Background

		Basics of the Federal Rulemaking Process

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. Agencies may also take other actions to gather information during  the rulemaking process; for example, agencies may hold a public meeting  to allow stakeholders to discuss specific aspects of the proposed  regulation. Under the APA, a person adversely affected by an agency’s  rulemaking is generally entitled to judicial review of that new rule. For  regulations developed and issued using the APA’s notice and comment  rulemaking process, the court may invalidate a 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 APA requirements, federal agencies typically must  comply with requirements imposed by certain other statutes and  executive orders. Some of the relevant laws include the Paperwork  Reduction Act and the Regulatory Flexibility Act, which were both enacted  in 1980; the Congressional Review Act, enacted in 1996;and the  Information Quality Act, enacted in 2000. (See app. II for an overview of  requirements that commonly apply to OSHA standard setting.) In  accordance with various presidential executive orders, agencies work  closely with staff from OMB’s Office of Information and Regulatory Affairs,  who review draft regulations and other significant regulatory actions prior  to publication.standard setting were established in 1980 or later.
Most of the additional requirements that affect OSHA  Agencies can supplement the notice and comment procedure for  developing regulations through a process called “negotiated rulemaking.”  Through this process, the agency convenes a negotiated rulemaking  committee, generally composed of representatives of the agency and the  various interest groups to be affected by a potential regulation, before  developing and issuing the proposed rule. If the committee comes to an  agreement on the content of a potential regulation, the agency may use it  as the proposed rule. However, any agreement by the negotiated  rulemaking committee is not binding on the agency or interest groups  represented on the committee. Negotiated rulemaking does not replace  any procedures required by the APA; rather, it can be used to help reach  agreement among the members of the committee on the content of a  proposed regulation, and according to proponents, it may help decrease  the likelihood of subsequent litigation over the regulation.

		Legal Framework and Staffing for OSHA’s Standard-Setting Process

OSHA administers the OSH Act, which was enacted to help assure, so far  as possible, safe and healthful working conditions for the nation’s  workers. Section 6(b) of the act authorizes the Secretary of Labor to  “promulgate, modify, or revoke any occupational safety or health  standard” when he or she determines that doing so would serve the  objectives of the OSH Act. Occupational safety and health standards  are a type of regulation and are defined as standards that require  “conditions, or the adoption or use of one or more practices, means,  methods, operations, or processes, reasonably necessary or appropriate  to provide safe or healthful employment and places of employment.”  Section 6(b) of the act also specifies the procedures by which OSHA  must promulgate, modify, or revoke its standards. These procedures  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 OSH 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. In general, national consensus standards are  safety and health standards that a nationally recognized standards- producing organization, such as the National Fire Protection Association,  adopts after reaching substantial agreement among those who will be  affected, including businesses, industries, and workers. Unlike OSHA’s  standards, which are mandatory, employers may choose whether to  voluntarily follow national consensus standards. The OSH Act specified  that OSHA set standards under section 6(a) without following OSHA’s  typical standard-setting procedures or the APA, including provisions for  public comment. Indeed, according to an OSHA publication, hundreds of  requirements in current OSHA standards make reference to or are based  on about 200 consensus standards, but the OSH Act does not explicitly   The  require OSHA to ensure that these standards are kept up to date.vast majority of these standards have not changed since originally  adopted, despite significant advances in technology, equipment, and  machinery over the past several decades. When a federal agency  decides to develop a rule, it is generally required by the National  Technology Transfer and Advancement Act of 1995 to use technical  standards developed or adopted by voluntary consensus standards  bodies, where appropriate, except when doing so is inconsistent with  applicable law or otherwise impractical. Under the OSH Act, if OSHA  issues a rule that differs substantially from an existing national consensus  standard, the agency must publish in the Federal Register an explanation  of why its rule will better effectuate the purposes of the OSH Act than the  national consensus standard.
OSHA’s Directorate of Standards and Guidance, working with staff from  other Labor offices, leads the agency’s standard-setting process. These  staff explore the 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.

	OSHA’S Standard- Setting Time Frames Vary Widely and Are Influenced by the Many Procedural Requirements and Other Factors

