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BY HAND

September 14, 1999
202-434-4249
sarvadi@khlaw.com

Mr. John T. Spotila
Office of Management and Budget
Director, Office of Information and Regulatory Affairs
New Executive Office Bldg
725 Seventeenth St. NW
Room 9026
Washington, D.C. 20503

Re: Supplemental Information Regarding OSHA's Draft Ergonomics Standard

Dear John:

Thank you very much for meeting with us on July 27, 1999. We feel that we had a productive and useful discussion and were disappointed that we ran short of time. We have prepared this letter to provide you with more background, and a more detailed analysis of the issues that were raised in our discussions. Of course, should you or your staff have any questions, please feel free to contact us through Pete Eide at the U.S. Chamber of Commerce, 202-463-5507, or David Sarvadi at Keller and Heckman, 202-434-4249.

We recognize that OSHA may have changed its approach and some of the specific provisions in the ergonomics proposal you are reviewing in light of the Small Business Regulatory Enforcement and Fairness Act (SBREFA) panel report. However, it has been our experience since 1995 that the Agency has ignored virtually every recommendation made by the business community. That is why we asked for the meeting and have provided these comments based on the draft used in the SBREFA review. That is also why we will be very cautious in reviewing any changes which the agency has made before concluding that they have truly responded to the concerns of the business community, and appropriately modified their proposal in a significant way.

We also believe that OSHA has engaged in a public relations effort designed to create the perception that OSHA is the only group concerned with ergonomics and workplace safety, that most businesses still do not have or recognize the benefits of an ergonomics program, and that the Washington trade associations (who constantly take the pulse of their members) are somehow not representing their members' real interests and desires. These representations are simply untrue. OSHA does not have the answers needed by employers to alleviate their concerns about OSHA's desire to regulate so-called ergonomic hazards in the workplace, as evidenced by the vague and over-reaching provisions in the draft.

Many of the trade associations and companies who are our members have not waited for OSHA to develop a standard. The associations prepared guidance documents on how to apply ergonomic principles and practices in their industries, and many of the companies in each industry adopted or modified practices in their facilities based on the application of ergonomic principles. Where those changes sometimes result in reductions in injuries and illnesses, we take that as an added benefit, but not one that can be predicted reliably. Indeed, ergonomics as an engineering discipline evolved to address efficiency more than safety or health issues.

OSHA has a narrow focus which can distort its assessment of ergonomics and the best approach to incorporating those principles in workplace design. Our members and others who use ergonomic principles have not genrally adopted the OSHA model because it has not been proven to work and it is clearly inefficient. The experience of most if not all of our members is that, while ergonomic principles are useful, they have by no means developed to the point that generalized guidelines on methods of evaluation or control can be developed. The Government Accounting Office (GAO) report frequently cited by OSHA as showing that its approach is viable explicitly rejected the conclusion that the companies studied had found the ergonomic solution. The science simply does not exist.

Finally, OSHA has refused to engage in the debate over the scientific questions we raise. The central issue of whether there is a sufficient basis to regulate the workplace by imposing one model of ergonomic methods has never been openly and fully debated. The business community has experienced the same close-minded attitude in attempting to engage the members of the National Safety Council's (NSC) Accredited Standards Committee (ASC) Z-365 on Control of Upper Extremity Musculoskeletal Disorders (MSD) on this issue. When efforts are made to raise questions about the basis for the premise that the injuries are caused by ordinary activities, we are told that discussion will be held later; of course, later never comes. The experience of our members at the OSHA stakeholders meetings in 1997 and 1998 (in Lockport, New York; Chicago, Illinois; Kansas City, Missouri; and Atlanta, Georgia) was illustrative. When the industry participants tried to raise these questions, they were ruled out of order, told to hold the questions to discussion sessions that never occurred, or told their position had no merit. ¹ OSHA has avoided the issues since its 1995 draft risk assessment was shown to be false, misleading, and scientifically unsupportable. ²

It is imperative that this issue be addressed before OSHA issues a draft proposal, because OSHA standards have the unintended effect of freezing perceptions and developments in practices. Recent changes, for example, in asbestos and other chemical exposure standards, to delete requirements the medical community deemed unnecessary or carrying their own risk ³ illustrate this fact. OMB should direct OSHA to address the technical, medical question directly, instead of allowing OSHA to sidestep the questions by deferring them to some undefined future. The time for that discussion will come when the National Academy of Sciences (NAS) committee currently studying the question completes its review of the open literature.

