NACOSH's Report and Recommendations related to OSHA's Standards Development Process (June 6, 2000)

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OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
(OSHA)

THE NATIONAL ADVISORY COMMITTEE ON
OCCUPATIONAL SAFETY AND HEALTH
(NACOSH)

Report and Recommendations related to

OSHA'S STANDARDS DEVELOPMENT PROCESS

June 6, 2000

This Report was approved unanimously by those members of NACOSH present on June 6 which included: Public Members Byron K. Orton (Chair), Nancy Lessin, Daniel Hryhorczuk and Letitia K. Davis; Management Members Henry B.Lick and Dennis W. Scullion; Labor Members Margaret M. Seminario and Michael J. Wright; Safety Member Margaret M. Carroll; and Health Member Phil Harter . Health Member Bonnie Rogers, who was not present, also voted to accept the report. Safety Member David J. Heller, who was unable to attend a number of meetings during development of the report, abstained from voting.

TABLE OF CONTENTS

Part I Introduction

Part II Summary of Panel Discussions

Part III    Discussion of Issues and Recommendations

Part IV    Specific Recommendations Related to OSHA's Standards Development Process

Part V    Appendices

A REPORT AND RECOMMENDATIONS

Related to

OSHA's STANDARDS DEVELOPMENT PROCESS

PART I - INTRODUCTION

Over the years, the National Advisory Committee on Occupational Safety and Health (NACOSH) has been concerned with the degree of difficulty and the excessive time needed for OSHA to promulgate safety and health standards. Since its reactivation in 1994, NACOSH has actively provided advice to OSHA on the development of standards or rules on Recordkeeping, Ergonomics and Safety and Health Programs. NACOSH considers these three areas particularly important to the advancement of safety and health in the American workplace. In 1998, after four years during which none of these standards had yet been proposed, and at the request of OSHA Assistant Secretary Charles Jeffress, NACOSH began this study. The goal of the study is to determine the reasons why the OSHA standards setting process has in many respects become inefficient and ineffective to the detriment of a healthful workplace.

NACOSH has taken note that since consensus standards were first adopted in the two years after the passage of the Occupational Safety and Health Act, a relatively small number of standards have been promulgated. Further, standards such as Permissible Exposure Limits have not been successfully updated. The average time to develop and promulgate a standard is ten years, depending on how the time of the introduction of the standard is measured. The first ANPR for the Confined Space Entry Standard was 1975 and the final rule was promulgated in 1993. The request for information on the Lockout/Tagout Standard was published in 1977 and the final rule was 1989. A more complete listing of standards and their development history is included as Appendix F. During the time these important standards were under consideration, hundreds of workers continued to be killed or seriously injured annually by these hazards.

OSHA and the standards it has developed have reduced the number of deaths and rate of injuries in the American workplace. Since 1970, the number of fatal workplace injuries has declined from 13,800 to 6,026 in 1998, and the fatality rate has declined from 18 per 100,000 workers to 4.5 per 100,000 workers. Similarly, since 1973, according to the Bureau of Labor Statistics (BLS) Annual Survey, the reported workplace injury rate has decreased from 11.0 per 100 workers to 6.7 in 1998. The greatest declines in workplace injury rates have occurred in manufacturing, construction and mining--the industries where OSHA and its sister agency, MSHA, have focused their regulatory and enforcement activities.

Comprehensive accurate data on the incidence and trends of occupational illnesses and related mortality are not available. However, data that are available show significant declines in blood lead levels and reported cases of byssinosis since the promulgation of OSHA's lead standard and cotton dust standard in 1978. Similarly, worker exposures to vinyl chloride, coke oven emissions, asbestos and other toxic substances have been reduced dramatically as a result of OSHA standards for these hazards.

Despite these improvements, the toll and related costs of workplace fatalities, injuries and illnesses remains substantial. In a study conducted by J. Paul Leigh et al, published in the Archives of Internal Medicine, Leigh concluded that in 1992:

6500 workers were killed
13.2 million workers were injured, and
the overall impact on the U. S. economy amounted to $171 billion

However, over the years the speed of regulatory solutions has decreased. NACOSH realizes that standards have economic and productivity impact and are thereby subject to political debate, but OSHA needs to identify the internal and external barriers in this process to rationalize the political reality with the promise of the Occupational Safety and Health Act to protect workers from harm. NACOSH believes that OSHA shares this responsibility with the National Institute for Occupational Safety and Health (NIOSH).

To identify the root causes, NACOSH sought information from panels of various stakeholders involved in the process and from individuals and organizations that had participated in previous standards setting at OSHA or other governmental agencies. These panels consisted of representatives of:

OSHA and SOL senior management staff charged with standards setting
Stakeholders involved in the development of the methylene chloride standard
Negotiated rulemaking and standards advisory committee participants
Consensus standards setting organizations and professional associations
Other federal agencies involved in health and safety rulemaking

After hearing from the panelists, NACOSH has concluded that the standards setting process is not working as intended in the Occupational Safety and Health Act of 1970. In fairness to OSHA, many external legislative barriers and court interpretations have made the process more difficult than that originally intended. Several layers of review are now mandated that were not foreseen in the OSH Act. However, NACOSH believes that OSHA and NIOSH have not developed sufficient management systems to address the anti-regulatory environment that exists. Further, NACOSH has concluded that OSHA and NIOSH do not act synergistically in the standards setting process.

Although some OSHA state program states have actually been able to develop and implement standards on their own prior to promulgation by OSHA, there are a significant number of other state plan states who are prohibited by law from taking such action and must wait for the release of OSHA standards which increases the impact of delay in the OSHA standards setting process.

Other agencies with major regulatory responsibilities, such as the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), have been more successful in setting standards. This is due partially to their success in gaining public support for their regulatory agenda. This success has been translated into the addition of more resources to apply to standards setting. In addition to a lack of success in gaining public support and resources, OSHA has not managed and supported its internal and advisory resources as effectively as it could. This is due to weaknesses in strategic and tactical planning and the subsequent failure to meet established goals in a timely manner.

OSHA must use the tested management techniques that are available today and aggressively pursue new technology. The internet can provide a virtual forum to receive and process information. NACOSH recognizes the importance and difficulty of OSHA being able to attract the highly qualified technical staff essential to carrying out its mission. Further, NACOSH considers it very important that OSHA aggressively recruit, support and retain such personnel. If appropriate staff is not available, OSHA should make full use of contractors and consultants. OSHA and NIOSH must adapt to today's realities.

OSHA and NIOSH should not shoulder all of the blame for the standards setting process not working. Consensus standards setting organizations and professional associations could be more consistent and uniform in their support. OSHA and NIOSH must form stronger alliances with these entities and attempt to reduce differences of scientific opinion early in the standards setting process.

Table of Contents

PART II - SUMMARY OF PANEL DISCUSSIONS

A copy of a letter from the American Society for Testing and Materials (ASTM) to Assistant Secretary Charles Jeffress recommending that OSHA make increased use of consensus standards was sent to NACOSH by ASTM and was discussed at its meeting on May 8, 1998. The committee concluded that they would like to have an in-depth discussion of the standards development process, including the role of consensus standards, at its next meeting.

On August 6, 1998, Joe Woodward, SOL, and Marthe Kent, OSHA, began by comparing the three inches (on one page) of text which constituted the preamble for the air contaminants proposed standard in 1971 with the two large volumes of preamble which accompanied the 1988 proposal for update, saying that even more requirements had been added to the standards development process since that time. They said that many people continually asked why it takes so long to produce a standard. In response they described all of the legal criteria OSHA must meet: hazard must pose significant risk of material impairment; standard must be technologically and economically feasible, cost effective and better effectuate the purposes of the act than the applicable consensus standard. In addition, health standards must eliminate significant risk or reduce to the extent feasible; and safety standards must afford a high degree of employee protection. They cited the many regulations/processes governing the development of a standard: Executive Orders, OMB Implementing Guidelines, Regulatory Impact, the Regulatory Plan and Agenda, the Paperwork Reduction Act, the Regulatory Flexibility Act, SBREFA, Small Business Compliance Guidelines, Lookback Reviews, Unfunded Mandates, Executive Memorandum on Plain Language, and Equal Access to Justice as just some of the laws or regulations which add steps to the standards development process. They summarized public participation steps as including peer review, stakeholder meetings, other public meetings, review by advisory committees, and public hearings. All of these requirements are superimposed on the basic structural requirement of: (1) publication of either an Advanced Notice of Proposed Rulemaking (ANPRM) or a Notice of Proposed Rulemaking, (2) a Public Comment Period, (3) public hearings on a proposed standard, (4) post-hearing comments and briefs, and (5) publication of a final standard. They provided a handout to the committee listing some 111 major steps in the process. To summarize, the committee was simply overwhelmed by the complexity of the process.

At its November 9-10, 1998, meeting, NACOSH decided to undertake a comprehensive project related to the standards development process in which the committee would examine and discuss the different models available to the agency for promulgating standards and regulations, including the full 6(b) process, the use of negotiated rulemaking and standards advisory committees. In addition, the committee decided to discuss the use of voluntary consensus standards and guidelines, the role of professional organizations, and the processes of other Federal agencies. They decided to use the methylene chloride standard as an example of the 6(b) rulemaking process, the Steel Erection Negotiated Rulemaking Advisory Committee as an example of negotiated rulemaking and the Metalworking Fluids Standards Advisory Committee as an example of a regular 6(b) advisory committee. NACOSH expressed its intent to hold a series of panel discussions and invite key players including industry and labor, health and safety professionals, and OSHA/SOL/NIOSH staff involved in each standard to learn what went right, what went wrong and how the process could be improved.

Table of Contents

Panel Presentation on the 6(b) Standards Development Process used for the Methylene Chloride Standard - February 11, 1999

In opening comments, NACOSH Chair Kathy Rest said that the committee was about to embark on an examination of OSHA's standards setting process and had decided to begin the process by using the methylene chloride standard as an example of the 6(b) process. She added that talking points had been given to each presenter to assist in focusing the discussion.

How did you become involved in the process? What was your role?
What were the key issues in the process; e.g. technical, economic, political, feasibility, scope of the standard, nature of the regulated community?
What went right and what went wrong with the process? What were the major obstacles and what were the strengths of the process?
Based on your experience and expertise, how could the process be improved? How could it be done better, faster, more efficiently, less contentiously. Consider what all the different parties might contribute in this context--not just what OSHA should do.
What advice would you give OSHA if it were to embark on another similar rulemaking using the same process?

Rest added further questions which she said would have to be confronted such as:

What is/should be the role of the government in protecting and promoting worker health and safety? To what extent are we conscious of these different roles?
How does the agency view its role? How do the stakeholders view the role of the agency?
How can standards be fashioned to obtain the most appropriate level of protection for workers? What determines how tradeoffs are made in the standard setting process?
Was the process fair? Was the outcome fair?

She noted that it would be important to keep the distinction between process and outcome in mind.

John Martonik, OSHA, who had served as Deputy Director for Health Standards from 1981 to 1996, reviewed the history of the development of the standard and outlined the major events including: UAW petitioning OSHA for a standard in July 1985; OSHA publication of an ANPRM in November 1986; proposed standard sent to OMB in January 1991; start of public hearings in September 1992; draft final standard submitted to OMB in September 1994; revised draft final standard submitted to OMB in June 1996; final standard published January 1997; industry and UAW filed petitions for review in Court of Appeals in January 1997; OSHA, UAW and industry informed Court of agreement in principle to settle suits in January 1998; final standard published in September 1998. Chuck Gordon, SOL, then discussed the legal actions which took place after publication of the final standard, and Adam Finkel, OSHA, the current Director of Health Standards, commented on the need to restructure the risk assessment and resubmit to OMB in June 1996. Paul Schulte, NIOSH, outlined NIOSH's participation in the development of the standard starting with a criteria document in 1976. He summarized NIOSH's role as one of recommending, consulting and providing technical assistance.