		OSHA’s Time Frames for Developing and Issuing Standards Vary

We analyzed the 58 significant health and safety standards that OSHA  issued between 1981 and 2010 and found that the time frames for  developing and issuing them ranged from 15 months to about 19 years  (see table 1). At any given point during this period, OSHA staff worked  to develop standards that eventually became final, represented in the  table below. On average, OSHA took a total of about 93 months (7 years,  9 months) to develop and issue these standards. After the agency  published the proposed standard, it took an average of about 39 months  (3 years, 3 months) to finalize the standard. The majority of these  standards—47 of the 58—were finalized between 1981 and 1999. In  addition to these final standards, OSHA staff have 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.
We found that the time it takes OSHA to develop and issue standards  varied over the 30-year period and by the type of standard. First, as  shown in table 1, it took OSHA about 70 percent longer, on average, to  finalize standards in the 1990s than it took during the 1980s, and about  30 percent longer than during the 2000s. While we were not able to  determine the reason for this through our analysis, it demonstrates that  there is no clear trend of OSHA developing and issuing standards more  or less quickly over time. Second, we found that it took OSHA longer to  develop and issue safety standards than health standards—an average of  about 8 years, 6 months for safety standards compared with about 6  years, 4 months for health standards—even though several experts to  whom we spoke stated that health standards are more difficult for OSHA  to issue than safety standards (see figs. 1 and 2 for a depiction of the  timelines for safety and health standards issued between 1981 and  2010). Part of this difference may be explained by the fact that a larger  portion of the health standards (6 of 23, compared with only 3 of 35 safety  standards) were standards for which Congress or the courts articulated  time frames for their issuance or development.
Experts and agency officials frequently cited the increased number of  procedural requirements established since 1980, shifting priorities, and  the relatively high standard of judicial review required for OSHA  standards as factors that lengthen OSHA’s time frames for developing  and issuing standards. In addition to these primary factors, several of the  experts and agency officials also noted two secondary factors affecting  the standard-setting process: significant data challenges and an  institutional apprehension about setting standards in the wake of adverse  court decisions. We have characterized these as secondary factors  because they are both related to the three primary factors.
Experts and agency officials indicated that the increased number of  procedural requirements affects standard-setting time frames because of  the complex requirements for OSHA to demonstrate the need for  standards. Experts and agency officials named a variety of statutes and  executive orders that have imposed an increasing number of procedural  requirements on OSHA since 1980.
The process for developing and issuing standards is complex and  directed by multiple procedural requirements. According to Labor staff,  agency consideration of a new standard can be the result of information  OSHA receives from stakeholder petitions; occupational safety and health  entities, such as the National Institute for Occupational Safety and Health  (NIOSH) and the U.S. Chemical Safety and Hazard Investigation Board;  OSHA’s enforcement efforts; or staff research (see fig. 3). To publicly  signal OSHA’s intent to pursue development of a new safety or health  standard, OSHA typically publishes a Request for Information or an  Advance Notice of Proposed Rulemaking on the topic in the Federal  Register. In this report, we refer to these events as “initiation.” OSHA also  signals the beginning of standard-setting efforts by placing the issue on  its regulatory agenda. However, OSHA can stop the standard-setting  process either informally—by ceasing to actively work on the standard— or through a public announcement.
The process for developing OSHA standards varies, but the typical  process involves multiple steps. After OSHA initiates a standard-setting  effort, staff typically schedule meetings with stakeholders—employer  groups, worker groups, and other interested parties—to solicit feedback  and discuss issues related to the potential standard, including its potential  cost to employers.
Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 513 n.31 (1981). standards on butadiene, methylene chloride, hexavalent chromium, silica,  and diacetyl. When OSHA performs the economic feasibility analysis, it  concludes that a standard is economically feasible if the affected industry  or industries will maintain long-term profitability and competitiveness. To  do this, staff and contractors, by analyzing information they collect when  visiting worksites, must assess the extent to which employers in the  affected industries can afford to implement the required controls. In  addition to the site visits, OSHA staff sometimes conducts industry-wide  surveys to determine baseline practices and collect other relevant  information needed for the technological and economic feasibility  analyses. According to OSHA officials, the process of developing a  survey and having it approved by OMB takes a minimum of 1 year.
In addition to the feasibility analyses, OSHA staff generally must also  conduct economic analyses. First, OSHA must assess the costs and  benefits of significant standards as required by Executive Order 12866.   Second, under the Small Business Regulatory Enforcement Fairness Act  of 1996, if OSHA determines that a potential standard would have a  significant economic impact on a substantial number of small entities,  such as businesses, it is one of three federal agencies that must initiate a  panel process that seeks and considers input from representatives of the  affected small businesses.several months of work that many other federal regulatory agencies do  not have to complete in order to issue regulations. Agency officials told us  they want to consult with small businesses, but that the provisions laid out   The small business panel process takes  in the requirement make it too formal a process and are duplicative of the  public hearings they hold after publishing the proposed rule. Finally,  according to OMB guidelines, if a potential standard is projected to have  an economic impact of more than $500 million, OSHA must initiate a peer  review of the underlying scientific analyses.
After completing the above steps, OSHA submits the preamble and text  of the potential standard to OMB for review. Notice of Proposed Rulemaking in the Federal Register to alert the public  that OSHA intends to issue a new final standard and to invite interested  parties to comment on the proposed standard. Although OSHA is only  required under the OSH Act hold public hearings upon request, as a  general practice, officials told us that OSHA holds such hearings and has  issued regulations governing its hearing procedures.administrative law judge presides over the hearings, and stakeholders  have the opportunity to submit evidence to support their views on specific  provisions of the proposed standards. The administrative law judge may  also permit cross-examination by stakeholders or OSHA attorneys to  bolster or challenge testimony presented during the hearing. Finally,  stakeholders can submit data and other written documents subsequent to  the hearing that OSHA must consider when crafting the final standard.
Executive Order 12866 requires that OMB review all significant regulatory actions prior  to their publication in the Federal Register. The executive order generally limits this review  period to a maximum of 90 days; however, this period may be extended on a one-time  basis for up to 30 days upon written approval of the OMB Director, or indefinitely at the  request of the head of the rulemaking agency. business panels, which agency officials estimated adds about 8 months  to the standard-setting process.
According to agency officials and experts, OSHA’s priorities may change  as a result of changes within OSHA, Labor, Congress, or the presidential  administration. During the 30-year period covered by our review,  administrations have alternately favored and resisted the development of  new federal regulations or revisions of existing regulations. For example,  officials told us that Assistant Secretaries typically serve for about 3  years, and that new appointees tend to change the agency’s priorities.  Some agency officials and experts told us that, regardless of the agency  leadership’s motivation for changes in priority, these changes often cause  delays in the process of setting standards. Further, officials told us that,  ultimately, political appointees make decisions about what standards, if  any, to pursue based on their goals and the agency’s resources.
Other experts described instances in which changes in the agency’s  standard-setting priorities affected the process. One example some cited  was OSHA’s efforts to develop the ergonomics standard. OSHA worked  for several years in the 1990s to develop a proposed rule on ergonomics  to address workers’ exposure to risk factors leading to musculoskeletal  disorders. After being in the preproposal stage through much of the  1990s, there was interest in the late 1990s for OSHA to publish a  proposed rule, and OSHA issued a final standard just 1 year after  publishing the proposed rule. Several experts and agency officials noted  that, in order to develop the rule so quickly, the vast majority of OSHA’s  standard-setting resources were focused on this rulemaking effort, taking  attention away from several standards that previously had been a priority.  Agency officials told us, for example, that work on this standard used  nearly 50 full-time staff in OSHA’s standards office, half the staff  economists, and 7 or 8 attorneys, compared with the more typical 5 total  staff assigned to develop a new standard.
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, according to some experts and  agency officials. OSHA standards are subject to a different standard of  judicial review than most other federal regulatory agencies’ regulations.  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  whole.” stringent standard requires a higher level of scrutiny by the courts and,  therefore, requires OSHA staff to perform more extensive research and  analysis to support a new standard. For example, OSHA officials  explained that the substantial evidence standard requires that OSHA staff  conduct a large volume of detailed research in order to understand all  industrial processes that involve the hazard being regulated and to  ensure that a given hazard control would be feasible for each process.
OSHA officials and experts discussed two additional factors that cause  OSHA officials to perform an extensive amount of work in developing  standards, which are related to the factors described above.
29 U.S.C. § 655(f). need for or feasibility of a standard contribute to substantial challenges to  attaining information required for setting standards. They cited court  decisions interpreting the OSH Act’s requirements as one of the reasons  they must rigorously support the need for and feasibility of standards. For  example, in 1980, the Supreme Court held that before it can issue a  standard, OSHA must determine that the standard is necessary to  remedy a “significant risk” of material health impairment among workers.  As a result of this decision, OSHA generally conducts quantitative risk  assessments for each health standard, which it must ensure are  supported by substantial evidence.decision essentially established a standard of medical and scientific  certainty and has resulted in OSHA staff having to spend an inordinate  amount of effort gathering data to support the need for a standard.
OSHA’s standard-setting process has been significantly influenced by  court decisions interpreting statutory requirements. A key example is the  1980 “benzene decision,” in which the Supreme Court invalidated an  OSHA standard that set a new exposure limit for benzene because OSHA  failed to make a determination that benzene posed a “significant risk” of  material health impairment under workplace conditions permitted by the  current standard. Another example is a 1992 decision in which the U.S.  Court of Appeals for the Eleventh Circuit struck down an OSHA health  standard that would have set or updated the permissible exposure limit   In that case, the court found that  (PEL) for over 400 air contaminants.OSHA had not adequately demonstrated that current exposure to each  hazard posed significant risk, or that each standard reduced that risk to  the extent feasible. Labor officials told us that the court’s decision  discouraged them from trying to expedite the standard-setting process by  combining many standards into one rulemaking effort. Several experts  with whom we spoke observed that such adverse court decisions have  contributed to an institutional culture of trying to make OSHA standards  impervious to future adverse decisions. These experts cited the threat of  litigation as a disincentive to issuing standards. In contrast, agency  officials commented that while OSHA tries to avoid lawsuits that might  ultimately invalidate a standard, in general OSHA does not try to make a  standard “bulletproof.” Agency officials noted the agency is frequently  sued.

