Document 2jy1mnDOgDvr7Vw3qyaw84wzg

from biomedical information service (MON) 10. 13' 03 16: 12/ST. 16:1 O/NO. 4862209230 P 6 AIHAJ A Journal for the Science of Occupational and Environmental Health and Safety HWBUI0008650 FROM BIOMEDICAL INFORMATION SERVICE AIHAJ 62:208-217 (2001) (MON) 1 0. 13' 03 16:1 2/ST. 16:1 O/NO. 4862209230 P 7 Ms. #203 Authors John F. Martonik Edith Nash Elizabeth Grossman United States Department of Labor, 200 Constitution Ave., NW, Washington, DC 20210 The History of OSHA's Asbestos Rulemakings and Some Distinctive Approaches that They Introduced for Regulating Occupational Exposure to Toxic Substances Q in l- O ul lO cc UJ a a. LU ia 03 %3 "g rr UJ t, ^5 ^ bi cc o >in a. S3 u--t. >cJ3 , The Occupational Safety and Health Administration (OSHA) has regulated occupational exposure to asbestos since 1971. Since issuing its first asbestos standard, OSHA has modified it several times in response to new information about the health risk of exposure and concern expressed by workers and public health groups. As each modification has reduced worker exposure and disease risk, each also has introduced new concepts including emphasis on ancillary provisions in standards regulating occupational exposure to toxic substances to enhance worker health; medical removal protection; two attempts at emergency temporary standards; use of historical and objective exposure data to assess worker exposure; the need to eliminate significant risk of disease posed by asbestos; and the presumption of hazard in absence of exposure information. These and other advances have affected all subsequent OSHA standards aimed at reducing occupational exposure to toxic substances. Keywords: asbestos, Occupational Safety and Health Administration, standards he Occupational Safety and Health Ad notices of proposed rulemaking (NPRMs) for as Tministration (OSHA) issued its first as bestos, 3 final asbestos standards, and 31 Federal bestos standard for general industry in Register notices related to asbestos regulation 1971.*') This standard set the permissible that address various procedural, substantive, and exposure limit (PEL) at 12 fibers per cubic cmeinnor asbestos-related issues. Clearly, the nature timeter (f/cc) as an 8-hour time weighted aovef rprescribed worker protections has become age (TWA) based on the 1968 American Con more complex over time, changing from a simple ference of Government Industrial Hygienists PEL-based standard to a complex standard com (ACGIH) threshold limit value (TLV). No an prised of mandatory work practices for specific cillary provisions were included except for the asbestos jobs and operations. These changes are "hierarchy of controls," which required employ due in part to increased knowledge of the health ers to use feasible administrative or engineering effects resulting from asbestos exposure, better controls to achieve compliance. Twenty-three measurement and control technology; pressure years later, in 1994, OSHA issued its most recent from labor representatives; changing regulators' asbestos standard, setting the PEL at 0.1 f/cc as policies within OSHA and other regulatory an 8-hour TWA.*-1 The 1994 asbestos standard agencies; and court decisions directing specific is comprehensive and requires engineering con regulatory actions. This article describes OSHA trols; specific work practices; exposure monitor experience regulating asbestos as well as the con ing; respirators; housekeeping practices; medical sequences of this experience for all subsequent surveillance; and hazard communication. Be OSHA standards. tween 1971 and 1994, OSHA issued 2 asbestos During Congressional debate on the Occu emergency temporary standards (ETSs), 3 major pational Safety and Health (OSH) Act of 1970. 208 AIHAJ (62) March/April 2001 HWBUI0008651 from biomedical information service (MON) 1 0. 1 3' 03 16:1 2/ST. 16:1 O/NO. 4862209230 P 8 occupational asbestos exposure was cited as an example of the judicial review of the standard. For the convenience of the read types of hazards Congress sought to reduce by passage of the act. er, Table I contains a list of all Federal Register publications arid As one senator noted: other noteworthy actions regarding OSHA's standards for oc For 40 years it has been known that exposure to asbestos caused the severe lung scarring called asbestosis. Neverthe less, as an eminent physician and researcher, Dr. Irving Selikoff testified during the hearing on this bill: "It is depress ing to report, in 1970 that the disease that we knew well 40 years ago is still with us just as if nothing was ever known."*31 cupational exposure to asbestos. A though the OSH Act requires the agency to follow pre scribed rules for adopting new permanent standards, it also gives the agency the authority to issue ETSs without providing notice and allowing for comment, In the scheme of OSHA standard set ting, however, promulgation of an ETS is an extraordinary event. The OSH Act itself greatly restricts the use of ETSs. An ETS must be necessary to protect employees from "grave danger" from ex During rhe early years of regulatory activity, OSHA determined posure to substances or physical agents determined to be toxic or limits for occupational asbestos exposure based on general obser physically harmful. There is no opportunity for public comment vations from studies of the health effects of asbestos exposure. under the ETS process. .An ETS may remain in effect for no longer Since the Supreme Court handed down its benzene decision in 1980,1!'" however, this qualitative approach has been replaced by a quantitative one in which the agency estimates the rate of worker morbidity and mortality from exposure to asbestos. A detailed dis cussion of the health effects associated with occupational exposure than 6 months, by which time OSHA must issue a permanent standard using the procedures described above. The ETS is of limited utility, especially' for toxic substances, because it requires employers to institute immediate controls. In many cases, moni toring of exposures, identification and purchase of control tech to asbestos and derivation of the corresponding estimates of risk are beyond the scope of this article. In brief, the quantitative risk assessment estimated cancer and asbestosis risks to workers ex posed to low levels of asbestos by extrapolating the dose and re nology, and installation of that technology can take much more than the 6-month duration of an ETS. Furthermore, the courts of appeals have struck down ETSs. This is because of the courts' concern with unidentified economic disruption of business in rhe sponse data from worker epidemiological studies and exposure as absence of public comment. sessment studies. Based on the quantitative estimates of risk to workers, OSHA made important policy findings that the new stan dards substantially reduced worker risk, but, as a general matter, ASBESTOS REGULATION IN THE 1970s did not entirely protect employees from a significant risk of as bestos-related disease. Because OSHA's statutory mandate for tox ic substances calls for standards to eliminate significant risk, this residual risk caused OSHA to continue strengthening the standard OSHA first regulated asbestos as part of its "start-up" authority to quickly issue standards without conducting rulemaking us ing established federal standards or "consensus" standards. On iyhen feasible controls were identified.