Opinion ID: 584066
Heading Depth: 2
Heading Rank: 2

Heading: significant risk of material health impairment

Text: 22 Section 3(8) of the OSH Act defines occupational health and safety standard as a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment. 29 U.S.C. § 652(8) (emphasis added). The Supreme Court has interpreted this provision to require that, before the promulgation of any permanent health standard, OSHA make a threshold finding that a significant risk of material health impairment exists at the current levels of exposure to the toxic substance in question, Benzene, 448 U.S. at 614-15, 642, 100 S.Ct. at 2850-51, 2864; ATMI, 452 U.S. at 505-06, 101 S.Ct. at 2488-89, 13 and that a new, lower standard is therefore 'reasonably necessary or appropriate to provide safe or healthful employment and places of employment.'  Benzene, 448 U.S. at 615, 100 S.Ct. at 2850. OSHA is not entitled to regulate any risk, only those which present a significant risk of material health impairment. Id. at 641-42, 100 S.Ct. at 2863-64. OSHA must therefore determine: (1) what health impairments are material, Texas Independent Ginners, 630 F.2d at 407, and (2) what constitutes a significant risk of such impairment, Benzene, 448 U.S. at 641-42, 655, 100 S.Ct. at 2863-64, 2870-71. Moreover, OSHA ultimately bears the burden of proving by substantial evidence that such a risk exists and that the proposed standard is necessary. Id. at 653, 100 S.Ct. at 2869-70. The agency has no duty to calculate the exact probability of harm, id. at 655, 100 S.Ct. at 2870-71, or to support its finding that a significant risk exists with anything approaching scientific certainty, id. at 656, 100 S.Ct. at 2871. However, OSHA must provide at least an estimate of the actual risk associated with a particular toxic substance, see Public Citizen Health Research Group v. Tyson, 796 F.2d 1479, 1502-03 (D.C.Cir.1986), and explain in an understandable way why that risk is significant. Benzene, 448 U.S. at 646, 100 S.Ct. at 2866. 14 In past rulemakings, OSHA has satisfied this requirement by estimating either the number of workers likely to suffer the effects of exposure or the percentage of risk to any particular worker. 15 See ATMI, 452 U.S. at 503, 505 n. 25, 101 S.Ct. at 2487-88, 2870-71 n. 25; Building & Constr. Trades Dept., AFL-CIO v. Brock, 838 F.2d 1258, 1263 (D.C.Cir.1988); Public Citizen, 796 F.2d at 1502; ASARCO, Inc. v. OSHA, 746 F.2d 483, 488 (9th Cir.1984). 23 Once OSHA finds that a significant risk of material health impairment exists at current exposure levels for a given toxic substance, any standard promulgated to address that risk must comply with the requirements of section 6(b)(5) of the OSH Act. 29 U.S.C. § 655(b)(5). That section provides that the agency 24 in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired. 25 Id. (emphasis added). In other words, section 6(b)(5) mandates that the standard adopted prevent material impairment of health to the extent feasible. ATMI, 452 U.S. at 512, 101 S.Ct. at 2492 (emphasis omitted).
