Occupational Exposure to Respirable Crystalline Silica, 56273-56504 [2013-20997]

Download as PDF Vol. 78 Thursday, No. 177 September 12, 2013 Part II Department of Labor mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, and 1926 Occupational Exposure to Respirable Crystalline Silica; Proposed Rule VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\12SEP2.SGM 12SEP2 56274 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, and 1926 [Docket No. OSHA–2010–0034] RIN 1218–AB70 Occupational Exposure to Respirable Crystalline Silica Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION: Proposed rule; request for comments. AGENCY: The Occupational Safety and Health Administration (OSHA) proposes to amend its existing standards for occupational exposure to respirable crystalline silica. The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary of Labor for Occupational Safety and Health that employees exposed to respirable crystalline silica face a significant risk to their health at the current permissible exposure limits and that promulgating these proposed standards will substantially reduce that risk. This document proposes a new permissible exposure limit, calculated as an 8-hour time-weighted average, of 50 micrograms of respirable crystalline silica per cubic meter of air (50 mg/m3). OSHA also proposes other ancillary provisions for employee protection such as preferred methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. OSHA is proposing two separate regulatory texts—one for general industry and maritime, and the other for construction—in order to tailor requirements to the circumstances found in these sectors. DATES: Written comments. Written comments, including comments on the information collection determination described in Section IX of the preamble (OMB Review under the Paperwork Reduction Act of 1995), must be submitted (postmarked, sent, or received) by December 11, 2013. Informal public hearings. The Agency plans to hold informal public hearings beginning on March 4, 2014, in Washington, DC. OSHA expects the hearings to last from 9:30 a.m. to 5:30 p.m., local time; a schedule will be released prior to the start of the hearings. The exact daily schedule may be amended at the discretion of the presiding administrative law judge mstockstill on DSK4VPTVN1PROD with PROPOSALS2 SUMMARY: VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 (ALJ). If necessary, the hearings will continue at the same time on subsequent days. Peer reviewers of OSHA’s Health Effects Literature Review and Preliminary Quantitative Risk Assessment will be present in Washington, DC to hear testimony on the second day of the hearing, March 5, 2014; see Section XV for more information on the peer review process. Notice of intention to appear at the hearings. Interested persons who intend to present testimony or question witnesses at the hearings must submit (transmit, send, postmark, deliver) a notice of their intention to do so by November 12, 2013. The notice of intent must indicate if the submitter requests to present testimony in the presence of the peer reviewers. Hearing testimony and documentary evidence. Interested persons who request more than 10 minutes to present testimony, or who intend to submit documentary evidence, at the hearings must submit (transmit, send, postmark, deliver) the full text of their testimony and all documentary evidence by December 11, 2013. See Section XV below for details on the format and how to file a notice of intention to appear, submit documentary evidence at the hearing, and request an appropriate amount of time to present testimony. ADDRESSES: Written comments. You may submit comments, identified by Docket No. OSHA–2010–0034, by any of the following methods: Electronically: You may submit comments and attachments electronically at http:// www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow the instructions on-line for making electronic submissions. Fax: If your submissions, including attachments, are not longer than 10 pages, you may fax them to the OSHA Docket Office at (202) 693–1648. Mail, hand delivery, express mail, messenger, or courier service: You must submit your comments to the OSHA Docket Office, Docket No. OSHA–2010– 0034, U.S. Department of Labor, Room N–2625, 200 Constitution Avenue NW., Washington, DC 20210, telephone (202) 693–2350 (OSHA’s TTY number is (877) 889–5627). Deliveries (hand, express mail, messenger, or courier service) are accepted during the Department of Labor’s and Docket Office’s normal business hours, 8:15 a.m.–4:45 p.m., E.T. Instructions: All submissions must include the Agency name and the docket number for this rulemaking (Docket No. OSHA–2010–0034). All comments, including any personal PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 information you provide, are placed in the public docket without change and may be made available online at http:// www.regulations.gov. Therefore, OSHA cautions you about submitting personal information such as social security numbers and birthdates. If you submit scientific or technical studies or other results of scientific research, OSHA requests (but is not requiring) that you also provide the following information where it is available: (1) Identification of the funding source(s) and sponsoring organization(s) of the research; (2) the extent to which the research findings were reviewed by a potentially affected party prior to publication or submission to the docket, and identification of any such parties; and (3) the nature of any financial relationships (e.g., consulting agreements, expert witness support, or research funding) between investigators who conducted the research and any organization(s) or entities having an interest in the rulemaking. If you are submitting comments or testimony on the Agency’s scientific and technical analyses, OSHA requests that you disclose: (1) The nature of any financial relationships you may have with any organization(s) or entities having an interest in the rulemaking; and (2) the extent to which your comments or testimony were reviewed by an interested party prior to its submission. Disclosure of such information is intended to promote transparency and scientific integrity of data and technical information submitted to the record. This request is consistent with Executive Order 13563, issued on January 18, 2011, which instructs agencies to ensure the objectivity of any scientific and technological information used to support their regulatory actions. OSHA emphasizes that all material submitted to the rulemaking record will be considered by the Agency to develop the final rule and supporting analyses. Informal public hearings. The Washington, DC hearing will be held in the auditorium of the U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Notice of intention to appear, hearing testimony and documentary evidence. You may submit (transmit, send, postmark, deliver) your notice of intention to appear, hearing testimony, and documentary evidence, identified by docket number (OSHA–2010–0034), by any of the following methods: Electronically: http:// www.regulations.gov. Follow the instructions online for electronic submission of materials, including attachments. