Document DdYjJG48drnykomzMG6gg0zra

Over the past few decades, there has been a steadyaccumulation of scientific data on occupational and environmental carcinogens. There has also been a parallel increase in our ability to test for car cinogenic effects of chemicals in animals and to rec ognize such effects in humans. Not only is the level of this information generally adequate, but there are ample laws -- in spite of their occasional inconsis tencies and ambiguities -- to translate such infor mation into regulatory action. Yet this has rarely been done. The problem is thus not one of inadequate infor mation or limited authority, but rather one that de rives from economic and political constraints. The combination of powerful and well-focused pressures from industry, together with an indifferent scientific community, public confusion, and a relatively weak public-interest movement, has created a major polit ical imbalance. Tins has been further exacerbated by the "anti-inflation" policies of the Carter adminis tration which fail to recognize that the true costs of failure to regulate arc excessive and inflationary. Cancer strikes one in every four Americans and kills one in five. It is not a disease of degeneration or ag ing. There is little or no evidence that viruses play a significant role. Similarly, migration studies have shown that genetic factors are unlikely to be impor tant deteiminants of human susceptibility. Cancer affects all ages and is largely an expression of past exposures to carcinogens m air, water, food, drugs, consumer products, and the workplace. Our overall ability to treat and cure cancer -- once it has been manifested -- has not materially improved over the past few decades. With the ex ception of prostate cancer and certain relatively rare cancers such as Hodgkin's disease and acute leuke mia in children, the odds of a cure for the major cancer killers -- those of the lung, breast, and colon, for example, -- are not much better now than they were 20 years ago (sec table, p. 44). This is true de spite the billions of research dollars spent on a cure for cancer, despite the high priorities for cancer re search created by the 1971 National Cancer Act (which have been and continue to be directed toward curing rather ihan preventing cancer), and despite the optimistic assurances of the American Cancer So ciety (even though based on the same National Can cer Institute (N.C.I.) data such as in the table). RSV0030546 If industrial chemicals remain underregulated, they will yield costs -- quite apart from suffering and loss of life -- that far outweigh the immediate, supposedly inflationary costs of control. RSV0030547 Cancer is now the only major fatal disease whose incidence is on the rise. Standardized cancer death rates (i.e., adjusted for age and based on the total U.S. population) show an overall and progressive in crease of about 11 percent from 1933 to 1970. This increase has been even more striking over the last decade (see table, p. 48), and cannot be accounted for by smoking or increased longevity, At today's death rates, the probability of a person born today getting cancer by the age of 85 is 27 per cent (in contrast to about 20 per cent for a person born m 1950). In addition to the documented increase in overall cancer death rates in this century, evidence for the environmental causes of the disease is provided by a constellation of other scientific findings: The striking increase in cancer death rates for certain "high-risk" population sub-groups: such as workers in asbestos or petrochemical industries, premenopausal women who have been subjected to repeated mammography, and postmenopausal women who have been administered estrogen "re placement therapy" for prolonged periods. The major international geographical variations (in some instances by as much as 2,000 per cent) in specific organ cancer rates which have largely disap peared over the course of one or two generations fol lowing population migration front high to low cancer areas. The clustering of excess overall cancer races and organ-specific cancer rates in men and women living m heavily industnahzed U.S. counties (see table, p, 47), particularly those with a high concentration of petrochemical and certain mining and processing industries. The experimental demonstration of the car cinogenic effects of a wide range of chemicals, par ticularly synthetic organics. Since the advent of the petrochemical era in the 1930s, a vast array of new synthetic organic chemi cals has been introduced into commerce -- and into the environment -- generally without prior testing for carcinogenic and other chronic toxic effects. By 1976, total U.S. production of synthetic organic chemicals had reached 300 billion pounds per year, . up from about 1 billion pounds in 1940 fcee figure above). And about 700 new chemicals are presently being introduced into commerce each year. But it must be appreciated that the "cancer problem" thus created can readily be solved. The property of carcinogentcity is in fact relatively rare, and can be prac tically and economically detected by animal tests that are highly predictive of human effects. Of the Above. Production ol synthetic organic cnemicals in the U.S has grown dramatically during this century. In 1940. (or example, one billion pounds were produced, by 1976. total production reached 300 bil lion pounds (Arrows indicate when usage ot specific product types became officially "significant ") (Source. U S. International Trade Commission) Below These data -- obtained in 1979 from the National Cancer Institute s Surveillance Epidemiology and End Results (SEER) Program -- suggest that our overall ability to cure cancer has not materially improved over the past decade. 