	OSHA has Authority to Address Urgent Hazards through Emergency Temporary Standards, Enforcement, and Education

		Although It Has the Authority, OSHA Has Found it Difficult to Issue Emergency Temporary Standards

OSHA has not issued any emergency temporary standards in nearly 30  years, citing, among other reasons, legal and logistical challenges.  Section 6(c) of the OSH Act authorizes OSHA to issue these standards  without following the typical standard-setting process if two legal  requirements are met. The Secretary of Labor must determine that: (1)  workers are exposed to grave danger from exposure to substances or  agents determined to be toxic or physically harmful, or from new hazards,  and (2) an emergency temporary standard is necessary to protect  workers from that danger.effective immediately upon publication in the Federal Register and must   An emergency temporary standard becomes  be replaced within 6 months by a permanent standard issued using the  process specified in section 6(b). OSHA officials told us that meeting the  statutory requirements and issuing a permanent standard within the 6- month time frame has proven difficult. Furthermore, OSHA’s emergency  temporary standards have received close scrutiny by federal courts,  whose decisions have characterized OSHA’s emergency temporary  standard authority as an extraordinary power to be used only in limited  situations.
OSHA officials noted that the emergency temporary standard authority  remains available, but the legal requirements to issue such a standard  are difficult to meet. OSHA issued nine emergency temporary standards  between 1971, when the agency was established, and 1983, and none  since that year. Five of those nine emergency temporary standards were  either stayed or invalidated, at least in part, by federal courts.
For OSHA to satisfy the first of the OSH Act’s two requirements for  issuing an emergency temporary standard, the agency must determine  that workers will be exposed to grave danger during the time an  emergency temporary standard is in effect. Establishing sufficient  evidence of grave danger to withstand a court challenge can be difficult,  even for substances whose hazards are well-known, such as asbestos. In  1983, OSHA issued an emergency temporary standard lowering the PEL  for asbestos, which was subsequently challenged in federal court by  representatives of the asbestos industry. The court held that OSHA failed  to show sufficient evidence that workers faced grave danger from  exposure under current limits for the 6 months the emergency temporary  standard would be in effect. OSHA had estimated, based on mathematical projections from long-term epidemiological studies, that  during the 6 months the emergency temporary standard would be in  effect, it could prevent at least 80 eventual asbestos-related deaths.  However, the court found these projections too uncertain to establish a  grave risk over a 6-month period and noted that the type of analysis  OSHA used merited the public scrutiny of the notice and comment  standard-setting process.
OSHA has also found it challenging to meet the second OSH Act  requirement: establishing that an emergency temporary standard is  necessary to protect workers from the grave danger. In the asbestos  case, the court found that OSHA was on its way to issuing a permanent  standard within a year, already had the authority to conduct the education  activities the emergency temporary standard contained, and could  achieve many of the same benefits by increasing enforcement of the  existing standard. The court, therefore, invalidated the emergency  temporary asbestos standard because OSHA failed to meet both of the  OSH Act’s requirements. OSHA officials cited diacetyl, a food flavoring  ingredient, as a recent example of a hazardous substance for which the  OSH Act’s second requirement might have been difficult to meet if the  agency had chosen to pursue an emergency temporary standard. In  2006, the agency was urged to issue an emergency temporary standard  for diacetyl after investigations showed its association with severe,  irreversible lung disease among workers in microwave popcorn factories.  OSHA officials told us they could likely have established that diacetyl  exposure under then-current workplace conditions presented grave  danger to workers in the near term. These officials noted, however, that  because manufacturers responded quickly after diacetyl’s danger became  clear, OSHA had less evidence that an emergency temporary standard  was necessary. For example, they noted that manufacturers responded  with a combination of measures including improved ventilation and  housekeeping, reducing the concentration of diacetyl used, and  substituting other ingredients.
In addition to the legal requirements, OSHA has found that issuing an  emergency temporary standard presents a logistical challenge. OSHA’s  emergency temporary standards are effective on the date of publication in  the Federal Register, but they must be replaced within 6 months by a  permanent standard.evidence required for the typical standard-setting process—which, as  noted above, involves engaging with stakeholders and can take many  years—in this abbreviated time frame. OSHA officials noted that the  Congress intended this emergency temporary standard-setting authority  to be used under very limited circumstances.
This means OSHA must compile the same  OSHA has not issued an emergency temporary standard since 1983,  despite many requests that it do so. Labor unions and public health and  other advocacy organizations continue to petition OSHA to issue  emergency temporary standards to address a variety of workplace  hazards. According to OSHA records, it has received 23 petitions to issue  emergency temporary standards on hazardous chemicals, such as  formaldehyde, and also for safety hazards such as shock or injury from  unsecured equipment. One petition, submitted in September 2011, urges  OSHA to issue an emergency temporary standard to protect workers from  potentially fatal exposure to heat. Although OSHA has generally denied  these petitions, officials told us the agency considers whether to issue an  emergency temporary standard and takes the information into account  when setting its priorities for permanent standards.

