Document 1Q3MoXMvXZDa0a4bm2pz7mewj

A C/'-r; Cfc>(3 "TA/'A Tv \ Toxic Substances Control Legislation: The History andStatin? by Stephen Altman In the long history of progress toward a toxic substances control act,Congress is now closer than ever before to passing legislation to better protect the American worker and to provide more extensive information on which to base regulations. y now, of course, you've heard the names. B Asbestos. Vinyl chloride, pcb's. bcme. Arsenic. Mercury. There are others. Each is a toxic substance, and each came into widespread use before its capacity to do harm was fully recognized. If you've heard their names recently, and been alerted to the tragedies and potential tragedies they represent, so have many other Americans, and so has the Congress. In fact, public sensitivity to the problem of toxic substances has never been higher. That's the main reason why the 94th Congress may^ succeed where the last two have failed. By the fall, it may deliver to the President a Toxic Substances Control Act. Federal regulations already cover food addi tives, drugs, cosmetics, pesticides, and to a great er or lesser extent pollutants in the air, water, and workplace. But as John Quarles, Deputy Administrator of the Environmental Protection Agency (epa) told a House panel last summer, "Our patchwork defense is woefully inefficient and ineffective." A toxic substances act would place a closer watch, and stricter controls as well, on the whole spectrum of metals, metallic compounds, and synthetic chemicals which enter the nation's commerce each year. The reasoning is simple enough: The more we know about hazardous substances before they reach produc tion and use, the better we can protect ourselves against the dangers they may entail. Strike one, strike two Congress became aware of the need for toxic substances legislation back in April of 1971, when a report on the subject was issued by the federal Council on Environmental Quality (ceq). The report estimated that at that time there were more than 1.8 million known chem ical compounds, many thousands of which are in use and production. But not all of these sub stances, of course, are toxic; the problem is in ascertaining early enough the health and en vironmental implications of their use. The report pointed out that while more than 1,000 widely used compounds are known to be harmful in large doses, the environmental impact of most substances is not well understood. Each year the problem becomes more complex, as an esti mated quarter million additional substances are developed, of which more than 300 eventually find their way into commercial production. Chemical testing, though, largely confined as it is to the effects of short-term, large-dosage ex posures, leaves us inadequately prepared for the effects of the chronic, low-level exposures which are likely to occur in the environment. Too many chemicals, said ceq, are entering the nation's commerce, and being applied to a growing di versity of uses, without adequate screening in advance. We cannot, it said, "continue to allow the entire population or the entire environment to be used as a laboratory." Within a year of the report, both houses of the 92nd Congress were considering toxic sub stances control measures. The Senate passed its version unanimously; the House its own by a vote of 240-61. But the bills were different, the Senate measure being the much more rigorous of the two, and no House-Senate conference committee was called to arrange a compromise. 19 DPMC-13647 LAM 012287 The next Congress brought the same dilemma: Each house passed its own version of the bill. The key difference lay in the crucial area of pre-market notification. The Senate bill required that the Administrator of epa be notified of each new chemical substance no less than 90 days before commercial production, epa would then determine whether the manufacturer must pro vide testing information to assure the safety of the chemical, and if so, what kind. The House version, however, required the Administrator to formulate a list of substances deemed likely to pose "an unreasonable risk" to health or the environment. Manufacturers would then have to notify the Administrator and provide test data only about compounds already judged to be hazardous. Another sticking point was the very status of the new legislation among such other environ mental and health statutes as the Clean Air Act, the Water Pollution Control Act, and the Occu pational Safety and Health Act. The House bill called for exhausting all other remedies--laws already on the books--before resorting to the new toxic substances regulations. The Senate bill said that, in each specific case, all relevant statutes should be considered and the most effec tive one applied. This time a House-Senate conference com mittee did meet to find some blend of the two bills. But neither side, as it turned out, would yield on important issues. House conferees were unwilling to endorse unlimited pre-market screening; Senate members preferred no bill to what they considered a weak one. So there was no bill. Another try The drive in Congress to enact toxic sub stances legislation did not die. In fact, as more chemical hazards came to light--vinyl chloride being merely the most notorious--the legisla tion's proponents found their support growing stronger. As one Senate staffer puts it, "Such revelations are always sad to see, but let's face it: They've awakened the public to the urgent need for this sort of measure." At hearings held on the House and Senate sides last year, the Administration made its own support plain. As