, assessing the nature and magnitude of risk that chemicals may present to human health and the environment is a nec-
banned most non-essential aerosol uses of chlorofluorocarbons (CFC’s), to help protect the earth’s ozone layer. Also in May, the first comprehensive inventory of commercial substances ever published ed to chemical firms, libraries, and state environmental offices around the country. To publish this inventory, E P A collected information about 44 000 chemical substances manufactured and imported during 1977. Also collected, for the first time, was information on where these chemicals are manufactured, and in what published inventory. With this information, E P A will be able to set informed priorities for selecting the most broad-based chemical substances for possible attention. Now in a chemical emergency, other federal toxic-related programs will be able to use the file information to identify possible sources of exposure to specific chemicals. essary element of most T S C A implementation activities.
Risk assessment To focus resources on the highest priority chemicals as much as possible, all major risk-assessment processes will be multi-staged. In the comprehensive assessment process, large numbers of chemicals will first undergo preliminary assessments, to identify those which are likely to present significant risks for which additional information is needed. Where it becomes apparent that regulatory action may be needed, detailed risk evaluations will be made. Risk assessment activities involving a substantial number of chemicals is now underway or has been completed.
For instance, Preliminary assessment of 49 chemicals has been completed. Nineteen chemicals are in the second stage of assessment, which involves a more detailed review of adverse effects and exposure sources. Three chemicals are in the third stage, which involves in-depth review of validity and significance of existing data. These three are asbestos, chlorofluorocarbons, and nitrilotriacetic acid (NTA). Risk assessment is also a part of the effort required for evaluation of the substantial risk information submitted under T S C A Section 8(e). A substantial risk notice is the mechanism provided by Congress for persons or firms possessing information that reasonably supports a conclusion that a particular substance could present a risk to health or the environment. EPA has received about 281 such notices. Although the agency was concerned about the quality of the first notices received, the notices now being submitted are, in general, not only responsible, but are enabling the agency to identify and address some possible problem areas. Some of the notices received contained information of possible interest to other federal agencies, such as O S H A and the N a tional Institute of Occupational Safety and Health, and has been transmitted to them. As was mentioned earlier, EPA has published the “Chemical Substance Inventory.” This action sets in motion the premanufacturing notification ( P M N ) program, which is TSCA’s basic vehicle for preventing unreasonable chemical risks to society from new chemicals. On July 1, thirty days after the official publication date of the inventory, EPA became legally able to review all new chemicals (that is, those not listed on the inventory) for potential health and environmental risks before they are manufactured-or imported-for commercial purposes. In the January 10 Federal Register, EPA proposed its rule, and the forms to be used, to implement a premanufacturing notice. A 75-day comment period ending March 26 was provided. The proposed regulations for P M N do not have industry’s approval. Industry complains that the reporting requirements are too lengthy and too involved; that it will cost too much to prepare a notice for submission; and that the review process could be unnecessarily extended by technicalities. Most industry spokesmen fear that the proposed P M N regulations also will stymie innovation and technological progress. On the other hand, enVolume 13, Number 8, August 1979
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vironmentalists believe EPA is not requiring enough testing information to assure that the public will face minimal risk when the new substance enters the marketplace.