<2) May 29, 1971, OSHA published a list ofPELs for general industry for many toxic substances including asbestos based on the existing standards under the Walsh Healy Act, which, in turn, were based BACKGROUND on the 1968 ACGIH TLVs.*11 On April 17, 1971, OSHA pub lished a list of PELs for the construction industry based on the The Occupational Safety and Health Administration (OSHA) is 1970 ACGIH TLVs. For both industry sectors, the PEL for as charged with assuring safe and healthful working conditions for bestos was 12 f/cc.<6) Table II presents a summary of the major working men and women. One tool the agency has at its disposalprovisions in OSHA's final asbestos standards promulgated from is the promulgation of occupational safety and health standards. During its first 2 years of existence, OSHA adopted consensus organization recommendations and established federal standards without going through notice and comment rulemaking. After the 2-year limit expired, OSHA could issue or change standards only by adhering to the rulemaking procedures spelled out in the OSH Act.*51 The act requires OSHA to provide public notice of any standard the agency proposes to adopt along with a preamble laying out the agency's reasons and the evidence supporting the proposal or alternative proposals. This notice, called an NPRM, must be published in the Federal Register. The public is invited to comment and provide evidence supporting either the proposal or alternative proposals. These comments are placed in a public docket for review. OSHA's docket for asbestos rulemakings is designated as H-033. OSHA conducts a public hearing on its proposal. Afterward, OSHA gives the public another opportu nity to comment. Once all comments, data, and testimony are received, OSHA reviews them and develops and publishes a final standard based on the entire rulemaking record. Like the pre amble to the NPRM, a preamble to the final standard justifies agency's decisions and responds to public comment. The 1971 to 1999. On November 4, 1971, the AFL-CIO petitioned OSHA for an ETS to reduce worker exposure to asbestos based on a report from Dr. Irving J. Selikoff and staff at the Mt. Sinai Medical School in New York City.(7) Dr. Selikoff had recommended enact ment of a work practice standard to control occupational exposure to asbestos rather than a standard that simply set a PEL. The AFLCIO petitioned OSHA for a similar type of standard. At the time, there were many problems associated with measuring worker ex posure to airborne asbestos, and furthermore, there was no con sensus about a protective exposure limit. The standard in place in Great Britain at that time specified a 2 ffee limit.*71 In its petition the AFL-CIO argued that an ETS was necessary because the incipient stages of a massive epidemic ot asbestos- related diseases existed and that "only drastic and immediate ac tion will contain and slow the developing incidence and prevalence of death from these diseases." On December 7, 1971, OSHA granted the petition and issued an ETS.131 The preamble to the ETS provided little detail or justification. Rather, OSHA simply wrote: cedures are described in 29 Code of Federal Regulations Part In light of increasing information on the results of exposure 1911. Persons, organizations, and entities adversely affected by of employees to airborne asbestos dust, including recent a standard may petition the United States Court of Appeals for studies by the National Institute for Occupational Safety HWBUI0008652 FROM BIOMEDICAL INFORMATION SERVICE (MON) 1 0. 1 3' 03 1 6 : 1 3/ST. 1 6 : 1 O/NO. 4862209230 P 9 TABLE 1. Chronology of Actions Taken on OSHA's Asbestos Standards (1971-1998) _________________________ __ Date Action Citation May 29, 1971 April 17, 1971 December 7, 1971 January 12, 1972 January 24, 1972 (on or about) February 1, 1972 February 25, 1972 March 14, 1972 March 17, 1972 June 7, 1972 April 15, 1974 October 9, 1975 November 4, 1983 March 7, 1984 April 10, 1984 June 20, 1986 October 17, 1986 May 12, 1987 February 8, 1988 September 14, 1988 December 20, 1989 February 5, 1990 July 20, 1990 January 1991 February 1991 November 3, 1992 August 19, 1994 June 29, 1995 August 23, 1996 July 24, 1997 June 29, 1998 final standard published setting the first asbestos PEL for general industry final standard published setting the first asbestos PEL for the construction Industry ETS published lowering the asbestos PELS for all industries proposed standard published lowering the asbestos PEL and establishing several ancillary industrial hygiene provisions Asbestos Advisory Committee established NIOSH Criteria Document on Asbestos received report of the Asbestos Advisory Committee received public hearing on the asbestos proposal opened public hearing on the asbestos proposal concluded final standard published lowering the asbestos PEL for all industries and establishing ancillary industrial hygiene provisions to the standard U.S. Circuit Court of Appeals issued its decision in IUD-AFL-CIO v. Hodgson proposed standard published lowering asbestos PEL for ail industries and expanding and strengthening the ancillary industrial hygiene provisions to the standard ETS published lowering the asbestos PEL for all industries U.S. Circuit Court of Appeals issued its decision in Asbestos information Association v. OSHA proposed standard lowering the PELs for all industries and updating the ancillary industrial hygiene provisions to the standard final standard published lowering the PEL for all industries and updating the ancillary industrial hygiene provisions to the standard notice published staying the application of the asbestos standard to nonasbestiform minerals* final standard published making minor technical amendments and giving notice of paperwork approval U.S. Circuit Court of Appeals issued its decision in BCTD v. Brock final standard published adding an excursion limit for asbestos final standard published in response to issues remanded to OSHA by the court (Phase 1) final standard published in response to issues remanded to OSHA by the court (Phase 2) proposed standard published in response to the remaining issues remanded to OSHA by the court (Phase 3 and others issues) public hearing on the asbestos proposal opened public hearing on the asbestos proposal concluded amendment to the proposed asbestos standard published requesting comment on the need to protect workers in public and commercial buildings final standard published responding to the remaining issues remanded to