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George Washington University Regulatory Studies Center Public Interest Comment1 on The Occupational Safety and Health Administration’s Proposed Standards for Occupational Exposure to Respirable Crystalline Silica Docket No. OSHA-2010-0034 RIN: 1218-AB70 December 4, 2013 Susan E. Dudley and Andrew P. Morriss2 The George Washington University Regulatory Studies Center The George Washington University Regulatory Studies Center works to improve regulatory policy through research, education, and outreach. As part of the Center’s mission, Center scholars conduct careful and independent analyses to assess rulemaking proposals from the perspective of the public interest. This comment on the Occupational Safety and Health Administration’s (OSHA) proposed standards for occupational exposure to respirable crystalline silica does not represent the views of any particular affected party or special interest, but is designed to evaluate the effect of OSHA’s proposal on overall social welfare. It builds on an article by the authors, “Defining What to Regulate: Silica & the Problem of Regulatory Categorization,”3 which we attach to this comment and respectfully submit for the record in this rulemaking. 1 This comment reflects the views of the authors, and does not represent an official position of the GW Regulatory Studies Center or the George Washington University. The Center’s policy on research integrity is available at http://research.columbian.gwu.edu/regulatorystudies/research/integrity. 2 Susan E. Dudley is director of the GW Regulatory Studies Center and research professor in the Trachtenberg School of Public Policy and Public Administration. Andrew P. Morriss is D. Paul Jones, Jr. & Charlene A. Jones Chairholder in Law and Professor of Business at the University of Alabama and a Research Scholar at the GW Regulatory Studies Center. 3 Andrew P. Morriss & Susan E. Dudley, “Defining What to Regulate: Silica & the Problem of Regulatory Categorization,” Administrative Law Review, Vol. 58, No.2 (Spring 2006). The George Washington University Regulatory Studies Center 1 Introduction OSHA is proposing to amend its existing standards for occupational exposure to respirable crystalline silica by establishing a new permissible exposure limit (PEL) as well as a series of ancillary provisions for controlling exposure, providing for respiratory protection and medical surveillance, communicating hazard, and recordkeeping. Crystalline silica refers to a group of minerals composed of silicon and oxygen atoms that are arranged in a three-dimensional repeating pattern. Because oxygen and silicon are the two most common elements in the Earth’s crust, silica is abundant in nature. Crystalline silica comes in several forms, the most common of which are quartz, cristobalite, and tridymite. According to the Bureau of Mines: this group of minerals has shaped human history since the beginning of civilization. From the sand used for making glass to the piezoelectric quartz crystals used in advanced communication systems, crystalline silica has been a part of our technological development.4 Because crystalline silica is ubiquitous in nature and valuable for a wide variety of materials and uses, workers may be exposed to it in a large variety of industries and occupations.5 Scientists have long recognized that prolonged exposure to free crystalline silica is associated with silicosis, a progressive, incurable disease that involves scarring of the lungs and impaired respiratory function.6 The U.S. National Toxicology Program (NTP) has also found associations 4 U.S. Department of Interior, Bureau of Mines, Crystalline Silica Primer, 1992. Available at: http://www.co.goodhue.mn.us/countygovernment/committees/MiningCommittee/Studies/Crystalline%20Silica%2 0Primer%20-%20US%20Bureau%20of%20Mines.pdf 5 IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, “Silica Dust, Crystalline, in the Form of Quartz or Cristobalite” Vol. 100C. p. 377. Available at: http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-14.pdf 6 See William G.B. Graham, “Quartz and Silicosis,” in Occupational Lung Disease: An International Perspective 191, 191 (Daniel E. Banks & John E. Parker eds., 1998) ("Silicosis is the term used to designate the occupational lung disease caused by inhaling crystalline silica (alpha-quartz or SiO[2]) or its polymorphs, tridymite or cristobalite."); see also William Jones et al., “Dust Particles: Occupational Considerations,” in Handbook of Hazardous Materials 213, 213 (Morton Corn ed., 1993) ("Pneumoconiosis is the reaction of the lungs to inspired dust."). The authors added that "silicosis is a fibrotic disease produced by inhalation of silica-containing dusts. High exposures to crystalline silica can