Frank Mirer, UAW, said that the most difficult problem was "getting OSHA to act". He said he sympathized with OSHA about the difficulty of the process but said that most of the obstacles are not "in the Act". He said that what was right, in this case, was the result--that the U.S. now had the strictest limit in the world and the only one with good criteria for exposure determination and medical monitoring. He added that one of the problems was that industry and OMB forced an elaborate pharmacokinetic model on the agency that he thinks is fundamentally flawed and underestimates the risks because it ignores rat data. Randy Rabinowitz, representing UAW also, started by saying that she disagreed with the Chair's opening statement with regard to a question of "tradeoffs". She said that Congress had unequivocally said that no employee should suffer material impairment of health, even if that employee is exposed to a particular substance for his or her entire working life. She said that she hoped the discussion would focus on what the law says OSHA's job should be. She said she thought there was a huge gulf between what the law requires OSHA to do and what OSHA has taken upon itself to do in the standard-setting process. She said that OSHA keeps trying to set standards that are going to be immune from challenge in the courts, which she considers impossible to do and, therefore, a waste of time. She said that another waste of time was OSHA's insistence on reopening the record and soliciting comments before it added provisions for methylene chloride. She said that the Lockout/Tagout case law specifically allowed OSHA to add provisions as long as they were supported by the original record, and that notice and comment were unnecessary. She also mentioned that since the PEL decision, OSHA felt that it was required to do its economic analysis at the four-digit SIC level, which she said was absolutely untrue. Both she and Frank Mirer said that they considered the Advance Notice of Public Rulemaking (ANPRM) to be, at best, a waste of time and, at worst, a stalling tactic. Rabinowitz added that she thought OSHA should stop spending so much time searching for consensus when it was unlikely to be found.

Representing industry, Dick Olson, Industrial Hygienist retired from Dow Chemical, said that it was important for OSHA staff to get out into the plants. He then went on to say that what went right and what went wrong were both the same thing--communications. He said that in the beginning of the standards development process the communications had been very good; then, all of a sudden, communications deteriorated and OSHA couldn't talk about what was going on. He said that he thought the process was pretty good but that it didn't go fast enough. With regard to stakeholder meetings, he said they were too big to accomplish anything, and that there needed to be fewer people around the table. He said that NIOSH needs to get practical information out to help OSHA, industry and labor, and that OSHA needs to draw state programs into the standards development process.

Steve Risotto, Halogenated Solvents Industry Association, said that his group represents producers and some users of methylene chloride and other chlorinated solvents. He said that during the long period of rulemaking, several unusual events were taking place. First, at least one new use of MCl emerged as OSHA was doing its analysis of end uses; second, the scientific understanding of the cancer mechanism was evolving as this assessment was being done; and third, cartridge respirators turned out not to be applicable at the levels under study, all of which added complicating factors to developing a standard. He thought what went right was the ability of OSHA, UAW and HSIA to develop in a short period of time an agreement that addressed the needs of all three parties without compromising the needs of any of the three. He also commended OSHA staff's willingness to consider new information that was brought to their attention. He said that he thought one of the key problems was the general perception that OSHA's benefit analysis was based on actual rather than theoretical data. He said he was concerned about what appeared to be a compromising of the feasibility analysis to accommodate the health effects assessment. He added that the process was unnecessarily complicated by the debate on issues much broader than methylene chloride. He said he considered it important in the future to address just exposure limits and confine the broader issues such as medical surveillance and medical removal to general rulemaking. He said he felt stakeholders should be engaged in discussions sooner, rather than later. He said that the benefits of convening stakeholders early include not just what OSHA can learn from the participants, but also what participants can learn from each other. He agreed with Randy Rabinowitz that OSHA should not view litigation as entirely negative. He added that industry and labor groups should seek out each other to assess the potential to reach a consensus outside the rulemaking process and hopefully prior to litigation. He said OSHA should seek public comment on a prioritization strategy for standards to be reviewed over the next 5 to 10 years.

Frank White, ORC, focused his comments on the post-promulgation phase of the rule. He raised concerns about what ORC considers to be the breakdown of procedural safeguards to ensure the fairness of the rulemaking process after the rulemaking process is completed. ORC objected to the fact that, before a court did anything or before anything was filed in court, Labor and HSIA got together and hammered out a deal and took it to OSHA, which cut out of the process other interested parties who chose not to sue OSHA. He said that, at least with regard to medical removal protection and multiple physician review, the rest of the world had no clue that OSHA was going to propose these provisions until it issued a notice of proposed rulemaking for a period of 30 days. This occasioned ORC to ask for more time and be accused of trying to "ruin the deal". White said he felt that OSHA had an obligation to ensure procedural fairness that had been undermined here. He said that the solution was that OSHA had to either agree not to negotiate after rulemaking or develop a procedure to bring non-suing parties into the discussion. He added that corporate safety and health directors want to see a vigorous OSHA (although many would not stand up and say so), but that heavy emphasis on a number of mantras during the past few years such as voluntary compliance, partnership programs and stakeholder involvement had led to some confusion about the tools that really drive safety and health improvement. He urged OSHA to go back to its original values.

There was considerable discussion among panel and committee members about the possible benefits of "incrementalism" in order to gain support from both sides. But many resource, political, philosophical and legal problems were mentioned. Mike Wright wondered if anyone in OSHA had ever determined the cost of the various steps involved in the development of a standard. There was agreement that it had not been done but that it would be very interesting to know the cost of each step. Wright added that the fact that it had not been done indicated that OSHA had not developed an adequate workplan for setting a standard.

Charles Jeffress asked panel and committee members if they thought there should be a post-hearing process for OSHA to share with people who participated in the hearing information on the direction OSHA thought they would take in promulgating a final standard. There were various responses, but Frank White said he would like to go in the other direction and improve the pre-proposal process. He said he considered stakeholder meetings very valuable but they had to be more than "let's try to make the stakeholders happy" meetings where there was a kind of good feeling and then no action. He said there needed to be a fairly fast turnaround to get out a proposal and then move forward with the process. With good stakeholder input up front there should be no surprises at the end. Randy Rabinowitz urged OSHA not to waste time trying to get everybody to buy in and negotiate away all disagreement because it would take an enormous period of time. But, she said, the purpose should be to get a sense of where everybody stands. She said that trying to have the "perfect proposal" was a new phenomenon, and a political desire on OSHA's part, but one that was not required in any legal sense. She said that a bare bones proposal with bare bones data, giving a legitimate notice of the range of issues OSHA is considering, could be released and the legal doctrine says that as long as the final standard is a logical outgrowth of the proposal, there is no legal problem. Peg Seminario added that the critical element was strong leadership at the top with a really strong, clear commitment to a strong regulatory agenda that is aggressive with no apologies.

The Chair summarized the panel discussion as follows: (1) The process is not broken, but is too slow. We need to improve the efficiency of the process. (2) Litigation should not indicate that the agency has failed. (3) A strong regulatory and enforcement presence of the agency is really important. (4) There are some unnecessary procedural requirements that OSHA has taken on that it may want to look at and revise. (5) Compliance assistance is critical. (6) Pre-proposal stakeholder input is essential.

Table of Contents

Panel Discussions on the Use of Negotiated Rulemaking and Standards Advisory Committees in the Standards Development Process - May 12, 1999

On May 12, two separate panels were convened composed of government and industry individuals who had been involved with two separate advisory committees: (1) Steel Erection Negotiated Rulemaking Advisory Committee, and (2) Metalworking Fluids Standards Advisory Committee. Members of each group were asked to describe their connection with the committee and, in general, what they thought worked and what didn't work and the value of the process. They were provided the same discussion points as the previous panel with two additions:

How would you define OSHA's role in the process?
What are/were your expectations for the process? What will you consider a successful outcome?

Steel Erection Negotiated Rulemaking Committee

Bart Chadwick, retired OSHA Regional Administrator (Denver), began by saying that at the time he was OSHA's Denver Regional Administrator and represented OSHA on the committee. He said that he was very enthusiastic about the process but that it was a very difficult one. He said that it was his job to carry back to OSHA all of the determinations made by the committee. Claudia Thurber and George Henschel represented the Solicitor's Office even though neither actually served on the committee. They discussed the role of the Solicitor's Office and the importance of determining: need for the standard, balance of interests on the committee, ability to complete the process in a timely fashion, and commitment of the agency to work with the product that is developed. Henschel pointed out that there were a lot of statutory requirements which had to be met and that it was not always possible to propose all recommendations. Dr. Rosie Sokas, NIOSH Lead Senior Scientist, commented briefly, that although she had not served on the committee she had talked with Ronald Stanevich and Tim Pizzatella who had both been involved with the committee and that they thought the process had worked quite well. They felt that one of the hardest tasks was narrowing the scope, and that the large size of the committee made it more difficult to accomplish the task. They felt that data needs were often determined at the last minute and had to be supplied on an emergency basis and that, in the future, advance planning on the part of OSHA and NIOSH could alleviate some of the stress. Phil Harter, a Washington attorney, who served as Facilitator for the committee, said that in the very beginning the scope (instead of being large) was really just one issue: how high before tieing off. It was during the early committee meetings that the scope expanded significantly because members felt there were other hazards of greater importance and proceeded to review all fatality reports to determine the cause of each fatality. He said that was one of the great values of this process. The proposed standard is far broader and far deeper than it would have been without the committee. Another important benefit is that OMB has said that they won't even look at a negotiated rule with full consensus. He said that the problem he considered most significant was what he termed the "disconnect" between the time the committee reached consensus on a negotiated rule proposal and the promulgation by the agency. He added that it appears that OSHA is about three times slower in getting a proposal into a final rule than any other agency. Steve Cooper, Executive Director, International Association of Bridge, Structural & Ornamental Iron Workers (Labor Member), described the multitude of hazards and problems the committee discussed and said it would have been impossible for OSHA alone to have the background to develop such a comprehensive standard. He said that it is vital that the people most active in the industry should play a very large part with the regulatory agencies in negotiated rulemaking. He said that, although the final standard is not yet out, they have ended up with eight training modules, an outreach program and a standard that is already being used by the industry across the nation. Phil Cordova, Alliance Riggers & Constructors (Industry Member), said that he represented small business on the committee and really appreciated having the opportunity to have his view heard, even though at times the complexity of all of the legal constraints and many rules to be followed was a bit overwhelming. He echoed Cooper's comments about the importance of identifying so many other issues of concern in addition to fall protection. He said that they had been able to take the subjectiveness out of the standard and had written it in a "no-nonsense" manner which was easy to read and understand. He commended Chadwick's ability to take controversial recommendations to OSHA and explain them sufficiently to get agreement. He said that as a small businessman it was a considerable burden to pay all of his own expenses for the nearly five years the process took. At this point Peg Seminario asked a clarifying question as to the timeline of the process. Phil Harter said the first meeting was in August 1993 and that the proposal was delivered in December 1995. OSHA's official proposal was released in May 1997 after which a series of hearings was held.

Metalworking Fluids Standards Advisory Committee

Peter Infante, OSHA Director of Health Standards Review and the OSHA Designated Federal Official for the advisory committee, described briefly the events that led to the formation of the committee. In 1994, the Priority Planning Committee selected metalworking fluids as a high priority for regulatory action and, as a result, the OSHA Assistant Secretary asked NACOSH for advice on whether to form an advisory committee, a negotiated rulemaking committee, or follow the standard 6(b) process. NACOSH recommended the formation of an ad hoc standards advisory committee as described in sections 6(b)(1) and 7(b) of the Act. He said that one of the primary issues was whether to take a regulatory (standard) or non-regulatory (guideline) approach to mitigate the hazard. Maura Sheehan, Professor of Environmental Health at West Chester University (Public Member) and Chair of the Committee, said that keeping people of diverse backgrounds working together has been a real challenge. She said that because fluids in the workplace change, creating a moving target, it was difficult to "get their hands around the project" and that it was hard for OSHA to define what it wanted. Each member had to be educated on the specialties of the others. She said that OSHA needed to do a better job of making very clear to the committee just where its subject matter stands in its overall priority system, and who will run with the project when it is completed. She said she felt that a specific time limit would have been beneficial. She also emphasized the importance of determining "best practices" which could be implemented by responsible employers quickly, without waiting to see what OSHA did with the committee's report. Rosie Sokas, NIOSH, presented comments from Dennis O'Brien, the NIOSH member of the committee, who said that although he devoted only about 5% of his time to the committee, he got 80% of his job satisfaction from it. He said that the clarity in goals and expectations could be improved and that considerable time could have been saved if OSHA had prepared at least an outline for the project that could have been followed. Jim Frederick, Industrial Hygienist with Steelworkers (a Labor Member), said that his expectations coming into the committee were quite different than they are today. He said that he had hoped that by this point OSHA would have developed some draft language, based on earlier committee discussions, for the group to discuss and vote on. He added that he and a number of other members had expected that OSHA would devote more resources to the committee than had been the case. He commended the Chair for keeping the group focused through all of the problems. John Cox, National Tooling & Machining Association (an Industry Member), submitted a short, prepared statement to the record. He said he did not feel that the committee membership was representative of those impacted by potential action (with only two small business members) and was heavily weighted with public and environmental health community members. He recommended that OSHA appoint a pool of experts from OSHA, NIOSH and other sources recommended by the committee, to provide information to the committee, and that OSHA should provide the committee with information on both sides of the issue and set a limit on the number of meetings allowed to reach a conclusion on risk assessment; if no conclusion could be reached, the committee should be disbanded. He criticized the statement on OSHA's web site "Occupational exposure to these fluids has resulted in various cancers, respiratory disease, and skin problems" and the fact that no mention was made of the NIOSH study that found that 77% of all small shops surveyed had exposure levels that were less than 0.5 milligrams per cubic meter of air. He said he thought it was very important that OSHA paid attention to all of the comments made during the NACOSH meeting.

