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Scientists, Engineers, and the Burdens of Occupational Exposure: The Case of the Lead Standard RONALD BAYER The toxic effects of lead exposure have long been known. By the late nineteenth century the consequences of working with lead had become the focus of attention of writers like Dickens, Hardy, and Shaw (Hunt, 1979, p. 2011. However, despite the recognition of how lead could maim workers, efforts to control exposure remained rudimentary. For Alice Hamilton, writing in the early twentieth century, "lead intoxication" was the most prevalent of occupational diseases. Not only were the medical implications to be found in workers but in their children as well. Because lead could be passed on through exposed women to their children, Hamilton termed it a "race poison" affecting not just one generation but two (Hunt, 1979, p. 2021. About a half century later, the Centers for Disease Control (CDC) reported on an epidemiological study of workers exposed to lead at a scrap smelter (Levine et al., 1976~. Of the 37 employees who had been followed, 30 displayed signs of toxicity. Nine had at some point been hospitalized with lead-related disorders. Commenting on this evidence, Morton Corn (1976), a former director of the Occupational Safety and Health Administration (OSHA), referred to the "grim" details of "this alarming story." This discovery on the part of the CDC reveals that although the most extreme examples of lead poisoning had by and large been eliminated from the American industrial landscape by the early 1970s, the toxic conse- quences of such exposure remained a critical problem. For those concerned Work on this paper was supported by the Program in Ethics and Values in Science and Technology, National Science Foundation 60

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OCCUPATIONAL EXPOSURE AND THE LED STANDARD 61 with occupational health and safety, the issue of lead poisoning had a con- tempora~y importance that was amplified by its historic significance. With the enactment of legislation establishing the National Institute for Occupa- tional Safety and Health (NIOSH) and the Occupational Safety and Health Act in 1970, it was inevitable that efforts would be made to use Washington's new regulatory authority to protect workers exposed to lead. In the bitter almost decade-long struggle that surrounded efforts to promulgate a national lead standard, it became clear that the goal, held by some, of safety and health regulation based on scientific findings that were free of the bias of political and social interests was a chimera. At every stage of the process, from the time of the first NIOSH reports on lead exposure until OSHA's promulgation of the final standard for occupational exposure to lead, the centrality of politics was evident. This was not an aberration but an inevita- ble consequence of the fact that the process of risk assessment and that of standard setting both involved not only the threshold matters of whether given exposures posed a potential hazard for workers but also questions of how the burdens of risk were to be borne. Such determinations are inherently political because, whatever their empirical bases, they require a confronta- tion over matters of equity and distributive justice. BACKGROUND OF THE OSHA LEAD STANDARD Before enactment of the OSHA lead standard, exposure of workers to lead in the workplace was guided by a series of both public and quasi-public safety standards that were more often exceeded than adhered to. In the 1930s and 1940s, the prevailing standard was 150 micrograms of lead per cubic meter of air (150 ,ug/m3 air). Based on the implications of a Public Health Service survey ofthe health of battery workers in 1928, this standard was far below the once-accepted 500 ,ug/m3 air. The standard of 150 ,ug/m3 of air was raised to 200 ,ug/m3 in 1957 on the advice of the American Council of Government Industrial Hygienists. Although the prevailing standard was shifted downward to 150,ug/m3 some years later, it again rose when OSHA adopted its first standard for lead exposure in 1971 and incorporated the recommendation of the American National Standards Institute of a 200,ug/ m3 level (OSHA, 1975~. Despite this constantly shifting standard, the practice of American indus- t~ remained such that large numbers of workers continued to be exposed to levels of lead in excess of prevailing "scientifically" grounded recommen- dations. Thus in 1977 before adoption ofthe OSHA lead standard, more than 61 percent of workers in the primary and secondary lead smelting industry were exposed to lead concentrations exceeding 200 ,ug/m3 in air. This was

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62 RONALD BilYER also true for more than 20 percent of those who worked in storage battery plants (Hattie et al., 1982~. It was against this background that NIOSH in 1973 issued its first report on the risk posed to workers by lead exposure. In its criteria document, NIOSH (1972) sought to provide those concerned with the future course of regula- tion with data that reflected the prevailing scientific consensus. NIOSH thus presented, without any attempt at critical analysis, a broad body of research findings, much of which was derived from studies conducted under industry sponsorship. This research and the NIOSH conclusions upon which it was grounded incorporated traditional clinical notions of how the pathological was to be defined. By narrowly drawing the boundaries of its concern, a significant array of physiological changes in lead workers was placed beyond the range of regulatory concern. Based on this clinical standard, the criteria document asserted that work- ers whose blood levels remained at or below 80 ,ug/100 g of blood would be unharmed by their exposure. Although the margin of safety provided by such a blood level could not be established, NIOSH had determined that there would be "few if any cases" of lead poisoning below blood levels of 90 ,ug/100 g (NIOSH, 1972, p. V-4~. To maintain a blood level of 80 ,ug, NIOSH proposed that no worker be exposed to an air lead level of more than 150 ,ug/m3 (NIOSH, 1972, p. V-51. By rejecting the 1971 OSHA standard forlead in air es insufficiently protect- ive, NIOSH would have required a return to a standard of safe exposure that had long existed. Such a standard, however, would have required a modifi- cation of prevailing industrial practice, which, as noted, often resulted in lead exposures of more than 200 ,ug/m3 of air. The reaction by representatives of industry and labor to the NIOSH find- ings prefigured the more bitter confrontation that was to occur when OSHA sought to promulgate a standard of lead safety for workers. At a 1974 conference convened by the Lead Industries Association (LIA) to discuss the NIOSH report, industry representatives and their scientific allies found much to recommend the institute's efforts. The 80 ,ug blood level had long been put forth as providing an adequate margin of safety by George Kehoe, the preeminent figure in lead toxicity research, who was viewed by industry as sympathetic to its interests. Concern was voiced, however, over the proposed reduction in permissible levels of lead in air. Not only was a scientific basis for the more stringent standard lacking, but the very basis for suggesting that exposure to lead in air could serve as an appropriate occupa- tional health standard was brought into question (Proceedings, 1975, p. 95~. The most critical note during the LIA conference was struck by Sheldon Samuels of the AFL-CIO's Industrial Union department. He charged NIOSH with participating in a "vile numbers game" (Proceedings, 1975, p.

