702 F.2d 1150 (D.C. Cir. 1983), 83-1071, Public Citizen Health Research Group v. Auchter

Docket Nº83-1071.
Citation702 F.2d 1150
Party NamePUBLIC CITIZEN HEALTH RESEARCH GROUP, et al. v. Thorne G. AUCHTER, Assistant Secretary, Occupational Safety and Health Administration, et al., Appellants.
Case DateMarch 15, 1983
CourtUnited States Courts of Appeals, United States Courts of Appeals. United States Court of Appeals (District of Columbia)

Page 1150

702 F.2d 1150 (D.C. Cir. 1983)

PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al.

v.

Thorne G. AUCHTER, Assistant Secretary, Occupational Safety

and Health Administration, et al., Appellants.

No. 83-1071.

United States Court of Appeals, District of Columbia Circuit

March 15, 1983

Argued Feb. 16, 1983.

As Amended .

Page 1151

Appeal from the United States District Court for the District of Columbia (D.C.Civil Action No. 81-02343).

Dennis K. Kade, Laura V. Fargas, Attys., Dept. of Labor, Washington, D.C., for appellants.

Stanley S. Harris, U.S. Atty., R. Craig Lawrence and John D. Bates, Asst. U.S. Attys., Washington, D.C., entered appearances for appellants.

David C. Vladeck, Washington, D.C., with whom Alan B. Morrison and John Cary Sims, Washington, D.C., were on the brief, for appellees.

Before ROBINSON, Chief Judge, and WILKEY and GINSBURG, Circuit Judges.

Opinion Per Curiam.

PER CURIAM:

In this expedited appeal, Assistant Secretary of Labor Thorne G. Auchter 1 challenges a January 5, 1983, district court order, 554 F.Supp. 242, order directing the Occupational Safety and Health Administration (OSHA) to issue by January 25, 1983, an emergency temporary standard (ETS) regulating workplace exposure to ethylene oxide (EtO), a synthetic organic chemical. 2 Used, inter alia, as a sterilizing agent, fumigant, pesticide, and industrial chemical additive, EtO is critically employed as a sterilant in

Page 1152

the health care and medical products industries. The exposure of workers who work near sterilizing equipment in the health care industry is the principal focus of this case. 3

The current OSHA standard for EtO has been in effect for well over a decade; it allows a permissible exposure limit in the workplace of 50 parts per million (ppm) averaged over an eight hour workday ("time-weighted average" or TWA). 29 C.F.R. Sec. 1910.1000. 4 That level, information now available reveals, poses a serious risk of causing chromosomal abnormalities and cancer in exposed animals and humans.

In August 1981, Public Citizen Health Research Group ("Public Citizen") 5 petitioned OSHA to issue an emergency temporary standard reducing the permissible exposure limit of EtO to a TWA of 1 ppm. Public Citizen invoked a provision of the Occupational Safety and Health Act, 29 U.S.C. Secs. 651-78 (1976 and Supp. IV 1980) (OSH Act or 'Act'), that authorizes OSHA to adopt an immediately effective temporary standard upon determining that failure to take emergency action would subject employees to "grave danger" from exposure to a toxic substance. 29 U.S.C. Sec. 655(c). 6 In September 1981, OSHA denied the petition on the ground that "on the available evidence ... current conditions do not constitute an emergency situation." App. 5a. The evidence did persuade the Assistant Secretary, however, that "the current OSHA standard of 50 ppm may not be sufficiently protective"; he therefore stated he would proceed with normal non-emergency rulemaking to revise the standard. App. 5b; Brief for the Appellants at 4, 25 (hereafter referred to as OSHA Brief).

Four months later, in January 1982, OSHA published an "Advance Notice of Proposed Rulemaking." 47 Fed.Reg. 3566 (Jan. 26, 1982); App. 170-75. 7 The Assistant Secretary projects issuance of an actual Notice of Proposed Rulemaking in June

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1983, 8 and a final regulation sometime in the fall of 1984.

Shortly before OSHA denied its petition, Public Citizen commenced this civil action to obtain an order commanding the issuance of an emergency standard. On cross-motions for summary judgment, the district court concluded that "[t]he record before the agency presented a solid and certain foundation showing that workers are subjected to grave health dangers from exposure to ethylene oxide within the currently permissible range." App. 141. OSHA had abused its discretion, the district court held, by denying the Public Citizen petition and, instead, proceeding on a course "which insured the continuing existence of the challenged standard." Id. Accordingly, the district court ordered OSHA to "promulgate within 20 days ... an appropriate emergency temporary standard addressing worker exposure to ethylene oxide." App. 146.