0022062 BSB RSV0030548 Conservative estimates of the total national cost of cancer for 1979 are in the region of $30 billion. mynad ofsynthetic chemicals in commerce, less than 1,000 have been shown to be carcinogenic in ani mals, and these mostly belong to special sub-classes -- such as chlorinated olefins, alkyl halides, and aro matic amines -- widely used by industry. There is substantial evidence incriminating indus trial chemicals as major causes of cancer. Consider, for example, "Estimates of the Fraction of Cancer in the United States Related to Occupational Factors," a draft report issued by the U.S. Department of Health, Education and Welfare (H.E.W.) in Sep tember, 1978. (The final report is in the process of being submitted to the Journal of the National Cancer Institute.) Prepared by ten leading experts from the National Cancer Institute, the National Institute of Environmental Health Sciences, the Na tional Institute for Occupational Safety and Health (N.I.O.S.H.), and the International Agency for Re search on Cancer, the report conservatively esti mates (with documented exposure and epidemiolog ical evidence) that up to 38 per cent of total cancer mortality over the next three decades will be as sociated with asbestos and five other "highexposure" carcinogens (arsenic, benzene, chromium, nickel oxides, and petroleum fractions). The report is m striking contrast to industry "guesstimates" that occupational exposures cause less than 5 per cent of all cancers. Not only are such industry allegations undocumented in relation to exposure data -- which industry still insists are confidential -- but they also reflect simplistic as sumptions that single causes (including questionable carcinogenic factors such as high-fat diets) are re sponsible for most cancers. The causes of cancer are generally multiple, with more than one factor con tributing to risk (as illustrated, for example, by synergistic interactions between smoking and asbes tos exposure m the induction of lung cancer among workers). "I he findings of the H.E.W. report, alarming as they arc, still represent a serious underestimate of the impact of occupational carcinogens: they exclude the effects of radiation and about twelve other cpidcmiologically confirmed occupational carcinogens; the effects of occupational carcinogens on the general community, due to their discharge or escape from industrial plants into the outside air, water, and land, are not considered; the effects of more recently introduced industrial chemicals have mot been gauged through cui rent cancer rates; the majority of epidemiological studies so far underta ken im the workplace, and on which the estimates are based, have been in larger industries which arc likely to be less hazardous than the more numerous small plants (manufacturing, handling, or proces sing carcinogenic chemicals under even more poorly controlled conditions); and the duration of follow up in most epidemiological studies on carcinogenic exposures in industr) has been for periods less than the necessary lifetime observation period, and are therefore likely to minimize the degree of risk. These exclusions from the H.E.W. estimates are likely to outweigh possible overestimates of exposure due to alleged industry-wide improvements in work prac tices. The Costs of Cancer Total direct costs of treatment for an individual cancer patient were estimated by H.E.W. in 1971 to range from $5,000 to 530,000. Indirect costs, such as loss of earnings from premature disability, are often much greater. Total national costs from cancer, both direct and indirect, were estimated by H.E.W. in 1971 to be about $15 billion annually, and estimates for 1979 arc in the region of $30 bil lion. In addition to these recognized costs of cancer, there are a variety of other costs -- often referred to as "externalized" costs -- that ha\e generally been ignored or denigrated. Consider workers' compen sation. Payments to workers who have contracted occupationally related cancer result not only in externalization of industry's costs but also seriously mask the full extent of the national costs of the dis ease. And the efficiency and cquitabiliry of these procedures leave much to be desired. For instance, state compensation systems have abjectly failed to deal with occupational health problems, particularly for diseases with long latency periods (such as cancer). Impossibl) heavy burdens are placed on workers, or their heirs, to unequivocally demon strate causal relationships between their cancers and prior occupational exposure to carcinogenic agents. Furthermore, state compensation systems make no provisions for identification and medical examina tion of former workers (retired or active elsewhere) who were previously exposed to carcinogens but who are not yet clinically ill. Workers' compensation laws, which vary from state to state only in their degree of inequity, are based on an implied trade-off in which workers sur render their rights to sue their employer in exchange for the guarantee of adequate compensation in a 0022083 BSB '-ttn r-- nrfFTTT-- RSV0030549 nonadversarial process. The courts have almost consistently upheld the legality of the denial of right to sue, but have generally failed to maintain the right to an unconrestcd adequate compensation. Results of recent surveys by the Department of Labor highlight the problem: The average length of time fiom onset of disabil ity to the first disability payment is one year for a discaseclaun (compared to two months for an injury case). 