Regulations (Preambles to Final Rules) - Table of Contents Regulations (Preambles to Final Rules) - Table of Contents
• Record Type: Air Contaminants
• Section: 3
• Title: Section 3 - III. Pertinent Legal Authority

III. Pertinent Legal Authority

The issuance of this final standard is authorized by section 6 of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 655. Section 6(b)(5) governs the issuance of occupational safety and health standards dealing with toxic materials or harmful physical agents.
It states:
The Secretary in promulgating standards dealing with toxic materials or harmful physical agents under this subsection shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired.

Section 3 (8) defines an occupational safety and health standard as "a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment."

The Supreme Court has held under the Act that the Secretary, before issuing any new standard, must determine that it is reasonably necessary and appropriate to remedy a significant risk of material health impairment. Industrial Union Department v. American Petroleum Institute, (IUD v. API). 488 U.S. 607 (1980). The Court stated that "before he can promulgate any permanent health or safety standard, the Secretary is required to make a threshold finding that a place of employment is unsafe in the sense that significant risks are present and can be eliminated or lessened by a change in practices" (448 U.S. at 642). The Court also stated "that the Act does limit the Secretary's power to require the elimination of significant risk" (488 U.S. 644, n. 49).

The Court indicated, however, that the significant risk determination is "not a mathematical straitjacket," and that "OSHA is not required to support its finding that a significant risk exists with anything approaching scientific certainty." The Court ruled that "a reviewing court [is] to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge [and that] . . .the Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking error on the side of over protection rather than under protection" (448 U.S. at 655, 655).

The Court also stated that "while the Agency must support its finding that a certain level of risk exists with substantial evidence, we recognize that its determination that a particular level of risk is 'significant' will be based largely on policy considerations." (488 U.S. at 655, n. 62).

After OSHA determines that a significant risk exists and that such risk can be reduced or eliminated by the proposed standard, it must set a standard which is technologically and economically feasible. In American Textile Manufacturers Institute v. Donovan, 452 U.S. 490, 531, n. 32 (1981) the Supreme Court held that "cost-benefit analysis is not required by statute because feasibility analysis is." The aim is to set the lowest feasible level necessary to eliminate significant risk.

As previously noted OSHA is required under its statutory authority to "set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life" under the provisions of 6(b)(5) of the OSH Act. "Material impairment" is therefore a term which needs to be considered when issuing standards.

In this rulemaking, OSHA is considering establishing new or revised PELs for over 400 separate substances. The health effects for these substances cover a wide spectrum of severity including: life threatening effects; disabling effects; various diseases; irritation to different organs or tissues; and changes in organ functions indicative of future health decrements.

The statutory requirements in Sec. 3(8) and 6(b)(5) are quoted above. Other statutory criteria are set forth in Sec. (2)(b) which states:

The Congress declares it to be its purposes and policy, through the exercise of its powers to regulate commerce among the several States and with foreign nations and to provide for the general welfare, to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources.

One of the earlier Senate drafts of the OSHA bill did not include the word "material" before the word "impairment." That word was added by an amendment of Senator Dominick. The Senator stated in respect to that amendment:

What we were trying to do in the bill - unfortunately, we did not have the proper wording or the proper drafting - was to say that when we are dealing with toxic agents or physical agents, we ought to take such steps as are feasible and practical to provide an atmosphere within which a person's health or safety would not be affected. Unfortunately, we had language providing that anyone would be assured that no one would have a hazard, or at least, we would require the Secretary to set standards so stating, and that in the HEW standard there would be a requirement to proceed on that basis so that no one would have any problem for the rest of his working life. It was an unrealistic standard. As modified, we would be approaching the problem by looking at the problem and setting a standard or criterion which would not result in harm (Legislative History p. 502).

The D.C. Circuit Court considered the concept of material impairment and reviewed the Legislative History in the Lead Case. It stated:

The essential question under Section 6(b)(5) for this case is whether OSHA acted within the limits of this mandate to establish "material" impairment of health when it set a standard designed to protect workers from the subclinical effects of lead. As a statutory matter, after examining precedent and legislative history, we hold that Section 6(b)(5) empowers OSHA to set a PEL that prevents the subclinical effects of lead that lie on a continuum shared with overt lead disease. (United Steelworkers v. Marshall, 647 F. 2d at 1248-49. See also the more extended discussion there).

The legislative history and judicial analysis indicate that OSHA is to take a balanced but protective approach. Some impairments are so slight a discomfort that they are not material and do not provide a basis for regulation. A complaint of minor discomfort, in and of itself, is not material impairment. However, the OSH Act is designed to be protective of workers and is to protect against impairment with less impact than severe impairment. These health effects are related to two different types of exposure: acute and chronic. Because of the difference between the health effects associated with these two types of exposures, OSHA must consider different types of PELs (TWA, STEL, or ceiling) to protect against material impairment. OSHA asked for comment on the subject of "material impairment" (Question 21), especially with regard to whether sensory irritation should be considered to be material impairment. There was a relatively limited amount of comment. The most complete response was provided by NIOSH (Ex. 8-47) which stated:

The recognition of sensory irritation as potentially being "material impairment of health" is consistent with the current scientific consensus related to health effects of environmental agents.