26 In this rulemaking, OSHA grouped the 428 substances into eighteen categories by the primary health effects of those substances, for example, neuropathic effects, sensory irritation, and cancer. See 54 Fed.Reg. at 2402-03. Industry petitioners charge that for several categories of substances OSHA failed to adequately justify its determination that the health effects caused by exposure to these substances are material impairments. We disagree. 27 Petitioners cite the category of sensory irritation as a particularly egregious example. Id. at 2434. At the beginning of the discussion for each category, the agency summarized the types of health effects within that category, and discussed why those effects constituted material impairments. The Description of Health Effects for the sensory irritation category includes the following discussion: 28 The symptoms of sensory irritation include stinging, itching, and burning of the eyes, tearing (or lacrimation), a burning sensation in the nasal passages, rhinitis (nasal inflammation), cough, sputum production, chest pain, wheezing, and dyspnea (breathing difficulty).... 29 These effects may cause severe discomfort and can be seriously disabling, as is the case with dyspnea or wheezing. The tearing and eye irritation associated with exposure to sensory irritants are often severe and can be as disabling as the weeping caused by exposure to tear gas. In addition to these primary effects, workers distracted by material irritant effects are more likely than nonexposed workers to have accidents and thus to endanger both themselves and others. (These adverse health effects also clearly have substantial productivity impacts.) 30 .... 31 During the rulemaking, the question arose as to the level of irritation that constitutes a significant risk of material impairment.... Some commenters were of the opinion that transient irritant effects should not be considered material impairment of health.... 32 Most commentators, however, recommended that these signs and symptoms be regarded as material health impairments.... 33 .... 34 ... [A]ccording to NIOSH 16 sensory irritants interfere with job performance and safety, cause inflammation, may increase the victim's susceptibility to other irritants and infectious agents, lead to permanent injury or dysfunction, or permit greater absorption of hazardous substances. 35 .... 36 OSHA concludes that exposure limits are needed for those substances for which PELs are being established in this rulemaking to protect against sensory irritant effects that result in objective signs of irritation, such as coughing, wheezing, conjunctivitis, and tearing. Such levels of mucous membrane irritation may require medical treatment, adversely affect the well-being of employees, and place the affected individuals at risk from increased absorption of the substance and decreased resistance to infection. Exposing workers repeatedly to irritants at levels that cause subjective irritant effects 17 may cause workers to become inured to the irritant warning properties of these substances and thus increase the risk of overexposure. 37 54 Fed.Reg. at 2444-45 (citations omitted). In addition, in the more general discussion of OSHA's approach to this rulemaking, OSHA also recognized that 38 irritation also covers a spectrum of effects, some serious and some trivial. Hence, complaints of minor irritation would not in and of itself constitute material impairment. 39 In addition, OSHA would weigh irritation with physical manifestations more heavily than irritation with purely subjective responses. This does not mean that purely subjective responses would not constitute material impairment. That judgment would depend on the magnitude of the irritation. 40 Id. at 2362. We interpret this explanation as indicating that OSHA finds that although minor irritation may not be a material impairment, there is a level at which such irritation becomes so severe that employee health and job performance are seriously threatened, even though those effects may be transitory. We find this explanation adequate. OSHA is not required to state with scientific certainty or precision the exact point at which each type of sensory or physical irritation becomes a material impairment. Moreover, section 6(b)(5) of the Act charges OSHA with addressing all forms of material impairment of health or functional capacity, and not exclusively death or serious physical harm or grave danger from exposure to toxic substances. See 29 U.S.C. §§ 654(a)(1), 655(c). Overall, we find that OSHA's determinations of what constitute material impairments are adequately explained and supported in the record.