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OCCUPATIONAL EXPOSURE AND THE L~D STANDARD 63 801. The scientific community, by assenting to the institute's determinations and by providing the empirical foundations for its conclusions, was "engaged in a massive, destructive game of deception greater than this society, perhaps, has ever encountered" (Proceedings, 1975, p. 811. Samuels argued that scientists who asserted that the proposed NIOSH rec- ommendations provided a margin of safety for lead workers were making "authoritarian social decisions and labeling them scientific" (Proceedings, 1975, p. 811. Not only were essentially social determinations thus being masked, but hidden assumptions about how the burden of risk ought to be borne were being incorporated into the NIOSH calculations. Samuels put forth what was for that moment in the public debate on lead toxicity and the protection of workers a radical proposition. Blood lead levels had to be reduced to 40 ,ug/ 100 g-half the standard adopted by those who focused on conventional definitions of the pathological consequences associated with lead exposure. Furthermore, to achieve the required blood lead levels, Samuels demanded that air lead exposure be reduced to 50 ,ug/m3 of air 25 percent of the prevailing OSHA standard, and one-third of the standard being proposed by NIOSH (Proceedings, 1975, p. 811. Forthose who heard these proposals, it was clear that Samuels was calling for a massive expendi- ture in resources and thoroughgoing changes in production processes to ensure the health of workers. In discussing the clash between labor and industry's representatives, Irv- ing Tabershaw, editor of the Journal of Occupational Medicine, within which the proceedings of the LIA conference were reproduced, expressed his hostility toward those who would radically challenge the professional and social consensus then dominant in the lead industry. "Most revealing perhaps is the emotional attitude of labor towards the scientists and profes- sionals practicing industrial hygiene and occupational medicine. The accu- sation of industry's malfeasance is so broad, nonspecific and unsubstanti- ated that it defies an answer, but it is illustrative of the climate in which occupational health standards are being developed" (Proceedings, 1975, p. 751. It was within this politically charged climate, a climate characterized by the emergence of strong environmentalist and women's movements and increased senstitivity to risks in the workplace, that social and scientific perceptions of the risks of lead exposure began to change. Changes in the practice of industrial toxicology fueled and were fueled by increasing con- cern about the ever more subtle effects of lead exposure. As a consequence, no sooner had NIOSH issued its first criteria document on lead than the process of reevaluation began. Two years later, in August 1975, NIOSH issued a revised set of recommendations (OSHA, 1975, p. 459341. No longer was a blood lead level of 80 ~g/100 g considered safe for workers; the

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64 RONALD B2lYER level now was reduced to 60,ug/100 g (NIOSH, 1978, p. XII-3). Althoughit was unable to determine the appropriate air lead level that would produce such a margin of safety for workers, NIOSH did note that it ought to be below the initially proposed 150 ,ug/m3 of air (NIOSH, 1978, p. XII-31. There seemed, however, no justification for forcing it down as low as 50,ug, as had been proposed by Sheldon Samuels. The August 1975 NIOSH recommendation served as a basis for OSHA's preliminary 1975 proposal for a lead standard (OSHA, 19751. Issued as part of a flurry of regulatory initiatives designed to mute the growing dissatisfac- tion with OSHA's lackluster and sluggish performance, the 1975 proposal was to be characterized by representatives from industry and labor as well as professionals within government as inadequate in its formulation of the scientific and policy issues at stake. Despite these limitations, OSHA's pre- liminary proposal was noteworthy in several respects. It broke with the tradition of lead toxicology that had been dominated by George Kehoe, and indeed with much prevailing professional opinion, by asserting that clini- cally significant changes might well occur at blood lead levels below 80,ug/ 100 g (OSHA, 1975, p. 459351. In adopting this position, OSHA rejected the conventional toxicological focus on gross manifestations of lead pathol- ogy and sought to underscore the relevance of more subtle occurrences. "Lead may produce changes in biochemical and physiological parameters which occur at blood levels lower than those usually associated with overt clinical effects. The point at which sub-clinical changes become sufficiently serious to represent a threat to health is not clearly defined" (OSHA, 1975, pp. 45935-459361. Faced with such uncertainty, OSHA adopted a "conservative" posture. An appropriate margin of safety for lead workers required that attention be given to "subclinical" changes. The burden of uncertainty was to be shifted from exposed workers to those who would be forced to make the necessary modifications in the production process. Thus, rather than focusing on encephalopathy and "wrist drop," the conventional signs of advanced lead toxicity, the OSHA standard targeted neurological changes that involved the slowing of nerve conduction (OSHA, 1975, p.459351. Rather than focusing on gross anemia, a traditional indication of lead poisoning, the OSHA standard expressed a concern about alterations in hemesynthesis and their impact on blood production (OSHA, 1975, p. 459361. Instead of a standard designed to prevent renal failure, OSHA's proposal was directed at avoiding reduced renal function (OSHA, 1975, p. 459371. Finally, rather than the "race poison" so central to Alice Hamilton's concerns and to those fearful of the potential effects of lead on women in the workplace, OSHA addressed its attention to a spectrum of reproductive hazards, including failures of con- ception and reduced fertility (OSHA, 1975, p. 459351.