		OSHA Addresses Urgent Hazards through Enforcement and Education

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: a high-profile citation or enforcement  initiative on an urgent hazard generates attention that can improve worker  safety industry-wide.
OSHA may cite employers for failing to adequately protect workers from a  specific workplace hazard even if it has not set a standard on that hazard.  Under section 5(a)(1) of the OSH Act, known as the general duty clause,  OSHA has the authority to issue citations to employers even in the  absence of a specific standard under certain circumstances. The general  duty clause requires employers to provide a workplace free from  recognized hazards that are causing, or are likely to cause, death or  serious physical harm to their employees. OSHA relied on the general  duty clause when it cited Walmart for inadequate crowd management in  the 2008 trampling death of a worker. OSHA’s investigation found that the  company failed to protect its employees from the known risks of being  crushed or suffocated by a large unmanaged crowd—in this case, about  2,000 shoppers surging into the store for a holiday sale. To cite an  employer under the general duty clause, OSHA officials told us they must,  among other things, have evidence that the hazard is “recognized” in the  industry and that the employer failed to take reasonable protective  measures. According to OSHA officials, using the general duty clause  requires significant agency resources so is not always a viable option, for  example when OSHA cannot prove an employer knows the hazard exists  or when a hazard is just emerging.
Some of OSHA’s standards require general protective measures that are  sufficiently broad to cover a variety of hazardous substances or practices.  Such standards may be the basis for enforcement actions regarding  urgent hazards that are not the subject of a specific standard. OSHA  officials explained that not every conceivable workplace hazard can be  the subject of its own standard. The agency has issued specific exposure  limits for some hazardous substances, such as formaldehyde, but  indicated it would be impossible to test and establish specific exposure  limits for all chemicals present in the modern workplace. OSHA’s general  standards include, among others, requirements for employers to follow  protective housekeeping practices, provide respiratory protection under  certain conditions, and inform workers about hazardous chemicals they  are exposed to on the job.
OSHA uses education to promote voluntary protective measures against  urgent hazards along with its enforcement and standard-setting activities.  Standards and enforcement are critical parts of OSHA’s education  activities: standards inform employers about their responsibilities, and  enforcement initiatives raise awareness of urgent hazards. OSHA officials  believe high-profile citations serve to focus attention throughout the  relevant industry and can create a ripple effect of improved worker  protection. In addition to setting standards, OSHA offers on-site  consultations and publishes health and safety information to inform  employers and workers about urgent hazards. 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 employees.
OSHA officials also use education to improve safety in the near term  while the agency compiles the information necessary to develop a  standard. For example, OSHA decided not to issue an emergency  temporary standard on diacetyl in part because, as it gathered evidence  to support the standard, employers implemented changes to improve  worker safety. As evidence mounts that other ingredients in food  flavorings may be hazardous, OSHA is gathering information but has not  yet published a proposed standard on diacetyl. OSHA has, in the  meantime, published educational documents such as alerts and  information bulletins for employers on diacetyl and flavorings in general,  describing protective measures, compliance assistance programs, and  employer responsibilities under the OSH Act and existing OSHA   The agency has also developed material for workers, giving  standards.them the information they need to determine when they may be exposed  to diacetyl or similar substances and the types of protection they need.
OSHA’s education efforts also address other hazards for which it has  received petitions to issue emergency temporary standards. For example,  OSHA officials told us they are addressing the risks of exposure to heat  primarily through education, along with targeted enforcement in cases  where workers are known to be most at risk. OSHA’s education efforts on  this hazard include an initiative intended to reach and educate agricultural  workers through training materials designed to be culturally appropriate  and accessible, including a train-the-trainer approach for wide distribution.  These training materials were supplemented by public service radio  announcements intended to reach workers at risk of heat-related illness.

	Other Regulatory Agencies’ Experiences Offer Limited Insight into OSHA’s Challenges

Although the rulemaking experiences of two other federal agencies 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. Other regulatory agencies may also face  challenges similar to OSHA’s. For example, as GAO has previously  reported, EPA has faced difficulties regulating under the Toxic  Substances Control Act of 1976. Some of these differences in statutory  frameworks and resources may facilitate rulemaking efforts at other  agencies. For example, EPA is directed to regulate specified air pollutants  and review its existing regulations within specific time frames under  section 112 of the Clean Air Act, and MSHA benefits from a narrower  scope of authority than OSHA and has more specialized expertise as a  result of its more limited jurisdiction.
Similar to OSHA, EPA’s Office of Air and Radiation regulates a wide  range of hazards across diverse industries to protect the public health.  This office implements the Clean Air Act, including section 112, which  requires EPA to regulate certain sources of air pollution and specifies the  substances to be controlled. For example, under section 112, EPA must  establish standards for sources of 187 specific hazardous air pollutants.
EPA officials told us that this provision gave the agency clear  requirements and statutory deadlines for regulating hazardous air  pollutants, which it previously lacked. In contrast, some experts and  agency officials we spoke with identified OSHA’s relatively broad  discretion to set and change its regulatory agenda as a contributing factor  to the length of time it takes OSHA to issue standards. Even with this  relatively specific statutory mandate, EPA has faced challenges  implementing its section 112 mandate, such as insufficient funding and  court-imposed deadlines that make it difficult for the agency itself to  implement its own agenda.
EPA also has a statutory mandate to periodically review the standards  issued under section 112. For example, section 112 requires that EPA set  technology-based standards for stationary sources of hazardous air  pollutants, and further requires that EPA review these standards at least  every 8 years and revise them, as necessary, taking into account  developments in practices, processes, and control technologies. contrast, the OSH Act does not specify when OSHA is to revise its  standards. OSHA’s attempt to update its standards efficiently—by  lowering the PELs for 212 air contaminants in one rulemaking—was   The court held that OSHA failed to show  struck down by a federal court.adequate evidence that each individual substance presented a significant  risk at the existing exposure limit, or that the lower limit would reduce the  risk to workers to the extent feasible. OSHA and Labor officials noted  that, because the agency lacks an efficient update process, many of its  standards lag behind advances in technology.
42 U.S.C. § 7412(d)(6). risks to human health or the environment. In contrast, OSHA must  determine that significant risks to workers are present under current  conditions before it can establish or change existing standards. OSHA  has had to perform a specific risk assessment for every new toxic agent  for which it intends to set a PEL.
MSHA’s mission is more focused than OSHA’s because its authority is  limited to one industry and it can target its regulatory resources more  easily. In addition, the Federal Mine Safety and Health Act of 1977  requires that MSHA inspect each mine in the United States at least two  times a year, which facilitates its regulatory work. Officials at MSHA  noted that both this frequent on-site presence and relatively homogenous  industry helps agency staff maintain a current knowledge base.officials contrasted this with the vast array of workplaces and types of  industries OSHA oversees. Officials with OSHA and Labor noted that  OSHA’s scope of authority is so large that it cannot inspect more than a  fraction of workplaces in any given year. As a result, OSHA and Labor  officials told us they can call upon inspectors when researching a  standard but must often supplement the agency’s inside knowledge by  conducting site visits using OSHA staff or contractors.
MSHA’s legal framework may also present fewer challenges to standard  setting than OSHA’s. First, MSHA standards are subject to the arbitrary  and capricious standard of review, unlike OSHA standards, which are  reviewed under the generally more stringent substantial evidence  standard. Second, according to MSHA officials, the agency has met the  statutory requirements for the five emergency temporary standards it has  issued since 1987, and no legal challenges to these standards were filed.  Similar to OSHA’s authority to issue emergency temporary standards,  MSHA has statutory authority to issue “an emergency temporary  mandatory health or safety standard” without following the APA’s notice  and comment rulemaking procedures if the Secretary of Labor determines  that (1) miners are exposed to grave danger from exposure to substances  or agents determined to be toxic or physically harmful, or to other  hazards, and (2) such a standard is necessary to protect miners from  such danger. MSHA’s most recent emergency temporary standard  required underground bituminous coal mine operators to increase the  incombustible content of rock, coal, and other dust, in order to address  the risk of explosion posed by such dust.
Both OSHA and MSHA supplement their employees’ knowledge by  calling upon the expertise at NIOSH, with MSHA benefiting from a  specialized research group within NIOSH focused on the mining industry.  According to officials with both NIOSH and OSHA, coordination between  the two has varied over time and has improved significantly in recent  years. For example, in 2011, NIOSH and OSHA adopted a Memorandum  of Understanding that provides OSHA with access to specified NIOSH  data on the health hazards of diacetyl and allows OSHA to coordinate  with NIOSH in preparing a risk assessment to support the development of  a new diacetyl standard.