Our Position, Unchanged and Unanswered Since 1994

We believe that it is well established that (1) the scientific evidence showing a quantitative relationship between workplace activity and illness or injury is entirely lacking, and (2) inadequate information exists to allow OSHA to prepare an adequate occupational safety and health standard.

We recognize that there are some studies in which the authors conclude that some un-quantified association may exist between some workplace activities and some medical conditions which have more recently become known as work-related musculoskeletal disorders (WMSD). ⁴ It is our contention that, upon careful examination, many if not most of these authors' conclusions are not supported by their evidence. We base our position on a number of analyses conducted by other scientists who compared the methods used against generally accepted scientific methods, and concluded that the methods left much to be desired. Indeed, the epidemiologic studies purporting to prove a causal relationship or association between injury and workplace activity are based on studies which have serious flaws. These flaws prevent the use of the studies in defining, with any degree of precision or specificity, (1) the work activities that may have a causal relationship to injury or illness, and (2) effective preventive measures that have a reasonable prospect of success. Among the fatal flaws in the epidemiology studies to date are: deficiencies in case definition; deficiencies in exposure definition, quantification, and assessment; inappropriate grouping of cases; inadequate design; lack of prospective designs; and others. ⁵ Other studies lack adequate controls and description of methods, fail to follow generally accepted techniques, or have similar fatal flaws. ⁶

Lacking studies that address these specific deficiencies, scientists are unable to answer the fundamental question of dose-response: what workplace activities present a risk of injury, and how large is that risk. Without these answers, OSHA cannot define the hazards at all, let alone sufficiently to satisfy the applicable statutory and constitutional provisions authorizing OSHA to regulate significant risks with clear and unambiguous requirements. Unable to define the hazards, it follows that OSHA cannot prescribe the changes in the workplace that would mitigate the risks it seeks to reduce or eliminate. These are two fundamental requirements of OSHA's enabling statute, without which OSHA has no power to mandate employer actions or workplace changes.

Medical science must answer four questions before the level of scientific knowledge will be adequate to allow OSHA to meet these legal requirements. Studies must be performed to reach agreement on:

1. objectively defining the medical conditions that should be addressed;
2. describing the tools and categories of medical diagnosis;
3. identifying the particular exposures in magnitude and nature which cause those medical conditions; and
4. prescribing the changes necessary to prevent their recurrence.

Quantification is essential because the medical conditions OSHA seeks to prevent are equally (perhaps more) likely to occur as a result of non-occupational activity as from work; the resulting conditions are presently indistinguishable from non-occupational conditions. ⁷ It is critical to understand that the incidence and occurrence of the soft tissue injuries OSHA is targeting among the general population is substantial. For example, a prevalence of low back pain in middle-aged adults is 100%.

OSHA Needs to Clearly Identify What Injuries or Illnesses Are to Be Prevented

With few exceptions (including the paradigm of these conditions, carpal tunnel syndrome), OSHA has not identified the harm it seeks to prevent with systematic, medically recognized diagnoses. It has not separated real injury and illness from transient symptoms and the aches and pains of daily life, combined with the normal process of aging, that are experienced by the everyone to some degree. The category known as "work-related musculoskeletal disorders" (WMSD) selected by OSHA to address these conditions is too large to allow meaningful analysis. For example, back injuries and hand problems have nothing in common except generically. They are conditions of pain involving muscles, nerves, and bones; we cannot even say they share a common physiological basis. ⁸ Thus, a meaningful analysis cannot be produced when these conditions are combined, but it is only by such aggregation that the Agency can then claim that large numbers of WMSDs (more than 650,000 cases with lost workdays) allegedly occur in the United States.

Although the term WMSD is over-inclusive, there is not an adequate database which tracks MSDs, and the agency has not accurately quantified the number of OSHA 200 MSDs which qualify as WMSDs. The assumption that all cases reported in the workplace are work- related, ⁹ and that all reported cases can be prevented by changes in the workplace, is unfounded.

Unlike other occupational diseases, these soft tissue conditions do not bear markers of their occupational origin. With chemical exposures, the conditions they cause are often characteristic; the chemicals attack the body in readily identifiable ways. Moreover, measurement of exposure is easy; one simply measures how much is in the workplace air. Even where the chemicals may be ubiquitous, producing non-occupational exposure from natural sources or general environmental contamination, the difference in the magnitude of exposure from occupational sources is generally a factor of 100 to 1000 greater, producing dramatic differences in the response to the exposure. In the case of soft tissue injury, however, we can only describe the factors thought to contribute to risk in the most general, qualitative terms: heavy lifting, extreme postures, frequent repetition, and the magnitude of non-occupational response is often less than that on the job.