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OCCUPATIONAL EXPOSURE AND THE L~D STANDARD 65 The medical and technical shift represented by OSHA's attention to changes in biochemical and physiological parameters had important moral and political implications. So too did the preliminary standard's commit- ment to protecting the most vulnerable groups within the working population (see gingham, in this volume). Rather than designing protections for those workers who were especially robust, OSHA believed that the margin of safety being proposed had to be such that all workers could endure work with lead. The impact on those with sickle cell trait and on women of reproductive age was a matter of special concern. "It is appropriate to consider these sizable groups in setting a standard which applies to all workers" (OSHA, 1975, p. 45936~. Having established 60 ,ug as the body burden that would provide an adequate margin of safety for workers, OSHA next had to address the question of an air lead standard that would produce that effect. Like NIOSH, OSHA acknowledged that the correlation between air lead levels and blood lead levels was not definitive. Available data simply did not permit a specifi- cation of a precise air lead level at which workers exposed to lead would have a mean blood level of 40 ,ug/100 g and a maximum blood level of 60 ,ug/ 100 g. NIOSH had indicated that something below 150 ,ug but above 50 ,ug would be necessary. In setting a standard within that range, OSHA adopted a compromise that owed as much to a social determination of tolerable risk as to empirically based conclusions: "In the circumstances we believe it is appropriate to propose a PEL [permissible exposure limit] that falls in the middle range: 100" (OSHA, 1975, p. 45938~. In setting forth this preliminary lead standard, OSHA called for public comment on five broad areas touched upon in this effort: ( 1 ) Should subclini- cal effects be considered in setting appropriate margins of safety? (2) Does the air lead level of 100 ,ug/m3 provide an appropriate margin of safety? (3) Should biological monitoring supplement ambient air monitoring? (4) Are there especially susceptible groups, and how should they be considered in setting of standards? (5) What is the technical feasibility of the proposed standard? HEARINGS ON THE OSHA STANDARD: SCIENCE, POLITICS, AND THE CLASH OF INTERESTS It was not until March 1977, 18 months after publication of the prelimi- na~y OSHA standard, that hearings were held to elicit public reaction. This setting provided an occasion for representatives of industry, labor, govern- ment, and the scientific community to submit responses that were at once empirical, political, and moral. Most striking in the drama that unfolded during the course of the hearings And reproduced in thousands of pages of

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66 RONALD Bed testimony) was how few surprises were encountered. With a predictability that was almost stunning, not only did differing policy perspectives conform to economic interests, but so too did matters of scientific judgment. The clash of social interests was not only reflected in the response to the proposed regulatory interventions, but in the characterization of the lead exposure risks for workers. Social interests determined not only judgments of whether the cost of regulation was justified, but whether the changes required in the production process were at all feasible. Most often called on because their assessments met the political requirements of antagonistic constituencies, scientists and engineers who testified before OSHA were enmeshed in a process that was radically partisan. The long-standing professional and political tension between OSHA and NIOSH was reflected in the merely lukewarm support given by the latter to the former's recommendations. Although not opposed to the suggestion that the maximum blood lead level be set at 60 ,ug/100 g, with a mean of 40 ,ug/ 100 g, NIOSH could not support the position of OSHA's expert witnesses that the proposed blood level standard should be below that which was put forth in the preliminary proposal. " To go below 60 would place considerable emphasis upon a limited number of observations which have not been con- firmed by multiple investigators. To do this would place the recommenda- tions of a blood level in the workplace on less than firm ground" (NIOSH, 1978, p. XII-181. The lead industry and scientists who testified on its behalf, however, believed both OSHA and NIOSH already had gone beyond the realm of empirically based regulation. Four issues were central to the indust~y's attack: (1) it questioned the grounds upon which OSHA had determined the level of risk associated with elevated blood levels; (2) it doubted the appro- priateness of setting a standard based on assumptions of the relationship between lead levels in air and in blood; (3) it rejected OSHA's determination that the 100 ,ug/m3 air lead level was necessary to provide an appropriate margin of safety for workers; and (4) it believed that the standard proposed by OSHA was neither technologically nor economically feasible. Citing what they termed the "seminal" work of Kehoe, representatives of the lead industry testifying before OSHA asserted, "There is no persuasive evidence that even the slightest clinical lead intoxication occurs below 80 ,ug/100 g" (Lead Industries Association, 1976, p. 171. A physician testifying on behalf of industry asserted, "My experience over 25 years suggests that in reports of lead intoxication [at blood lead levels below 80], the diagnosis is wrong or the method of establishing blood lead levels is inaccurate or the estimation was delayed for some time after the occurrence of the symptoms" (Lead Industries Association, 1976, p. 19) . Most significant in the lead industry's attack on the OSHA standard was

