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Informal Public Hearing on the Proposed Rule for
Occupational Exposure to Respirable Crystalline Silica

Opening Statement of

Mr. William Perry
Acting Director, Directorate of Standards and Guidance
Occupational Safety and Health Administration

March 18, 2014

Good morning, Judge Solomon, ladies and gentlemen.  I am Bill Perry, Acting Director of the Directorate of Standards and Guidance of the Occupational Safety and Health Administration (OSHA).  I would like to echo Dr. Michaels' remarks and welcome you to this informal public hearing on the proposed standard for occupational exposure to respirable crystalline silica.

Accompanying me today are:

Bob Burt, Acting Deputy Director of the Directorate of Standards and Guidance;
Robert Stone, Director of the Office of Regulatory Analysis – Health;
B.J. Albrecht and Daniel Johansen, Chemists at OSHA's Salt Lake Technical Center;
Dr. Joe Coble, Director of the Office of Technological Feasibility;
David O'Connor, Director of the Office of Chemical Hazards – Non-Metals;
Annette Iannucci, a Health Scientist in the Office of Chemical Hazards – Non-Metals;
Kristen Lindberg, an Attorney in the Department of Labor's Office of the Solicitor; and
Ian Moar, Counsel for Health Standards in the Office of the Solicitor.

This public hearing is a very important step in OSHA's efforts to develop a scientifically sound, feasible, and health-protective final rule addressing occupational exposure to respirable crystalline silica dust. The development of a clear, accurate, and complete public record is a critical part of the rulemaking process. The Agency appreciates your participation and your contributions to the public record and will fully consider all comments, testimony, and recommendations as this rulemaking progresses.  We all share the same goal of protecting workers.

OSHA's current permissible exposure limits, or PELs, for workplace exposure to crystalline silica were adopted in 1971. The general industry PEL is a respirable dust formula that is approximately 100 µg/m3 for respirable quartz and approximately 50 µg/m3 for cristobalite and tridymite, two other forms of crystalline silica, as an eight-hour time-weighted average.  In construction and shipyards, the PEL for respirable quartz is a formula based on particle count measurement, and is approximately 250 µg/m3 as an eight-hour time-weighted average.

OSHA believes there is credible evidence, which will be discussed shortly, that indicates that these PELs are not sufficiently protective.  In addition, particle count limits reflect obsolete measurement methods that have not been used for decades, and many employers find the existing formula limits confusing. OSHA believes the proposed PEL, expressed as a gravimetric measurement of respirable crystalline silica, will be more protective of workers and easier for employers to understand.

The Agency has therefore proposed a new PEL for all covered industry sectors of 50 µg/m3 as an eight-hour time-weighted average for all forms of respirable crystalline silica, along with other proposed requirements.  The proposed PEL is consistent with the 1974 recommendation from the National Institute for Occupational Safety and Health, or NIOSH, and reaffirmed by NIOSH in 2002, that workplace exposures be limited to 50 µg/m3.  Published on September 12, 2013, OSHA's proposed rule is the culmination of years of work, data from dozens of site visits, and examination of hundreds of published reports.

The proposal includes two separate standards—one for general industry and maritime and a second for construction—in order to tailor requirements to the circumstances found in each of these sectors. OSHA is also proposing ancillary provisions for employee protection such as methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. The Agency anticipates that the ancillary provisions in the proposed standard will further reduce the risk beyond the reduction that would be achieved by the proposed PEL alone. 

For the construction proposal, OSHA developed a novel approach that would give employers an option, for certain operations, to implement dust controls and practices that are specified in a table included in the standard and not have to conduct periodic exposure monitoring.  Including this optional, alternative approach reflects what we heard from small business stakeholders in construction to simplify the standard and for OSHA to just “tell us what we have to do.”  OSHA expects that the methods of compliance for construction operations included in the proposal will make it easier for employers to know what dust controls to implement to protect workers from exposure.  Alternately, employers could assess worker exposures to determine if they are in compliance with the PEL, and implement controls of their choosing as necessary to meet the PEL. In either case, the proposed rule would provide a basis for ensuring that appropriate measures are in place to limit worker exposures.

In developing standards, OSHA must meet several legal tests. The Agency must demonstrate that the standard addresses a significant risk of material health impairment, that it will reduce that risk substantially, that there are technologically and economically feasible means of reducing that risk, and that the regulatory approach chosen is cost effective. Your input will help the Agency to ensure each of these tests are met, and that a final rule is developed that adequately protects workers, is feasible for employers, and is based on the best available evidence.