OSHA misleads and forces a mis-allocation of resources in another way. Broadly defining work-related MSD as OSHA does, employers will be forced to examine all the jobs the affected employees perform. The result is that many jobs that have no increased risk of injury will be improperly classified - and much time, money, and effort will be wasted - trying to analyze and control imaginary risks. OSHA's decision to aggregate, for purposes of analysis and control, all injuries involving muscles, bones and nerves is over-inclusive, and creates far too many false positives. ¹⁰

The workplace conditions that purportedly give rise to these markedly different medical conditions are also completely unrelated. The actions that OSHA believes lead to carpal tunnel syndrome are often described as repetition, posture, and frequency or, sometimes, recovery time. For back injuries, the principal cause is thought to be lifting more than 25 pounds. OSHA frequently recommends reducing exposure to an alleged "risk factor" (e.g.,frequency, repetition, or force) ¹¹ by increasing the number of workers or allowing more time to perform the task as a means of control, but never offers proof that such changes will result in fewer complaints, let alone injuries. Only by creating these large categories of injuries and risk factors, and making broad generalizations about the methods of control can OSHA begin to discuss them in common terms, but the generalizations are so broad that the prescriptions are too general to be effective. The question OSHA has never been able to answer, and still cannot, is -- how many additional workers or how much more time is needed? Given this inability, OSHA has to rely on broad generalizations that leave unfettered discretion in the hands of relatively untrained inspectors.

OSHA Must Clearly Identify What Factors, Or, More Likely, What Combination of Factors Cause Each Injury or Illness of Concern, Whether There Is a Significant Workplace Component, and Whether That Workplace Component Is Subject to Control Through an OSHA Standard Before Attempting to Regulate Ergonomics in the Workplace

It is necessary to identify the specific exposures which cause the injury or illness of concern if employers are to be able to take measures to prevent them. OSHA has failed to do this. There is no reliable dose-response, or threshold of response, data which could be used to develop and set permissible exposure limits of the type OSHA has traditionally established for other health standards. As a result, OSHA lacks the scientific knowledge essential to issue a performance standard based on objective criteria. OSHA cannot meet its statutory obligations.

Lacking the essential scientific knowledge, OSHA simply assumes that certain soft tissue injuries and complaints are caused by the mechanical aspects of work activities, ignoring personal activities, pre-disposing personal factors, social, or psycho-social factors. Indeed, many of the studies, including the National Institute for Occupational Safety and Health (NIOSH) review of the literature published in 1997, do not even consider non-occupational activities in their analysis. ¹² As many scientists have noted, failing to consider all possible causes makes finding the true one(s) a matter of pure luck.

The ergonomic analytical methods currently available do not allow us to analyze jobs which are essentially different to find common causes of soft tissue injuries and common methods of control because we do not know what the causes are. As George Page mentioned in his locomotive repair example, ergonomists do not know in many cases what to change, let alone by how much.

Another interesting perspective is from that of the sports/health/fitness industry. General principles of fitness suggest that muscles must be worked until fatigue sets in to increase strength, endurance, and overall muscle tone. In the context of fitness, the general principles are, do it harder, longer, and more. What is the difference between exercise and work? To put the question in another way, OSHA needs to be able to tell why, on the one hand, a particular activity is good for you when it is exercise, and bad for you when it is work.

OSHA Would Adopt and Enforce a Vague and Ambiguous Standard Granting the Agency Virtually Unfettered Discretion to Decide its Scope and Application

Under OSHA's draft proposal, OSHA inspectors would have virtually unfettered discretion to:

1. determine all of the of the required elements of compliance with the standard: the covered medical condition, the covered employer, the covered task or activity;
2. define the hazard to be addressed ex post facto allowing a shifting and undefinable standard;
3. specify the control measure to be implemented, subject only to the limits of feasibility, without knowing, in any particular case, whether it would lead to a material improvement in the workplace. In other words, OSHA would require the employer community to engage in an unreasonably burdensome and inefficient nation-wide experiment in which employers must do everything which OSHA determines to be feasible to assist employees in avoiding soft tissue discomfort.

Such a standard does not meet constitutional due process requirements regarding notice and vagueness of the standard of care.

At the present time, in response to strong market incentives, and based on currently available scientific knowledge, employers are already doing what can reasonably be done to minimize significant MSDs, and MSDs are declining dramatically without OSHA intervention. This means the current level of knowledge is adequate to support an employer's voluntary application of ergonomic principles to workplace activities but is insufficient to justify adoption of an OSHA standard that would impose unlimited mandatory requirements on all employers.