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OCCUPATIONAL EXPOSURE AND THE LEAD STANDARD 67 the testimony of British expert Michael Williams, a medical adviser to two battery plants since 1962. In his testimony he claimed to have conducted 50,000 routine medical examinations of workers exposed to lead: "Except for 2-3 cases of anemia where blood lead levels exceeded 80 ~g/100 g of blood, I have not seen one single case of lead poisoning in these lead workers nor has there been one day's sickness absence due to lead known to me" (OSHA, 1977, p. 18861. Williams also dismissed the significance of the subclinical changes deemed so important by OSHA. "Nerve conduction velocity is of course of no importance in the short run unless it results in some material deficit or diminution of function.... The hemesynthesis argument can, I think, be totally discounted. It is surely reasonable to interpret these changes as one of many thousands of homeostatic mechanisms of the body whereby the effect of an alteration in the external environment is fully compensated by a biological response" (OSHA, 1977, p. 18861. Unlike the proposed standard, which suggested the importance of considering subclini- cal responses, the industry sought to preserve the standard of traditional clinical diagnosis. "We feel that a measure of health is the absence of illness; and we feel that you can correlate the absence of illness with blood lead levels below 80 ,ug/100 g" (OSHA, 1977, p. 30941. However, industry's rejection of OSHA's proposal was not only based on a philosophical difference about the appropriate focus of health regulations. At almost every juncture, the scientific evidence used to make the case for reducing lead concentrations in blood and in air was subjected to method- ological challenge by the lead industry. The studies upon which OSHA depended had been conducted in an inferior fashion. The data on which it relied were inaccurate and could not provide the basis for stringent controls (OSHA, 1977, pp. 610, 41831. The industry also rejected OSHA's assertion that a meaningful relationship could be drawn between ambient air lead levels and blood lead levels. Williams claimed that his own study, which OSHA used in its argument, had been misinterpreted and could not be so used (Lead Industries Association, 1976, p. 471. Kenneth Nelson of ASARCO, Inc. (formerly the American Smelting & Refining Company) a former president ofthe Industrial Hygiene Association and a founder of the Academy of Industrial Hygiene, empha- sized the inadequacy of the scientific basis for postulating a relationship between the level of lead in air and that in blood: "I do not think that one can do any predicting at all of individual blood lead levels in connection with any air concentrations of lead as we presently measure them" (OSHA, 1977, p. 40321. The conclusion of the 1968 International Conference on Lead, that the relationship between lead levels in air and in blood was insufficiently precise to warrant establishment of an air standard, was seized by industry to make the argument that such a standard could have no rational justification.

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68 RONAlLD BAYER As a consequence, indust~y's representatives asserted that biological monitoring of the level of lead in the blood of individual workers rather than environmental monitoring of the level of lead in the air was the only reason- able approach to the control of lead intoxication (Lead Industries Associa- tion, 1976, p. 52~. But if an environmental standard were established, the appropriate level should be 200,ug rasher then the 100,ug proposed by OSHA (Lead Industries Association, 1976, p. 764. This point was made by Jerome Cole, Director of Environmental Health forthe Lead Industries Association. Acknowledging that "few, if any," major segments of the lead industry complied with the existing OSHA standard of 200 ,ug, he stated: "This is significant because it means that we simply do not know what health improvements, if any, would be achieved if the industry complied consis- tently with the present air lead requirements" (OSHA, 1977, p. 30174. Faced with indeterminant data on heals improvement and the certain costs associated with the reduction of exposure levels, the industry argued for regulatory restraint. "To require the lead industry to spend millions of dollars for engineering controls which are likely to have no significant impact on employees' health is obviously wrong" (Lead Industries Associa- tion, 1976, p.524. Finally, the lead industry questioned OSHA's assumption regarding the feasibility of the proposed standard. Knowlton Caplan, a prominent indus- trial engineer, was relied upon by industry to make its case. The cost esti- mates of the economic consulting firm hired by OSHA and the results of OSHA's own economic and technological analysis were subjected to chal- lenge (OSHA, 1977, p. 3923~. Said Caplan: "I believe that there are por- tions of the secondary and primary lead smelting industry that will not be able to achieve the goal of 100,ug/m3 of lead per cubic meter of air" (OSHA, 1977, p. 39314. He even doubted the capacity of segments of the industry to achieve the 200 fig level established by OSHA in 1971 (OSHA, 1977, p. 3931~. According to Caplan, many firms would be forced out of business by the OSHA standard, and the lead industry would suffer, as would the entire economy (OSHA, 1977, p. 38561. The picture of an unreasonable govern- ment attempt at control thus emerged. Michael Williams captured the spirit of the industIy's opposition when he concluded his testimony by stating: "It is wrong to demand action in advance of facts, for that is the way not of reason, but of hysteria" (OSHA, 1977, pp. 1886 ff.~. If NIOSH seemed unwilling to require a blood lead level standard below 60 ,ug/m3, and if industry believed that such a standard was "medically unnecessary," scientifically groundless, and practically impossible, OSHA, in contrast, had begun to doubt that its proposed lead standard was suff~- ciently restrictive. In the period between the publication of OSHA's initial standard in 1975 and the public hearings in 1977, Eula gingham, closely