OSHA by the court (i.e., reduction of remaining significant risk) final standard published making minor changes consistent with record to the standard published August 19, 1994 final standard published making additional minor changes and clarifications to the standard published August 19, 1994 U.S. Circuit Court of Appeals Issued its decision in Asbestos Information Association!NA v. Reich final standard published removing the standards application to roofing cement, mastics, and coatings containing asbestos 36 FFt 10466 36 FR 7340 36 FR 23207 37 FR 429 37 FR 11318 499 F .2d 467 (DC Ci r. 1974) 40 FR 47652 46 FR 51086 727 F. 2d 415 (5th Cir. 1984) 49 FR 14116 51 FR 22612 51 FR 37002 52 FR 17752 833 F. 2d 1258 (DC Cir. 1988) 53 FR 35610 54 FR 52024 55 FR 3724 55 FR 29712 57 FR 49657 59 FR 40964 60 FR 33974 61 FR 43454 IV7 F ,3d 891 (5th Cir. 1997) 63 FR 35137 'Several other regulatory actions occurred with regard to nonasbestos minerals with asbestitorm analogs. These proceedings are outside ot the scope of this article. Studies and Health and others, and recommendation by the ACG1H, it is hereby determined that . . . working conditions constituted a grave danger and that an ETS was neces sary."'61 The asbestos ETS, however, did not follow the recommended model. It was PEL-based and reduced the exposure limit to only 5 f/cc instead of 2 f/cc as requested by the petitioners. In addi tion, rather than simply adopting work practices as well as specific engineering controls, the ETS contained several specifications for respirator usage including provisions for respirator selection. Although OSHA's permanent asbestos rules have paved the way for increasingly ambitious health rules, OSHA's ETSs for as bestos have marked die beginning and the end of the agency's use of that emergency authority. The first asbestos ETS was unchal lenged most likely because of public and congressional concern about the "asbestos hazard." Perhaps the ETS lacked the vigor that would draw industry challenge. The preamble to the ETS recited the statutory criteria of "grave danger," "necessity," and "feasibility" and little else. Subsequent ETSs for vinyl chloride'* (39 FR 12342) and DBCP(l0> (42 FR 45536) were not challenged either. By 1983, however, when OSHA issued its second asbestos ETS,<n> courts had overturned four ETSs for various reasons. The 210 AiHAJ (62) March/AorU 2001 HWBUI0008653 FROM BIOMEDICAL INFORMATION SERVICE TABLE II. List of the Date and Citation May 29, 1971 | 36 FR 10466 December 7, 1971 36 FR 23207 June 7, 1972 37 FR 11318 ' Paragraph Permissible Exposure Limit Methods of Compliance Permissible Exposure Limit Methods of Compliance Permissible Exposure Limit Methods of Compliance Exposure Monitoring Respirators June 20, 1986 51 FR 22612 Housekeeping and Hygiene Hazard Communication Medical Surveillance Recordkeeping Permissible Exposure Limit Action Level Methods of Compliance Exposure Monitoring Respirators Housekeeping June 20,1986 51 FR 22612 (Special provisions | for construction V activities) Hazard Communication Medical Surveillance Methods of Compliance Competent Person Hazard Communication Medical Surveillance (MON) 1 0. 1 3' 03 1 6 : 1 3/ST. 16:1 O/NO. 4862209230 P 10 New or Modified Provisions PEL = 12 f/cc as an 8-hour time-weighted average (TWA). Feasible administrative or engineering controls required. PEL = 5 f/cc as an 8-hour TWA. PEL = 10 f/cc as a 15-min ceiling. Engineering controls required. PEL = 5 /fee as an 8-hour TWA effective 1972. PEL = 10 f/cc as a 15-min ceiling effective 1972, PEL = 2/fcc as an 8-hour TWA effective 7/1/76. Engineering controls required to meet the PEL. Specified work practices required to meet the PEL. Employee rotation as a means to reduce exposure prohibited Employee exposures must be monitored where fibers are released. Monitoring must be repeated every 6 months or when employee exposures are reasonably foreseen to exceed the PEL. Employees' environment must be monitored. Employees must be given an opportunity to observe monitoring. Establishment of respirator program required if engineering controls are not feasible. Respirator selection must be based on exposure levels. Medical removal protection must be provided for employees who cannot wear respirators. Protective clothing must be provided if exposure exceeds the PEL. Hygiene facilities must be provided if exposure exceeds the PEL. Surfaces must be maintained to prevent accumulations that could cause excessive air concentrations. Employees must be notified when their exposures exceed the PEL. Warning signs must be displayed in areas where concentrations may exceed the PEL. Caution labels must be affixed to materials containing asbestos. Annual medical examinations must be provided to every employee exposed to any asbestos. Specific tests required include chest X-ray and pulmonary function tests. Monitoring records must be kept for 3 years. Medical results must be kept for at least 20 years. PEL = 0.2 f/cc as an 8-hour TWA. Action level = 0.1 f/cc. Compliance programs must be established and implemented. Engineering controls required to meet the PEL except for specified operations; they must be used to meet a level of 0.5 f/cc. Spray application of asbestos-containing materials prohibited. Use of objective data to determine initial exposure is allowed. Monitoring must be repeated every 6 months or when employee exposures are reasonably foreseen to exceed the action level. Monitoring of employees' environment is not required. Required analytical method Is specified in Appendix. Fit-testing Is required. Employees are allowed to choose powered, air-purilying respirators. Provisions apply wherever asbestos is present. Surfaces must be maintained as free as practicable from accumulations of dust. HEPA filters are required for vacuuming. Wet methods are required for cleanup. Waste must be placed in impermeable containers. Retention of records is required as specified in 29 CFR 1910.20, Standard contains eight appendices with mandatory and nonmandatory information. Training program required for all employees exposed above the action level. Program must be instituted for employees exposed over the action level. Negative pressure enclosures and decontamination facilities must be established for asbestos removal, demolition, and renovation operations. A competent person must be designated to oversee compliance operations. Other employers must be informed of asbestos work. Employers with more than 30 days' exposure per year must be provided medical surveillance. HWBUI0008654 FROM BIOMEDICAL INFORMATION SERVICE (MON) 1 0. 