epa's John Quarles told the House Subcommittee on Consumer Protection and Finance last July, `The two chief weak nesses in our approach today are: first, that we do not have effective authority to impose con trols on the chemicals and, second, that we do not require adequate testing of them early enough to discover what sorts of problems may be posed by the chemicals. The toxic substances control legislation that is before you would address this problem in a way that would put us into a much sounder position to handle the difficulties that we face." Spokesmen from the National Institute for Occupational Safety and Health (niosh) and the National Cancer Insti tute (nci) said much the same thing, and ceq Chairman Russell W. Peterson added that "In my view, this legislation is among the most important now pending before Congress." Administration supporters of the legislation are part of a growing crowd. As that Senate staff member says, "The number of groups who have become interested in this legislation and are actively working for it has picked up enor mously with this Congress. In previous sessions, the Sierra Club was the key environmental group working for this bill. Today there are many. Environmental Action being high up on the list. The health groups are starting to come on board, too--the March of Dimes, for in stance, and Blue Cross-Blue Shield, the Ameri can Public Health Association, the American Lung Association, and many others. And then, of course, there's labor." Representatives from the afl-cio, its Indus trial Unions Department, and the United Steel workers were prominent at the House and Sen ate hearings. Labor has backed some sort of toxic substances act throughout its legislative history, but only in the last year or two have unions very actively worked to ensure passage. The reason is a shift in perspective: Whereas labor long considered the bill a purely environ mental measure, it has come to recognize the significance to occupational health. Since 1971, the federal agency primarily responsible for worker safety and health has been osha, but as the United Steelworkers' John J. Sheehan told the House Subcommittee, osha "does not con trol toxic substances until such time as they are entered into the workplace. It is that void that we wish to see plugged, and a toxic substances act will do that." It would also, as Sheehan pointed out, provide epa with another specific power which osha lacks--the power to restrict or altogether prohibit the manufacture of a hazardous toxic substance. 20 i lam 012288 DPMC-13648 Qualified support The chemical industry itself now supports toxic substances legislation "in principle," al though it has long contended that new sub`ances are already extensively tested, and that .oxic substances in general are already ade quately regulated by existing statutes. The in dustry also has voiced fears of the sort of broad ened government control which it feels would inhibit innovation and production, force smaller firms out of business, cost jobs, fuel inflation, and hurt the nation's balance of trade. No two parties, in fact, seem to be able to agree on the potential economic impact of a toxic substances act The Manufacturing Chem ists Association (mca), whose 185 members represent more than 90 percent of the nation's chemical production capacity, sponsored one study last year by an economic consulting firm, Foster D. Snell, Inc. The Snell report estimated the annual cost to the chemical industry would range between $358 million and $1.3 billion, depending upon the scope of both the toxic substances act and epa's administrative policies. Dow Chemical had already predicted a yearly cost of $2 billion, epa had first placed its esti mate at $45 million, then raised it to somewhere between $80 million and $140 million annually. One reason why cost estimates vary so greatly is that no one is sure of how many chemicals would require testing each year, epa estimates that about 1,000 new substances reach the mar ketplace annually; industry estimates reach six or seven times as high. Of that number, and of the chemicals already in production, just how many would require testing is not certain. As mca president William J. Driver says, "Basic ally, we agree with the government people on the costs, in terms of upper and lower limits, of testing a specific chemical substance. The big question is the number of such substances to be tested--you get a difference of opinion when you try to estimate what that multiplier will be." The various versions of the legislation have differed in this very area. All have upheld the principles of pre-market notification and testing requirements, but they have differed in the scope and detail of their application. The chemical industry has pressed for a scrupulous definition of the Administrator's authority to require noti- 21 DPMC-13649 LAM 012289 fication and testing of harmful substances. "We have favored toxic substances legislation," Driv er says, "provided it was written in language specific enough so that we knew exactly what was intended and just how it would be exer cised, and so that it was aimed at specific risks as distinguished from mere conjecture or possi bilities of risk." MCA endorsed the bill passed in the last Congress by the House of Representa tives, and at present favors the version intro duced last year by Rep. John Y. McColIister (R-Neb.), which once again calls for the Ad ministrator to formulate a list of chemical sub stances or specific uses of substances that "are likely to pose substantial danger to health or environment," substantial danger being defined as