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OCCUP~ION~L EXPOSURE AND THE LED STANDARD 69 identified with labor's concern for a safe workplace, had assumed director- ship of OSHA. Committed to adoption of rigorous standards to protect all workers, including fertile women who had been faced with exclusionary hiring practices (see gingham, in this volume), gingham found the initial OSHA proposals weak. That OSHA had become disenchanted with its own proposal was clear from the testimony ofthe experts it brought forth on its own behalf. In almost every instance, calls were made by OSHA's expert witnesses for standards significantly more restrictive than those proposed in 1975. OSHA's primary witness on the effects of blood lead levels on the nervous system, Finnish researcher Anna Seppalainen, concluded that there were significant effects on the peripheral nervous system when blood lead levels exceeded 50 ,ug/ 100 ml of blood (OSHA, 1977, p. 1231. Richard Wideen, testifying on renal function, asserted that blood lead levels above 40 ,ug posed a risk to the capacity of kidney function (OSHA, 1977, p. 17321. Vilma Hunt, citing the data on lead's impact on children, asserted: "If there is any good that can come from calamity, we now know that the biological response to lead of a heterogeneous population of children is increasingly manifest as pathologi- cal changes when the blood lead levels rise to 30 ,ug/100 ml. Until we can show that all workers are different from all children in their response to lead exposure, we are obliged to use those tragic data for the protection of all" (OSHA, 1977, p. 661~. Involved here was not simply an empirical redefinition of the toxic effects of lead but a transformation of the very concept of acceptable risk, a decreased tolerance for biological changes with potentially important conse- quences for health. Commenting on this shifting perspective, R. L. Zielhuis (1979) noted: "To take into account factors which are not detectable by normal clinical methods and which are not known to give rise to any long- term clinical effects, represents a change in philosophy as to what is or is not acceptable." This shift in philosophical perspective was clearly reflected in the testi- mony of Sergio Pionelli, Director of the Pediatric Hematology Unit at New York University. Starting from the fact that the alteration in hemesynthesis produces no subjective evidence of impairment of health unless it reaches extreme depression in severe lead intoxication, he concluded, "I do not believe that it is any longer possible to restrict the concept of health to the individual's subjective lack of feeling of adverse effects. This is because we know that individuals may get adjusted to suboptimal health and believe they are well.... We have moved from restrictive medicine to a functional preventive medicine. It is the responsibility of preventive medicine to detect those alterations which may precede frank symptomatology and to prevent their occurrence" (OSHA, 1977, p. 4644.

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70 RONALD Bed Although there was some divergence of opinion about the appropriate level of ambient lead exposure not surprising, given the uncertainty about the way in which lead directly affects the body burden most of those who testified on behalf of OSHA saw the proposed standard of 100 ,ug/m3 of air as unacceptable (OSHA, 1977, p. 4891. Central to OSHA's position on the protection of workers exposed to lead was the determination that engineering controls had to provide the first line of defense forthose at risk. Although it acknowledged that the use of protect- ive equipment and administrative efforts might be necessary to supplement the control of ambient lead levels in air, they were viewed as inherently less effective and socially less desirable (OSHA, 1975, p. 459401. As a result, OSHA, in this instance as in other cases affecting the potential threat to exposed workers, stressed the importance of redesigning the workplace to protect the health of workers. In some cases such efforts would entail retro- fitting, in others the building of new plants. Finally OSHA believed it had an obligation to force the development of new technologies when necessary. But was such a strategy feasible? OSHA's primary engineering witness, Melvin First of Harvard Univer- sity, put forward an exceptionally optimistic picture on prospects for reduc- ing lead exposure through engineering controls. "Every operation that can be mechanized and automated is capable of being enclosed by tight physical barriers and placed under slight negative pressure to prevent outleakage of dust or fume-ladened air" (OSHA, 1977, p. 22301. The prospect of major financial outlays would, he believed, provide the industry with an incentive to design improved and less costly control methods. The clash that occurred between First and Caplan during the hearings is revealing. Caplan's attention to the details of the lead industry production process was intended to demonstrate that First grasped neither the technical nor the economic dimensions of the problems posed for an industry being challenged by government regulation. To First's assertions that industry could technically achieve the standards of protection being proposed by OSHA, Caplan responded, "Yes, but you were leaving cost out of here" (OSHA, 1977,p.23501. First acknowledged the importance of economic considerations in all engineering efforts but asserted that Caplan had overes- timated the costs that would be generated by OSHA's regulations (OSHA, 1977,p.23701. As OSHA was pressed by its own witnesses to enact a stricter standard, labor's representatives also expressed their dissatisfaction with the early proposal. Leonard Woodcock of the United Auto Workers thus asserted: "I must say that if high body-burdens of lead cause anemia and low levels of lead disrupt the production of blood, then we want protection from low levels.... If it is known that high levels of lead cause kidney failure and low