NACOSH Member Mike Wright described his experience on EPA's Coke Oven Negotiated Rulemaking Committee. He mentioned that Phil Harter had also served on that committee. He said it had been a really satisfying experience, that they had completed their task within nine months, and that a standard was issued eight months afterward. He said that only six parties were involved and that the process works best with a limited number of parties. He said that the real advantage of the process is that it brings forth creativity and, that to make it work, the agency must make clear that there will be a standard, set a short time frame, and establish a drop dead date. But, the agency cannot defer its authority and must provide good staff support. The agency should pay the expenses of those for whom it would otherwise be a burden. It is also important that the agency respect the process and publish the consensus proposal in the Federal Register as quickly as possible. If OSHA doesn't like the proposed rule, it should publish its own recommendations as well.

After a brief recess, the meeting resumed with discussion between the committee and the panel. Phil Harter asked how OSHA decided to use a negotiated rulemaking committee to provide advice on steel erection. Phil Harter replied that it was in response to a joint petition from the National Erectors Association and the Ironworkers Union, but that it still took 2-3 years to get the committee formed. Peg Seminario asked the group what they thought OSHA should be doing concurrently while an advisory group was developing its recommendations. She said that it appeared that the agency did not work on the issue during that time and started over from scratch doing all of the work all over again after the recommendations were submitted to OSHA. Maura Sheehan said that a timeline was important--that OSHA was doing a few things while the committee was in process but that more staff was needed and that they needed to get away from linear thinking that first you did A, then B and then C, rather than concurrently. Phil Harter added that other agencies conducted a limited analysis while the committee was active and, since they were doing a negotiation where the full range of parties would sign off on it, the agency had enough confidence that all major issues would be raised that a full analysis was unnecessary prior to the proposal stage. Phil Cordova mentioned that individual members of their committee had obtained money on their own to test such things as "slippery paint" and steel joists. He suggested that a small budget would have been helpful in solving some of these problems. Steve Cooper said that NegReg works if the committee gets the cooperation of the agency. He said that he did not think this was the case with the steel erection committee and complained that no one in either OSHA or SOL was spending any significant time on the proposal. He suggested that a Negotiated Rulemaking Office be formed with one professional and one support person to track products of advisory groups to be sure they don't just disappear. Dennis Scullion asked if anyone from OSHA had asked either group to evaluate the process. Maura Sheehan said "not yet" and Phil Harter said no, but that he had talked with Joe Dear about the process and written articles in law reviews. Bart Chadwick said that he had had many discussions with former OSHA Assistant Secretary Joe Dear and others about the process, but that most of these people were now gone. Mike Wright said that it had been his understanding that the Metalworking Fluids committee was a Standards Advisory Committee and that its task was to recommend a standard, but George Henschel had said that was not the case, and that the goal of the committee was to "gather data". Wright asked for clarification. Peter Infante said that he believed that the committee charter indicated that the advisory committee was to advise the agency on how best to mitigate the hazards associated with metalworking fluids whether it be a standard or guidelines. George Henschel said that he had not intended to imply that data gathering was all the committee was expected to do, but that that was a very important part of rulemaking. Peg Seminario surfaced the question of what resources were needed (committee and agency). Several people said it was essential that OSHA assign a relatively high level person who knows essential internal linkages on a full time basis to tie all activites together and keep the committee moving. Everyone agreed that it was essential to have a drop-dead date. They also agreed that things can get brutal as the date approaches and that the hard issues don't get tackled until that point. In answer to a question about resources involved, Peter Infante said that to date they had held eight meetings with an approximate cost of $20,000 per meeting. Phil Cordova said that, as a small business representative on the steel erection committee, he had to pay all of his own expenses which totaled over $100,000 of his own money. In a discussion of the differences between OSHA and EPA use of commiees, John Cox said that the difference between agencies was not so much resources as it was emphasis. In answer to a question from Peg Seminario about which of the advisory committee processes works best in what particular circumstances, George Henschel commented that neither process was appropriate in all cases, and that there needed to be a finite number of issues with a reasonable number of interested parties. "Go to the mat" issues should be avoided. He added that one of the differences between the two processes is that OSHA is a member of the negotiated rulemaking committee whereas OSHA simply provides technical and administrative support to a standards advisory committee. The full 6(b) standards setting process must be followed with the use of either committee. Mike Wright said that one of the basic differences between OSHA and EPA handling of committees was that EPA did not expect the committee to do basic staff work (such as developing a risk assessment), and that EPA provided a tremendous amount of staff work to the committee while concurrently working on the project itself. He said that he felt negotiated rulemaking works best when the basic problem has been defined and a decision has been made that a standard is needed. The parties are those with a very direct stake in the outcome. On the other hand, he felt that a standards advisory committee worked best when there were still scientific uncertainties that scientists on the panel could begin to reconcile, which was why there were public members on that type of committee. He concluded by saying that any of the processes can work if there is an agency commitment to the project.

Peg Seminario said that it would be useful to get some information on the resources of OSHA's two standards development offices to compare with those of other similar agencies. She said it would be beneficial to have someone from OSHA who was involved in the standards setting process assigned to work with the committee on a continuing basis until it completes its review of the standards development process. She said that it would be useful to interview some of the OSHA staff who are directly involved in writing standards to see what they think the difficulties are and what they see as their successes. It would be good to ask them that if they were able to set up a process that did the job in a way that worked, what would it be. This could be done either as a small workgroup, or on an individual basis. Hank Lick expressed concern that this might put OSHA staff in an untenable position. There was considerable discussion about how this might be done in order to get critical information on what works, what doesn't work and what the impediments are. Mike Wright said that he was a big critic of how long it takes to get something out of OSHA, whether it is a standard or an enforcement action and said that at least half of the problem rested with the Solicitor's Office (SOL) which, like OSHA, was severely underfunded and overworked for the amount of work they needed to do. He added that at some point NACOSH needs to examine the role of SOL in relation to OSHA and the standards setting process. He summarized by saying that there are too many levels of review and that it would be good to track a single standard, as well as a citation, through the process and see where it went, how long it was there and what value was added. Margaret Carroll added that many of the issues and deficiencies discussed were part of a larger problem--that there was no integration across the agency and that even if there was a good strategic plan, there was no tactical or operational plan. Hank Lick brought up the subject that the committee had told Marthe Kent during her presentation on the standards development process in August 1998 that the committee would like to have a wall chart that displayed the process in time line fashion and felt it was also essential for OSHA staff. He said that he had spoken with her recently and knew that the chart did not yet exist. The committee discussed the subject intensively and determined that they would once again make this request. Byron Orton emphasized that OSHA and NACOSH must keep in mind the original promise to workers that was contained in the Occupational Safety and Health Act of 1970. He expressed his concern about Congressional attempts to gut OSHA enforcement and deplored the state of labor laws in this country. He described a situation in which Iowa state enforcement personnel had been denied entry on four occasions to a workplace where there had been 36 ambulance calls in 9 months. They "went to the mat" on the case and succeeded in having that employer found to be in contempt of court, but he said he was disappointed that they had to do that without the support of Federal OSHA. He summarized by saying that when Congress or others, including OSHA, do things that are contrary to the simple promise made in the 1970 OSH Act, then NACOSH ought to "stand up and be heard."

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Panel Discussions - Role of Consensus Standards Setting Organizations and Professional Associations in OSHA's Standards Development Process - September 21/22, 1999

Because the questions provided to both of these panels are quite lengthy, they are included as Appendices C and D.

Consensus Standards Setting Organizations

On September 21, Marthe Kent, OSHA Director of Safety Standards and Acting Director of Health Standards, opened the discussion by stating that OSHA had been working with the consensus standards setting organizations for years but was particularly interested in pursuing any new ways of accelerating the standards development process. She mentioned the possibility of trying to do a "direct final rule" if they could come up with a relatively non-controversial subject. In this process, the proposal stage would be skipped and a final rule would be put out with 30 days for public comment. If there was no adverse reaction, the rule would become final. She said that OSHA standards people and solicitors had been studying the concept, and that several of the consensus organizations had come forward with suggested subjects. Kent said that OSHA used consensus standards as a starting point for all applicable standards and that just recently she was delighted to receive the ASTM silica standard because it contained material on all of the required OSHA provisions such as exposure monitoring and hygiene facilities. She said that during the next few months she would be talking with consensus groups to discuss what they can do to make their standards more useful to OSHA and pointed out that OSHA cannot simply adopt consensus standards, as some people believe, because of the many legal requirements of its process. Joe Woodward, DOL Associate Solicitor for OSHA, added that there were certain criteria that rules had to meet under the OSHA Act with the main ones being reducing a significant risk, being economically and technologically feasible, and cost effective. He said that one of the difficulties encountered in using consensus standards was that they usually contained no explanation of the basis for decisions involved in determining the various provisions, and had no data on significant risk, economic/technical feasibility and cost effectiveness. He acknowledged that the National Technology Transfer and Advancement Act (Morella Amendment) required federal agencies to use consensus standards whenever consistent with their laws, but that the OSHA Act had contained provision section 6(b)(8) since 1970 which required OSHA to explain the reasons for any of their standards provisions which differed from existing consensus standards. He added that one of the most serious problems for OSHA was trying to find a more workable way of updating consensus standards that had been incorporated by reference but were now outdated. Dr. Paul Schulte, NIOSH, explained that NIOSH does not make rules but does conduct research, makes recommendations, and provides technical support to OSHA on a variety of issues such as risk assessment, engineering controls and the like. He then discussed the idea of entering into partnerships with other entities throughout the world to produce criteria documents, occupational exposure limit recommendations and risk assessments. He added that from an efficiency point of view this would be idea l so that agencies like NIOSH all over the world would not be expending resources to do the same research. He said that NIOSH was working with the International Program for Chemical Safety to develop Concise International Chemical Assessments (CICADs). He told the committee that he would like to know what role it thought NIOSH should play in these matters.

Jane Schweiker, Director of Public Policy and Government Relations for the American National Standards Institute (ANSI), prefaced her remarks by saying that in addition to the NTTAA there were at least three other significant pieces of legislation urging greater use of voluntary consensus standards throughout the government. She said that the level of cooperative approach to standards development and the use of consensus standards had increased dramatically in the last few years. She added that many government agencies are full members of ANSI and that ANSI does not itself develop standards but sets the basic rules of the road and accredits standards developers. She said that they considered it essential that the process be open and balanced with all materially affected parties involved. She said that ANSI had met with Assistant Secretary Jeffress to see how ANSI could be of more use to OSHA and to encourage OSHA to take a more active part in ANSI.