A rule that is overly vague and broad will discourage innovation, will lead to a substantial mis-allocation of resources, and is prohibited by law. OSHA should focus its resources on further developing the body of knowledge which will assist employers and employees in addressing this issue and providing information technical issues related to ergonomics. Any attempts to develop a standard are premature and counterproductive.

Should OSHA Do Anything?

Arguments can be made that OSHA need not do anything that imposes mandatory requirements on employers. First, although in individual MSD cases, the injuries and illnesses can be debilitating and serious, the vast majority leave no lasting impact and most people recover fully, many without significant treatment. ¹³ There is often pain, sometimes mild and sometimes severe, and sometimes it can last a few weeks, but recovery occurs in the vast majority of patients. What is a national tragedy is the number of people who have been crippled by the treatments ergonomists and some medical professionals propose. For example, unnecessary, repetitive hand surgeries occur, with reports of patients enduring five and six surgical treatments. *(A scientific review of this practice is clearly warranted.)

Second, the number of cases being reported to the Bureau of Labor Statistics is falling. Since its peak in 1994, the number of cases, both those with lost workdays and total cases, have fallen nearly 20%. As George Page mentioned, a similar situation occurred in Australia now nearly 15 years ago when media reports appeared to inspire claims of ergonomic injury, and, after a periodf of rapid growth, the injury and illness rates subsequently subsided nearly to their original level. We enclose several papers on that experience. If the U.S. is following the same pattern, there is little or no need for a massive program, as the "crisis" will resolve itself.

What Should OSHA Do?

OSHA argues that the number of cases being reported by the Bureau of Labor Statistics is so significant that it must "do something." Some may feel this way, but in fact, OSHA's statutory authority authorizes OSHA to address significant risks of material impairment of health or functional capacity. Until OSHA can prove that what it wants to do is reasonably necessary and appropriate to mitigate to a significant degree a significant risk, OSHA may not create any mandatory requirements. What it can and should do is seek to inform itself, employers and employees about the current state of knowledge, encourage research and innovation, and work cooperatively to understand the problem better. Specifically, we think there are four things OSHA should do:

1. At the very least, wait until January of 2001 before evaluating the current state of knowledge when the National Academy of Sciences (NAS) completes its comprehensive review of the literature to establish the baseline of what is known and what is still needed. The study will provide a sounder basis for OSHA to reach the required statutory findings on the scientific issues. It may prevent or remove from contention important and complex issues that are likely to be focal points in any subsequent litigation, and it will provide a basis to begin to reach consensus on some of these issues. (Practically, it will not delay OSHA's efforts significantly, because, if experience is any guide, OSHA cannot complete the rulemaking process within the next 15 months.) Meanwhile, OSHA can embark on a program of education and facilitation, described below, as well as research to foster progress in this controversial area. No enforcement actions under the GDC seem warranted in light of OSHA's repeated failure to prove even the existence of a hazard in several prior general duty cases. ¹⁴
2. Work with NIOSH to develop a research program reasonably calculated to address the fundamental questions that exist: what are the quantitative relationships between activity and injury; what are the physiological causes of the injuries; and what specific, quantitative changes in the way activities are performed are necessary to mitigate the risk of injury.
3. Examine in a systematic and detailed manner the experience of those companies who signed consent agreements to settle OSHA ergonomics citations between 1985 and the present. Arguably, OSHA must complete this review before it even issues a proposal, because the statute requires OSHA to base standards governing health hazards on the "best available evidence." Anecdotal evidence of effective control methods - developed through informal discussion groups such as the stakeholder meetings OSHA has held - is insufficient as the legal basis for a standard . As noted above, there were nearly 500 cases between 1985 and 1995. An evaluation of the injury and illness experience for the affected employers (considering the specific medical conditions experienced, the various jobs and activities involved, and the control measures employed) should provide OSHA with the ability to develop specific information about causes, and equally important, the magnitude of risks, as well as the efficacy of OSHA's prescriptions. A comparison of the injury and illness rates of those employers before citation with the rates after implementation of the settlement agreements would indicate whether the OSHA approach is valid. Such a study should examine the employer's changes in injury and illness rates by job, type of injury, or other appropriate category. Unfortunately, OSHA has not attempted such a systematic approach. ¹⁵
4. In cooperation with trade associations, labor organizations, and industry groups, prepare industry- and task-specific materials for use by employers in adopting voluntary programs, and fund, at a much higher level than presently contemplated, assistance programs for business. Support workshops and seminars by diverse groups to incubate the scientific research needed. Assure that research is conducted according to the highest practical standards, and require all results and data to be made available for examination and review by independent scientists without restriction.