Data, not testing Throughout the discussions which were held with various groups during the development of the P M N proposed regulations, the subject of how much testing was required and what tests should be performed was heavily, and a t times heatedly, debated. Actually, the law does not permit the agency to demand testing. T S C A requires only that the manufacturer submit the data that he has already developed, or is reasonably ascertainable to him. O n the other hand, without some basic information, how can EPA, in its P M N review, say that a chemical is reasonably safe to manufacture? Naturally, the next question is-what should this information be? In developing its policy for P M N , the agency could not tie any testing programs directly to the P M N regulation, because such a direct tie-in might be interpreted as mandatory, and would therefore not be legal. However, many firms wanted some indication of the types of testing that might be performed for substances having different uses, and therefore, different exposures, to assist in their evaluation. So the EPA developed a discussion paper of the policy and technical issues concerned with guidance for premanufacturing testing of new chemical substances. This document, which appeared in the Federal Register of March 16, contains a series of tests and methods which the agency has tentatively identified as appropriate for testing certain properties and effects of chemical substances. It solicits public comment in formulating a proposed guidance package. Agency cooperation In another area, where there are less immediately visible results, but which, nevertheless, has benefits to industry, some progress is being made. Through the formation, in August 1977, of a task force known as the Interagency Regulatory Liaison Group (IRLG), EPA and other federal agencies have developed a number of innovative ways to deal with cross-agency concerns (ES&T, February 1979, p 146). The I R L G is composed of members from EPA, the Food and Drug Administration, the Consumer Product Safety Commission, the Occupational Safety and Health Administration, and the Department of Agriculture’s Food Safety Quality Service. Basically, 928
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these agencies have agreed to share their individual research, data, and analyses; avoid duplicative regulations; and attempt to set consistent standards to control hazards. Cleaner, more consistent regulations, and a reduction in multiple data reporting, as well as more consistent testing requirements should originate with the IRLG. One of the group’s major accomplishments was the recent issuance of a document reflecting the best judgment of scientists in the member agencies on the scientific concepts and methods useful. in identifying and evaluating substances that may pose a cancer risk to humans. Publication of the document represented a significant step in the Federal Government’s efforts to assure consistent evaluation of cancer-causing substances in the environment, foods, consumer products, and work places.
The IRLG also is engaged in an effort to develop testing guidelines acceptable to all member agencies. Draft guidelines for a variety of health effects and environmental tests have already been developed and are being reviewed. Guidelines for documenting epidemiological studies also are being prepared. IRLG’s work in this area is designed to reduce testing burdens imposed on the chemical industry, by eliminating any unnecessary differences in methodological details that would otherwise require duplicative testing. This group has also published a report listing 24 hazardous chemicals and substances, many of which have already been subject to some sort of regulatory action (such as CFC’s and PCB’s). In addition, the report says that new controls on target compounds, such as nitrosamines, will be issued by several agencies. For example, EPA will propose new air and water pollution regulations governing nitrosamines, while FDA is currently studying the hazards of nitrosamines in foods and cosmetics. This report is
a starting point for joint agency action against major chemical hazards. Further, IRLG has completed a survey of government research efforts. This survey revealed that little duplication exists between agencies. It also identified research gaps which need to be bridged. The group expects to save Federal funds by sharing laboratory space, scientific equipment, and expertise; by combining field offices in several cities, and by forming its recently established joint FDA-EPA neuro-toxicology research program a t EPA laboratories in North Carolina.
Improved analysis The group also found that the specificity and limit of detection of analytical procedures, or the identification of many carcinogenic substances, have been improved in recent years. Still, progress in analytical chemistry must undergo still further refinement in the future, to obtain a fuller understanding of all the chemical substances that may be producing hazards. Thus, analytical chemistry has a role to play in the activities discussed above. Analytical chemists will be the actors in this important stage. EPA is moving vigorously to fulfill, with the highest degree of responsibility, the mandates Congress set forth in TSCA. Openness, and public consultation in the development of regulations will, with the cooperation of the regulated sector, achieve the end result of having a clean environment, while maintaining progressive industries, even though it may take a little longer. Further, EPA believes that its efforts will help to unify the whole regulatory process, with a goal of reducing its overall burden. Acknowledgment This article was one of three plenary addresses on toxic chemical controls a t the 9th annual symposium on the Analytical Chemistry of Environmental Pollutants, May 7-9, 1979, at Jekyll Island, Ga.
John B. Ritch, Jr., has been director of the EPA’s Office of Toxic Substances’ Industry Assistance Office since late 1976. From 1972-1 976, he was director of pesticide registrations. A U S . Naval Academ y graduate, Ritch served as a commissioned officer in the Navy until 1966, a f e r which he spent six years in industry. Coordinated by J J