This difficult case, which we must decide under pressing circumstances, has two novel aspects. First, OSHA has in the past, on its own initiative, issued emergency standards which were promptly brought to court for review by industry complainants. See Florida Peach Growers Association, Inc. v. United States Department of Labor, 489 F.2d 120 (5th Cir.1974); Dry Color Manufacturers' Association, Inc. v. United States Department of Labor, 486 F.2d 98 (3d Cir.1973) (both vacating emergency temporary standards). We are unaware, as was the district court, App. 134, of any prior case in which a court was invited to review OSHA's denial of a petition to issue an emergency standard. Second, in declining to replace the current standard on an emergency basis, and in justifying its position in court, OSHA did not rely on any government action. Rather, it relied heavily on voluntary efforts of employers, "alerted and responsive to the new health data concerning [EtO]," to "lower[ ] their in-house allowable exposure limits to a fraction of the OSHA standard." OSHA Brief at 22, 23.

The Assistant Secretary has emphasized the extraordinary authority and large measure of discretion 29 U.S.C. Sec. 655(c) vests in him to determine whether an "emergency standard is necessary to protect employees from [grave] danger." While it is a close question, our review of the record indicates that, in ordering an emergency standard, the most drastic measure in the Agency's standard-setting arsenal, the district court impermissibly substituted its evaluation for that of OSHA. Nonetheless, we fully agree with the district court that "OSHA has embarked upon the least responsive course short of inaction." App. 135. Beyond question, despite the efforts of "[m]any companies," OSHA Brief at 23, the record shows a significant risk that some workers, and the children they will hereafter conceive, are subject to grave danger from the employees' exposure to EtO. We therefore hold that OSHA must expedite the rulemaking in which it is now engaged. 9

Congress has instructed OSHA, in determining the priority for establishing standards, to "give due regard to the urgency of the need for mandatory ... health standards for particular ... workplaces." 29 U.S.C. Sec. 655(g). 10 Further, the Administrative Procedure Act directs an agency "to conclude [within a reasonable time] a matter

Page 1154

presented to it." 5 U.S.C. Sec. 555(b). Complementing that provision, this court has authority, pursuant to 5 U.S.C. Sec. 706(1), to compel agency action unreasonably delayed. There is an obvious need, apparent to OSHA, for an EtO standard that reflects, as the current standard does not, the mutagenic and carcinogenic potential of the chemical. Because it is also plain that industry efforts fall a considerable distance from taking every worker exposed to EtO out of the grave danger zone, 11 a more than three-year span from Public Citizen's petition to projected final regulation is not tolerable. OSHA's failure to date to issue even a notice of proposed rulemaking--some eighteen months after announcing its intention to commence rulemaking--is in our judgment, and in light of the risk to current and future lives, agency action unreasonably delayed.

To assure that OSHA will give due regard to the need, urgent for some workers, for a new EtO standard, and to prevent undue protraction in OSHA's conclusion of this matter, we direct the Assistant Secretary to issue a notice of proposed rulemaking within thirty days of the date of this decision and to proceed expeditiously thereafter toward issuance of a permanent standard for EtO. 12

I. BACKGROUND

It is undisputed that evidence now available shows EtO to pose serious qualitative health risks unappreciated when OSHA adopted the current standard. The chemical is both mutagenic and carcinogenic in animals and humans. One uncontradicted study finds significant chromosomal aberrations in workers chemically exposed to 36 ppm, App. 996-1003; another study shows similar results for concentrations described, more generally, as within the current 50 ppm standard. App. 1488-99. In addition, dose responsive relationships between exposure to EtO and fertility in rats have been observed. 47 Fed.Reg. 3568 (Jan. 26, 1982); App. 172.

OSHA concedes that scientific reports show a "statistically significant" increase in cancer in animals exposed at 33 ppm and above. 13 The National Institute of Occupational Safety and Health (NIOSH) 14 determined from the prior reports that "exposures as low as 10 ppm increased the proportion of female rats with ... leukemia." App. 954. OSHA has acknowledged this dose responsive relationship at 10 ppm. 47 Fed.Reg. 3568 (Jan. 26, 1982); App. 172.

The two principal human studies reported a "significant excess" of both leukemia and stomach cancer from exposure to EtO, OSHA Brief at 15; see also 47 Fed.Reg. 3568; App. 172; the same cancers appeared in animals exposed to EtO. 15 The human studies indicated a 15-fold increase in leukemia at 20± 10 ppm...

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