Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Methylene Chloride|
| Title:||Section 10 - X. Summary and Explanation of the Final Standard|
X. Summary and Explanation of the Final Standard
The final standard for occupational exposure to methylene chloride (MC) is different in several important respects from the proposed MC standard published in the Federal Register in 1991 (56 FR 57036). For example, the standard has been written in plain language, is more performance-oriented than the proposal, and substantially reduces the amount of paperwork employers will have to complete. Employers will thus find compliance with the standard easier, their paperwork less extensive, and their obligations clearer and less burdensome. These changes are discussed in greater detail in the appropriate sections of this Summary and Explanation. OSHA seeks input from users of the standard on whether these changes are helpful and what other changes could be made to future standards to increase their user-friendliness. OSHA will also be conducting a number of compliance assistance and outreach projects in connection with this standard to assist employers and employees to comply.
As part of the Agency's new approach to standards writing, OSHA has included an introductory paragraph in the standard to provide readers with information on MC, its health effects and principal uses, and the reasons OSHA is regulating this toxic substance. This introductory language is non-mandatory and is intended only to provide information and enhance compliance.
This final rule is an occupational health standard that establishes requirements to control employee exposure to MC, a chemical compound found in many different types of industries. OSHA has determined that this standard is necessary because exposure to MC places employees at significant risk of developing exposure-related adverse health effects. These effects include cancer, effects on the heart and central nervous system, and skin and eye irritation. Employee exposure to MC can occur through inhalation or through skin absorption or contact with the skin. This substance is frequently used as a solvent in many different kinds of jobs, including furniture stripping, foam blowing, film manufacturing and metal degreasing.
Although the final rule covers many different types of workplaces where MC is used, the extent of coverage depends on the magnitude of employee exposure. Although all covered employers, i.e., those with MC in the workplace, must determine initially the extent to which their employees are exposed to MC, those with exposures at or below the action level will only have to document the results of this initial determination, provide employee information and training, and provide means of protecting employees from contact with liquid MC. The standard's other requirements, such as those for engineering controls, medical surveillance, etc. apply only to workplaces where employee exposures to MC exceed the action level.
Paragraph (a) Scope and application
This standard applies to all occupational exposures in workplaces covered by OSHA in general industry, construction and shipyards where MC is produced, released, stored, handled, or used.
As discussed in the Health Effects and Significance of Risk sections of this preamble, OSHA has determined that exposure to MC at the former PEL creates a significant risk that employees' health will be materially impaired. Possible adverse health effects include cancer, cardiac effects, central nervous system effects, and skin or eye irritation. Exposures to MC are found in various general industry, construction, and shipyard facilities, and OSHA has determined that there are feasible measures to control them in each of these types of employment.
In the proposal's Authority section, OSHA preliminarily determined, under Section 4(b)(2) of the OSH Act, that it would be appropriate for the MC standard to supersede any corresponding longshoring standards in Sec. 1910.16 and 29 CFR part 1918. The Agency therefore proposed to add a new paragraph (m) to Sec. 1910.19. In addition, in questions raised by the Agency in its Notice of Public Hearing, OSHA requested input regarding the use of MC in longshoring. However, OSHA has subsequently proposed (59 FR 28594, June 2, 1994) to revise its marine terminal (part 1917) and longshoring (part 1918) standards. Those proposed standards (proposed Secs. 1910.16(b)(2), 1917.1(b)(2)(xiv), and 1918.1(b)(1)) would apply OSHA's toxic substance standards (part 1910, subpart Z) only when the packaging in which a substance is being transported in the maritime environment has broken open. This language, based on the existing marine terminal standard (Sec. 1910.16(b)(2)(ii)), reflects the view that hazardous substances, when properly packaged, do not pose significant exposure risks for the shipyard employees transporting them in closed packages.
Therefore, as revised, final rule Sec. 1910.19(m) states that Sec. 1910.1052 will address MC exposure in marine terminal and longshore employment only where leaking or broken packages allow MC exposure that is not addressed through compliance with 29 CFR parts 1917 and 1918. Given the promulgation of Sec. 1910.19(m), the Agency has determined that it is unnecessary to mention marine terminals and longshoring in final rule Sec. 1910.1052(a), Scope and application.
OSHA has not learned of any circumstances in which marine terminal or longshore employees have been exposed to MC because of damage to packaging. The Agency, accordingly, anticipates that the MC final rule will have little or no impact on the marine terminal and longshoring industries.
In developing this rule, OSHA has consulted with its Shipyard Employment Standards Advisory Committee (SESAC) to obtain information on MC use and exposure in shipyards and has taken the Committee's input into consideration in developing the standard. In particular, OSHA has relied on data provided by SESAC in assessing the technological feasibility and costs of compliance of the standard for shipyards covered by the rule.
Since the construction industry is also included in the scope of the final rule, OSHA is required to consult the Advisory Committee on Construction Safety and Health (ACCSH) in accordance with section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 333) (the Construction Safety Act) and 29 CFR 1911.10. On July 28, 1992, OSHA formally consulted with ACCSH regarding the construction-specific aspects of occupational exposure to MC. The Agency solicited comment and testimony regarding ACCSH's recommendations through a Federal Register notice (57 FR 36964, August 17, 1992). One of ACCSH's suggestions was that the rule specifically require originators of contract bids to stipulate a requirement for compliance with the MC standard in their bids. OSHA has not adopted this suggestion in the final rule because construction contracts already require compliance with all relevant Federal regulations. The specific suggestions made by ACCSH and OSHA's responses to ACCSH's input are discussed below in the relevant paragraphs of the Summary and Explanation.
In the proposal, the scope and application paragraph included an exemption for employers with workplaces where MC products were present but objective data were available to demonstrate that the product could not release MC above the action level or STEL under those foreseeable conditions of processing, use, and handling that would cause the greatest possible release. This concept remains in the final standard, although the provision has been moved to the exposure monitoring section (paragraph (d)), because this provision constitutes, in effect, an exception to the standard's requirement for initial monitoring.
The Air Transport Association [Ex. 19-75] requested that airlines be excluded from the general industry standard, and that a separate standard covering MC use in the airline industry be developed. OSHA has specifically determined that the exposures, work operations, and means of compliance for aircraft-related MC uses are similar to those in many other establishments and thus that there is no substantive basis for the requested exemption. Consequently, OSHA has concluded that no industry-specific standard for airlines is warranted. MC uses in the airline industry are discussed in the section of the final economic analysis entitled "Aircraft Stripping."
Paragraph (b) Definitions
This paragraph includes definitions of a number of terms used in the regulatory text of the final standard. Although some of these terms are in common use, OSHA believes that these definitions will help to ensure that their meaning in the context of the standard is clear.
Action level means an airborne concentration of MC of 12.5 ppm, measured as an 8-hour time-weighted average. One purpose of the action level is to relieve the burden on employers by providing a cut-off point below which many of the compliance activities in the standard are not required. In addition, due to the variable nature of employee exposures to airborne concentrations of MC, compliance with an action level provides employers with greater assurance that their employees will not be exposed to MC concentrations above the permissible exposure limits.
The action level also increases the cost-effectiveness and performance orientation of the standard while improving employee protection. The standard will encourage employers who can, in a cost-effective manner, identify approaches or innovative methodologies to reduce their employees' exposures to levels below the action level, because this will eliminate the costs associated with exposure monitoring and medical surveillance, two provisions of the standard that are triggered by exposure exceeding the action level. At the same time, the employees of such employers will be protected because their MC exposures will be less than half of those permitted by the permissible exposure limit. Employees of those employers who are not able to lower exposures below the action level will have the additional protection provided by medical surveillance, exposure monitoring, and the other provisions of the standard that are triggered by the action level.
The statistical basis for using an "action level" has been discussed in connection with several other OSHA health standards [see, for example, acrylonitrile (29 CFR 1910.1045) and ethylene oxide (29 CFR 1910.1047)]. In brief, although all employee exposure measurements on a given day may fall below the permissible exposure limit, some probability exists that on unmeasured days the employee's actual exposure may exceed the permissible exposure limit. Where exposure measurements are above the action level, the employer cannot reasonably be confident that the employee may not be overexposed on a given day. Therefore, requiring periodic employee exposure measurements to begin at the action level provides the employer with a reasonable degree of confidence in the results of his or her exposure measurement program [Ex. 7-248]. OSHA's decision to set the action level at one-half the PEL is based on its successful experience using this fraction as the action level in many standards, such as arsenic, ethylene oxide, vinyl chloride and benzene.
OSHA received comments from a number of rulemaking participants [Exs. 19-16, 19-20, 19-22, 19-31, 19-47, 19-75] suggesting that the proposed PELs and, by association, the action level, be revised. For instance, Hukill Chemical Corporation [Ex. 19-47] argued that the action level should be set at 100 ppm because it believes that: 1) CNS effects from MC are not observed in humans until 300 ppm; and 2) there is no evidence of excess cancer mortality in humans up to a level of 475 ppm. As explained in the Health Effects and Quantitative Risk Assessment sections of this preamble, OSHA disagrees with this commenter because the Agency has determined that significant risks exist at levels substantially below those referred to by the commenter and therefore that the suggested levels would not be adequately protective.
The Pharmaceutical Manufacturers Association (PMA) [Ex. 19-25] commented that the action level of 12.5 ppm is appropriate, but requested an exemption from "various requirements of the standard" if exposure occurs on fewer than 30 days a year. In particular, PMA suggested that periodic monitoring be required only when there is exposure above the PEL or STEL for at least 10 days a year or at or above the action level for at least 30 days a year. OSHA has considered this issue, along with similar concerns raised by ACCSH, and agreed that in cases where exposure occurs only on a few days per year, it was appropriate to alter the exposure monitoring requirements. Specifically, paragraph (d)(2)(iii) would permit employers whose employees are exposed to MC on fewer than 30 days per year to forego the initial monitoring required by paragraph (d)(2), provided that the employer has taken measurements that give immediate results (such as those taken by detector tube) and that provide sufficient information about exposures to determine what (if any) control measures are necessary. In addition, the medical surveillance requirement (paragraph (j)), with the exceptions described in the final rule, applies only where employees are exposed above the action level on at least 30 days within a year or above the PELs on at least 10 days within a year.
Newport News Shipbuilding [Ex. 19-37] suggested that the action level be set at 15 ppm. However, adopting this suggestion would not be consistent with the statistical basis for establishing the action level at one-half the PEL, as described above. In addition, Markey Restoration Company [Tr. 2671-72, 10/16/92] recommended that the action level be eliminated based on the costs of medical surveillance triggered by that level. As noted above, an action level is based on the probability of exceeding the PEL and is designed to enhance both employee protection and the standard's cost-effectiveness, and OSHA does not believe it would serve either employers or employees to eliminate this concept from the final rule.
The UAW [Tr. 1885-86, 9/24/92] questioned the statistical arguments underpinning the action level that OSHA has used for some years. According to the UAW's calculations, the action level should actually be set at one-tenth the PEL to accomplish the purpose OSHA intended. Accordingly, the UAW argued that: "[I]f you leave it [the action level] at 1/2, [there is] almost the virtual certainty that workers are overexposed on that job." In response, OSHA notes that its experience with action levels set at one-half the 8-hour TWA PEL has been favorable and that employers and employees have benefitted from the use of the action level concept. In particular, it is OSHA's experience that, for most workplaces, variability is normally such that an action level set at one-half the TWA PEL is appropriate. The final standard thus continues this practice.
Emergency means any occurrence, such as but not limited to, equipment failure, rupture of containers, or failure of control equipment, which results, or is likely to result in an uncontrolled release of MC. The word "uncontrolled" was changed from "unexpected" in the proposal to be more descriptive and to be consistent with the Hazard Communication Standard (29 CFR 1910.1200) and the Hazardous Waste Operations and Emergency Response Standard (29 CFR 1910.120). Incidental releases of MC -- i.e., those where the substance can be absorbed, neutralized, or otherwise controlled at the time of release by maintenance personnel or other employees working in the immediate release area -- are not considered to be emergencies within the scope of this standard. Dow Chemical Company [Ex. 19-31] indicated that the examples of emergencies provided in the proposal (purging lines and cleaning sludge from tanks) should not be included in the final rule. Other commenters [Exs. 19-25, 19-28, 19-57] agreed with Dow that the examples provided with the definition in the proposal were inappropriate. In particular, Eli Lilly and Company [Ex. 19-28, p. 7] stated
Lilly agrees with the concept that an emergency should be tied to unexpected releases. It is therefore curious and illogical that the examples given -- purging of lines and cleaning tanks -- are not unexpected events. To the contrary, in the pharmaceutical industry these are planned events which could even occur daily.
On the other hand, the Upjohn Company [Ex. 19-49] commented as follows:
The language "unexpected significant release" is very vague and will not result in any consistent interpretation as to what type of a release meets this definition. We would recommend that the language be changed to "* * * which may lead to employee exposure at or above the eight hour, timed-weighted average (TWA) or at or above the short-term exposure limit (STEL)."
OSHA acknowledges that the language in question could be misunderstood and has deleted the parenthetical listing of some examples of emergency situations. Furthermore, the Agency recognizes that emergency situations, by their very nature, are difficult to anticipate and describe. Therefore, OSHA has not provided examples of emergency situations in the final rule. Instead, the final rule lists situations that OSHA does not consider emergencies, because these will help employers to identify situations in their workplaces that do constitute emergencies. OSHA recognizes that emergencies have certain aspects in common but that other aspects are specific to a given workplace. For example, employee exposure must be uncontrolled for an emergency to exist. Provisions of the standard that include requirements that employers must meet in case of an emergency include Methods of Compliance, Respiratory Protection, Medical Surveillance, and Employee Information and Training.
Employee exposure is defined as that exposure to airborne MC which occurs or which would occur if the employee were not using respiratory protective equipment. This definition is consistent with OSHA's previous use of the term "employee exposure" in other health standards.
Methylene chloride (MC), or dichloromethane, means an organic compound with the chemical formula, CH2Cl2. Its Chemical Abstracts Registry Number is 75-09-2. Its molecular weight is 84.9 g/mole. Other information regarding the characteristics of MC may be found in the appendices to the final standard. MC is a colorless, volatile, liquid with a chloroform-like odor and is not flammable by standard tests in air, but will burn under extreme conditions. It has a boiling point of 39.85 C (104 F) at standard atmospheric pressure, a lower explosive limit of 12% and an upper explosive limit of 19.5% in air. It is completely miscible with most organic solvents but is sparingly soluble in water (1.3% by weight at room temperature). It has an extensive oil and fat solubility. Decomposition products during combustion or fire include phosgene, hydrochloric acid and carbon monoxide.
Physician or other licensed health care professional is defined as a person whose legally permitted scope of practice allows him or her to independently provide or be delegated the responsibility to provide some or all of the health care services required by final rule paragraph (j), Medical Surveillance. Use of this phrase is designed to increase the flexibility of the standard; the proposal used the more restrictive term "physician." OSHA intends that employers should consider the opinion of the applicable state licensing board, which defines the scope of practice for licensed health care professionals, when they are determining the appropriate provider to supply some or all of the medical services required by the standard. The new terminology recognizes that there are many services that non-physicians can provide, that some non-physicians have particular expertise in diagnosing and treating occupationally related diseases, and that the use of these providers is often a cost-effective and protective approach to the provision of medical care.
Regulated area means an area, demarcated by the employer, where an employee's exposure to airborne concentrations of MC exceeds or can reasonably be expected to exceed either the eight (8)-hour time-weighted average limit or the short-term exposure limit. The wording of this definition has been changed slightly from that in the proposal for clarity. The requirements for regulated areas are discussed below in relation to paragraph (e).
OSHA has added a definition for symptom to the final rule to clarify what is meant by that term when it is referred to in the regulatory text. MC has a wide range of possible adverse health effects. This definition clarifies what portion of that range would be considered a symptom for purposes of the standard. The covered symptoms would include indications of central nervous system effects, such as headaches, disorientation, dizziness, fatigue, and decreased attention span; cardiac effects, such as chest pain and shortness of breath; and skin effects, such as chapping, erythema, or skin burns.
"Director" and "This section" are consistent with OSHA's previous uses of these terms in other health standards.
The Boeing Company [Ex. 19-26] suggested that a definition be added for "work area" to preclude unnecessary monitoring in areas that do not contain MC. OSHA does not believe that this is necessary. If there is no MC present in an area, no monitoring needs to be performed for MC. In addition, the focus of this standard is employee exposure, as measured by personal monitoring, and not particular locations.
Paragraph (c) Permissible Exposure Limits
OSHA is promulgating an 8-hour time-weighted average (TWA) permissible exposure limit (PEL) of 25 ppm, and a short-term exposure limit (STEL) of 125 ppm averaged over 15 minutes, as proposed. OSHA has determined, based on evidence in the record, that occupational exposure to MC at the current 500 ppm 8-hour TWA PEL presents a significant risk of material health impairment, and particularly of cancer, to exposed employees and that compliance with the new standard will substantially reduce that risk. In combination with the STEL, the 8-hour TWA PEL and the other industrial hygiene provisions of the standard will also protect exposed employees from the other health effects caused by exposure to MC.
The basis for the 8-hour permissible exposure limit is discussed above in the sections on Health Effects and Significance of Risk, as well as in the economic analysis. OSHA believes that compliance with the new 25 ppm 8-hour TWA PEL is feasible and necessary to protect exposed employees from this significant risk of material health impairment.
OSHA received comments from a number of rulemaking participants suggesting that the proposed PELs and, by association, the action level be revised. The arguments for revising the proposed PELs were based on interpretations of the scientific support for given PELs and the feasibility of particular PELs in certain situations. Some commenters felt that the current level of 500 ppm does not provide adequate protection for employees and agreed that the PEL should be set at 25 ppm [Exs. 19-15, 19-49]. Specifically, Striptech International, Inc. [Ex. 19-15] stated:
The OSHA proposed 25 ppm standard for MC does substantially eliminate significant risk and it is feasible and definitely appropriate. The technology exists to enable the industries using MC to comply or to use an alternate method.
However, a number of rulemaking participants [Exs. 19-22, 19-23, 19-36, 19-38, Tr. 530, 9/18/92, Tr. 1776, 9/24/92, Tr. 1869, 9/24/92] suggested that OSHA set the 8-hour TWA PEL below 25 ppm, because they believe that the proposed 25 ppm limit would not adequately protect workers. For example, the UAW stated that setting a PEL at 25 ppm "will permit too much exposure to methylene chloride, therefore placing workers at great risk, contrary to the requirements of the OSHA Act" [Tr. 1869, 9/24/92]. The UAW stated that the proposed limit "would permit 2 deaths per thousand workers," and therefore suggested setting a PEL of 10 ppm, which the union felt would be feasible through specified engineering and work practice controls [Ex. 19-22, Tr. 1869, 9/24/92]. Scott Schneider, representing the IUE, also suggested that "because of the evidence of health effects from low level exposures" to MC, the PEL should be lowered below 25 ppm [Ex. 19-38]. The IUE and the ACTWU both supported the UAW recommendation of 10 ppm [Tr. 530, 9/18/92, Tr. 1776, 9/24/92].
The Laborers' Safety and Health Fund of North America [Ex. 19-36] suggested that worker exposure should be controlled to the lowest feasible level, which is consistent with NIOSH's position. NIOSH recommended "that occupational exposure to methylene chloride, which is a potential occupational carcinogen and may induce ischemic heart disease, be reduced below the proposed PEL to the lowest feasible level" [Tr. 868, 9/21/94]. OSHA agrees with these commenters that a significant risk remains at 25 ppm, but believes that this level is the lowest level for which OSHA can currently document feasibility across the affected application groups and industries.