	Experts Suggested Many Ideas to Improve OSHA’s Standard-Setting Process, Including More Interagency Coordination and Statutory Deadlines

		Improve Coordination with Other Federal Agencies to Leverage Expertise

To fully leverage expertise at other federal agencies, experts and agency  officials suggest improving interagency coordination. Specifically, they  indicated that OSHA has not fully leveraged available expertise at other  federal agencies, especially NIOSH, when developing and issuing its  standards. As mentioned previously, NIOSH conducts research and  makes recommendations on occupational safety and health, and it was  created at the same time as OSHA by the OSH Act. OSHA has a number  of staff with subject matter expertise relevant to standard setting,  including industrial hygienists and scientists, but the agency does not  always take advantage of the expertise and data at NIOSH on  occupational hazards. One expert noted that NIOSH is uniquely  positioned as a primary research institution to help OSHA develop  standards using EPA-produced data and analysis on chemical hazards.  OSHA officials said their agency’s staff consider NIOSH’s input on an ad  hoc basis, but do not routinely work closely with NIOSH staff to analyze  risks of occupational hazards. An OSHA official cited one case in which  OSHA staff worked closely with NIOSH staff to prepare the technological  feasibility analysis for a proposed silica standard, drawing on an  extensive body of work on dust control technology by NIOSH engineers.  In addition, officials described other cases of collaboration between the  two agencies during OSHA’s process of visiting worksites. However,  NIOSH officials told us that this type of coordination has been more  common recently than it was in the past, when the two agencies  performed separate risk assessments for hazards, such as hexavalent  chromium.
OSHA officials stated that collaborating with NIOSH on risk assessments  could reduce the time it takes to develop a standard by several months.  OSHA and NIOSH have coordinated on a number of OSHA standards  projects; currently, the two agencies have a Memorandum of  Understanding stipulating that NIOSH will perform the risk assessment for  the OSHA standard on diacetyl. However, some experts and officials at  both agencies noted that collaborating in a more systematic way could  facilitate OSHA’s standard-setting process.

		Expand OSHA’s Ability to Use Industry Voluntary Consensus Standards

To ensure that OSHA’s standards keep pace with changes in technology  and best practices, experts suggested the agency be allowed to more  easily adopt industry voluntary consensus standards. According to OSHA  officials, many OSHA standards incorporate or reference outdated  consensus standards, which results in challenges for employers in  complying with the standards and OSHA in enforcing them. Officials also  said that the majority of OSHA’s health standards were adopted from  existing federal standards—originally adopted under the Walsh-Healy  Act—during the agency’s first 2 years using section 6(a) of the OSH Act,  which directed OSHA to set standards without following the typical  section 6(b) standard-setting procedures or the APA. Although current at  the time, many industry consensus standards have since been updated to  reflect advancements in technology and science. However, according to  OSHA, most of OSHA’s standards have not been similarly updated, so  employers following current industry consensus standards may be out of  compliance with OSHA’s standards. As a result, some employers may be  discouraged from updating processes or technology at their worksites in  order to avoid OSHA citations. One expert said, and OSHA reported, that  this could leave workers at these worksites exposed to hazards that are  insufficiently addressed by OSHA standards that are based on out-of-date  technology or processes. OSHA has reported that these types of  standards are challenging because their inspectors must spend time  addressing them during worksite inspections. Additionally, officials told us  that issuing citations to employers that are following the most up-to-date  industry consensus standards reflects poorly on the agency. OSHA has  attempted to update some of its standards to incorporate advances in  technology and science, but the lengthy standard-setting process  presents significant challenges for updating them. In accordance with the  requirements in the OSH Act and the National Technology Transfer and  Advancement Act, when updating its standards, OSHA considers using  voluntary consensus standards. However, OSHA officials told us that,  since standards developing organizations typically do not have to meet  scientific requirements in developing voluntary standards, OSHA’s ability  to base its standards on voluntary consensus standards is limited  because staff must still perform a full quantitative risk assessment for new  standards. Since 2004, OSHA has been engaged in an effort to update  several of its standards using industry consensus standards, which  officials told us started by first identifying standards that would be well- suited to more streamlined rulemaking approaches, such as issuing a  direct final rule. For example, they said they chose to update the  standard on personal protective equipment first because they expected  employers would be amenable to the update, as changes would be  consistent with the current industry consensus standard.
To address the problem of standards based on outdated consensus  standards, 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 based on current industry voluntary  consensus standards or the Threshold Limit Values developed by the  American Conference of Governmental Industrial Hygienists. In 1989,  OSHA attempted to revise the PELs for over 200 air contaminants by  combining them into a single rulemaking effort, but the rule was  invalidated by the court for failing to follow the OSH Act requirements for  each hazard. To save OSHA time, experts specified that any new law to  this effect should contain a provision similar to the one in the OSH Act  that excused the agency during its first 2 years from following the  standard-setting provisions of section 6(b) of the OSH Act or the APA.  One potential disadvantage of this proposal is that OSHA may need to do  a substantial amount of independent scientific research to ensure that  consensus standards are based on sufficient scientific evidence. While  such a law, if enacted, could exempt OSHA from conducting this  research, an abbreviated regulatory process could also result in  standards that fail to reflect relevant stakeholder concerns, such as an  imposition of unnecessarily burdensome requirements on employers. For  example, one expert stated that, while following the APA process takes  time for regulatory agencies, it leads to higher quality standards and  ensures that the basis for agency action is clear and defensible. Also,  while this change could help ensure that existing OSHA standards are  kept up to date, it could divert resources away from efforts to set new  standards.