an unreasonable risk of death, of widespread or severe personal injury or illness, or of wide spread or severe harm to the environment. Pre market notification requirements would be limit ed to substances appearing on the list. To require the testing or regulate the use of a substance, the Administrator would have to deem such a ruling "necessary to protect against unreasonable risk to health or the environment." Versions of the legislation which provide for broader pre-market notification or broader dis cretion on the part of the Administrator in re quiring testing and applying controls have been vigorously opposed by the chemical industry as excessive and unnecessary. "The chemical in dustry," Driver says, "has for many years been dealing with toxic substances and for the most part has a really high record of safety in this regard. It's very sensitive to its responsibilities; if you will, just consider the legal liabilities that attend the introduction of a new substance in the marketplace. One cannot at all approach that lightly." Driver attributes most health prob lems that have arisen from toxic substances to unforeseeable actions or mistakes in the use or application of specific chemicals. `This sort of thing will probably continue forever," he says. "No amount of regulation can absolutely settle or make safe for all time the production and use of chemical substances." Why, then, would the chemical industry sup port any sort of new controls? "Well, I think it's something whose time has come," Driver says. "There is a legislative history of better than four years on this subject with a good deal of loose talk in the press, even to the point where some people have erroneously stated that there are no controls on toxic substances--so that in our opinion the new legislation woi help set straight a lot of misinformation, would also establish in the minds of a lot people the parameters of the controls which government would and should exert in reg; to toxic materials. And since it would regulai some things from the standpoint of law, it wo certainly furnish a better platform on which discuss the issues with government regulators the state and federal levels." Administration's stand Of the four toxic substances control b pending last year before the Congress--one the Senate and three on the House side-- Administration last November announced support of H.R. 7664, the McColIister versi as the bill most closely in accord with Adm istration policy. This came after a reassessm of the Administration's earlier stand in supp of S. 776, the Senate measure introduced Sen. John Tunney (D-Cal.). The Tunney was essentially the same which had passed previous Senate, differing most significantly fr the McColIister bill in that it provided for mi broader pre-market screening. The Adminisi tion's current position endorses legislation wh would: provide for the control of toxic substan to the greatest extent possible through exist regulatory authorities; empower epa to obtain information fr manufacturers that would facilitate the coni of these substances; require that pre-market notification requ ments and the exercise of new regulatory pow focus only on those chemicals and chem families determined to pose an unreason:, risk to health or the environment. Support for H.R. 7664 as the appropri vehicle to achieve these goals, however, hin; on the adoption of certain modifications to bill to "improve the effectiveness of adminis tion of the legislation by epa." The sugges changes were developed with input from E ceq, dol, hew, the Department of Commei and omb. Some adjustment to the pre-mar screening area of H.R. 7664 was among th changes. That bill would require the Admit trator to formulate a list of substances that " likely to pose substantial danger"; the Admii tration recommends the words "may pose unreasonable risk." The old language provi for testing or regulation only where "necess 22 DPMC-13650 LAM 012290 to protect against unreasonable risk"; this would be changed to "when there may be an unreason able risk." These are small but crucial changes in word ing. With them, the Administrator of epa would still have to provide a specific list of hazardous substances to be screened, but the range of substances he could include on that list would be greatly broadened. The Administrator would also gain the authority to require testing when there simply are insufficient data to determine risk, and further, be allowed to call for test data without having to prescribe specific testing pro tocols or procedures. He could also, given another modification roposed by the Administration, issue a final ruling on a chemical without providing a de tailed statement on the expected economic im pact of that ruling. Instead, he would merely have to take such effects into consideration while developing the ruling. There are many other proposed modifications in the Administration's package, most of which are incorporated in the bill as reintroduced by Senator McCollister this session. In general, the Administration's suggestions tend to bring the McCollister bill more in line with the ver sion currently under review in the House, and in fact already passed in the Senate. After hearings last year before the Subcommittee on Consumer Protection and Finance of the House Commerce Committee, Rep. Bob Eckhardt (D-Tex.) and lep. William M. Brodhead (D-Mich.) with drew their versions of the legislation and Eck hardt introduced H.R. 10318, with Brodhead and Subcommittee Chairman Rep. Lionel Van Deerlin (D-Cal.) as co-sponsors. A correspond ing measure was soon under consideration by the Senate