Mucous membrane irritants can cause increased blink frequency and tearing; nasal discharge, congestion, and sneezing; and cough, sputum production, chest discomfort, wheezing, chest tightness, and dyspnea. Work environments often require levels of physical and mental performance considerably greater than encountered in daily living. Even in the absence of any permanent impairment, the symptoms listed can interfere with job performance and safety.

Mucous membrane irritation can result in inflammation, which may lead to increased susceptibility to nonspecific irritants and infectious agents. For example, experimental ozone exposure in humans results in increased airway reactivity. Also, studies of exposure to environmental tobacco smoke have shown irritative symptoms and evidence of increased frequency of respiratory tract illnesses in young children and decreased pulmonary function in adults. . .

Mucous membrane irritation is associated with respiratory illnesses, depending on the composition of specific exposure and on the dose, duration, and frequency of exposure. No universally applicable conclusion can be drawn at this time regarding the association between irritative symptoms and permanent injury or dysfunction. Where certain individuals show no measurable impairment after an exposure, even when experiencing irritative symptoms, others may develop identifiable dysfunction.

Aside from the effects of irritations, mucous membrane exposure may result in absorption of a substance, with resultant systemic toxicity. An inflamed mucous membrane may be an even more effective route of absorption, either for the irritant or for other substances. Furthermore, injury to bronchopulmonary membranes can impair removal of particulates from the respiratory system.

Thus, according to NIOSH, sensory irritants interfere with job performance and safety, cause inflammation, may increase the victim's susceptibility to other irritants and infectious agents, lead to permanent injury or dysfunction, or permit greater absorption of hazardous substances (Ex. 8-47). In sum, NIOSH and most other respondents agree that sensory irritation caused by occupational exposure to the irritant substances included in this final rule constitutes a material impairment of health (see Section VI.C.3).

Of course, irritation also covers a spectrum of effects, some serious and some trivial. Hence, complaints of minor irritation would not in and of itself constitute material impairment. In addition, OSHA would weight irritation with physical manifestations more heavily than irritation with purely subjective responses. This does not mean that purely subjective responses would not constitute material impairment. That judgment would depend on the magnitude of the irritation.

OSHA also believes that clinical, tissue or organ changes, or properly documented pain, chest tightness, migraine headache or similar reactions reflected in responses by persons, may also represent material impairment of health. Each of these are considered on a case-by-case basis in this Rulemaking. OSHA believes that its approach is consistent with the Act and Congressional intent regarding material impairment of health.

All of the revised or new PELs in this rulemaking involve material impairment interpretation of health. In a few instances, PELs noted in the Proposal have been modified, or deleted, because it was determined that the proposed level was not needed to reduce a significant risk of material impairment of health. These substances are identified in the Preamble.

OSHA's analyses regarding material impairment of health, as applied in this Rulemaking, are provided in three separate ways. First, they are included in the introductory discussion for Sections VI-C-1 through VI-C-18 in the Preamble. Second, the discussion of each of the 428 substances contains health effect information for all new or revised PELs. Third, this following discussion provides examples and general guidance regarding the OSHA decision process, and accounts for the severity spectrum of health effects, and the separate cases involving chronic and acute exposures.

As previously indicated, health effects cover a wide range of severity levels. A precise delineation between material impairment and non-material impairment is not possible since a variety of factors must be considered, such as the composite health effect and frequency and duration of the effect, to determine if a substance represents a material impairment of health. For example, nerve damage would normally constitute material impairment of health. However, a small reduction in nerve conductivity may not constitute material impairment. Moreover, an occupational, transitory, non-progressive and/or non-intensive coughing reaction may represent non-material impairment. Major intensification of some of these factors could result in a health effect which represents material impairment of health.

Consequently, general considerations can be stated but they must be applied on a case-by-case basis taking into account the scientific evidence, public comments and agency expertise.

OSHA has concluded that updating the Z-Tables to reflect recent information is the highest priority for the Agency. This will reduce exposure limits for approximately 212 substances regulated currently by the Z-Tables and add exposure limits for approximately 164 substances which are currently unregulated. The health literature indicates this must be accomplished to improve worker health; it is one of Congress's concurrent goals and will greatly increase occupational health protection for a very large number of workers.

In order to accomplish this high priority task in a reasonable time in the light of limited administrative resources, it is necessary to narrow somewhat the issues to be faced by the Agency in this proceeding. Consequently, it is necessary to delay other worthwhile goals and concurrent Congressional purposes.

This approach is consistent with the general principles of administrative law. An Agency may set priorities within the framework of its statutory authority. Secondly, an Agency may take substantial steps towards its statutory goals, without having to achieve them completely, when Agency resources are not sufficient to complete all aspects initially.

Congress recognized that the Secretary could not address all occupational safety and health problems simultaneously. It therefore gave the Secretary discretion to set priorities in exercising his rulemaking authority. As Section 6 (g) of the Act, 29 U.S.C. 655 (g), states:

In determining the priority for establishing standards under this section, the Secretary shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments.