1 Sixty per cent of disease cases that are eventually compensated arc contested (compared to ten per cent of injury awards). The probability of litigation approaches ninety per cent for serious diseases such as cancer. Fifty-five per cent of disease claims are settled by compromise and release agreements (compared with sixteen per cent of injury cases). The total average compensation payment for permanent occupational disease is less than $10,000 (compared with $23,400 for similar injury cases). Compensation for death caused by occupational disease averages about $3,500 (compared to S57.500 for an injury case). Foreign countries settle proportionately more disease claims than docs the United States. (In the case of Sweden, the disparity is about twelve-fold.) The daims-determination process in most other countries is in the hands of a disinterested party, in contrast to the U.S. procedure. An important recent development in attempts to reform the inequities of current compensation sys tems, which would help to internalize some of the costs of occupational cancer, has been the introduc tion of S.3060 by the Senate Human Resources Sub committee on Labor. This bill is designed to provide comprehensive reform of compensation programs, and to mandate uniform national guidelines, while allowing a reasonable degree of autonomy at the state level. Regrettably, S.3060 has not been re ported out of committee, and its chances for passage are slim (even though earlier versions of this bill were introduced beginning in 1972). Consider also occupational surveillance costs. N.I.O.S.H. has recently estimated that for the rela tively small number of regulated carcinogens alone, the associated cost of worker surveillance is in the region of S8_5 billion. Another category of externalized costs derive from medical malpractice suits against company doctors who fail to inform workers of medical findings that might otherwise have motivated them to hnnt further exposure. For example, there arc ten lawsuits (totaling over $50 million) against Kent Wise, former physician for a'Johns-Manvillc plant in Pittsburgh, Calif., on the grounds that he delib erately withheld information from workers on X-ray evidence of asbestos-induced lung disease. In the fu ture, such professional malpractice lawsuits -- for failure to protect workers and to inform them of oc cupational hazards -- will almost certainly be filed against company-employed engineers, chemists, in dustrial hygienists, and executives. Tile "spillover effect," and potential community cancer suits, represent a major hut as yet unexplored additional set of externalized costs. Toxic and car cinogenic chemicals from inside a petrochemical plant, for example, are discharged or escape to the outside community, so that the occupational disease hazards arc "shared" with local residents. It is also awesome to note that an entire calculus of other ex ternalized costs -- the dimensions of which have been barely considered -- reflects the consideration that many carcinogenic chemicals possess other toxic effects, notably teratogenic (causing birth de fects) and mutagenic. Industry's Responses: A Poor Track Record "Industry," a heterogeneous array of interests and objectives, has generally presented a common front of intransigence in response to proposed regulation of toxic and carcinogenic chemicals. Accumulation of information on chemical hazards in the work place has not been paralleled by development of technological means to control them. Indeed, indus try insists that attempts at regulation are stifling technological innovation. In support of the status quo, industry appears to have evolved a complex set of strategies. Their es sence is to downplay risks due to a particular prod uct or process, to overstate the social benefits and uniqueness of the product or process, and to exag gerate the costs and difficulty of regulation. These strategies are sometimes presented frankly as indus try positions, but they usually come from industry front organizations and quasi-professional associa tions (such as the Nutrition Foundation, the Ameri can Council on Science and Health, and the Council on Agricultural Science and Technology), or from well-selected academic consultants who usually give no hint of their often close atui pre-existing relation ship with the client industry. The elemems of these strategies, with some examples, include: 46 Technology Review December/ January, 1980 0022084 BSB RSV0030550 taviiy mduslrauiea Males such as New Jersey, experience excess' overall and organ-specific cancer rales (Dala displayed here are for while females. age-ad|usted, and expressed as annual mortality rale per 100.000 population tor the 1950-1959 period ) (Source Mason and McKay) < Minimizing risks. The Quebec Asbestos Mining Association maintains that asbestos-caused disease is a reflection of past working conditions that have improved so much that rhc industry is now safe. A frequent position of trade