41 However, the agency's determination of the extent of the risk posed by individual substances is more problematic. No one could reasonably expect OSHA to adopt some precise estimate of fatalities likely from a given exposure level, and indeed the Supreme Court has said that the agency has 'no duty to calculate the exact probability of harm.'  International Union, UAW v. Pendergrass, 878 F.2d 389, 392 (D.C.Cir.1989) (quoting Benzene, 448 U.S. at 655, 100 S.Ct. at 2870-71). Nevertheless, OSHA has a responsibility to quantify or explain, at least to some reasonable degree, the risk posed by each toxic substance regulated. See id. (OSHA necessarily seeks to quantify the risk posed by each toxic threat. (Emphasis added.)); see also Benzene, 448 U.S. at 614-15, 100 S.Ct. at 2849-50 (We agree ... that § 3(8) requires the Secretary to find, as a threshold matter, that the toxic substance in question poses a significant health risk.... (Emphasis added.)). Otherwise, OSHA has not demonstrated, and this court cannot evaluate, how serious the risk is for any particular substance, or whether any workers will in fact benefit from the new standard for any particular substance. If each of these 428 toxic substances had been addressed in separate rulemakings, OSHA would clearly have been required to estimate in some fashion the risk of harm for each substance. OSHA is not entitled to take short-cuts with statutory requirements simply because it chose to combine multiple substances in a single rulemaking. 42 However, OSHA's discussions of individual substances generally contain no quantification or explanation of the risk from that individual substance. 18 The discussions of individual substances contain summaries of various studies of that substance and the health effects found at various levels of exposure to that substance. However, OSHA made no attempt to estimate the risk of contracting those health effects. Instead, OSHA merely provided a conclusory statement that the new PEL will reduce the significant risk of material health effects shown to be caused by that substance, see, e.g., 54 Fed.Reg. at 2508 (bismuth telluride), without any explanation of how the agency determined that the risk was significant. However, OSHA did make a generic finding that the Air Contaminants Standard as a whole would prevent 55,000 occupational illnesses and 683 deaths annually. Id. at 2725. 43 Moreover, a determination that the new standard is reasonably necessary or appropriate, 29 U.S.C. § 652(8), and that it is the standard that most adequately assures ... that no employee will suffer material impairment of health or functional capacity, id. § 655(b)(5), necessarily requires some assessment of the level at which significant risk of harm is eliminated or substantially reduced. See Benzene, 448 U.S. at 653, 100 S.Ct. at 2869-70. Yet, with rare exceptions, the individual substance discussions in the Air Contaminants Standard are virtually devoid of reasons for setting those individual standards. In most cases, OSHA cited a few studies and then established a PEL without explaining why the studies mandated the particular PEL chosen. For example, the PEL for bismuth telluride appears to be based on a single study that showed almost no effects of any kind in animals at several times that concentration. 54 Fed.Reg. at 2508. Similarly, the PEL for ferrovanadium dust was based on pulmonary changes at exposure levels many hundreds of times higher than OSHA's new standard. Id. at 2510. See also, e.g., iron pentacarbonyl, id. at 2412; cesium hydroxide, id. at 2455; iron salts, id. at 2466; ethylene dichloride, id. at 2484; sulfur tetrafluoride, id. at 2526. For some substances, OSHA merely repeated a boilerplate finding that the new limit would protect workers from significant risk of some material health impairment. For example, OSHA did not cite any studies whatsoever for its aluminum welding fume standard, id. at 2554, or its vegetable oil mist standard, id. at 2601. See also, e.g., starch, id. at 2599-2600. 44 While our deference to the agency is at a peak for its choices among scientific predictions, we must still look for some articulation of reasons for those choices. Pendergrass, 878 F.2d at 392 (emphasis added). 45 Explicit explanation for the basis of the agency's decision not only facilitates proper judicial review but also provides the opportunity for effective peer review, legislative oversight, and public education. This requirement is in the best interest of everyone, including the decision-makers themselves. If the decision-making process is open and candid, it will inspire more confidence in those who are affected. Further, by opening the process to public scrutiny and criticism, we reduce the risk that important information will be overlooked or ignored. 46 AFL-CIO v. Marshall, 617 F.2d at 651-52. Mere conclusory statements, such as those made throughout the Air Contaminants Standard, are simply inadequate to support a finding of significant risk of material health impairment. 47 On the other hand, OSHA established PELs for carbon tetrachloride and vinyl bromide, both carcinogens, at levels where OSHA itself acknowledged that the risk of material health impairment remained significant. 54 Fed.Reg. at 2679-80, 2694. For carbon tetrachloride, OSHA stated that at the new level, residual risk continues to be significant ... 3.7 excess deaths per 1,000 workers exposed over their working lifetimes. Id. at 2680. For vinyl bromide, OSHA stated that the new PEL will not eliminate this significant risk, because ... residual risk [at the new level] is 40 excess deaths per 1,000 exposed workers ... [and thus] is clearly significant. Id. at 2694. The only explanation given by OSHA in the final rule for setting its standard where a significant risk of material health impairment remains was that the time and resource constraints of attempting to promulgate an air contaminants standard of this magnitude prevented detailed analysis of these substances. See id. at 2363, 2694. 19 OSHA did not claim in the final rule that the PELs for these two substances were necessary because of feasibility concern. 20 48 The agency's response to this criticism is unpersuasive. OSHA first contends that quantitative risk analysis using mathematical models like the ones developed for carcinogens was impossible for this rulemaking because no such models exist for noncarcinogens. 