In proposing this addition to the Act, Senator Javits explained that its purpose was "to relieve the Secretary of the necessity for waiting to promulgate whatever standards he wishes to promulgate across the board but, rather, allowing him to yield to more urgent demands before he tries to meet others." Leg. Hist 505. Thus, the Act has "built in flexibilities" that the Secretary may use, such as establishing "the priorities between the various occupations that may require standards." National Congress of Hispanic American Citizens v. Usery, 554 F. 2d 1196, 1199 (D.C. Cir. 1977); see also National Congress v. Marshall, 626 F. 2d 882 (D.C. Cir 1979). The flexibility expressed in the statute and legislative history is consistent with the well-established principle that an administrator may adopt a "rational, 'one step at a time' approach" to rulemaking. National Roofing Contractors Ass'n v. Brennan, 495 F. 2d 1294, 1299 (7th Cir.), cert. denied, 419 U.S. 1105 (1974)(OSHA roofing standard); cf., Industrial Union Dept. v. American Petroleum Institute, 488 U.S. 607, 663, (1980) (Burger, concurring) (OSHA can act in its legislative capacity "to focus on only one aspect of a larger problem"); United Steelworkers v. Auchter, 763 F. 2d 728, 738 (3rd Cir. 1985) (Although OSHA's decision to exclude workers in some industries from a standard requires explanation, "[s]ection 6(g) clearly permits the Secretary to set priorities for the use of the agency's resources and to promulgate standards sequentially."); IUD v. Hodgson, 499 F. 2d 467, 480 n. 31 (D.C. Cir 1974) ("The [OSHA] statutory scheme is generally calculated to give the Secretary broad responsibility for determining when standards are required and what those standards should be.").

OSHA has concluded that setting exposure limits for the large number of substances involved in this rulemaking has priority at this stage over exploring the need for accompanying medical surveillance, exposure monitoring and industrial hygiene provisions for a much smaller number of substances. Section 6(b)(7) of the Act, of course, indicates that "where appropriate" such provisions are to be included. That was a concurrent goal of Congress as was Congress's goal to lower exposure for the many unregulated or inadequately regulated substances when scientific data indicate lower exposures are needed. However, OSHA has inadequate resources to accomplish both goals at this time. Lowering exposures is a higher priority because it is more effective in reducing diseases and material impairments of health.

OSHA has already addressed some of Sect. 6(b)(7)'s goals, as they relate to labels and warnings, in the generic Hazard Communication Standard, 29 CFR 1910.1200. It is working on a standard to improve respirator use for all chemicals (47 FR 20803). It is considering generic regulation for exposure monitoring (53 FR 32591-32595) and medical surveillance (53 FR 32595-32598). OSHA does not have the resources to conclude this rulemaking in any reasonable time, and also consider these issues.

OSHA does have legal authority not to address ancillary provisions in this rulemaking and determinations about the appropriateness of ancillary provisions have not been made. That is a rational use of its priority setting authority in the light of OSHA's limited resources. The language of Sec. 6(b)(7) is not an absolute requirement to include such provisions and this is an "appropriate" circumstance not to include them. The actions already initiated by OSHA indicate it is facing the issue of ancillary provisions in a responsible and reasonable manner.

OSHA is utilizing its priority setting authority for several other matters. There are several substances (both carcinogens and non carcinogens) where more detailed analysis of the evidence might in the future lead to the conclusion that there is remaining significant risk. If that were the case in a single substance rulemaking, OSHA would explore that issue in great depth and do much more extended economic analysis of several different exposure levels to determine what the lowest feasible level might be.

Past experience has shown this to be a major undertaking both from a health and economic point of view. OSHA, for example, spends an average of $500,000 and takes one year of study to determine the lowest feasible level for a single substance. OSHA does not have the resources to engage in that kind of analysis for more than a few substances. The attempt to do so in this rulemaking would significantly reduce the chances of it ever being completed and would result in far more workers being exposed to significant risk in exchange for the incremental risk reduction attained by further lowering the PEL for a small group of substances in this Rulemaking.

When evidence has been available to determine that the proposed level resulted in remaining significant risk and a lower level was feasible, OSHA has issued that lower level. Three chemicals fit that category in this rulemaking. Two are based on OSHA's analysis of evidence presented by NIOSH and a third, perchloroethylene, is based on OSHA's analysis of evidence supplied by the Amalgamated Clothing and Textile Workers Union and the dry cleaning industry.

OSHA has indicated that further, more extensive analysis may lead to the conclusion that significant risk remains for other substances. However, the extensive investment of resources needed to arrive at such conclusions would be determined by the Agency's future priorities.

OSHA's first priority is to achieve substantial reductions in significant risk for this large number of substances. The accomplishment of this goal will create the greatest health benefits for the American worker. OSHA's decisions in this Rulemaking are consistent with the evidence on risk and feasibility which is available at this time. Further consideration of these issues for specific substances can be achieved in future rulemakings as new evidence becomes available and as priorities indicate.

OSHA concludes this is both rational priority setting and a reasonable integration of its priority setting authority and relevant case law. Clearly multi-issue and multi-substance rulemaking require a different balancing than single substance or single issue rulemaking.

OSHA has met legal requirements also in the regulation of carcinogens in the light of priorities and Agency resources. Potential carcinogens tend to require far more administrative resources per substance to regulate, in part because their regulation tends to create more controversy. There are a number of expert organizations which analyze and develop lists of suspect or probable carcinogens. These organizations include ACGIH, NIOSH, the National Toxicological Program (NTP) and the International Agency for Research on Cancer (IARC). These organizations utilize somewhat different criteria and categories for their lists.