1 3' 03 16:1 3/ST. 16:1 O/NO. 4862209330 P 11 TABLE II. List of the Major Provisions New to Each of OSHA's Final Asbestos Standards (1971-1998) (continued) Date and Citation Paragraph New or Modified Provisions September 14, 1988 53 FR 35610 December 20, 1989 February 5, 1990 August 19, 1994 59 FR 40964 August 19, 1994 59 FR 40964 , (Special provisions for construction) Permissible Exposure Limit Methods of Compliance Exposure Monitoring Methods of Compliance Permissible Exposure Limit Appendices Excursion limit = 1 f/cc for 30 min. Prohibition on spray application of asbestos-containing materials removed. Exposure monitoring must be done when conditions change. Smoking prohibited where asbestos exposure occurs. Smoking cessation information must be provided to employees. Warning signs must be comprehensible to employees. PEL = 0.1 f/cc as a TWA. Certain materials are presumed to contain asbestos unless determined otherwise. Building owners held responsible for notifying tenants, employees, and other employers of potential asbestos exposures and the presence of asbestos-containing materials. Other employers and employees including prospective bidders must be informed of the presence of asbestos-containing materials. Responsibilities at multiemployer work sites are specified. Competent person capable and empowered to .control asbestos exposures is required. Four classes of construction work are established independent ot exposure levels. Controls established for each class specified including details for special types of regulated areas, posting of signs, in-depth training of competent person and other employees, handling of waste materials, use of glove bags, and other controls. Activities defining classes are: Eleven appendices provide more detail and guidance. 'ed Studies judicial rejection of the second asbestos ETS<12) was the fifth re jection of an ETS. Given this record, OSHA has not issued an ETS for any hazard since the second asbestos ETS. OSHA promulgated the 1972 permanent asbestos standard quickly. In 183 day's OSHA published an NPRM (January 12, 1972),<13) established an advisory committee and obtained rec ommendations (February 25, 1972), held public hearings (March 14 through March 17, 1972), and issued a final standard (June 7, 1972).(HI This timetable seems remarkable when compared with more recent OSHA rulemakings, which have taken from 4 years (e.g., benzene, arsenic) to more than 10 years (c.g., 1,3butadiene, methylene chloride) from proposal to completion. As with the ETS, OSHA provided minimal written justification for the 1972 final asbestos standard. The preamble to the final standard was only two pages long. Not a single study was specif ically cited.(l4) This contrasts with more recent standards that con tain lengthy written support, analysis, and explanation in their pre ambles For example, the preamble to the final methylene chloride standard was 106 pages!15) As with the ETS, OSHA provided no explanation in the preamble to its 1972 final asbestos standard for adopting a PF.L-based approach and rejecting the specified work practice regulatory approach recommended by the AFL-CIO. The standard required asbestos exposure levels to be reduced to 5 f/cc immediately and a delayed 2 f/cc requirement until July 1, 1976, because certain industries needed more time. In addition to the PEL, the 1972 final standard contained several ancillary provisions that enhanced the effectiveness of the PEL. They also established a framework for the content of future OSHA toxic substance standards. One important provision covered medical re moval protection. It required employers to maintain benefits for employees who could not wear the required respirators. The Industrial Union Department of the AFL-CIO petitioned the Court of Appeals for the D.C. Circuit to review the 1972 final standard, the first legal challenge to a standard promulgated hv OSHA. The petitioners challenged the delay in requiring the lower PEL, and objected to that portion of the standard concerning methods of compliance, monitoring intervals and techniques, can tionary labels and notices, and medical examinations and records that were not sufficiently rigorous. The court upheld the standard in most respects and only asked OSHA to provide better exp)a nation for the requirements of the uniform application of the 2 f/cc standard in 1976 and the 3-year retention period for rnor.i toring records!161 Even though the court stated titan OSHA could impose different start-up daces for different industries if various industries have different capabilities, OSHA had not reconsidered this point by 1976, the date for all industries to comply with the 2 f/cc standard. At that point, the issue was moot. Although the major provisions of the standard were upheld b\ the court, the most important consequence of the judicial review was the court's decision that "substantial evidence" required to uphold a standard can include policy considerations, indudmg when OSHA based a rule on policy considerations. There was no reliable data available to predict health effects precisely at various levels of exposure to asbestos dust. The court ruled that OSHA's choice of limits must be justified with a careful identification of the reasons one course was taken over another. Only when OSHA's choice purported to be based on the existence of certain determinable facts could OSHA, in form as well as substance, find those facts from evidence in the record. By the same token, when OSHA was obliged to make policy judgment where no factual certainties existed or where facts alone did not provide die answer, OSHA had to state this and go on to identify the considerations that are found to be persuasive. 212 A1HAJ (62) March/April 2001 HWBU10008655 FROM BIOMEDI CAL INFORMATION SERVICE (MON) 1 0. 1 3' 03 1 6 : 1 4/ST. 1 6 : 1 O/NO. 4862209230 P 12 The court also specified criteria that OSHA must use to dem onstrate that a rule is economically feasible. The court stated that Congress did not appear to intend to protect employees by put ting their employers out of business--either by requiring protective devices unavailable under existing technology or by making financial viability generally impossible. However, the court stated: This qualification is not intended to provide a route by which recalcitrant employers or industries may avoid the re forms contemplated by the Act. Standards may be econom ically feasible even though, from the standpoint of employers, they are financially burdensome and affect profit margins adversely. Nor does the concept of economic fea sibility necessarily guarantee the continued existence of in dividual employers. It would appear to be consistent with the purposes of the Act or envisage the economic demise of an employer who has lagged behind the rest of the industry in protecting the health and safety of employees and is con sequently financially unable to comply with new standards as quickly as other employers ,*1<S> feature of this ETS was; the inclusion of numerical estimates show ing the grave danger of disease workers faced from exposure to asbestos at existing levels. Based on studies of worker cancer mor tality, this quantitative risk assessment predicted that 210 cancer deaths would be prevented by reducing the asbestos PEL from 2 to 0.5 f/cc for the 6-month period covered by the ETS. This quantitative assessment of risk was a result of the Supreme Court's 1980 benzene decision requiring OSHA to perform such an analysis when appropriate data are available. Quantitative risk assessment was relatively new to rulemaking at the time. Asbestos was one of the agency's first uses of the technique. Unlike the qualitative descriptive methods of the past, the quantitative risk assessment involved an in-depth review of the studies, develop ment of dose-response models, and estimation of risks at condi tions outside the range of observation. The Asbestos Information Association (AIA) petitioned the U.S. Circuit Court of Appeals for judicial review of the ETS. The court vacated the ETS on March 7, 1984.