OSHA's primary justification for the new standard is the risk of cancer associated with exposure to MC. Some commenters stated that the carcinogenicity of MC has not been proven and therefore that carcinogenicity should not be the basis for setting the PEL [Exs. 19-18, 19-29, 19-31, 19-45]. In particular, Kodak [Ex. 19-18] stated that it "does not believe that the human or animal data demonstrate a need to establish methylene chloride exposure limits at the levels proposed by OSHA in order to adequately protect employee health." Mr. Bixenman, representing Benco Sales, testified [Tr. 2638, 10/16/92] "And surely with our current level of technology, if methylene chloride were a human carcinogen, it could be established without question with actual diagnosed cases." Also, the Air Transport Association stated [Ex. 19-75]:
[T]he limited findings regarding cancer in mice at high MC dosage is weak justification for the proposed regulatory action. None of our members have found permanent health symptoms related to the use of MC, while usage at some facilities goes back at least 30 years. We have no data or experience connecting heart disease with MC use.
As discussed more extensively in the Quantitative Risk Assessment section, above, OSHA has based its assessment of MC cancer risk on the determination (supported by the NTP, EPA, and other agencies) that there is clear evidence of MC carcinogenicity in mice and rats. Although there are a few substances for which clear evidence of carcinogenicity in rodents has been deemed to be irrelevant to humans due to compelling evidence of mechanisms of action unique to the species tested, no such evidence exists for MC. In fact, as discussed in the Risk Assessment section, mechanistic evidence adds to the weight-of-the-evidence suggesting that MC is also carcinogenic in humans.
OSHA's final risk estimate indicates a risk of 7.5 deaths per 1000 workers exposed to MC at 50 ppm over a working lifetime and a risk of 3.6 deaths per thousand workers exposed to MC at 25 ppm over a working lifetime. OSHA has determined, using quantitative risk assessment, that the estimated risk of developing cancer warrants setting the 8-hour TWA PEL at 25 ppm and a 15-minute STEL at 125 ppm; in fact, at the 25 ppm PEL the residual risk still greatly exceeds any significant risk threshold, and only the lack of documentation of the feasibility of lower PELs across the affected industries has convinced the Agency not to reduce the PEL even further at this time.
OSHA disputes the contention of Mr. Bixenman that "actual diagnosed cases" are a precondition for establishing that a particular substance is carcinogenic to humans. Due to the natural background rate of all cancers, epidemiologic studies of groups are the only way to analyze human cause-effect relationships. As discussed in the Quantitative Risk Assessment section, OSHA has concluded that some of the available epidemiologic studies suggest a positive association between MC exposure and human cancer and that no epidemiologic studies of sufficient power exist to cast serious doubt on such conclusions.
Several commenters preferred a PEL of 50 ppm, which is the current ACGIH threshold limit value for MC, because they felt that a 25 ppm PEL would be either too costly to implement or the technology to achieve such a level of control was not available [Exs. 19-2, 19-3, 19-12, 19-14, 19-15, 19-29, 19-31, 19-35, 19-37, 19-39, 19-48, 19-50, 19-56, 19-57]. For example, Abbott Laboratories [Ex. 19-29] commented that specific processes in the pharmaceutical industry "cannot be controlled through existing conventional engineering controls." Also, AMETEK [Ex. 19-12] stated that "It will be hard for many industries to reach the 50 ppm level and extremely difficult, if not, impossible, for most to reach the 25 ppm level." Therefore, this commenter proposed "that OSHA set the PEL for methylene chloride at 50 ppm (8-hour TWA) with no AL [action level] and leave the STEL at 125 ppm (15-minute average) as originally written." AMETEK contended that this approach "combines aspects of both ACGIH guidelines and OSHA's proposed standard into a regulation which would be both protective of worker health and economically feasible for industry" [Ex 19-12].
Many other commenters argued for a PEL of at least 100 ppm [Exs. 19-1, 19-4, 19-10, 19-11, 19-16, 19-24, 19-47, 19-51, 19-52, 19-53, 19-54, 19-67, 19-75, 19-79, 98, 115-3, Tr. 397, 9/17/92, Tr. 2216, 10/14/92, Tr. 2627, 10/16/92, Tr. 2671, 10/16/92, Tr. 2702, 10/16/92]. For example, Besway Systems, Inc., testified [Tr. 397, 9/17/92]: "We would like to see a PEL for these companies of 200 ppm, which we've been able to show is safe and economically attainable in our real life experience. We believe that the absolute maximum PEL for our industry should be set at 100 ppm eight hour time weighted average. . . ." Also, Benco Sales [Tr. 2627, 10/16/92] stated "We feel the American workers would receive more benefit by implementation of an exposure level of 100 parts per million, which is achievable, and the subsequent enforcement of that level." ChemDesign Corporation [Ex. 19-24] believes that the "sharp reduction in the exposure limit is unjustified based on lack of credible data that this chemical has the potential to cause cancer in humans." This commenter therefore suggested that the PEL be "lowered by a factor of five to 100 parts per million" [Ex. 19-24].
Other commenters supported a variety of PEL values. One suggested that a lower PEL be phased in over time, with 75 ppm for two years, then 50 ppm for two years, and finally 30 ppm [Ex. 19-20]. The reasoning behind this suggestion was that, during this period, alternative options to best fit specific operations could be evaluated and implemented and sufficient time provided to gather the funds necessary to implement the entire system [Ex. 19-20]. OSHA holds, however, that the types of engineering controls required under this standard are relatively simple and that engineering to 75 ppm, then 50 ppm, then 30 ppm is likely to be more costly in time and money than engineering to or below 25 ppm initially. The suggested phase-in would also be administratively burdensome for employers, who would be subject to changing OSHA requirements over the years, with no clear advantage in reducing the costs of compliance. In addition, if OSHA allowed such a phase-in period, workers would be exposed to MC at higher levels than would occur if OSHA required no phase-in period. Therefore, the Agency sees no advantage to using the phased-in approach described. Moreover, the Agency notes that the time-frames for compliance with the provisions of the standard, including implementation of engineering controls, have been tailored to the size of the establishments, in order to give all employers a reasonable amount of time to gather resources and information necessary to comply with this regulation. See the discussion of start-up dates later in this document.
Smith Fiberglass Products, Inc. suggested that the PEL should remain at 500 ppm because there is no evidence of human harm at the present PEL and STEL, since "studies with rats and mice show that only a serious overdose far above the present STEL can cause carcinogenic effects" [Ex. 19-82]. Another commenter [Ex. 19-86] stated that "The present PEL of 500 parts per million (ppm) is not protective enough of employees based on toxicological data developed since the PEL was established." This commenter therefore suggested that the PEL should be lower than 500 ppm but higher than 25 ppm (no specific value identified). As discussed above, however, OSHA has determined that exposure to MC above 25 ppm poses significant cancer risks and that it is feasible to protect affected employees from those risks (see the Significance of Risk section of the preamble).
A number of commenters addressed the availability of suitable substitutes for MC in their concerns about feasibility [see, e.g., Exs. 19-6, 19-8, 19-37, 19-43, 19-55, 19-74, 19-79, 19-84, 115-3; Tr. 433, 9/17/92; Tr. 1591, 9/23/92; Tr. 1712-13, 9/24/92; Tr. 2636-38, 10/16/92]. Substitution is often a valid means of controlling exposures to a particular hazardous chemical when a less hazardous substitute is available that can be used to perform a similar function. In particular, some commenters stated that there are no viable substitutes for MC products used to perform particular tasks. These participants argued that companies would go out of business because they would be unable to comply with the final standard in a feasible way [Exs. 19-6 and 19-8]. In addition, one commenter [Ex. 19-8] expressed concern that substitute products would pose fire hazards. The National Tank Truck Carriers, Inc. testified [Tr. 1712, 9/24/92]:
One company which discontinued the use of methylene chloride found it necessary to supplement the methylene chloride substitute with even more hazardous acetone and toluene in order to remove the residues from the trailers and containers and properly service the industry by providing clean trailers.
OSHA has determined that for all application groups, compliance with this regulation can generally be achieved through the use of engineering controls and work practices. The Agency's Final Economic Analysis estimated the cost of compliance assuming that almost all firms would continue using MC and that only a small fraction of firms would substitute away from MC. OSHA agrees that, in an individual establishment, the potential use of substitution as a means of control must be evaluated carefully to ensure that the magnitude of the hazard posed is not the same or increased as a result of the substitution. For some applications described in this regulation, many substitutes for MC are available for specific applications that do not pose increased health or safety hazards. In general, however, OSHA has based it findings of feasibility not on the ability of companies in the affected sectors to substitute away from MC but on their ability to implement conventional engineering and work practice controls.
In addition to the 8-hour TWA PEL, OSHA is promulgating a short-term exposure limit (STEL) of 125 ppm, measured over a 15-minute period, to protect employees from the acute toxicity of MC and its metabolites. The acute toxicity of MC is characterized primarily by CNS effects, such as decreased alertness and coordination, headaches, and dizziness, which may lead, in turn, to accidents on the job as well as material impairment of health. Absence of a STEL would mean that employees could be exposed to up to 800 ppm for 15 minutes. Such levels are clearly associated with central nervous system effects.
MC is also metabolized to carbon monoxide (CO). CO produced from MC exposure has the same toxic effects in the body as direct exposure to CO does. The primary toxic effect of CO is reduction of the ability of the blood to carry oxygen to the tissues of the body.
In the body, carbon monoxide is converted to carboxyhemoglobin. Background levels of carboxyhemoglobin in the non-smoking U.S. population vary from approximately 0.5% to 2.0%. Carboxyhemoglobin in smokers ranges from approximately 3% to 10%. Additional body burden of CO (carboxyhemoglobin) due to MC or direct CO exposure can have adverse health effects on affected individuals. For example, exposure to relatively low levels of carbon monoxide (for example, levels which increase carboxyhemoglobin by 2%) reduced time to angina in patients with pre-existing heart disease exposed to occupational levels of CO [Ex. 21-93]. Exposure of pregnant women to CO has been shown to produce adverse health effects on the developing fetus. Workers with anemia or other blood abnormalities may be at increased risk of material impairment to health because of an already decreased oxygen-carrying capacity.
The carbon monoxide-mediated cardiac effects of MC exposure are of particular concern in the occupational setting because a significant fraction of the U.S. working population (some investigators estimate 30% of the U.S. population) has silent or symptomatic heart disease. NIOSH has expressed concern that the STEL proposed by OSHA is not low enough to protect workers from the adverse central nervous system and cardiac effects of MC.
In addition to reducing risks of cardiac and CNS effects, the STEL will also enhance employee protection from MC-induced carcinogenesis by reducing total exposure to MC and by limiting the metabolism of MC by the GST pathway (the putative carcinogenic metabolic process). Metabolic evidence suggests that the GST pathway produces more than proportionately greater quantities of the putative carcinogenic metabolite when MC concentrations reach levels of about 100 ppm. For this reason, it is important to limit high concentration, short duration exposures to MC. Thus the STEL will reduce the exposure-related risks of acute CNS effects, episodes of carboxyhemoglobinemia, and cancer.
Another advantage in requiring a STEL is that it focuses attention on sources of MC exposure in the workplace. General industrial hygiene principles state that a well-controlled process should have peaks no higher than five times the 8-hour TWA. Measurement of STEL exposures can indicate point sources which have unacceptably high MC emissions and help the employer target those processes for abatement. This can be an efficient mechanism to concentrate industrial hygiene resources on those emission sources which, when controlled, will reduce total employee MC exposure.
In addition, it has been established that "[i]f in fact a STEL would further reduce a significant health risk and is feasible to implement, then the OSH Act [section 6(b)(5)] compels the agency to adopt it barring alternative avenues to the same result." (emphasis in the original) Public Citizen Health Research Group v. Tyson, 796 F.2d 1479, 1505 (D.C. Cir. 1986) (Ethylene oxide). See also Building and Construction Trades Department, AFL-CIO v. Brock, 838 F.2d 1258, 1271 (D.C. Cir. 1988) (Asbestos).
In summary, many commenters questioned the need for a reduced PEL, for a PEL of 25 ppm, and for the particular 8-hour TWA PEL-STEL combination proposed by OSHA, citing concerns about the feasibility of these limits and the ability of companies to identify controls and/or substitutes to comply with them. However, as discussed in the final economic analysis, OSHA has determined that it is both technologically and economically feasible for facilities in all affected sectors to comply with the final rule. In almost every case, companies will be able to use conventional engineering controls and work practices to reduce their employees" exposures to these levels. In addition, many employers will find that substitution is a viable approach to eliminating the significant risk posed to workers by MC. As the economic analysis points out, many firms in many of the covered industries have already substituted away from MC, and have enjoyed considerable cost savings in the process. Finally, it is important not to lose sight of the reasons for regulating MC in the first place: this substance poses a significant risk of cancer, central nervous system and cardiac effects, and sensory irritation to the quarter of a million workers who manufacture, formulate, use, or transport this substance in the workplace.
As the Quantitative Risk Assessment and Significance of Risk sections of the preamble demonstrate, the cancer risk remaining at an 8-hour TWA PEL of 25 ppm is clearly of great concern, in that it exceeds the 1/1000 level indicated by the Supreme Court to be clearly significant. OSHA therefore encourages employers to further reduce the MC exposures of their employees wherever it is feasible to do so. Because the residual risk remaining at 25 ppm is great, the Agency intends to gather data and information on the feasibility of reducing the 8-hour TWA PEL to reduce remaining significant risk in a future rulemaking action. The priority assigned to any future rulemaking activity will depend in large measure on the prevailing exposure levels, feasibility, scientific advances and other information, at the time OSHA considers further proposals; to the extent prevailing levels are significantly below 25 ppm, the need for subsequent proposals will diminish.
Paragraph (d) Exposure Monitoring
Paragraph (d) addresses the employee exposure monitoring requirements for workplaces where employees are exposed to MC. As discussed in the preamble to the proposed rule (57 FR 57118-20), OSHA requires employee monitoring to facilitate compliance with the PELs. As a general matter, exposure monitoring of employee exposure to toxic substances is a well-recognized and accepted risk management tool. The monitoring provisions of this final MC standard are consistent with the monitoring provisions of other OSHA standards. Section 6(b)(7) of the OSH Act, which addresses rulemaking requirements for hazardous chemicals, requires health standards to include provisions for monitoring employee exposures. In the final rule, the exposure monitoring provisions have been reorganized and rewritten to improve their clarity and readability. The substance of the requirements is essentially the same, with the few exceptions noted below.
The provisions of proposed paragraph (d) elicited a considerable amount of comment and testimony. Several rulemaking participants [Ex. 19-57; Tr. 249, 9/17/92; Tr. 458, 9/17/92; Tr. 1711, 9/24/92] stated that the proposed requirements for exposure monitoring would impose excessive economic burdens on some employers (e.g., paint strippers, tank cleaners). However, in the final rule OSHA has structured the exposure monitoring requirements to minimize the burden for employers whose employees have lower exposures and for workplaces where groups of employees have similar exposures. In addition, the Agency has included some alternatives to the initial monitoring provisions that will reduce the amount of monitoring required for some workplaces. Ultimately, however, the Agency has determined that it is essential to the protection of exposed employees that exposure levels be quantified in order to select and implement the proper measures to reduce employee exposures to MC.
The overall rulemaking record supports the need for exposure monitoring to ascertain exposure levels for the purpose of designing appropriate protective measures for employees. In addition, evidence in the record indicates that the exposure monitoring requirements are economically and technologically feasible for firms in all of the affected industry sectors. (See the discussion in the Final Economic Analysis [Ex. 129].) Paragraph (d)(1) sets forth the general requirements that apply to all monitoring provisions. Paragraph (d)(1)(i) states that employers must characterize the MC exposure of each employee. Employers may chose one of two ways to determine an employee's MC exposure level. First, the employer can take a personal air sample in the breathing zone of each affected employee. This approach is the most precise method of exposure monitoring because it allows each employee's exposure to be individually ascertained. However, OSHA recognizes that this approach may be burdensome for employers with many employees. Therefore, paragraph (d)(1)(ii) permits employers to establish a representative monitoring scheme.
Under this option, a personal breathing zone air sample may be considered representative of another employee's 8-hour TWA or STEL exposure if the following conditions are met. First, the sampled employee must be that employee who is likely to have the highest MC exposure among the employees included in the group that is to be represented by the sample. Second, if the employer wishes a sample taken on an employee in a given job on one work shift to represent the exposure of another employee in the same job classification on another shift, the employer must sample at least one employee in each job classification in each work area during every work shift. Paragraph (d)(1)(ii) also contains an exception under which a personal breathing zone sample taken on one employee in one job classification in a given work area and on a particular shift will be considered representative of the exposure of employees on other shifts, where the employer documents that the tasks performed and conditions in the workplace are similar for all employees whose exposures are represented.
The provision for representative sampling, which is very similar to the corresponding provision of the proposed rule, eliminates unnecessary monitoring and thus further improves the cost-effectiveness of the standard. In a change from the proposal, the final standard also allows employers to use representative monitoring to comply with the standard's requirement for initial monitoring. OSHA believes that representative initial monitoring is appropriate in those cases where the employer can accurately determine which employees are likely to have similar exposures.
The accuracy of the methods used to perform exposure monitoring is addressed under paragraph (d)(1)(iii). For monitoring of airborne concentrations above the 8-hour TWA PEL or the STEL, the results must be accurate within plus or minus 25 percent at a confidence level of 95 percent. Where concentrations are above the action level but at or below the PEL, the accuracy must be within plus or minus 35 percent at a confidence level of 95 percent.
Methods of measurement are presently available that can detect MC within these limits. One such method is OSHA method 80, which has a limit of detection of 0.201 ppm. Copies of this method are available from OSHA and can be downloaded from OSHA's World Wide Web site on the Internet at "http.www.osha.gov/." Sampling and analysis may also be performed by portable direct reading instruments, real-time continuous monitoring systems, passive dosimeters or other methods that meet the accuracy and precision requirements of the standard under the particular conditions which exist at the employer's worksite.
Paragraph (d)(2) requires employers to make an initial determination of affected employees' exposure to MC. OSHA anticipates that most employers will need to perform monitoring in order to characterize employee exposure and has framed the rule accordingly. The standard allows employers to characterize their employee exposures using other means, providing that they can meet the requirements for such other means presented in the standard. For example, as discussed above, some employers may have objective data that establishes that employees will not be exposed above the action level or the STEL under reasonably foreseeable circumstances. Some employers generate such data themselves, while others rely on information provided by the manufacturer or supplier. Accordingly, paragraph (d)(2)(i) provides that employers can rely on objective data in certain circumstances in lieu of performing initial monitoring. The objective data must represent the highest MC exposures likely to occur under reasonably foreseeable conditions of proccessing, use, or handling in the workplace, and the employer must document the objective data relied on (see paragraph (m)). This provision corresponds to proposed paragraph (a)(2), which was the subject of several comments [Exs. 19-14. 19-31, 19-57].
Occidental Chemical testified [Tr. 2010 and 2023, 10/14/92] that OSHA should expand the proposed objective data exemption so that mixtures with less than one percent MC would be excluded from the scope of the MC standard. The Hazard Communication Standard (HCS) addresses mixture composition for the purpose of identifying those constituents and concentrations that impart their hazardous characteristics to the mixture as a whole. According to the HCS, carcinogenic substances such as MC are considered to impart their carcinogenic characteristics to the mixture if they are present in concentrations of more than one-tenth of one percent or can be released in concentrations that exceed an existing PEL. This is a much more protective requirement than that suggested by Occidental, and the Agency believes it would be inappropriate to lessen the protections provided to employees under the HCS in this substance-specific MC standard. Therefore, OSHA has not made the suggested change.
In addition, OSHA recognizes that it would be unreasonable to require initial monitoring under this standard where employers have already performed the monitoring needed to characterize employee exposure. Paragraph (d)(2)(ii) allows employers who have monitored their employees' exposures to MC within one year prior to April 10, 1997 and that monitoring complies with the accuracy and other requirements for monitoring contained in the final rule, to designate such monitoring results as sufficient in lieu of performing the initial monitoring.
Dow Chemical Co. [Ex. 19-31] commented that OSHA should allow monitoring data collected as much as two years prior to the effective date of the final rule to qualify as initial monitoring data. The Agency believes that data more than a year old would be unlikely to provide a reliable basis for characterizing employee exposure, because workplace conditions may well have changed since such data were collected. Accordingly, the Agency has not made the suggested change.