		Impose Statutory Deadlines and Provide Relief from Procedural Requirements for Setting Standards

To minimize the time it takes OSHA to develop and issue safety or health  standards, experts and agency officials suggested that statutory  deadlines for issuing occupational safety and health standards be  imposed by Congress and enforced by the courts. 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. For example, the  Needlestick Safety and Prevention Act directed OSHA to make specified  revisions to its bloodborne pathogens standard within 6 months and  exempted the agency from the typical procedural requirements under  section 6(b) of the OSH Act or the APA. OSHA had already spent some  time developing the standard before the law was passed, so it was able to  complete the revised standard within the required time frame. Including  the time spent on developing the standard before passage of the Act,  OSHA completed the revised standard in less than 3 years. Another  alternative to the full rulemaking process is for an agency to issue an  interim final rule, which is immediately effective as a final rule but still  allows for subsequent public comment. However, similar to one of the  disadvantages described above, 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 statutory deadlines  make its priorities clear, but this is sometimes to the detriment of other  issues that must be set aside in the meantime. Although a more  streamlined approach could reduce opportunities for stakeholder  comments and minimize agency flexibility, OSHA has used alternative  rulemaking procedures in the past to issue standards for which officials  perceive broad industry support.

		Change the Standard of Judicial Review for OSHA Standards

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. As the court stated in the case involving PELs for 428 air  contaminants, under the substantial evidence test, “ must take  a ‘harder look’ at OSHA’s action than we would if we were reviewing the  action under the more deferential arbitrary and capricious standard  applicable to agencies governed by the Administrative Procedure Act.”  As a result, OSHA officials said they spend a significant amount of time  collecting evidence to ensure that its standards can withstand challenge  under the substantial evidence standard of judicial review and to satisfy  procedural requirements for setting standards. One expert said he  understood that OSHA’s more stringent standard of judicial review was  paired with informal rulemaking procedures as a congressional  compromise.
According to the author of a 1999 law review article, one justification for  judicial review of agency rulemaking is when there is a genuine concern  about the power many agencies have in the regulatory process. Congress has similar concerns about OSHA, it may be preferable to keep  the current standard of review. However, the Administrative Conference  of the United States has recommended that Congress amend laws that  mandate use of the substantial evidence standard because it can be  unnecessarily burdensome for the agency or confusing because it has  been inconsistently applied by the courts. As a result, changing the  designation for the standard of judicial review to “arbitrary and capricious”  could reduce the agency’s evidentiary burden.
Mark Seidenfeld, “Bending the Rules: Flexible Regulation and Constraints on Agency  Discretion,” Administrative Law Review (spring, 1999).

		Improve Strategies for Supporting Economic and Technological Feasibility Analyses

Experts suggested that OSHA minimize on-site visits by using surveys or  basing its analyses on industry best practices, which could reduce the  time, expense, and need for industry cooperation in conducting economic  and technological feasibility studies. Primarily because OSHA has broad  authority to regulate occupational hazards in nearly all private industries,  the technological and economic feasibility analyses required by the OSH  Act entail an extensive amount of time and resources. OSHA must  conduct its feasibility analyses on an industry-by-industry basis, which  requires numerous site visits—an activity that is time-consuming and  largely dependent on industry cooperation. According to agency officials,  in many cases, OSHA hires contractors to gather information from  worksites that will support standards’ feasibility analyses.
Two experts suggested OSHA could streamline its economic and  technological feasibility analyses by surveying worksites rather than  visiting them. However, one limitation to this method is that, according to  OSHA officials, in-person site visits are imperative for gathering sufficient  data in support of most health standards. Specifically, officials told us that  to fully understand the industrial processes and application of a chemical  to be regulated, OSHA staff or contractors must be able to observe the  work being performed and ask questions of workers at the site. In  addition, the only way for OSHA to know about ambient chemical levels is  to collect on-site air samples all day long. In light of this limitation, this  method may be more appropriate for safety hazards. The other method  experts suggested is allowing OSHA to base economic and technological  feasibility assessments on industry best practices, which one expert  noted would require a statutory change. For example, OSHA could base  these analyses on the fact that a minimum percentage of workplaces in a  particular industry use technology or methods that decrease exposure to  hazards. However, the broad scope of OSHA’s authority would still result  in this being a substantial amount of work at the outset, as OSHA would  still be required to determine feasibility on an industry-by-industry basis.

		Adopt a Priority-Setting Process for Addressing Hazards

Experts suggested that OSHA develop a priority-setting process for  addressing hazards. GAO has reported that, by developing strategies  such as aligning agencywide objectives, federal agencies can  demonstrate a commitment to a course of action. Similarly, having a  priority-setting process could lead to improved program results. Currently,  however, OSHA has no process or guidance to use in setting priorities, as  officials told us they do not have a document that explains how priorities  are or should be set. OSHA officials also said that ideas for which  hazards to regulate come from a number of sources, including petitions  from stakeholders, information from NIOSH, OSHA’s enforcement efforts,  recommendations from the Chemical Safety Board, and staff research.  While staff in OSHA’s standards office use this information to make  recommendations to Labor’s Assistant Secretary for OSHA and the  Deputy Secretary on which hazards to regulate, not all of their  recommendations make it to the agency’s regulatory agenda, which is  developed according to agency goals and resources. In addition,  according to OSHA officials, decisions about which hazards to regulate  guide OSHA standards activity for 6 months, the duration of the biannual  regulatory agenda. As a result, the ability of the managers of OSHA’s  standards office to plan with certainty work beyond this 6-month time  frame may be limited.
One expert suggested that OSHA develop a priority-setting process that  more directly involves stakeholders with expertise in occupational safety  and health in recommending new standards. OSHA attempted such a  process in 1994 when it initiated a formal priority planning process.  However, the expert said that, after an established committee of experts  identified a list of priority hazards, the political climate changed with a new  Congress that was generally more critical of the role of executive  agencies in developing new standards, and OSHA shifted its focus away  from this initiative. Nevertheless, this process allowed OSHA to articulate  its highest priorities for addressing occupational hazards. Reestablishing  a similar priority-setting process could have several benefits for OSHA,  such as improving a sense of transparency among stakeholders and  facilitating OSHA management’s ability to plan its staffing and budgetary  needs. However, adopting such a process may not immediately address  OSHA’s challenges in expeditiously setting standards because a process  like this could take time and would require commitment from agency  management.