<18) One reason for the court's action was the sophistication of the quantitative risk as sessment used by OSHA to justify the ETS. The court felt that In October 1975, staring that "sufficient medical and scientific evidence has been accumulated to warrant die designation of as bestos as a human carcinogen'' and because of advances in mon itoring and protective technology, OSHA published an NPRM to again revise its asbestos standard.*17) This standard would have ap plied to general industry employers only and would have excluded construction work. Unlike the 1972 NPRM that contained no description of the health studies, the preamble to this NPRM con tained summaries of the newly available studies on the adverse health effects associated with occupational exposure to asbestos and explained their impact on selection of a new asbestos PEL. The main feature of the proposed standard was a reduction in the JpEL to 0.5 f/cc. such an assessment required the kind of peer review available only through rulemaking under Section 6(b) of the act. On April 10, 1984, OSHA supplemented the ETS with pub lication of an NPRM with more detailed provisions than were contained in the ETS.(1S) OSHA held lengthy hearings and re ceived a large volume of comments. More than 2 years later, on June 20, 1986, OSHA published two final asbestos standards.'|g' One applied to asbestos exposure in general industry (codified at 29 CFR 1910.1001), whereas the other applied to construction operations (codified at. 29 CFR 1926.1101). Some of the major provisions contained in these standards are summarized in Table II, (Note: Table II only highlights provisions to illustrate signifi cant approaches in the standards. The full standards, as codified, Many comments were submitted in response to this proposal. Most comments from industry opposed designating asbestos as a carcinogen and stated that the PEL of 0.5 f/cc could not be achieved. Four senators and two congressmen asked that the pro posal be changed because it appeared infeasible. Representatives contain employer duties.) Unlike previous standards, the type of work performed by an employee, rather than the type of business or product manufac tured, determined which of the 1986 standards was applicable. OSHA grouped most operations involving the handling of previ of the maritime and construction industries asked OSHA to pro ously installed asbestos-containing material into the construction pose rules that were more suited to their unique workplaces. Only standard. In addition to the usual construction activities such as labor representatives and some isolated industrial hygiene groups the demolition or salvage of structures and the removal or encap supported OSHA's proposed PEL and rationale. The comments can be found in OSHA Docket No. H-033C. Given the extent of the opposition to the proposal, OSHA did not conduct a hear sulation of materials, the construction standard applied to main tenance and repair activities normally covered by a general indus try standard. For example, if employees of a chemical company ing. OSHA's rulemaking efforts turned instead to arsenic, cotton dust, and other occupational hazards needing their own compre hensive health standard. The agency never issued a rule based on were removing asbestos insulation from a portion of pipe, the con struction standard would apply to this activity, regardless of the fact that the employer was not a construction company. Although the 1975 proposal. both standards contained many of the same ancillary require ments, extra work practice requirements were added to the con ASBESTOS REGULATION IN THE 1980s struction asbestos standard. OSHA stated that the specific work practices were necessary because the use of airborne measurements to determine compliance with a PEL was not effective for con In June of 1983 the International Association of Machinists and Aerospace Workers petitioned OSHA for a second asbestos trolling exposures in construction type activities. In most situa tions work activities arid exposures would change before the sam ETS.*'" The petition requested that OSHA reduce the PEL from pling results were available. Also, the day-to-day variability' of 2 f/cc to 0.1 f/cc, modify some existing work practice require asbestos exposure during construction-type activities made it dif ments, and require other protective provisions regardless of an ficult for an employer or an employee to determine what types of employee's exposure level. Sixteen other unions joined the Inter controls would be needed to reduce exposures to the extent nec national Association of Machinists and Aerospace Workers in its essary to meet a PEL. The specified work practice controls clearly equest.*n) stated an employer's obligations.<191 On November 4, 1983, OSHA granted the request and pub One innovation in the 1986 asbestos standards was a new ap lished an ETS that reduced the PEL to 0.5 f/cc.(U) A central proach for the initial monitoring of employee asbestos exposure. AIHAJ (62) March/April 2001 213 HWBU10008656 ppued Studies* FROM BIOMEDICAL INFORMATION SERVICE (MON) 10. 1 3' 03 16:1 4/ST. 16:1 O/NO. 4862209230 p 1 All OSHA toxic substance standards require employers to do ini tial monitoring of employees to determine whether exposures are above or below the PEL. Under the 1972 asbestos standard, every employer had to monitor every employee's asbestos exposure any where asbestos fibers were released to make this determination for each employee. In contrast, the 1986 standards allowed employers to use "objective data" for initial exposure determination of em ployee exposure levels. OSHA did not define or explain the mean ing of "objeedve data." It seems reasonable that objeedve data was meant to be factual information characterizing the upper lim its of exposure for an operation. For example, demonstrations of dust levels resulting from installation of new well-bound asbestoscontaining products without loose dust on the surface could be provided by the manufacturer. Objective data also could be used to determine exposures in buildings containing asbestos products when the products are not disturbed. This approach to initial monitoring, that is, the use of objective data, has been adopted in subsequent OSHA toxic substance standards (for example, see the standards for cadmium at 29 CFR 1910.1027; formaldehyde at 29 CFR 1910.1048; 1,3-butadiene at 29 CFR 1910.1051; and methylene chloride at 29 CFR 1910.1052). Both final 1986 asbestos standards reduced occupational ex posure to 0.2 f/cc based on OSHA's quantitative risk assessment. The risk assessment estimated that the standard would prevent 7815 cancer deaths due to occupational exposure to asbestos over a 45-year working lifetime. In terms of rates, OSHA estimated that the cancer risk to workers exposed to asbestos for 45 years at 0.2 f/cc is approximately 3 cancer deaths per 1000 exposed work ers. OSHA stated that this risk is "significant" but determined that lowering of the PEL further was not technologically or eco nomically feasible. OSHA believed that 0.2 f/cc was the lowest PF,L to meet these criteria, thus, it set the 1986 PEL at 0.2 f/cc despite the remaining significant risk.