Addressing this point, Scott Schneider of the International Union of Electronic, Electrical, Salaried, Machine and Furniture Workers (IUE) testified [Tr. 531, 9/18/92] as follows:
While we support the requirements for exposure monitoring that were proposed, we have reservations about section (d)(2)(ii) regarding the use of "earlier monitoring results" to satisfy the initial monitoring requirements. OSHA must specify exactly which requirements the data must meet, in terms of both quality and quantity. Otherwise, it will be an enormous loophole for companies to avoid monitoring.
The International Brotherhood of Painters & Allied Trades (IBPAT) agreed with Mr. Schneider; the union stated that the use of "historical monitoring data to characterize exposures for similar processes * * * may lead to erroneous estimates of actual exposures" [Ex. 19-23]. OSHA believes that the concerns of these commenters have been addressed in the final rule because, to be acceptable under the standard, any previously gathered exposure data must meet the analytical, sampling, and other requirements specified for initial monitoring.
A number of commenters addressed the application of monitoring requirements in construction [Ex. 19-23; Tr. 544-45, 9/18/92; Tr. 814-17, 9/21/92; and Tr. 1377-80, 9/23/92]. OSHA agrees that conditions on construction sites often present special industrial hygiene and monitoring problems, particularly since the job may be completed before sampling results taken by conventional personal monitoring methods have been returned from the laboratory. For example, IBPAT [Ex. 19-23] pointed to the exposure variability that typifies construction sites, noting that weather, a highly transient workforce, and other factors often complicate accurate characterization of construction worker exposures. OSHA's Advisory Committee for Construction Safety and Health (ACCSH) and other participants suggested that OSHA allow the use of direct-reading instruments to address this problem [ACCSH Tr. 100-103, 7/28/92; Workgroup report, pp. 3-4; Tr. 814-818, 9/21/92; Tr. 1377-1382, 9/23/92].
In response to these comments, the final rule has been revised to allow the use of such instruments where employees are exposed to MC on fewer than 30 days within a given year. This means that construction employers who are involved in short-term construction projects will be able to use these instruments to characterize the MC exposures of their employees. Paragraph (d)(2)(iii), which addresses transient workplaces or work operations where employees are exposed on fewer than 30 days a year, permits employers to use direct reading instruments such as detector tubes to estimate exposure and determine what protective measures to provide to their MC-exposed employees. Although these simple measurement tools often do not meet the accuracy requirements that other types of monitoring methods do, they have the advantage of immediate results and thus allow employers to provide protection immediately. OSHA believes that this provision is responsive to the comments discussed above and represents an effective solution to a difficult worker protection problem.
Paragraph (d)(3) addresses periodic monitoring. Table X-1, below, which corresponds to Table 1 of paragraph (d)(3), displays the various monitoring scenarios possible under the final rule's periodic monitoring requirements. When the initial determination shows employee exposures to be at or above the action level or above the STEL, the employer is required to establish a periodic monitoring program. The 8-hour TWA monitoring is to be done every six months if exposures are at or above the action level but at or below the 8-hour TWA PEL and the STEL. The 8-hour TWA or STEL monitoring must be done every three months if the initial determination or subsequent monitoring shows results that are above the 8-hour TWA PEL or the STEL, respectively. If two consecutive subsequent monitoring results taken at least seven days apart show that exposures have decreased to or below the 8-hour TWA PEL, but above the action level, the frequency may be decreased to every six months. Eight-hour TWA monitoring may be terminated when two consecutive monitoring results taken at least seven days apart show that exposures are below the action level. STEL monitoring may be terminated when two consecutive monitoring results taken at least seven days apart show that exposures are at or below the STEL (See note to paragraph (d)(3)).
There are six possible initial determination exposure scenarios, or combinations of 8-hour TWA and short-term exposures, that determine the frequency of required monitoring. Table X-1 below lists these six exposure scenarios, along with their monitoring frequencies. As shown by Table X-1, the action level trigger largely determines whether employers must monitor employee exposure to MC. The only exception is the scenario in which 8-hour TWA exposures are below the action level and short-term exposures are above the STEL. In this case, exceeding the STEL obligates employers to monitor short-term exposures four times per year at those job locations where the STEL was exceeded, but employers are not required to monitor 8-hour TWA exposures at those job locations.
Table X-1. -- Six Initial Determination Exposure Scenarios and Their Associated Monitoring Frequencies _____________________________________________________________________ Exposure Scenario | Required Monitoring Activity ___________________________________|_________________________________ Below the action level and at or | No 8-hour TWA or STEL below the STEL....................| monitoring required. Below the action level and above | No 8-hour TWA monitoring the STEL..........................| required; monitor STEL | exposures every three months. At or above the action level, at or| Monitor 8-hour TWA exposures below the TWA, and at or below the| every six months. STEL. | At or above the action level, at or| Monitor 8-hour TWA exposures below the TWA, and above the STEL.| every six months and monitor | STEL exposures every three | months. Above the TWA and at or below the | Monitor 8-hour TWA exposures STEL..............................| every three months. Above the TWA and above the STEL...| Monitor 8-hour TWA exposures | and STEL exposures every three | months. ___________________________________|_________________________________
Several commenters stated that the proposal required unnecessarily frequent monitoring [Exs. 19-25, 19-26, 19-28, 19-30, 19-31, and 19-57]. Some commenters [Exs. 19-30, 19-31] said that the frequency of monitoring should be the same as that in the benzene standard (29 CFR 1910.1028 (e)(3)), since frequent monitoring does nothing to reduce or control exposures. The benzene standard requires monitoring at least every six months if employee exposure exceeds the 8-hour TWA, at least every year if exposure is at or above the action level but at or below the 8-hour TWA, and "as necessary" to evaluate short-term exposures. OSHA believes that MC exposure is highly variable due to the substance's volatility (vapor pressure = 350 mmHg at 20 C, compared with a vapor pressure for benzene of 75 mmHg at the same temperature) and the way that it is commonly used (e.g., in manual applications), and that reducing the frequency of exposure monitoring could therefore result in inadequate employee protection. The frequency of monitoring required by this MC standard is similar to that in other OSHA standards such as Ethylene Oxide (29 CFR 1910.1047), and is sufficient to characterize employee exposure and to evaluate the effectiveness of exposure control strategies.
The Advisory Committee on Construction Safety and Health suggested that OSHA trigger exposure monitoring by frequency of use as well as the exposure level. OSHA believes, however, that the magnitude of an employee's exposure is the appropriate determinant of monitoring frequency (and the selection of protective measures based on the results of that monitoring) because it is cumulative MC dose, not frequency of use, that determines the significance of the risk to which employees are exposed. Therefore, the Agency has not made the suggested change.
The Polyurethane Foam Association (PFA) [Ex. 19-39] questioned the necessity of requiring exposure monitoring at the action level. According to the PFA [Ex. 19-39], "An action level of 12.5 ppm would require that workers be monitored at a level that has only a remote health risk associated with it. The costs of such monitoring, however, would be significant." OSHA disagrees strongly with the PFA's analysis of the significance of the risk remaining at the action level. As discussed in the Significance of Risk and Economic Analysis sections of this preamble, only feasibility has constrained the Agency from reducing the 8-hour TWA PEL in the final rule to levels below the action level, because even at 10 ppm, the risk remaining is significant. That is, an employee exposed to an MC concentration of 10 ppm as an 8-hour TWA over a working lifetime would still be at significant risk of dying of MC-induced cancer.
Under paragraph (d)(4)(i), employers are required to perform additional monitoring when workplace conditions change or there is an indication that employee exposures may have increased. Paragraph (d)(4)(ii) requires that, where exposure monitoring is performed due to a spill, leak, rupture or equipment breakdown, the employer must clean up the MC and perform repairs and then monitor MC levels. The changes referred to in these provisions would include deliberate changes, such as a process or production change, or unexpected changes, such as a leak, rupture, or other breakdown. In the case of the latter, the employer is to perform the monitoring after taking whatever immediate action is required to clean-up or repair the equipment or source of exposure. OSHA recognizes that such occurrences can result in very high exposures. Several rulemaking participants [Exs. 19-31, 19-57, Tr. 2035, 10/14/92] stated that remonitoring is not necessary after a spill or leak since MC has a high vapor pressure, there would be no visible residual MC and no opportunity for significant exposure. However, OSHA believes that such remonitoring is an appropriate way to ascertain if proper corrective methods have been instituted and if the magnitude of an employee's exposure has changed significantly as a result of the leak or spill.
Employees are to be notified in writing of the results of exposure monitoring under paragraph (d)(5). This is to be done within 15 working days of the time the employer receives the monitoring results, and can be done either individually or by posting. When the results show that the 8-hour TWA PEL or the STEL has been exceeded, the employer must also notify employees of the corrective action being taken, and the schedule for completion of the action. This provision is effectively identical to the corresponding provision of the proposed rule.
One commenter [Ex. 19-49] argued that 15 working days is not enough time to develop corrective actions, especially where engineering controls are involved. OSHA believes that this comment misunderstands the requirement, which merely states that employers are required to "describe the corrective action being taken * * * and the schedule for completion of this action." The Agency believes that 15 working days is adequate time for the employer to make a preliminary assessment that includes the immediate steps being taken to reduce employee exposure, such as utilization of air-supplied respirators, and the employer's plan for implementing permanent controls and/or work practices. This requirement is necessary to assure employees that the employer is making efforts to furnish them with a safe and healthful work environment, in accordance with section 8(c)(3) of the Act. OSHA would expect employers to update the notification when plans for permanent controls are made.
Employees or their designated representatives are provided by paragraph (d)(6) with the opportunity to observe any required monitoring of employee exposure to MC. This provision is required by section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)). It was relocated to paragraph (d)(6) of the final rule from proposed paragraph (l) to consolidate all of the exposure monitoring requirements in one place. The observer, whether an employee or a designated representative, must be provided (at no cost to the observer) with any personal protective clothing or equipment required to be worn by employees working in the area that is being monitored, and must additionally comply with all other applicable safety and health procedures. These provisions of the final rule are identical to those of the proposed rule.
As noted above, OSHA received a number of comments on the monitoring provisions proposed in the NPRM. For example, Occidental Chemical Corporation requested that OSHA consider using what they termed "exposure assessment" rather than monitoring, testifying [Tr. 2012-2013, 10/14/92] as follows:
[I]nstead of just looking at monitoring, which is in the middle of the process, exposure assessment looks at a basic * * * characterization: What is the characterization of the work force? What is the characterization of the workplace? What is the characterization of the contaminants in the workplace? All of that is weighed together; it's a collection of information.
The next step, then, is to interpret that information and determine what are the actual exposure levels, what category would they fit into * * *. If, at that point, and this is still just a paper exercise based on that information, you * * * conclude that exposures [are] unacceptable * * * you act. You may conclude that you have insufficient data and you'd like to monitor. Or you may conclude the data are acceptable; in this case, you would act and * * * change something and go through the process again. Or, in the case they [employee exposures] are acceptable, * * * you would document that it is acceptable and then reevaluate at some regular frequency, say annually or something like that.
In response to this comment, OSHA notes that nothing in the standard prevents employers from conducting exposure assessments. Indeed, the fact that the final standard allows employers to use objective data and recent (within the past year) exposure data are both examples of the kinds of evaluation made by industrial hygienists performing exposure assessments. An employer unable to avail himself or herself of the exclusions to initial monitoring offered by the standard would logically move to the next step in the exposure assessment process: the direct monitoring of employees' exposures to MC. Thus the final rule, far from interfering with exposure assessment, actually both reflects this process and encourages employers to engage in such assessments themselves.
Paragraph (e) Regulated Areas
Paragraph (e)(1) requires employers to establish a regulated area wherever an employee's exposure to airborne concentrations of MC exceeds or can be reasonably expected to exceed either the 8-hour TWA PEL or the STEL. This paragraph was changed slightly from the proposal to clarify that OSHA is concerned with employee exposures that can reasonably be anticipated to exceed one of the PELs, rather than excessive exposures that "may" occur. Regulated areas can be either temporary or permanent, depending on the characteristics of a given workplace. Such areas are required by the standard to reduce employee exposures and to alert employees to those areas in the workplace that present the greatest danger of MC overexposures.
Paragraph (e)(2) limits access to regulated areas to authorized persons (a term which is defined in the definitions paragraph (b)). This provision applies when either the TWA PEL or STEL is exceeded or can reasonably be expected to be exceeded. OSHA believes that the establishment of a regulated area will help to ensure that employees are aware of areas in the workplace where MC levels are above the 8-hour TWA PEL or STEL. OSHA believes that regulated areas are an effective means of limiting the risks of high exposures to substances suspected of being carcinogenic to humans to as few employees as possible.
Comments from Bristol-Myers Squibb [Ex. 19-14] suggested that OSHA delete the regulated area concept from the standard and replace it with a "regulated job classification" for jobs exceeding the PEL and a "regulated procedure" for procedures exceeding the STEL. This commenter's rationale was that since airborne concentrations are measured by personal monitoring and by job classification, it does not make sense to define an "area" of exposure. OSHA does not agree, for a number of reasons. First, in many workplaces, specific areas, such as quality control monitoring stations, mixing tanks, cutoff saw stations, spray booths, etc., are known to be associated with high levels of MC on a routine basis, and demarcating these areas protects employees by making them aware of the potential for these exposures in these locations. Second, it is standard industrial hygiene practice to use area monitoring to identify areas of exceptionally high exposures so that all non-authorized employees can be protected from overexposure. Finally, OSHA does not believe that the approach suggested by Bristol-Myers has the same potential to alert employees to the presence of high airborne concentrations that a demarcated area does, and therefore believes that the suggested change would not provide equivalent protection from overexposure.
The Laborers' Safety and Health Fund of North America [Tr. 1378-79, 9/23/92] testified that, in construction, a regulated area should be established wherever MC is used. Although there are many uses of MC on construction sites that may warrant establishing regulated areas, there are also engineering controls available (for example, portable ventilation) which may reduce employee exposures so that a regulated area would be unneccessary. OSHA believes that employers should not be required to establish regulated areas unless potential exposure levels warrant them. The Agency also believes that the employer is in the best position to determine whether the exposures from a particular MC application will warrant establishing regulated areas at a particular work site. The Advisory Committee on Construction Safety and Health also suggested that the establishment of regulated areas could replace some of the standard's monitoring requirements [Ex. 21-69]. As discussed previously, however, OSHA believes that both employers and employees benefit from knowing what exposures to MC are in a given workplace or on a specific job assignment. OSHA has therefore not revised the final rule's requirement for regulated areas in locations where exposures exceed or can reasonably be expected to exceed either or both of the PELs.
The proposal would have required that employers supply employees entering regulated areas with appropriate respiratory protection and ensure its use in such areas at all times. Several commenters [Exs. 19-25, 19-31 and 19-49] argued that respirator use in such areas should be required only if occupational exposures in such areas either exceeded the 8-hour TWA PEL or the STEL or could reasonably be expected to exceed one or both of these limits. OSHA agrees with these commenters and has revised the final rule accordingly. Paragraph (e)(3) states that employers must supply a respirator to each person who enters a regulated area, but shall require each affected employee to use that respirator only if MC exposures are likely to exceed the 8-hour TWA PEL or STEL. Thus, not all workers in regulated areas will be required to wear respirators in regulated areas at all times.
For example, under the final rule, an employer would be required to demarcate the area around a cutoff saw operator's work station in a foam blowing plant as a regulated area and to train the operator to recognize the area as regulated; however, the operator would only be required to wear a respirator in the area at times when the foam "bun" was coming out of the tunnel for cutting. The employer would demarcate the area because he or she recognizes, based on monitoring results for the cutoff saw operator, that this work station is one where the 8-hour TWA PEL is regularly exceeded during foam blowing operations. Because of the intermittent nature of many foam blowing operations, however, respirators would need to be worn by the operator (or other workers assisting the operator) only when foam was actually being blown. This example assumes that foam blowing operations are intermittent and that exposures at the cutoff saw would exceed the PELs only during foam blowing, although this may not be the case in all plants or at all times. In facilities where foam is blown continually and the saw operator is stationed at the end of the tunnel over the full shift, respiratory protection would likely be required to be worn in the regulated area at all times because exposures would routinely exceed the PEL in that area.
Under paragraph (e)(4), which has been added to the final rule, the employer shall ensure that, within a regulated area, employees do not engage in non-work activities which may increase dermal or oral MC exposure. This provision indicates that such non-work activities as eating, drinking, smoking, taking medication, applying lotions or cosmetics or storing such products in regulated areas are prohibited. Proposed paragraph (e)(4) has been promulgated as final rule paragraph (e)(6), as discussed below.
In addition, under paragraph (e)(5), which has been added to the final rule, the employer shall ensure that employees who are wearing respirators do not engage in activities (such as taking medication or chewing gum or tobacco) which interfere with respirator seal or performance. Proposed paragraph (e)(5) has been promulgated as final rule paragraph (e)(7), as discussed below.
Final rule paragraphs (e)(4) and (e)(5) are based on the response to NPRM Issue 41 (56 FR 57043) which indicated that OSHA was considering a provision to prohibit activities such as eating, drinking, smoking, etc. in regulated areas and asked for comments on this subject. This prohibition was supported by some rulemaking participants [Ex. 19-36, Tr. 1379, 9/23/92]. OSHA notes that it is standard industrial hygiene practice to limit such activities in regulated areas, both because employees should be aware at all times that they are working in a high-exposure area and because of health concerns. Among other things, since respirators are generally (although not always) required to be worn in regulated areas, engaging in the prohibited activities while wearing respirators might interfere with the respirator seal, placement or performance, thus reducing the effectiveness of the respirator. Furthermore, in the case of MC, smoking while being exposed to high MC concentrations (such as those prevailing in regulated areas) is particularly hazardous because MC is metabolized to CO in the body and leads to carboxyhemoglobinemia, a potentially life-threatening condition for some individuals, e.g., those with silent or symptomatic heart disease. Other OSHA health standards (e.g., asbestos, cadmium, ethylene oxide) have included similar prohibitions, and OSHA has concluded, based on the reasons discussed above and the Agency's experience with other standards, that including these provisions in the final MC standard is appropriate.
OSHA has broadened the language and separated it into two provisions (paragraphs (e)(4) and (e)(5)) to differentiate the types of activities which would generally not be allowed in a regulated area and those which would interfere with the effective use of respiratory protection. This is consistent with OSHA's intent in this rule to allow establishment of regulated areas, but require respirator use only when the 8-hour TWA PEL or STEL is likely to be exceeded.
Paragraph (e)(6), which is essentially unchanged from the proposed provision, requires employers to demarcate their regulated areas, but it does not specify how this is to be done as long as employees are aware of the location of the area and access to it is thus minimized. Factors that the Agency believes are appropriate for employers to consider in determining how to demarcate their areas include the configuration of the area, whether the regulated area is permanent, the airborne MC concentration present in the area, the number of employees in adjacent areas, and the period of time the area is expected to have exposure levels above the PEL or STEL. Permitting employers to choose how to identify and limit access to regulated areas is consistent with OSHA's belief that employers are in the best position to make such determinations, based on the specific conditions of their workplaces. This performance-oriented approach gives employers compliance flexibility without compromising employee health.
Paragraph (e)(7), proposed as paragraph (e)(5), requires employers at multi-employer worksites who establish a regulated area to communicate information to other potentially affected employers at the worksite about the location and access restrictions pertaining to the regulated area. OSHA believes that such communication will reduce the likelihood that unauthorized persons will enter the area or that workers not involved in MC-related operations will be exposed inadvertently. Those employers whose employees are exposed to MC at concentrations above either or both of the PELs must coordinate their operations with other employers whose employees could suffer excessive exposure because of their proximity to a regulated area where MC is being used. Compliance with this provision will ensure that only those employees at multi-employer worksites who are properly authorized, trained, and equipped enter regulated areas. This provision also recognizes OSHA's awareness that, although multi-employer worksites are common in construction, they are also increasingly found in other industry sectors.
