Appeals from the United States Department of Labor Occupational Safety & Health Administration (Agency No. OSHA-1: H054A).
The opinion of the court was delivered by: Rendell, Circuit Judge.
Before: SCIRICA, Chief Judge, RENDELL, Circuit Judge, and O'CONNOR, Retired Associate Justice, U.S. Supreme Court*fn1
Petitioners challenge a standard promulgated by the Occupational Safety and Health Administration ("OSHA") to regulate the occupational exposure of workers to hexavalent chromium ("Cr(VI)"), a toxic substance. Public Citizen Health Research Group and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Worker's International Union, (collectively "HRG") join in arguing that OSHA violated its statutory mandate in adopting a standard that under-regulates Cr(VI) exposure. The Edison Electric Institute ("EEI") separately argues that OSHA improperly adopted a standard that is over-inclusive of coal and nuclear electric power generating plants. For the reasons stated below, we will grant HRG's petition with regard to the employee exposure notification requirements of the standard. We will deny both petitions on all other grounds.
Cr(VI) is a state of the metal chromium that generally results from man-made processes. Occupational Exposure to Hexavalent Chromium, 71 Fed. Reg. 10,100, 10,104 (Feb. 28, 2006). Compounds containing Cr(VI) can exist in mist, dust, or fume form, and have long been known to jeopardize the health of workers when inhaled, or upon contact with skin. Cr(VI) has been known to cause lung cancer, asthma, and damage to skin and the lining of the nasal passage. Id. at 10,108. Compounds containing Cr(VI) are used intentionally to perform metal electroplating, and in the production of chemical catalysts and pigments for textile dyes, paints, inks, glass, and plastics. Cr(VI) compounds are also encountered incidentally, for example as a by-product of certain welding processes, and as an impurity found in portland cement. Id. According to OSHA, there are over 30 industry sectors in which workers may be exposed to Cr(VI). Id. at 10,246-55.
In 1971, OSHA adopted a permissible exposure limit ("PEL") of 52 micrograms of Cr(VI) per cubic meter, or 52 ug/m3, which had been a recommended industry limit since 1943. Id. at 10,101-03. The early standard was established to protect nasal tissues from irritation and damage, but, over time, government and private organizations came to recognize Cr(VI) as a carcinogen. Id. at 10,103. In 1998, this Court denied a petition by the Oil, Chemical and Atomic Workers Union and Public Citizen's Health Research Group to compel OSHA to establish a lower PEL for Cr(VI). Oil, Chem. & Atomic Workers Union v. OSHA, 145 F.3d 120 (3d Cir. 1998). In 2002, however, this Court directed OSHA to "proceed expeditiously with its [Cr(VI)] rulemaking" after finding that OSHA's delay in promulgating a new standard had become unreasonable. Pub. Citizen Health Research Group v. Chao, 314 F.3d 143, 159 (3d Cir. 2002).
OSHA subsequently proposed a new Cr(VI) standard in 2004, and opened the matter for comment. The proposed rule contemplated reducing the PEL from 52 to 1 ug/m3.
Occupational Exposure to Hexavalent Chromium, 69 Fed. Reg. 59,306 (Oct. 4, 2004). After extensive comments and hearings, OSHA issued its final rule on February 28, 2006. 71 Fed. Reg. 10,100. Upon examining the health risks to workers, and the feasibility of implementing various PELs, OSHA replaced the proposed 1 ug/m3 PEL with a universal PEL of 5 ug/m3. 71 Fed. Reg. 10,100-385. OSHA issued corrections to the final rule on June 23, 2006, and a minor amendment on October 30, 2006, reflecting a settlement agreement with various parties. 71 Fed. Reg. 36,008 (June 23, 2006); 71 Fed. Reg. 63,238 (Oct. 30, 2006).
HRG and EEI level a number of attacks on the methodology employed and conclusions reached by OSHA. We accordingly summarize OSHA's relevant methodology and findings as background for our decision.
A. Estimation of Health Risk
In adopting a new standard, OSHA must establish that workers face a significant risk of material harm. OSHA considered more than 40 studies of workers in order to assess the relationship between exposure to Cr(VI) and lung cancer.