If OSHA had started these processes in 1995, the answers might already be in. As it is, we will have to wait for the research to be conducted before the fundamental issue before us is resolved. The following describes in more detail our concerns over the scientific issues.

Practical Issues: The Ergonomist's View

During our meeting, ergonomist George Page outlined various issues of importance to ergonomic practitioners, highlighting the fact that even professionals who deal with ergonomics every day can not identify, with an appropriate degree of accuracy, the causes and exact nature of ergonomics injuries. Instead of adequately defining workplace conditions that cause injury, the proposed draft relies on endless loops of hazard identification, analysis, and control. The draft implicitly recognizes that even the experienced practitioner cannot look at a job and say how much is too much in terms of the changes that lead to systematic means of control. Moreover, even when risk factors can be identified, the practitioner cannot state how much exposure to each of the purported risk factors must be reduced. An employer would be required to engage in continuous shop floor experimentation. The OSH Review Commission concluded that the OSH Act did not allow OSHA to require companies to conduct endless experimentation. Under the 1975 2nd Circuit Court of Appeals vinyl chloride decision, ¹⁶ OSHA can force technological innovation when there is a reasonable prospect that success is on the horizon, but the standard is not open-ended. OSHA usually recognizes that technical feasibility limits its ability to impose standards on employers.

Others recognize this deficiency. Jerry Laws, editor of Workplace Ergonomics, raised this point in the title and content of his editorial in the October/November issue titled "Is that a hazardous job?" The endless-loop of hazard identification, analysis, and control raises the costs and regulatory burden of compliance to unknown levels with unknown results. OSHA acknowledged this lack of dose-response and threshold information when the agency decided not to include the quantitative assessment checklists of their 1995 draft proposal in the current proposals.

Mr. Page went on to point out that, in making improvements to a job, the practitioner is often faced with trade-offs among the purported risk factors. For example, when improving impact power tools for a given application, heavier impact tools generally produce less vibration because the added weight dampens the vibration. However, the added weight translates to greater grip force to use the tool. Which way does the practitioner go? What is the correct trade- off? Without dose-response and threshold information, such a determination cannot be made; nor can prediction be made in terms of potential risk of specific MSDs. How can a mandatory standard be defined, let alone enforced?

Basing mandatory actions on reports of symptoms is not consistent with the intent of the OSH Act. Congress intended to prevent material impairment of health or functional capacity. Using symptoms to trigger prevention is useful only if (1) the underlying condition progresses from the symptoms with sufficient frequency and (2) the symptoms are sufficiently specific to the underlying condition that appropriate treatment can be identified. Otherwise, resources are wasted and misallocated. Treating individuals based only on the symptoms without understanding the underlying cause is not appropriate medical treatment; making wholesale changes in jobs based on unconfirmed symptom reports is unreasonable.

Consider carpal tunnel syndrome (CTS) as an example. Symptoms of CTS are typically described as pain or tingling in the thumb and first three fingers of the hand, often at night. Such symptoms can arise from other causes, such as restricted blood flow from sleeping in various positions and other medical conditions. Studies which examine the incidence of CTS among groups reporting symptoms show that relying on symptoms alone results in a false positive rate of approximately 80%, compared to electrodiagnostically confirmed cases (see attached articles by Franzblau et al). In these circumstances, alterations to an individual's workplace or job will not reduce the symptoms or affect the underlying medical condition, because the workplace is not the cause of the symptoms.

Thus if employers are required to act based on symptom reports, ¹⁷ which the proposed draft standard released in February 1999 apparently would require, hazard analysis and control measures required by the standard would be unnecessary. Unfortunately, OSHA cannot presently predict with any degree of reliability which 20% of the symptom reports represent real cases of CTS, let alone which of the cases are caused by the job. The result is an undue regulatory burden and wasted cost, and more importantly, no real relief for the employees. The deleterious effect of this approach on the macro level is described in the two articles by Damion Ireland regarding the "Australian Experience."

This does not mean that the application of ergonomics to the workplace cannot be beneficial. Because ergonomists cannot yet predict how much actual risk will be reduced (e.g., incidence and severity of injuries) when exposure to specific risk factors is modified, the legal basis for a regulatory mandate does not exist.