	Conclusions

Setting occupational safety and health standards is one of OSHA’s  primary methods for ensuring that workers are protected from  occupational hazards, but OSHA faces a number of challenges in setting  these standards promptly and efficiently. The 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. The process for  developing new standards for previously unregulated occupational  hazards and new hazards that emerge 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.  In addition, ideas for changes to the regulatory process must weigh the  benefits of addressing hazards more quickly against a potential increase  in the regulatory burden to be 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. NIOSH’s and OSHA’s  current efforts to coordinate on the development of a new standard, which  officials and staff from both agencies support, provides a useful template  for increased and regular coordination on similar efforts.

	Recommendation for Executive Action

To enhance collaboration and streamline the development of OSHA’s  occupational safety and health standards, we recommend that the  Secretary of Labor and the Secretary of the Department of Health and  Human Services instruct the Assistant Secretary of Labor for  Occupational Safety and Health and the Director of the National Institute  for Occupational Safety and Health to develop a more formal means of  collaboration between the two agencies. Specifically, the two agencies  should establish a more consistent and sustained relationship through a  formal agreement, such as a Memorandum of Understanding, allowing  OSHA to better leverage NIOSH’s capacity as a primary research  institution when building the scientific record required for standard setting.

	Agency Comments

We provided a draft of this report to the six agencies that assisted us in  gathering information: Labor (OSHA and MSHA), Department of Health  and Human Services (NIOSH), EPA, U.S. Chemical Safety and Hazard  Investigation Board, OMB, and the Department of Commerce (National  Institute of Standards and Technology). We received written comments  from Labor and the Department of Health and Human Services; both sets  of comments are reproduced in appendices III and IV, respectively. Both  Labor’s Assistant Secretary for OSHA and the Department of Health and  Human Services’ Assistant Secretary for Legislation agreed with GAO’s  recommendation. They also both described the ways in which OSHA and  NIOSH currently collaborate, each noting the expected benefits of  maintaining collaboration through a formalized agreement. Labor’s OSHA  and MSHA, EPA, and the Department of Commerce also provided  technical comments, which we incorporated in the report as appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees and other interested parties. In addition, this  report will be available at no charge on the GAO website at  http://www.gao.gov.
If you or your staff members have any questions about this report, 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 report. Key contributors to this report are listed in  appendix V.

Appendix I: Objectives, Scope, and Methodology

To determine how long it takes the Occupational Safety and Health  Administration (OSHA) to develop and issue safety and health standards,  we reviewed occupational safety and health standards and substantive  updates to those standards. We selected standards that met two criteria:  (1) they were published as a final rule between calendar years 1981 and  2010 and (2) OSHA identified each standard as significant. To identify our  universe of standards for this analysis, we first conducted an electronic  legal database search for final rules published by OSHA in the Federal  Register between 1981 and 2010. We chose this time frame because it  spans multiple executive administrations and changes in congressional  leadership. Also, several statutes, executive orders, and key court  decisions affecting OSHA’s standard-setting process became effective in  or after 1980. We excluded from our review any rules that were not  occupational safety or health standards, such as recordkeeping  requirements or general administrative regulations, and any rules that  were minor or technical amendments to existing standards. For this list,  we included only standards for which OSHA’s semiannual regulatory  agenda or other evidence indicated that OSHA considered the standard  to be important or a priority, including but not limited to standards that met  the definition of “significant” under Executive Order 12866. For each  standard, we identified the dates of three regulatory benchmarks— initiation, proposed rule, and final rulebetween each benchmark to analyze trends. We confirmed with OSHA  staff the accuracy of our selected benchmark dates and that the list of  standards met our criteria.  —and calculated the time elapsed  There are some limitations to this approach because the development of  a standard may not have a clear beginning or end point. For example,  OSHA may have begun work on a standard prior to its appearance on the  regulatory agenda or the publication of a Request for Information or  Advance Notice of Proposed Rulemaking in the Federal Register.
Conversely, it is possible that although a standard appeared on the  regulatory agenda, work did not begin on the standard until sometime  later. According to OSHA officials, once development of a particular  standard has begun, work may stop and start again due to various factors  such as changing priorities. Furthermore, the date a final rule was  published does not necessarily coincide with the date the rule took effect,  which may be some time later. While our analysis will not reflect these  distinctions, we selected these benchmarks to ensure consistency and  maximize comparability across different standards.
To identify the key factors affecting OSHA’s time frames for issuing  standards and ideas for improving OSHA’s standard-setting process, we  conducted semistructured interviews with current and former Labor staff,  as well as occupational safety and health experts, and analyzed their  responses. We identified these experts, who represented both workers  and employers, through our own research and through recommendations  from other experts. The experts had direct experience with setting  standards at OSHA, testified at past congressional hearings on  occupational safety and health issues, or published written material on  federal rulemaking. Finally, we reviewed relevant federal laws,  regulations, executive orders, and other guidance and interviewed  officials from the Office of Management and Budget to determine the  required steps in the standard-setting process and how those  requirements affect the time it takes OSHA to develop and issue  standards.
To identify alternatives to the typical standard-setting process available  for OSHA to address urgent hazards, we reviewed relevant federal laws  and interviewed current OSHA staff and attorneys from the Department of  Labor’s Office of the Solicitor. We also interviewed experts identified as  described above. We assessed the extent to which OSHA has used its  authority to issue emergency temporary standards by analyzing a history  of petitions for these standards provided to us by Labor staff.
To determine whether rulemaking at other regulatory agencies offers  insight into OSHA’s challenges with setting standards, we explored the  regulatory process at three other federal regulatory agencies and offices.  For these comparisons, we selected agencies with authority to issue  regulations relating to public health or safety. We also included some  agencies whose statutory frameworks were similar to OSHA’s and some  whose statutory frameworks were different than OSHA’s. We based our  selection of comparison agencies and offices on our interviews with  experts, as well as a review of the literature, previous GAO work, and  relevant federal laws. Using these criteria, we initially selected Labor’s  Mine Safety and Health Administration (MSHA) and two offices of the  Environmental Protection Agency (EPA): the Office of Pollution  Prevention and Toxics and the Office of Air and Radiation. For the EPA  offices, we specifically focused on their rulemaking experiences under  section 6 of the Toxic Substances Control Act and section 112 of the  Clean Air Act. However, after further review, we concluded that the Office  of Pollution Prevention and Toxics did not offer insights for OSHA  because of the office’s limited recent standard-setting experience and, as  a result, we excluded the Toxic Substances Control Act from our review.  Through a review of relevant federal laws and semistructured interviews  with staff in EPA’s Office of Air and Radiation and at MSHA, we learned  about challenges each agency faces when developing and issuing  regulations and the factors that affect their time frames. Although states  may also issue standards in the absence of an applicable federal  standard or under an OSHA-approved plan, we did not look to these  states to gain insight into OSHA’s challenges with setting standards.  Based on our interviews with experts, and because rulemaking at the  state level is governed by state law and is not subject to federal  rulemaking procedural requirements, we determined that any  comparisons between OSHA and states with respect to time frames for  issuing standards would be inapt.
We compiled the ideas for improving OSHA’s standard-setting process by  analyzing statements from interviews with current and former agency  officials and experts representing both workers and employers. The six  ideas discussed in the report represent those most frequently mentioned  that are not otherwise addressed by other parts of our report.
We conducted this performance audit from February 2011 to April 2012 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusion based on our audit objectives.