Paragraph (f) Methods of Compliance
Paragraph (f) addresses the means by which employers are to reduce employee exposures to or below the 8-hour time-weighted average (TWA) PEL or the STEL. Under paragraph (f)(1), employers are required to institute and maintain the effectiveness of engineering controls and work practices to reduce employee exposure to or below the PEL and STEL, except to the extent the employer can demonstrate such controls are not feasible. Where these measures cannot reduce the concentration of airborne MC to or below the TWA PEL and STEL, the employer is nevertheless required to implement them to achieve the lowest feasible level. The employer is required to supplement these controls with respirators where necessary to ensure that employees are not exposed to MC at levels above either the 8-hour TWA PEL or the 15-minute STEL. Section 1910.134(a)(1) of the respiratory protection standard requires respirators to be used where effective engineering controls are not feasible.
One commenter [Ex. 19-57] indicated that it should be left to professional judgment to determine whether engineering controls or respirators are the best method for protecting employees. OSHA does not agree with this comment because it fails to acknowledge the industrial hygiene hierarchy of controls, which places engineering controls ahead of administrative or personal protective equipment as methods of protecting employees from hazardous exposures. The hierarchy of controls has been established industrial hygiene practice since the 1950s and is based on the fact that engineering controls are the most effective method of protecting employees because they remove the hazard from the workplace. In contrast, respirators merely prevent employees from breathing the contaminant -- it remains in the workplace air. Effective respirator use also requires constant supervision, extensive employee training and fit testing, and regular (often daily) care and maintenance of the respirator. Consequently, respirators should only be used as a means of achieving the PELs where feasible engineering controls are not available (such as in some vessel cleaning and non-stationary maintenance operations) or are not sufficient to control exposures to required levels. All OSHA substance-specific health standards have recognized and required employers to observe the hierarchy of controls, and OSHA's enforcement experience with these standards has reinforced the importance of this concept to the protection of employee health.
In the Final Economic Analysis, OSHA has described feasible control technologies for each industry affected by the final MC standard. Many employers have already implemented such controls in their workplaces and are currently achieving the MC levels required by the final rule. Examples of such feasible control strategies include dilution and local exhaust ventilation, chilling coils, magnetic pumps and magnetic floating gauges, exhausted lances for drum filling, and inline quality control sampling equipment.
OSHA acknowledges that there may be a few operations where the use of engineering and work practice controls to control exposure to MC is infeasible because exposures are highly intermittent in nature and limited in duration. In particular, OSHA is aware that the use of engineering and work practice controls to comply with the PELs is infeasible for some maintenance and repair operations and during emergency situations. Where it is infeasible to reduce workplace MC levels below the PELs through engineering and work practice controls, the employer is required to protect employees from excess exposure by providing and requiring the proper use of personal protective equipment, in this case supplied-air respirators.
As discussed in the NPRM (56 FR 57120-21), OSHA asked for comments on whether employers should be allowed to place increased reliance on the use of respirators to protect employees exposed to MC. The International Brotherhood of Painters and Allied Trades [Ex. 19-23] commented that "[w]ith the exception of emergencies that require use of a SCBA respirator, engineering and work practice controls should be the sole method of compliance."
[R]equirements to control those exposures using engineering controls are particularly important because of the lack of adequate chemical cartridge respirators for methylene chloride. For that reason, we reject the question posed by OSHA regarding the provisions to allow greater use of respirators which came from earlier proceedings on revisions to 1910.1000.
NIOSH supports the existing OSHA policy on methods of compliance, that is the hierarchy of controls for controlling exposures to hazardous agents. Generally, this policy states that whenever feasible, engineering controls and work practices should be used to prevent exposures, and that personal protective equipment, including respiratory protection, should be used only when engineering controls are not feasible.
As discussed above, OSHA agrees with these comments. The Agency considers the use of respirators to be the least satisfactory approach to exposure control because respirators provide adequate protection only if employers ensure, on a constant basis, that they are properly fitted and worn. Also, unlike engineering and work practice controls, respirators protect only the employees who are wearing them from a hazard, rather than reducing or eliminating the hazard from the workplace as a whole. Moreover, respirators are uncomfortable to wear, cumbersome to use, and interfere with communication in the workplace, which can often be critical to maintaining safety and health. As mentioned above, OSHA has reached similar conclusions for other standards promulgated to protect employees from exposure to toxic substances. Paragraph (g) of the final standard discusses respiratory protection requirements.
The NPRM also proposed requirements for a written compliance program that would have required employers to detail their plans for implementing engineering and other controls. However, OSHA has decided to eliminate these provisions from the final rule for MC to reduce the amount of paperwork employers would be required to complete. The Paperwork Reduction Act of 1995 (PRA 95), (44 U.S.C. 3501 et seq.), requires agencies to minimize the paperwork burdens on the public. Preparation of written compliance plans would be classified as paperwork under the new Act. OSHA believes that the lack of a written compliance plan will not substantially reduce the effectiveness of the standard; the Agency solicits comment on this point. One of the primary benefits of a written plan is that it encourages employers to consider remedial actions soon after the standard is promulgated. For MC, however, this may not be an issue because the necessary control measures are not complex and, except for the very smallest employers, the period for compliance allowed by the standard is relatively short. Nevertheless, OSHA believes that many employers will voluntarily develop these plans because they make it easier for employers and employees to monitor progress toward compliance. OSHA will be considering including compliance plans in its standards on a case-by-case basis in future rulemakings when they are appropriate. The Agency believes that employers benefit from having a plan to meet the start-up dates, and has included examples of how this might be done in Appendix B. There were very few comments about the written compliance plan requirements, other than one stating that a written plan is reasonable but annual review and update of it is not [Ex. 19-26].
Paragraph (f)(2), proposed as paragraph (f)(1)(iv), precludes use of a schedule of employee rotation as a means of compliance with the PELs. Employee rotation reduces the extent of exposure to individual employees, but increases the number of employees exposed. OSHA is regulating MC as an occupational carcinogen, and the Agency therefore prohibits practices that would place more employees at risk. No threshold has been demonstrated for the carcinogenic action of MC, and it is therefore prudent public health policy to limit the number of workers exposed. In addition, since the dose-response relationship for MC is convex, exposure to higher concentrations for shorter periods of time is riskier than exposure to the equivalent ppm-hour concentration spread over 8 hours (when rotation is used as a method of employee exposure control, employees tend to be exposed to higher concentrations for shorter durations).
Paragraph (f)(3) requires employers to address leak and spill detection in the workplace. Employers must implement procedures to detect leaks and contain spills as well as follow appropriate methods to dispose of contaminated materials and clean-up or repair the spill or leak. These requirements were addressed in proposed paragraph (f)(1)(iii), but in the final rule have been separated out and clarified to emphasize their importance. Appendix A provides examples of procedures that would meet these requirements. Liquid MC has a high vapor pressure (350 mm Hg at 20 C). Accordingly, leaks and spills of MC-containing products could generate high airborne MC levels. The leak and spill detection program reduces the possibility of worker overexposure to MC.
Bristol-Myers Squibb (BMS) [Ex. 19-14] and Dow [Ex. 19-31] supported OSHA's performance-oriented requirement for a program to detect leaks and spills. For example, BMS stated:
[T]here are many ways in which this can be done (e.g. monitoring of tank levels, walks through areas where leaks may occur). In some cases, continuous monitoring can be done to detect leaks, however, this is not always feasible. Monitoring equipment may be very difficult and expensive to maintain and may not provide the sensitivity needed for early detection. We recommend that OSHA leave this section as it is and not specify the system or the equipment which should be used for the detection program.
Proposed paragraph (h) required employers to develop emergency plans, implement those plans when necessary, equip employees correcting emergency situations with appropriate PPE, and alert and evacuate employees potentially affected by emergencies, as necessary. In reviewing the proposed rule, OSHA concluded that the proposed requirements duplicated provisions of the Hazardous Waste Operations and Emergency Response (HAZWOPER) standard (Section 1910.120). The Agency has therefore deleted the separate MC requirement for an emergency plan, and has added a note to final rule paragraph (f)(3)(ii) which refers employers to the HAZWOPER standard for the applicable requirements.
Paragraph (g) Respiratory Protection
Paragraph (g) of the final rule addresses requirements for respiratory protection allowed to be used to comply with the MC standard. Paragraph (g)(1) requires that employers provide respirators at no cost to each affected employee, and to ensure that each affected employee uses a respirator under the following conditions:
(1) Whenever an employee's exposure to MC exceeds or can reasonably be expected to exceed the 8-hour TWA PEL or the STEL;
(2) During the time interval necessary to install or implement feasible engineering and work practice controls;
(3) In a few work operations, such as some maintenance operations and repair activities, for which the employer demonstrates that engineering and work practice controls are infeasible;
(4) Where feasible engineering and work practice controls are not sufficient to reduce exposures to or below the PELs; or (5) In emergencies.
These limitations on the required use of respirators are consistent with OSHA's longstanding position on the hierarchy of controls in the workplace, as reflected in the respiratory protection requirements in other OSHA health standards (e.g., asbestos, Sec. 1910.1001; ethylene oxide, Sec. 1910.1047; benzene, Sec. 1910.1028; cadmium, Sec. 1910.1027) and with good industrial hygiene practice. They reflect OSHA's determination that respirators are inherently less reliable in providing protection to exposed employees than engineering and work practice controls.
However, to reflect the changes made to the final rule's regulated area provision (paragraph (e)(1)), the final rule's respiratory protection requirements differ somewhat from those in proposed paragraph (g). In the NPRM, OSHA proposed to require that employers provide respirators in the following circumstances: (1) During the time interval necessary to install or implement feasible engineering and work practice controls; (2) in work operations, such as maintenance and repair activities, vessel cleaning, or other activities for which engineering and work practice controls are demonstrated to be infeasible, and when exposures are intermittent in nature and limited in duration; (3) in work situations where feasible engineering controls are not yet sufficient to reduce exposure to or below the PELs; and (4) in emergencies. In the final rule, another situation where respirator use is appropriate is acknowledged: whenever an employee's exposure to MC exceeds or can reasonably be expected to exceed either or both of the PELs.
The Building and Construction Trades Department, AFL-CIO, testified [Tr. 816-17, 9/21/92] that proposed paragraph (g)(1)(ii) could be interpreted by construction contractors "as an exemption from the requirement for adopting a control strategy that places engineering and work practice controls above that of the PPE." In response, OSHA has revised final rule paragraph (g)(1)(ii) to clarify OSHA's intent. OSHA recognizes that it may be infeasible to control MC exposure with engineering and work practice controls during certain maintenance and repair operations, although OSHA is also aware that portable local exhaust, "elephant trunks," and other means of providing ventilation to, and removing contaminated air from, process vessels and other difficult-to-reach work spaces are widely used in construction and elsewhere. The Agency also recognizes that there may be other MC-related activities where an employer could establish the infeasibility of controls, particularly where employee exposure is highly intermittent or of short duration. Accordingly, OSHA has revised proposed paragraph (g)(1)(ii) as described above. This change also addresses comments made by the Pharmaceutical Manufacturers Association (PMA) [Ex. 19-25; Tr. 1430, 9/23/92], which stated that it was infeasible for employers to protect employees during manual unloading of batch operated centrifuges and manual loading of dryers from MC exposure with engineering and work practice controls. The PMA suggested that OSHA revise proposed paragraph (g)(1)(ii) to include those loading and unloading activities in the list of operations allowed to protect affected employees through the use of air-supplied respirators. However, OSHA included examples in the proposal only to provide a general indication of the situations where the Agency would accept the use of air-supplied respirators in lieu of engineering and work practice controls. OSHA believes that the examples suggested by the PMA are too narrowly focused for inclusion in such a list. It would not be possible for OSHA to enumerate in the final rule all of the workplace-specific operations where engineering and work practice controls may be infeasible. Therefore, in accordance with longstanding OSHA practice, employers claiming that engineering and work practice controls are infeasible must establish infeasibility on an objective basis.
Other commenters were concerned about requiring respirators during emergency escape situations, noting the time involved in donning a respirator in an emergency. The Dow Chemical Company stated "Dow believes the respiratory protection requirements for emergency escape are excessive. For the short period of time it takes to escape a release of MC, considering the minor acute effects of the material, it is excessive to require, as a minimum, a gas mask with an organic vapor canister" [Ex. 19-86].
Similarly, comparing escaping right away or first finding a respirator and then escaping during an emergency situation, Occidental Chemical testified [Tr. 2041, 10/14/92]:
Methylene chloride is not incapacitating so the goal should be to escape as fast as possible not trying to find a device -- and it may be close, it may be further -- and then put it on, which could take a minute or so, 30 seconds or a minute, and then decide about escape. That whole process becomes much longer. So I'm not advocating we don't have escape respirators, just that the process should be, escape should be the number one priority.
OSHA agrees that escape is the first priority for employees exposed to MC in an emergency situation. Furthermore, the Agency has determined, in general, that the ready availability of escape respirators is essential to ensure that employees are able to escape safely. To that end, emergency plans must provide for fast access to escape respirators where the potential for emergency exposure situations has been identified by the employer. In addition, employees must be trained to don those respirators properly and quickly and to recognize any foreseeable situations where taking the time to obtain and put on their respirators would significantly reduce their ability to escape or where they can safely escape an emergency situation without using respirators. OSHA recognizes that immediate escape is not always possible, so respirators are needed to protect those employees while they are still in the exposure area.
Paragraph (g)(2), proposed as paragraph (i)(1)(ii), requires employers to determine that any employee required by this standard to wear a supplied-air respirator in the negative pressure mode or a negative-pressure respirator for escape purposes is medically fit to use such a respirator. This provision has been changed from the proposal to recognize that medical fitness for respirator users under this standard is appropriate only for negative-pressure respirators or those operated in that mode. This change will assist employers to direct their medical surveillance resources effectively. In addition, in keeping with the greater flexibility provided by this standard to employers in selecting an appropriate health care professional, paragraph (g)(2) uses the final rule's language, "Physician or other licensed health care professional," in lieu of the proposal's exclusive use of "physician."
Paragraph (g)(3), proposed as paragraph (g)(2), requires employers to select appropriate atmosphere-supplying respirators from among those listed in Table 2 (Table 1 in the proposed rule), which sets forth the minimum requirements for respiratory protection and is unchanged from the proposal. Employers may use respirators approved for a higher level of protection in lower concentrations of MC. Employers are required to select atmosphere-supplying respirators that have been approved by NIOSH under the provisions of 42 CFR Part 84. Also, employers must select vapor canisters which have been approved by NIOSH when they provide gas masks with organic vapor canisters for use in emergency escape. The final rule differs from proposed paragraph (g)(2) in that it does not require employers to give employees who cannot wear negative pressure air-supplied respirators or who cannot wear a negative pressure (organic vapor canister) during an emergency escape the option of wearing a respirator with less breathing resistance. OSHA believes that the respirators required by the final rule will not strain an employee's respiratory system during such use.
Issue 30 (56 FR 57042) asked if the proposed respirator selection table (Table 1 in the proposal) appropriately regulated the choice of respirators. Several commenters suggested changes. For example, Abbott Laboratories [Ex. 19-29] suggested that OSHA allow the use of a continuous flow air-supplied hood or helmet for exposures up to 5,000 ppm instead of 625 ppm of MC. On the other hand, the Laborers' Health & Safety Fund of North America [Ex. 19-36] suggested that OSHA require employers to provide positive pressure SCBAs or airline positive-pressure full facepieces with auxiliary escape for all exposures over 25 ppm, instead of allowing any flexibility, in keeping with NIOSH recommendations for respiratory protection against carcinogens. The Advisory Committee on Construction Safety and Health [Ex. 21-69] recommended that respirators, when used, be pressure-demand, supplied air respirators with an auxiliary self-contained breathing apparatus, because of MC's fast cartridge/canister breakthrough and the lack of effective end-of-service-life indicators.
OSHA is currently in the process of developing a final standard to revise its general respiratory protection provisions in 29 CFR 1910.134. Until that rulemaking is completed the Agency will continue to rely on NIOSH's Assigned Protection Factors (APF) for determining the types of respirators required for protection to airborne concentrations of MC. The APF for continuous flow hoods/helmets is 25 in the NIOSH Respirator Decision Logic. The maximum specified use concentration for a respirator is generally determined by multiplying the exposure limit, in this case 25 ppm, by the protection factor, which is 25; therefore, these hood/helmets could be used only up to 625 ppm of MC. Using the same decision logic, OSHA believes that adequate protection can be provided by the respirators described in Table 2 when they are used under appropriate exposure conditions.
Some commenters questioned the reliability of atmosphere-supplying respirators. For example, in the furniture stripping industry commenters noted that MC could cause damage or potential damage to the hoses, the plastic lens, and the gasket of the facepiece of air line respirators or other kind of respirators, resulting in inadequate protection. [Ex. 19-11; Tr. 348-9, 9/17/92; Tr. 2146-7, 10/14/92; Tr. 2505-2506, 10/15/92]. In addition, the Occidental Chemical Corporation [Tr. 2115, 10/14/92] noted that none of the manufacturers contacted had hoses resistant to MC-induced corrosion. The Agency acknowledges that MC may damage respirator components, if the MC is left on them for extended periods of time. However, existing Sec. 1910.134 (f) already requires employers to inspect respirators frequently and to maintain respirators at their original effectiveness. In addition, MC does not damage rubber components which are available. Most importantly, if feasible engineering controls and work practices are not available, properly utilized air-supplied respirators are the only way to protect employee health from significant risk.
Issue 30 also requested information on the circumstances under which air-purifying respirators may be used. Dr. Morton Corn of Johns Hopkins University testified [Tr. 2352, 10/15/92] that "* * * with the current state of knowledge and the breakthroughs I indicated, [allowing gas masks with organic canisters for emergency escape only] is a prudent restriction at this time."
Several commenters disagreed with Dr. Corn and remarked that there are some situations where air-purifying respirators may be appropriate in addition to emergency situations, and recommended that OSHA expand the provision to allow the use of air-purifying (filter) respirators. For example, Occidental Chemical testified [Tr. 2113-4, 10/14/92] as follows:
Transportation workers who make deliveries in trucks can have intermittent exposure to methylene chloride inside the truck and, if you set the PEL too low, and in that emergency situation * * * you can't have engineering controls on some types of trucks, especially if they are rented. You ought to allow the use of respirators in that case; it's a very short type exposure, goes in, takes the drum out, and then gets back in the truck. Now it may be possible to schedule operations in certain industries where the PEL is exceeded for short periods of time. Filter cartridge respirators could be used to protect the worker during the short periods of time without the use of cumbersome supplied-air respirators. Of course, you have to have changes in the regulated areas in the rules also if you're going to allow the use of respirators where you have intermittent exposures above the PEL.
And a short breakthrough time does not mean a respirator is useless. If you use the NIOSH calculations, at 200 parts per million which might be typical of paint stripping, you ought to have about 118 minutes worth of time before you get breakthrough; and that may be enough in paint stripping operations.
Similarly, Bristol-Myers Squibb stated that air-purifying respirators may be appropriate in certain circumstances [Ex. 19-14]:
Based upon the scientific information now in the record, BMS requested that OSHA consider allowing chemical cartridge air-purifying respirators for specific types of activities (lower MC concentrations, shorter durations).
Organic vapor cartridges can be used for protecting employees against exposures to MC where using an air-supplied respirator would not be feasible due to costs or process (e.g. multiple working areas). Only air-supplied respirators should be used for operations involving the need for extended wear (e.g. greater than several hours).
The Eastman Kodak Company [Ex. 102] also requested that OSHA allow air-purifying respirators "in circumstances where their effectiveness can be adequately demonstrated, engineering controls are not feasible and supplied-air respirators are impractical or potentially unsafe. OSHA also should permit the use of half mask respirators" [Tr. 1196-7, 9/22/92]. In addition, Kodak described specific situations where it believed the use of air-purifying respirators was appropriate:
The use of air-supplied respirators must be an essential component of the exposure-control strategies for both the Roll Coating Division and the Dope Department. Moreover, the evidence demonstrates that air-purifying canister or cartridge-type respirators may appropriately be used in some operations, such as certain dope maintenance tasks. The use of air-purifying respirators is appropriate where: (1) air-supplied respirators or other controls are impractical or potentially unsafe, (2) personal monitoring of employees is conducted regularly, (3) the extremes and conditions of the exposure potential are well characterized, and (4) used cartridges are tested after use to verify the absence of unacceptable breakthrough. It is essential that OSHA permit the use of air-purifying respirators under these circumstances so that Kodak can control employee exposure when engineering and work practice controls and air-supplied respirators are infeasible, ineffective or potentially unsafe.