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OCCUPaTIONaL EXPOSURE AND THE LED STANDARD 71 levels cause kidney damage, then we want protection from low levels" (OSHA, 1977, p. 50401. Like Lloyd McBride of the United Steelworkers (OSHA, 1977, p.2959), Woodcock demandedlowerexposurelevelstolead and argued that no more than 40 ,ug would be tolerable (OSHA, 1977, p. 29591. For Sol Epstein, testifying on behalf of the AFL-CIO, the OSHA standard failed to meet the requisite criterion of providing a margin of safety adequate to protect all workers (OSHA, 1977, p. 50411. For those urging OSHA to adopt very restrictive standards for lead levels in air and in blood, the burdens of uncertainty were not to be borne by workers but by the lead industry. Ambiguity regarding scientific data was to be acknowledged but not used as a subterfuge for inaction. Sidney Wolf, testifying on behalf of the Public Citizen's Health Research Group, thus stated: "The Health Research Group does not claim that all of the suspected effects . . . will necessarily be proven by future research . . . [but] if a doubt exists as to the danger of long-term exposure to lead, that doubt must be resolved in favor of the workers" (OSHA, 1977, p. 41351. Woodcock stressed the disjunction between what he saw as the level of protection afforded to the public under conditions of uncertainty and that provided to workers. "Our members are troubled when it is explained to them that a food additive or pesticide must be proven to be safe as it is used, whereas an industrial chemical must be proven harmful before it can be regulated" (OSHA, 1977, p. 50411. Emblematic of how differently uncertainty might be viewed and used in regulation of toxic substances is the response evoked by one important study that detailed the morbidity end mortality of workers exposed to lead. For the lead industry, the Cooper-Gaffey study (1975), which it had sponsored, proved that current levels of exposure to lead and conventional appreciations of the pathological consequences of lead toxicity posed no risk to workers (Lead Industries Association, 1976, p. 441. For Sidney Wolf, however, that same study suggested the need for regulation and reform: "Though not statistically significant, the standard mortality ratios for major cardiovascu- larand renal disease were increased" (OSHA, 1977, p. 41341. Most important to labor and recognized by OSHA at the outset of its hearings was the necessity of a provision for medical removal protection with rate retention for those whose blood lead levels rose above the maxi- mum permissible levels. Such a provision would mandate the removal of workers whose blood lead levels indicated that they are at risk to jobs that involve no lead exposure; if no such job is available, workers are to be given leave. In either case, such workers would continue to receive their current wages without loss of seniority rights. Only such a provision that would guarantee, at whatever cost, the earning capacity of workers whose health required that they be removed from exposure to lead would be effective and

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72 RONALD Bed equitable. Without rate retention, workers would refuse to participate in medical surveillance programs so crucial to the standard. Without rate reten- tion, workers with elevated blood lead levels would be forced to bear the economic burdens of toxicity (OSHA, 1977, p. 10351. "A worker with excessive blood lead levels should not have to suffer the additional indignity of being unable to support a family" (OSHA, 1977, p.29671. Labor's representatives were mindful that an adequate standard of protection-one that would include medical removal protection with rate retention would create added social costs in the production of lead. But from their perspective it was wrong to ask workers to bear the burden of disease so that the cost of lead products could be kept down. "We just cannot expect a group of employees to be put on a sacrificial table because we happen to need lead and because it is a vital metal and we cannot do without it" (OSHA, 1977, p.29711. THE FINAL LEAD STANDARD When at last OSHA issued its final standard in November 1978, the result was a set of regulations far stricter than those initially prepared and indeed stricter than many advocates of reform had anticipated. The acceptable limits for blood lead levels were reduced from 60,ug to 40,ug/ 100 g (OSHA, 1978a, p.529541; the permissible air lead level was reduced from 100 fig to 50,ug/m3 (OSHA, 1978a, p. 529631. Medical removal protection with rate retention was mandated (OSHA, 1978a, p.529731. Based on a model of the interaction of blood lead levels and air exposure developed by the Center for Policy Alternatives at the Massachusetts Insti- tute of Technology, OSHA believed it had resolved the issue of scientific uncertainty that had plagued the hearings on the proposed lead standard (OSHA, 1978a, p. 529631. That formulation, an adaptation of the Bernard model, provided a mathematical basis for asserting that protection of work- ers required not only reduction of the prevailing 200,ug standard but that the initially proposed 100 ,ug standard be reduced by half. But even that very strict standard represented a compromise between the demands posed by the goal of worker health and the economic and technological feasibility of modifying the production process. OSHAjs model indicated that, at a 50,ug lead level, 29.3 percent of exposed workers would have blood lead levels above the 40 ,ug/100 g established as providing the necessary margin of safety (OSHA, 1978a, p.529631. Despite its commitment to engineering controls, OSHA recognized that to achieve the mandated reduction in blood lead levels it would be necessary, for an interim period, to rely on protective equipment for workers and a