associations and industry front organizations in general is that there is no risk in exposure to "relatively low" levels of car cinogenic chemicals. Blaming the victim. The American Industrial Health Council, an offshoot of the Manufacturing Chemists' Association (M.C.A.), ascribes cancer among workers to smoking, poor diet, alcohol, sun light, and individual hypersusceptibility rather than to exposure to carcinogens in the workplace. Diversionary tactics. Industries insist on degrees of scientific precision and legal definition that can not possibly be met in toxicological or epidemiolog ical studies, often coupling this wirh rejection of carcinogenicity test data in animals and demands for long-term human studies over the next few decades. Naturally, regulatory action should be deferred until the results of such studies are in. Influencing policy. Powerful, wcll-focused, and well-financed industry lobbyists, and the national Chamber of Commerce network, represent a na tional force that has often been galvanized to sub vert the enactment of protective legislation and the promulgation and implementation of standards. Exhausting the agencies. Once an agency has de cided to regulate, or has been obliged to regulate m response to pressure from labor or public interest groups, industry generally resorts to legal action, insisting on a protracted casc-by-case reexamination of fundamental principles of toxicology and car- cinogcnesis, while at rhe same time claiming trade secrecy on related questions of exposure and alter native noncarcmogemc products and processes. Central to rhe complex of industry strategies has been control of the data -- their generation, in terpretation, and availability --- which form the basis for regulation. Such data extend beyond health and safety to product efficacy and to manufacturing, marketing, and compliance costs as well. Detailed analyses of rhe track record of industry, wirh refer ence to a wide range of case studies in the work place, consumer products, and the general environ ment, provide ample documentation for the overall rhesis rhar information provided by industry, or by individuals and institutions with direct or indirect' industry connections, should be suspect until proven otherwise. Data are commonly destroyed, manipu lated, or suppressed. Examples of suppression include: The policy of the Chemical Manufacturers' As sociation (formerly the M.C.A.) to deny workers rhe right to know what chemicals they are exposed ro in trade-name products; The assertions of the asbestos industry that the hazards of asbestos products were largely unknown before the 1960s, when as recently revealed (particu larly by the 1978 "Asbestos Pentagon Papers"), such information was known to industry executives and scientists in the 1930s; The early failure of the Dow Chemical Company to reveal to the Occupational Safety and Health Administration (O.S.H.A.) and the Environmental Protection Agency (E-P.A.) results of rests showing chromosome damage in workers who were exposed 0022005 8S8 1- rnnokMlV r'"r' RSV0030551 ro levels of benzene under 10 ppm. Simultaneously, the company was fighting against regulations de signed to limit such exposures and was insisting on their harmlessncss; The action of the Pharmaceutical Manufacturers Association and American College cf Obstcrncians and Gynecologists in filing suit against the Food and Drug Administration's September, 1976, decision to label estrogens with warnings of the risk of uterine cancer. Examples of manipulation include the alteration of records and reporting of nonexisrent slides by Hazleton Laboratories in the course of toxiocological tests on the sweetener Aspartame and the drug Aldactone; and the economic analysis, commis sioned by the Society of the Plastics Industry, on the tmpact of meeting a less-than-one ppm vinyl chloride standard in the workplace, winch predicted massive costs that subsequent experience proved to be exaggerated by many orders of magnitude. Examples of destruction include both the tovt'we -- Dow and Du Pont admitted in 1973 that woikers' records were destroyed after ten years, even while both companies had claimed in-house epidemiological evidence of the long-term safety of three occupational carcinogens (eti.ylencimine, 1-naphthylamine, and MOCA) that O.S.H.A. was at tempting to regulate; and the dramatic -- im mediately prior to a federal investigation in April, 1977, Industrial Biotcsr Laboratories destroyed its records on thousands of industrial cnemica's, drugs, food additives, and pesticides (many of which had been developed under contract to rhs Chemical In dustry Institute of Toxicology, a proclaimed source of reliable data for the major chemical companies}. But industry is now evolving a new set of strategies -- as before, to counter and limit the regu lation of toxic and carcinogenic chemicals -- which represent a radical departure from previous policies. Industry is now shifting emphasis front denial of risks to an admission that these risks do exist but must be accepted as part of a trade-off for alleged societal economic benefits. This shift in emphasis derives from the depressed economic climate and other considerations, including: a continuing series , of damaging disclosures on the extreme unreliability and self-serving nature of much industry safety data; the evolution of independent scientists whose con- ccrns about public health have encouraged suc cessful challenges of a wide range of industry's con tentions in toxicology and epidemiology; and some outstanding new administrative appointments to Since 1933. and especially ove.' Ihe Iasi decade, there have been progressive -ncreases in cancer incidence rales lor el` ages inrougho'it the U S (Source NCI, Thai National Cancer Sur vey. 1969-1977, and S E.E R Program) 1719108 DH1 48 Technology Review. December/Janoaty 1980 0022086 BSB RSY0030552 L.