OSHA considered including a provision in the final rule to allow exceptions for the use of air-purifying respirators in limited circumstances where very tight control of the respirator program is implemented. However, the Agency has rejected this alternative for several reasons. First, the record strongly supports the inadequacy of such respirators for employee protection. Consequently, the use of air-purifying respirators should only be considered when the use of air-supplied respirators presents major disadvantages. Second, a program to use air-purifying respirators would have to be very detailed and be tailored to a specific workplace. It would be difficult, if not impossible, to list all of the relevant factors and criteria for such a program in the regulatory text, which must necessarily be appropriate to apply to many workplaces. (Below, OSHA discusses the Agency's variance procedures, which employers wishing to use air-purifying respirators may use to apply for a variance.) While there may be circumstances when the use of filter respirators may seem preferable to the use of atmosphere-supplied respirators, OSHA has concluded, as a general matter, that air-purifying respirators do not provide sufficient, consistent, and reliable protection to employees exposed to MC. In support of this conclusion, NIOSH testified as follows [Tr. 887-89, 9/21/92]:
At the request of OSHA, NIOSH has completed an in-depth study of the breakthrough characteristics of MC for organic vapor respirator cartridges and canisters under a variety of test conditions. This work was undertaken to determine MC breakthrough time for commercially available, organic vapor respirator cartridges and canisters. Several MC challenge concentrations were studied, ranging from 50 ppm to 1,000 ppm. As received cartridges and canisters were tested at equivalent flow rates of 64 Lpm through the respirator and at both 50% and 80% relative humidities (RHs). Breakthrough times were determined for individual cartridges and canisters, as well as stacked cartridges. The results of this study show rapid breakthrough of MC for organic vapor cartridges even for low concentrations of MC (e.g., 5 ppm breakthrough at approximately 30 minutes for 50 ppm challenge concentration and 80% RH). Appendix D is a detailed report of this study. At 125 ppm challenge concentration, 5 ppm breakthrough, and 80% RH, one brand of cartridge showed breakthrough times of approximately 40 minutes. The same brand of chin-style canister, that contains approximately 2 and (1/2) to 3 times more sorbent than two cartridges (i.e., two cartridges per respirator) showed breakthrough times of approximately 100 minutes when tested at the same conditions. The same brand of front- or back-mounted canister, that contains approximately 10 times more sorbent than two cartridges, showed breakthrough times of approximately 600 minutes. Based on the results of this study, NIOSH supports the OSHA proposal to require the use of air-supplied respirators in lieu of air-purifying respirators. However, because of the potential carcinogenicity of MC, NIOSH continues to recommend only the most protective positive-pressure respirators as noted previously.
The NIOSH study indicated that MC quickly penetrates organic vapor cartridges (in a fraction of a typical work shift), contrary to the assertions of Occidental Chemical and the other commenters mentioned above. Larger canisters, which contain greater amounts of absorbent, last longer, but are still effective for less than a work shift (except for very large canisters). Another problem with organic vapor cartridges and canisters is that MC migrates through the absorbent even when the respirator is not being used. This further decreases the breakthrough time and raises the possibility that the employee will be exposed to significant concentrations of MC. Also, humidity decreases the amount of MC collected by the absorbent.
Another problem with air-purifying respirators in the case of MC is this substance's poor warning properties, which mean that workers will not be able to smell or sense the presence of MC when breakthrough occurs. OSHA believes that employees wearing air-purifying respirators could easily have a false sense of security and be lulled into believing that they were being protected against MC when it could already have broken through the absorbent. Accordingly, OSHA has concluded that it would be inappropriate to allow broad-scale use of air-purifying respirators because of MC's quick breakthrough time and its carcinogenic health effects.
Employers who believe that the use of filter respirators is appropriate for their operations may apply for a permanent variance from the requirements of paragraph (g)(3) of this section, pursuant to the authority granted by Sec. 6(d) of the Occupational Safety and Health Act and the procedures set out in 29 CFR part 1905. In particular, an applicant would need to establish that the use of filter respirators in a specific workplace would provide employee protection equivalent to that which would be provided through compliance with final rule paragraph (g)(3). As discussed below, the respirator program, procedures, and data needed to support the use of such respirators under a variance are extensive.
A successful variance application for an exception that would allow air-purifying respirators would have to address a number of the characteristics that employers such as Eastman-Kodak [Ex. 102] indicate they have undertaken with regard to the use of such equipment. For example, extensive exposure monitoring would have to be done to accurately characterize employee MC exposure levels. Furthermore, the breakthrough time for MC when used in the airborne concentrations expected in the workplace would have to be known, and cartridges would have to be changed before employees are unacceptably exposed. The program would have to be carefully monitored by a trained and experienced individual such as a certified industrial hygienist or the equivalent. Finally, the respirators would have to be appropriately fit tested for each affected employee. For all of the reasons stated above, OSHA has determined that the interests of employee protection will be best served by requiring all employers, except those whose respiratory program, procedures, and exposure data can support a variance request, to provide their employees with the respirators shown in Table 2.
Paragraph (g)(4), which is identical to the proposed (g)(3), requires employers to implement a respiratory protection program in accordance with 29 CFR 1910.134 whenever respirator use is required by this standard. The respiratory protection program must include basic requirements for proper selection, fit, use, training of employees, cleaning, and maintenance of respirators. For employers to ensure that employees use respirators properly, OSHA has found that the employees need to understand the respirator's limits and the hazard against which it is providing protection in order to appreciate why specific requirements must be followed.
Paragraph (g)(5) (effectively identical to proposed paragraph (g)(4)) requires that employers allow employees wearing respirators to leave the regulated area to readjust the respirator facepiece to their faces for proper fit. In addition, employers must permit employees who wear respirators to leave the regulated area to wash their faces as necessary to prevent skin irritation associated with respirator use. These requirements encourage the proper use of respirators by authorizing employees to take specific actions that ensure the effective functioning of respirators and reduce the likelihood that employees will experience adverse side effects from wearing respirators.
Paragraph (g)(6), which is essentially the same as the corresponding proposed paragraph, addresses situations where employers provide gas masks with organic vapor cartridges for purposes of emergency escape. If gas masks are used, the canisters are to be replaced before the gas masks are returned to service. This requirement is necessary because actual MC exposures during emergencies are generally not known, so the expected service life of the canister cannot be determined. In addition, the migration of MC within the canister after emergency exposure further reduces the amount of useful life remaining, posing exposure risks for subsequent users.
Paragraph (g)(7) addresses respirator fit and is essentially identical to the corresponding provision of the proposal. It requires the employer to ensure that each respirator issued is properly fitted and has the least possible facepiece leakage.
Under paragraph (g)(7)(ii), the employer must perform qualitative or quantitative fit testing initially and at least annually thereafter for each employee wearing a negative pressure respirator, including those employees for whom emergency escape respirators of this type are provided. A note has been added to this provision to indicate clearly that the only supplied-air respirators to which this provision would apply are SCBAs operated in the negative pressure mode and full facepiece supplied-air respirators operated in negative pressure mode. Quantitative fit testing relies on objective data generated by measurements of facepiece seal leakage, in contrast to qualitative fit testing, which is based on subjective observations made by the respirator wearer. Many commenters expressed a preference for quantitative fit testing over qualitative fit testing. For example, Newport News Shipbuilding (NNS) [Ex. 19-37, p. 2] stated: "Quantitative respirator fit testing is the method of choice. At NNS we use quantitative fit testing exclusively, as this method is more definitive than qualitative fit testing and provides a record of the fit test." The Shipbuilders Council of America [Ex. 19-56, p. 11] took the same view.
Several commenters noted the importance of proper selection and fit testing of respirators [Exs. 19-12, p. 3; 19-31, pp. 15-17; 19-71, p. 4]. Dr. David Newcombe of the Department of Environmental and Health Sciences at The Johns Hopkins University testified as follows:
I think that's [quantitative fit testing] a very important parameter because, first of all, respiratory protection when it's required takes a reasonable amount of time to ensure that the individual is properly fitted so that the mask fits if that's the piece that's going to be used and is protective against the substance that you're protecting against and, in addition, I think it's important to note that some people may have deformities that cause a poor fit and, therefore, don't protect and so I would think that you have to have a careful assessment of the type of respiratory protection you're going to use, its fit in a single individual as well [Tr. 800, 9/18/92].
In most cases, OSHA has determined that positive pressure respirators are the respirators of choice for MC exposure, especially loose-fitting models such as hoods or helmets; for these respirators, fit testing is generally not needed. However, for those situations where negative pressure respirators are used, fit testing is needed. Qualitative or quantitative fit testing allows the employer to test various respirators on the employee until the appropriate fit is identified and selected for the employee.
Paragraph (h) Protective Work Clothing and Equipment
Paragraph (h) requires that, where needed, employers provide and ensure the use of the appropriate protective clothing and equipment. The requirements for protective work clothing and equipment were separated from proposed paragraph (g) (respiratory protection and personal protective equipment) and moved to paragraph (h) to facilitate compliance. Proposed paragraph (g)(6) was effectively identical to this paragraph.
Protective clothing used during exposure to MC, such as gloves or aprons, must be resistant to MC. The Building and Construction Trades Department, AFL-CIO [Tr. 832, 9/21/92] suggested that OSHA codify NIOSH's recommendations for protective clothing materials suitable for use with MC. MC is a constituent of so many different products that a codification of guidance regarding appropriate protective clothing would be unwieldy and unlikely to be complete. Further, the continual formulation and reformulation of MC products virtually ensures the early obsolescence of any protective clothing guidelines.
Therefore, OSHA believes that it is appropriate for paragraph (h) to set general criteria and for the Agency to adopt the NIOSH recommendations in a nonmandatory appendix so employers will have more detailed guidance and so OSHA can update that guidance, without rulemaking, as advances in PPE technology cause existing guidance to become outdated. As discussed above, this performance-oriented approach reflects OSHA's belief that employers are in the best position to select protective measures that are tailored specifically to the needs of their workplaces.
Paragraph (h) requires the employer to provide all necessary protective clothing and equipment at no cost to the employee and to launder, repair, replace and safely dispose of that clothing and equipment. The final rule is performance-oriented so the employer has the flexibility to provide only the protective clothing and equipment necessary to protect employees in each particular work operation from MC exposure. The generic requirements for PPE in the general industry, construction, and shipyard standards also apply to PPE for MC, except where a specific provision of the MC standard applies.
Paragraph (i) Hygiene Facilities
Paragraph (i) of the final rule establishes requirements for hygiene facilities in establishments where it is reasonably foreseeable that an employee's eyes or skin may contact solutions containing 0.1 percent or greater MC. Although such provisions were not part of the proposed rule, OSHA requested comment on the appropriateness of including such requirements in Issue 38 (56 FR 57122). Specifically, the Agency requested comment on the appropriateness of including requirements for quick-drench showers and eye-wash facilities in the final rule. OSHA described quick-drench showers as," * * * showers that could drench an employee with piped-in water applied with force," and eyewash facilities as devices "that could flush the eyes repeatedly with a great amount of water." In response to comments, described below, the Agency has decided that it is not necessary to specify in the final rule when showers and eyewash facilities are required to protect employees from skin or eye contact with MC, because employers are in the best position to determine whether the MC used in their establishments meets the 0.1 percent cutoff specified in this provision and whether contact of the eyes or skin with MC can reasonably be foreseen.
Paragraph (i)(1) requires employers to provide conveniently located washing facilities appropriate to removing MC if it is reasonably foreseeable that the employee's skin may contact a solution containing 0.1 percent or greater MC through splashes or spills. MC can be absorbed into the body through skin contact (percutaneous absorption), which would add to the dose employees receive via inhalation and thus increase the risk of cancer and other adverse health effects. However, MC is not a corrosive chemical, and, if left on the skin for short periods, is not likely to cause long-term or irreversible damage. Therefore, it is important that employers make provisions to remove MC from the skin of employees quickly, although immediate drenching is not usually required. This requirement has been stated in performance-oriented language in the final rule to allow employers to determine what type of washing facilities are needed and at what distance from affected employees. This provision thus recognizes that employers in some facilities, such as furniture stripping shops where a thick MC gel is used that may burn the skin on contact, employers need to position washing facilities in closer proximity to affected employees than is the case where less hazardous solutions of MC are used. OSHA believes that this requirement of the final rule strikes the right balance between employee protection and employer flexibility by ensuring that washing facilities for the skin will be available and appropriately placed in workplaces where such contact is likely.
MC splashed into the eyes will cause irritation if the MC is not promptly washed out, and immediate flushing is therefore required. Paragraph (i)(2) requires employers to provide appropriate eyewash facilities within the immediate work area for emergency use if it is reasonably foreseeable that an employee's eyes will contact solutions containing 0.1 percent or greater MC through splashes or spills.
Existing OSHA requirements at Sec. 1910.141 and Sec. 1926.51 establish generic provisions for hygiene facilities but do not focus on MC-specific situations. Existing Sec. 1910.151(c) and Sec. 1926.50 (g) require employers to provide suitable facilities for quick-drenching or flushing of body and eyes within the immediate work area for immediate emergency use, when the body or eyes may be exposed to injurious corrosive materials. However, because MC is not classified as a corrosive material, these existing requirements would not apply. Thus the final rule's performance-oriented requirements will provide guidance to employers about what facilities and access distances are appropriate for conditions in their workplaces. In addition, Appendix A provides examples of both washing facilities and eyewash facilities that would satisfy this requirement.
The response to Issue 38 emphasized the need for eyewash and shower facilities [Exs. 19-37, 19-56; Tr. 2644-2645, 10/16/92; Tr. 1942-1943, 9/24/92]. For example, PRMA testified [Tr. 348, 9/17/92] that MC splashes happen "almost every day" in furniture stripping workplaces.
Commenters also addressed the health effects associated with such accidental exposures. The Amalgamated Clothing and Textile Workers Union testified [Tr. 1825, 9/24/92]:
I would advocate including it [the provisions for showers and eyewash facilities]. It [methylene chloride] has skin effects. Anyone who's ever stripped paint can tell you about what it's like to get it on their skin or their eyes. So it's very important to be able to irrigate an affected area promptly.
One means to provide protection from prolonged skin or eye exposure to MC from accidents is to specifically require quick-drench showers and eyewashes. The NPRM sought comments on whether or not the final rule should require employers to provide quick-drench showers and eyewash facilities. Many commenters recommended that the final rule contain such provisions [Exs. 19-15; 19-36; Tr. 532, 9/18/92; Tr. 1380, 9/23/92; Tr. 2352-53, 10/15/92]. For example, PRMA [Ex. 19-11] favored a requirement for eyewash/quick drench facilities, stating as follows:
An eyewash station is a safety device that should be required in any work environment where there is the possibility of splashing chemicals into ones eyes. Quick drench showers are also a safety device that should be standard equipment in every facility. MC paint removers are one of the few paint removers that are easily rinsed from one's eyes.
The Dow Chemical Company commented [Ex. 19-31]:
Washing facilities are always a good idea when working with any material, however, it is not always necessary to have quick-drench showers, etc. Incidentally, quick-drench showers do not deliver water "applied with force." They work on a deluge system delivering a large amount of water to wash off the material, not force it off. Installing showers and eyewash fountains in all workplaces may not be economically feasible. There are other systems such as water hoses, portable eye-washes, etc. that work effectively for MC. MC is a material that, in some cases, may be painful if held against the skin for a period of time, but is not eye nor skin nor life threatening. Therefore, an immediate shower is not required.
OSHA agrees that quick drench and eyewash facilities are effective means for treating employees who have been accidentally exposed to MC by spills or splashes. However, the Agency agrees with Dow Chemical that quick drench showers are not the only means to ensure proper first aid treatment for MC exposure due to accidental splashes or spills and believes that other types of washing facilities can also provide effective treatment for accidental exposure.
In some cases, the availability of a hose attached to a potable water supply would enable employers to provide effective first aid treatment. This could be an especially effective means of protection at a construction worksite. Several commenters [Ex. 19-23, 19-38; Tr. 859, 9/21/92] agreed that construction employers should have potable water at the worksite in case of accidental exposure. For example, the Building and Construction Trades Department, AFL-CIO, testified [Tr. 817, 9/21/92]:
The standard does not address the need for available hygiene facilities. Since methylene chloride can damage the skin and eyes and potable water is often in limited supply on construction sites, the requirement for potable washing areas must be clearly stated in the standard. Potable water supplies should be of sufficient volume to provide at least 15 minutes of continuous flushing.
The Occupational Health Foundation testified that the MC standard should require that hygiene facilities be provided within a reasonable distance at construction worksites [Tr. 858-859, 9/21/92]:
Unlike in a lot of other work sites where at least there's a sink nearby, in construction you really need to specifically mandate that provision to be sure that there's going to be water anywhere remote, you know, within a reasonable distance to the work site.
Issue 38 also requested information on the extent to which MC-exposed employees are already provided with quick drench showers and eye wash facilities. Several commenters described workplaces that have emergency shower or eyewash facilities in place. The United Automobile, Aerospace and Agricultural Implement Workers of America (UAW) testified [Tr. 1942-1943, 9/24/92] "[t]here are a lot of showers and eye washes in areas where you have open-top chemicals or use of chemicals." In addition, the Occidental Chemical Corporation testified [Tr. 2159, 10/14/92]:
. . . we conducted a survey of our customers that were not CMA and not NACCD members recently and asked them questions like that. We have some information on that. It doesn't necessarily mean that we hit a large percentage of our methylene chloride customers, though.
. . . we have safety shower[s] and eyewash[es] [in our plants], certainly. We have . . . recommendations on it and we certainly follow the ANSI standards on it.
Newport News Shipbuilding (NNS) and the Shipbuilders Council for America both commented [Exs. 19-37 and 19-56] that "[p]rocedures at NNS now require eyewash units. For the most part we use portable (5 gallon) units. Plumbed combination units would be better." The National Tank Truck Carriers, Inc. also indicated that their facilities are already equipped with emergency showers [Tr. 1750-51, 9/24/92].
With regard to the proximity of employees to emergency showers and eye washes, commenters and testimony indicated that, depending on the work operation, shower facilities have been installed as close as eight feet or as far away as 100 feet. For example, the J. M. Murray Center, testified [Tr. 1047-48, 9/21/92] that they have both eye washes and showers that are ten to twelve feet from the employees.
The Polyurethane Foam Association (PFA) testified [Tr. 1630, 9/23/92] that the proximity of shower facilities and eye washes depends on the plant and operation within the plant, stating as follows:
We've got methylene chloride in bulk storage area and we also use it at the foam machine. The total range from those things that you might be would be anywhere from eight feet to may be 60 feet. And I'm guessing at the 60 feet. That, again, is specific for those plants that I am responsible for. There are 80-some-odd plants out there, and I can't speak for that particular physical setup in each one of those plants.
Eye wash and drench showers are available in the production areas. These are located within 10 to 15 feet of the work stations, such as near bulk storage tanks and the mixing head, where a higher risk of employee exposure exists. Hygiene facilities may be 50 to 75 feet away from other work areas [Ex. L-100A].
The Eastman Kodak Company testified [Tr. 1259, 9/22/92] that emergency eye-wash and quick-drench showers are available in their workplaces, and that such stations are between 50 and 100 feet from all work areas where exposure to chemicals may occur.
Striptech International, which advocated requirements for pressure showers and eyewash facilities where workers are exposed to MC [Ex. 19-15], also testified that hygiene facilities are not readily accessible in the aircraft paint stripping industry [Tr. 1834-35, 9/24/92]:
I've heard people ask about deluge in eye wash. Does it exist in aircraft maintenance hangars? Yes, it surely does; but you also have to look at where they normally are. They're normally on the walls. When a man or a lady is on top of an aircraft, on the tail of an aircraft, they may be nine stories in the air. If they get methylene chloride in their eyes or really a bad shot of it, they've got to come down nine stories and may be cross a 400 to 600-foot-long hangar to get to it. Deluge showers, yes; all aircraft people have them. Are they readily accessible? No.
