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)).
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, 459 U.S. 987, 103 S. Ct. 340, 74 L. Ed. 2d 382 (1982) (agency recission 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.
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.
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 reduced standard would actually decrease the incidence of leukemia. Emphasizing that the Act empowered the Secretary to eliminate significant harms rather than make workplaces absolutely safe, the Court alluded to decisions of two circuits as examples of the constraints imposed upon the Secretary's authority to issue emergency temporary standards. Id. at 651 n. 59, 100 S. Ct. at 2868 n. 59. Those cases demonstrate the standard which the Secretary must satisfy to support emergency regulations.
The Fifth Circuit vacated an emergency temporary standard in Florida Peach Growers Association, Inc. v. U.S. Department of Labor, 489 F.2d 120, 129 (5th Cir.1974), finding that the administrative record did not support the Secretary's implementation of section 655(c).
Stating that "the key to the issuance of an emergency standard is the necessity to protect employees from a grave danger," id. at 124,
the Court determined that the record did not contain evidence that the emergency standard was necessary although exposure to the toxic substance was acknowledged as harmful.
The Act requires determination of danger from exposure to harmful substances, not just a danger of exposure; and, not exposure to just a danger, but to a grave danger; and, not the necessity of just a temporary standard, but that an emergency standard is necessary.
Id. at 130 (emphasis in original).
Similarly, in Dry Color Manufacturers Association v. Department of Labor, 486 F.2d 98 (3d Cir.1973), the court vacated an emergency temporary standard where the record showed that the regulated substances posed only a potential cancer hazard. Thus, the court remanded the proceeding because, inter alia, studies of one of the substances were outdated and revealed a possible carcinogenic effect in rodents but no attributable instances of cancer in humans.
Although the Court is unaware of any cases reviewing the denial of such a petition, the cases examining OSHA's authority to issue emergency standards demonstrate the substantial showing of grave danger and necessity which must be made before such a standard will issue. Since that showing has been made in this case the Act requires the issuance of an emergency standard.
2. The Sufficiency of the Record Before the Agency
Examination of the administrative record in this proceeding compels the conclusion that the agency's decision resulted from a clear error of judgment. The failure to issue an emergency standard could not have been based upon a proper assessment of the relevant considerations since the vast majority of the scientific studies before OSHA plainly show that workers, particularly in health care, are subjected to a grave health hazard when exposed to ethylene oxide at levels in compliance with the current standard. Despite the overwhelming administrative record favoring issuance of an emergency temporary standard, OSHA has embarked upon the least responsive course short of inaction, with the effect that the current standard will remain in place until September 1984.
Although a sufficiently grave finding of danger can be extrapolated from animal experiments, e.g., Dry Color Manufacturers Association, 486 F.2d at 104, OSHA was presented in this proceeding with considerable data pertaining to human as well as animal exposure. The Hogstedt Studies,
submitted to the Court as part of the administrative record compiled by OSHA, examined the incidence of leukemia among a sample of Swedish factory workers in one study and followed up on earlier tests of a broader sampling in a more recent study. Both found marked increases in the likelihood of developing leukemia and other cancer when exposed to ethylene oxide at levels below the current OSHA standard. One Hogstedt study noted, for example, that while three cases of leukemia were discovered among its sample of 230 employees who worked near a sterilizer for several years, the expected rate for such a group was only 0.2 (Document 90 at 1).
Similarly, a study conducted by the American Hospital Supply Corporation
concluded that human exposure at levels in compliance with the current standard yields significant increases in the likelihood of chromosomal damage. An industry-sponsored effort, that study found increases in mutagenic injury among a group of approximately 100 workers exposed to ethylene oxide.
These conclusions are consistent with those of the animal studies before OSHA, including the recent Bushy Run Study
which found high rates of leukemia, mortality and abdominal cancer among rats. Uncontroverted scientific studies such as the MITRE Report
and a study by the National Institute for Occupational Safety and Health
point unmistakably to the conclusion that significant exposure levels still exist in the health care field.
These studies are only a sampling of the evidence before the agency, however, they are the principal studies and they are compelling. Although the government challenges the findings of the studies, suggesting that they are inconclusive or that the samples were exposed to more than one hazardous substance, the combined effect of the findings is significant -- workers are exposed to EtO in significant dosages and exposure at such levels, in compliance with OSHA's standard, poses a grave health risk to those workers. Furthermore, the government has pointed to no comparable group of studies which concludes otherwise.
The government contends that because many private institutions using EtO have voluntarily reduced exposure levels within limits which OSHA believes are "safe," it properly concluded that imposition of an emergency standard would not be necessary to protect workers. That argument is suspect. Such actions do nothing to protect those workers who are still exposed to EtO at hazardous levels or those employed at institutions which may at any time elect to withdraw the voluntary restrictions.
Of particular significance in reviewing the record is the government affidavit (dated June 28, 1982) prepared by John Martonik, Acting Director of OSHA's Directorate of Health Standards.
In the first paragraph of his affidavit, Martonik stated that he
retained overall responsibility for all actions relating to health standards promulgation, revision, and revocation under OSHA, including any review or revision of OSHA's present standard governing employee exposure to ethylene oxide.