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Fax: If your written submission does not exceed 10 pages, including attachments, you may fax it to the OSHA Docket Office at (202) 693–1648. Regular mail, express delivery, hand delivery, and messenger and courier service: Submit your materials to the OSHA Docket Office, Docket No. OSHA–2010–0034, U.S. Department of Labor, Room N–2625, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–2350 (TTY number (877) 889–5627). Deliveries (express mail, hand delivery, and messenger and courier service) are accepted during the Department of Labor’s and OSHA Docket Office’s normal hours of operation, 8:15 a.m. to 4:45 p.m., ET. Instructions: All submissions must include the Agency name and docket number for this rulemaking (Docket No. OSHA–2010–0034). All submissions, including any personal information, are placed in the public docket without change and may be available online at http://www.regulations.gov. Therefore, OSHA cautions you about submitting certain personal information, such as social security numbers and birthdates. Because of security-related procedures, the use of regular mail may cause a significant delay in the receipt of your submissions. For information about security-related procedures for submitting materials by express delivery, hand delivery, messenger, or courier service, please contact the OSHA Docket Office. For additional information on submitting notices of intention to appear, hearing testimony or documentary evidence, see Section XV of this preamble, Public Participation. Docket: To read or download comments, notices of intention to appear, and materials submitted in response to this Federal Register notice, go to Docket No. OSHA–2010–0034 at http://www.regulations.gov or to the OSHA Docket Office at the address above. All comments and submissions are listed in the http:// www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through that Web site. All comments and submissions are available for inspection and, where permissible, copying at the OSHA Docket Office. Electronic copies of this Federal Register document are available at http://regulations.gov. Copies also are available from the OSHA Office of Publications, Room N–3101, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–1888. This document, as well as news releases and VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 other relevant information, is also available at OSHA’s Web site at http:// www.osha.gov. FOR FURTHER INFORMATION CONTACT: For general information and press inquiries, contact Frank Meilinger, Director, Office of Communications, Room N–3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–1999. For technical inquiries, contact William Perry or David O’Connor, Directorate of Standards and Guidance, Room N–3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–1950 or fax (202) 693–1678. For hearing inquiries, contact Frank Meilinger, Director, Office of Communications, Room N–3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–1999; email meilinger.francis2@ dol.gov. SUPPLEMENTARY INFORMATION: The preamble to the proposed standard on occupational exposure to respirable crystalline silica follows this outline: I. Issues II. Pertinent Legal Authority III. Events Leading to the Proposed Standards IV. Chemical Properties and Industrial Uses V. Health Effects Summary VI. Summary of the Preliminary Quantitative Risk Assessment VII. Significance of Risk VIII. Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis IX. OMB Review Under the Paperwork Reduction Act of 1995 X. Federalism XI. State Plans XII. Unfunded Mandates XIII. Protecting Children From Environmental Health and Safety Risks XIV. Environmental Impacts XV. Public Participation XVI. Summary and Explanation of the Standards (a) Scope and Application (b) Definitions (c) Permissible Exposure Limit (PEL) (d) Exposure Assessment (e) Regulated Areas and Access Control (f) Methods of Compliance (g) Respiratory Protection (h) Medical Surveillance (i) Communication of Respirable Crystalline Silica Hazards to Employees (j) Recordkeeping (k) Dates XVII. References XVIII. Authority and Signature OSHA currently enforces permissible exposure limits (PELs) for respirable crystalline silica in general industry, construction, and shipyards. These PELs were adopted in 1971, shortly after the Agency was created, and have not been PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 56275 updated since then. The PEL for quartz (the most common form of crystalline silica) in general industry is a formula that is approximately equivalent to 100 micrograms per cubic meter of air (mg/ m3) as an 8-hour time-weighted average. The PEL for quartz in construction and shipyards is a formula based on a nowobsolete particle count sampling method that is approximately equivalent to 250 mg/m3. The current PELs for two other forms of crystalline silica (cristobalite and tridymite) are one-half of the values for quartz in general industry. OSHA is proposing a new PEL for respirable crystalline silica (quartz, cristobalite, and tridymite) of 50 mg/m3 in all industry sectors covered by the rule. OSHA is also proposing other elements of a comprehensive health standard, including requirements for exposure assessment, preferred methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. OSHA’s proposal is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so. See Section II of this preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements. OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. The Agency has also developed estimates of the risk of silica-related diseases assuming exposure over a working lifetime at the proposed PEL and action level, as well as at OSHA’s current PELs. These analyses are presented in a background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ and are summarized in this preamble in Section V, Health Effects Summary, and Section VI, Summary of OSHA’s Preliminary Quantitative Risk Assessment, respectively. 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). E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56276 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules As discussed in Section VII, Significance of Risk, in this preamble, OSHA preliminarily finds that worker exposure to respirable crystalline silica constitutes a significant risk and that the proposed standard will substantially reduce this risk. Section 6(b) of the OSH Act requires OSHA to determine that its standards are technologically and economically feasible. OSHA’s examination of the technological and economic feasibility of the proposed rule is presented in the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA), and is summarized in Section VIII of this preamble. For general industry and maritime, OSHA has preliminarily concluded that the proposed PEL of 50 mg/m3 is technologically feasible for all affected industries. For construction, OSHA has preliminarily determined that the proposed PEL of 50 mg/m3 is feasible in 10 out of 12 of the affected activities. Thus, OSHA preliminarily concludes that engineering and work practices will be sufficient to reduce and maintain silica exposures to the proposed PEL of 50 mg/m3 or below in most operations most of the time in the affected industries. For those few operations within an industry or activity where the proposed PEL is not technologically feasible even when workers use recommended engineering and work practice controls, employers can supplement controls with respirators to achieve exposure levels at or below the proposed PEL. OSHA developed quantitative estimates of the compliance costs of the proposed rule for each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has preliminarily concluded that compliance with the requirements of the proposed rule would be economically feasible in every affected industry sector. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 OSHA directed Inforum—a not-forprofit corporation (based at the University of Maryland) well recognized for its macroeconomic modeling—to run its LIFT (Long-term Interindustry Forecasting Tool) model of the U.S. economy to estimate the industry and aggregate employment effects of the proposed silica rule. Inforum developed estimates of the employment impacts over the ten-year period from 2014– 2023 by feeding OSHA’s year-by-year and industry-by-industry estimates of the compliance costs of the proposed rule into its LIFT model. Based on the resulting Inforum estimates of employment impacts, OSHA has preliminarily concluded that the proposed rule would have a negligible— albeit slightly positive—net impact on aggregate U.S. employment. OSHA believes that a new PEL, expressed as a gravimetric measurement of respirable crystalline silica, will improve compliance because the PEL is simple and relatively easy to understand. In comparison, the existing PELs require application of a formula to account for the crystalline silica content of the dust sampled and, in the case of the construction and shipyard PELs, a conversion from particle count to mg/ m3 as well. OSHA also expects that the approach to methods of compliance for construction operations included in this proposal will improve compliance with the standard. This approach, which specifies exposure control methods for selected construction operations, gives employers a simple option to identify the control measures that are appropriate for these operations. Alternately, employers could conduct exposure assessments to determine if worker exposures are in compliance with the PEL. In either case, the proposed rule would provide a basis for ensuring that appropriate measures are in place to limit worker exposures. The Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires that OSHA either certify that a rule would not have a significant economic impact on a substantial number of small firms or prepare a regulatory flexibility analysis and hold a Small Business Advocacy Review (SBAR) Panel prior to proposing the rule. OSHA has determined that a PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 regulatory flexibility analysis is needed and has provided this analysis in Section VIII.G of this preamble. OSHA also previously held a SBAR Panel for this rule. The recommendations of the Panel and OSHA’s response to them are summarized in Section VIII.G of this preamble. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget, and the remainder of this section summarizes the key findings of the analysis with respect to costs and benefits of the rule and then presents several possible alternatives to the rule. Table SI–1—which, like all the tables in this section, is derived from material presented in Section VIII of this preamble—provides a summary of OSHA’s best estimate of the costs and benefits of the proposed rule using a discount rate of 3 percent. As shown, the proposed rule is estimated to prevent 688 fatalities and 1,585 silicarelated illnesses annually once it is fully effective, and the estimated cost of the rule is $637 million annually. Also as shown in Table SI–1, the discounted monetized benefits of the proposed rule are estimated to be $5.3 billion annually, and the proposed rule is estimated to generate net benefits of $4.6 billion annually. These estimates are for informational purposes only and have not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for this proposed silica rule. The courts have ruled that OSHA may not use benefit-cost analysis or a criterion of maximizing net benefits as a basis for setting OSHA health standards.1 1 Am. Textile Mfrs. Inst., Inc. v. Nat’l Cotton Council of Am., 452 U.S. 490, 513 (1981); Pub. Citizen Health Research Group v. U.S. Dep’t of Labor, 557 F.3d 165, 177 (3d Cir. 2009); Friends of the Boundary Waters Wilderness v. Robertson, 978 F.2d 1484, 1487 (8th Cir. 1992). E:\FR\FM\12SEP2.SGM 12SEP2 Both the costs and benefits of Table SI–1 reflect the incremental costs and benefits associated with achieving full compliance with the proposed rule. They do not include (a) costs and benefits associated with current compliance that have already been achieved with regard to the new requirements, or (b) costs and benefits associated with achieving compliance with existing requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements. They also do not include costs or benefits associated with relatively rare, extremely high exposures that can lead to acute silicosis. Subsequent to completion of the PEA, OSHA identified an industry, hydraulic fracturing, that would be impacted by the proposed standard. Hydraulic fracturing, sometimes called ‘‘fracking,’’ is a process used to extract natural gas and oil deposits from shale and other tight geologic formations. A recent cooperative study by the National Institute for Occupational Safety and Health (NIOSH) and industry partners identified overexposures to silica among workers conducting hydraulic fracturing VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 operations. An industry focus group has been working with OSHA and NIOSH to disseminate information about this hazard, share best practices, and develop engineering controls to limit worker exposures to silica. OSHA finds that there are now sufficient data to provide the main elements of the economic analysis for this rapidly growing industry and has done so in Appendix A to the PEA. Based on recent data from the U.S. Census Bureau and industry sources, OSHA estimates that roughly 25,000 workers in 444 establishments (operated by 200 business entities) in hydraulic fracturing would be affected by the proposed standard. Annual benefits of the proposed 50 mg/m3 PEL include approximately 12 avoided fatalities—2.9 avoided lung cancers (mid-point estimate), 6.3 prevented non-cancer respiratory illnesses, and 2.3 prevented cases of renal failure—and 40.8 avoided cases of silicosis morbidity. Monetized benefits are expected to range from $75.1 million at a seven percent discount rate to $105.4 million at a three percent discount rate to undiscounted benefits of $140.3 million. OSHA estimates that under the proposed PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 56277 standard, annualized compliance costs for the hydraulic fracturing industry will total $28.6 million at a discount rate of 7 percent or $26.4 million at a discount rate of 3 percent. In addition to the proposed rule itself, this preamble discusses several regulatory alternatives to the proposed OSHA silica standard. These are presented below as well as in Section VIII of this preamble. OSHA believes that this presentation of regulatory alternatives serves two important functions. The first is to explore the possibility of less costly ways (than the proposed rule) to provide an adequate level of worker protection from exposure to respirable crystalline silica. The second is tied to the Agency’s statutory requirement, which underlies the proposed rule, to reduce significant risk to the extent feasible. If, based on evidence presented during notice and comment, OSHA is unable to justify its preliminary findings of significant risk and feasibility as presented in this preamble to the proposed rule, the Agency must then consider regulatory alternatives that do satisfy its statutory obligations. E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.000</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56278 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency’s findings of significant risk and feasibility. To facilitate comment, the regulatory alternatives have been organized into four categories: (1) Alternative PELs to the proposed PEL of 50 mg/m3; (2) regulatory alternatives that affect proposed ancillary provisions; (3) a regulatory alternative that would modify the proposed methods of compliance; and (4) regulatory alternatives concerning when different provisions of the proposed rule would take effect. In addition, OSHA would like to draw attention to one possible modification to the proposed rule, involving methods of compliance, that the Agency would not consider to be a legitimate regulatory alternative: To permit the use of respiratory protection