-nicer is now the only major fatal disease whose incidence is on the rise. federal regulatory and research agencies. Faced with these conditions, industry is now shifting its prime focus from the scientific debate in regulatory agen cies to the economic debate m Congress, the courts, and the Council on Wage and Price Stability. Ever sensitive to changing national moods, indus try's demands for deregulation have recently become more clamorous and linked to Proposition 13-style tax reform, inflation, alleged free-spending by runaway regulatory agencies, and the grow.ng biggovernment intrusion into free enterprise. Full-page advertisements in leading national newspapers complain that "the spiraling costs of regulation" (both for administration and compliance) are inflationary and innovation-stifling. The industry position is buttressed by articles and letters in lead ing journals and newspapers from prominent academic spokesmen and industry front organiza tions, and by restrictions on health and environmen tal regulations originating from the White House it self. Apart from the self-serving nature of industry demands for deregulation, these reflect the myopia of traditional economists preoccupied with the G.N.P. and the immediate costs of compliance rather than with the heavier and largely externalized delayed costs of failure to regulate. Industry demands for deregulation in pollution and preventive health areas are in interesting con trast with its insistence on continued economic regu lation to protect monopolistic practices. In spite of all the praise lavished by industry and its public re lations machinery on the concept of free competition in a deregulated market, industry fights vigorously to foster economically protective regulation ("cor porate socialism"} whenever its interests are threatened. To Regulate or Not to Regulate In March, 1978, President Carter issued an execu tive order on regulatory reform which included the requirement that regulatory agencies develop eco nomic impact analyses (i.e., to estimate the effects on business) of all major proposed standards. The order was warmly received by the business commu nity and was promptly endorsed by the U.S. Chamber of Commerce, among othets. Since then, the administration has imposed increasing restric tions on healch and environmental regulations, par ticularly through its agent, the Regulatory Analysis Review Group of rhe Council on Wage and Price Stability (C.O.W.P.S.). C.O.W.P.S. issued a report m October, 1978, for example, sharply critical of O-S.H.A.'s "generic" cancer policy (which would require automatic but flexible rule-making procedures for all proven car cinogens instead of developing rules on a tedious and protracted chenucal-by-chcmical basis). C.O.W.P.S. cited the economic impact analysis pre pared for the American Industrial Health Council by Booz, Allen, &c Hamilton -- admitted by C.O.W.P.S. to be "seriously flawed" -- as us au thority for stating that the total costs of the pro posed regulation would be inflationary. The CO.W.P.S. report was roughly coincident with President Carter's announcement of his new antimflanon program, asserting that inflation is the na tion's number one problem and that prompt reme dial action, including across-the-board austerity measures, must be undertaken. C.O.W.P.S, was also critical of the O.S.H.A. benefirs analysis which, not' surprising m a generic approach, failed to address the cost-benefit question on a carcinogen-bycarcmogen basis. This criticism was buttressed by reference to the October, 1978 decision of the Fifth Circuit Court which overturned O.S.H.A.'s pro posed benzene standard largely on grounds of eco nomic infeasibility and cost-benefit considerations. The case is now pending before the Supreme Court. Cost-benefit analyses (upon which the adminis tration's approach heavily depends) do not ade quately reflect the delayed costs of deregulation, or of failure to regulate, in terms of disease, death, and environmental degradation. Some uncertainties inherent in quantitative risk assessment from animal test data are illustrated by the 10-million-fold range in current estimates of the carcinogenic hazards of saccharin (see table, p, SI), Quantitative risk assess ment is a premature science fostered by pressures to express public health hazards in economically sim plistic terms. And complicating, difficult-to-mcasure factors, such as synergisms and multiple exposures, only magnify the uncertainties. The recognized an nual costs of cancer (in the region of S30 billion) reflect medical bills and income loss -- minimal but hardly adequate value estimates for pain, suffering, and loss of life -- quite apart from a wide range of externalized costs. Furthermore, cost-benefit analyses raise impor tant questions of equity. Those few who profit from the manufacture or processing of the carcinogen and who resist bearing the immediate costs of com pliance (despite the fact that many