*19' Both industry and labor participants in the rulemaking process petitioned the U.S. Court of Appeals for judicial review of the 1986 asbestos standards. On the one hand, labor, represented by the AFL-CIO and the Building and Construction Trade Depart ment of the AFL-CIO, challenged the standards primarily on the grounds that a lower PEL was both economically and technolog ically feasible. They stated that OSHA should have required em ployers to implement additional controls to reduce die significant risk remaining at the new PEL. On the other hand, the asbestos manufacturing industry, represented by the ALA, challenged the standards primarily on the grounds that the new PEL was neither economically nor technologically feasible. The AIA also challenged OSHA's inclusion of smokers in its quantitative risk assessment. The worker population for which OSHA estimated risk had contained the prevailing proportions of smokers and nonsmokers found in the general population. Be cause there is synergism between smoking and asbestos exposure, however, the magnitude of the lung cancer risk for workers who smoked and were occupationally exposed to asbestos was substan tially higher than the magnitude of the lung cancer risk for non smoking workers who were similarly exposed. It was OSHA's po sition that employers had to protect the smoking population even though smoking was the personal choice of individual workers.119' On February 2, 1988, the U.S. Court of Appeals for the Dis trict of Columbia issued its decision.(20) It upheld most of the major provisions challenged by the petitioners. Certain issues, however, were remanded to OSHA for reconsideration. For ex ample, the court asked OSHA to explain the reasons it found a PEL of 0.1 f/cc to be technologically infeasible given that most asbestos-exposed workers were automotive mechanics whose ex posures were indeed below 0.1 f/cc when cleaning brakes. The court agreed with the AFL-CIO that OSHA had not adequately explained its reasons for not adopting particular provisions. Be cause the standard did not eliminate the significant cancer risk to workers, the court ordered OSHA to reconsider those challenged provisions. For example, one provision recommended by the union had included requiring companies to notify OSHA in writ ing before commencing with asbestos removal projeers. The ALA recommended that OSHA require employers to provide smoking cessation programs for workers exposed to asbestos, The same court had made a similar finding a scant 6 months earlier in its review of OSHA's ethylene oxide (ErO) standard.'-1. In that case the court held that the agency had to adopt a short term exposure limit as an ancillary provision to its EtO standard (as opposed to a risk-based provision like the PEL) unless the agency could prove that a short-term exposure limit, was not fea sible. The court reasoned that OSHA's mission was to eliminate significant risk. OSHA added a 1 f/cc 20-min excursion limit to the asbestos standard on September 14, 1988.,22) The asbestos decision was the first for which a court held that ancillary provisions completely unrelated to exposure levels that were claimed to be effective and feasible had to be adopted by OSHA when a new PEL did not eliminate significant risk. This appeared to reduce OSHA's discretion to decide which ancillary provisions were needed to actually reduce a health risk. Although it is true that proponents had to submit some evidence backing up their claims, almost any report or study appeared to be suffi cient. Thus, when workers face continued significant risks at a new PEL, OSHA must explain why it did not require all proposed ancillary measures. This decision extended the judicial interpreta tion of the Supreme Court's benzene decision, which focused on the PEL. It also resulted in major changes to the asbestos standard in the 1990s as OSHA concentrated on non-PEL requirements. Most of the issues the court asked OSHA to reconsider in volved ancillary provisions that were proposed by participants in the rulemaking process. These participants were unsuccessful in convincing the agency to adopt their proposals, but they were successful in convincing the court than the agency's reasons for not adopting their proposals were inadequate. Some of these pro visions would change OSHA's prevailing policy positions. For ex ample, industry wanted OSHA to require smoking cessation pro grams or adopt even more stringent smoking restrictions in asbestos workplaces. During the court challenge OSHA resisted, arguing that it should not be required to control confounding exposures to a workplace contaminant. On reconsideration, how ever, the agency adopted a compromise solution: require employ ers to inform employees about smoking cessation programs with out requiring employers to actually pay for or administer such programs. I ASBESTOS REGULATION IN THE 1990s On July 20, 1990, OSHA once again proposed changing its asbestos standards.124' This time it was to address die court's concerns expressed in its decision on the 1986 asbestos standards. The changes from the 1986 final asbestos standards were major: reduce the PEL to 0.1 f/cc across the board; require various spec ified work practices for most asbestos abatement maintenance and repair activities regardless of exposure levels; require a designated "competent person" for all abatement activities even if an em ployer's business is not in construction; and hold building owners 214 AIHAJ (62) March/April 2001 HWBUI0008657 FROM BIOMEDICAL INFORMATI ON SERVICE (MON) 1 0. 