The ACGIH TLVs include some substances which it categorizes as carcinogens, but does not set the exposure limit based on carcinogenicity. It includes other substances which it may or may not categorize as carcinogens but for which the exposure limit is set taking into account carcinogenicity. It is only this last category which OSHA considered as carcinogens in its proposal. (This is a separate issue from what exposure limit to set). If NIOSH recommended a different limit for a chemical in this grouping, OSHA considered which of the recommended limits was best supported. OSHA concludes this was a rational use of its priority setting authority. A categorization of carcinogenicity along with a proposed exposure limit is much more useful to OSHA as a starting point for its analysis than a categorization without a recommended numerical limit. IARC never recommends numerical limits and in some instances neither has NIOSH. Attempts to analyze for carcinogenicity a substantially larger number of substances would again require far more scientific and administrative resources than OSHA has available and would probably prevent the prompt completion of this rulemaking. In addition OSHA has spent much of its past efforts in regulating carcinogens. It concludes that it is important to concentrate some of its efforts through this project on noncarcinogenic health hazards. Substances which cause liver/kidney or cardiovascular disease can be just as deadly as carcinogens and can cause higher risks.

Accordingly, OSHA concludes it is a rational use of its priority authority not to consider for regulation as a carcinogen every substance included, for which there is some evidence or recommendation that it may be carcinogenic. Such substances often require exposure limits to protect against other health hazards they cause, which results in OSHA setting limits in this rulemaking based on non-carcinogenic effects. In these circumstance 29 CFR 1990 need not apply when there is no determination to consider regulating a substance as a carcinogen.

There are several substances which OSHA proposed regulating as carcinogens, for which participants submitted evidence to the contrary. In some of those cases OSHA has concluded that it is inappropriate to regulate a substance as a carcinogen at this time because further analysis is necessary. In several cases participants submitted evidence that substances included in the proposal which OSHA did not propose to regulate as carcinogens should be regulated as carcinogens. When OSHA concluded there was sufficient evidence and analysis to meet legal requirements, OSHA has in this final rule regulated the substance as a carcinogen. However, as just stated, OSHA has not itself attempted to analyze further for carcinogenicity substances which it did not propose regulating as carcinogens, unless participants supplied relevant evidence.

For the substances OSHA is regulating as carcinogens, it has met all requirements of IUD v. API and has acted consistently with 29 CFR 1990. Specifically, OSHA reviewed all data to determine whether there were studies of sufficient merit to determine that the substance was qualitatively a carcinogen.

Secondly, OSHA contracted with Dr. Nathan J. Karch, President of Karch & Associates, Inc., consultant experts in risk assessment, to analyze the available studies of potential carcinogens for two purposes (Ex. 85): first to determine whether there was sufficient evidence to perform a quantitative risk assessment or to state the reasons why there was not; second, to perform a quantitative risk assessment where the studies permitted, using techniques generally accepted by the scientific community. The risk assessments were presented in the proposal preamble (53 FR 21109 - 209) and elaborated upon in Dr. Karch's statement. Dr. Karch responded to questions on the risk assessments. (OSHA did not ask Dr. Karch to independently review the strength of the qualitative data since OSHA had preliminarily made that review.) Utilizing these data, public comments and OSHA analysis of the data, OSHA has issued exposure limits which will substantially reduce significant risk and are feasible. Where a public participant has supplied evidence that a lower level than that proposed would further reduce significant risk and was feasible, OSHA has promulgated that lower level.

For carcinogens, as well as for other substances, OSHA's decisions in this Rulemaking are based on the entire evidence in the public record, and that the final PEL substantially reduces significant risk and is feasible. OSHA may reconsider the issues for individual substances as further information becomes available.

For the reasons stated above and in line with its priority setting authority, OSHA concludes it has authority, in the circumstances of a rulemaking which considered changes to PELs for 428 substances not to perform more detailed analyses for substances being regulated at this time. The regulation of these substances and of other substances as carcinogens, may be considered in future 6(b) rulemakings where priorities indicate the issue is important and when administrative and scientific resources become available. OSHA concludes this is consistent with its legal authority and reasonable health policy.

A few of the substances which OSHA is regulating principally for non-carcinogenic effects, but for which there is some evidence of carcinogenicity, fit into an additional category. In these cases here was uncertainty concerning which of two levels would eliminate significant risk of the non-carcinogenic effect. In those cases OSHA used the evidence of carcinogenicity as an additional factor in determining whether the lower level was appropriate.

Most of the chemicals OSHA is regulating are not carcinogens. There are effects which occur immediately, or a relatively short time after exposure. Sometimes the effects are reversible after removal from exposure and treatment, and sometimes the effects are not.

Many of these substances are believed to have effective thresholds, that is there is a level of exposure above which some number of persons will suffer the effect. There is a level somewhat below that, where it appears that few persons would suffer the effect, and there is a lower level where scientists are more confident of that conclusion. At levels below a properly well defined threshold the risk would not be significant. However, there may be a smaller group of employees who might be susceptible at very low levels.

The studies which tend to be performed, examine relatively small groups of animals or persons exposed at one or several levels. A determination is made at which of these levels effects are seen and at which they are not.