of these costs are generally "redistributed" through tax write-offs and Technology Review, December/January, 1980 49 0022087 BSB RSV0030553 Federal research efforts emphasize cure instead of prevention. And for an environmentally induced disease such as cancer^ this is irrational. price pass-throughs) are not the many who suffer the long-delayed but serious consequences of failure to regulate. It would seem reasonable to require that the interests of a worker exposed to hazardous con ditions and of a consumer exposed to hazardous consumer products (both generally involuntarily and unknowingly) should receive substantially more protection than is now afforded by the regulatory process. The costs of regulation are incorrectly evaluated, often falling to incorporate the economic advantages of regulation-stimulated innovations such as alternate technologies and product or process sub stitutions. (A good example was the substitution of toluene for benzene in the early 1960s, an action that virtually eliminated occupational leukemia m the photogravure and shoe-making industries in northern Italy.) Compliance may also encourage substantial economies by recovering and recycling valuable chemicals, otherwise lost as air and water pollutants, and may create whole new pollutioncontrol industries that provide goods and services and, of course, jobs. An important consideration for "economic im pact" is that in most cases the regulated industry -- not the regulatory agency -- has a virtual monopoly on data needed to assess costs of compliance. And it is no great surprise that industry estimates of the costs of regulation are often highly exaggerated. The clear need for detailed independent scrutiny of industrial compliance estimates and economic impact assesments (and of analyses by C.O.W.P.S. based on industry claims) is afforded by the vinyl chloride (VC) example. The plastics industry strongly objected to the 1974 O.S.H.A. proposal for a less-than-one ppm occupational standard for VC on the grounds that it was beyond their compliance capability and too expensive besides. To bolster these claims, the Society of the Plastics Industry hired Arthur D. Little, Inc., and O.S.H.A. hired Fos ter D. Snell, Inc., to estimate the economic impacts of the new standard. The consulting firms predicted costs as high as $90 billion and the loss of up to 2.2 million jobs. These estimates were grossly exagger ated and also failed to reflect the high costs of VC- induced cancer and other dis-eascs in workers as well as excess miscarriages in women living m proximity to VC plants. In spite of massive industry lobbying and pressures, O.S.H.A. stood firm on the new 1 ppm standard, which it put into effect on April 1, 1975. The above estimates, in light of subsequent exper V ience in the plastics industry, prosed to be incorrect by several orders of magnitude. Within one year, the new standard was met without any maj'or economic dislocation. B.F. Goodrich, one of the industry giants, redesigned its manufacturing technology to enclose VC manufacturing and handling processes and to plug possible soutces of leaks. Additionally, a "stripping" process was developed to reduce levels of the unrcacted VC monomer in the polyvinyl chloride (PVC) resin and to decrease VC loss in the process (thus reducing both worker exposure and contamination of the surrounding community). The initial capital costs of compliance were about $34 million. Contrary to the estimates of the consulting firms, B.F. Goodrich found that the new clean-up technology actually cut labor costs and could be profitably leased. (In spite of this, B.F. Goodrich in creased the price of its PVC products in 1976, claim ing higher production costs and blaming theft on regulatory standards.) The experience of Union Carbide was similar. Late in 1975, a company official acknowledged how unexpectedly easy it had been to comply with the 1 ppm standard. Currently, the VC/PVC industry is enjoying an unprecedented boom. Compliance costs are generally estimated on the implicit and self-serving assumption that a particu lar product has societal efficacy and ucihty, even in the absence of supporting evidence or in the pres ence of contrary evidence. Such assumptions cannot be substantiated for a wide range of carcinogenic products. Saccharin's efficacy in the treatment of di abetes and obesity, for example, has never been documented in the scientific literature, and its main use, ironically, is by healthy adolescents. Aldrin and Dieldnn have produced widespread environmental and human contamination, but their manufacturer (Shell Chemical Co.) was unable to produce evi dence of efficacy in the 1973 E.P.A. cancellation hearings. The major target insect population, it turns out, is resistant to these pesticides. The costs of carcinogenicity tests arc often cited by industry as a heavy and unjustified compliance expense, particularly on the grounds that too many new chemicals are being introduced into commerce each year to be handled by conventional animal rest ing and that the cost of such testing would be pro hibitive. In fact, the number of these new chemicals is under 700 annually. There is every reason to be lieve that current facilities could be expanded to cope with this number of chemicals, and without ex cessive strain. There are large potential facilities at 0022088 8SB RSV0030554 Estimating risk is by no means an objective, universally