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. SS 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. SS 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. They stated that collaborating with NIOSH on risk assessments, and generally in a more systematic way, could reduce the time it takes to develop a standard by several months, thus facilitating OSHA's standard-setting process. Expand use of voluntary consensus standards: According to OSHA officials, many OSHA standards incorporate or reference outdated consensus standards, which could leave workers exposed to hazards that are insufficiently addressed by OSHA standards that are based on out-of-date technology or processes. Experts suggested that Congress pass new legislation that would allow OSHA, through a single rulemaking effort, to revise standards for a group of health hazards using current industry voluntary consensus standards, eliminating the requirement for the agency to follow the standard- setting provisions of section 6(b) of the OSH Act or the APA. One potential disadvantage of this proposal is that any abbreviation to the regulatory process could also result in standards that fail to reflect relevant stakeholder concerns, such as an imposition of unnecessarily burdensome requirements on employers. Impose statutory deadlines: OSHA officials indicated that it can be difficult to prioritize standards due to the agency's numerous and sometimes competing goals. In the past, having a statutory deadline, combined with relief from procedural requirements, resulted in OSHA issuing standards more quickly. However, some legal scholars have noted that curtailing the current rulemaking process required by the APA may result in fewer opportunities for public input and possibly decrease the quality of the standard. Also, officials from MSHA told us that, while statutory deadlines make its priorities clear, this is sometimes to the detriment of other issues that must be set aside in the meantime. Change the standard of judicial review: Experts and agency officials suggested OSHA's substantial evidence standard of judicial review be replaced with the arbitrary and capricious standard, which would be more consistent with other federal regulatory agencies. The Administrative Conference of the United States has recommended that Congress amend laws that mandate use of the substantial evidence standard, in part because it can be unnecessarily burdensome for agencies. As a result, changing the standard of review to "arbitrary and capricious" could reduce the agency's evidentiary burden. However, if Congress has concerns about OSHA's current regulatory power, it may prefer to keep the current standard of review. Allow alternatives for supporting feasibility: Experts suggested that OSHA minimize on-site visits--a time-consuming requirement for analyzing the technological and economic feasibility of new or updated standards--by using surveys or basing its analyses on industry best practices. One limitation to surveying worksites is that, according to OSHA officials, in-person site visits are imperative for gathering sufficient data in support of most health standards. Basing feasibility analyses on industry best practices would require a statutory change, as one expert noted, and would still require OSHA to determine feasibility on an industry-by-industry basis. Adopt a priority-setting process: Experts suggested that OSHA develop a priority-setting process for addressing hazards, and as GAO has reported, such a process could lead to improved program results. OSHA attempted such a process in the past, which allowed the agency to articulate its highest priorities for addressing occupational hazards. Reestablishing such a process may improve a sense of transparency among stakeholders and facilitate OSHA management's ability to plan its staffing and budgetary needs. However, it may not immediately address OSHA's challenges in expeditiously setting standards because such a process could take time and would require commitment from agency management. The process for developing new and updated safety and health standards for occupational hazards is a lengthy one and can result in periods when there are insufficient protections for workers. Nevertheless, any streamlining of the current process must guarantee sufficient stakeholder input to ensure that the quality of standards does not suffer. Additional procedural requirements established since 1980 by Congress and various executive orders have increased opportunities for stakeholder input in the regulatory process and required agencies to evaluate and explain the need for regulations, but they have also resulted in a more protracted rulemaking process for OSHA and other regulatory agencies. Ideas for changes to the regulatory process must weigh the benefits of addressing hazards more quickly against a potential increase in the regulatory burden imposed on the regulated community. Most methods for streamlining that have been suggested by experts and agency officials are largely outside of OSHA's authority because many procedural requirements are established by federal statute or executive order. However, OSHA can coordinate more routinely with NIOSH on risk assessments and other analyses required to support the need for standards, saving OSHA time and expense. In our report being released today, we recommend that OSHA and NIOSH more consistently collaborate on researching occupational hazards so that OSHA can more effectively leverage NIOSH expertise in its standard-setting process. Both agencies agreed with this recommendation. Mr. Chairman, this concludes my prepared statement. I would be pleased to respond to any questions you or other Members of the Committee may have. For questions about this testimony, please contact me at (202) 512-7215 or moranr@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this statement. Individuals who made key contributions to this statement include, Gretta L. Goodwin, Assistant Director; Susan Aschoff; Tim Bober; Anna Bonelli; Sarah Cornetto; Jessica Gray; and Sara Pelton. The following two figures (fig. 2 and fig. 3) depict a timeline for each of the 58 significant safety and health standards OSHA issued between 1981 and 2010.