1 3' 03 16:1 5/ST. 16:1 O/NO. 4862209230 P 14 responsible for communicating asbestos hazards in their buildings. OSHA maintained the regulatory scheme whereby the type of work performed, rather than the industry sector of the employer, determined which asbestos standard would apply to the employer. Throughout the 1980s the Environmental Protection Agency (EPA) had worked to develop rules addressing the environmental hazard from asbestos in public and commercial buildings. In 1988, however, the EPA had to confront a stark worker health issue. The Service Employees "International Union (SEIU) petitioned the EPA to require inspection for asbestos in all public and com mercial buildings. When the EPA failed to respond, the SEIU sued the EPA to force its hand. In response, EPA held a series of "pol icy dialogues" to develop consensual solutions among insurance interests, asbestos manufacturers and consultants, state govern ments, unions, and public interest groups as well as OSHA. There was general agreement that the presence of asbestos should be known to building service workers although no agreement was reached on how large the risk was to these workers or how as bestos-containing building materials should be identified and in spected. The dialogues seemed to have had a policy benefit to OSHA because they resulted in having the positions of the various groups understood and clarified. Also, it seems as though the di alogue group activities improved coordination of regulatory ac tions between OSHA and EPA.(2S) During these dialogues the unions recommended that OSHA require the inspection of all buildings for asbestos. Realty interests opposed this approach. When the dialogues deadlocked on the identification and inspection issue, OSHA reopened its own ru lemaking record and asked for public comment on its proposed solution.(26) The agency proposed that before employees disturbed building materials that might contain asbestos, their employers and the building owncr(s) must identify where and how much asbestos they might encounter. OSHA also proposed allowing em;^P ployers/owners to treat certain potentially high-risk building ma terials as if they contained asbestos and thereby relieve employers/ owners of any inspection and identification requirements for those materials. OSHA noted that these solutions would be much less expensive than an overall inspection requirement that was not tied to potential disturbance. Furthermore, the agency believed this approach would provide better protection to workers. Although the reopening of the rulemaking record delayed the issuance of a final asbestos standard, OSHA believed its solution to the public/ commercial inspection problem that had plagued labor, industry, and the regulatory community for 5 years was effective and pro tective. On August 19, 1994, OSHA published two final asbestos stan dards: one for general industry and one for construction.*25' The 1994 standards differed from the 1986 standard in many substan tial ways. The PEL was reduced to 0.1 f/cc. All employers were required to communicate information about asbestos hazards to each other and to their employees. On construction projects, gen eral contractors were required to exercise general supervisory au thority over all asbestos work on those projects covered by the standard. As such, general contractors were required to determine whether asbestos contractors were in compliance with the standard and had the authority to compel such contractors to come into compliance. The 1994 final standards incorporated the comments received in response to OSHA's request for comments. Owners of build ings and facilities who were also employers were held responsible for identifying asbestos in order to warn contractors and employ ees who might come in contact with the material. Before asbestos material was disturbed, employers had to inform all potentially exposed employees as to its location. The construction standard did not explicidy require owners to test building materials for as bestos, but it did require owners/employers to assume that all thermal system insulation, sprayed on or troweled on surfacing material, and all resilient flooring material installed prior to 1981 contained asbestos unless these materials were tested. The identification of asbestos and the presumption or asbestos as a high-hazard material are central features of the of the 1994 standards. The result of these features is that certain work practices as well as training are mandatory regardless of employee exposure levels. OSHA justified these mandatory work practices on the grounds that workers continued to face a significant risk of death from occupational exposure to asbestos even at the new PEL. These work practices were necessary to reduce that risk. The man datory work practices included demarcation of regulated areas where materials containing asbestos are disturbed; enclosing or isolating those processes that produced asbestos dust; using neg ative pressure when enclosure was used; ventilating regulated areas to move contaminated air away from employee's breathing zones and toward a collection device; using barrier or isolation methods to prevent migration of airborne dust from the regulated area; using specified materials (e.g., 6-mL thick plastic for glove bags); and using wet methods to control exposure during die handling, mixing, removal, cutting, application, or cleanup of asbestos. As with the previous final asbestos standards, industry and labor petitioned the appeals court for judicial review of the 1994 stan dards. Over the next 4 years OSHA worked out setdements that clarified the intent of the standard in certain applications.,272,i> Such detailed specifications were within the scope of the standard, but in those applications the settlements apply. The citations for these actions are listed in Table I. The most recent change to the standard was made on June 29, 1998. In response to a court ruling, OSHA removed the application to asbestos-containing as phalt roof coatings, cements, and mastics.*29'30' DISCUSSION One goal of the current study was to explain how certain reg ulatory approaches developed and how the regulatory process slowly evolved over the years. OSHA's regulation of asbestos has broken regulatory ground in many ways. The lessons and strate gies learned from the asbestos rulemaking efforts have been ap plied by OSHA and the public to other occupational exposure standards for other toxic substances. Table III presents a summary of the more important regulatory concepts and events that shaped subsequent rulemakings for other toxic substances. Some of the lessons learned from regulating asbestos, however, do not appear to have been taken to heart. For example, unlike asbestos, more recent OSHA health standards have not specified certain engi neering and work practice controls. It is noteworthy that the work practice provisions contained in the most recent asbestos standards are akin to those requested by the AFL-CIO in 1971. The union position was that asbestos ex posure is difficult to measure and that mandated work practices are easier for employers and employees to understand than is de termining the types of controls necessary to achieve a specified exposure level. OSHA's 1994 standard is heavily oriented toward engineering and work practice controls. One striking lesson from the current study is how the rulemaking process has lengthened over the years. It took only 6 months from publication of the NPRM to publication of the final A1HAJ (62) March/April 2001 215 HWBUI0008658 FROM BIOMEDICAL INFORMATION SERVICE (MON) 1 0. 