Commerce Committee Subcommittee on the Environment, was unanimously approved by the Senate Commerce Committee itself, and by March 26 was passed by the entire Senate by a vote of 60-13. Meanwhile, the House Sub committee marked up the bill and brought it before the entire House Commerce Committee. The significant development here is that, for the first time in the legislative history of the toxic substances control act. House and Senate mea sures are very nearly parallel. And if both these measures are passed this session, the task facing a new House-Senate conference committee will be much less formidable than it has been in the past H.R. 10318 Given the growing support in the Congress for these versions, it might be worthwhile to outline their contents. Here, then, is a brief overview of H.R. 10318, whose provisions, by and large, are mirrored by the Senate version, S. 3149. The bill proclaims that it is the policy of the United States that hazardous and potentially hazardous chemical substances should be ade quately tested, and that such testing should be the responsibility of those who manufacture and process such substances. It states further that adequate authority should exist to regulate chem ical substances which cause or contribute to an unreasonable risk to health or the environment, but also that such authority should be exercised in a way not to impede unduly technological innovation or to create unnecessary economic barriers for industry. The Administrator of epa is to carry out the act "in a reasonable and prudent manner" and "shall consider the en vironmental, economic, and social impact" of any action he may take. The Administrator is empowered to issue rules requiring the manufac turer or processor of any potentially harmful chemical substance to conduct tests on that substance. The bill does not, however, cover tobacco and tobacco products, pesticides, nu clear materials, foods, drugs, or cosmetics. Be fore the Administrator may issue a rule requir ing the testing of a chemical, he must make three specific findings: that the chemical may cause or contribute to an unreasonable risk to health or the environ ment or that there may be substantial human or environmental exposure to the chemical; and that there are insufficient data available upon which to determine or predict its health or environmental effects; and that testing of the chemical is necessary to develop such data. Any rule to require testing must specify who will perform such tests, identify the compound or mixture involved, specify standards for the development of test data, and provide a time period within which the data must be submitted. "Standards for the development of test data" include whatever information the Administrator may require concerning the health or environ mental effects as well as all pertinent character istics of the chemical being tested. To whatever extent is necessary to ensure the adequacy and 23 DPMC-13651 LAM 012291 reliability of the test data, the Administrator may prescribe testing protocols or procedures which the manufacturer or processor must fol low. At least once each year, the Administrator must review the adequacy of the standards for the development of data which he has pre scribed. The bill also establishes an advisory commit tee composed of one representative from each of seven federal agencies having research or regula tory responsibilities involving chemicals: epa, CEQ, osha, niosh, the National Institute of En vironmental Health Sciences, the National Can cer Institute, and the National Science Founda tion. Within a year after the passage of the bill, the advisory committee must submit to the Administrator a list of chemical substances and mixtures for which he should issue testing re quirements. The list must be reviewed and revised every six months thereafter. Within a year after any substance's appearance on the list, the Administrator must either begin pro ceedings to issue a testing requirement, or publish in the Federal Register his reasons for not doing so. Chemical manufacturers must notify epa no less than 90 days before the manufacture of any new chemical substance, or the manufacture or processing of any existing chemical for a use which the Administrator has determined, by rule, to be a significant new use. The notifica tion must include a variety of information: the name of the chemical; its chemical identity and molecular structure; the proposed categories of its use; an estimate of the amount to be mant factured; the byproducts resulting from the man ufacture, processing, and disposal of the chemi cal; and any test data the manufacturer may have relating to the health and environmental effects of the substance. In addition, if the Ad ministrator has already issued a ruling to require that the chemical undergo testing, the manu facturer must submit the required test data along with the other information. If the chemical is on a list of chemicals the Administrator has determined may cause or contribute to an unreasonable risk to health or the environment, but no specific testing requirement has been issued, the manufacturer must submit data he believes show that the chemical will not in fact pose a hazard. There is a significant exception to the notifi cation requirement: It does not apply to chemi cals manufactured in small quantities for scien tific experimentation or for chemical research or analysis, including research or analysis for product development Regarding any substance or new use that is subject to notification, the Administrator may put into immediate effect a rule prohibiting or limiting the