Summary:
This testimony discusses the challenges the Department of Labor's (Labor) Occupational Safety and Health Administration (OSHA) faces in developing and issuing safety and health standards. Workplace safety and health standards are designed to help protect over 130 million public and private sector workers from hazards at more than 8 million worksites in the United States, and have been credited with helping prevent thousands of work-related deaths, injuries, and illnesses. However, questions have been raised concerning whether the agency's approach to developing standards is overly cautious, resulting in too few standards being issued. Others counter that the process is intentionally deliberative to balance protections provided for workers with the compliance burden imposed on employers. Over the past 30 years, various presidential executive orders and federal laws have added new procedural requirements for regulatory agencies, resulting in multiple and sometimes lengthy steps OSHA and other agencies must follow. The remarks today are based on findings from our report, which is being released today, entitled "Workplace Safety and Health: Multiple Challenges Lengthen OSHA's Standard Setting." For this report, we were asked to review: (1) the time taken by OSHA to develop and issue occupational safety and health standards and the key factors that affect these time frames, (2) alternatives to the typical standard-setting process that are available for OSHA to address urgent hazards, (3) whether rulemaking at other regulatory agencies offers insight into OSHA's challenges with setting standards, and (4) ideas that have been suggested by occupational safety and health experts for improving the process. In summary, we found that, between 1981 and 2010, the time it took OSHA to develop and issue safety and health standards ranged from 15 months to 19 years and averaged more than 7 years. Experts and agency officials cited several factors that contribute to the lengthy time frames for developing and issuing standards, including increased procedural requirements, shifting priorities, and a rigorous standard of judicial review. We also found that, in addition to using the typical standard-setting process, OSHA can address urgent hazards by issuing emergency temporary standards, although the agency has not used this authority since 1983 because of the difficulty it has faced in compiling the evidence necessary to meet the statutory requirements. Instead, OSHA focuses on enforcement activities--such as enforcing the general requirement of the Occupational Safety and Health Act of 1970 (OSH Act) that employers provide a workplace free from recognized hazards--and educating employers and workers about urgent hazards. Experiences of other federal agencies that regulate public or worker health hazards offered limited insight into the challenges OSHA faces in setting standards. For example, EPA officials pointed to certain requirements of the Clean Air Act to set and regularly review standards for specified air pollutants that have facilitated the agency's standard-setting efforts. In contrast, the OSH Act does not require OSHA to periodically review its standards. Also, MSHA officials noted that their standard-setting process benefits from both the in-house knowledge of its inspectors, who inspect every mine at least twice yearly, and a dedicated mine safety research group within the National Institute for Occupational Safety and Health (NIOSH), a federal research agency that makes recommendations on occupational safety and health. OSHA must instead rely on time-consuming site visits to obtain information on hazards and has not consistently coordinated with NIOSH to assess occupational hazards. Finally, experts and agency officials identified several ideas that could improve OSHA's standard-setting process. In our report being released today, we draw upon one of these ideas and recommend that OSHA and NIOSH more consistently collaborate on researching occupational hazards so that OSHA can more effectively leverage NIOSH expertise in its standard-setting process.