796 F.2d 1479 (D.C. Cir. 1986), 84-1252, Public Citizen Health Research Group v. Tyson

Docket Nº:84-1252, 84-1392 and 85-1014.
Citation:796 F.2d 1479
Party Name:1986-1987 O.S.H.D. ( 27,640 PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Petitioners, v. Patrick R. TYSON, Acting Assistant Secretary, Occupational Safety & Health Administration, and Raymond J. Donovan, Secretary of Labor, Respondents, Association of Ethylene Oxide Users, Intervenor. ASSOCIATION OF ETHYLENE OXIDE USERS, Petitioner, v. Patrick R.
Case Date:July 25, 1986
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit

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796 F.2d 1479 (D.C. Cir. 1986)

1986-1987 O.S.H.D. ( 27,640



Patrick R. TYSON, Acting Assistant Secretary, Occupational

Safety & Health Administration, and Raymond J.

Donovan, Secretary of Labor, Respondents,

Association of Ethylene Oxide Users, Intervenor.



Patrick R. TYSON, Acting Assistant Secretary, Occupational

Safety & Health Administration, and Raymond J.

Donovan, Secretary of Labor, Respondents.



Robert A. ROWLAND, Assistant Secretary, Occupational Safety

and Health Administration, Respondent.

Nos. 84-1252, 84-1392 and 85-1014.

United States Court of Appeals, District of Columbia Circuit

July 25, 1986

Argued Jan. 22, 1986.

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[Copyrighted Material Omitted]

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David C. Vladeck with whom Alan B. Morrison, Washington, D.C., was on brief, for petitioners, Public Citizens Health Research Group, et al., in Nos. 84-1252 and 85-1014.

David H. Larry for petitioner, Association of Ethylene Oxide Users in No. 84-1392, and intervenor in Nos. 84-1252 and 85-1014.

Alfred R. Mollin, Atty., Dept. of Justice, Richard K. Willard, Acting Asst. Atty. Gen., Robert E. Kopp, Director, Dept. of Justice, Leonard Schaitman, Asst. Director, Dept. of Justice, Frank A. White, Associate Sol., Dept. of Labor, Joseph M. Woodward, Counsel, Dept. of Labor and Laura V. Fargas, Atty., Dept. of Labor, Washington, D.C., were on brief, for respondents in Nos. 84-1252, 84-1392 and 85-1014.

Robert C. Barnard and David Zoll, Washington, D.C., were on brief, for amicus curiae, Ethylene Oxide Industry Council, in Nos. 84-1252, 84-1392 and 85-1014, urging affirmance.

James F. Fitzpatrick, John M. Quinn, Merrick B. Garland, and Edward L. Wolf, Washington, D.C., were on brief, for amici curiae, Representatives John D. Dingell, et al., in Nos. 84-1252, 84-1392 and 85-1014, urging reversal.

Before ROBINSON, Chief Judge, WRIGHT [*], Circuit Judge, and McGOWAN, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge McGOWAN.

McGOWAN, Senior Circuit Judge:

In these consolidated cases, we review the Occupational Safety and Health Administration's rule limiting exposure to ethylene oxide, a chemical widely used in manufacturing and in hospital instrument sterilization. The Administration's rule sets a long-term exposure limit but does not set a short-term limit. We find substantial evidence in the record to support OSHA's long-term exposure limit. We thus affirm that aspect of the rule. We also find, however, that OSHA's decision not to issue a short-term exposure limit is not supported by the record, and we remand for further consideration on that point. Since we remand for further proceedings, we do not reach the constitutional questions raised by several petitioners and amici.


Congress enacted the Occupational Safety and Health Act (OSH Act) "to assure ... every working man and woman in the Nation safe and healthful working conditions." 29 U.S.C. Sec. 651(b) (1982). To achieve this goal, the Secretary of Labor may hold hearings, id. Sec. 655(b)(3), promulgate standards, id. Secs. 655(b)(2), 655(b)(4), conduct inspections, id. Sec. 657, issue citations, id. Sec. 658, and pursue enforcement proceedings, id. Secs. 659, 662, 666. The Occupational Safety and Health Administration (OSHA) assists the Secretary in accomplishing these tasks.

In this case, the litigants challenge a standard issued by the Secretary regulating permissible exposure to ethylene oxide (EtO), a chemical of major significance in American industry. Occupational Exposure to Ethylene Oxide, Final Standard, 49

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Fed.Reg. 25,734, 25,734-35 (1984). The bulk of EtO usage occurs in manufacturing, and a small fraction is consumed in the sterilization of hospital instruments. EtO is a highly reactive gas. Thus, in manufacturing processes employing EtO, tightly closed and highly automated systems are used. Nevertheless, workers can be exposed to the chemical during both shipping and equipment maintenance. While hospital sterilization accounts for only a small portion of the nation's EtO usage, it is far more hazardous to workers. Workers must enter areas where EtO is, or has been, present. For example, instruments are typically placed in a sterilization chamber which is then flooded with EtO. These sterilization chambers must be purged of the gas before workers can enter. The process is imperfect, and workers risk exposure to the chemical. Id.

