The basic process by which all federal agencies typically develop and issue regulations is set forth in the Administrative Procedure Act (APA), and is generally known as the rulemaking process. Rulemaking at most regulatory agencies follows the APA’s informal rulemaking process, also known as “notice and comment” rulemaking, which generally requires agencies to publish a notice of proposed rulemaking in the Federal Register, provide interested persons an opportunity to comment on the proposed regulation, and publish the final regulation, among other things. Under the APA, a person adversely affected by an agency’s notice and comment rulemaking is generally entitled to judicial review of that new rule, and a court may invalidate the regulation if it finds it to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” sometimes referred to as the arbitrary and capricious test. In addition to the requirements of the APA, federal agencies typically must comply with requirements imposed by certain other statutes and executive orders. In accordance with various presidential executive orders, agencies work closely with staff from the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs, who review draft regulations and other significant regulatory actions prior to publication.requirements that affect OSHA standard setting were established in 1980 or later. The process OSHA uses to develop and issue standards is spelled out in the OSH Act. Section 6(b) of the act specifies the procedures OSHA must These procedures use to promulgate, modify, or revoke its standards. include publishing the proposed rule in the Federal Register, providing interested persons an opportunity to comment, and holding a public hearing upon request. Section 6(a) of the act directed the Secretary of Labor (through OSHA) to adopt any national consensus standards or established federal standards as safety and health standards within 2 years of the date the OSH Act went into effect, without following the procedures set forth in section 6(b) or the APA.publication, the vast majority of these standards have not changed since originally adopted, despite significant advances in technology, equipment, and machinery over the past several decades. In leading the agency’s standard-setting process, staff from OSHA’s Directorate of Standards and Guidance, in collaboration with staff from other Labor offices, explore the According to an OSHA appropriateness and feasibility of developing standards to address workplace hazards that are not covered by existing standards. Once OSHA initiates such an effort, an interdisciplinary team typically composed of at least five staff focus on that issue. We analyzed the 58 significant health and safety standards OSHA issued between 1981 and 2010 and found that the time frames for developing and issuing them averaged about 93 months (7 years, 9 months), and ranged from 15 months to about 19 years (see table 1). During this period, OSHA staff also worked to develop standards that have not yet been finalized. For example, according to agency officials, OSHA staff have been working on developing a silica standard since 1997, a beryllium standard since 2000, and a standard on walking and working surfaces since 2003. For a depiction of the timelines for safety and health standards issued between 1981 and 2010, see appendix I. These analyses are necessary because the Supreme Court has held that the OSH Act requires that standards be both technologically and economically feasible. Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 513 n.31 (1981). businesses. According to agency officials, the small business panel process takes about 8 months of work, and OSHA is one of only three federal agencies that is subject to this requirement. Experts and agency officials also told us that changing priorities are a factor that affects the time frames for developing and issuing standards, explaining that priorities may change as a result of changes within OSHA, Labor, Congress, or the presidential administration. Some agency officials and experts told us such changes often cause delays in the process of setting standards. For example, some experts noted that the agency’s intense focus on publishing an ergonomics rule in the 1990s took attention away from several other standards that previously had been a priority. The standard of judicial review that applies to OSHA standards if they are challenged in court also affects OSHA’s time frames because it requires more robust research and analysis than the standard that applies to many other agencies’ regulations, according to some experts and agency officials. Instead of the arbitrary and capricious test provided for under the APA, the OSH Act directs courts to review OSHA’s standards using a more stringent legal standard: it provides that a standard shall be upheld if supported by “substantial evidence in the record considered as a According to OSHA officials, this more stringent standard whole.” (known as the “substantial evidence” standard) requires a higher level of scrutiny by the courts and as a result, OSHA staff must conduct a large volume of detailed research in order to understand all industrial processes involved in the hazard being regulated, and to ensure that a given hazard control would be feasible for each process. According to OSHA officials and experts, two additional factors result in an extensive amount of work for the agency in developing standards: Substantial data challenges, which stem from a dearth of available scientific data for some hazards and having to review and evaluate scientific studies, among other sources. In addition, according to agency officials, certain court decisions interpreting the OSH Act require rigorous support for the need for and feasibility of standards. 