Dr. Lisa Brosseau, representing the TLV Committee of the American Council of Government Hygienists (ACGIH), discussed the structure of the Threshold Limit Values Committee. She mentioned that their membership represented government, academia and the labor organizations and was drawn from four disciplines: industrial hygiene, toxicology, occupational medicine and occupational epidemiology. She emphasized that they set guidelines and recommendations, not regulations, and that they publish an annual booklet of recommended limits for chemical substances and physical agents, primarily for use by industrial hygienists. She discussed some of the additional information that has been added to their booklet, how they identify new substances to be covered, and how their process works. She echoed Dr. Schulte's comments about the need for international cooperation.

Kathleen (Kitty) Kono, Washington Representative for the American Society for Testing and Materials (ASTM), started by telling the group that ASTM's portfolio contained 11,000 standards (which includes specifications, guides, practices and definitions). She said that buyers, sellers, regulators, people from government, and people from academia are among those who participate in their 132 technical committees. ASTM's voluntary consensus standards setting process is based on: (1) openness, (2) balance, and (3) due process. She cited an example of active OSHA participation (electrical protective equipment for workers) that produced excellent results, and two others (silica and metalworking fluids) where the OSHA representative simply watched what was going on and took no active part. She said that it was essential that we find ways to improve this working relationship.

June Ling, Associate Executive Director of the American Society of Mechanical Engineers (ASME), mentioned that their work in developing codes, standards and assessments dates back to 1884 when they developed the first test code for boilers. She said that many of their codes and standards are adopted by federal, state and local regulations, and that their vessel code is referenced by 48 states. She said ASME's process was based on: openness, balance of interest, and the key factor that usually when their codes/standards are referenced by federal agencies, they are not listed as the only means of compliance. In discussing the problem of outdated codes/standards listed by reference in OSHA standards, she offered ASME's willingness and eagerness to work with OSHA in trying to find a solution. She said that in their discussions with federal agencies there was a common thread: that they needed to provide more rationale and more cost-benefit analysis in their standards development process. She said they were currently attempting to incorporate the concepts of risk assessment into their process.

Anthony (Tony) O'Neill, Vice President of Government Affairs for the National Fire Protection Association (NFPA), pointed out that in the early 1970s OSHA adopted some 50 NFPA codes and standards as part of its regulations through the 6(a) process, many of which are outdated and still on the books. He said that he saw the purpose of the panel discussion as trying to find a way to close the gap between what is happening in the rest of the world relative to adoption of codes and standards, and what is happening in OSHA because of requirements somewhat beyond its control. He added that, from the beginning through the present time, their working relationship with OSHA has been outstanding. He said that OSHA participation had been better in some areas of specialty than others and he reitterated NFPA's offer of free training to OSHA compliance officers in how to utilize and properly interpret the NFPA codes and standards. He added a comment related to rewriting 25-30 year old standards in plain English and said that their industrial members all agreed that it doesn't work because it suffers from variations of interpretation. On the contrary, he felt that the Q and A approach could work.

NACOSH member Hank Lick asked the group if it was difficult for them to get active participation in their committee activities. The responses varied indicating that it depended a lot on how major the impact of the committee would be on the regulated industry. ASTM indicated that they were having some success using electronic standards development forums where they actually developed standards on-line. ASME agreed that they saw this as the wave of the future. NFPA reitterated that there was a direct correlation between the intended use of the code/standard and the ability to attract active participants. ANSI added that they were exploring use of the Internet for public notice and review of its proposed standards. Peg Seminario said that the unions had a severe resources problem (both time and money) in deciding which committees they could devote resources to, and that they had to favor those which could directly change conditions and add protections. On another subject, she asked if the consensus organizations could provide some assistance to OSHA in listing which of their standards were referenced in OSHA standards, the date of the standard referenced, and the date of the most recent version of the referenced standard. With a great deal of enthusiasm, ASTM produced a complete copy of the 900 references to ASTM standards in OSHA regulations. Kitty Kono said that ASTM had completed the same task for EPA, CPSC and the Coast Guard with very positive results but had been told by OSHA that it had other priorities. NFPA offered to work with OSHA to do the same thing, but urged OSHA to determine its priorities first. ASME agreed to do the same thing and added that it would be helpful to have more specific information on the required OSHA criteria that Joe Woodward mentioned so that in doing their assessments they could gear them toward addressing those particular points. Joe Woodward suggested that they have a meeting to go over the criteria.

Mike Wright asked Joe Woodward if, when the consensus standards were incorporated by reference, the actual date of the referenced standard was part of the reference to which Woodward responded that it was and that rulemaking was required to update that date. Wright said it was too bad they could not automatically incorporate the latest version to which Marthe Kent responded that would indicate that OSHA approved whatever came out, which would not be possible to do.

The cost of obtaining ANSI standards was discussed and the fact that they were not accessible to "shop floor" people when they were incorporated by reference in the standard, and that unions could not afford to provide them. ANSI explained that the costs were necessary to defray the costs of the standards developers. Dennis Scullion asked how long it took the organizations to develop a standard. The responses ranged from 18 months to 5 years, depending on the type and scope.

At this point Charles Jeffress joined the group and said that when he heard the discussion of "balanced interests", the focus appeared to be on producers, users, and perhaps public regulators, and that OSHA was concerned with a different balance. He also mentioned OSHA's need to prove both technological and economic feasibility, and that a significant risk is being reduced. He asked how their standards might be produced to meet that criteria. NFPA indicated that, in an informal manner that probably would not meet OSHA's test, they were probably meeting most of that criteria. Joe Woodward added that in an ideal world the associations would be applying the same criteria OSHA had to meet and would produce evidence of how they met that criteria and what studies they relied upon; they would also explain how they decided the subject was a significant risk. He suggested that any part of that data that they could produce would be extremely useful to OSHA. Peg Seminario added that she felt the subject was more complex than simply obtaining consensus standards with sufficient supporting data to meet the required tests, and that thought should be given to both the process and the product of the consensus standards organizations. She said that in general their standards were much more specific and less performance oriented than OSHA standards needed to be and were much more useable as a reference than as a substitute for an OSHA standard. She added that she felt more weight should be given to the work done by both NIOSH and the consensus organizations, and that there should be a presumption of feasibility and risk in their efforts so that OSHA did not have to start from ground zero in developing documentation on every issue on every standard on every hazard. There has to be a shifting of presumptions to allow the work that is going on in the rest of the community to have some greater weight than it now does.

Professional Associations

The second panel met on September 22. Mandy Evans, from OSHA's Health Standards Directorate, started the discussion by saying that her first interaction with the various organizations represented on the panel had been somewhat formal but that over the years it had evolved through stakeholder meetings and other related interactions into a much more informal process which had benefitted OSHA by helping define the issues a little bit better prior to writing the proposal.

Jerry Lynch, Past President of the American Industrial Hygiene Association (AIHA), discussed the fact that AIHA serves as the secretariat for three ANSI standards setting groups: Z9 which covers five safety standards; Z88 on respiratory protection; and Z10 which covers occupational health and safety systems. He added that their many other activities include emergency response planning guidelines, standards of practice guidelines and codes, gaps analysis, laboratory accreditation programs, and working with NIOSH to try to identify areas in need of research and mechanisms to support research. He mentioned the many ways in which they interact with OSHA in the standards development process and said that the relationship was better now than it had been, but could be even better. He noted that the difficulty of the PELs update process had resulted in their being inadequate to protect the health of employees, and that we needed to find an alternative regulatory means, similar to that used in the United Kingdom, for protecting worker health. He wondered if perhaps the safety and health programs standard might serve as a framework. He said that AIHA planned to convene a scientific meeting some time in the year 2000 to discuss broad issues such as this and would welcome OSHA participation.

Tom Bresnahan, Deputy Executive Director and Director of Professional Affairs for the American Society of Safety Engineers (ASSE), said that ASSE was currently serving as the secretariat for 8 ANSI standards committees and that their involvement dated back to 1921 with the A14 ladder standards. He noted that ASSE's relationship with OSHA had been very positive and suggested a few ideas for improvement including: reestablishment of the OSHA Office of Professional Affairs, including this office in the standards development process of the agency, and including nominees from professional organizations on all advisory committees. He recognized that OSHA could not simply adopt consensus standards because of its legal mandates, but urged OSHA to meet with other similar agencies to see how they make use of consensus standards. He also asked OSHA to improve its participation in consensus standards setting committee activities, stating that such participation had diminished significantly.

Kae Livsey, Public Policy and Advocacy Manager for the American Association of Occupational Health Nurses (AAOHN), said that one of their primary goals was active participation of their members in key committees, such as NACOSH, and that they were very happy that former AAOHN President Bonnie Rogers was currently a member of NACOSH. She said that their members actively participate in a variety of committee activities related to standards development, both consensus and mandated, as well as in public hearings and stakeholder meetings. She said that their mission was to bring "front line experience" to these groups in an effort to reduce injuries and illnesses. She emphasized that it was essential that they be involved in the earliest stages of the development of standard s. She said that they occasionally do special studies, as they did in the case of the TB standard in which they quantified the role of occupational health nurses in health surveillance activities, which are then submitted to the docket.

Dr. Robert J. McCunney, President of the American College of Occupational and Environmental Medicine (ACOEM), and also Director of Occupational Medicine at MIT, said that ACOEM's mission was the prevention of work-related injuries and illnesses. He said that although they did not function as a secretariat for consensus standards, they provided considerable research support and that the position papers published in the Journal of Occupational and Environmental Medicine served as a useful foundation for related activities. He added that since becoming President of ACOEM he had formed a special committee on research to develop an agenda which they could share with NIOSH in relation to NORA. He said that they had been involved in OSHA's standards development activities only in a few special cases but would like to take a more active part. He said that they had participated in stakeholder meetings and public hearings, and that thanks to recent initiatives had been asked to participate early in the silica stakeholder meetings. He cited other examples (primarily the respirator standard) where he thought earlier involvement would have been beneficial to OSHA. He said he thought it was essential that OSHA's standards be based on a firm, scientific foundation; otherwise, the impediments to promulgating standards becomes enormous. He said that it was crucial for the agency to increasingly rely on the knowledge, training, and experience of physicians who are board certified in occupational medicine. He urged OSHA to enhance the role of its Office of Occupational Medicine in formulating policy by moving it to the Office of the Assistant Secretary.

Jane Lipscomb, Chairperson Elect for the Occupational Health and Safety Section of the American Public Health Association (APHA), noted that APHA is the largest (50,000 members ) and the oldest (1872) organization of its type and that it serves as an extremely productive forum for discussing interdisciplinary and multidisciplinary issues which impact OSHA. She said that at last year's national meeting a panel discussion about professional practice in relationship to medical surveillance and OSHA standards elicited some serious concerns which led to further discussion with OSHA staff about the standards development process. She emphasized that early collaboration in the standards development process could be very useful to both OSHA and APHA, and that the sections develop resolutions and position papers which the government council reviews and votes upon and which have, when approved, the voice of the 50,000 members behind them. She cited recent resolutions on lead exposure, HIV transmission, occupational disease and injury, medical surveillance, child labor, ergonomics and workers' compensation. She added that one of the proposed resolutions coming from the 1999 meeting is to encourage and mandate the use of safe needles in health care, and that APHA had written a letter in support of House Bill 1899 which called for reopening OSHA's bloodborne pathogens standard to ensure that safer devices are used in health care settings.

To begin the discussion with NACOSH, Hank Lick asked the panel members how their associations could work together more effectively on such issues as infrastructure and outreach activities, both with each other and with OSHA. ACOEM responded that such forums as the NACOSH panel discussion were excellent in improving relations both within the organizations and with OSHA. He added that it was very important to let the professional organizations know well in advance what OSHA's rulemaking priorities were, and perhaps to convene workshops to resolve areas of difference or support areas of mutual interest. AAOHN mentioned that most of the organizations participate in an inner-society forum to discuss a variety of issues. She added that they could be of great value in outreach activities for OSHA in the education of their members in such subjects as ergonomics and new recordkeeping regulations. ASSE concurred that the inner-society forum provided a way for organizations to get together but said he thought the charter was too soft and needed to be changed so that they could discuss the "hard issues". AIHA expressed its concern that the organizations on the panel represented only a fraction of the employers and that they needed to find a way to reach those companies who were not served by physicians, nurses and industrial hygienists. AAOHN mentioned that a number of years ago they had participated in a "pro bono" initiative to provide training to small businesses. She suggested that they consider reactivating that effort. ACOEM expressed its concern with trying to reach small businesses and said that the American Hospital Association had developed occupational health programs primarily to provide clinical and consultative services to small businesses.