71 Fed. Reg. 10,175. OSHA decided to base its risk analysis on the so-called "Gibb" and "Luippold" cohorts, which were both derived from studies of workers in chromate production facilities. Id. at 10,176, 10,220. According to OSHA, the Gibb cohort and the Luippold cohort, were found to be the strongest data sets for quantitative assessment . . . . Of the various studies, these two had the most extensive and best documented Cr(VI) exposures spanning three or four decades.
Both cohort studies characterized observed and expected lung cancer mortality and reported a statistically significant positive association between lung cancer risk and cumulative Cr(VI) exposure.
OSHA found that a "linear relative risk model" best described the relationship between Cr(VI) exposure and lung cancer, whereby the exposure level over the course of a hypothetical 45-year career was directly correlated to the risk of cancer. Id. at 10,194. OSHA used the Gibb and Luippold cohorts to establish upper and lower estimates of cancer cases per 1000 workers, and tabulated the estimated cases for exposure levels ranging from 0.25 ug/m3 to the pre-existing PEL of 52 ug/m3. Id. at 10,195. According to the resulting table, exposure at 1 ug/m3 would result in an estimated 2.1 to 9.1 cancer cases, exposure at 5 ug/m3 would result in 10 to 45 cases, and exposure at the pre-existing PEL would result in 101 to 351 cases. Id.
Based in part on this information, OSHA concluded that "Cr(VI) causes 'material impairment of health or functional capacity' within the meaning of the OSH Act." Id. at 10,221. OSHA further determined that the cancer risk of 100 to 350 cases under exposure at the pre-existing 52 ug/m3 PEL was "clearly significant." Id. at 10,224. OSHA also found that the estimated 10 to 45 cases at a career exposure level of 5 ug/m3, the PEL ultimately selected, would represent a substantial improvement, but the risk of impairment would remain "clearly significant." Id.
By law, OSHA is required to demonstrate both the "technological" and "economic" feasibility of a standard. After exploring the technological and economic feasibility of alternative Cr(VI) PELs, OSHA concluded that implementation of the proposed 1 ug/m3 PEL would not be feasible. Although the agency recognized that a PEL of 5 ug/m3 still presented significant health risks to workers, the agency found the higher level to be feasible, and adopted it as a universal PEL. A summary of OSHA's relevant technological and economic feasibility analyses follows.
1. Technological Feasibility
To assess technological feasibility, OSHA expressly applied the standard articulated by the Court of Appeals for the D.C. Circuit in United Steelworkers of America, AFL-CIO-CLC v. Marshall, 647 F.2d 1189 (D.C. Cir. 1980) ("Lead"). 71 Fed. Reg. 10,335. The Lead decision provides:
[W]ithin the limits of the best available evidence, and subject to the court's search for substantial evidence, OSHA must prove a reasonable possibility that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations.
647 F.2d at 1272. OSHA explained that, in harmony with the Lead standard, it favored engineering and work practice controls to reduce the presence of toxins in the air over reliance on respirators.*fn2 OSHA explained its "long-held view" that extensive reliance on respirators to achieve a PEL should be avoided due to independent health, safety, and reliability problems that arise when workers are required to perform tasks with respirators. 71 Fed. Reg. 10,335.
For technological feasibility purposes, OSHA chose to define employee exposure in terms of "application groups," or "groups of firms where employees are exposed to Cr(VI) when performing a particular function," rather than in terms of product-based industries. Id. at 10,226. OSHA justified this approach as follows:
This methodology is appropriate to exposure to Cr(VI) where a widely used chemical like chromium may lead to exposures in many kinds of firms in many industries but the processes used, exposures generated, and controls needed to achieve compliance may be the same. For example, because a given type of welding produces Cr(VI) exposures that are essentially the same regardless of whether the welding occurs in a ship, or a construction site, as part of a manufacturing process, or as part of a repair process, it is appropriate to analyze such processes as a group.
Id. OSHA accordingly identified and analyzed dozens of application groups in which employees were exposed to Cr(VI). Id. at 10,228-44.