Most of the ergonomic literature bases its evaluation of health and safety on the occurrence of symptoms of discomfort and pain, not on specific diagnoses or disease entities. While it may be useful to reduce such symptoms, OSHA's authority is directed at predictably reducing the risk of material impairment of health or functional capacity-- that is, specific recognized diseases. The draft proposed regulation of necessity aims more at regulating "discomfort" than hazards of specific diseases. Generally, ergonomic practitioners operate on the assumption of improving the "ease and comfort" of the workplace, not whether actual risk will or will not be reduced.

OSHA's draft does not include any information on the kinds of factors, their measurement, or their magnitude that relate to injury or illness. This generic risk factor approach asserts that each of the risk factors is applicable to each of the variety of musculoskeletal diseases that may be included under the proposed draft standard. Yet the ergonomic literature to date varies significantly as to which factors may be relevant to different conditions and symptom complaints. Until OSHA is able to point to scientific information quantitatively relating the risk factors to specific complaint syndromes, and provides appropriate and effective methods of measurement, the only approach available to OSHA is so vague as to be unenforceable.

Practical Issues: The Business Manager's View

Bill Walker, of Ottenberg's Bakery, gave a few examples of how ergonomics issues arose in his workplace and how they were dealt with. In one case, an employee reported that his lower back was sore from working at a roll sorting station. Bill asked the employee how he thought the problem could best be handled. The employee suggested that if he could have a chair to sit on occasionally throughout his shift, that this might alleviate the problem. The chair was provided and no subsequent back pain was reported. The same employee complaint in a workplace implementing the draft standard would also trigger the medical management and record keeping requirements, even though the basic concern of the employee was addressed. This, in turn, would result in unnecessary medical expenses and loss of productivity. Ultimately, however, the solution would be the same. Hence, the requirements of the draft standard will make the lengthen the time it takes to solve these types of problems, which will ultimately add extra costs yet provide no additional benefit to the employee.

Economic Issues

When examining the requirements of the draft rule and how they would be implemented, OSHA substantially overestimated the benefits and substantially underestimated the costs of compliance. Indeed, it can be argued that OSHA should only attempt to impose a mandatory legal requirement if the economic justification is too weak to persuade employers to adopt the principles on their own-- that is, there is a failure of market forces. At the very least, responsible government regulation takes advantage of market forces and incentives, and the natural inclination of citizens to live within the law.

The anticipated costs of compliance need to be better quantified, along with the estimated risks and the estimated reductions in risks, so that a rational relationship between the costs and the benefits of the standard can be examined. This is not to say that a cost-benefit analysis is required or should even be done, but that the costs should bear some reasonable relationship to the benefit to be gained. The costs may not be so excessive that whole industries will be forced out of the U.S. or that entire classes of jobs will be lost completely to automation or extinction.

The standard anticipates that every employer involved in manufacturing or manual handling will bear the additional overhead for some kind of written ergonomics management program that will require the training of every covered employee without regard to the risk that the employee faces. Indeed, because the risk cannot be adequately identified , the only sound economic analysis is one that assumes that every manufacturing and material handling job in the US will be covered. The cost of such an undertaking would be enormous, and completely out of proportion to the benefit to be gained.

The standard also assumes that each employer will implement all feasible control measures until the undefined hazard is completely eliminated. The costs of achieving zero risk would be monumental (and the Supreme Court has already rejected OSHA's contention that zero risk Congress intended OSHA to achieve as an acceptable standard).

The draft standard would provide a medical removal benefit for up to six months with full salary and benefits for these almost universally subjective conditions. This clear invitation to fraud and abuse would create astronomical increases in the costs of compliance.

OSHA includes in its benefits estimates the savings from productivity improvements, when in fact, many of the changes leading to productivity improvements are likely to be made even if there is no OSHA standard. OSHA admits that such changes are likely to be adopted, because, it argues, the productivity benefits exceed the costs. If so, what benefit does the OSHA regulation provide?

OSHA argues that industry overestimates the costs of compliance, and points to industry's assertions in the vinyl chloride and cotton dust rulemakings as examples. These are inapposite for two reasons. In the case of vinyl chloride, the industry was completely unsophisticated about the kinds of things that could be done to reduce exposure, especially downstream of the primary resin manufacturing operations. Thus, there was room for improvement that reduced potential exposures by whole orders of magnitude. In the case of ergonomics, as has been demonstrated by efforts over the last 25 years, improvements occur infrequently and incrementally.