Mike Wright told the panel that more help was needed in studying how the organization of work impacts safety and health in the workplace generally, and especially the impact of changes in work organization. Jane Lipscomb pointed out that NIOSH through NORA had established "work organization" as one of its priorities for research and that the University of Maryland had received money to look at work organization factors.

Peg Seminario addressed the issue of the increasing industry hostility toward OSHA, and also NIOSH with regard to its study on diesel particulates, not just in the standards setting process but also in the release of technical information such as OSHA's bulletin to its field staff on latex allergies. She said that just trying to get information out the door and actually answer questions was now under attack because there were people who just didn't want the answers out there because they might have to do something about the problems. She added that attacks on the underlying science are also attacks on the underlying purpose of the organizations. She said that unless there is more active support and involvement from the professional associations on these basic issues such as the science behind occupational safety and health issues, the job of protecting workers is going to become nearly impossible. Dan Hryhorczuk agreed with her and added that they should consider expanding their advocacy from the leadership level to the general membership level by encouraging members to take an active role in promoting some of OSHA's standards development activities which have been nearly paralyzed, such as ergonomics and the safety and health programs rule. Dennis Scullion mentioned that there can be problems because professionals, such as nurses, have responsibilities and allegiancies to both their profession and their employer which on certain issues may be diametrically opposed. AAOHN responded with an example of one of their members who works for a very large company which was strongly opposed to an ergonomics standard. By working with top management, the nurse convinced them that they would end up being regulated anyway, and that it would be better to work together positively to get a good standard. This highlighted the need for OSHA to seek practical input from workers and professionals in the early phases of standards development to ensure that proposals would be as practical as possible. AIHA added that there was often a difference between what an industry would choose to do voluntarily and what they would accept as a regulation, and that often internal practices were considerably more stringent than proposed regulations would require -- yet they objected to the proposed regulation.

Margaret Carroll challenged both OSHA and NIOSH to make better use of the "voice of 100,000 professionals" represented by the members of the various professional associations on the panel, to further their efforts, especially in the standards setting process. Peg Seminario said that, with the ergonomics standard coming out in the near future and hopefully the safety and health programs rule after that, it would be critical for OSHA and NIOSH to enlist the aid of these associations in their outreach activities. She emphasized that the associations needed to have information in order to be useful and urged more use of conference calls to make it easier to get people together. She suggested the possibility of having a regular dialogue with a core group representing the associations.

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Panel Discussion on the Regulatory Process in Other Federal Agencies - January 18, 2000

Panel members were furnished a list of 11 questions to serve as focus for the discussion which are included as Appendix E. Marthe Kent, Director of Safety Standards and Acting Director of Health Standards for OSHA, opened the panel presentations by describing briefly OSHA's regulatory process and her role in it. She said that the most time consuming and troublesome part of the process was the development of the proposal which requires all sorts of in-depth research into economic issues, technological feasibility, risk analyses and many other technical/scientific issues. She added that some of the simplifications or innovations they are studying include the use of multidisciplinary teams and the development of a regulatory handbook. Emphasis is being placed on demonstrating that, for each standard, the hazard being addressed poses a significant risk to workers right now and that the approach being taken will in fact substantially reduce that risk and is economically and technologically feasible. She added that, although OSHA does not do a cost-benefit analysis, they do provide both cost data and benefit data but do not tie the two together, and that this is a very time-consuming process. She said that OSHA usually does a lot of on-site data gathering by looking at all the places where a particular rule will have an impact and actually measuring what people are currently doing at those sites and what kind of controls they are using. Kent added that, although OSHA was not required to do peer review, they had chosen to do an ever increasing amount of it on both risk assessment and economic analysis. She acknowledged that some of the regulatory reform measures recently introduced in Congress would have significantly increased the burden in this area. In answer to the question of whether or not the use of peer review had increased public acceptance of either OSHA's risk assessments or economic analyses, she said she had seen no such indication. She said that internal reviews represented one of the most troublesome and time consuming parts of the process but that she was sure that no one in the room would recommend shortening this process. She added that the external reviews, such as that done by OMB, were very rigorous and that the addition of the SBREFA review had increased the burden significantly. She said that OSHA often had extremely large dockets to deal with and was increasingly making use of electronic processing. She concluded by saying that OSHA's "informal" hearing process was quite unusual since it allowed OSHA to question participants, and participants to question both OSHA and each other.

Ron Medford, Assistant Executive Director for Hazard Identification and Reduction, Consumer Products Safety Commission (CPSC), pointed out that CPSC was somewhat unique in that they were an independent regulatory agency made up of three commissioners appointed by the President and that all rulemaking activities were decided by the majority vote of the commission (which must have members from both political parties). They administer four statutes that cover about 15,000 products. All of the statutes except for the Poison Prevention Packaging Act require cost-benefit analysis which means that they must first establish technical feasibility. They also have a requirement under the Federal Hazard Substances Act to follow the first stage of rulemaking (for example an ANPR) within twelve months with the second stage (a proposal), and again within twelve months to the third stage (final rule). They have great difficulty keeping these timeframes, which can be extended "for good cause" by the commission. Medford said that one of the most difficult challenges was defining the product and then describing the scope of the standard and issues to be addressed by the rule. He said that technical feasibility could also be very difficult depending on how the performance requirements are written and whether a new technology or new application of an existing technology is required. Since CPSC is an independent agency, their rules are not subject to OMB review nor are they required to do risk assessments. Chronic chemical hazards require an additional step in that a chronic hazard advisory panel of scientists nominated by the National Academy of Sciences must first be formed, and their report reviewed by the commission, before the first regulatory step can be taken. They do peer reviews selectively, primarily when they feel that the information they are relying on may be controversial. To speed up their internal review process, they do as many concurrent reviews as possible. He said that one thing they consider very important is that there be no surprises at any stage in their regulatory process. All study designs and protocol tests are generally reviewed by stakeholders who are invited to comment on them. Their public hearings take place between the Advance Notice of Proposed Rulemaking (ANPR) and the proposed rule when any company can come in and give testimony before the commission. Their statutes also prohibit the commission from issuing a federal safety regulation if there is a voluntary consensus standard in place that is believed to be adequate to address the risk and there is significant compliance by the specific industry to which it applies. They also use multidisciplinary teams headed by a technical expert.

Joe Fitzgerald, Deputy Assistant Secretary for Worker Safety, Department of Energy (DOE), said that they were in a rather unique situation because they function as owner, operator and regulator all at the same time. He noted that some of their regulations date back to the fifties with the advent of the nuclear energy industry, but that rulemaking didn't happen in a big way at DOE until ten years ago when Congress directed DOE to set up an enforcement program which required that DOE develop the necessary rules to be enforced. He cited their recent experience in developing a beryllium standard which actually goes back about 20 years and included attempted rulemaking about six or seven years ago. Fitzgerald said that DOE's earlier lack of success in rulemaking was due largely to failure to develop constituencies with stakeholders and other agencies. In the case of beryllium they set a specific goal to make a real difference at the working level. They then enlisted the support of the Secretary of Energy and set about developing a solid constituency. When they went to OMB with their proposed rule supported by other agencies such as OSHA and NIOSH, as well as the laboratories and contractors who were involved, they met with success.

Ed Mazzullo, Director of Hazardous Materials Standards for the Department of Transportation (DOT), said that his office issues hazardous materials regulations covering all modes of transportation that address classification, risk categorization, packaging, and hazard communication in transportation. They also regulate people who manufacture packagings intended for use in transporting hazardous materials. He said that it was a time consuming, troublesome task to develop sound regulations, flush out all of the alternatives and do the cost-benefit analysis. He said that they had recently developed a 3-page checklist on the statutory authorities that have to be complied with before they issue a final rule. He said that he had been involved in this process for a long time but that he and others were becoming increasingly confused about how to comply with the continually changing mandates. They have no requirement to do risk assessments but do them with increasing frequency as justification for issuing rules where the cost-benefit data is scarce. In one recent instance, the technology to comply with a particular rule was said not to exist. So they gave the industry time to come up with the technology as a sort of negotiated rulemaking effort. They also use a multidisciplinary team approach to rulemaking. Their internal review process involves concurrent reviews and does not significantly delay the process. Their external reviews are becoming increasingly complex with new requirements for federalism, consultation with state and local elected officials, consultation with Indian tribes and, of course, OMB which they said they had fairly good luck with. He said that they did find an increasing amount of attention coming from their inspector general's office and the Government Accounting Office (GAO) in relation to documenting delays. He said that they had a very good docket system and that all comments are processed electronically. Because over 90% of the people they regulate are small businesses, they make special efforts to reach this audience. They have used electronic public meetings to encourage small businesses to participate by making electronic comments on proposed rules. Their hearings are informal and they question participants if they are willing to be questioned and they allow the audience to question participants also if they are willing.

Paul Lapsley, Director of Regulatory Management for the Environmental Protection Agency (EPA), started by stating that they put out about 600 significant rules a year of which about 170 were what they call substantive. He said that seven major statutes authorize their regulatory activities and that the requirements under each are quite different. For example, in some cases under the Clean Air Act they are prohibited from considering the cost or the benefit whereas under the Toxic Substances Control Act a risk benefit determination is required. He added that getting the cost information is very difficult and getting the benefit information is even more difficult. They have no requirement to do peer review but during the past two years have started doing peer reviews on all regulations. He said it is too soon to tell whether this process will improve the acceptability of their rules by the public. He added that they had started using the regulatory negotiation process about ten years ago and that they felt this had the greatest potential for saving a significant amount of time in the rulemaking process, but that it can only be applied in certain limited situations. He said that their greatest success in shortening their regulatory process had come through the development of a three-tiered system, with tier three having far greater autonomy than tier one.

Linda Horton, Director of the International Agreements Staff for the Food and Drug Administration (FDA), explained that for 14 years she had served as Deputy Chief Counsel for Regulations. She said that for food and cosmetics they regulate safety, but that for pharmaceuticals and medical devices they regulate safety, effectiveness and product quality. They also regulate animal foods and drugs, as well as radiation emissions from television sets and cellular phones. She said that although the agency is over a hundred years old, the era of modern rulemaking began in 1970. The 1980s became the era of questioning regulation and deregulation in which FDA came under a lot or criticism for what was called the "drug approval lag" which has since been turned around. Horton described the 1990s as the era of leveraging in which FDA has looked everywhere for partners to help them do their job. She acknowledged that the policy formulation part of rulemaking was often the most difficult, but that the drafting stage and the compilation of the record were also challenging, especially if the necessary research had not been done. She said that the Prescription Drug User Fee Act which had been reauthorized in 1997 imposed performance targets in exchange for the right to charge user fees. She cited FDA's recent regulation finding that "cigarettes and smokeless tobacco are drug delivery medical devices" as an example of dealing with a large volume of evidence, old and new. The comment period which ended in January 1996 produced over 700,000 comments. By using contractor help they were able to analyze all comments and produce a final rule by August 1996. With regard to peer review, Horton said that their technical advisory committees fulfill that function to some extent. She said that in general they do not balance risks and benefits in an economic sense, although in a couple of areas they were required to consider economics. She added, though, that many would interpret efficient enforcement of the Act as taking into account the cost of a regulation as well as its effectiveness. She said that they have a very active stakeholder outreach program and provide extra assistance to small businesses. She said that FDA regulations involved a wide variety of types of public hearings, including in some cases a statutory requirement for a trial-type hearing. As an alternative, they created a "public board of inquiry" to be used if the parties would agree to it. They also have public hearings that look like public meetings and other regulatory hearings that are due process hearings. She added that only in the trial-type hearings was there formal cross examination, but in the other types of hearings there was usually some amount of reasonable questioning.