The Supreme Court in IUD v. API was faced with the situation, as is often the case with carcinogens, that high risk is known at relatively high levels of exposure. But scientists do not have direct measurements of what the risk may be at lower levels. Indeed for statistical and methodological reasons they may never be in position to directly measure risk at lower levels or indeed to determine if it is ever eliminated. Consequently, modeling techniques must be used to estimate risk at various levels so as to determine the significance of risk at various levels.

In the case of this rulemaking the type of evidence available makes such modeling techniques generally unnecessary for significant risk determinations. The studies provide direct evidence of whether or not there is an effect and the probability of that effect occurring at the levels to which the Agency is regulating. Consequently, a judgment can be made whether the effect is a significant risk directly from the studies. Similarly, a judgment can be made directly from the studies whether that significant risk is reduced or eliminated.

An example may illustrate this method of analysis. The current OSHA exposure limit for hydrogen sulfide (H2S) is a 20 ppm STEL and a 50 ppm peak. There are studies showing that at 20 ppm and perhaps below workers develop conjunctivitis, eye irritation and other ocular effects. Those effects present a significant risk of material impairment because they would prevent work, require medical treatment, and would make it difficult to work safely with the condition. Another study shows that the deleterious health effects do not develop in workers exposed continually at 10 ppm. Consequently OSHA is issuing a final standard of a 10 ppm TWA with a 20 ppm ceiling which should eliminate that significant risk. Direct evidence of significant risk and its probable elimination exist and there would be no point in applying mathematical modeling to the data for purposes of making a significant risk determination.

Often the data are not as clear cut. There may be only an effect study. There may be uncertainty about exposures levels or conflicting results. There may be a no effect study with exposure data and an effect study without exposure data. Studies are often of small size with fairly wide ranges of uncertainty. Consequently, they do not take into account variability of response among humans. Of course, many studies are based on animal data and adjustments must be made to take into account the differences between human and animal susceptibility.

However, judgments as to levels which create, reduce or eliminate significant risk still have the greatest scientific validity in most cases when based directly on specific studies. The uncertainties which exist are likely to be magnified, rather than reduced, when combined with the uncertainties of modeling techniques.

Accordingly OSHA concludes that the type of significant risk analysis undertaken in this rulemaking is most consistent with the studies generally available and is a valid scientific approach. OSHA concludes it is fully consistent with the requirements of the Supreme Court in IUD v. API.

OSHA has made quantitative estimates of the benefits of this entire standard. These are discussed in Section VII D and are substantial. That analysis demonstrates that on a general basis there is a significant risk of occupationally related illness and death and that this new standard substantially reduces that risk.

Some of the exposure levels incorporate an uncertainty factor. This is sometimes referred to as a "safety factor." Studies are often of small size and, since there is a large variation in human susceptibility, a study because of its small size may not demonstrate an effect that actually exists. (In scientific terminology it lacks statistical power.) For this reason, it is not uncommon to set a limit below that level which the study may have indicated no effect.

This has been the standard approach for recommending exposure limits for non-carcinogens by scientists and health experts in the field for many years. (See testimony of Mastromatteo (Ex. 22) and Key (Ex. 17)). Generally, a greater safety or uncertainty factor is used for more severe health effects.

This use of uncertainty or safety factors in a reasonable manner generally does not lead to reducing exposures below the level of significance. Rather, it takes into account the likelihood that effects may exist at levels below the level of the study.

Of course, use of uncertainty factors or safety factors is even more clearly justified when the studies available determine only a level at which there is a significant risk of a health effect exists rather than the level at which there clearly is no significant risk, or when animal studies are used. Clearly, to substantially reduce significant risk, an exposure level must be set below the level where significant risk exists in humans. Similarly, to take into account the possibility of interspecies variability, a level set for humans usually is set below the observed no effect level in an animal. See the extended discussion in the Health Effects Section, specifically Section VI A.

Section 6(b)(5) of the OSH Act states that standards shall be based on many factors including "the best available evidence," the "latest available scientific data in the field," and "experience gained under this and other health and safety laws." OSHA concludes that its approach meets these provisions.

OSHA utilized the research and recommendations of two expert organizations, NIOSH and ACGIH, as the starting point for its analysis. Those organizations regularly review the literature and update their recommendations. (See testimony of Mastromatteo (Ex. 22) and NIOSH (Ex. 8-47)). When participants brought to OSHA's attention other studies, made other recommendations for exposure limits or the proposal was controversial, OSHA fully reviewed the available scientific information. (The final preamble does not always discuss studies which OSHA did not believe were important or relevant to the determination of an exposure limit.) Where there was little or no comment on particular parts of the OSHA proposal, and the evidence OSHA relied on appeared substantial, OSHA did not attempt additional searches of the literature.

OSHA concludes that this is a rational approach to make use of the best available and latest scientific information for making final decisions on exposure limits. An approach attempting to analyze and discuss every single study for substances where the proposed exposure limit is not seriously disputed would not add to the quality of OSHA's final decisions and would interfere with the statutory goal to protect employees from material health impairments. As discussed elsewhere OSHA also relied upon its experience in making final decisions as is encouraged by Sect. 6(b)(5).