agreed' - upon procedure, as the divergence of these data -- derived by a variely of methods -- can allest (Source Committee tor a Study on Saccharin and Food Safety Policy (National Academy ot Sciences)} 0022089 BSB Technology Review, Dfcernber'January 1980 51 RSV0030555 The absence of a national public health constituency at a grass-roots level is probably the single most important impediment to cancer prevention. the national laboratories, such as at Oak Ridge, Tcnn. and Argonne, 111., in addition to a large facil ity at the National Center for Toxicological Re search in Arkansas. In addition, the bioassay pro gram (under the new leadership of the National Toxicological Program) is planning to subtantially increase its testing program to handle larger num bers of chemicals. With regard to expense, the annual cost of testing one chemical for carcinogenicity (in groups of 50 mice and rats, of each sex, at two dose levels) is about $200,000. Properly conducted carcinogenic ity tests also provide information on a wide range of other chronic toxic effects, including testicular dam age (leading to sterility), central nervous system damage (leading to paralysis or behavioral changes), and damage to the liver (leading to cirrhosis). The $140-million cost for testing 700 chemicals would be unlikely to result in substantial increases in pro duction and retail product costs. Such testing costs are about 0.2 per cent of the 1976 $72-biIhon gross sales of the chemical industry. The immediate costs of testing should be further contrasted with the far greater delayed costs of failure to test and regulate. Federal efforts arc substantial but misplaced -- they emphasize cure instead of prevention. And for an environmentally induced disease such as cancer, this is irrational. Health care leads the nation's inflationary spiral, having soared from S30 billion in total national expenditures in 1960 to $185 billion by 1978. In the last five years, the total has grown by 15 per cent annually. In 1978, health care costs were roughly 9 per cent of the G.N.P. and $55 billion more than the defense budget. But as former H.E.W. Secretary Joseph Califano has pointed out, fully 96 per cent of the $48 billion federal expenditures on health care in 1978 were directed to treatment -- leaving only 4 per cent for disease prevention pro grams. Few would doubt the need to fight inflation, to avoid needless regulation, and to implement only those rules that yield some net benefit to society at large. But the administranon's initiatives raise im portant constitutional and legal issues, particularly as they appear to represent direct executive usurpa tion of legislative authority. However, such initiatives are likely to forestall in temperate Congressional antiregulatory sentiments, such as those embodied in the September, 1979 amendment introduced by Senator Dale Bumpers (D-Ark.). Attached to a routine judicial improve ments bill, this amendment would switch the burden of proof to agencies who would then be obligated to show "preponderance of evidence" before they could regulate. If enacted, therefore, it would effec tively produce regulatory paralysis and declare open season for assault by toxic agents. Ironically, past Republican administrations have achieved more effective environmental regulation with weak agency heads than has been or is likely to be achieved by the present Democratic and liberal administration aided by strong and progressive agency leadership. Determinants of this paradox in clude emerging fiscal conservatism, increasing pres sures by the administration and industry for deregu lation in the name of anti-inflation, the public and Congressional perception of major uncertainties in the scientific base of environmental decision making and risk assessment, and the false issue of freedom of choice being pitted against regulation. In addi tion, there is concurrently a strong decline in the environmental and anticancer forces in Congress with the recent retirement of Congressmen James Delaney (D-N.Y.), John E. Moss (D-Cahf.), and Paul Rogers (D-Fla.), and with the emergence of the new fiscal conservatives. The future role of labor has been made uncertain by recent wage limitations im posed by President Carter, and it is unclear whether organized labor will make wage or environmental controls its mam priority. The likelihood of success of the deregulation trend seems enhanced by the ab sence of an effective national environmental and an ticancer constituency. The Single Greatest Impediment It is difficult to mobilize a national constituency against carcinogenic products and processes when these hazards cannot easily be quantified and when the penalties of failure to regulate them will be man ifest only in 20 years or so. It is simple, however, for an industry to mobilize immediate pressures against the regulation of its activities. Despite increased funding of federal agencies, priorities on cancer prevention are still low. For in stance, only about 10 per cent of the National Cancer Institute (N.C.I.) budget, approaching $1 billion, is spent on research activities that can be rea sonably defined in terms of cancer prevention. Additionally, there is no requirement for N.C.I. Cancer Centers to involve themselves in actual cancer prevention -- such as carcinogenesis testing, surveillance of high-risk populations, and estab lishment of tumor registries geared to occupational 