Mike Wright asked the panelists if they had any data on the number of staff members devoted to the rulemaking process. CPSC said it was hard to determine this because many of their technical staff of 160 do other activities in addition to rulemaking. DOT said that within the Hazardous Materials unit 40 of the 125 person staff were devoted to the rulemaking process. FDA said that it was difficult to determine but that it might be between 100 and 200 people. All agreed that it was impossible to come up with a reliable figure. Hank Lick asked the group what they thought the public perception of their regulatory activities was. EPA said that public support was probably their most valuable resource and that they were paying an increasing amount of attention to public outreach, especially with small communities and small businesses. FDA said that they have a lineup of people from other countries wanting to set up an FDA in their countries. Nancy Lessin asked how many agencies other than OSHA had gone through a "near-death experience" where there was large non-support for the agency in Congress in which they had to deal with congressional riders on the agency budget which prohibited them from going forward with a regulation that the agency felt was needed. CPSC responded that it had actually had its budget zeroed out by the Director of OMB. Even though the Congress kept the agency alive, their staff was cut in half and additional requirements were added to their rulemaking procedures. They have also had congressional riders on controversial rulemakings. They have struggled to regain lost resources while trying to do what is required by Congress. DOT said they had not had near-death experiences but had appropriation language added preventing them from doing a specific regulation until a certain study or action was completed. EPA described a near-death experience in 1980 when their regulatory program was actually shut down. This lasted for 12-18 months during which time they lost a lot of their best staff. Public support turned things around in a big way. They have had congressional riders which require another cost-benefit analysis or some specific action which they simply do since they feel there is no way to get around it. FDA said that although they had not had a near-death experience, they have had plenty of problems. One was the "drug lag", another was a bribery scandal in the late 1980s, and being called the "second worst" agency in 1994. Although they have not had congressional riders as such, language in the Congressional Record has created long delays on controversial issues such as whether the use of animal feed, or overuse of human medicine, promotes the growth of resistance to antibiotics. As soon as they start to make progress, Congress requires additional studies so that action is prevented. LaMont Byrd asked DOT and EPA how they prioritized their regulatory activities. EPA said that they build their budget around congressional requirements and that little of their regulatory activity was discretionary. For example, if Congress passes a Safe Drinking Water Act, then a lot of related rules have to be developed. CPSC said that most of their priority regulation comes from analyzing hospital emergency room data which is collected daily to see what products are injuring consumers. DOT said that most of their rulemaking was discretionary. Priorities are determined based on the seriousness of the need. They do not have a formal procedure for setting priorities, but if there is a major safety problem they drop everything and take care of it immediately. Many of their other priorities are of a regulatory reform nature in an effort to make regulations easier to understand and less burdensome on industry. Mike Wright added that it was clear from the panel discussion that OSHA could benefit from discussions with other agencies and he expressed his hope that OSHA would discuss how to use the negotiated rulemaking process with EPA because of EPA's highly refined use of the system. However, he added that although there were always improvements which could be made, OSHA had nothing to be ashamed of in its rulemaking process. He said that it was the only agency, other than EPA, that spent a significant portion of its time working on economically significant rules and that EPA had literally 80 times the resources devoted to rulemaking that OSHA had. Moreover, most of the other agencies have the entire general public as its constituency including groups like children which are certainly a political help in getting rules past Congress. He cited OSHA's proposed standards on ergonomics and safety and health programs as examples of regulations with a very broad base of potential opposition in virtually every business in the country. He added that "given the resources OSHA has and the forces arrayed against it, given the political realities that its mission is only protecting workers and not the general public, I think OSHA people do a pretty good job of working through this problem."

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PART III - DISCUSSION OF ISSUES AND RECOMMENDATIONS

At the conclusion of the panel discussions, NACOSH began to consider recommendations for improving the standards setting process by first attempting to narrow the issues. NACOSH determined that the quality of OSHA standards was not a problem and that OSHA probably spends more time gathering and considering the evidence than any similar agency in any other country. That evidence is presented and analyzed in a lengthy preamble to every new OSHA standard, along with an extensive explanation of the justification for each provision of the standard. In the preamble, OSHA responds to views that run contrary to its final decisions, explaining why the agency decided to take a different approach. In most cases, the OSHA preamble becomes the most important reference worldwide on the subject of the regulation. OSHA preambles are used extensively by other countries considering regulation.

OSHA standards have been a major factor in the dramatic drop in workplace fatalities. An example is the standard for grain elevators, which virtually eliminated dust explosions in that industry. The OSHA Lead Standard led to a large decrease in blood lead levels among exposed workers. The Hazard Communication Standard helped start a global movement for the "right-to-know" the names and hazards of chemicals used in the workplace. The United Steelworkers of America report that most fatal accidents and occupational injuries among its members result from conditions not directly addressed by specific OSHA standards, an indication that those standards are effective.

Of course, many OSHA standards are controversial, but this does not mean that they are ill considered or ineffective. A 1995 report by the Office of Technology Assessment found that "The agency's findings and estimates on hazard control and regulatory impacts are often the subject of vigorous review and challenge by stakeholders and various experts on all sides of rulemaking issues. But this reaction does not generally indicate underlying agency analytical neglect. The agency's rulemakings are often lightning rods for controversy and are conducted in a politically polarized setting." (OTA, Gauging Control Technology and Regulatory Impacts in Occupational Safety and Health, 1995, p. 10)

Many OSHA standards are challenged in court, but few of those challenges succeed in forcing major changes to those rules. Two important exceptions were the Supreme Court's 1980 decision on the Benzene Standard (Industrial Union Department v. American Petroleum Institute, 448 U.S. 607) that required OSHA to make a specific showing of significant risk, instead of assuming that workplace carcinogens always present a significant risk; and the Third Circuit's 1985 decision on the Hazard Communication Standard, which effectively expanded the standard's coverage to all workers in OSHA's jurisdiction and restricted employer use of the trade secret exemption (United Steelworkers v. Auchter, 763 F.2d 729).

Nor is procedural fairness a significant problem. Any evidence relied on by the agency must be placed in a public docket. OSHA must accept and fairly consider public comment on proposed rules. OSHA holds open public hearings on proposed rules; equivalent agencies in many other countries do not. At those hearings, members of the public can question OSHA and other members of the public giving testimony, and can testify themselves. Few other federal or state regulatory agencies allow such extensive cross-examination by the public. Much of this is mandated by the OSH Act, but OSHA has gone beyond legal requirements by voluntarily holding stakeholder meetings on important rules, and circulating pre-proposal drafts.

However, one aspect of the rulemaking process clearly is a problem -- the lengthy delays in setting new standards, and OSHA's resulting inability to promulgate more than a handful of standards in any 4-year Administration. OSHA began work on a confined spaces standard in 1975. The final rule was issued in 1993, eighteen years later. The Lockout/Tagout Standard took twelve years, from 1977 to 1989. Labor Secretary Elizabeth Dole first suggested an ergonomics standard in 1989. Eleven years later, the hearings have only just concluded.

The 1910.1000 Z-Tables provide an especially glaring example of OSHA's inability to update standards in the light of new information. The tables cover most of the toxic substances specifically regulated by OSHA. They were adopted in 1971 from existing lists of federal and consensus standards, many of which were first published by the American Conference of Government Industrial Hygienists (ACGIH). Those values are now thirty years old. The 2000 ACGIH list contains different, and usually lower, values for many of the substances on the list, as well as a substantial number of additions. However, changing the permissible exposure limit for any substance on the list requires extensive rulemaking. Since 1971, OSHA has completed rulemaking for only 28 toxic substances. In 1988, OSHA attempted to overcome this limitation by undertaking a large generic rulemaking for more than 300 substances. However, the 11^th Circuit Court of Appeals vacated the standard on the grounds that OSHA had not properly made the required determinations of significant risk or feasibility for each individual chemical (AFL-CIO v. OSHA, 965 F.2d 962). Meanwhile, OSHA can only enforce the old values, notwithstanding thirty years of evidence that they may be harmful.

The human cost of these delays is unacceptable. In the preamble to its 1993 Confined Spaces Standard, OSHA estimated that the standard would save 63 lives per year. OSHA estimates that its proposed ergonomics standard will prevent an average of 300,000 work-related musculoskeletal disorders per year. If these numbers are true for the future, they were true in the past. Clearly, unnecessary delays result in preventable workplace injuries of significant proportions.

No one is more aware of this than OSHA personnel themselves. Beginning with Morton Corn in 1975, almost every confirmed and acting Assistant Secretary for OSHA has complained about the slow pace of rulemaking. The record of the Clinton Administration is no better than most. In 1993 and 1994 OSHA promulgated six standards or rules that were close to completion when the Administration took office (Lead in Construction, Logging, Fall Protection in Construction, Enclosed Spaces in Shipyards, Electric Power Generation, Personal Protective Equipment in General Industry, and the Reporting of Fatalities or Multiple Hospitalizations). In 1994, OSHA also modified the Asbestos Standard in response to a remand from the District of Columbia Circuit Court of Appeals. Since then, OSHA has published health standards on Methylene Chloride (1996) and 1,3-Butadiene (1997), both of which were begun under previous Administrations; revisions to the Confined Spaces Standard (1998) pursuant to a legal settlement agreement; safety standards on Scaffolds in Construction (1996), and Powered Industrial Truck Operator Training (1998); rules on Respiratory Protection (1997) and Personal Protective Equipment in Shipyards; and has rewritten its existing Dip and Coat regulation in plain language. No major standard has been both initiated and completed in the past seven years. However, one is pending (Ergonomics) and three are scheduled for promulgation later this year (Employer Payment for Personal Protective Equipment, Tuberculosis and Steel Erection).

One important part of the OSH Act has not worked in more than two decades. Between 1972 and 1978, OSHA promulgated Emergency Temporary Standards for Asbestos, Vinyl Chloride, the "fourteen carcinogens," 1,2-Dibromo-3-Chloropropane (DBCP), Acrylonitrile, and Benzene. Acrylonitrile and most of the 14 carcinogen ETSs were upheld in court. However, ETSs automatically expire in six months. The courts stayed the Benzene ETS until it expired and vacated the Asbestos ETS in March 1984. Since that time, OSHA has never successfully promulgated an ETS, and in recent years the agency has stopped trying, denying every petition for an ETS.

Some delays in standards setting result from extra burdens imposed by the courts, Congress, and the Executive Branch. The Supreme Court's Benzene Decision requires OSHA to perform lengthy risk assessments for new health standards. The Small Business Regulatory Fairness Act of 1996 creates an additional stakeholder process specifically for small business.

Since the early 1980s, the Office of Management and Budget (OMB) has performed an extensive review of new OSHA standards, often sending them back to the agency for additional documentation. OMB has an important role to play in assessing the overall burden of a new standard and ensuring regulatory consistency between different federal agencies. A 1993 study of OSHA for the Administrative Conference of the United States strongly criticized "the tendency of OMB economists to range beyond their technical competence," and stated that "OMB's constant interventions have made a slow OSHA decision-making process even slower." (Thomas O. McGarity & Sidney A. Shapiro, Workers at Risk: The Failed Promise of the Occupational Safety and Health Administration, Praeger, Westport, Connecticut, 1993, pp. 229-243.)

In addition, OSHA's pace looks somewhat better when the resources available to the agency are taken into account. Other federal agencies, such as the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) promulgate many more rules, but have far greater resources available to them. However, NACOSH members are unanimous in their belief that significant reforms are entirely within OSHA's power. Most of our recommendations fall into that category. Only two are addressed to Congress and the Executive Branch.

In making our recommendations, NACOSH was guided by three principles: First, the recommendation should be effective in reducing the time it takes to promulgate a new standard. Second, it should not diminish the quality of OSHA standards, or the fairness of rulemaking process. Third, the recommendation should be practical. For example, a major increase in the number of OSHA staff assigned to standards might be desirable, but it is not practical given the agency's budget constraints. Nor can we expect Congress to streamline the rulemaking process any time soon, although we have included a more practical recommendation for Congress.

The thirty recommendations are divided into four sections: The first fifteen deal with OSHA's internal management of the standards development process, and its relationship with NIOSH and MSHA. The next five recommendations cover OSHA's use of advisory committees. Eight recommendations suggest ways in which OSHA could more effectively partner with consensus and professional organizations. The last two recommendations are addressed to the Executive Branch and Congress.

