Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 65 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. 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 commitment to protecting the most vulnerable groups within the working population (see Bingham, 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 µg 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 specification of a precise air lead level at which workers exposed to lead would have a mean blood level of 40 µg/100 g and a maximum blood level of 60 µg/100 g. NIOSH had indicated that something below 150 µg but above 50 µg 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 subclinical effects be considered in setting appropriate margins of safety? (2) Does the air lead level of 100 µg/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 preliminary OSHA standard, that hearings were held to elicit public reaction. This setting provided an occasion for representatives of industry, labor, government, 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
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 66 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. 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 µg/100 g, with a mean of 40 µg/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 confirmed by multiple investigators. To do this would place the recommendations of a blood level in the workplace on less than firm ground" (NIOSH, 1978, p. XII-18). 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 industry'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 appropriateness 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 µg/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 µg/100 g" (Lead Industries Association, 1976, p. 17). 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
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 67 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. 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 2â3 cases of anemia where blood lead levels exceeded 80 µmg/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. 1886). 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. 1886). Unlike the proposed standard, which suggested the importance of considering subclinical 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 µg/100 g" (OSHA, 1977, p. 3094). 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 methodological 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, 4183). The industry also rejected OSHA's assertion that a meaningful relationship could be drawn between ambient air lead levels and blow 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. 47). Kenneth Nelson of ASARCO, Inc. (formerly the American Smelting & Refining Company) a former president of the Industrial Hygiene Association and a founder of the Academy of Industrial Hygiene, emphasized 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. 4032). 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.
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 68 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. As a consequence, industry'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 reasonable approach to the control of lead intoxication (Lead Industries Association, 1976, p. 52). But if an environmental standard were established, the appropriate level should be 200 µg rather than the 100 µg proposed by OSHA (Lead Industries Association, 1976, p. 76). This point was made by Jerome Cole, Director of Environmental Health for the Lead Industries Association. Acknowledging that "few, if any," major segments of the lead industry complied with the existing OSHA standard of 200 µg, 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 consistently with the present air lead requirements" (OSHA, 1977, p. 3017). Faced with indeterminant data on health 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 Association, 1976, p. 52). Finally, the lead industry questioned OSHA's assumption regarding the feasibility of the proposed standard. Knowlton Caplan, a prominent industrial engineer, was relied upon by industry to make its case. The cost estimates of the economic consulting firm hired by OSHA and the results of OSHA's own economic and technological analysis were subjected to challenge (OSHA, 1977, p. 3923). Said Caplan: "I believe that there are portions of the secondary and primary lead smelting industry that will not be able to achieve the goal of 100 µg/m3 of lead per cubic meter of air" (OSHA, 1977, p. 3931). He even doubted the capacity of segments of the industry to achieve the 200 µg 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. 3856). The picture of an unreasonable government attempt at control thus emerged. Michael Williams captured the spirit of the industry'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 µg/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 sufficiently restrictive. In the period between the publication of OSHA's initial standard in 1975 and the public hearings in 1977, Eula Bingham, closely
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 69 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. identified with labor's concern for a safe workplace, had assumed directorship of OSHA. Committed to adoption of rigorous standards to protect all workers, including fertile women who had been faced with exclusionary hiring practices (see Bingham, in this volume), Bingham found the initial OSHA proposals weak. That OSHA had become disenchanted with its own proposal was clear from the testimony of the 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 µg 100 ml of blood (OSHA, 1977, p. 123). Richard Wideen, testifying on renal function, asserted that blood lead levels above 40 µg posed a risk to the capacity of kidney function (OSHA, 1977, p. 1732). 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 pathological changes when the blood lead levels rise to 30 µg/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 consequences 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 testimony 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. 464).
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 70 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. Although there was some divergence of opinion about the appropriate level of ambient lead exposureânot surprising, given the uncertainty about the way in which lead directly affects the body burdenâmost of those who testified on behalf of OSHA saw the proposed standard of 100 µg/m3 of air as unacceptable (OSHA, 1977, p. 489). 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 for those at risk. Although it acknowledged that the use of protective 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. 45940). 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 retrofitting, 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 University, put forward an exceptionally optimistic picture on prospects for reducing 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. 2230). 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. 2350). First acknowledged the importance of economic considerations in all engineering efforts but asserted that Caplan had overestimated the costs that would be generated by OSHA's regulations (OSHA, 1977, p. 2370). 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
SCIENTISTS, ENGINEERS, AND THE BURDENS OF OCCUPATIONAL EXPOSURE: 71 THE CASE OF THE LEAD STANDARD original typesetting files. Page breaks are true to the original; line lengths, word breaks, heading styles, and other typesetting-specific formatting, however, cannot be About this PDF file: This new digital representation of the original work has been recomposed from XML files created from the original paper book, not from the retained, and some typographic errors may have been accidentally inserted. Please use the print version of this publication as the authoritative version for attribution. levels cause kidney damage, then we want protection from low levels" (OSHA, 1977, p. 5040). Like Lloyd McBride of the United Steelworkers (OSHA, 1977, p. 2959), Woodcock demanded lower exposure levels to lead and argued that no more than 40 µg would be tolerable (OSHA, 1977, p. 2959). 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. 5041). 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. 4135). 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. 5041). 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 and 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. 44). For Sidney Wolf, however, that same study suggested the need for regulation and reform: "Though not statistically significant, the standard mortality ratios for major cardiovascular and renal disease were increased" (OSHA, 1977, p. 4134). 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 maximum 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
