Government
Toxic substances law falling short of mark Speakers at ACS symposium conclude that TSCA hasn't nearly lived up to its potential, also has had problems in implementation
I «LAS VEGAS* Five years is a long time, but it still is too early to tell what effect a law as comprehensive as the Toxic Substances Control Act will have on an industry as complex as the chemical industry and what benefits it will confer on society as a whole. Nevertheless, speakers at a symposium sponsored by the Division of Industrial & Engineering Chemistry did try to assess TSCA's impact so far. The general consensus appears to be that it hasn't had anywhere near the impact it could have had, although there are problems with the way the law is being implemented. Noting that the Environmental Protection Agency had made several false starts in getting its act together, E. Hamilton Hurst, vice president for environmental health and safety at Nalco Chemical, said the agency nevertheless has accomplished two major actions—creation of the TSCA inventory of more than 55,000 chemicals, and review of more than 1100 premanufacture notification notices (PMNs). The agency's experience with PMNs has demonstrated two things, he says. First, very few chemicals are capable of presenting the unreasonable risk that TSCA is designed to prevent, and second, most of the new chemicals coming through the PMN system are merely modifications of an existing type of chemistry. "This [second] fact has been helpful to the agency since experience with the family of chemistry is helpful in making [its] evaluation and assessment of risks. But this also says one
other thing—our industry's R&D effort is not producing new 'chemistry.' We continue to massage the old chemistry." And, he asks, does this reflect the impact of the PMN regulation on innovation and invention? One person who answers that question affirmatively is Carl W. Umland, environmental health coordinator for Exxon Chemical Americas. He points out that the introduction of new commercial chemical substances as measured by the number of PMNs submitted annually has fallen from between 1000 and 2200 a year to 600 to 700 in the latest 12 months. "Without trying to be precise," he says, "it can be seen that there has been an apparent drop in new substance introduction on the order of 35 to 70%." Umland argues that this is largely a consequence of higher costs and uncertainties engendered by the PMN process at an economically vulnerable point in the life cycle of innovative products. The costs of filing an average PMN are estimated to be about $7000, a significant amount for a chemical that will be produced in small volumes. For example, he says, if one assumes that a typical chemical's cost is about 50 cents per lb and that it will have no more than a three-year marketing lifetime, and
Blair: significant amount of data
further assume that PMN costs have to be recovered during that lifetime, then the percentage increase in costs for a chemical with an annual production volume of 2500 lb is 187%. If annual production is 25,000 lb, the percentage increase is 19%, and at 100,000 lb only 5%. Thus, the problem is especially acute for small-volume chemicals for which innovation often depends on a quick reaction to market opportunities and low costs. Umland notes that the development costs of most new chemicals cannot be passed on readily to consumers. Therefore, an increase in cost generally will not be reflected in a higher price but in a decision by the manufacturer to forgo production. And that is exactly what is happening, Umland argues, pointing to an Arthur D. Little Inc. study that estimates that prior to the PMN requirement about 70% of commercial new chemicals were produced in quantities less than 1000 lb per year. When PMN requirements went into effect, however, that proportion fell to 33% almost immediately and since has declined to only 11%. Thus, he concludes, "PMN requirements have changed the way that companies do business and chemicals with small production volumes clearly have been hurt. The decline in the production of new, small-volume chemicals suggests that chemical companies now are concentrating on products that have ready markets. The companies are taking fewer economic risks and consequently will produce fewer innovative products." As one step toward remedying this situation, Umland suggests that EPA exempt from PMN requirements substances produced in quantities less than 25,000 lb annually. However, J. Clarence Davies, executive vice president of the Conservation Foundation, argues that the estimates of the decline in the number of new chemicals marketed since TSCA's passage are quite unreliable. "But even assuming they are reliable," he says, "we do not know anything about the dollar value or the economic importance of the chemicals not marketed. We assume that, April 19, 1982 C&EN
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Government whether measured by dollar sales or production volume or originality of the chemical, the chemicals not marketed were less important than the chemicals marketed. But we do not know whether the difference is large or small." Davies is more concerned about E P A's lack of progress in meeting the two major goals of TSCA—preventing unreasonable risks from chemicals, and obtaining adequate information about the risks of chemicals. He says, "The most solid evidence of the effect of TSCA on obtaining more adequate information about new chemicals, namely the data submitted with the PMNs, indicates that the act has not had any significant benefits in this respect, except to give us for the first time a definition of the universe of new chemicals and a way of tracking them, if such tracking seems desirable." Davies concludes that the whole implementation of the PMN program needs to be examined to reduce the time spent on