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PART IV - SPECIFIC RECOMMENDATIONS RELATED TO OSHA'S STANDARDS DEVELOPMENT PROCESS

OSHA should devise and implement an effective system for managing the standards development process

OSHA should identify the specific obstacles in the standards setting process, determine the source of each obstacle, and determine whether it results from statutory or other legal requirements or is an artifact of internal policy or procedure. OSHA should further research the rulemaking process by estimating the cost in time and resources, and the value added, at each stage in the process of promulgating several past rules.
OSHA should streamline the process of internal review so that the objectives, key issues and broad outline of a regulation are reviewed and agreed upon before the specific regulatory text and accompanying preamble are written. In addition, OSHA should ensure that each step in the internal review adds value and accountability.
OSHA should improve the internal organization and management of the standards development resources including establishing firm deadlines and holding managers accountable for failing to meet deadlines.
OSHA should use Advanced Notices of Proposed Rulemaking (ANPR) only where it is necessary to gather information or to notify the regulated community that OSHA intends to initiate rulemaking. OSHA should issue a proposal within one year of the close of the comment period of the ANPR unless the information gathered shows that a rule is unnecessary or infeasible.
OSHA should develop a regulatory handbook to be used by all staff involved in the standards development process to improve understanding of the process and avoid unnecessary delays. OSHA should take steps to ensure that all standards development staff understand and use consistently the established interpretations of terms such as "hazard", "material impairment", "significant risk", "economic feasibility", and "technical feasibility".
OSHA should implement a standards development operational control center with wall charts illustrating every phase of the standards development process in order to integrate efforts across the agency and ensure that goals are met.
OSHA should develop constituencies early in the conceptual phase and later in the writing phase by more effective outreach efforts to all stakeholders including, but not limited to, employers, unions, trade and professional associations. The goals of the stakeholder process should be to gather information and hear the views of interested parties. It is not realistic to expect that stakeholder meetings will achieve consensus on the desirability of a new rule.
OSHA should move to promulgate a safety and health programs standard as soon as resources permit. This should be followed by building-block standards on medical surveillance and exposure monitoring, thus reducing the need to consider those topics separately in every new health standard.
A major review of the priority setting process should be conducted at least every four years with an annual update concurrent with the strategic planning process. OSHA should develop standards based on national hazard trends and issues consistent with the priority and strategic planning processes.
OSHA and NIOSH should take steps to improve the coordination of standards setting activities. NIOSH should take a more active role in providing support to OSHA's rulemaking activities, rather than acting as just another interested party who submits comments and appears at the hearing. Specifically, NIOSH should work with OSHA to provide literature reviews, risk estimates, and feasibility determinations. NIOSH should also provide scientific support to advisory committees, and help in the analysis of scientific evidence contained in the hearing record. This would free OSHA personnel to concentrate on economic and regulatory analyses. Both OSHA and NIOSH should take steps to improve the integration of their strategic plans.
OSHA should develop a tactical plan that includes gap analyses, timing milestones, comprehensive outreach, and compliance staff training once a commitment to develop a standard is made.
OSHA and MSHA should work together on standards where their priorities coincide, and where a shared effort will save time and resources.
OSHA should consider how it can better recruit, support and retain qualified technical staff.
OSHA should make full use of the internet and other electronic means of gathering and disseminating information and comment.
OSHA should evaluate each rulemaking process after the promulgation of the standard.

OSHA should make more effective use of standards advisory committees and negotiated rulemaking committees

OSHA should continue to make use of advisory committees established under 7(b) of the OSH Act, or the Negotiated Rulemaking Act, for some rules. However, OSHA should make clear to each committee its particular mandate and provide it with the necessary administrative, report writing and technical support. Specifically:
1. OSHA should make the decision whether to use an advisory committee or a negotiated rulemaking committee early in the standards development process.
2. Where there is uncertainty about the need for a rule, or with respect to certain scientific issues, OSHA should appoint a balanced expert 7(b) advisory committee with employer, employee, scientific and government representation. The committee should then be used primarily as a mechanism for gathering and evaluating information.
3. Where the need for a new regulation has been established on a preliminary basis, and where the substance of the regulation is the main issue, OSHA should utilize negotiated rulemaking. In that case, most or all of the members of the committee should represent employers and employees. Negotiated rulemaking committees generally work best where the number of discrete stakeholders is relatively small.
Both types of committees should operate under the following ground rules:

A reasonable timetable should be set by OSHA for the committee to deliver its report or recommendations.
OSHA and NIOSH should provide comprehensive administrative and technical support to the committee, including the gathering of data, analysis of alternatives, and the drafting of regulatory text where appropriate.

Negotiated rulemaking committees should also adhere to the following:

The committee should be told that OSHA has made a preliminary determination to issue a rule, and the job of the committee is to recommend the provisions of that rule. If the committee cannot do so by the deadline, it should be told that OSHA will proceed on its own.
The committee should be told that OSHA cannot give up its authority to set the standard that best comports with the Act, notwithstanding the recommendations of the committee. However, OSHA will give the recommendations considerable weight and, at the very least, will publish them as one regulatory alternative.
Members of the committee who agree with the final recommendation should be asked to sign it, and also agree not to oppose the recommendation during the rulemaking process, barring the introduction of new and compelling scientific evidence.
OSHA should publish a proposed rule as quickly as possible after the committee makes a recommendation, or reports that it cannot achieve consensus. OSHA should remain accountable for the product and the timetable of advisory committees and maintain active involvement, rather than divesting itself of responsibility during this period of time.

OSHA should establish a resource activity that can expand and contract as needs dictate to support, coordinate and communicate the activities of advisory committees.
OSHA should ensure that an adequate budget is established to fully support committee operational plans and travel expense.

OSHA should partner more effectively with consensus standards setting organizations and professional associations

OSHA should reestablish the Office of Professional Association Liaison and see that it is suitably staffed and integrated into the standards development process.
OSHA should monitor, prioritize and participate in the overall consensus standards setting process as well as increasing and improving OSHA technical staff participation on key consensus standards setting committees.
OSHA and NIOSH should involve consensus standards setting organizations and professional associations in their strategic and tactical planning processes.
OSHA and NIOSH should maintain a continuous dialogue and partner with these organizations in developing outreach and communications strategies.
OSHA and NIOSH should support workshops, seminars, and conferences organized by these groups in areas related to the agencies' strategic initiatives.
OSHA should encourage professional organizations to use and strengthen the Inter-Society Forum as a platform to discuss contentious issues and to develop broadly supported priorities.
OSHA should encourage professional organizations to research key issues and submit data relative to standards that have been proposed or are under development.
OSHA should encourage these organizations to develop a speakers bureau to promote important safety and health actions to the public and Congress.

Congress and the Executive Branch should take appropriate action

All communications between OSHA and OMB with respect to a particular rule should be placed in the public docket. Ex-parte communication between interested parties and OMB should follow the same rules as communication between those parties and OSHA. By executive order, OMB's role should be limited to analyses of economic impact and paperwork burdens, and ensuring that OSHA regulations are consistent with other federal regulations. OMB should not have a mandate to review OSHA proposals with respect to risk assessment, health effects, technical means of control, or other areas outside OMB's expertise.
Congress should amend the OSH Act by:

Giving the Secretary authority to rapidly update the 1910.1000 Z-Tables without requiring extensive and lengthy Section 6 rulemaking.
Making it possible for OSHA to issue and sustain Emergency Temporary Standards, and increasing the tenure of such standards from six months to two years.

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PART V - APPENDICES

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APPENDIX A

NATIONAL ADVISORY COMMITTEE ON OCCUPATIONAL SAFETY AND HEALTH (NACOSH)

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
U. S. DEPARTMENT OF LABOR
Byron Orton, Chair

PUBLIC REPRESENTATIVES
Byron K. Orton, Chair
Commissioner of Labor
1000 East Grand
Des Moines, Iowa 50319

Nancy Lessin
Coord.,Natl.COSH Network Proj.
8 Beacon St., - 3rd Floor
Boston, MA 02108

Daniel Hryhorczuk, MD,MPH
Dir., Great Lakes Ctr. for Occ. & Env. Safety & Health (M/C 922)
U. of Illinois School of Pub.Health
2121 W. Taylor
Chicago,IL 60612

Letitia K. Davis, Sc.D
Occ.Health Surveillance Program
Bureau of Health Statistics
Research and Evaluation
Mass. Dept. of Public Health
250 Washington St.
Boston, MA 02108

MGMT. REPRESENTATIVES
Henry B. Lick PhD.
Mgr.,Occ.& Env.Health Sciences
Ford Motor Company
15000 Century Drive Rm. 104
Dearborn, Michigan 48120-1220

Dennis W. Scullion, Sr.
Scullion & Associates
3324 Chaney Lane
Plano, TX 75093

LABOR REPRESENTATIVES
Margaret M. Seminario
Director, Dept. of Occupational
Safety & Health - AFL-CIO
815 16th Street, N.W. #704
Washington, D.C. 20006

Michael J. Wright
Director of Health, Safety
& Environment
United Steelworkers of America
5 Gateway Center
Pittsburgh, Pa. 15222

SAFETY REPRESENTATIVES
Margaret M. Carroll, CSP,PE
Mgr., Safety Engineering
Sandia National Labs
P. O. Box 5800
Albuquerque, NM 87185-1094

David J. Heller, CSP, Vice Pres.
Risk Management & Compliance
U S WEST, Inc.
1801 California St., Suite 5100
Denver, CO 80202

HEALTH REPRESENTATIVES
Bonnie Rogers, RN, DrPH
Occ. Health Nursing
School of Public Health
U.of North Carolina at Chapel Hill
Rosenau Hall, CB 7400
Chapel Hill, NC 27599

LaMont Byrd
Dir., Safety & Health Dept.
Int. Brotherhood of Teamsters
25 Louisiana Ave., NW
Washington, D.C. 20001

COMMITTEE CONTACTS
Joanne L. Goodell
Room N-3641 (OSHA)
(202) 693-2400, ext.31925 (W)
(202) 693-1641 (FAX)
joanne.goodell@osha.gov

Rosemary Sokas,MD,MOH
NIOSH, Room 715H
200 Independence Ave.SW
Washington, DC 20201

COMMITTEE ADDRESS:
US Dept. of Labor
OSHA/ Rm. N-3641
200 Constitution Ave., NW
Washington, D.C. 20210
ATTN: JOANNE GOODELL

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APPENDIX B

ADVISORY COMMITTEE CHARTER

National Advisory Committee on Occupational Safety and Health
(NACOSH)

OFFICIAL DESIGNATION

The National Advisory Committee on Occupational Safety and Health (NACOSH)

THE COMMITTEE'S OBJECTIVES AND THE SCOPE OF ITS ACTIVITY

The Committee was established by Section 7(a) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 656) to advise, consult with, and make recommendations to the Secretary of Labor and the Secretary of Health and Human Services on matters relating to the administration of the Act.

PERIOD OF TIME NECESSARY FOR THE COMMITTEE TO CARRY OUT ITS PURPOSES

Indefinite. Under the Occupational Safety and Health Act of 1970, the Congress intended the Committee to have a continuing duration.

THE AGENCY AND/OR OFFICIAL TO WHOM THE COMMITTEE REPORTS

The Committee shall submit its recommendations to the Assistant Secretary of Labor for Occupational Safety and Health.

THE AGENCY RESPONSIBLE FOR PROVIDING THE NECESSARY SUPPORT FOR THE COMMITTEE

The Occupational Safety and Health Administration

A DESCRIPTION OF THE DUTIES FOR WHICH THE COMMITTEE IS RESPONSIBLE

The Committee is responsible for advising, consulting with, and making recommendations to the Secretary of Labor and the Secretary of Health and Human Services on matters relating to the administration of the Occupational Safety and Health Act of 1970.

MEMBERSHIP

The Committee consists of 12 members, appointed by the Secretary of Labor, four of whom are designated by the Secretary of Health and Human Services. The members are representatives of management, labor, occupational safety and occupational health professions, and of the public. The term of membership will normally be for two years. However, members may continue to serve until replaced as long as they continue to qualify for their particular category of membership.

The members shall not be compensated and shall not be deemed to be employees of the United States by virtue of their membership on NACOSH.

THE ESTIMATED ANNUAL OPERATING COSTS IN DOLLARS

The estimated annual operating cost of NACOSH will be approximately $197,000 including 1.4 person years.

THE ESTIMATED NUMBER OR FREQUENCY OF COMMITTEE MEETINGS

Approximately five meetings per year.

