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PUBLIC CITIZEN HEALTH RESEARCH GROUP v. AUCHTER

January 5, 1983

PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Plaintiffs,
v.
Thorne G. AUCHTER, et al., Defendants



The opinion of the court was delivered by: PARKER

 BARRINGTON D. PARKER, District Judge:

 The plaintiffs in this proceeding are Public Citizen Health Research Group, a nonprofit organization engaged in research and advocacy on health and safety matters and the American Federation of State, County and Municipal Employees, a labor union representing employees of public and private nonprofit organizations. *fn1" The defendants are officials of the United States Department of Labor charged with the responsibility of administering the Occupational Safety and Health Act of 1970 (Act), 29 U.S.C. §§ 651 et seq.

 Under subsection 6(c) of the Act, the Secretary of Labor is required to issue an emergency temporary standard regulating industrial exposure to a toxic substance if he finds that employees are placed in "grave danger" from exposure to that substance and that such a standard is "necessary" to protect the employees from that danger. 29 U.S.C. § 655(c).

 Because of increased health risks to exposed workers, the plaintiffs challenge a decision by Thorne G. Auchter, Administrator of the Occupational Safety and Health Administration (OSHA) refusing to issue such a standard reducing the permissible levels of worker exposure to the industrial chemical ethylene oxide (EtO). Plaintiffs assert that in light of the administrative record, Administrator Auchter and the Secretary of Labor have failed to carry out and perform their statutory duties. Specifically, they seek an order requiring the defendants to issue an emergency standard for ethylene oxide which assures "as far as possible . . . healthful working conditions" under section 651 of the Act while the OSHA's permanent rulemaking responsibilities are completed.

 This litigation presents the question whether the Secretary's decision, based on the record before him, was arbitrary and capricious and an abuse of discretion. The parties have filed cross motions for summary judgment on this issue. For the reasons stated below, this Court determines that the Secretary's decision was unsupported by the record and an award of summary judgment to the plaintiffs is appropriate.

 BACKGROUND

 The Nature and Use of Ethylene Oxide

 Ethylene oxide, a gas, has a variety of uses. The substance is valuable, for example, as a sterilizing agent, fumigant, pesticide and chemical additive. It is widely used as an intermediate chemical in producing a number of industrial products including automotive antifreeze, textiles, films, bottles and detergents. Since EtO is reactive and potentially explosive, manufacturing plants which rely upon the substance typically use closed and automated systems.

 EtO is regarded as a critical component of the sterilization process in the health care industry. That process generally requires its injection into sealed vessels containing objects to be sterilized. The gas is vented at the conclusion of the process. There is considerable potential for undue or excessive worker exposure to ethylene oxide during this process through the use of faulty equipment and the presence of inadequate ventilation or human error. Indeed, a study by the National Institute of Occupational Safety and Health has shown that a significant number of health care workers are exposed to the gas and many of them are exposed on a regular basis. *fn2"

 The existing OSHA standard governing worker exposure to ethylene oxide has been in force since 1971. *fn3" Scientific studies of humans and laboratory animals, however, show that exposure to the gas at levels which comport with the current standard yields a significant risk of contracting cancer and chromosomal damage. Experiments with animals, for example, show an increased incidence of leukemia, abdominal cancer and mortality at exposure levels within the OSHA standard. Studies of humans whose working environments expose them to ethylene oxide show similarly elevated rates of leukemia and other cancer as well as mutagenic or chromosomal abnormalities. Many hospitals and other users of the gas have voluntarily implemented measures to reduce worker exposure levels.

 In late 1981, the plaintiffs petitioned OSHA seeking an emergency reduction of the current EtO standard from 50 to one part per million. The plaintiffs' request was denied. In denying the petition, Administrator Auchter concluded that the record did not support the required finding of exigent circumstances -- that workers are exposed to a grave danger which, by necessity, requires immediate issuance of a standard under 29 U.S.C. § 655(c). He further noted that by virtue of its regulation of ethylene oxide as a pesticide, the Environmental Protection Agency had preempted OSHA's authority to regulate the gas. The Assistant Secretary nevertheless indicated that scientific studies suggested that a change in the current standard may be appropriate and therefore directed the implementation of rulemaking proceedings, beginning with an advance notice of proposed rulemaking (ANPR) which was subsequently published on January 26, 1982. 47 Fed. Reg. 3566.

 OSHA is currently engaged in rulemaking procedures. The Department of Labor recently reported that several analyses of the EtO standard have been conducted including risk and alternative analyses. However, additional phases of agency consideration will not be completed until the fall of 1984. OSHA anticipates consideration of the notice of proposed rulemaking package during 1983 and consideration of the final rule package in late 1984. Both stages include review at the departmental level and before the Office of Management and Budget. The government has explained that the estimated 2 1/2 year period between issuance of the ANPR and publication of a final standard is consistent with its experience in promulgating standards for other substances including lead, arsenic and cotton dust. (See Notice of Filing (October 27, 1982)).

 ANALYSIS

 A.

 1. The Standard of Review

 Congress has shouldered the Courts with the responsibility of overturning agency action which is found to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A). This standard of review contemplates a searching and thorough investigation, however, administrative determinations are necessarily accorded substantial deference in recognition of an agency's expertise ...


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