49 Dose-response models 21 have often been used in the quantitative assessment of the risks associated with exposures to carcinogenic substances. However, less scientific effort has been devoted to models to be used with non-carcinogenic substances. Mathematically precise methods to establish the true no-effect level or to define the dose-response curves have not been developed for most of the more than 400 substances involved in this rulemaking. 50 Most of the scientific work that has been done was designed to identify lowest observed effect or no-effect levels for a variety of acute effects.... It is possible to use these data, combined with professional judgment and OSHA's expertise and experience, to determine that significant risk exists at current levels of exposure and that a reduction in these levels will substantially reduce this risk of material impairment of health. 51 54 Fed.Reg. at 2399-2400. Yet, in several previous rulemakings, OSHA apparently succeeded in determining how many workers were exposed to a particular substance or how much risk would be alleviated by a new standard, even though those particular substances were not carcinogens. See United Steelworkers, 647 F.2d at 1245-51 (lead poisoning); AFL-CIO v. Marshall, 617 F.2d at 646 (byssinosis caused by cotton dust); see also Building & Constr., 838 F.2d at 1263 (asbestosis and cancer). It is therefore unclear whether the lack of a method to quantitatively assess the risk for noncarcinogens is a cause or a result of the agency's approach. In this rulemaking, OSHA concluded that current exposure to 428 substances posed a significant risk of material health impairment, and that its new standards were required for most of these substances to eliminate or substantially reduce that risk. It is not unreasonable to require that the agency explain how it arrived at that determination, and, indeed, this is precisely what Congress required. 52 The agency further claims that no quantification was required because OSHA's final standards  'fall[ ] within a zone of reasonableness.'  OSHA Brief at 40-41 (quoting United Steelworkers, 647 F.2d at 1207). However, without any quantification or any explanation, this court cannot determine what that zone of reasonableness is or if these standards fall within it. 53 OSHA also responds by noting that it incorporated uncertainty or safety factors into many PELs. However, OSHA did not use a uniform safety factor, but instead claims to have made a case-by-case assessment of the appropriate safety factor. 54 Fed.Reg. at 2398-99. Studies are often of small size and, since there is a large variation in human susceptibility, a study because of its small size may not demonstrate an effect that actually exists....  For this reason, it is not uncommon to set a limit below that level which the study may have indicated showed no effect. Id. at 2365. OSHA claims that use of such uncertainty factors has been the standard approach for recommending exposure limits for non-carcinogens by scientists and health experts in the field for many years. Id. In this rulemaking, the difference between the level shown by the evidence and the final PEL is sometimes substantial. We assume, because it is not expressly stated, that for each of those substances OSHA applied a safety factor to arrive at the final standard. Nevertheless, the method by which the appropriate safety factor was determined for each of those substances is not explained in the final rule. 54 We find OSHA's use of safety factors in this rulemaking problematic. First, OSHA's use of safety factors in this rulemaking is very similar to the approach criticized by the Supreme Court in Benzene. Second, even assuming that the use of safety factors is permissible under the Act and Benzene, application of such factors without explaining the method by which they were determined, as was done in this case, is clearly not permitted. 55 From OSHA's description, safety factors are used to lower the standard below levels at which the available evidence shows no significant risk of material health impairment because of the possibility that the evidence is incorrect or incomplete; i.e., OSHA essentially makes an assumption that the existing evidence does not adequately show the extent of the risk. That may be a correct assumption, but beyond a general statement that the use of safety factors is common in the scientific community, OSHA did not indicate how the existing evidence for individual substances was inadequate to show the extent of the risk from those substances. Such a rationale is very reminiscent of the benefits are likely to be appreciable rationale rejected in Benzene as insufficient to satisfy the agency's obligations under the OSH Act. In Benzene, the Supreme Court noted that 56 [t]he evidence in the administrative record of adverse effects of benzene exposure at 10 ppm [the former PEL] is sketchy at best. OSHA noted that there was no dispute that certain nonmalignant blood disorders, evidenced by a reduction in the level of red or white cells or platelets in the blood, could result from exposures of 25-40 ppm. It then stated that several studies had indicated that relatively slight changes in normal blood values could result from exposures below 25 ppm and perhaps below 10 ppm. OSHA did not attempt to make any estimate based on these