In 1968, the American Conference of Governmental Industrial Hygenists (ACGIH) recommended a long-term permissible exposure limit (PEL) of 50 parts EtO per million parts air (ppm) as a time-weighted average (TWA) exposure level over eight hours. ACGIH based this recommendation on two types of studies. Six-month animal inhalation studies found ill effects only at levels at or above 50 ppm. A study of employees exposed for at least a decade to levels of 5 to 10 ppm reported no adverse effects. At the time ACGIH recommended the 50 ppm PEL, researchers had not yet discovered the carcinogenic properties of EtO. Id. at 25,736. In 1971, pursuant to 29 U.S.C. Sec. 655(a) (1982), which permits the promulgation of "national consensus standards," the Secretary of Labor adopted the 50 ppm PEL as a limit on workers' exposure.

Soon, however, the body of knowledge surrounding EtO began to grow, and researchers discovered more alarming health effects. In 1977, the National Institute for Occupational Safety and Health (NIOSH) 1 concluded that a 75 ppm short-term exposure limit (STEL), in addition to the long-term 50 ppm PEL, was necessary to protect workers. A STEL regulates the maximum average exposure over a shorter period--usually fifteen minutes. NIOSH based its conclusion on studies showing that EtO exposure alters cell genetic material. In 1979, ACGIH began considering a PEL of 10 ppm, based on a number of more recent studies, including a study of actual worker exposure to EtO. These studies reinforced the belief that EtO exposure effects cell genetics. Moreover, a study of workers exposed to the chemical revealed a possible connection between EtO and leukemia, a cancer of the blood.

In 1981, ACGIH lowered its recommended PEL to 10 ppm. Moreover, the Conference designated EtO as a suspected carcinogen and proposed an even lower PEL of 5 ppm. Id. ACGIH based this reconsideration of the PEL on a two-year study of rats exposed to EtO. NIOSH also responded in 1981 to the new data on EtO by issuing a bulletin to employers and employees about the potential carcinogenic hazards posed by EtO. NIOSH recommended a revision in the then-current OSHA standard. Id. at 25,737. In June of 1982, ACGIH recommended a PEL of 1 ppm, to take effect in 1984.

In January of 1982, OSHA issued an advance notice of proposed rulemaking, inviting interested individuals to submit data or comments on revising the OSHA EtO standard. See Advance Notice of Proposed Rulemaking, 47 Fed.Reg. 3566 (1982). After some delay, petitioner Public Citizen Health Research Group (Public Citizen) objected to OSHA's lack of progress on promulgating an EtO standard. A year of litigation over OSHA's progress ensued, and this court ordered OSHA to propose a rule by April, 1983. Public Citizen Health Research Group v. Auchter, 702 F.2d 1150

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(D.C.Cir.1983) (per curiam). The court also expected that the agency would "bring this matter to a close within a year." Id. at 1154 n. 12. OSHA complied by publishing a proposed rule, suggesting a PEL of 1 ppm (replacing the 1971 standard of 50 ppm) and a short-term exposure limit (STEL) "ranging from 5 to 50 ppm for 30 minutes or less." Occupational Exposure to Ethylene Oxide, Proposed Rule, 48 Fed.Reg. 17,283, 17,284 (1983).

OSHA held public hearings on the proposed rule in July of 1983. Each aspect of the proposed rule was supported and opposed by a wide range of witnesses. The hearing produced 1600 pages of transcript and over 300 exhibits. 49 Fed.Reg. at 25,737. Despite this court's ruling, however, OSHA did not issue a final rule by March of 1984. After some prodding by Public Citizen, OSHA stipulated that it would complete the rulemaking by June 15, 1984. On June 14, OSHA had a final rule in hand. It provided for a 1 ppm PEL eight-hour TWA and a 10 ppm STEL fifteen-minute TWA. See Proposed Final Standard, reprinted in Joint Appendix (J.A.) at 12. OSHA did not publish that final rule.

Pursuant to Executive Order No. 12,291, 3 C.F.R. 127 (1981), reprinted in 5 U.S.C. Sec. 601 note, at 431 (1982), OSHA transmitted its final rule to the Office of Management and Budget (OMB) for review. Executive Order 12,291 provides that to the extent permissible by law, regulations of agencies within the executive branch must comply with certain substantive requirements. The Order requires agencies to consider cost/benefit analysis, cost effectiveness, maximization of benefit to society, condition of the regulated industries, and conditions of the national economy. Exec. Order No. 12,291, Sec. 2. Moreover, the Order requires agencies to prepare a "Regulatory Impact Analysis," a document evaluating the proposed regulations in light of the above substantive requirements. This analysis must be sent to OMB. Id. Sec. 3. Finally, agencies must defer final action until they have responded to OMB's view. Id. Sec. 3(f)(1). In this case, OMB questioned several aspects of OSHA's final rule, especially the benefits that the EtO rule would provide to society and its cost-effectiveness. These objections applied to both the PEL and the STEL. OMB objected to the STEL in...

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