TERMINATION DATE

The charter will expire two (2) years from the date below.

FILING DATE

This charter is filed on the date indicated below.

                                                            (signed by Alexis M. Herman)
                                                            Secretary of Labor

                                                            January 5, 1999
                                                            Date

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APPENDIX C

Questions for Consensus Standards Setting Organizations

ANSI, ACGIH, ASTM, ASME, NFPA

"How Can We Work Together More Effectively In Support of OSHA's Standards Development Process?"

Our plan is to take only 5-10 minutes for each participant briefly describe his/her organization and role. Please use the questions below guide your presentation. presentations will be followed by an informal, in-depth discussion between committee panel. No formal papers are required.

Briefly describe your organization, its membership and your role.
What types of standards does your organization develop? How do you determine when to develop a new standard or revise a current standard?
Briefly describe the process.
How are team members selected? Is balance considered? Is there any mechanism for reimbursing potential members who could not otherwise participate because of cost? Are unions and small businesses represented on standards setting committees? How is broad representation in the process ensured?
Is economic and technical feasibility considered and documented?
Is there any mechanism for public input?
How is "consensus" defined in your organization's standards setting activities? How is membership concurrence obtained? What percentage concurrence is required for action?
How are major disagreements over content of standards resolved? Are minority reports submitted and circulated?
Do you feel that OSHA has taken an active part in your standards setting activities?
Have OSHA staff members contacted your organization or individual standards setting committees to discuss a standard that is being developed by OSHA? Have you or your members made presentations at OSHA's public hearings on a proposed standard?
What ideas do you have for increasing the usefulness of your organization's standards to OSHA rulemaking?
Has your organization's relationship with OSHA changed over the years? What suggestions do you have for improving this relationship?

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APPENDIX D

Questions for Professional Associations

AIHA, ASSE, AAOHN, ACOEM, APHA

"How Can We Work Together More Effectively In Support of OSHA's Standards Development Process?"

Our plan is to take only 5-10 minutes for each participant to briefly describe his/her organization and role. Please use the questions below to guide your presentation. The presentations will be followed by an informal, in-depth discussion between the committee and the panel. No formal papers are required.

Briefly describe the membership of your organization and your role in it.
Has your organization ever served as a Secretariat for a consensus standards setting group? Describe briefly.
Does your organization sponsor any occupational safety or health studies that could be of use to OSHA in its standards setting process?
How does your organization interact with OSHA? Have OSHA standards development staff members contacted your organization during the OSHA standards development process? Have you made presentations at public hearings on proposed standards? Are OSHA staff members active in your organization?
Has your organization's relationship with OSHA changed over the years? What suggestions do you have for improving this relationship?
What role do you see for your organization in OSHA's standards development process?

Table of Contents

APPENDIX E

Questions for Federal Agency Panel

Our plan is to take only 5-10 minutes for each participant to briefly describe his/her organization and role. Please use the questions below to guide your presentation. The presentations will be followed by an informal, in-depth discussion between the committee and the panel. No formal papers are required.

Briefly describe the regulatory functions of your agency.
What is your role in the regulatory process (now or previously)?
What are the most time consuming/troublesome tasks in developing your regulations?
Have you found any shortcuts, simplifications or new approaches?
What are your requirements related to risk assessment? How do you handle them? Have you found any shortcuts, simplifications or new approaches?
What are your requirements related to technical/economic feasibility and cost/benefit analysis? How do you handle them? Have you found any shortcuts, simplifications or new approaches?
Do you use peer review? If so, has its use increased the acceptance of either your risk assessments or economic analyses?
What are your most time consuming/troublesome internal reviews? Have you found any shortcuts, simplifications or new approaches?
What are your most time consuming/troublesome external reviews? Have you found any shortcuts, simplifications or new approaches?
The size of dockets is becoming an increasingly troublesome issue, both in receiving and analyzing, plus the use of electronic systems and the problems related to attachments. Have you developed any innovative systems to deal with these issues?
How do you involve small business in your process?
Describe your hearing process. Does it allow for questioning of participants: (1) by the agency? (2) by another participant?

Table of Contents

APPENDIX F

Chronology of Selected OSHA Safety and Health Standards *

Cotton Dust
1974    ANPR
1976    NPR
1978    Final Rule

Respiratory Protection
1982    ANPR
1985    Draft Proposal
1994    NPR
1995    Record Reopened
1998    Final Rule

1,3 - Butadiene
1983    NTP Study
1984    Request for Information
1984    ETS Petition
1984    ETS Petition Denied
1986    ANPR
1990    NPR
1996    Final Rule

Methylene Chloride
1985    NTP Report
1985    UAW ETS Petition
1986    ETS Petition Denied
1986    ANPR
1991    NPR
1994    Record Reopened
1995    Record Reopened
1997    Final Rule

Cadmium
1986    HRG/ICWU ETS Petition
1987    ETS Petition Denied
1990    NPR
1992    Final Rule

Hazard Communication
1975    Advisory Committee Report
1977    ANPR
1981    NPR1(Withdrawn)
1982    NPR2
1983    Final Rule
1987    Final Rule(Expansion of Scope)

Confined Space Entry
1975    ANPR
1979    ANPR2
1980    ANPR Construction
1980    Public Meetings
1989    NPR
1993    Final Rule(General Industry Only)

Lock-Out/Tag-Out
1977    Request for Information
1979    UAW Petition
1980    ANPR
1988    NPR
1989    Final Rule(General Industry Only)

Scaffolds in Construction
1977    Construction Advisory Committee
           Recommendation
1986    NPR
1988    Informal Hearing
1993    Record Reopened
1994    Record Reopened
1996    Final Rule

          * Prepared by: AFL-CIO
          Source: Code of Federal Regulations

OSHA SAFETY STANDARDS SINCE 1971 *

Standard	Date Final Standard Issued
1. Cranes/derricks (load indicators)	1972
2. Roll-over protective structures (construction)	1972
3. Power transmission and distribution	1972
4. Scaffolding, pump jack scaffolding, and roof catch platforms	1972
5. Lavatories for industrial employment	1973
6. Trucks, cranes, derricks, and indoor general storage	1973
7. Temporary flooring--skeleton steel construction	1974
8. Mechanical power presses--("no hands in dies")	1974
- Modified	1988
9. Telecommunications	1975
10. Roll-over protective structures of agricultural tractors	1975
11. Industrial slings	1975
12. Guarding of farm field equipment, farmstead equipment and cotton gins	1976
13. Ground-fault protection	1976
14. Commercial diving operations	1977
15. Servicing multi-piece rim wheels	1980
16. Fire protection	1980
17. Guarding of low-pitched roof perimeters during the performance of built-up roofing work	1980
18. Design safety standards for electrical standards	1981
19. Latch-open devices (on gasoline pumps)	1982
20. Marine terminals	1983
21. Servicing of single-piece and multi-piece rim wheels	1984
22. Electrical Safety in Construction (Part 1926)	1986
23. General Environmental Controls--TAGS Part (1910)	1986
24. Marine Terminals--Servicing Single Piece Rim Wheels (Part 1917)	1987
25. Grain Handling Facilities (Part 1910)	1987
26. Safety Testing of Certification of Certain Workplace Equipment and Materials (Laboratory Accreditation Revision)	1988
27. Crane or Derrick Suspended Personnel Platforms (Part 1926)	1988
28. Concrete and Masonry Construction (Part 1926)	1988
29. Powered Platforms (Part 1910)	1989
30. Underground Construction (Part 1926)	1989
31. Hazardous Waste Operations (1910) (Mandated by Congress)	1989
32. Excavations (Part 1926)	1989
33. Control of Hazardous Energy Sources (Lockout/Tagout)BR Part (1910)	1989
34. Stairways and Ladders (Part 1926)	1990
35. Concrete and Masonry Lift-Slab Operations	1990
36. Electrical Safety Work Practices (Part 1910)	1990
37. Welding, Cutting and Brazing (Part 1910) (revision)	1990
38. Chemical Process Safety	1992
39. Confined Space Entry	1993
40. Fall Protection	1994
41. Electrical Power Generation	1994
42. Hazardous Material, Department of Transportation Markings and Placards	1994
43. Personal Protective Equipment	1994
44. Logging Operations	1995
45. Scaffolds	1996
46. Powered Industrial Truck Operator Training	1998

* Prepared by: AFL-CIO
Source: Code of Federal Regulations

OSHA HEALTH STANDARDS SINCE 1971 *

Standard	Date Final Standard Issued
1. Asbestos	1972
2. Fourteen Carcinogens	1974
3. Vinyl Chloride	1974
4. Coke Oven Emissions	1974
5. Benzene	1978
6. DBCP	1978
7. Arsenic	1978
8. Cotton Dust	1978
9. Acrylonitrile	1978
10. Lead	1978
11. Cancer Policy	1980
12. Access to Medical Records	1980
- Modified	1988
13. Hearing Conservation	1981
14. Hazard Communication	1983
15. Ethylene Oxide	1984
16. Asbestos (revised)	1986
17. Field Sanitation	1987
18. Benzene	1987
19. Formaldehyde	1987
20. Permissible Exposure Limits (PELs) Update (Vacated)	1989
21. Chemical Exposure in Laboratories	1990
22. Bloodborne Pathogens	1991
23. 4,4'-methylenedianiline	1992
24. Cadmium	1992
25. Asbestos (Partial Response to Court Remand)	1992
26. Lead -- (Construction)	1993
27. Asbestos (Response to Court Remand)	1994
28. 1,3-Butadiene	1996
29. Methylene Chloride	1997
30. Respiratory Protection	1998

* Prepared by: AFL-CIO
Source: Code of Federal Regulations

Table of Contents

APPENDIX G

List of Panel Members

The Standards Development Process - August 5, 1998

Joseph M. Woodward, Assoc. Sol. for OSHA, SOL, DOL
Marthe Kent, Dir., Safety Standards, OSHA

6(b) Process (Methylene Chloride Standard) - February 11, 1999

John Martonik and Adam Finkel, OSHA
Chuck Gordon, SOL
Paul Schulte, NIOSH
Frank Mirer (UAW) and Randy Rabinowitz representing Labor
Frank White (ORC), Dick Olson (Dow retired), Steve Risotto (HSIA) representing Industry

Steel Erection Negotiated Rulemaking Advisory Committee - May 12, 1999

Bart Chadwick, OSHA (retired)
George Henschel and Claudia Thurber, SOL
Rosie Sokas, NIOSH
Phil Harter, Committee Chair
Steve Cooper, Ironworkers representing Labor
Phil Cordova, Alliance Riggers and Constructors representing Industry

Metalworking Fluids Standards Advisory Committee - May 12, 1999

Peter Infante, OSHA
George Henschel and Claudia Thurber, SOL
Rosie Sokas, NIOSH
Maura Sheehan, Committee Chair
Jim Frederick, Steelworkers representing Labor
John Cox, National Tooling & Machining Association representing Industry

Consensus Standards Setting Organizations - September 21, 1999

Marthe Kent, OSHA
Joe Woodward, SOL
Paul Schulte, NIOSH
Jane Schweiker, American National Standards Institute (ANSI)
Lisa M. Brosseau, American Council of Government Industrial Hygienists (ACGIH)
Kathleen Kono, American Society for Testing and Materials (ASTM)
June Ling, American Society of Mechanical Engineers International (ASME)
Anthony R. O'Neill, National Fire Protection Association International (NFPA)

Professional Associations - September 22, 1999

Jerry Lynch, American Industrial Hygiene Association (AIHA)
Thomas F. Bresnahan, American Society of Safety Engineers (ASSE)
Kae Livsey, American Association of Occupational Health Nurses (AAOHN)
Robert McCunney, American College of Occupational and Environmental Medicine (ACOEM)
Jane Lipscomb, American Public Health Association (APHA)

Federal Agencies - January 18, 2000

Marthe Kent, OSHA

Ron Medford, Consumer Products Safety Commission (CPSC)
Joseph Fitzgerald, Department of Energy (DOE)
Ed Mazzullo, Department of Transportation (DOT)
Paul Lapsley, Environmental Protection Agency (EPA)
Linda Horton, Food and Drug Administration (FDA)

Revision Date: 11 July 2000

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