It is important for the employer to evaluate the potential hazard posed by the particular use of MC and to provide appropriate washing facilities within a reasonable distance and eyewash facilities within immediate reach. In addition, employers are required to provide employees who are at risk of skin and/or eye contact with MC with appropriate protective clothing and eye protection. Portable eyewash units, which would significantly reduce any delay in irrigating the eyes, are available and can be located within easy access distance of affected employees. As described above, access to washing facilities should be quick, but immediate showering is not generally necessary to address the MC skin hazard. Therefore, an employee stripping an airplane would likely have time to get to the showers located along the walls of the hangar to wash MC from the skin. (Note: Some paint stripping compounds do contain corrosives, and immediate access to quick-drench facilities is essential in such cases.) Based on a review of the rulemaking record, the Agency has determined that performance-oriented provisions for hygiene facilities are reasonably necessary to supplement the other requirements of the final rule and has promulgated paragraph (i) accordingly.
Paragraph (j) Medical Surveillance
Section 6(b)(7) of the OSH Act requires that, where appropriate, occupational health standards shall prescribe the type and frequency of medical exams or other tests to be made available, by the employer or at the employer's cost, to exposed employees in order to determine if the employee's health is being adversely affected by exposure to workplace hazards.
A medical surveillance program that complies with paragraph (j) enables the employer to:
(1) Determine if an employee has an underlying health condition that places the employee at increased risk from the effects of exposure to MC;
(2) detect, insofar as possible, early or mild clinical conditions arising as a result of MC exposure, so that appropriate preventive measures can be taken;
(3) identify any occupational diseases that occur as a result of MC exposure; and
(4) help to evaluate possible trends in the incidence of these diseases.
The most serious health effect that may result from MC exposure is cancer. Although a medical surveillance program cannot detect MC-induced cancer at a preneoplastic stage, OSHA anticipates that, as in the past, methods for early detection and treatments leading to increased survival rates will continue to evolve. Moreover, the cardiovascular disease, central nervous sytem and dermal irritation effects caused by MC exposure can already be detected at early or mild stages by medical surveillance provisions such as a medical history and a medical exam. MC has not been tested adequately for the full range of possible health effects that may result from exposure, so it is also not presently possible to identify all diseases that may be associated with exposure to MC. The specific level of protection afforded the worker by the final standard cannot be predicted with certainty, although the risk of exposure for those effects that have been identified are significant, and the record shows that reducing the exposure of employees will significantly reduce that risk. An important goal of the medical surveillance program is to provide information related to the adequacy of the PELs for MC by documenting the health condition of exposed employees, particularly in the area of carcinogenicity.
Several rulemaking participants [Exs. 19-31, 19-83, Tr. 1802-3, 9/24/92] stated that the proposed medical surveillance provision should be deleted from the final rule because it would not detect employee exposure to harmful levels of MC. In addition participants contended [Ex. 19-83, Tr. 458, 9/17/92] that the medical surveillance provision is too expensive and burdensome. OSHA has determined that the medical surveillance program required by the final rule is reasonably necessary for the protection of workers. In particular, medical surveillance will directly benefit workers with cardiovascular disease, central nervous system effects, and dermal irritation. These conditions can be detected by the medical surveillance program required by this paragraph of the final rule, and the detection of such conditions can, in turn, alert the employer to potential overexposures to MC in the workplace and to the need to limit MC exposures for certain employees with underlying heart disease or other conditions.
In addition, by increasing the performance orientation of the rule, OSHA has minimized the costs of medical surveillance while maintaining its effectiveness. For example, the final rule leaves the content of laboratory surveillance for individual employees to the discretion of the physician or other licensed health care professional. Also, the requirement for a physical examination has been tailored to the age of the employee, so that employees younger than 45 generally receive an exam only every three years, instead of annually. The medical surveillance program also will aid in the evaluation of cancer incidence in the workplace and temporal trends therein.
Paragraph (j)(1) specifies the circumstances under which employers must provide medical surveillance for employees who are or may be exposed to MC. Under paragraph (j)(1)(i), employers must make medical surveillance available to all employees who are exposed to MC at or above the action level for 30 days or more in any year or above either of the PELs for at least 10 days in any year. This provision is effectively identical to the corresponding provision of the proposed rule. Also, this requirement is consistent with the approach taken by OSHA in the benzene standard (29 CFR 1910.1028). OSHA recognizes that the health effects associated with MC exposure are, in general, the result of chronic exposures to MC. Accordingly, employees exposed only for a few days in any year will be at relatively low risk of developing MC-induced disease. The exposure duration thresholds in the final rule will thus enable employers to focus valuable medical resources on high-risk employees.
Some commenters were concerned about the use of the PELs and action level as triggers for medical surveillance. The Building and Construction Trades Department, AFL-CIO [Tr. 817, 9/21/92] was concerned that this provision would preclude medical surveillance for some employees with MC exposures that exceeded the PELs on fewer than 10 days in a given year but who might nonetheless be at risk of adverse health effects. OSHA has determined that employees who have been identified by a physician or other licensed health care professional as being at risk for cardiac disease or some other serious MC-related health condition and who are exposed to MC at levels that exceed the PELs on fewer than 10 days in any year should have the option of participating in a medical surveillance program. Accordingly, paragraph (j)(1)(ii) has been added to the final rule. This provision states that medical surveillance must be provided to any employee (1) who is exposed above the 8-hour TWA PEL or STEL for any time period, and (2) who has been identified by a physician or other licensed health care professional as being at risk from cardiac disease or from some other serious MC-related health condition, and (3) who requests inclusion in the medical surveillance program. As noted in the Health Effects section, above, OSHA is concerned that any MC exposure above either of the PELs could exacerbate cardiac problems. This paragraph enables such high-risk employees to participate in a medical surveillance program.
Under paragraph (j)(1)(iii), appropriate surveillance is required to be made available to employees exposed in an emergency regardless of the airborne concentrations of MC normally present in the workplace. Where very large amounts of materials are kept in a sealed system, routine exposure may be very low. However, rupture of the container might result in extremely high MC exposures. Thus, it is appropriate for employers who have identified operations where there is a potential for an emergency involving MC to plan ahead so that emergency medical surveillance would be available if needed. This provision is effectively identical to proposed paragraph (i)(1)(iii).
Proposed paragraph (i)(1)(ii) would have required that the employer have the examining physician or other licensed health care professional determine if affected employees are physically fit to wear respirators. OSHA has placed this requirement with the other respiratory protection provisions in paragraph (g) of this final rule.
Paragraph (j)(2) requires that employers offer examinations without cost to employees, at a reasonable time and place, and without loss of pay. OSHA believes that this provision is necessary to encourage employees to participate in the medical surveillance program. Final rule paragraph (j)(2), which is essentially identical to proposed paragraph (i)(2), is also consistent with other OSHA health standards and with provisions contained in the OSH Act.
Paragraph (j)(3) requires that all medical procedures be performed by or under the supervision of a physician or other licensed health care professional, defined as "an individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows him or her to independently provide or be delegated the responsibility to provide some or all of the health care services required by paragraph (j) of the standard." The proposal required that all medical procedures be performed only by or under the supervision of a physician. Only one commenter [Ex. 19-31] specifically supported this provision.
OSHA has long considered the issue of whether and how to identify the particular professionals who are to perform the medical surveillance required by its health standards. The Agency has determined that other professionals who are licensed under state laws to provide medical surveillance services would also be appropriate providers of such services for the purposes of the MC standard. The Agency recognizes that the personnel able to provide the required medical surveillance may vary from state to state, depending on state licensing laws. Under the final rule, an employer has the flexibility to retain the services of a range of qualified licensed health care professionals, thus potentially reducing costs, increasing flexibility, and allowing employers to identify those professionals, who may not necessarily be physicians, with the greatest expertise in diagnosing and treating occupational diseases. In future rulemakings, OSHA may attempt, with the cooperation of interested stakeholders, to specify which licensed health care professionals are the most appropriate to perform each of the diagnostic, therapeutic, medical management and other services required by the Agency's standards.
Paragraph (j)(4) of the final standard addresses when medical examinations and consultations are to be provided.
Initial surveillance. Under paragraph (j)(4)(i), initial medical surveillance must be provided before an employee's initial assignment to work in an area where they would be exposed to MC or by the start-up dates described in paragraph (n)(2)(iii) of the final MC standard, whichever is later. The employer need not repeat equivalent medical surveillance if it has already been provided within the past 12 months. OSHA's requirement for a preplacement examination is intended to determine if an individual is at increased risk of adverse effects from exposure to MC. It also establishes a general baseline for future reference. The provisions of final rule paragraph (j)(4) are effectively identical to those in proposed paragraph (i)(3), except that the proposed rule did not take into account medical surveillance provided prior to the effective date of this section. In the preamble to the NPRM (56 FR 57124), OSHA stated that it was considering a provision that would give employers credit for medical examinations provided within one year of the standard's effective date. The Agency requested comment on the usefulness of such a provision. Commenters [Exs. 19-31, 19-55b, 19-83] supported such a provision. In particular, Dow Chemical [Ex. 19-31] stated "[i]f this is not done this section will be unfair to those employers who have on-going health surveillance programs." OSHA agrees with these commenters and has promulgated the final rule accordingly.
Periodic surveillance. Paragraph (j)(4)(ii) addresses periodic medical surveillance. OSHA proposed to require annual medical surveillance for all affected employees. In the final rule, this has been changed so that the employer is required to update the medical and work history for each affected employee every year but must only provide physical examinations on a schedule that varies with the age of the employee. For affected employees 45 years of age or older, the physical examination must be conducted every year. For employees less than 45 years of age, the examination need only be done every three years.
OSHA differentiated these groups of employees in an effort to target surveillance resources effectively. The probability of developing heart disease (which can be exacerbated by MC exposure) increases as employees age. Age 45 is a rough approximation of the point at which medical professionals would have heightened concern for cardiac effects. In other words, it is generally more likely that employees 45 years and older would experience the adverse cardiac effects of MC exposure. Three-year intervals between physical examinations for workers younger than 45 seemed the proper interval to balance the conservation of valuable medical resources and the provision of a medical surveillance program that is useful for detecting adverse MC health effects. The annual updates on medical and work history will enable the physician or other licensed health care professional to identify those individuals for whom more frequent examinations would be appropriate.
To a lesser extent, this would be true for the detection of MC-induced cancer as well. Although MC-induced cancer cannot currently be detected at the pre-neoplastic stage, early detection of cancer generally increases the survival rate, so it is important to include employees exposed to MC in a medical surveillance program that may detect tumors. Since any cancers caused by MC are more likely to be found in older employees and employees exposed to MC for longer durations, it is reasonable to concentrate medical surveillance resources on older employees.
The main goal of periodic medical surveillance for workers is to detect adverse health effects at an early, and potentially still reversible, stage. The intervals chosen based on the age of the employee are consistent with this purpose and with other OSHA health standards. The Agency believes that these periodic surveillance requirements strike a proper balance between the need to diagnose health effects, such as cancer, at an early stage, thus increasing the effectiveness of medical intervention, and the expectation that a limited number of cases will be identified through the surveillance program. This approach decreases the cost burden of surveillance by lengthening the period of time between examinations for younger employees who have fewer years of exposure and thus have a lower risk of adverse health effects.
Termination of employment or reassignment. Paragraph (j)(4)(iii) requires the employer to provide medical surveillance when an employee terminates employment or is reassigned to an area where exposure is consistently at or below the action level and the STEL. The termination examination need not be conducted if medical surveillance has been performed within the past six months. This requirement reduces the likelihood that an employee who terminates employment has an active, but undiagnosed, disease related to his or her MC exposure. In the NPRM, OSHA had proposed that the termination examination be performed unless medical surveillance had been conducted on that employee within the past three months. The Motor Vehicle Manufacturers Association [Ex. 19-42] requested that the exam should only be required if the employee has not had a medical exam within six months of termination or reassignment, instead of three months as had been proposed. The MVMA stated that "six months is adequate and consistent with other OSHA health standards (Cadmium, Sec. 1910.1027(l)(8)). We see no contribution to reducing employee risk from examining such employees at an earlier date, especially since the exposure to methylene chloride has been removed." Upon reconsideration of the issue, OSHA has adopted this suggestion in the final rule.
The Agency requested public comment on whether continued annual surveillance should be offered to employees who have left employment, retired, or transferred to other areas within the employer's operations. Such an approach would be consistent with the requirement in the Benzene standard (29 CFR 1910.1028), which makes medical surveillance available to certain employees who have been exposed to benzene during their employment with their current employer. Several commenters [Exs. 19-31, 19-38, 19-42, 19-48, 19-55b, 19-58] stated that there should be no medical surveillance after an employee leaves a job in an exposure area or for employees previously exposed to MC. In particular, Dow Chemical [Ex. 19-31] stated: "[W]e do not believe that the employer should be responsible for continued medical surveillance for employees who leave MC exposure areas * * *. [T]he continued surveillance does nothing more than divert occupational medical resources from more important work." Taking a different view, the IUE [Tr. 533, 9/18/92] testified that formerly exposed retirees should be included in the medical surveillance program. They also stated that retirees, presently employed workers formerly exposed to MC in previous jobs, and workers relocated to nonexposed areas should be included in the medical surveillance program. The ACTWU agreed, testifying [Tr. 1763-1764, 9/24/92] that employees who continue to work for the same employer after their exposure to MC is terminated should be entitled to participate in the medical surveillance program.
OSHA has decided that it would be inappropriate to include retirees and other formerly exposed employees in the medical surveillance program. A major value of medical surveillance is to detect the acute heart disease and CNS effects associated with MC exposure. Workers no longer exposed to MC, or retirees, would be at much less risk of experiencing these effects.
Additional surveillance. Paragraph (j)(4)(iv) requires employers to provide additional surveillance when the physician or other licensed health care professional recommends that it be provided. This may be warranted, for example, for an employee who is under 45 years of age but has a health condition that requires surveillance more frequently than every 3 years. Inclusion of this provision in the final rule will ensure that all employees receive the most appropriate level of surveillance for their particular health situation. The proposed provision was essentially identical.
Paragraph (j)(5) of the final rule, like paragraph (i)(4) of the proposal, establishes the requirements for the content of medical exams. This provision requires a comprehensive medical and work history, a physical examination, laboratory surveillance, and any additional information determined to be necessary by the physician or other licensed health care professional. The language in the proposed rule, which was similar, has been revised for clarity and to provide guidance about what constitutes adequate medical surveillance. For example, the final rule addresses medical and work history in greater detail than the proposal because, in some cases, three years may elapse before a subsequent physical examination is provided. On the other hand, the specific content of the physical examination and laboratory surveillance has been left largely to the discretion of the physician or other licensed health care professional.
Paragraph (j)(5)(i) requires that a comprehensive medical and work history be obtained from each participating employee. This paragraph requires a medical evaluation that includes a comprehensive medical and work history with special emphasis on neurological symptoms, skin conditions, history of hematologic or liver disease, signs or symptoms suggestive of heart disease (angina, coronary artery disease), risk factors for heart disease, MC exposures, and the work practices and personal protective equipment used to control exposures. OSHA has included an example of a medical and work history format that would satisfy this requirement in non-mandatory Appendix B of the standard. The proposed provision required a comprehensive or interim medical and work history with emphasis on neurological symptoms, mental status, and cardiac health. Final rule paragraph (j)(5)(i) has been revised to indicate clearly what is required.
The medical and work history component of the initial medical evaluation will assist the physician or licensed health care professional in identifying pre-existing conditions that might place the employee at increased risk when exposed to MC. It also establishes a health baseline for future monitoring. The subsequent annual updates will identify changes in neurological symptoms, skin conditions or cardiac health, and, in combination with laboratory analyses and information on exposure history, may provide early warnings of MC toxicity. The information derived from a medical evaluation assists the physician or other licensed health care professional in distinguishing between MC-related effects and those effects that are unrelated to MC exposure. This information is particularly important because the health effects associated with MC exposure are not unique to such exposure. For example, the proposed requirement to assess mental health status has been eliminated from the final rule because no specific correlation has been demonstrated between mental health status and MC exposure.
Paragraph (j)(5)(ii) requires that the extent and nature of the required physical examinations be determined by the physician or licensed health care professional based on the health status of the employee and analysis of the medical and work history for that employee. The standard also requires that the examiner give particular attention to the lungs, cardiovascular system (including blood pressure and pulse), liver, nervous system and skin. Proposed paragraph (i)(4)(ii) specifically would have required that the examination address the lungs, liver, nervous system and breast. OSHA has determined that, in order to indicate clearly that the physician or licensed health care professional should assess the potential cardiac health impacts of MC, the medical exam should give attention to the cardiovascular system, blood pressure and pulse. In addition, the Agency has decided that, because of the skin irritation effects of MC, it is necessary to include evaluation of the skin in the medical exam.
Two hearing participants [Tr. 803, 9/18/92; Tr. 2434-35, 10/15/92] testified that men over 40 years old should be given electrocardiograms (ECGs), which should be repeated every 1 to 3 years. OSHA is not requiring ECGs because there is no evidence in the record that associates specific changes in ECGs with MC exposures. However, the physician or licensed health care professional has the discretion to order an ECG for any employee where it is deemed appropriate.
Proposed paragraph (i)(4)(iv) also required the physician to make a determination of any reproductive difficulties of the employee. Vulcan Chemicals [Ex. 19-48] and Organization Resources Counselors (ORC) [Ex. 19-51] commented that the evidence for a relationship between reproductive effects and MC exposure did not warrant inclusion of such a provision in the final rule. OSHA agrees with these commenters that the evidence associating MC exposure and specific reproductive health effects is sparse. Therefore, the Agency has not included reproductive effects in the list of effects the physician or other licensed health care professional should focus on. However, the Agency will continue to monitor the literature to determine if future evidence indicates that inclusion of this provision is warranted.
Two commenters [Exs. 19-28, 19-42] stated that the breast examination requirement should be eliminated from the final rule because breast exams would be highly unlikely to identify effects related to exposure to MC. In the proposal OSHA placed attention on the breast because of concern raised by the increased number of breast tumors in the rat bioassay. Upon further consideration, OSHA has dropped the requirement for breast exams. The Agency notes that rats are particularly sensitive to mammary tumors and it is unclear that humans have similar risks of developing breast cancer after exposure to MC. The Agency remains concerned about the potential for MC carcinogenicity evidenced by the rat mammary tumors, however, and has relied, in part, on mammary tumor data in identifying MC as a cancer hazard.
In final rule paragraph (j)(5)(iii), laboratory surveillance of employees is to be conducted as the examining physician or licensed health care professional determines to be necessary and appropriate, based on the employee's health status and the medical and work history. This is a more performance-oriented provision than the corresponding provision of the proposed rule. The proposal would have required several specific laboratory tests, while the final rule leaves laboratory test requirements to the discretion of the physician or other licensed health care professional. Non-mandatory Appendix B includes guidance regarding the types of tests that may be appropriate.
Some commenters [Exs. 19-28, 19-42, 19-48, 19-49] stated that COHb levels, which had been included among the tests in the NPRM, are not a good measure of toxic exposure to MC. In particular, the MVMA [Ex. 19-42] stated that it is difficult to determine the COHb level attributable to MC exposure for employees who are smokers or who may have other exposures to CO. Several other participants [Exs. 19-25, 19-57, 19-83 and Tr. 1438, 9/23/92] suggested that COHb testing should be done only after over-exposure to MC, such as after an emergency. The Laborers Health and Safety Fund [Tr. 1386, 9/23/92] testified,
[W]e're not convinced that that's [COHb monitoring] an appropriate and accurate measure of exposures, given other sources of carbon monoxide on construction sites as well as the issue of smokers versus non-smokers.
However, the Department of the Army [Ex. 19-55b] suggested that COHb levels are a more cost-effective measurement of the oxygen-carrying capacity of blood than a complete blood count. Similarly, the California Department of Health Services [Ex. 19-17] requested that references to COHb testing be moved from the appendix to the regulatory text.