as an alternative to engineering and work practice controls as a primary means to achieve the PEL. As described in Section XVI of the preamble, Summary and Explanation of the Proposed Standards, OSHA is proposing to require primary reliance on engineering controls and work practices because reliance on these methods is consistent with long-established good industrial hygiene practice, with the Agency’s experience in ensuring that workers have a healthy workplace, and with the Agency’s traditional adherence to a hierarchy of preferred controls. The Agency’s adherence to the hierarchy of controls has been successfully upheld by the courts (see AFL–CIO v. Marshall, 617 F.2d 636 (D.C. Cir. 1979) (cotton dust standard); United Steelworkers v. Marshall, 647 F.2d 1189 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981) (lead standard); ASARCO v. OSHA, 746 F.2d 483 (9th Cir. 1984) (arsenic standard); Am. Iron & Steel v. OSHA, 182 F.3d 1261 (11th Cir. 1999) (respiratory protection standard); Pub. Citizen v. U.S. Dep’t of Labor, 557 F.3d 165 (3rd Cir. 2009) (hexavalent chromium standard)). Engineering controls are reliable, provide consistent levels of protection to a large number of workers, can be monitored, allow for predictable performance levels, and can efficiently remove a toxic substance from the workplace. Once removed, the toxic substance no longer poses a threat to employees. The effectiveness of engineering controls does not generally depend on human behavior to the same extent as personal protective equipment VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 does, and the operation of equipment is not as vulnerable to human error as is personal protective equipment. Respirators are another important means of protecting workers. However, to be effective, respirators must be individually selected; fitted and periodically refitted; conscientiously and properly worn; regularly maintained; and replaced as necessary. In many workplaces, these conditions for effective respirator use are difficult to achieve. The absence of any of these conditions can reduce or eliminate the protection that respirators provide to some or all of the employees who wear them. In addition, use of respirators in the workplace presents other safety and health concerns. Respirators impose substantial physiological burdens on some employees. Certain medical conditions can compromise an employee’s ability to tolerate the physiological burdens imposed by respirator use, thereby placing the employee wearing the respirator at an increased risk of illness, injury, and even death. Psychological conditions, such as claustrophobia, can also impair the effective use of respirators by employees. These concerns about the burdens placed on workers by the use of respirators are the basis for the requirement that employers provide a medical evaluation to determine the employee’s ability to wear a respirator before the employee is fit tested or required to use a respirator in the workplace. Although experience in industry shows that most healthy workers do not have physiological problems wearing properly chosen and fitted respirators, common health problems can sometime preclude an employee from wearing a respirator. Safety problems created by respirators that limit vision and communication must also be considered. In some difficult or dangerous jobs, effective vision or communication is vital. Voice transmission through a respirator can be difficult and fatiguing. Because respirators are less reliable than engineering and work practice controls and may create additional problems, OSHA believes that primary reliance on respirators to protect workers is generally inappropriate when feasible engineering and work practice controls are available. All OSHA substance-specific health standards have recognized and required employers to observe the hierarchy of controls, favoring engineering and work practice controls over respirators. OSHA’s PELs, including the current PELs for respirable crystalline silica, also incorporate this hierarchy of controls. In PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 addition, the industry consensus standards for crystalline silica (ASTM E 1132–06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626–09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities) incorporate the hierarchy of controls. It is important to note that the very concept of technological feasibility for OSHA standards is grounded in the hierarchy of controls. As indicated in Section II of this preamble, Pertinent Legal Authority, the courts have clarified that a standard is technologically feasible if OSHA proves a reasonable possibility, . . . within the limits of the best available evidence . . . that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations. [See United Steelworkers v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)] Allowing use of respirators instead of engineering and work practice controls would be at odds with this framework for evaluating the technological feasibility of a PEL. Alternative PELs OSHA has examined two regulatory alternatives (named Regulatory Alternatives #1 and #2) that would modify the PEL for the proposed rule. Under Regulatory Alternative #1, the proposed PEL would be changed from 50 mg/m3 to 100 mg/m3 for all industry sectors covered by the rule, and the action level would be changed from 25 mg/m3 to 50 mg/m3 (thereby keeping the action level at one-half of the PEL). Under Regulatory Alternative #2, the proposed PEL would be lowered from 50 mg/m3 to 25 mg/m3 for all industry sectors covered by the rule, while the action level would remain at 25 mg/m3 (because of difficulties in accurately measuring exposure levels below 25 mg/ m3). Tables SI–2 and SI–3 present, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed PEL of 50 mg/m3 and for the regulatory alternatives of a PEL of 100 mg/m3 and a PEL of 25 mg/m3 (Regulatory Alternatives #1 and #2), using alternative discount rates of 3 and 7 percent. These two tables also present the incremental costs, the incremental benefits, and the incremental net benefits of going from a PEL of 100 mg/ m3 to the proposed PEL of 50 mg/m3 and then of going from the proposed PEL of 50 mg/m3 to a PEL of 25 mg/m3. Table E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Jkt 229001 25b!9/m3 ~ Discount Rate Frm 00007 Fmt 4701 Annualized Costs Engineering Controls (includes Abrasive Blasting) Respirators Exposure Assessment Medical Surveillance Training Regulated Area or Access Control Sfmt 4725 E:\FR\FM\12SEP2.SGM Siljca~Related Mortality Silicosis Morbidity ~ ~ 50l;!g/m --EL 3 ~ 3% ~ $187 $88 $26 $28 $0 $344 $422 $203 $227 $50 $86 $0 $330 $131 $143 $0 $66 $0 $331 $129 $148 $0 $66 $330 $91 $73 $76 $49 $19 ~ ~ $1,308 $1,332 $670 $674 $637 $658 $339 Cases Cases 3 Incremental Costs/Benefits $330 $421 $203 $219 $49 $65 Total Annualized Costs (point estimate) Annual Benefits: Number of Cases Prevented Fatal Lung Cancers (midpoint estimate) Fatal Silicosis & other Non~Malignant Respiratory Diseases Fatal Renal Disease Incremental Costs/Benefits $344 $91 $74 $79 $50 Cases 100b!g/m ~ ~ 3% $197 $88 $26 $29 $0 ~ $143 $2 $47 $48 $49 $9 ~ $351 $299 $307 Cases $147 $3 $48 $50 $50 Cases 257 75 162 79 83 527 152 375 186 189 258 108 151 91 1,023 $4,811 $3,160 335 $1,543 $1,028 1,770 $2,219 $1,523 186 $233 $160 60 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 Monetized Annual Benefits (midpoint estimate) $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 Net Benefits $5722 $3352 $1105 $514 $4617 $2838 $2157 $1308 $2460 $1529 Source: U.S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory AnalysIs breaks out costs and benefits by major industry sector. PO 00000 Millions ($2009) 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 