It has been suggested to OSHA that two of its selected categories do not constitute material impairment of health. The first category includes particulates which cause physical irritation and other effects. In the Proposal, OSHA followed for clarity purposes the historical terminology of "nuisance" dust which is misleading. The term "nuisance" is used by ACGIH to cover dusts that, although they do not cause pneumoconiosis or permanent scarring of the lungs, can cause many material health impairments such as chronic bronchitis, chronic throat irritation, skin irritation or eye inflammation. Consequently there is a health need for an exposure limit for all particulates. See the discussion under particulates (Section VI, Health Effects).

Secondly, three chemicals are listed as odorants by ACGIH and also have other effects. In these cases OSHA has not changed the existing PEL. These levels were identified in the Proposal and there was not significant comment that the limits should be raised. No new chemicals are regulated as odorants. Accordingly, OSHA has not had to visit the issue of when an odorant has become so severe as to constitute a material impairment of health.

OSHA feasibility determinations are based on both the statute and on a consistent and extensive body of case law extending over its entire history. In addition to ATMI (supra) see for example: AFL-CIO v. Hodgson, 499 F. 2d 467 (D.C. Cir., 1974); Society of Plastics Industries v. OSHA (SOCMA), 509 F. 2d 1301 (2d Cir., 1975); American Iron and Steel Inst. v. OSHA (AISI), 577 F. 2d 825 (3rd. Cir., 1977); United Steelworkers v. Marshall, 647 F. 2d 1189 (D.C. Cir., 1980); ASARCO v. OSHA, 746 F. 2d 483 (9th Cir., 1984) and others.

Standards may be expensive and still be feasible if necessary to protect occupational health.

"Standards may be economically feasible, though from the standpoint of employers, they are financially burdensome and affect profit margins adversely. Nor does the concept of economic feasibility necessarily guarantee the continued existence of individual employers. It would appear to be consistent with the purpose of the Act to envision the economic demise of an employer who has lagged behind the rest of industry in protecting the health and safety of employees..." (Hodgson; 499 F. 2d at p. 478)

An OSHA standard may be technology forcing. OSHA may demonstrate feasibility by showing that only a few plants are now in compliance. Moreover, a standard is still feasible even though some respirator use is needed to achieve compliance.

"[T]he Secretary is not restricted by the status quo. He may set standards which require improvements in existing technologies or the development of new technology...." (SOCMA, 509 F. 2d at p. 1309).

"The experience at (2) batteries provides a sufficient basis for the Secretary's reasoned belief that the 0.15 mg/m(3) limit could be met (for the entire industry)" (AISI, 577 F. 2d at p. 834; See also SOCMA, p. 1309).

"The limited respirator use that the standard requires does not in any way render the standard infeasible..." (ASARCO, 746 F. 2d at p. 483. See also ATMI generally and SOCMA 509 F. 2d at p. 1310, etc.)

OSHA must show a general presumption of feasibility in most operations in an industry with engineering controls to place the burden of proof in enforcement action on the industry to show that compliance with engineering controls cannot be attained in a particular circumstance. But a showing by a particular industry that compliance requires respirators in certain operations or an admission by OSHA that that is the case does not make a standard infeasible. Rather it "will reduce the strength of the presumption a firm will have to overcome in justifying its use of respirators" in an enforcement or variance action. United Steelworkers, pp. 1272-73. See also Building and Construction Trades (Supra).

In addition, a gloss of experience has been added to this general legal guidance. In the two standards where OSHA thought at the time that it was regulating to the limits of its legal authority on feasibility, subsequent studies indicated the standard was achieved more easily than OSHA predicted.

OSHA predicted the cotton dust standard would cost $500 million in 1977 dollars whereas industry predicted twice the cost and anticipated substantial technical problems. As a matter of fact, a later detailed study indicated that the standard cost only $250 million in 1983 dollars, improved industry competitiveness and productivity as well, and improved health more than predicted. See 50 FR 51121, 51164-67 (Dec. 13, 1985).

OSHA's contractor predicted that the OSHA vinyl chloride standard could not generally be achieved with engineering controls and the attempt would cost $1.5 billion. As a matter of fact, compliance was achieved with engineering controls within three years at a cost of less than 10 percent of that predicted. See 49 FR 5001, 5253 (Jan. 22, 1980).

In this rulemaking, OSHA concludes that it has demonstrated feasibility without taking that concept to the full limits of its legal authority. Many of the substances regulated constitute acute hazards with apparent thresholds; the limit set to protect health does not approach the limits that could feasibly be achieved.

There are some substances covered by this regulation for which further analysis might indicate a lower limit is needed, possibly the lowest feasible limit. However, the limit set is clearly within the limits of feasibility.

In the case of a few substances, industry has argued that the limit proposed was not technically and/or economically "feasible." In some circumstances where OSHA believed it did not have enough evidence of feasibility in the record to support the level proposed, it has raised the limit to that level which the evidence available demonstrated is clearly feasible. In other circumstances where industry contended that engineering controls could not achieve the proposed level in a specific operation, and there was not sufficient evidence in the record indicating that it could be achieved with engineering and work practice controls, the preamble indicates that respirator use may be appropriate. In any event, the burden of proof would be on OSHA in an enforcement action to demonstrate the level in that operation could be achieved with engineering and work practice controls. Since OSHA's feasibility analysis was based on what industry is already achieving or what could be achieved with standard "off-the-shelf" technology, there are few if any cases where OSHA is attempting to force technology.