COHb levels greater than 3% can exacerbate angina symptoms, decrease exercise tolerance and increase risks for myocardial infarctions (heart attacks) in susceptible individuals. COHb concentrations can also be used as a rough estimate of worker exposure to MC (taking into consideration smoking behavior, time since exposure, and exposure to other CO sources) to calibrate personal MC monitoring measurements. Before- and after-shift COHb determinations can be useful in correlating recent MC exposures with COHb levels. The Agency is not requiring COHb testing, however, because confounding factors, such as smoking or exposure to a CO source, can reduce the usefulness of the results of the tests and, in addition, COHb does not measure a health effect per se but is instead a surrogate measure of MC exposure. However, COHb testing may be clinically important in the evaluation of a symptomatic worker and therefore remains an option for the physician or other licensed health care professional to pursue. Exposure monitoring (see paragraph (d) of the final rule) must be performed to quantify an employee's exposure to MC.
In the comments received subsequent to publication of the ANPR for MC [Exs. 10-3, 10-10, 10-28], several industry commenters indicated that urine analysis, liver function tests and chest X-rays are commonly performed as part of the medical surveillance programs of these companies. OSHA believes that annual urine analysis or chest X-ray would not be relevant to detection of MC-related health effects. Liver function tests have also been evaluated for inclusion as a requirement in the medical surveillance provision. As discussed above in the Health Effects section, animal studies and human clinical studies show an association between chronic MC exposure and some changes in liver enzymes, particularly after high exposures or doses of MC for prolonged periods of time. The changes in liver enzyme levels after MC exposure are not consistent in the human clinical studies, however, and in general, changes in liver enzymes are not specific or unique to MC exposure. Therefore, the Agency believes that it should be left to the physician's or other licensed health care professional's discretion to determine if laboratory analysis of liver enzymes is warranted.
Several commenters [Exs. 19-11, 19-26, 19-42, 19-48, 19-55b] agreed that routine use of all of the tests included in the proposal would not be appropriate or necessary for the detection of MC-related health effects. The Agency also sought comments on the inclusion of other medical tests in the final MC rule. Two commenters [Exs. 19-31, 19-48] stated that a complete blood count was not necessary because the results of this test may not correlate with MC overexposure. In particular, the Dow Chemical Co. [Ex. 19-31] commented that a complete blood count is not necessary because blood cell volume and hemoglobin findings would suffice. OSHA has reevaluated the utility of the proposed tests and has decided that leaving laboratory surveillance to the discretion of the physician or licensed health care professional is more cost-effective than the approach taken in the proposal and will not negatively impact worker health.
In paragraph (j)(5)(iv), the final rule requires the medical surveillance program of the employer to include any other information or reports the physician or other licensed health care professional determines are necessary. This is to ensure that a complete medical profile is available to the physician or licensed health care professional to make decisions regarding the employee's health and exposure status. This provision is essentially identical to that proposed.
Paragraph (j)(6) of the final rule describes the required contents of emergency medical surveillance. The proposed rule did not specify what elements should be included in an emergency medical exam. The final rule clarifies that emergency medical surveillance should include any appropriate emergency treatment and decontamination of the exposed employee, a comprehensive physical exam, an updated medical and work history, and laboratory surveillance, if needed.
The Dow Chemical Company [Ex. 19-31] commented that employees exposed to MC during an emergency should not automatically be included in the regular medical surveillance program. Instead, this commenter argued that only those components of a medical examination that are appropriate in a given situation should be conducted. OSHA believes that it is important for an employer to provide medical examinations and appropriate follow-up to employees exposed to MC during an emergency. After considering the issue and comments raised during the rulemaking, the Agency agrees with Dow that employees exposed to MC during an emergency should not necessarily be enrolled in the continuing medical surveillance program provided to employees routinely exposed to MC. To that end, OSHA has added language to the final rule that clearly indicates what emergency medical surveillance is required. OSHA believes that final rule paragraph (j)(6) allows the employer appropriate flexibility, while at the same time ensuring that those employees exposed to MC during an emergency receive appropriate medical surveillance.
Paragraph (j)(7) requires the employer to provide medical surveillance services, in addition to those specified in final rule paragraphs (j)(5) and (j)(6), when the physician or other licensed health care professional determines that they are necessary. Compliance with this requirement will ensure that the information needed to evaluate the effects of MC exposure on employees is available. This provision is essentially the same as proposed paragraph (i)(5).
Paragraph (j)(8) requires that the employer provide the physician or other licensed health care professional with (1) a copy of the standard, including the relevant appendices; (2) a description of the affected employee's past, current, and anticipated future duties as they relate to the employee's MC exposure; (3) a description of former, current or anticipated exposure levels (including the frequency and exposure levels anticipated to be associated with emergencies), as applicable; (4) a description of any PPE that the employee must use or will use, such as respirators; and (5) information from any previous medical examinations that would not otherwise be available to the examining physician or other licensed health care professional. OSHA has determined that the physician or other licensed health care professional needs the above-listed background information in order to place the information derived from medical surveillance in the proper context. For example, a well-documented exposure history assists the physician or other licensed health care professional in determining whether an observed health condition may be related to MC exposure. It also helps this individual to determine if the results of medical surveillance indicate a need to limit an employee's occupational exposure to MC. This paragraph is essentially the same as proposed paragraph (i)(6).
Paragraph (j)(9) of the final rule requires employers to ensure that the examining physician or other licensed health care professional provides the employer and the affected employee with a written opinion that addresses (1) the physician's or other licensed health care professional's opinion as to whether the employee has any detected medical condition that would place the employee at increased risk of material health impairment as a result of exposure to MC; (2) any recommended limitations on the employee's exposure or use of personal protective clothing or equipment and respirators; (3) a statement that the employee has been informed of the potential carcinogenicity of MC, the risk factors for heart disease, and the potential for exacerbation of underlying heart disease associated with exposure to MC; and (4) a statement that the employee has been informed of the results of the medical examination and any medical conditions related to MC exposure that require further explanation or treatment.
The physician or other licensed health care professional must provide copies of the written medical opinion to the employee and the employer within 15 days after completion of the evaluation of medical and laboratory findings, but no later than 30 days after the medical examination. This requirement was included to ensure that the employee and the employer have been informed of the above-mentioned results of the medical examination in a timely manner. This requirement differs slightly from that in proposed paragraph (i)(7)(i). Instead of the physician providing a copy of the written medical opinion to the employer, who then provides a copy to the employee, the final rule requires the physician or other licensed health care professional to supply a copy of the written medical opinion directly to both the employer and the employee. In addition, the time allowed for providing the opinion has been changed to recognize that time may be needed to receive and evaluate laboratory or other medical findings. The Agency believes that notifying both the employer and affected employees of the MC-related results of the medical surveillance at the same time is an efficient approach to disseminating this information to the appropriate parties. Providing copies of the same written opinion both to the employer and the employee ensures that the employer is aware of any factors that may influence work assignments or choice of personal protective equipment.
OSHA has added a requirement to the final rule that the physician or other licensed health care professional inform the employee of the carcinogenic and cardiac effects of MC to reinforce the information on MC's serious health effects that was transmitted during training. The Agency believes that this reinforcement will help to ensure that employees are aware of the potential effects of MC and take appropriate precautions when using this toxic substance.
OSHA received several comments on different aspects of paragraph (j)(9). For example, the UAW [Tr. 1884, 9/24/92] testified that the written opinion transmitted to the employer by the physician or other licensed health care professional should only state the limitations on the employee's exposure or use of respiratory or other personal protective equipment recommended by the physician or other health care professional, and should not include the medical or other reasons behind the recommended limitations.
OSHA agrees with the UAW that it is important to protect the privacy of employees enrolled in medical surveillance programs. Consequently, OSHA health standards have traditionally included a statement to the effect that no findings or diagnoses should be included in the physician's written opinion that are unrelated to occupational exposure. This requirement is intended both to protect the employee's privacy and to encourage employees to participate in the employer's medical surveillance program. The restriction on what may be revealed in the written opinion appears in the final rule as paragraph (j)(9)(ii), and is intended to apply to all of the information provided in the physician's or other licensed health care professional's written opinion, including that related to recommended limitations.
The MVMA [Ex. 19-42] and ORC [Ex. 19-57] stated that the proposed 15-day requirement for providing the employer with a copy of the written opinion should be 15 days from the physician's or other licensed health care professional's receipt of the test results rather than 15 days from the date of the examination. The Agency agrees and, as described above, has changed the requirement so that the written opinion must be provided within 15 days of completion of evaluation of medical findings, but not more than 30 days after the examination. OSHA believes that this strikes the proper balance between allowing sufficient time for the physician or other licensed health care professional to evaluate any laboratory findings while still providing the information to the employer and the employee in a timely manner.
Newport News Shipbuilding [Ex. 19-37] and the Shipbuilders Council of America [Ex. 19-56] stated that the written opinion should require only that employees be notified of abnormal test results, not normal results. In response to these comments, OSHA notes that such a provision would actually require many physicians and other licensed health care professionals to change their current practice because it would require them specifically to delete normal results from printouts of laboratory and other findings. Such reports routinely display all results, both normal and abnormal, for a given individual. In addition, OSHA believes that employees benefit from knowing which of their blood parameters and other test results are normal and which are abnormal. OSHA does not believe that requiring medical personnel to increase the amount of paperwork they perform is a good use of medical resources, and has therefore not revised the final rule to respond to these comments.
Under paragraph (j)(9)(ii) of the final rule, the physician or other licensed health care professional must exclude findings or diagnoses that are unrelated to MC exposure from the written opinion provided to the employer. As discussed above, OSHA has included this provision in the final rule to reassure employees participating in medical surveillance that they will not be penalized or embarrassed by the employer's obtaining information about them that is not directly pertinent to MC exposure. The above provisions are identical to those in proposed paragraph (i)(7)(ii). A note has been added to the final rule that states that the written opinion developed to comply with the MC standard may also contain information related to other OSHA standards. For example, an employer whose employees are enrolled in medical surveillance due to their exposure to benzene, formaldehyde and MC could receive a single, consolidated written opinion that addressed findings related to all three substances. This performance-oriented provision could result in reduced paperwork burdens for employers.
NPRM Issue 3 solicited input regarding whether the Agency should add a provision for Medical Removal Protection (MRP). Medical removal protection encourages employee participation in (and therefore increases the effectiveness of) the medical surveillance program by ensuring that reporting symptoms or health conditions to the physician or licensed health care professional will not result in loss of job or pay. Several rulemaking participants expressed support for the inclusion of MRP in the final rule [Exs. 19-23, 19-38; Tr. 1787, 9/24/92; Tr. 1802, 9/24/92; Tr. 1869, 9/24/92; and Tr. 1883, 9/24/92]. For example, the Amalgamated Clothing and Textile Workers (ACTWU) [Tr. 1793, 9/24/92] testified that OSHA should require MRP based on clinical judgment, as OSHA allowed in the final rule for formaldehyde (29 CFR 1910.1048). They also stated that they believed it was critical to have a medical removal protection provision in the MC standard in order to ensure worker participation. Mr. Frumin of the ACTWU testified as follows [Tr. 1792-1793, 9/24/92]:
As I say, the problems that employers, physicians and, for that matter, OSHA confront in trying to assure the integrity of medical surveillance programs are not limited to a particular substance. They deal with the general perception -- these problems arise from the general perception of workers, which is widespread through industry, that if they submit to a medical examination and it's not confidential, and employers could get the results of the medical findings, that health problems may result in some negative action.
You have a symptom-based medical surveillance program, at least for the non-cancer effects. And if workers are supposed to report the types of symptoms, for instance, that Dr. Soden was looking for, shortness of breath, things of that nature -- and they're concerned that reporting that might involve some negative action against them: either their job security or their pay. You know, they will be discouraged from participating in medical surveillance, and the whole structure of the program is undermined. So the fact that these health effects are symptom-based rather than, say, based on laboratory tests alone, makes it all the more important to include medical removal protection and multiple physician review in the final rule.
Two commenters [Exs. 19-23, 19-38] suggested that MRP should be based on COHb levels. However, Dr. Mirer of the UAW [Tr. 1940, 9/24/92] disagreed with this idea and concurred with Mr. Frumin's remarks that medical removal protection should be based on symptoms and professional discretion. He stated,
* * * the guidance for the physicians, once the physician decides this employee is at increased risk, if they continue in this exposure and I want to remove him or her from the job, that's the trigger. At this moment, I would leave it that way. Increased carboxyhemoglobin is more an index of exposure than an adverse clinical effect, so I don't have any particular guidance. If the doctor wants to pull that man or woman out of a job, that's where I am now.
* * * the other benefit of protecting the disclosure of symptoms is that it's going to identify sources of exposure, because one of the ways of determining exposure is by the presentation of symptoms. So the benefit of having them disclose symptoms is it will lead to lower exposure.
I can't think of anything much else that you would need to get out of MRP than improved participation, although at least our experience in lead is that MRP has been the driving force to reduce exposures independent of that.
OSHA considered the issues raised during the MC rulemaking and in general agrees with these worker representatives that MRP increases employee participation in medical surveillance. OSHA remains concerned about several issues, however. The Agency recognizes that employees may hesitate to participate in medical surveillance if they have reason to expect that the results may adversely affect them economically. However, OSHA has determined that there is no substantive guidance that it could give a physician or other licensed health care professional to indicate when it might be appropriate to remove an employee temporarily from the workplace, or what an appropriate trigger for return to work might be. Accordingly, OSHA has decided to promulgate the final rule for MC without including MRP provisions. The Agency will continue to monitor compliance with the medical surveillance and PPE provisions of this standard and the experience in industries subject to standards with medical removal protection provisions to determine whether any further action is warranted.
Paragraph (k) Hazard Communication
The requirements for hazard communication have been changed from proposed paragraph (j) (Communication of MC hazards to employees) and promulgated in paragraph (k) of the final rule. The paragraph addressing hazard communication in the final MC rule is consistent with the requirements of OSHA's Hazard Communication Standard (HCS). The HCS requires all chemical manufacturers and importers to assess the hazards of the chemicals they produce or import. It also requires all employers to provide information concerning the hazards of such chemicals to their employees. The transmittal of hazard information to employees is to be accomplished by such means as container labeling and other forms of warning, material safety data sheets and employee training.
Since the HCS "is intended to address comprehensively the issue of evaluating the potential hazard of chemicals and communicating information concerning hazards and appropriate protective measures to employees" (52 FR 31877), OSHA is including paragraph (k) in the final rule only to reference the HCS requirements for labels and material safety data sheets, and to indicate specifically the MC health effects that are required to be addressed under that rule. This additional guidance to employers simply reiterates the requirements of the HCS to convey information to affected employees about all health hazards to which they are potentially exposed. The health effects addressed by the final MC rule are cancer, cardiac effects (including elevation of carboxyhemoglobin), central nervous system effects, and skin and eye irritation. There may also be other health hazards or physical hazards associated with MC that meet the definitions of coverage under the HCS. These should be addressed appropriately on the label and MSDS as well.
Employers who have already met their longstanding requirements to comply with the HCS will have no additional duties with regard to labels and MSDSs under the MC final rule. This is consistent with the suggestions of some commenters that no requirements should be mandated beyond those listed in the HCS [Exs. 19-25, 19-31, 19-42]. OSHA agrees that the HCS addresses the issue comprehensively, and additional requirements are not necessary to protect MC-exposed employees specifically. As a result, the Agency has deleted the proposed requirement for warning signs. Such signs are not required under the HCS, although they may be useful in some situations and employers may choose to use them. The Organization Resources Counselors [Ex. 19-57] commented that the required signs should say "warning" and not "danger" as proposed, and suggested consistency with the benzene and ethylene oxide standards. It should be noted that the terms "warning" and "danger" have specific meaning in the context of labels, and there are criteria for their application under voluntary consensus standards such as the ANSI Z129.1 standard for precautionary labeling. ORC's comment is otherwise moot at this point since the relevant requirement has been deleted.
Paragraph (l) Employee Information and Training
The requirements for employee information and training, which were part of proposed paragraph (j) (Communication of MC hazards to employees), have been separated from the hazard communication requirements for labels and data sheets described above, and promulgated as paragraph (l) in the final MC rule. Some of the training provisions that were proposed duplicated requirements of the HCS. These have been removed, and a reference to the information and training required under the HCS has been added to simply remind employers of their longstanding obligations under that rule to ensure that employees are apprised of the hazards of the chemicals in their workplaces, as well as appropriate protective measures. The information and training requirements in the final MC rule build upon those requirements with additional information specific to MC that will help employees understand the risks of exposure and the means to prevent adverse health effects from occurring in their particular workplaces.
It should be noted that the information and training requirements in the final rule have been separated from each other rather than being addressed together, because they deal with different ways of conveying information. "Information" transmittal is simply that -- a passive process of making information available to employees should they choose to use it. In some cases, this may be done in writing or some other simple manner of information transfer. "Training," on the other hand, is not a passive process. The information provided to employees in training requires them to comprehend it and subsequently to use it in the performance of their duties in the workplace. There are many different ways to accomplish training effectively, but it cannot be a simple transfer of information such as handing someone a written document. OSHA's voluntary training guidelines, which are found in OSHA Publication No. 2252, are available to provide employers additional guidance in setting up and implementing an appropriate employee training program. An effective training program is a critical component of any safety and health program in the workplace. Workers who are fully informed and engaged in the protective measures established by the employer will play a significant role in the prevention of adverse health effects. Ineffective training will not serve the purpose of making workers full participants in the program, and the likelihood of a successful program for safety and health in the absence of an effectively trained workforce is remote.
Paragraph (l)(1) requires employers to provide all employees who are potentially exposed to MC with information and training on MC prior to or at the time of initial assignment to a job involving MC exposure. Thus employees will have the information they need to protect themselves before they are actually subject to exposure. The final rule further indicates in paragraph (l)(2) that employers shall ensure that the information and training is presented in a manner that is understandable to employees and that employees have received the information and training required under the HCS.
Paragraph (l)(3) addresses the information to be provided to affected employees. This includes the requirements of the final MC standard and information available in its appendices, as well as how the employee can access or obtain a copy of it in the workplace. This will ensure that MC-exposed employees are aware that specific requirements have been established to protect them from adverse health effects, and give them an opportunity to review those requirements themselves if they so desire. Wherever employee exposures exceed or can reasonably be expected to exceed the action level, the employer is required to inform employees about the location of MC in the workplace, what operations may be affected, particularly noting where in the workplace there may be exposures above the permissible exposure limits.
Paragraph (l)(4) requires each employer to train each affected employee as required under the Hazard Communication Standard (29 CFR 1910.1200, 29 CFR 1915.1200 or 29 CFR 1926.59, as appropiate). This provision simply reminds employers of their obligation to train employees regarding the hazards of MC under the Hazard Communication Standard.
The final rule does not provide a specific time period for updating the training, whereas the proposed standard included a requirement for annual retraining. Instead, the final rule indicates in paragraph (l)(5) that the employer shall re-train each affected employee as necessary to ensure that employees exposed above the action level or the STEL maintain a good understanding of the principles of safe use and handling of MC in the workplace. Employers can assess whether this understanding is generally present in exposed employees in various ways, such as by observing their actions in the workplace. For example, if an employee is not using appropriate protective equipment or following safe work practices routinely, this may be an indication that additional training is required. This provision of the final rule is a performance-oriented requirement that allows each employer to determine how much or how often training is needed.
Paragraph (l)(6) requires that the employer do additional training when the workplace is modified or changed in such a way that employees are subject to greater exposures and those exposures exceed or can reasonably be expected to exceed the action level and those employees need information and training to understand how to implement the modifications or training successfully. This provision was not in the proposal, but the Agency considers it necessary to further protect employees from the hazards of MC when significant changes in workplace conditions occur.
Paragraph (l)(7) requires the employer whose employees are exposed to MC at a multi-employer worksite to notify the other employers with work operations at that site regarding the use of MC-containing materials, the hazards associated with the use of those materials and the control measures implemented to protect affected employees from MC exposure, in accordance with the requirements of the Hazard Communication Standard (HCS). The HCS addresses sharing information at multi-employer worksites, and since this final rule covers construction where most of the sites are multi-employer, this provision was added to remind such employers of these requirements. OSHA is also aware that an increasing number of manufacturing worksites involve more than one employer.