manufacture of the substance if he makes two findings: that information available to him is insufficient to permit a reasoned evalu ation of the health or environmental effects of the chemical, and that in the absence of such information, the chemical may cause or contrib ute to an unreasonable risk to health or the environment. In general, the Administrator is empowered under the bill to issue rules to prohibit or limit the manufacturing, processing, or distribution of any chemical which "causes or contributes to, DPMC-13652 LAM 012292 \ or is likely to cause or contribute to, an unreas onable risk." He may also order labelling of specific substances. As with rules to require testing of chemicals, the Administrator's rules to control substances must be issued in accord ance with the orderly procedures of Section 553 of Title 5 of the United States Code, except that the bill provides for the opportunity for an oral hearing and, in certain instances, the crossexamination of witnesses. A proposed rule, how ever, may be placed into immediate effect upon its publication in the Federal Register, if the Administrator feels that a particular substance or mixture is likely to result in an unreasonable risk before the usual rulemaking proceedings puld be completed, and that such action is necessary to protect the public interest. The Administrator may also order a manu facturer to revise quality control procedures if the manufacturer's present procedures uninten tionally result in allowing a chemical to cause or contribute to an unreasonable risk. Before the Administrator may issue any such ruling, however, the manufacturer must be given a full adjudiciary hearing. H.R. 10318 also includes reporting provisions intended to help epa keep track of all chemicals in production around the country. The Admini strator must issue rules under the legislation requiring the manufacturers and processors of chemicals (not just new chemicals) to report for each the name, chemical identity, uses and Proposed uses, estimates of amounts produced, escription of byproducts, adverse health and environmental data, and estimates of the number of workers exposed. Manufacturers of mixtures and research chemicals must submit this data only to the extent the Administrator determines is necessary to efficiently enforce the act. The reporting provisions would allow the Administrator to compile an inventory of all chemicals in production, as opposed to the situ ation today, when no one is certain of the num ber or variety of chemicals used and produced. The bill also provides that manufacturers, processors, and distributors of chemicals retain records of adverse reactions in health or environ ment caused by any chemical substance. Further, the Administrator may require a manufacturer to provide a list of all safety and health studies performed on a chemical. If any manufacturer receives information indicating that a chemical causes or contributes to an unreasonable risk, he must report that information to epa. Other provisions of the bill allow for the protection of trade secrets, define the new legis lation's position among other statutes admin istered by epa and other agencies, and provide for civil actions on the part of citizens. If the summary of the bill seems long, the bill itself is much longer--stretching, in fact, over more than 80 pages. This proposed toxic substances bill reflects an effort on the part of its proponents to provide broad yet well-defined screening and regulatory powers at epa. This is the legislation already passed by the Senate and in the version with the greatest backing in the House committee concerned with the issue; but whether this bill, or the McCollister bill, or some other version, or no version at all will be passed by the entire Congress and signed into law this year remains to be seen. No cure-all What would a toxic substances act mean for osha? For one thing, it would mean that more substances than ever before would be tested before entering the workplace. And that testing would alert osha to the possible need for stan dards to protect the worker. Furthermore, re porting requirements of new legislation should supply osha with the sort of figures which have been all too hard to come by in the past, partic ularly those regarding the number of workers exposed to particular substances. A requirement that health and safety studies and records of adverse reactions be open to epa would make available to osha the most up-to-date informa-, tion possible regarding potential chemical haz ards. All of this would make osha's job just a little easier, and improve its capacity to guard against on-the-job health problems. The trouble with any toxic substances act, however, is that it can't do everything people would like it to do. Everyone would like it to erase the incredibly complex problem of human and environmental exposure to toxic substances, but it can't do that. No legislation can suddenly make perfect the developing science of toxicol ogy, or make the use of chemicals less vital to society, or make substances which are toxic less toxic than they are. It could, however, encourage science and industry to strive to better contain chemical hazards, learn more about the sub stances produced and used, and provide the government with far better knowledge on which to base regulation of toxic substances. Mr. Altman is a free lance writer. 25 DPMC-13653 LAM 012293 A Policy of Respect Astonishing industrial progress that has kept Japan in international headlines for years is now highlighted by government concern for workers' safety and health. DPMC-13654 LAM 012294