Similarly with cotton dust, the industry went through wholesale change, bringing its technology from the 19th (and in some cases the 18th) to the late 20th century in terms of the technology used in their facilities. Instead of fixing up existing plants, new plants were built because the existing economic justification to do so, which was nearly overwhelming on its own, was supplemented by the government's mandate, and effective methods of addressing the problem could be devised because the cause of the condition, brown lung, was known and equally important - measurable. This condition does not exist in the context of ergonomics because the "risk factors" that OSHA talks about are not quantifiable in any reliable way.

Unfunded Mandates

The draft ergonomics standard also raises the issue of unfunded mandates. State legislatures across the country have expressed a growing unwillingness to support federal programs funded out of state budgets. Congress has also voiced its concern over the unfunded mandates problem and is likely to look unfavorably on any regulatory scheme imposing unjustifiable costs upon already over burdened state treasuries.

One example given at our meeting was the dismay expressed by the North Carolina Department of Education at the magnitude of its cost estimate for compliance with the draft standard. A conservative estimate indicated that it would cost the state $131,857,200 to meet the requirements of the proposed standard. We have attached a copy of a letter issued by the North Carolina School Boards Association discussing this case in detail.

Workers Compensation Issues

Mr. Bruce Wood of the American Insurance Association discussed workers' compensation issues. Mr. wood, and Eric Oxfeld of an organization called, UWC -- Strategic Services on Unemployment & Workers' Compensation & The National Foundation for Unemployment Compensation & Workers' Compensation, wrote to you separately on this subject. We agree with their analysis.

Small Business Issues

The draft standard, if adopted, will also place an undue burden on small businesses. Unlike larger companies, small businesses are simply unable to pass on compliance costs, which, as discussed above, will likely be significant. From a small business perspective, it would be far more cost effective to rely on various non-regulatory alternatives, such as workers' compensation or other incentive based programs. Unfortunately, OSHA has consistently exhibited an unwillingness to explore or consider such alternatives.

That compliance costs will be substantial was made clear when OSHA admitted that the agency materially underestimated the costs of the ergonomics proposal. Furthermore, the vague terms used in the Agency proposal create uncertainty as to what must be done to achieve compliance and, thus, how much it will cost. For example, the proposal would require employers to implement all "feasible control measures."

Issues of Public Policy

There are serious public policy questions about whether the government should, even if it is able, insert itself so intimately into the private sector that OSHA inspectors will be able to second guess private decisions about how work is organized. Inevitably, when ergonomists get involved, one of the solutions is to reorganize work to increase the number of people who perform it or to change it in ways that make sense only from an ergonomist's limited point of view. When employers adopt these approaches on their own, they have determined it is an appropriate expenditure and the rest of society obtains the benefit through the interaction of market forces. But when the government is allowed to second guess the decisions of employers in such broad terms, control over the operations of the business transfers from an organization driven by market incentives to a bureaucracy which knows little if anything about how to run a successful business. If the history of the last twenty years is any guide, it is that such regulatory approaches stifle innovation, reduce standards of living, and slow economic growth.

Current market incentives are adequate to drive the application of ergonomics principles where their application makes sense, and the current decline in MSD rates demonstrates that fact. Further progress is constrained by a lack of adequate scientific knowledge, and a mandatory OSHA standard will not change that fact or improve the situation.

Fundamental Legal Issues

Generally, to sustain a standard on judicial review, OSHA must demonstrate the following: ¹⁸

1. current exposure levels to the identified hazards pose a significant risk of harm; ¹⁹
2. the proposed requirements would significantly reduce the risk posed by current exposure levels to the identified hazards;
3. the proposed requirements are technically and economically feasible; and
4. the proposed requirements are the most cost-effective approach for achieving the reduction in risk posed by the identified hazards.

OSHA must first define, so they can be reliably understood by individuals of reasonable intelligence, both the significant harm (injury or illness) of concern and the specific hazard or hazards which cause that harm. At the present time, because musculoskeletal disorders (MSD) are defined so broadly, medical science is inadequate to define either.

In fact, the Agency is bound by the OSH Act to promulgate standards "on the basis of the best available evidence." ²⁰ Given the uncertain scientific understanding of occupational ergonomics injuries, it absolutely crucial for OSHA to conduct a systematic scientific review of all available evidence so that they can determine which evidence is best. Reviewing studies, such as the National Academy of Science workshop report and the NIOSH review, is one aspect of the evidence gathered.

Such summaries are in and of themselves, however, insufficient to establish a foundation for promulgation of a major standard such as the one proposed here. Other evidence exists and should be considered before any conclusions are reached. This is fundamental to a consideration of the best available evidence and consideration of the evidence taken as a whole, and if ignored, would legally invalidate any subsequent findings by OSHA.