29 U.S.C. § 655(f). An example of one such decision cited by agency officials is a 1980 Supreme Court case, which resulted in OSHA having to conduct quantitative risk assessments for each health standard and ensure that these assessments are supported by substantial evidence. Response to adverse court decisions. Several experts with whom we spoke observed that adverse court decisions have contributed to an institutional culture in the agency of trying to make OSHA standards impervious to future adverse decisions. However, agency officials said that, in general, OSHA does not try to make a standard “bulletproof” because, while OSHA tries to avoid lawsuits that might ultimately invalidate the standard, the agency is frequently sued. For example, in the “benzene decision,” the Supreme Court invalidated OSHA’s revised standard for benzene because the agency failed to make a determination that benzene posed a “significant risk” of material health impairment under workplace conditions permitted by the Another example is a 1992 decision in which a current standard. U.S. Court of Appeals struck down an OSHA health standard that would have set or updated the permissible exposure limit for over 400 air contaminants. OSHA has not issued any emergency temporary standards in nearly 30 years, citing, among other reasons, legal and logistical challenges. OSHA officials noted that the emergency temporary standard authority remains available, but the legal requirements to issue such a standard— demonstrating that workers are exposed to grave danger and establishing that an emergency temporary standard is necessary to protect workers from that grave danger—are difficult to meet. Similarly difficult to meet, according to officials, is the requirement that an emergency temporary standard must be replaced within 6 months by a permanent standard issued using the process specified in section 6(b) of the OSH Act. OSHA uses enforcement and education as alternatives to issuing emergency temporary standards to respond relatively quickly to urgent workplace hazards. OSHA officials consider their enforcement and education activities complementary. It its enforcement efforts to address urgent hazards, OSHA uses the general duty clause of the OSH Act, which requires employers to provide a workplace free from recognized hazards that are causing, or are likely to cause, death or serious physical Under the general duty clause, OSHA has the harm to their employees. authority to issue citations to employers even in the absence of a specific standard under certain circumstances. Along with its enforcement and standard-setting activities, OSHA also educates employers and workers to promote voluntary protective measures against urgent hazards. OSHA’s education efforts include on-site consultations and publishing health and safety information on urgent hazards. For example, if its inspectors discover a particular hazard, OSHA may send letters to all employers where the hazard is likely to be present to inform them about the hazard and their responsibility to protect their workers. 29 U.S.C. § 654(a)(1). Although the rulemaking experiences of EPA and MSHA shed some light on OSHA’s challenges, their statutory framework and resources differ too markedly for them to be models for OSHA’s standard–setting process. For example, EPA is directed to regulate certain sources of specified air pollutants and review its existing regulations within specific time frames under section 112 of the Clean Air Act, which EPA officials told us gave the agency clear requirements and statutory deadlines for regulating hazardous air pollutants. MSHA benefits from a narrower scope of authority than OSHA and has more specialized expertise as a result of its more limited jurisdiction and frequent on-sight presence at mines. Officials at MSHA, OSHA, and Labor noted that this is very different from OSHA, which oversees a vast array of workplaces and types of industries and must often supplement the agency’s inside knowledge by conducting site visits. Agency officials and occupational safety and health experts shared their understanding of the challenges facing OSHA and offered ideas for improving the agency’s standard-setting process.involve substantial procedural changes that may be beyond the scope of OSHA’s authority and require amending existing laws, including the OSH Act. Improve coordination with other agencies: Experts and agency officials noted that OSHA has not fully leveraged available expertise at other federal agencies, especially NIOSH, in developing and issuing its standards. OSHA officials said the agency considers NIOSH’s input on an ad hoc basis but OSHA staff do not routinely work closely with NIOSH staff to analyze risks of occupational hazards.