studies of how significant the risk of nonmalignant disease would be at exposures of 10 ppm or less. Rather, it stated that because of the lack of data concerning the linkage between low-level exposures and blood abnormalities, it was impossible to construct a dose-response curve at this time. OSHA did conclude, however, that the studies demonstrated that the current 10 ppm exposure limit was inadequate to ensure that no single worker would suffer a nonmalignant blood disorder as a result of benzene exposure. Noting that it is customary to set a permissible exposure limit by applying a safety factor of 10-100 to the lowest level at which adverse effects had been observed, the Agency stated that the evidence supported the conclusion that the limit should be set at a point substantially less than 10 ppm even if benzene's leukemic effects were not considered. OSHA did not state, however, that the nonmalignant effects of benzene exposure justified a reduction in the permissible exposure limit to 1 ppm. 57 Benzene, 448 U.S. at 631-32, 100 S.Ct. at 2858-59 (footnotes and citation omitted; emphasis added). Comparing OSHA's rationale for using safety factors in this rulemaking with the Court's discussion of their use in the Benzene case, we find little appreciable difference. 58 The Supreme Court in Benzene did recognize that absolute scientific certainty may be impossible when regulating on the edge of scientific knowledge, and that so long as they are supported by a body of reputable scientific thought, the Agency is free to use conservative assumptions in interpreting the data ..., risking error on the side of overprotection rather than underprotection. Id. at 656, 100 S.Ct. at 2871. However, the Court also discussed the use of monitoring and medical testing as a backstop, permitting the agency to keep a constant check on the validity of the assumptions made in developing the permissible exposure limit, giving it a sound evidentiary basis for decreasing the limit if it was initially set too high. Id. at 658, 100 S.Ct. at 2872; see also National Cottonseed Prods. Ass'n v. Brock, 825 F.2d 482, 486 (D.C.Cir.1987), cert. denied, 485 U.S. 1020, 108 S.Ct. 1573, 99 L.Ed.2d 889 (1988). 59 The lesson of Benzene is clearly that OSHA may use assumptions, but only to the extent that those assumptions have some basis in reputable scientific evidence. If the agency is concerned that the standard should be more stringent than even a conservative interpretation of the existing evidence supports, monitoring and medical testing may be done to accumulate the additional evidence needed to support that more protective limit. Benzene does not provide support for setting standards below the level substantiated by the evidence. Nor may OSHA base a finding of significant risk at lower levels of exposure on unsupported assumptions using evidence of health impairments at significantly higher levels of exposure. Benzene, 448 U.S. at 656-58, 100 S.Ct. 2871-72; Texas Indep. Ginners, 630 F.2d at 409. Overall, OSHA's use of safety factors in this rulemaking was not adequately explained by this rulemaking record. 60 More generally, OSHA defends its failure to make more specific findings for each individual substance, as well as its decision to set the standards for several substances at levels where significant risks of material health impairment remain, by citing its authority to set priorities, 29 U.S.C. § 655(g), 22 and the discretion permitted the agency in making policy decisions. There were warning signs of this position in the Notice of Proposed Rulemaking, where OSHA expressed its view that to review and regulate many substances in a reasonable period requires some narrowing of the issues, focus of analysis, and reducing the length of the discussions in the preamble. 53 Fed.Reg. at 20963. Indeed, the agency stated that [t]he success of a project to regulate a large backlog of chemicals for which there is a generally recognized need for new or improved employee protection requires some recognition of the need for agency flexibility in several areas, for example, in less detailed discussion for each substance. Id. Moreover, the agency stated that 61 [i]n response to both the court challenges and the need to face difficult issues, OSHA has engaged in detailed and extensive analyses. These have resulted in lengthier preamble discussions and in-depth analyses for all issues.... 62 Now that OSHA has reviewed these issues in depth several times, has experience gained under this    law (sec. 6(b)(5)) on these issues, and has had its analysis upheld in the Courts, somewhat less detailed chemical-by-chemical analyses should be appropriate. The accumulated judicial guidance and agency experience reduces the need for as extensive a discussion of some of the issues. 63 Id. at 20964. This implies that OSHA need no longer perform detailed analysis and explanation when promulgating PELs because the agency's analysis for other substances has been upheld in prior rulemakings. Besides displaying more than a touch of hubris, this passage reveals a fundamental misperception of the OSH Act and the caselaw interpreting that act. 23 64 While OSHA has probably established that most or all of the substances involved do pose a significant risk at some level, it has failed to establish that existing exposure levels in the workplace present a significant risk of material health impairment or that the new standards eliminate or substantially lessen the risk.