Although the number of deaths attributed to silicosis, based on death certificate records, has declined over the past several decades, evidence indicates that a substantial number of workers continue to die from silica-related diseases. From 2006 through 2010, silicosis was listed as the underlying or a contributing cause of death on over 600 death certificates in the United States, including 101 workers who died in 2010, the most recent year for which data are available.  Based on data from the Bureau of Labor Statistics, this is comparable to the number of workers who died from other well-known safety hazards such as fires or explosions, being caught in or crushed in collapsing materials (such as the collapse of trenches and structures), or being caught in running equipment or machinery. However, OSHA believes the number of deaths reported where silicosis is an underlying or contributing cause does not reflect the totality of deaths and disease that can be attributed to exposure to crystalline silica.  First, there is evidence that the number of deaths due to silicosis is higher than reported from death certificate data due to misclassification of cause of death where silicosis goes undetected.  Second, as I will summarize, OSHA has reviewed evidence indicating that many silica-related deaths are caused by chronic bronchitis, emphysema, lung cancer, and kidney disease, in addition to silicosis. 

To characterize the adverse health effects of occupational exposure to silica, OSHA has reviewed extensive toxicological, epidemiological, and experimental research, as well as reviews conducted by several highly respected scientific organizations. The peer-reviewed scientific literature presents substantial data concerning the risk workers face in developing silicosis, chronic obstructive pulmonary disease, lung cancer, and kidney disease due to exposure to respirable crystalline silica at the current PEL. OSHA has preliminarily concluded that exposure to crystalline silica increases the risk of each of these diseases and that these conditions represent material impairments of health as they result in decreased life expectancy, permanent functional impairment, and reduced quality of life.  With respect to lung cancer, OSHA's preliminary findings are consistent with conclusions reached by NIOSH, the International Agency for Research on Cancer, the National Toxicology Program, the American Conference of Governmental Industrial Hygienists, and the American Thoracic Society.

The literature also includes several quantitative risk assessments that describe the mortality risk to exposed workers for each of these diseases. These assessments are based on multiple studies of occupational cohorts across a variety of industry sectors. As a result of a review of this literature, OSHA has developed preliminary quantitative estimates of the excess risk of mortality and morbidity at the current PEL, as well as the expected impact on these risks at the new proposed PEL.

At the current general industry PEL, OSHA estimates the lifetime mortality and morbidity risks to be significant: 22-29 deaths per 1,000 workers from lung cancer; 11 deaths per 1,000 workers from silicosis; 83 deaths per 1,000 from chronic lung disease; and 39 deaths in 1,000 from kidney disease. At the current construction and shipyard PELs, the estimated mortality and morbidity risks are even greater: 27 to 38 deaths per 1,000 workers from lung cancer; 17 to 22 deaths per 1,000 workers from silicosis; 188 to 321 deaths per 1,000 from chronic lung disease; and 52 to 63 deaths in 1,000 from kidney disease.

OSHA regards this level of risk as clearly significant and warranting remedial action.
OSHA's preliminary assessment also indicates that adoption of the proposed PEL would substantially reduce these risks; however, residual risks remain at the proposed PEL that OSHA believes pose a significant health risk. 

Following procedures set forth by the Office of Management and Budget, OSHA completed a peer review of the draft Health Effects Analysis and Preliminary Quantitative Risk Assessment in January 2010. Each peer reviewer submitted a written report to OSHA, and the Agency revised its draft documents as appropriate, making the peer review reports and revised documents available to the public as part of this Notice of Proposed Rulemaking. OSHA has scheduled tomorrow, Wednesday, March 19 and Thursday, March 20 for hearing participants to testify on the Health Effects Analysis and Preliminary Quantitative Risk Assessment in the presence of peer reviewers. The Agency has also requested the peer reviewers to submit any amended final comments they may wish to add to the record following the hearing. OSHA will consider all amended final comments received from the peer reviewers when determining how to proceed with this rulemaking and will make them publicly available as part of the silica rulemaking record. 