SI–2 breaks out costs by provision and benefits by type of disease and by morbidity/mortality, while Table SI–3 VerDate Mar<15>2010 Table 51·2: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 (.191m3 and 100 (.191m3 Alternative 56279 EP12SE13.001</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56280 3 Jkt 229001 251!g/m ~ Discount Rate 3 Incremental Costs/Benefits ~ ~ 50 l!9!m ~ ~ 3 3 Incremental Costs/Benefits ~ ~ 100 I!g/m ~ 3% ~ Frm 00008 Fmt 4701 Sfmt 4702 12SEP2 silica exposure (as demonstrated by the number of silica-related fatalities and silicosis cases avoided) and is both technologically and economically E:\FR\FM\12SEP2.SGM and an additional 632 cases of silicosis. Based on its preliminary findings that the proposed PEL of 50 mg/m3 significantly reduces worker risk from PO 00000 Annualized Costs Construction General Industry/Maritime $1,043 $264 $1,062 $270 $548 $122 $551 $123 $495 $143 $511 $147 $233 $106 $241 $110 $262 $36 $270 $37 Total Annualized Costs $1,308 $1,332 $670 $674 $637 $658 $339 $351 $299 $307 Annual Benefits: Number of Cases Prevented Silica-Related Mortality Construction General Industry/Maritime Total Silicosis Morbidity Construction General Industry/Maritime Total Monetized Annual Benefits (midpoint estimate) Construction General Industry/Maritime Total Net Benefits Construction General Industry/Maritime Total Cases Cases Cases Cases Cases 802 221 $3,804 $1,007 $2,504 $657 235 100 $1,109 $434 $746 $283 567 121 $2,695 $573 $1,758 $374 242 $1,158 115 $545 $760 $356 325 6 $1,537 $27 $998 $18 1,023 $4,811 $3,160 335 $1,543 $1,028 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,157 613 $1,451 $768 $996 $528 77 109 $96 $136 $66 $94 1,080 504 $1,354 $632 $930 $434 161 471 $202 $590 $139 $405 919 33 $1,152 $42 $791 $29 1,770 $2,219 $1,523 186 $233 $160 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 $5,255 $1,775 $3,500 $1,164 $1,205 $570 $812 $377 $4,049 $1,205 $2,688 $808 $1,360 $1,135 $898 $761 $2,690 $69 $1,789 $47 $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 $4,211 $1,511 $2,437 $914 $657 $448 $261 $254 $3,555 $1,062 $2,177 $661 $1,127 $1,029 $658 $651 $2,427 $33 $1,519 $10 $5,722 $3,352 $1,105 $514 $4,617 $2,838 $2,157 $1,308 $2,460 $1,529 Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and AnalYSiS, Office of Regulatory Analysis Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 As Tables SI–2 and SI–3 show, going from a PEL of 100 mg/m3 to a PEL of 50 mg/m3 would prevent, annually, an additional 357 silica-related fatalities VerDate Mar<15>2010 EP12SE13.002</GPH> 3 Table SI-3: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 j.lg/m and 100 jJg/m Alternative, by Major Industry Sector Millions ($2009) Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 feasible, OSHA cannot propose a PEL of 100 mg/m3 (Regulatory Alternative #1) without violating its statutory obligations under the OSH Act. However, the Agency will consider evidence that challenges its preliminary findings. As previously noted, Tables SI–2 and SI–3 also show the costs and benefits of a PEL of 25 mg/m3 (Regulatory Alternative #2), as well as the incremental costs and benefits of going from the proposed PEL of 50 mg/m3 to a PEL of 25 mg/m3. Because OSHA preliminarily determined that a PEL of 25 mg/m3 would not be feasible (that is, engineering and work practices would not be sufficient to reduce and maintain silica exposures to a PEL of 25 mg/m3 or below in most operations most of the time in the affected industries), the Agency did not attempt to identify engineering controls or their costs for affected industries to meet this PEL. Instead, for purposes of estimating the costs of going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3, OSHA assumed that all workers exposed between 50 mg/ m3 and 25 mg/m3 would have to wear respirators to achieve compliance with the 25 mg/m3 PEL. OSHA then estimated the associated additional costs for respirators, exposure assessments, medical surveillance, and regulated areas (the latter three for ancillary requirements specified in the proposed rule). As shown in Tables SI–2 and SI–3, going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3 would prevent, annually, an additional 335 silica-related fatalities and an additional 186 cases of silicosis. These estimates support OSHA’s preliminarily finding that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has preliminarily determined that a PEL of 25 mg/m3 (Regulatory Alternative #2) is not technologically feasible, and for that reason, cannot propose it without violating its statutory obligations under the OSH Act. Regulatory Alternatives That Affect Ancillary Provisions The proposed rule contains several ancillary provisions (provisions other than the PEL), including requirements for exposure assessment, medical surveillance, training, and regulated areas or access control. As shown in Table SI–2, these ancillary provisions represent approximately $223 million VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 (or about 34 percent) of the total annualized costs of the rule of $658 million (using a 7 percent discount rate). The two most expensive of the ancillary provisions are the requirements for medical surveillance, with annualized costs of $79 million, and the requirements for exposure monitoring, with annualized costs of $74 million. As proposed, the requirements for exposure assessment are triggered by the action level. As described in this preamble, OSHA has defined the action level for the proposed standard as an airborne concentration of respirable crystalline silica of 25 mg/m3 calculated as an eight-hour time-weighted average. In this proposal, as in other standards, the action level has been set at one-half of the PEL. Because of the variable nature of employee exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the PEL on days when no exposure measurements are made. Even when all measurements on a given day may fall below the PEL (but are above the action level), there is some chance that on another day, when exposures are not measured, the employee’s actual exposure may exceed the PEL. When exposure measurements are above the action level, the employer cannot be reasonably confident that employees have not been exposed to respirable crystalline silica concentrations in excess of the PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring. The action level is also intended to encourage employers to lower exposure levels in order to avoid the costs associated with the exposure assessment provisions. Some employers would be able to reduce exposures below the action level in all work areas, and other employers in some work areas. As exposures are lowered, the risk of adverse health effects among workers decreases. OSHA’s preliminary risk assessment indicates that significant risk remains at the proposed PEL of 50 mg/m3. Where PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 56281 there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr. Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA’s preliminary conclusion is that the requirements triggered by the action level will result in a very real and necessary, but non-quantifiable, further reduction in risk beyond that provided by the PEL alone. OSHA’s choice of proposing an action level for exposure monitoring of one-half of the PEL is based on the Agency’s successful experience with other standards, including those for inorganic arsenic (29 CFR 1910.1018), ethylene oxide (29 CFR 1910.1047), benzene (29 CFR 1910.1028), and methylene chloride (29 CFR 1910.1052). As specified in the proposed rule, all workers exposed to respirable crystalline silica above the PEL of 50 mg/ m3 are subject to the medical surveillance requirements. This means that the medical surveillance requirements would apply to 15,172 workers in general industry and 336,244 workers in construction. OSHA estimates that 457 possible silicosis cases will be referred to pulmonary specialists annually as a result of this medical surveillance. OSHA has preliminarily determined that these ancillary provisions will: (1) Help ensure that the PEL is not exceeded, and (2) minimize risk to workers given the very high level of risk remaining at the PEL. OSHA did not estimate, and the benefits analysis does not include, monetary benefits resulting from early discovery of illness. Because medical surveillance and exposure assessment are the two most costly ancillary provisions in the proposed rule, the Agency has examined four regulatory alternatives (named Regulatory Alternatives #3, #4, #5, and #6) involving changes to one or the other of these ancillary provisions. These four regulatory alternatives are defined below and the incremental cost impact of each is summarized in Table SI–4. In addition, OSHA is including a regulatory alternative (named Regulatory Alternative #7) that would remove all ancillary provisions. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56282 13% Discount Rate I Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GIIM Total Jkt 229001 Frm 00010 Fmt 4701 Sfmt 4702 $494,826,699 $142,502,681 $637,329,380 Option 3: PEL=50; AL=50 $457,686,162 $117,680,601 $575,366,763 -$37,140,537 -$24,822,080 -$61,962,617 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $606,697,624 $173,701,827 $780,399,451 $111,870,925 $31,199,146 $143,070,071 Option 5: PEL=50; AL=25, with medical exams annually $561,613,766 $145,088,559 $706,702,325 $66,787,067 $2,585,878 $69,372,945 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $775,334,483 $203,665,685 $979,000,168 $280,507,784 $61,163,004 $341,670,788 17% Discount Rate I Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GIIM Total 12SEP2 EP12SE13.003</GPH> Proposed Rule $511,165,616 $146,726,595 $657,892,211 Option 3: PEL=50; AL=50 monitoring requirements would be triggered only if workers were exposed E:\FR\FM\12SEP2.SGM m3 to 50 mg/m3 while keeping the PEL at 50 mg/m3. As a result, exposure PO 00000 Proposed Rule $473,638,698 $121,817,396 $595,456,093 -$37,526,918 -$24,909,200 -$62,436,118 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $627,197,794 $179,066,993 $806,264,787 $132,371,095 $36,564,312 $168,935,407 Option 5: PEL=50; AL=25, with medical exams annually $575,224,843 $149,204,718 $724,429,561 $64,059,227 $2,478,122 $66,537,350 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $791,806,358 $208,339,741 $1,000,146,099 $280,640,742 $61,613,145 $342,253,887 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Under Regulatory Alternative #3, the action level would be raised from 25 mg/ VerDate Mar<15>2010 Table 51-4: Cost of Regulatory Alternatives Affecting Ancillary Provisions mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules above the proposed PEL of 50 mg/m3. As shown in Table SI–4, Regulatory Option #3 would reduce the annualized cost of the proposed rule by about $62 million, using a discount rate of either 3 percent or 7 percent. Under Regulatory Alternative #4, the action level would remain at 25 mg/m3 but medical surveillance would now be triggered by the action level, not the PEL. As a result, medical surveillance requirements would be triggered only if workers were exposed at or above the proposed action level of 25 mg/m3. As shown in Table SI–4, Regulatory Option #4 would increase the annualized cost of the proposed rule by about $143 million, using a discount rate of 3 percent (and by about $169 million, using a discount rate of 7 percent). Under Regulatory Alternative #5, the only change to the proposed rule would be to the medical surveillance requirements. Instead of requiring workers exposed above the PEL to have a medical check-up every three years, those workers would be required to have a medical check-up annually. As shown in Table SI–4, Regulatory Option #5 would increase the annualized cost of the proposed rule by about $69 million, using a discount rate of 3 percent (and by about $66 million, using a discount rate of 7 percent). Regulatory Alternative #6 would essentially combine the modified requirements in Regulatory Alternatives #4 and #5. Under Regulatory Alternative #6, medical surveillance would be triggered by the action level, not the PEL, and workers exposed at or above the action level would be required to have a medical check-up annually rather than triennially. The exposure monitoring requirements in the proposed rule would not be affected. As shown in Table SI–4, Regulatory Option #6 would increase the annualized cost of the proposed rule by about $342 million, using a discount rate of either 3 percent or 7 percent. OSHA is not able to quantify the effects of these preceding four regulatory alternatives on protecting workers exposed to respirable crystalline silica at levels at or below the proposed PEL of 50 mg/m3—where significant risk remains. The Agency solicits comment on the extent to which these regulatory options may improve or reduce the effectiveness of the proposed rule. The final regulatory alternative affecting ancillary provisions, Regulatory Alternative #7, would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical surveillance, training, and regulated VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 areas or access control. However, it should be carefully noted that elimination of the ancillary provisions does not mean that all costs for ancillary provisions would disappear. In order to meet the PEL, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that employers would increasingly follow the many recommendations to provide medical surveillance for employees. OSHA has not attempted to estimate the extent to which the costs of these activities would be reduced if they were not formally required, but OSHA welcomes comment on the issue. As indicated previously, OSHA preliminarily finds that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has also preliminarily determined that 50 mg/m3 is the lowest feasible PEL. Therefore, the Agency believes that it is necessary to include ancillary provisions in the proposed rule to further reduce the remaining risk. OSHA anticipates that these ancillary provisions will reduce the risk beyond the reduction that will be achieved by a new PEL alone. OSHA’s reasons for including each of the proposed ancillary provisions are detailed in Section XVI of this preamble, Summary and Explanation of the Standards. In particular, OSHA believes that requirements for exposure assessment (or alternately, using specified exposure control methods for selected construction operations) would provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is particularly important because individuals exposed above the PEL (which triggers medical surveillance in the proposed rule) are at significant risk of death and illness. Medical surveillance would allow for identification of respirable crystalline silica-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA believes that regulated areas and access control are important because they serve to limit exposure to respirable crystalline silica to as few employees as possible. Finally, OSHA believes that worker training is necessary to inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize potential health hazards. Worker training on silicarelated work practices is particularly important in controlling silica PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 56283 exposures because engineering controls frequently require action on the part of workers to function effectively. OSHA expects that the benefits estimated under the proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed rule. For example, OSHA believes that the effectiveness of the proposed rule depends on regulated areas or access control to further limit exposures and on medical surveillance to identify disease cases when they do occur. Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to respirable crystalline silica. For example, the industry consensus standards for crystalline silica, ASTM E 1132–06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626–09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, as well as the draft proposed silica standard for construction developed by the Building and Construction Trades Department, AFL– CIO, have each included comprehensive programs. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance (ASTM, 2006; 2009; BCTD 2001). Moreover, as mentioned previously, where there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr. Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA preliminarily concludes that the additional requirements in the ancillary provisions of the proposed standard clearly exceed this threshold. A Regulatory Alternative That Modifies the Methods of Compliance The proposed standard in general industry and maritime would require employers to implement engineering and work practice controls to reduce employees’ exposures to or below the PEL. Where engineering and/or work practice controls are insufficient, employers would still be required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. Under the proposed construction standard, employers would E:\FR\FM\12SEP2.SGM 12SEP2 56284 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 be given two options for compliance. The first option largely follows requirements for the general industry and maritime proposed standard, while the second option outlines, in Table 1 (Exposure Control Methods for Selected Construction Operations) of the proposed rule, specific construction exposure control methods. Employers choosing to follow OSHA’s proposed control methods would be considered to be in compliance with the engineering and work practice control requirements of the proposed standard, and would not be required to conduct certain exposure monitoring activities. One regulatory alternative (Regulatory Alternative #8) involving methods of compliance would be to eliminate Table 1 as a compliance option in the construction sector. Under that regulatory alternative, OSHA estimates that there would be no effect on estimated benefits but that the annualized costs of complying with the proposed rule (without the benefit of the Table 1 option in construction) would increase by $175 million, totally in exposure monitoring costs, using a 3 percent discount rate (and by $178 million using a 7 percent discount rate), so that the total annualized compliance costs for all affected establishments in construction would increase from $495 to $670 million using a 3 percent discount rate (and from $511 to $689 million using a 7 percent discount rate). Regulatory Alternatives That Affect the Timing of the Standard The proposed rule would become effective 60 days following publication of the final rule in the Federal Register. Provisions outlined in the proposed standard would become enforceable 180 days following the effective date, with the exceptions of engineering controls and laboratory requirements. The proposed rule would require engineering controls to be implemented no later than one year after the effective date, and laboratory requirements would be required to begin two years after the effective date. OSHA will strongly consider alternatives that would reduce the economic impact of the rule and provide additional flexibility for firms coming into compliance with the requirements of the rule. The Agency solicits comment and suggestions from stakeholders, particularly small business representatives, on options for phasing in requirements for engineering controls, medical surveillance, and other provisions of the rule (e.g., over 1, 2, 3, or more years). These options will be considered for specific industries (e.g., industries where first-year or VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 annualized cost impacts are highest), specific size-classes of employers (e.g., employers with fewer than 20 employees), combinations of these factors, or all firms covered by the rule. Although OSHA did not explicitly develop or quantitatively analyze the multitude of potential regulatory alternatives involving longer-term or more complex phase-ins of the standard, the Agency is soliciting comments on this issue. Such a particularized, multiyear phase-in could have several advantages, especially from the viewpoint of impacts on small businesses. First, it would reduce the one-time initial costs of the standard by spreading them out over time, a particularly useful mechanism for small businesses that have trouble borrowing large amounts of capital in a single year. Second, a differential phase-in for smaller firms would aid very small firms by allowing them to gain from the control experience of larger firms. Finally, a phase-in would be useful in certain industries—such as foundries, for example—by allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However a phase-in would also postpone the benefits of the standard. OSHA analyzed one regulatory alternative (Regulatory Alternative #9) involving the timing of the standard which would arise if, contrary to OSHA’s preliminary findings, a PEL of 50 mg/m3 with an action level of 25 mg/ m3 were found to be technologically and economically feasible some time in the future (say, in five years), but not feasible immediately. In that case, OSHA might issue a final rule with a PEL of 50 mg/m3 and an action level of 25 mg/m3 to take effect in five years, but at the same time issue an interim PEL of 100 mg/m3 and an action level of 50 mg/m3 to be in effect until the final rule becomes feasible. Under this regulatory alternative, and consistent with the public participation and ‘‘look back’’ provisions of Executive Order 13563, the Agency could monitor compliance with the interim standard, review progress toward meeting the feasibility requirements of the final rule, and evaluate whether any adjustments to the timing of the final rule would be needed. Under Regulatory Alternative #9, the estimated costs and benefits would be somewhere between those estimated for a PEL of 100 mg/m3 with an action level of 50 mg/m3 and those estimated for a PEL of 50 mg/m3 with an action level of 25 mg/m3, the exact estimates depending on the length of time until the final rule is phased in. OSHA emphasizes that this regulatory PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 alternative is contrary to the Agency’s preliminary findings of economic feasibility and, for the Agency to consider it, would require specific evidence introduced on the record to show that the proposed rule is not now feasible but would be feasible in the future. OSHA requests comments on these regulatory alternatives, including the Agency’s choice of regulatory alternatives (and whether there are other regulatory alternatives the Agency should consider) and the Agency’s analysis of them. I. Issues OSHA requests comment on all relevant issues, including health effects, risk assessment, significance of risk, technological and economic feasibility, and the provisions of the proposed regulatory text. In addition, OSHA requests comments on all of the issues raised by the Small Business Regulatory Fairness Enforcement Act (SBREFA) Panel, as summarized in Table VIII–H– 4 in Section VIII.H of this preamble. OSHA is including Section I on issues at the beginning of the document to assist readers as they review the proposal and consider any comments they may want to submit. However, to fully understand the questions in