Several participants specifically argued that the proposed level was infeasible for a specific substance because in a specific operation it could not be achieved with engineering controls. As the case law clearly indicates, that does not make a standard infeasible. OSHA has in several cases concluded it did not have enough evidence to demonstrate that a level could be achieved with engineering controls in a specific operation. The case law clearly indicates that this does not make a standard infeasible. (See for example, ASARCO and United Steelworkers, supra). The industry does not have the burden of proving the technical infeasibility of engineering controls in an enforcement case involving these operations which are specifically identified in Section VII. The burden of proof would be on OSHA to prove that the level could be attained with engineering and work practice controls in an enforcement action if OSHA believed that was the case.

A few participants argued that, because engineering controls might not be appropriate in certain maintenance operations or in occasional or intermittent operations, the level set was therefore infeasible. First, these conditions relate to individual operations and do not indicate general difficulties of compliance with engineering controls. Secondly, as OSHA has stated, for some maintenance and intermittent operations, respirators may be the appropriate control methodology. See 52 FR 34549 for example.

Finally, 29 CFR 1910.1000(e) requires the use of engineering controls when feasible. If they are not feasible, the employer may use respirators. Consequently, this standard does not become infeasible simply because engineering controls may not achieve the PEL in a specific operation.

OSHA has a variety of data on technical feasibility. These include exposure data indicating that required levels are already being achieved by some employers in a sector. It also includes judgment by experts that standard controls have achieved or can achieve the required level in that or in analogous operations. Finally, the docket includes a significant amount of information on available existing control technology for each substance. (See for example, Ex. 6 and NIOSH Health Hazard Evaluation (HHE) reports). OSHA concludes that it has met its burden to demonstrate the technical feasibility for the substances it is setting new or more protective levels for. This is analyzed in Section VII.

OSHA also concludes, as discussed in the Economic Feasibility section, that the standard is economically feasible. Indeed, the costs do not approach the levels that would be the legal limits of economic feasibility in terms of affecting the economics of industry, either generally or by industry sector. The estimated annual cost is approximately $800 million. However, approximately, 5. million employees receive improved health protection making the cost per employee receiving additional protection approximately $150 each. The total cost is approximately $2 million per substance being regulated. See the detailed feasibility discussion in Section VII.

Secondly, the cost per industry sector is never more than a small fraction of one percent of sales and with two limited exceptions not more than 2 percent of net profits, assuming no costs would be shifted to consumers. As the courts have recognized, it is likely that some costs will be shifted to consumers. National Cottonseed Products Asso. v. Brock, 825 F. 2d 482, 488 (D.C. Cir. 1987). In the few subsectors where costs reflect a slightly larger percent of profit, OSHA explains in the specific analysis of Section VII why the proposed standard is feasible and will not create disruption to an industry or to competition, although it may have some temporary effects requiring some adjustment.

OSHA's cost and economic feasibility conclusions have a high degree of validity on a sector by sector basis. OSHA has provided much data at the subsector (4 digit SIC) level and has supplied more when requested by participants. That subsector data has probative merit, but there would not be quite as high a degree of confidence in the exact cost totals estimated. There was some questioning of OSHA and its economic panel on this matter. OSHA and the economics panel pointed out that OSHA's survey was designed to have a high degree of statistical certainty at the sector level, and provided useful evidence but not to the same high degree of statistical confidence at a subsector level.

OSHA's responsibility is to demonstrate economic feasibility for an industry. OSHA's feasibility analysis clearly shows feasibility for every sector. The costs are sufficiently low per sector to demonstrate feasibility not only for each sector but also for each subsector. Higher subsector costs would be reflected in higher sector costs. This is confirmed by the subsector data which OSHA initially provided or provided upon request. This also indicates costs are low in relation to sales and profits for subsectors. OSHA is not required to demonstrate feasibility for every plant in a subsector.

At the enforcement level, an employer's demonstration of economic infeasibility for a particular plant may lead to an extended period of time in which to come into compliance with engineering controls allowing the use of respirators during the extended interim period. The fact that this particular standard gives all employers a long period of time in which to comply will reduce feasibility problems for the few employers with possible economic difficulties.

As discussed in the approach and chronology sections, OSHA believes it has provided the public an extensive opportunity to comment and participate in this rulemaking and has complied fully with required administrative procedures. Nine months advance notice of the proposal was given. The proposal contained OSHA health reasoning for each substance proposed for revision or addition of a PEL and cited the studies OSHA relied upon. It discussed OSHA's feasibility reasoning for each sector. Underlying health studies were made available in the docket and are generally available in major libraries and/or computer data bases. The feasibility studies were also available in the docket.

The public was given more than the legal minimum time to comment. The time from proposal to final post-hearing briefs was 5 months. An oral hearing was held in which extensive presentations were made by participants and questioning was permitted of OSHA, its economic panel and witnesses, NIOSH and other participants. OSHA concludes that all of its decisions are based on substantial evidence in the docket which is analyzed in this final preamble.

Several procedural objections were made during the course of the proceeding. The first was that OSHA did not permit sufficient time for comments. OSHA believes the public has been given not only more than the legal minimum period in which to comment but has been given a fair amount of time to comment on the proposal.