Although a significant residual risk for death and illness is expected to remain at the proposed 50 µg/m3 PEL, OSHA's preliminary analysis indicates that the proposed PEL is the lowest level that is technologically feasible for affected industries.  OSHA based its preliminary findings on a large database of information describing worker exposures and the effectiveness of dust control technologies.  Sources of information include published literature; OSHA compliance case files; NIOSH reports and engineering control feasibility studies; site visits conducted by OSHA and its contractor Eastern Research Group, as well as by NIOSH; and information provided by stakeholders. Based on our review and analysis of these sources, OSHA preliminarily concluded that the proposed standard is technologically feasible in each of the 23 general industry and maritime sectors examined, and in 10 of the 12 construction operations studied.  In addition, OSHA reviewed data and literature describing the sensitivity and precision of sampling and analytical methods for crystalline silica, and preliminarily concludes that the proposed PEL and action level can be measured with acceptable precision when nationally recognized methods are followed.

The rule as proposed would cover about 2.2 million workers in 534,000 establishments.  This total includes 1.85 million workers in 477,000 establishments in the construction industry and 320,000 workers in 57,000 establishments in general industry and maritime.  Limiting exposures to the proposed PEL of 50 µg/m3 is estimated to prevent nearly 700 deaths per year once the full effects of the standard are realized.  Of these, 381 of these preventable deaths are from silicosis and other non-malignant lung diseases, 165 are from lung cancer, and 153 are from end-stage renal disease.  The proposed rule is also expected to prevent nearly 1,600 silicosis cases annually.

OSHA estimated that employers would incur annualized costs of $664 million (using a 3 percent discount rate); these include annualized costs of $495 million to construction industry employers and $169 million to general industry employers.  Estimated compliance costs are expected to be modest relative to revenue and OSHA preliminarily concludes that the proposed standard is economically feasible.  The proposed rule is estimated to provide average net benefits of about $2.9 to $4.7 billion annually over the next 60 years. OSHA has preliminarily determined that the proposed rule would be economically feasible for all affected industries.

OSHA has also preliminarily determined that the proposed rule will have a negligible, but slightly positive, net impact on employment.  This preliminary determination is based on a study conducted by Inforum, a non-profit firm at the University of Maryland with over 40 years of experience in designing and applying macroeconomic models of the U.S. economy. 

After completing the preliminary technological and economic feasibility analysis, OSHA became aware of a cooperative study between NIOSH and representatives of the hydraulic fracturing industry, which identified overexposures to crystalline silica among workers conducting operations on hydraulic fracturing sites.  An industry focus group has been working with NIOSH and OSHA to share best practices and develop engineering controls to reduce dust exposures.  Appendix A of the Preliminary Economic Analysis presents the results of OSHA's feasibility assessment for this industry; based on this assessment, OSHA believes the proposed rule would be technologically and economically feasible for firms engaged in hydraulic fracturing.  The estimated costs and benefits attributed to this industry sector were included in the figures I summarized earlier.

Throughout the development of the proposed rule and supporting analyses, OSHA has made every effort to collect the best available data.  These efforts included conducting site visits and consulting with scientific experts and many industry and labor representatives.  In 2004, OSHA convened a Small Business Advocacy Panel as required by the Small Business Regulatory Enforcement Fairness Act to obtain input from small business representatives on draft regulatory alternatives and economic analyses.  That process resulted in OSHA receiving over 70 recommendations on all aspects of the draft and how to minimize impacts on small business.  The substantial input OSHA received from small businesses was highly valuable and is reflected in the current proposal, including changes to the proposed rule and to the underlying cost, benefit, and economic analyses. OSHA has also presented information to, and has consulted with, the Agency's Advisory Committee on Construction Safety and Health and the Maritime Advisory Committee on Occupational Safety and Health, and their recommendations are also addressed in the proposal.

The importance of the public participation phase of this rulemaking cannot be over-emphasized.  The rule that we will be discussing over the coming days is still in the proposal stage. It should not be considered OSHA's final determination or position on the issues involved. The proposal serves to initiate the public rulemaking process by presenting OSHA's preliminary assessment of the content of an appropriate rule based on the information available to the Agency at the time the document was developed.

The purpose of this informal public hearing is to provide a forum for interested members of the public to deliver testimony and additional evidence to assist the Agency in developing a final standard that will effectively protect workers and be feasible for industry to implement.  Further opportunities for hearing participants to introduce evidence will be provided during the post-hearing comment period.  OSHA will consider all the information received during this hearing and the post-hearing comment periods, along with all the other materials submitted to the rulemaking record.

Thank you for your attention.  At this time, I am going to hand this statement to Kristen Lindberg, of the Office of the Solicitor, to mark as Exhibit 1.  After she does that, we will begin the OSHA question and answer portion of the hearing.

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