Public Citizen Health Research Group v. Auchter

• Decision Date: 05 January 1983
• Docket Number: Civ. A. No. 81-2343.
• Citation: 554 F. Supp. 242
• Parties: PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Plaintiffs, v. Thorne G. AUCHTER, et al., Defendants.
• Court: U.S. District Court — District of Columbia

554 F. Supp. 242

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

Civ. A. No. 81-2343.

United States District Court, District of Columbia.

January 5, 1983.

David C. Vladeck, Alan B. Morrison, Public Citizen Litigation Group, Washington, D.C., for plaintiffs.

John D. Bates, Asst. U.S. Atty., Washington, D.C., for defendants.

MEMORANDUM OPINION

BARRINGTON D. PARKER, District Judge:

The plaintiffs in this proceeding are Public Citizen Health Research Group, a non-profit 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.¹ 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.²

The existing OSHA standard governing worker exposure to ethylene oxide has been in force since 1971.³ 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 2½ 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 and competence in the areas it regulates. Courts will not substitute their judgment for that of the agency.

The standard of review is a narrow one requiring the court to determine whether the agency acted within the scope of its authority, whether the challenged decision was "based on a consideration of the relevant factors and whether there has been a clear error of judgment." Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 415-16, 91 S.Ct. 814, 823, 28 L.Ed.2d 136 (1971); accord, Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 285, 95 S.Ct. 438, 441, 42 L.Ed.2d 447 (1974) ("the agency must articulate a `rational connection between the facts found and the choice made'"). In Overton Park, the Court "interpreted the arbitrary and capricious test to require a `substantial inquiry' subjecting the agency's action to `a thorough, probing in-depth review.'" State Farm Mutual Auto Insurance v. Department of Transportation, 680 F.2d 206, 219 (D.C.Cir.1982), cert. granted, ___ U.S. ___, 103 S.Ct. 340, 74 L.Ed.2d 382 (1982) (agency rescission of regulations held arbitrary and capricious where decision was not supported by factual record and agency failed to duly consider alternatives).

OSHA's authority to establish workplace standards is derived from the Occupational Safety and Health Act which was enacted "to assure as far as possible every working man and woman in the Nation safe and healthful working conditions." 29 U.S.C. § 651. Subsection 6(b) of the Act, 29 U.S.C. § 655(b), authorizes the Secretary to promulgate permanent health standards pursuant to rulemaking procedures similar to those embodied in the Administrative Procedure Act, 5 U.S.C. §§ 551 et seq. Acknowledging the possibility that dangerous health situations will arise necessitating the adoption of immediate remedial measures, Congress provided authority to issue emergency temporary standards pursuant to subsection 6(c), 29 U.S.C. § 655(c):

The Secretary shall provide, without regard to the formal rulemaking procedure required for permanent standards, for an emergency temporary standard to take immediate effect ... if he determines (A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards and (B) that such emergency standard is necessary to protect employees from such danger.⁴

Emergency standards take effect immediately upon publication in the Federal Register thereby circumventing the thorough yet cumbersome rulemaking required for permanent standards. As a necessary safeguard, however, emergency standards remain effective for no more than six months and the Secretary is directed to conduct permanent rulemaking procedures within that period.⁵

In reviewing OSHA's actions in this case, it is instructive to note several cases examining the agency's authority to promulgate workplace standards under the Act. In Industrial Union Department v. American Petroleum Institute, 448 U.S. 607, 100 S.Ct. 2844, 65 L.Ed.2d 1010 (1980), for example, the Supreme Court struck down a permanent standard which OSHA based upon a finding of only an attenuated connection between a toxic substance and leukemia; the record was devoid of any finding that a...