OSHA concluded that a PEL of 1 ug/m3 was not technologically feasible based on several determinations. First, OSHA positively concluded that it was technologically infeasible for the sectors of welding and aerospace painting to achieve a 1 ug/m3 through engineering and work controls alone. OSHA, Final Economic and Regulatory Flexibility Analysis for OSHA's Final Standard for Occupational Exposure to Hexavalent Chromium, III-331, Feb. 23, 2006 ("FEA"). For welding, OSHA examined several types of welding processes employed in general industry, shipyards, and construction. Id. at III-332. OSHA found that two of the "most common" welding operations, shielded metal arc welding ("SMAW") on stainless steel, and stainless steel welding in confined and enclosed spaces, could not conform to a 1 ug/m3 PEL by altering work processes or through engineering controls. Id. at III-333-36. Although OSHA recognized that the standard may be feasible for less common welding operations, "the fact that welding is not easily separated into high and low exposure operations render[ed] OSHA unable to conclude that the proposed PEL of 1 ug/m3 is technologically feasible for any welding operations." Id. at III-336.
OSHA also determined that "approximately two thirds" of aerospace painting operations could not achieve the 1 ug/m3 PEL with engineering or work practice controls. Although smaller parts could be painted in compliance with the PEL through use of enclosed and ventilated rooms, such treatment for larger parts and assemblies was impractical. Thus, the proposed PEL was "not generally feasible for aerospace painting." Id. at III-336-37.
While OSHA positively concluded that the proposed 1 ug/m3 PEL was technologically infeasible for welding and aerospace painting operations, it also found that "the evidence in the record [wa]s insufficient" for it to conclude that the 1 ug/m3 would be technologically feasible for four other industries with relatively few employees. Id. at III-338. For the three operations of chromate pigment production, chromium catalyst production, and chromium dye production, OSHA found a "lack of clear evidence" that it would be technologically feasible to install protective enclosures to avert widespread respirator use in order to achieve the proposed PEL. Id. at III-340. For hard chrome electroplating, OSHA found that the diversity of such operations, and the lack of evidence as to whether involved facilities could employ fume suppressants, left it "unable to conclude that the proposed PEL of 1 ug/m3 would be technologically feasible for all hard chrome electroplating operations." Id. at III-341.
OSHA analyzed economic feasibility by questioning whether a standard under consideration would eliminate or alter the competitive structure of an industry. 71 Fed. Reg. 10,301. OSHA determined that the proposed 1 ug/m3 PEL was economically infeasible for electroplating job shops, which are businesses dedicated to providing electroplating services to others. OSHA concluded that these shops could not be expected to absorb the costs to comply with a 1 ug/m3 standard. The Agency found that compliance costs would "represent 2.7 percent of revenues and 65 percent of profits." Id. Under prior standards, OSHA had ensured that the most affected industries were not confronted with costs over 2 percent of revenues. Id. Also, OSHA found that the costs to electroplating job shops would not be significantly lower even if the shops were permitted to achieve the proposed 1 ug/m3 PEL through use of respirators. Id. OSHA further found that the high costs of compliance would be similar across various types of plating shops. Id. On this analysis, OSHA concluded that the proposed 1 ug/m3 PEL would "alter the competitive structure of the industry." Id. In comparison, OSHA determined that the industry could feasibly absorb the estimated compliance costs of 1.24 percent of revenues associated with a PEL of 5 ug/m3. Id.
In considering the proposed 1 ug/m3 PEL, OSHA determined that the technological and economic infeasibility determinations discussed above affected "almost 56% of the total number of employees occupationally exposed to Cr(VI)." Id. at 10,246-54. OSHA calculated this figure using the following estimates of affected employees:
* 33,400 in electroplating job shops
* 8,300 in aerospace painting
* 469 in chromium pigment, catalyst, and dye production
Id. at 10,337. This totals 312,169 employees, or 55.9% of the estimated 558,431 employees exposed to Cr(VI). OSHA did not include employees in hard chrome electroplating in order to avoid double counting workers included in the job shop electroplating figure. Id. OSHA stated that it "did not receive data or recommendations regarding setting the PEL at any levels between 1 ug/m3 and 5 ug/m3,"*fn3 but found that a PEL of 5 ug/m3 was technologically and economically feasible for "all industries." Id.