As we mentioned, one example of other types of evidence that should be considered is the body of data represented by the nearly five hundred ergonomics settlement agreements entered into by employers with OSHA between 1985 and today. This type of systematic analysis would allow for the formation of sound scientific conclusions regarding ergonomic injuries. The anecdotal method used by OSHA to date to assess these situations is woefully inadequate to support scientific conclusions and raises the question of whether OSHA is fulfilling is statutory mandate to base the standard on the "best available evidence."

Clearly, a trigger of one WMSD is not a reliable mechanism for identifying a significant hazard. Given the prevalence of soft tissue injuries in the general population, the increasing frequency as people age, and the presumption of work-relatedness that OSHA imposes through the recordkeeping standard (for administrative simplicity), the current proposal is inadequate to define conditions that should be subject to OSHA regulations. The proposed trigger is substantially over-inclusive and will, in many if not most cases, require full implementation of the standard in response to the manifestation of symptoms and transient aches and pains.

OSHA must show that the risk will be reduced. It is not enough to make, again, broad, general statements that OSHA "expects" reductions. Nor is it acceptable to point to anecdotal information suggesting that one company or another, by following a general pattern, has reaped significant benefits. These things need to be quantified, as does the risk, and the reductions in risk need to be similarly quantified so that a rational relationship between the requirements and the benefits of the standard can be examined. As noted above, we are not saying that OSHA has to perform a cost benefit analysis or bases its decision on the result, but that principles of good public policy require that the costs be reasonable relative to the benefits. Because of the impact this standard will have on the economy in terms if its requirements and coverage, we are more concerned in this case that the costs not be excessive, potentially forcing whole industries out of the U.S., or that jobs will be lost completely to automation or extinction. Importantly, when OSHA does point to anecdotal evidence from individual companies, it ignores the differences between the companies in the way that they implement their approach and integrate ergonomic principles into the management of their operations. The control measures which may be required by the draft standard remain undefined and unknown.

OSHA is attempting to avoid its statutory burden of proof in defining the hazard of concern, establishing a significant risk and reduction in risk, or demonstrating feasibility for each affected industrial segment by requiring employees to "minimize or control the [WMSD] hazards to the extent feasible." In other words, the agency begs the question on every issue and simply ignores its obligation to adopt the most cost effective approach which will provide the necessary protection.

Although we believe any standard is premature, California avoids the potential for arbitrary enforcement of this type of vague and unlimited requirement by providing that the measures taken by an employer satisfy the employer's obligations under the standard unless CAL/OSHA demonstrates "that a measure known to but not taken by the employer is substantially certain to cause a greater reduction in such injuries and that this alternative measure would not impose additional unreasonable costs."

What we are talking about is not the voluntary adoption of good practices, but mandatory government requirements that are enforceable by the exercise of the police power of the government. This is a an extremely important matter, and OSHA's views of what is best for workplace safety may not be used to justify its novel re-interpretation of the entire statutory claims for issuing standards.

Conclusion

OSHA has decided there is a workplace injury problem despite the inability of medical science to define it adequately, that it has to do something to address this problem despite the inability of medical science to provide objective criteria much less clear direction on what should be done, and that the something to be done is to issue a standard even though it cannot satisfy the applicable legal criteria. Under these circumstances, it is no surprise that the business community is more than a little apprehensive about OSHA's approach. It is perfectly logical and consistent with good business practice for the members of the business community to advocate and promote the implementation of voluntary ergonomics management programs while opposing a government mandated and enforced program which is vague, intrusive, overly broad in its scope, and virtually unlimited as to what it could require of employers.

An ambiguous and open-ended OSHA ergonomics standard can never be effective or fair. OSHA standards must address hazards that can be described with some particularity, by the nature and magnitude of conditions in workplaces that lead to injury. As described in detail above, OSHA standards should also:

1. Provide new information to assist employers in controlling hazards;
2. Codify a generally recognized set of practices;
3. Clarify the obligations imposed by the General Duty Clause;
4. Create a level playing field; and
5. Create a real safe harbor for employers with adequate, equally effective approaches, placing the burden on OSHA to show why a particular approach is inadequate.

Objective performance standards are necessary to prevent abusive OSHA enforcement practices, which have been documented in the past. Any ergonomics standard should be developed with past experience in mind.

As noted, we appreciate the opportunity to put our concerns before you, and look forward to answering any questions that you might have. Please feel free to contact us at your earliest convenience.

Respectfully submitted,

David G. Sarvadi
Counsel
National Coalition on Ergonomics

Occupational Safety and Health Act of 1970, §6(b)(5).