The rulemaking permitted 47 days after proposal for prehearing comments, oral testimony up to 79 days after proposal, post hearing evidence up to 4 months after proposal and post hearing briefs up to almost 5 months after proposal. The OSH Act only requires 30 days for comment. See Sect. 6(b)(2). Three Courts of Appeals have held comment periods of 30-45 days legally sufficient: Phillips Petroleum v. U.S. EPA 802 F. 2d 549, 558-559 (10th Cir., 1986); North American Van Lines v. I.C.C., 660 F. 2d 1087, 1092 (7th Cir., 1981) and Conn. Light v. N.P.C. 672 F/2d 529, 534 D.C. Cir., 1982.

The prehearing comment period alone met these requirements. In reality, and as OSHA agreed (Ex. 14 B p. 7), evidence not available by prescribed dates could be submitted as late as Oct. 7, 1988, the post hearing evidence deadline, which was four months after proposal. Final views did not have to be submitted until five months after the proposal. This far more than meets the legal minimums.

All data OSHA relied upon were cited in the preamble and available in the docket. The data were also usually available in libraries and on computer data bases as well. Few participants were interested in more than a few chemicals and none indicated an interest in more than 20. There was time to analyze the studies and submit comments in the time periods specified. Indeed, the trade associations and individual participants who objected the most about the time for comments were interested in only one chemical (carbon disulfide, sulfur dioxide, grain dust and styrene). These trade associations had been in existence for more than a decade and had immediate access to available studies, analyses and position papers to support their views. The unions divided up the 20 or so chemicals they expressed an interest in among the various unions and ultimately did not object to the final post hearing submission dates. Interested participants submitted extensive studies, comments and testimony averaging 3000 pages per controversial chemical. The reality was that all views were effectively presented.

The second procedural issue involves post hearing comments. The OSHA procedural rules initially grant the presiding officer authority to set the date for post hearing comments. (29 CFR 1911.16 (g)). The presiding officer set Nov. 14, 1988, for post-hearing submissions and Dec. 13, 1988, for post-hearing briefs (Ex. 81).

For the reasons just stated, OSHA concluded that these time periods were far more than required by legal minimums or for considerations of fairness. As stated in the approach section, such an extended time frame for post-hearing submissions would greatly delay the completion of this action. This would also interfere with OSHA's priority to complete in a timely fashion this project which is of such significant benefit in protecting the health of employees.

The Chief Administrative Law Judge held that he did not have jurisdiction to change the dates set by the presiding officer. (Ex. 81 B.) Accordingly, the Secretary of Labor and OSHA exercised their authority to set priorities for OSHA and by Federal Register Notice of Sept. 7, 1988, (53 FR 34708) set Oct. 7, 1988, for post hearing evidence and Oct. 31, 1988, for post hearing briefs.

The OSHA rule at 29 CFR 1911.4, gives authority to prescribe alternative requirements (such as the October date set) in order to expedite the conduct of the proceeding upon reasonable notice. Reasonable notice was given of the changed dates. There was a period of 30 days from the Federal Register notice to the date that post hearing evidence was due and OSHA gave notice prior to the Federal Register notice orally and by letter that it desired to have shorter dates for post hearing submissions than initially set. Clearly, the purpose of the new date was to expedite the rulemaking process. Accordingly, all procedural requirements have been met. See also OSHA's discussions in Exs. 60 and 81 A on these two issues and at 53 FR 34708.

Third, for several substances covered by this proceeding, OSHA had proposed new standards in the middle 1970's, held hearings and closed the record. However, no new standard was ever issued, nor was a statement made of why a new standard was not issued.

There were comments on two of those substances in this rulemaking, sulfur dioxide and beryllium. In light of this circumstance and at the request of participants, OSHA submitted the complete earlier record of those proceedings into the record of this rulemaking.

For sulfur dioxide OSHA is issuing a new limit. OSHA has reviewed both the old record and new submissions, and has concluded that the new level is needed to reduce significant risk and is feasible. The discussion in this final preamble meets the procedural requirements of Section 6 (b)(4) for both the prior and current rulemaking.

For beryllium, OSHA is retaining the existing limit. That limit is already very low. Extensive additional evaluation would be needed to determine if that limit should be changed. Accordingly, OSHA has concluded it is not of sufficient priority to determine if the limit should be changed at this time.

Several participants stated that ACGIH was not a national consensus organization and should not be used as a starting point for OSHA's evaluation. ACGIH is not a national consensus organization as defined by the OSH Act. However, that is not relevant to this rulemaking. Section 6(a) of the Act permitted OSHA to issue as OSHA standards, without rulemaking, national consensus standards. However, that authority expired in May of 1973. This standard is not issued under Section 6(a) but under the authority of Section 6(b) of the OSH Act. OSHA intends this to be a Section 6(b) standard and is following all of the procedures and meeting all of the requirements of Section 6(b).

This is a 1900-page typed document covering 600 substances. As a result of the editing process, sometimes slightly different conclusory language is used when an identical conclusion is intended. OSHA wishes to make it clear that wherever a new or more protective exposure limit has been issued, OSHA has concluded based on evidence in the record, and its experience, that such limit is needed to substantially reduce a significant risk of material impairment of health or functional capacity. OSHA has also concluded that such limit is technically and economically feasible.

[54 FR 2332, Jan. 19, 1989; 54 FR 14909, April 13, 1989; 54 FR 28154, July 5, 1989]



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