C. Application of a Uniform 5 ug/m3 PEL
OSHA selected a universal PEL of 5 ug/m3 that applies to all industries. Id. at 10,338. OSHA stated that it "has not interpreted [29 U.S.C. § 6(b)(5)] to require setting multiple PELs based on the lowest level particular industries or operations could achieve," and that, in the face of statutory silence, "OSHA has the authority to adopt the reasonable interpretation that it judges will best carry out the purposes of the Act." Id.
Although OSHA recognized that "lower PELs might be achievable in some industries and operations," which would reduce risks to workers, it determined that "these benefits would be offset by the significant disadvantages of attempting to establish and apply multiple PELs for the diverse group of industries and operations covered by the standard." Id. OSHA supported this conclusion by stating that multiple PELs would place an "enormous evidentiary burden on OSHA to ascertain and establish the specific situations, if any, in which a lower PEL could be reached," causing delays in the implementation of health standards. Id.
Also, OSHA asserted, "the demanding burden of setting multiple PELs would be complicated by the difficulties inherent in precisely defining and clearly distinguishing between affected industries and operations." Id. The "definitional and line drawing problem is far less significant when OSHA uses a unit of industries and operations for analytical but not compliance purposes," because the "consequences of imprecise classifications" for compliance purposes "would become much more significant." Id. OSHA determined that the existing North American Industry Classification System ("NAICS") for categorizing businesses would not be appropriate for delineating multiple PELs because NAICS categorizes businesses by primary activity, and sub-operations involving Cr(VI) would not necessarily be captured. Id.
OSHA also concluded that "disaggregation by operation has major practical disadvantages," in part because "many firms have exposures in two or more different categories." Id. Multiple PELs could therefore require single firms to achieve multiple standards in the same workplace, and possibly with the same employees. Employers would also have to monitor for multiple exposure levels in the same workplace, where the exposure of a particular employee might not be traceable to a single task. Id. OSHA determined that a single standard would make it easier for employers to understand and comply, and would simplify government enforcement. Id. at 10,338-39.
The final rule applies the 5 ug/m3 PEL through separate regulatory treatment for general industry, construction, and shipyards. Id. at 10,100. Only the distinctions pertaining to general industry, 29 C.F.R. § 1910.1026, and construction, § 1926.1126, are relevant to the instant petitions. The PEL pertains to "occupational exposures to [Cr(VI)] in all forms and compounds, except" for exposures governed by other government agencies, exposures to portland cement, or where employers are exempted by demonstrating that "a specific process, operation, or activity involving [Cr(VI)] cannot release dusts, fumes, or mists of [Cr(VI)] in concentrations above 0.5 ug/m3 . . . under any expected conditions of use." 29 C.F.R. §§ 1910.1026(a)(4), 1926.1126(a)(4).
Employers are required to use "engineering and work practice controls to reduce and maintain employee exposure to [Cr(VI)] to or below the PEL unless the employer can demonstrate that such controls are not feasible." Id. §§ 1910.1026(f)(1)(i), 1926.1126(e)(1)(i). Where further reductions are not feasible, employers must supplement the engineering and work practice controls with respiratory protection. Id. Also, if an "employer can demonstrate that a process or task does not result in any employee exposure to [Cr(VI)] above the PEL for 30 or more days per year," the employer may use respiratory protection in lieu of engineering and work practice controls to achieve the PEL. Id. §§ 1910.1026(f)(1)(ii), (g)(1)(iv), 1926.1126(e)(1)(i), (f)(1)(iv).
Employers are required to educate all affected employees about the contents of the controlling regulation, and about the applicable medical surveillance program. Id. §§ 1910.1026(l), 1926.1126(j). The regulations also establish an employee exposure "action level" of 2.5 ug/m3, or one half of the PEL, at which employers are subject to heightened ...