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OCCUP~IONAlL EXPOSURE AIND THE LEAD STAINDAlRD 73 variety of administrative devices to limit exposure of workers to airborne lead. Massive investments over an extended period would be needed to achieve the necessary reduction in air lead levels. Extended periods would be required for redesign of the production process. The primary lead indus- t~ was given 10 years to achieve the engineering controls necessary to reach the mandated airlead levels, and the secondary lead smelter and lead battery industries were given five years (OSHA, 1978a, p. 530081. Even the imple- mentation schedule for the medical removal protection was to reflect the limits imposed by the complex tasks involved in the modification of lead production (OSHA, 1978a, p. 529741. Rejecting the counsel of those who argued that the lead industry could not so radically transform itself, OSHA asserted that its commitment to the health of workers required it to act as an agent of technological change. Thus, in the primary lead smelting industry, OSHA believed that the health of workers ultimately would make it necessary to replace pyrotechnology by hydrotechnology (OSHA, 1978b, p. 54480), although there was only lim- ited evidence to suggest the feasibility of such a transformation. From a societal perspective, the demands that were to be placed on the lead industry and ultimately on the consumers of its products could be defended on both moral and economic grounds. The toll that would be generated by a failure to impose stringent controls would create private burdens on those least able to bear them- workers and their families. The most elemental principles of equity thus could be called on to redistribute those burdens by increasing the social costs of lead production. Further- more, a failure to control the intoxication associated with exposure of work- ers to lead, and even the risks of such intoxication, would generate medical and social costs that would not be reflected in the costs of lead production. The OSHA standard thus could be justified as entailing the internalization of the negative externalities associated with work in the lead industry. From the point of view of the industry, however, and especially of those firms that might be forced to close because of inability to meet the costs associated with implementing the OSHA standard, the new regulations appeared not only unfair but also irrational. The inherent tension between the private sector and the public is thus acutely underscored. It is not surpris- ing, therefore, that engineers speaking on behalf of the industry and particu- lar finds would find the final OSHA lead standard unacceptable and infeasl- ble. Nor is it surprising that the LIA sought to thwart the OSHA decision by appealing to the courts where it charged OSHA with failing to meet the administrative requirement that standards be based on a rational consider- ation of scientific evidence and the feasibility of implementation. When the District of Columbia Court of Appeals delivered its decision on

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74 RONALD BAYER August 15, 1980, it upheld the OSHA lead standard with minor exceptions involving the adequacy of some of the feasibility studies upon which deci- sions were based for marginal elements of the industry. The court acknowl- edged the difficulty in reviewing standards that require the application of a "substantial evidence test" to regulations that it viewed as essentially legis- lative. Agencies were compelled, the court held, to make "inferences from complex scientific and factual data," and "such determinations necessarily involved highly speculative projections of technological development in areas wholly lacking in scientific and economic certainty" (United Steel- workers of America, AFL-CIO v. MarshallD. Faced with such uncertainty, it was for OSHA and not the court to weigh the potential burdens associated with alternative policy options. Despite legal delays and variances granted in recent years for political and technological reasons, there already is clear indication that the lead standard has begun to reduce the burden of lead in the bodies of workers. In a report prepared for the Office of Technology Assessment on the impact of the standard (Goble et al., 1983), four broad conclusions were reached: 1. Blood lead levels of workers have declined in primary and secondary smelt- ers and in battery plants. Thus, the number of workers with blood lead levels over 40 ~g/100 g had been reduced by about one-third. Blood levels over 80 ,ug/100 g, which had been found in earlier studies in 16 percent of workers in the secondary smelting industry, 6 percent of workers in battery plants, and 2 percent in primary smelters, were practically unobserved in workers in the post-standard period. Finally, dramatic changes in the proportion of workers found to have blood lead levels in the 60-80 fig/ 100 g range had also been observed. 2. Although airlead levels in plants had dropped, a 50 ,ug/m3 level had not been reached in either secondary or primary smelters or in battery plants. Indeed, in primary and secondary smelters compliance with the 200 ,ug level had not yet been achieved. 3. Interestingly, the reduced body burden of lead that had been found in workers was not solely a consequence of OSHA's efforts. Between 30 percent and 50 percent of the observed reduction in blood lead levels could be attributed to the impact of regulations adopted by the Environmental Protection Agency (EPA). 4. The costs of medical removal protection, by forcing an internalization of the costs associated with elevated blood lead levels, had been a driving force for change, creating an economic incentive for the reduction in airlead levels. How far change will progress in the current political and economic climate is unknown. Efforts by industry representatives to force a reopening of the issue of the health effects of lead exposure have been resisted by the profes- sional staff of OSHA, although it has come to believe that the feasibility of developing engineering controls to attain a 50 ,ug level is increasingly remote, especially given the financial structure of the lead industry.

