This section contains the nature of the case and procedural background.

Congress enacted OSHA 'to assure . . . every working man and woman in the Nation safe and healthful working conditions.' To achieve this goal, the Secretary of Labor may hold hearings, id. § 655(b)(3), promulgate standards, id. §§ 655(b)(2), 655(b)(4), conduct inspections, id. § 657, issue citations, id. § 658, and pursue enforcement proceedings, id. §§ 659, 662, 666. Ps challenge a standard issued by the Secretary regulating permissible exposure to ethylene oxide (EtO). 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. Workers can be exposed to the chemical during both shipping and equipment maintenance. Hospital use for sterilization is far more hazardous to workers. Workers must enter areas where EtO is, or has been, present. 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. As time passed the bad news on exposure started to multiply. Exposure levels of 1 ppm were recommended. OSHA issued an advance notice of proposed rulemaking, inviting interested individuals to submit data or comments on revising the OSHA EtO standard. OSHA complied by publishing a proposed rule, suggesting a PEL (permissible exposure limit) 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.' Public hearings were held. They produced 1600 pages of transcripts and over 300 exhibits. On June 14, OSHA had a final rule in hand. It provided for a 1 ppm PEL eight-hour TWA (time-weighted average) and a 10 ppm STEL fifteen-minute TWA. OSHA published as a final rule the long-term limits embodied in the PEL. The rule sets an 'action level' of 0.5 ppm, which if detected, requires employers to engage in regular employee monitoring. If the EtO exposure level is above 1 ppm PEL, the employer is required to establish a written compliance program to achieve an exposure level below 1 ppm. On January 2, 1985, OSHA issued its final rule declining to impose a STEL. Ps claim that the decision not to issue a STEL is unsupported on the record. The Ethylene Oxide Industry Council (EOIC) appears as amicus to support OSHA's decision not to issue a STEL Ps argues that OMB's role in these proceedings was unlawful. P is joined by several members of the House of Representatives as amici. The Association of Ethylene Oxide Users (AEOU) also challenged OSHA’s model arguing that the model unlawfully assumed that there was no threshold level of EtO exposure and that EtO was harmful at low doses because the model was based on probable or suspected risks and OSHA’s assumptions were not scientifically proven. AEOU argues that OSHA's decision to issue the PEL is unsupported on the record. Pursuant to Executive Order No. 12,291, 3 C.F.R. 127OSHA transmitted its final rule to the Office of Management and Budget (OMB) for review. 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. Agencies are 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. Agencies must defer final action until they have responded to OMB's view. 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 particular as unsupported by any reasonable risk assessment or inference from the available scientific evidence. Notwithstanding OMB's objections, OSHA published as a final rule the long-term limits embodied in the PEL. OSHA did reserve judgment on the STEL. Rather than issue the STEL as part of the final EtO standard, OSHA reopened the record for comments on the desirability of a STEL.

The legal issues presented in this case will be displayed here.

The court's holding and decision will be displayed here.

Legal analysis from Dean's Law Dictionary will be displayed here.