Appendix II: Selected Procedural Requirements for Federal Rulemaking

Table 2 presents a summary of federal rulemaking requirements that  apply to OSHA standard setting. This table is not intended to be a  complete list of all procedural requirements that govern rulemaking at  OSHA or at other federal regulatory agencies. In addition, this table  presents only a selected summary of the requirements; for the complete  requirements contained in each source, refer directly to the cited source.

Appendix III: Comments from the Department of Labor

Appendix IV: Comments from the Department of Health and Human Services

Appendix V: GAO Contact and Staff Acknowledgments

	GAO Contact

	Staff Acknowledgments

In addition to the individual named above, Gretta L. Goodwin, Assistant  Director; Sara Pelton, Analyst-in-Charge; and Anna Bonelli, Analyst-in- Charge; managed all aspects of this assignment; Suzanne Rubins and  Sarah Newman made significant contributions to all phases of the work;  Sarah Cornetto made substantial contributions by providing legal advice  and assistance; Jean McSween provided assistance in designing the  study; Ashley McCall provided assistance with occupational safety and  health literature; Kate van Gelder and Susan Aschoff assisted in message  and report development; James Bennett created the report’s graphics;  and Ashanta Williams, Lise Levie, and Daniel S. Meyer reviewed the  report to check the facts presented.

Summary:
Why GAO Did This Study

Occupational safety and health standards are designed to help protect about 130 million public and private sector workers from hazards at more than 8 million U.S. worksites. Questions exist concerning how long it takes OSHA to issue its standards. GAO was asked to examine: (1) the time OSHA takes to develop and issue safety and health standards and the key factors that affect these time frames, (2) alternatives to the typical standard-setting process available for OSHA to address urgent hazards (3) whether other regulatory agencies rulemaking offers insight into OSHAs challenges with setting standards, and (4) ideas from occupational safety and health experts and agency officials for improving OSHAs process. GAO analyzed standards issued by OSHA between 1981 and 2010, interviewed subject matter experts and agency officials at OSHA and two similar federal regulatory agencies and offices, and reviewed the standard-setting process at OSHA and the comparison agencies and offices.

What GAO Found

Between 1981 and 2010, the time it took the Department of Labors Occupational Safety and Health Administration (OSHA) to develop and issue safety and health standards ranged widely, from 15 months to 19 years, and averaged more than 7 years. Experts and agency officials cited increased procedural requirements, shifting priorities, and a rigorous standard of judicial review as contributing to lengthy time frames for developing and issuing standards. For example, they said that a shift in OSHAs priorities toward one standard took attention away from several other standards that previously had been a priority.
In addition to using the typical standard-setting process, OSHA can address urgent hazards by issuing emergency temporary standards, directing additional attention to enforcing relevant existing standards, and educating employers and workers about hazards. However, OSHA has not issued an emergency temporary standard since 1983 because it has found it difficult to compile the evidence necessary to meet the statutory requirements. Instead, OSHA focuses on enforcement and education when workers face urgent hazards. For example, OSHA can enforce the general requirement of the Occupational Safety and Health Act of 1970 (OSH Act) that employers provide a workplace free from recognized hazards, as it did in 2009 when it cited a major retail employer after one of its workers was crushed to death by uncontrolled holiday crowds. To educate employers and workers, OSHA coordinates and funds on-site consultations and publishes information on matters as diverse as safe lifting techniques for nursing home workers and exposure to diacetyl, a flavoring ingredient used in microwave popcorn linked to lung disease among factory workers.
Experiences of other federal agencies that regulate public or worker health hazards offer limited insight into the challenges OSHA faces in setting standards. For example, officials with the Environmental Protection Agency noted that certain Clean Air Act requirements to set and regularly review standards for specified air pollutants have facilitated that agencys standard-setting efforts. In contrast, the OSH Act does not require OSHA to periodically review and update its standards. Officials with the Mine Safety and Health Administration 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 rely on time-consuming site visits for hazards information and has not consistently coordinated with NIOSH to engage that agencys expertise on occupational hazards.
Experts and agency officials identified several ideas that could improve OSHAs standard-setting process. While some of the changes, such as improving coordination with other agencies to leverage expertise, are within OSHAs authority, others call for significant procedural changes that would require amending existing laws. For example, some experts recommended a statutory change that would allow OSHA to revise a group of outdated health standards at the same time, using industry consensus standards as support rather than having to analyze each hazard individually.

What GAO Recommends

To streamline OSHA standards development, GAO recommends that OSHA and NIOSH more consistently collaborate on researching occupational hazards, so that OSHA can more effectively leverage NIOSH expertise in determining the needs for new standards and developing them. Both agencies agreed with the recommendation.