1 3' 03 16: 15/ST. 1 6 : 1 O/NO. 4862209230 P 15 TABLE III, Noteworthy Events Associated with and Original Regulatory Concepts Introduced by OSHA's Asbestos Standards ___________ ' Event Significance Publication of the 1971 ETS for asbestos Publication of the 1972 asbestos standard Industrial Union Department of the AFL-CIO petitions the D.C. Court of Appeals to review the 1972 asbestos standard Issuance of the U.S, Circuit Court of Appeals decision in IUDAFL-CIO v. Hodgson (1974) Publication of the 1983 ETS for asbestos Issuance of U.S. Circuit Court of Appeals decision in Asbestos Information Association v. OSHA (1984) Publication of the 1986 asbestos standard Issuance of the U.S. Circuit Court of Appeals decision in BCTD v. Brock (1988) Publication of the 1994 asbestos standard OSHA's first ETS first OSHA standard to use public notice and comment procedures established the formal of regulatory provisions for toxic substance standards assigned protection factors for different types of respirators instituted medical removal protection and benefits for workers unable to wear respirators first OSHA standard litigated in the U.S. Circuit Court of Appeals began the adversarial approach to standard setting upheld OSHA's written justification for essential features of the standard created "substantial evidence" criteria remanded the standard to OSHA for consideration of duration of record retention and time necessary to phase in engineering controls first OSHA ETS to use a quantitative risk assessment as justification vacated OSHA's 1983 ETS marked the last time OSHA attempted to issue an ETS allowed use of objective data in place of initial monitoring included provisions unique to construction significant risk not eliminated because OSHA found a more stringent standard to be infeasible provided equal protection to smokers and nonsmokers required OSHA to strengthen a standard when an existing standard does not eliminate a significant risk or an outside shows that a certain practice can substantially reduce the risk presumed certain thermal insulation and surfacing materials contain asbestos unless testing shows otherwise mandated work practices and controls based on worker disturbance of asbestos-containing material independent of exposure levels ! QfU rule in 1972. Four years elapsed between publication of the most recent NPRM for asbestos and publication of the final rule. The duration of these rulemaking proceedings makes a person wonder whether there is not a better way to regulate occupational safety and health hazards. It is unlikely that the authors of the OSH Act envisioned an agency working on asbestos standards from its inception in 1971 to 1998. The asbestos model points toward the need for a more streamlined rulemaking process. Both OSHA and the courts have exercised their authorities, which re sulted in these drawn-out rulemakings. Therefore, it appears that Congress should amend the OSH Act by clarifying OSHA's risk goals and lowering OSHA's burden of evidence to support a stan dard. REFERENCES 1. "Occupational Safety and Health Standards; National Consensus Standards and Established Federal Standards," Federal Register 3&. 10S (29 May 1971), pp. 10466-10506. 2. "Occupational Exposure to Asbestos; Final Rule," Federal Register 59: 153 (10 August 1994), pp. 40964-41158. 3. "Legislative History of the Occupational Safety and Health Act of 1970," (S. 2193, P. L. 91-596), 92nd Cong., 1st Sess., Committee Print, June 1971, p. 143. 4. Industrial Union Department, AFL-CIO v, American Petroleum- In stitute, 448 U.S. 601, 65 L Ed. 2d 1010, 100 S. Ct. 2844 (1980). 5. Occupational Safety and Health Act of 1970\ 29 U.S.C. 655(b), 657(c), and 657 (g)(2). 6. "Occupational Safety and Health Standards: Miscellaneous Amend ments," Federal Register 36:157 (13 August 1971), pp. 1510115104. 7. Taylor, G.H.R.: Letter to Secretary of Labor James D. Hodges, No vember 4, 1971. 8. "Emergency Standard for Exposure to Asbestos Dust," Federal Reg ister 36:234 (7 December 1971), pP. 23207-23208. 9. "Emergency Temporary Standard for Exposure to Vinyl Chloride." Federal Register, .39:67 (5 April 1974), pp. 12342-12343. 10. "Emergency Temporary Standard for Occupational Exposure to 1.2 Dibromo-3-chioropropanc (DBCP), Hearing," Federal Register 42: 175 (9 September 1977), pp. 45536-45549. 11. "Occupational Exposure to Asbestos; Emergency Temporary Stan dard," Federal Register 45:215 (4 November 1983), pp. 5108651140. 12. Asbestos Information Association v. OSHA, 727 F.2d 425, 5tb Circuit (1984). 13. "Standard for Exposure to Asbestos Dust; Notice of Proposed Rule Making," Federal Register 37:7 (12 January 1972), pp. 429-431. 14. "Standard for Exposure to Asbestos Dust," Federal Register 37:110 (7 June 1972), pp. 11318-11322. 15. "Occupational Exposure to Methylene Chloride: Final Rule," Federal Register 62:7 (10 January 1997), pp. 1494--1619. 16. Industrial Union Department, AFL-CIO v. Hodgson, 499 F. 2d 467, D.C. Cir. (1974). 17. "Occupational Exposure to Asbestos; Notice of Proposed Rulemak ing," Federal Register 40:197 (9 October 1975), pp. 47652-47665. 18. "Occupational Exposure to Asbestos," Federal Register 49 70 ! 1 0 April 1984), pp. 14116-14144. 19. "Occupational Exposure to Asbestos, Trcmolite, Anthopbylljte, and Actinolite; Final Rules," Federal Register 51:119 (20 June 1986) pp 22612-22790. 20. Building and Construction Trades Department, AFL-CIO v Brock 838 F.2d 1258, DC Cir (1988). 21. Public Citizen Public Rtstarcb Group v. Tyson, 796 F. 2d 1479 DC Cir (1986). 22. "Occupational Exposure to Asbestos, Trcmolite, Anthopbyllke, and Actinolite; Final Rules; Amendment," Federal Register 53:178 (14 September 1988), pp. 35610-35629. 23. "Occupational Exposure to Asbestos," Federal Register 55:24 (5 Feb ruary- 1990), pp. 3724-3731. 216 AIHAJ (62) March/April 2001 HWBUI0008659 FROM BIOMEDI CAL INFORMATION SERVICE (MON) 10. 13' 03 16:1 5/ST. 16:1 O/NO. 4862209230 P 16 24. "Occupational Exposure to Asbestos, Tremotite, Anthophyllite and Actinolite, Proposed Rule," Federal Register 55:140 (20 July 1990), pp. 29712-29753. 25. "Occupational Exposure to Asbestos; Final Rule," Federal Register I 59:153 (10 August 1994), pp. 40964-41158. 26. "Occupational Exposure to Asbestos," Federal Register 57:213 (3 November 1992), pp. 49657-49658. 27. "Occupational Exposure to Asbestos; Corrections; Final Rule," Fed eral Register 60:125 (29 June 1995), pp. 33974-24002. 28. "Occupational Exposure to Asbestos, Tremolite, Anthophyllite and Actinolite," Federal Register 61:165 (23 August 1996), PP- 43454,43459. 29. Asbestos Information Association/UA v. Reich 117 E. 3d 891, 5th Cir (1997). 30. "Occupational Exposure to Asbestos," Federal Register 63 (29 June 1998), pp. 35137-35138. AIHAJ (62) March/April 2001 217 HWBUI0008660