In paragraph (l)(8) of the final rule, OSHA has indicated that the Assistant Secretary or the Director may access all materials relating to employee information and training in the workplace. This would be done in conjunction with an inspection to ascertain compliance with the rule, or in the event of a NIOSH health hazard evaluation. Review of the available materials regarding information and training will help assess whether the program has been properly conducted, as well as evaluate what could be improved if employees do not appear to be effectively trained.
The information and training provisions of this standard are performance-oriented, because employees are exposed to MC in a wide variety of circumstances and the best method of conveying the necessary data may vary from site-to-site. The standard lists the categories of information to be transmitted to employees but does not specify the ways in which it is to be transmitted.
Some commenters [Tr. 531-32, 9/18/92; Tr. 545-49, 9/18/92; Tr. 828-32, 9/21/92; Tr. 1380, 1384-85, 9/23/92] suggested that OSHA make the proposed training provisions more specific, such as by including requirements for length of training, qualifications of instructors, or requirements for interactive training. In addition, hearing participants and commenters suggested that OSHA require employers to monitor the effectiveness of training [Ex. 19-38, Tr. 531-32, 9/18/92]. These participants suggested that provisions be made, as well, for training of workers in languages other than English and for training of workers with limited literacy [Ex. 19-38, Tr. 531-32, 9/18/92; Tr. 831-32, 9/21/92].
The International Brotherhood of Painters and Allied Trades, AFL-CIO, testified [Tr. 830-831, 9/21/92]:
We urge OSHA to promulgate a standard that requires that workers receive a minimum of 16 hours training. Such training would include at the minimum information on the hazards of methylene chloride and how it harms the body. Engineering controls that can be implemented in the field should be described and demonstrated. We will submit information on one such control to the record. Training should also include information on work practices associated with specific job assignments, methods by which workers can protect themselves, the limits of respirators use, appropriate procedures for work in confined spaces, employee rights under the standard, the purpose of medical surveillance and other elements of training as enumerated in Section (j)(4).
OSHA does not agree that specifying a time frame for training ensures that it will be complete, appropriate, or effective. The amount of training required will depend to a large extent on the conditions of use in a given workplace. It will also be related to the extent of training on MC that has already been done by the employer under the HCS. Therefore, the final rule provisions remain performance-oriented with regard to the time needed to convey the information and training.
With regard to the issues of literacy and language, these remain a significant consideration in the proper design and implementation of any training program. Because working safely with MC is such a significant concern, the employer must make every effort to ensure that the training is presented in such a way that employees can understand and act on the information.
OSHA expects that employers will ensure that the information and training is effective. Any good training program should include an evaluation component to help ensure effectiveness. The voluntary training guidelines previously recommended can provide additional guidance in this respect.
OSHA received comments that indicated that the MC standard should simply refer to the HCS rather than having separate requirements [Exs. 19-25; 19-49]. While the Agency agrees with these comments in reference to the label and MSDS requirements, it does not appear that this is the appropriate approach to training. While the HCS addresses training about the hazards of a chemical and appropriate precautionary measures, there are other items of training that are specific to the MC standard requirements and the determinations made in this rulemaking regarding MC. As such, it is important to ensure that the already-required HCS training is supplemented with information and training specific to MC.
Paragraph (m) Recordkeeping
Paragraph (m) of the final rule addresses requirements for employers to create and maintain records of their compliance with some of the provisions of this section. Section 8(c)(1) of the OSH Act authorizes the Agency to promulgate regulations requiring employers to keep necessary and appropriate records regarding activities to permit the enforcement of the Act or to develop information regarding the causes and prevention of occupational accidents and illnesses. Section 8(c)(3) of the Act specifically addresses the promulgation of "regulations requiring employers to maintain accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under section 6."
Paragraph (m)(1) requires that employers who rely on objective data to characterize potential exposures to MC, rather than conducting initial monitoring under paragraph (d) of this section, maintain records that show the information and methodology used in reaching their conclusion that exposures are at or below the action level and no additional monitoring is required. The record must include the MC-containing material evaluated; the source of the objective data; the testing protocol, and the results or analysis of the testing; a description of the operation(s) exempted from monitoring, and how the data support the exemption; and other relevant data.
Since the use of objective data exempts the employer from conducting monitoring, as well as establishing that most of the other provisions need not be complied with due to the low level of potential exposure, it is critical that this determination be carefully documented. Compliance with the requirement to maintain a record of objective data protects the employer at later dates from the contention that initial monitoring was improperly omitted. The record will also be available to employees so that they can examine the determination made by the employer. The employer is required to maintain the record for the duration of the employer's reliance upon objective data. This provision is effectively identical to proposed paragraph (k)(1).
Paragraph (m)(2) requires that employers establish and keep an accurate record of all measurements taken to monitor employee exposure to MC. For employers with 20 or more employees, the record must include at least: the date of measurement for each sample taken; the operation involving exposure to MC which is being monitored; sampling and analytical methods used and evidence of their accuracy; number, duration and results of samples taken; the type of personal protective equipment, such as respiratory protective devices worn (if any); and name, social security number, and job classification and exposure of all the employees deemed to be represented by such monitoring, indicating which employees were actually monitored. For employers with fewer than 20 employees, the record shall include, at a minimum: the date of measurement for each sample; the number, duration and results of samples taken; and name, social security number, job classification and exposure of all the employees deemed to be represented by such monitoring, indicating which employees were actually monitored. OSHA believes it is necessary to maintain these records so that employers, employees and OSHA can determine the extent to which MC exposure has been identified and subsequently controlled. Over time, the exposure records can help determine if additional measures are needed for employee protection. OSHA has reduced the amount of information required for small businesses in recognition of the more limited variety of operations and exposure levels there. This should ease these employers' recordkeeping burden without compromising employee safety and health in these types of facilities.
Two commenters [Exs. 19-25, 19-49] suggested that such documentation should only be required for each person actually monitored (paragraph (d)(1) provides for representative monitoring). However, OSHA believes that it is necessary for records to be kept for each employee represented by the exposure monitoring so that individual employees can access information that characterizes their own exposures to MC. If records were kept only for those actually monitored, it would be unreasonably difficult for an employee to identify the exposure measurement that is intended to represent his or her experience. Accordingly, OSHA has not made the suggested change.
Paragraph (m)(3) requires that the employer keep accurate medical records for each employee subject to medical surveillance. The information to be included in the record addresses identification of the employee; the physician's or other licensed health care professional's written opinions; and documentation of any employee medical conditions that are found to be related to MC exposure. Maintenance of employee medical records is necessary for the proper evaluation of the employee's health, as well as for appropriate followup.
Proposed paragraph (k)(3)(ii)(D) required that a copy of the information provided to the physician or other licensed health care professional be included in the employee record. The Dow Chemical Company [Ex. 19-31] requested that, because many larger companies have company medical facilities, some provision be made so that records do not have to be maintained in medical department records and duplicated in the personnel record of every employee potentially exposed to MC. The information required under paragraph (j)(8) of this section includes a copy of this section including its appendices, a description of duties involving MC exposure, exposure levels, personal protective equipment, and previous medical surveillance information. Since this information is available to the employee through other means, OSHA believes that the requirements under proposed paragraph (k)(3)(ii)(D) were unnecessarily burdensome, and OSHA has therefore deleted this paragraph from the final rule. OSHA has also deleted proposed requirements for maintaining records of employee fit testing as being unnecessarily burdensome. Dow also suggested that an employee identification number be permitted in lieu of social security number [Ex. 19-31]. OSHA does not agree with this suggestion. Social security numbers have much wider application, and are correlated to employee identity in other types of records. These numbers are a more useful differentiation among employees since each number is unique to an individual for a lifetime and does not change as an employee changes employers.
Paragraph (m)(4) of the final rule specifies that access to exposure and medical records by employees, employees" designated representatives, NIOSH and OSHA shall be provided in accordance with 29 CFR 1910.1020. OSHA promulgated 29 CFR 1910.1020 as the generic rule for access to employee exposure and medical records on May 23, 1980 (45 FR 35212). It applies to records created under specific OSHA standards and to records that are voluntarily created by employers. OSHA retains unrestricted access to medical and exposure records but its access to personally identifiable records is subject to the Agency's rules of practice and procedure concerning OSHA access to employee medical records, which have been published at 29 CFR 1913.10.
The time periods required for retention of exposure records and medical records is thirty years and the period of employment plus thirty years, respectively. These retention requirements are consistent with those in the OSHA records access standard and with pertinent sections of the Toxic Substances Control Act. It is necessary to keep records for extended periods of time because of the long latency periods commonly observed for the induction of cancer caused by exposures to carcinogens. Cancer often cannot be detected until 20 or more years after onset of exposure. The extended record retention period is therefore needed for two purposes. First, possession of past and present exposure data and medical records furthers the diagnosis of workers' ailments. In addition, retaining records for extended periods makes possible a review at some future date of the effectiveness and adequacy of the standard.
Paragraph (m)(5) requires employers to comply with the requirements of 29 CFR 1910.1020(h). That provision requires the employer to notify the Director of NIOSH in writing at least 90 days prior to the disposal of records and to transfer those records to NIOSH unless told not to do so by NIOSH. The employer is required to comply with any other applicable requirements set forth in the records retention standard.
Paragraph (n) Dates
This paragraph establishes the effective date for the MC final rule, and the start-up dates for the various provisions of the standard. The start-up dates allow employers additional time to comply with some of the provisions of the standard that require more effort to accomplish. It is expected that such work will commence by the effective date, and be completed as soon as possible but in no case later than the compliance deadline established by the effective date. All other obligations imposed by the standard become effective on the effective date unless otherwise indicated.
Paragraph (n)(1) of the final rule provides that this standard will become effective on April 10, 1997. This date is 90 days from the date of publication in the Federal Register. Proposed paragraph (m)(1) had provided that the final rule would become effective 60 days after publication in the Federal Register. OSHA stated in the preamble to the proposed rule [56 FR 57128] that the proposed effective date, in conjunction with the proposed start-up dates, would allow sufficient time for employers to achieve compliance with the substantive requirements of the proposed rule.
Although no commenters directly addressed the 60-day period proposed in paragraph (m)(1), several commenters addressed the reasonableness of the start-up dates in proposed paragraph (m)(2). Those comments, discussed below, indicated that some employers would need more time to comply than the proposed rule would have allowed.
The Agency sets the effective date to allow sufficient time for employers to obtain the standard, read and understand its requirements, and undertake the necessary planning and preparation for compliance. Section 6(b)(4) of the OSHA Act provides that the effective date of an OSHA standard may be delayed for up to 90 days from the date of publication in the Federal Register. Given the concerns expressed by commenters, OSHA's interest in having employers implement effective compliance efforts, and the minimal effect of the additional 30 day delay, the Agency has decided that it is appropriate to set the effective date at 90 days from publication, rather than at 60 days.
Paragraph (n)(2) of the final rule establishes the start-up dates for compliance with the provisions of the MC standard. The start-up dates are based on information in the record about the state of the art with regard to the types of provisions employers are expected to implement, such as available control measures, their complexity, and the time that is reasonably necessary to complete their installation and implementation. In the case of MC, the types of provisions included in the rule, such as requirements that will require conventional controls, are identical to the elements included in all OSHA health standards.
Proposed paragraphs (m)(2)(i), (ii) and (iii) required that initial monitoring be completed by all employers within 120 days of the effective date of the MC standard, engineering controls within one year of the effective date and all other requirements within 180 days of the effective date. As described below, OSHA received numerous comments on the appropriateness of the start-up dates, especially for small businesses. Given the large number of small employers covered by the requirements, and the special problems of many of those employers in identifying and implementing appropriate control measures, OSHA has decided to phase-in compliance and to permit these employers a longer time period in which to comply with the requirements of the standard. The schedule for compliance with the provisions of the standard are described below.
OSHA received a number of comments on the proposed periods for compliance with the control requirements. In 1992, Kodak [Exs. 19-18 and 19-102] described circumstances at its film base production facility that would prevent compliance with the PELs through engineering controls before mid-1995. Kodak stated "[it] is essential that OSHA be responsive to these considerations in promulgating the final rule. OSHA should permit adequate time for Kodak to implement feasible engineering controls in an orderly and minimally disruptive schedule." Considering the effective date and start-up dates in this regulation, OSHA has determined that affected parties will have sufficient time to comply with the standard.
Similar requests for longer time periods for compliance were also received from a variety of other commenters [Exs. 19-55, 19-57, 19-67, 19-72, 19-75, 115-3, 115-28, 115-33, 115-37, Tr. 1422, 1427-29, 9/23/92, Tr. 2103, 10/14/92, Tr. 2291-92, 2300, 10/15/92]. However, OSHA's Final Economic Analysis for this rulemaking indicates that readily available control measures can be used to control exposure in many of the operations where MC is present. In general, compliance will not require the development of new or novel control technology. Accordingly, OSHA believes that more extended time periods for compliance are not necessary for all affected industries. However, as discussed below, small businesses (for example, those with fewer than 20 employees and polyurethane foam manufacturers with 20 to 99 employees) have been granted additional time to comply.
As discussed above in Section VIII, several commenters [Exs. 19-14, 19-25, 19-28 and 19-29] stated that engineering controls to achieve compliance were not available. These commenters further stated that the development and implementation of the process changes and engineering controls needed to achieve compliance would take four years from the effective date, not the single year proposed. For example, the Pharmaceutical Manufacturers Association and Abbott Laboratories [Exs. 19-25 and 19-29] stated as follows:
[I]f the agency should rule that the exposure level to MC be reduced to 25 ppm for an 8-hour TWA and a 125 ppm STEL, a minimum of 1 year from the effective date must be allowed for identification of the engineering controls. A minimum of 3 years from the effective date must be allowed for compliance with paragraph (f)(1) of the proposed rule.
Those commenters and the HSIA [Ex. 19-45] also indicated that FDA approval is needed in the pharmaceutical industry for any alteration of manufacturing processes, substitution for MC, or modification of work practices to achieve compliance with OSHA's MC standard, and requested that OSHA consider the FDA's regulatory requirements when establishing start-up dates. In particular, Abbott Laboratories described how it took three years to obtain FDA approval for the substitution of hydroalcoholic or aqueous solutions for MC in tablet coating operations, stating "[p]resently, completion of required testing and obtaining FDA approval for production of a single product can take 3 months to three years, depending upon the extent of the change."
As stated previously, feasible engineering controls do not exist for the present bulk pharmaceutical centrifugal separation and drying equipment. Implementation of engineering controls would therefore require the use of a different process or a different production method. Changes of that degree require Abbott Laboratories to complete development work on an alternative process and/or identify new production equipment; erect a building to house the equipment; purchase, receive and install the equipment; train employees; and validate the process. This cannot be accomplished in one year.
OSHA is aware that pharmaceutical manufacturers must comply with other regulatory requirements, including those set by the FDA. The Agency has considered how affected employers, in general, need to coordinate their OSHA compliance efforts with their other regulatory compliance activities, that this regulation does not require implementation of particularly complicated or novel control technologies, and that the compliance time frames are in keeping with those in other OSHA standards. OSHA views the coordination of OSHA compliance with other regulatory compliance activities as an ongoing employer effort, not just an ad hoc response to a particular OSHA action (such as the revision of a PEL). For example, a pharmaceutical manufacturer would need to consider the implications for OSHA compliance of process changes undertaken due to FDA requirements or for other reasons, whether those changes were to be made during the MC standard's "start-up" period or subsequently.
Accordingly, the Agency has determined that the commenters have not established a need for the requested extension of the start-up dates. OSHA believes that the proposed one-year period in which to implement controls will, in general, be adequate and, therefore, has not made the suggested change. However, as discussed elsewhere, OSHA has tailored the compliance schedule to the size of the establishment and anticipated impact of the standard on those businesses.
Dow [Ex. 19-31] also expressed concern that many employers would be unable to meet the start-up dates, focusing on the time and resources that would be required to conduct initial monitoring. In addition, Dow stated as follows "OSHA should require that certain actions be completed within the stated time periods and that if the actions can not be completed, the employer should have a written plan and corresponding actions to show a good faith effort to meet the requirements." OSHA agrees that there may be circumstances where, despite good faith efforts, employers cannot achieve compliance within the time periods specified by paragraph (n)(2). OSHA further agrees that developing a written plan and taking other "good faith" actions towards compliance would be appropriate measures to mitigate any circumstances of non-compliance with the regulation. Indeed, the suggested procedure closely resembles the temporary variance process already established by OSHA.
Under section 6(b)(6) of the OSH Act, an employer can obtain a temporary variance from compliance with an OSHA standard if it shows that it cannot achieve compliance by the effective date; is taking all available steps to safeguard its employees from the pertinent hazard; and has an effective program for coming into compliance with the standard. The implementing regulations for the temporary variance process appear at 29 CFR part 1905. Employers who experience difficulties in meeting the start-up dates should contact OSHA and apply for a temporary variance.
The HSIA [Ex. 19-45] recommended that OSHA "provide a compliance schedule similar to that provided in the generic PEL update * * * [which] in some circumstances allows employers until December 31, 1993 to comply (a total of 4 years and 10 months)." In addition to mentioning the lengthy FDA approval process, the HSIA noted that "DCM users, particularly many of the smaller companies, will find compliance technologically and economically difficult at best."
As stated above, OSHA believes that the sort of extended compliance schedule set through the generic PEL update is unnecessary for the MC standard. Based on its review of the rulemaking record, the Agency has reached the general conclusion that employers will be able to achieve compliance within the time frames established in paragraph (n).
However, OSHA is concerned that some small facilities affected by this rulemaking, such as many of those in the furniture refinishing industry and the polyurethane foam manufacturing industry, may have difficulties determining the appropriate control measures to use and also may not be able to absorb the costs of compliance, particularly those associated with implementing the appropriate engineering controls within the time frames initially proposed. The Agency has estimated (see Section VIII, Summary of the Final Economic Analysis) that allowing a variable schedule of compliance, based upon size of establishment, will enable firms in all impacted sectors to absorb many of the compliance costs without endangering their financial health.
Based on these considerations, OSHA has determined that the following implementation schedule is reasonable and appropriate for businesses of all sizes:
_____________________________________________________________________ | Initial | Implementation | All other | monitoring | of engineering | provisions must Establishment | provisions must| controls must be | be complied size | be complied | completed within | with within | with within | | _______________|________________|__________________|_________________ Fewer than 20 | | | employees.... | 300 days of the| 3 years of the | 1 year of the | effective date.| effective date. | effective date. Polyurethane | | | foam | | | manufacturers | | | with 20 to 99 | | | employees. | 210 days of the| 2 years of the | 270 days of the | effective date.| effective date. | effective date. All other | | | employers.....| 120 days of the| 1 year of the | 180 days of the | effective date.| effective date. | effective date. _______________|________________|__________________|_________________
Paragraph (o) Appendices
The final paragraph of the standard simply states that the appendices which follow are not intended to create any additional obligations beyond those already specified in the standard. They are basically intended as non-mandatory guidance documents to supplement and complement the regulatory requirements in the standard, and to provide additional information about MC and its safe handling and use to exposed employees, employers, and health care professionals.
A few comments were received by OSHA regarding the text of the appendices as proposed. These addressed the need for additional information [Ex. 57, Tr. 832, 9/21/92, Tr. 1380 and 1384-85, 9/23/92], or whether information should appear in an appendix or in the regulatory text itself [see, e.g., Tr. 2435-36 and 2448-49, 10/15/92]. OSHA has reviewed and updated the text in the appendices to address these comments and ensure that they are consistent with the new regulatory text in the final standard.
Also, proposed Non-mandatory Appendix C, which addressed respirator fit testing, has not been included in the final rule, because OSHA has determined that very few of the respirators used to comply with this standard will require fit testing. In addition, OSHA's revision of the generic respirator standard (29 CFR 1910.134) will contain an up-to-date appendix that addresses fit testing for all respirators.
Regulations (Preambles to Final Rules) - Table of Contents|