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OCCUP~ION~L EXPOSURE AND THE LED STANDARD CONCLUSIONS 75 In its evaluation of the efforts of both EPA and OSHA to regulate exposure to lead, the National Research Council has underscored the extent to which regulatory agencies faced with politically contested alternatives have at times sought to justify their actions by reliance on the protective mantle of value-free science (National Research Council, l98O). Although OSHA explicitly acknowledged that it could not wait for the resolution of the full range of scientific controversies surrounding the health effects of lead before issuing its standard, it did seek to ground its much-disputed limit on expo- sure to lead in air on a mathematical model. For the National Research Council, however, "The data base that supported [both the EPA and OSHA] models was small, and neither the exact form of the mathematical function nor the slope of the resulting curve [could] be determined with great accu- racy" (National Research Council, i980, p. 2131. That OSHA had sought to provide a scientifically objective basis for its policy determinations should come as no surprise. Like other regulatory bodies, either because of demands placed upon them or because of the ideological commitments ofthe scientists upon whom they rely, OSHA must adopt a posture in which the tasks of hazard evaluation and risk assessment are viewed as above politics and the influence of social values. The contro- versy surrounding regulation of lead demonstrates, however, that even the putatively technical tasks of hazard evaluation and risk assessment inevita- bly involve judgments that are social and moral. As a consequence, they, as much as the more explicitly political tasks of risk management and regula- tion, must be judged within a broad ethical framework that has at its core the issue of distributive justice. Thus, the widely read report of the National Research Council Committee on the Institutional Means for the Assessment of Risks to Public Health, Risk Assessment in the Federal Government: Managing the Process, which attempts to draw a sharp distinction between the value-free task of risk assessment and the value-laden task of policymak- ing,~must be viewed as flawed and as an oversimplification. Because scientists, engineers, and other professionals are asked to make determinations on the basis of data that are of highly variable quality with often ambiguous implications for policy and regulation, it is inevitable that the interpretations will be affected by social and political interests (Crandall and Lave, 19811. In the struggle over adoption of a lead standard, scientists confronted each other as partisans. For some, this was an unseemly encoun- ter. If the perspective presented in this paper is correct, however, such conflicts must be viewed as unavoidable. Indeed, efforts to eliminate them can result only in a process of obfuscation one ~ which social values and interests will be masked.

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76 RONALD BAYER None of this is to make the practice of science irrelevant to occupational health. It is rather to make the sociopolitical context within which science is asked to collaborate more than the sideshow so hoped for by those guided by positivist dreams. REFERENCES Cooper, W. C., and W. R. Gaffey. 1975. Mortality of lead workers. Journal of Occupational Medicine 100:7. Corn, M. 1976. Lead poisoning in industry. American Journal of Public Health 66:531-532. Crandall, R., and L. Lave, eds. 1981. The Scientific Basis of Health and Safety Regulation. Washington, D.C.: Brookings Institution. Goble, R., D. Hattis, D. Thurston, and M. Ballew.1983. Implementation of the Occupational Lead Exposure Standard. Report to the Office of Technology Assessment. November. Mimeo. Hattis, D. R., R. Goble, and N. Ashford. 1982. Airborne lead: a clearcut case of differential protection. Environment24:14-42. Hunt, V. 1979. Work and the Health of Women. Boca Raton, Fla.: CRC Press. Lead Industries Association. 1976. Comments, objections and a summary of evidence by the Lead Industries Association to the proposed standard for exposure to lead. January 16, 1979. Mimeo. Levine, R. J., R. M. Moore, and G. O. McLaren. 1976. Occupational lead poisoning, animal deaths and environmental contamination at a scrap smelter. American Journal of Public Health 66:548-552. National Institute for Occupational Safety and Health (NIOSH). 1972. Criteria for a Recom- mended Standard. Occupational Exposure to Inorganic Lead. National Institute for Occupational Safety and Health. 1978. Criteria for a Recommended Standard. Occupational Exposure to Inorganic Lead, Revised Criteria-1978. National Research Council. 1980. Lead in the Human Environment. Committee on Lead in the Human Environment. Washington, D.C.: National Academy of Sciences. National Research Council.1983. Risk Assessment in the Federal Government: Managing the Process. Committee on the Institutional Means for the Assessment of Risks to Public Health. Washington, D.C.: National Academy Press. Occupational Safety and Health Administration (OSHA). 1975. Lead. Occupational Expo- sure; Proposed Standard. Federal Register (October 3) :45934. Occupational Safety and Health Administration. 1977. Informal Public Hearings on Proposed Standard for Exposure to Lead, Transcript of Proceedings. Docket No. H004. Occupational Safety and Health Administration. 1978a. Occupational Exposure to Lead, Final Standard. Federal Register (November 14):52952-53014. Occupational Safety and Health Administration. 1978b. Occupational Exposure to Lead, Attachment to the Preamble for the Final Standard. Federal Register (November 21) :54480. Proceedings of 1974 Lead Industries Association Conference. 1975. Standards for occupa- tional lead exposure. Journal of Occupational Medicine 17:95. United Steelworkers of America, AFL-CID v. ~ Ray Marshall, 647 Fed. 2d 189 (1980). Zielhuis, R. L. 1979. Second International Workshop on Permissible Levels for Occupational Exposure to Inorganic Lead. International Archives of Occupational and Environmental Health 39:59-72.