result in acute silicosis. Acute silicosis develops rapidly (1-3 yr) and is characterized by labored breathing (dyspnea), fatigue, cough, and weight loss." Id. at 215; see also Paul Stark et al., “Standard Imaging in Silicosis and Coal Worker's Pneumoconiosis,” in 30 The Radiological Clinics of North America: Occupational Lung Disease 1147, 1147-48 (Theresa C. McCloud, MD ed., 1992) (describing acute, chronic, and accelerated forms of silica dust exposure). The George Washington University Regulatory Studies Center 2 between exposure to certain forms of crystalline silica and lung cancer, and concluded that “respirable crystalline silica (RCS), primarily quartz dust occurring in industrial and occupational settings, is known to be a human carcinogen, based on sufficient evidence of carcinogenicity from studies in humans indicating a causal relationship between exposure to respirable crystalline silica and increased lung cancer rates in workers exposed to crystalline silica dust.”7 As discussed in the attached article, OSHA faces a number of challenges in developing regulations to reduce the risk associated with exposure to respirable crystalline silica. First, a successful risk reduction strategy must consider the complex biological, mineralogical, chemical, physical, and other characteristics of silica, as well as avenues of exposure, and a range of individual factors including personal characteristics unrelated to the exposure, such as whether the individual smokes. Second, given the limitations on our understanding of what forms of silica are most hazardous and what factors mediate those hazards, as well as what practices will best reduce risks, OSHA faces the problem of trying to bring about desirable behavior without having a clear idea of what that behavior should look like. In essence, the risks associated with exposure to respirable crystalline silica are not the result of lack of motivation on the part of employers or employees to achieve a safer workplace, but lack of information on how best to do that. This comment begins with a brief review of OSHA’s proposed regulatory approach, and the statutory authority on which its proposal is based. It then focuses on OSHA’s preliminary determination of significant risk, and its analysis of the risk reduction achievable by its proposed controls. It then evaluates alternatives to OSHA’s proposal that would be more consistent with President Obama’s regulatory guidance and also would be more likely to generate information to improve employee outcomes. The comment concludes with recommendations. We are also attaching for the record an article we authored on the challenges of regulating crystalline silica, which appeared in the Administrative Law Review in 2006. Summary of Statutory Authority & OSHA Proposal Section 6(b)(5) of the Occupational Safety and Health Act (OSH Act), requires OSHA to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so. OSHA proposes to find that 1) occupational exposure to respirable crystalline silica at current PELs constitutes a “significant risk” and 2) the proposed standard will substantially reduce that risk. 7 National Institute of Health, Toxicology Program, Report on Carcinogens, Twelfth Edition (2011) http://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/Silica.pdf The George Washington University Regulatory Studies Center 3 The available evidence indicates that employees exposed to respirable crystalline silica well below the current PELs are at increased risk of lung cancer mortality and silicosis mortality and morbidity. Occupational exposures to respirable crystalline silica also may result in the development of kidney and autoimmune diseases and in death from other nonmalignant respiratory diseases, including chronic obstructive pulmonary disease (COPD). [Preamble, p. 9] To reduce this risk, OSHA is proposing a new PEL of 50 micrograms per cubic meter of air (μg/m3) for respirable crystalline silica (defined as quartz, cristobalite, and tridymite). This represents a significant reduction from the current PELs, which OSHA adopted in 1971 and which are expressed as formulas. The current PEL for quartz in general industry is approximately equivalent to 100 μg/m3 as an 8-hour time-weighted average. The PEL for quartz in construction and shipyards is a formula based on a 1962 consensus standard relying on a now- obsolete particle count sampling method that OSHA reports is approximately equivalent to 250 μg/m3. The current PELs for cristobalite and tridymite are one-half of the values for quartz in general industry. In addition to the PEL, OSHA proposes to impose requirements for exposure assessment, preferred methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. Analysis OSHA’s
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