low-risk chemicals, improve the information on potentially high-risk chemicals, and to develop a reasonable followup program. He sees signs that EPA is moving in this direction, most notably the socalled 100-day report issued by Donald R. Clay, director of the Office of Toxic Substances. But Davies is concerned about another part of the report that says priority will be given only to information collection efforts required by law or political necessity. This means, he says, that attempts to identify new problems or to collect information to establish overall priorities about potential chemical risks are not likely to be pursued. "For those of us who are impressed by how much we do not know about chemical risks, this narrowed focus is disturbing," he says. "It also surrenders what should be one of the main benefits of TSCA, the authority to review comprehensively the universe of commercial chemicals and to establish priorities." But even if EPA had such information, it probably wouldn't do anything with it. Davies notes that although 400 substantial risk notices about existing chemicals have been filed with the agency by industry, EPA hasn't taken any regulatory action. And, he says, "efforts to use TSCA actually to control unreasonable risks of existing chemicals have been almost nonexistent." The reasons for this lack of regulatory action and emphasis on data gathering are many and varied, Davies says. They include a very conservative legal view 24
C&EN April 19, 1982
about the scope of TSCA in relation to other laws, a tendency in the Office of Toxic Substances to prefer analysis to action, opposition by industry to any controls, and the legal, bureaucratic, and political obstacles within the government that make taking any action a Herculean task. Davies believes that "since the law does not seem able to be used to regulate existing chemicals, we need to explore whether to try to make these aspects of TSCA workable or to consider abandoning them altogether." To try and get a picture of what EPA is up against in its efforts to control existing chemicals, Etcyl H. Blair, vice president and director of health and environmental sciences for Dow Chemical, took a close look at the TSCA inventory. "We found," he says, "that structurally well-defined organic substances, the materials we are most concerned about in testing, were the most numerous as they represented 34% of the inventory, but they account for only 6% of total production." As for the inventory as a whole, a small number of the organic substances account for the bulk of the production volume, with the 3.3% of the organics produced in excess of a billion pounds accounting for 77% of total organic production. "Obviously," Blair says, "control decisions cannot be made on the basis of volume alone, but certainly the higher-volume materials deserve early scrutiny and consideration." And, he adds, "as one reviews all the discussion on the need for testing in order to obtain all the data necessary to make an appropriate risk assessment of a substance, one gets the feeling that there is so much to be done that there must be very little going on or completed. This is not the case at all." For example, he says there are concerns that because there are no concerted efforts to coordinate testing under way in various laboratories in the world, there might be some important substances that are missed, thereby presenting the possibility of harm being done to people or the environment. To determine if this was the case, he undertook an examination of the 50 largest-volume chemicals produced in the U.S. as compiled by C&EN. "Without trying to carry out an exhaustive search, we accumulated information on the physical, chemical, toxicological, and ecological properties of these 50 substances. Although the amount of data varied for each chemical, as would be expected, what he found was that there
were physical and chemical properties data on all 50. There were only five substances—ammonium nitrate, ethylene, nitrogen, oxygen, and propylene—for which there were no data on human health and mammalian toxicology. But, he points out, in every case these substances are well known and would not be expected to present problems. In the case of ecotoxicology, there were fewer data, but there were still at least some, for all except eight of the 50 substances—ammonium sulfate, carbon dioxide, sodium carbonate, nitrogen, oxygen, sulfuric acid, terephthalic acid, and sodium silicate. In addition, Blair notes that after scrutiny by the EPA Interagency Testing Committee, only four of the substances—ethylene oxide, propylene oxide, toluene, and xylene—have been recommended for priority testing. And the Chemical Industry Institute of Toxicology and the Chemical Manufacturers Association are either testing or considering for testing 21 of the substances on the list. Thus, he concludes, "If one narrows down the large universe of commercial chemicals to those produced in sufficient quantities to such that they might be expected to pose a possible health or unwarranted threat, it is apparent that there is a significant amount of information known about these substances or that studies are being considered for a number of them. This is not to say that there is no need for continued testing, but the picture is not so bleak as some would want us to believe." G
Economics of acid rain control probed
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It was an unusual technical session for a national meeting—a group of economists addressing an audience of chemists. What brought these two rather diverse groups together at a session sponsored by the Division of Environmental Chemistry was that vexing environmental problem—acid rain. The primary purpose of such a meeting, according to Alan Carlin, an economist with the Environmental Protection Agency's office of re-