52 Technology Review December/January 1980 0022090 bsb ninf n' nn v RSV0030556 1 t Xi , i and environmental carcinogenic exposures. The American Cancer Society has been an impor tant element in the distortion of N.C.l. priorities toward cancer treatment rather than prevention, and the society has misled the public into the reas suring viewpoint that there have been major ad vances in the treatmenr of cancer. The society has fought against or withheld critically needed support from both legislative (for example, the Clean Air Act, the Safe Drinking Water Act, and the Toxic Substances Control Act) and regulatory (of saccha rin, red dye number 2, hair dyes, Tris, DES in cattle feed, and Aldrin/Dieldnn, for example) actions de signed to control carcinogens. While the traditional explanation for the society's position on cancer pre vention lies m an amalgam of conservatism and ig norance, questions have recently been raised in the press about the possible influence of the wide range - of industries in which society directors have direct or indirect financial interests. In any case, it seems un likely that the society will play an effective role in cancer prevention unless its public image and fund raising ability are threatened. The absence of a national public health consti tuency at a grass-roots level is probably the single most important impediment to serious attempts at cancer prevention. The efforts of public interest groups and organized labor, both of which have been responsible for instigating most regulatory ac, tions against carcinogens over the last decade, are unlikely to prevail in the future unless their spheres _of influence can be extended. Important and key additional constituencies that do not yet appear to have been mobilized include senior citizens, on whom the impact of unregulated carcinogens is heaviest in terms of cancer incidence and their abil ity to meet crippling medical costs, and the church, whose historic mission of social equity needs to be .-introduced into the debate on disease prevention ` versus cost. The costs of current failure to regulate toxic agents will be a crippling inflationary legacy to fu ture generations, and industry will sow a grim har vest of burgeoning cancer carnage unless it develops long-term policies more consistent with public health and welfare. Suggested Reading "Ashford, N.A. cl al, "Mobilising National Resources for the Control of Occupational Cancer," Report to the Office ofTechnology Assessment, U.S. Congress, April, 197V, Bingham, . et al., "Scientific Bases for Identification of I'ottntial Carcinogens and Estimation of Risks," Journal of the National Cancer institute, vol 63, pp 243-268, July, 1979 (report of the Interagency Regulatory Liason Croup, Work Group on Risk Assessment). Committee for a Study on Saccharin and Food Safety Policy, "Sac charin. Technical Assessment of Risks and Benefits," Report no. 1, N A S. Institute of Medicine, November, 1978. Fraumeni, J. F., Jr,, ed.. Persons at High Risk ofCancer An Approach to Cancer Etiology and Control, Academic Press, Nra York, 1975. Hiatt, H. H, j. D. Watson, and j A Winstcn, eds. Origins of Human Cancer, Cold Spring Harhor Laboratory, 1977. Huepncr, W. C , Medico-Legal Considerations of Occupational and Nonoccupational Environmental Cancers," Lawyers' Medical Encyc lopedia, vol JB, The Allen Smith Co , Indianapolis, 1972. Mason, T. J. and F. W. McKay, "U.S. Cancer Mortality by County, 1950-1969," D.H EW. publication (N.l.H.) 74-615, Washington, D.C. 1973. The Regulatory Council, "Regulation of Chemical Carcinogens," September 28,1979, New Executive Office Building, Washington, D C. 20460. Saffioctt, U- and J. K. Wagoner, eds., Occupational Carcinogenesis, Annals of the New York Academy of Sciences, sol 271, New York, 1976. Proceedings of a conference on occupational carcinogenesis held March 24-27, 1975. Speth, G., "Toward a Better Bull's-Eye: Corporate Responsibility and Accountability," speech to the American Bar Association -- National Resources Section, November 28, 1978. Tomatis, L. ct al., "Evaluation of the Carcinogenicity of Chemicals A Review of the Monograph Program of the International Agency for Re search on Cancer," Cancer Research 38 (1978). l!.S. Department of Health, Education, and Welfare, Center for Dis ease Control, National Institute for Occupational Safety and Health, "The Right to Know: Practical Problems and Policy Issues Arising from Exposure to Hazardous Chemical and Physical Agents in the Work place." Washington, D C, July, 1977. U.S. Public Health Service, "Evaluation of Environmental Carcino gens," Report to the Surgeon General, April 22, 1970. Samuel S. Epstein, M.D., is professor of occupational and environmen tal medicine at the School of Public Health, University of Illinois Medi cal Center in Chicago. An authority on toxic and carcinogenic hazards due to chemical pollutants, he is the author of over two hundred scien tific publications and four books; he has served as consultant to various congressional committees, federal agencies, and organized labor, and he is president of the Rachel Carson Trust and cluurpcrson of the Com mission for the Advancement of Public lnrcrcst Organizations in Wash ington, D.C This article is based on material from bis hook. The Politics of Cancer (Anchor Prcss/Doublcday, Newlork, 1979). 0022091 B$B U19961--BWZ v r Technology Review. Oecemoerf Januarv 1980 53 RSV0030557