this section and provide substantive input in response to them, the parts of the preamble that address these issues in detail should be read and reviewed. These include: Section V, Health Effects Summary; Section VI, Summary of the Preliminary Quantitative Risk Assessment; Section VII, Significance of Risk; Section VIII, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis; and Section XVI, Summary and Explanation of the Standards. In addition, OSHA invites comment on additional technical questions and discussions of economic issues presented in the Preliminary Economic Analysis (PEA) of the proposed standards. Section XIX is the text of the standards and is the final authority on what is required in them. OSHA requests that comments be organized, to the extent possible, around the following issues and numbered questions. Comment on particular provisions should contain a heading setting forth the section and the paragraph in the standard that the comment is addressing. Comments addressing more than one section or paragraph will have correspondingly more headings. Submitting comments in an organized manner and with clear reference to the issue raised will enable all participants E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules to easily see what issues the commenter addressed and how they were addressed. This is particularly important in a rulemaking such as silica, which has multiple adverse health effects and affects many diverse processes and industries. Many commenters, especially small businesses, are likely to confine their interest (and comments) to the issues that affect them, and they will benefit from being able to quickly identify comments on these issues in others’ submissions. Of course, the Agency welcomes comments concerning this proposal that fall outside the issues raised in this section. However, OSHA is especially interested in responses, supported by evidence and reasons, to the following questions: mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Health Effects 1. OSHA has described a variety of studies addressing the major adverse health effects that have been associated with exposure to respirable crystalline silica. Has OSHA adequately identified and documented all critical health impairments associated with occupational exposure to respirable crystalline silica? If not, what adverse health effects should be added? Are there any additional studies, other data, or information that would affect the information discussed or significantly change the determination of material health impairment? Submit any relevant information, data, or additional studies (or the citations), and explain your reasoning for recommending the inclusion of any studies you suggest. 2. Using currently available epidemiologic and experimental studies, OSHA has made a preliminary determination that respirable crystalline silica presents risks of lung cancer, silicosis, and non-malignant respiratory disease (NMRD) as well as autoimmune and renal disease risks to exposed workers. Is this determination correct? Are there additional studies or other data OSHA should consider in evaluating any of these adverse health risks? If so, submit the studies (or citations) and other data and include your reasons for finding them germane to determining adverse health effects of exposure to crystalline silica. Risk Assessment 3. OSHA has relied upon risk models using cumulative respirable crystalline silica exposure to estimate the lifetime risk of death from occupational lung cancer, silicosis, and NMRD among exposed workers. Additionally, OSHA has estimated the lifetime risk of silicosis morbidity among exposed workers. Is cumulative exposure the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 correct metric for exposure for each of these models? If not, what exposure measure should be used? 4. Some of the literature OSHA reviewed indicated that the risk of contracting accelerated silicosis and lung cancer may be non-linear at very high exposures and may be described by an exposure dose rate health effect model. OSHA used the more conservative model of cumulative exposure that is more protective to the worker. Are there additional data to support or rebut any of these models used by OSHA? Are there other models that OSHA should consider for estimating lung cancer, silicosis, or NMRD risk? If so, describe the models and the rationale for their use. 5. Are there additional studies or sources of data that OSHA should have included in its qualitative and quantitative risk assessments? What are these studies and have they been peerreviewed, or are they soon to be peerreviewed? What is the rationale for recommending the studies or data? 6. Steenland et al. (2001a) pooled data from 10 cohort studies to conduct an analysis of lung cancer mortality among silica-exposed workers. Can you provide quantitative lung cancer risk estimates from other data sources? Have or will the data you submit be peer-reviewed? OSHA is particularly interested in quantitative risk analyses that can be conducted using the industrial sand worker studies by McDonald, Hughes, and Rando (2001) and the pooled center-based case-control study conducted by Cassidy et al. (2007). 7. OSHA has made a preliminary determination that the available data are not sufficient or suitable for quantitative analysis of the risk of autoimmune disease, stomach cancer, and other cancer and non-cancer health effects. Do you have, or are you aware of, studies, data, and rationale that would be suitable for a quantitative risk assessment for these adverse health effects? Submit the studies (or citations), data, and rationale. Profile of Affected Industries 8. In its PEA of the proposed rule, summarized in Section VIII of this preamble, OSHA presents a profile of the affected worker population. The profile includes estimates of the number of affected workers by industry sector or operation and job category, and the distribution of exposures by job category. If your company has potential worker exposures to respirable crystalline silica, is your industry among those listed by North American Industry Classification System (NAICS) code as affected industries? Are there PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 56285 additional data that will enable the Agency to refine its profile of the worker population exposed to respirable crystalline silica? If so, provide or reference such data and explain how OSHA should use these data to revise the profile. Technological and Economic Feasibility of the Proposed PEL 9. What are the job categories in which employees are potentially exposed to respirable crystalline silica in your company or industry? For each job category, provide a brief description of the operation and describe the job activities that may lead to respirable crystalline silica exposure. How many employees are exposed, or have the potential for exposure, to respirable crystalline silica in each job category in your company or industry? What are the frequency, duration, and levels of exposures to respirable crystalline silica in each job category in your company or industry? Where responders are able to provide exposure data, OSHA requests that, where available, exposure data be personal samples with clear descriptions of the length of the sample, analytical method, and controls in place. Exposure data that provide information concerning the controls in place are more valuable than exposure data without such information. 10. Please describe work environments or processes that may expose workers to cristobalite. Please provide supporting evidence, or explain the basis of your knowledge. 11. Have there been technological changes within your industry that have influenced the magnitude, frequency, or duration of exposure to respirable crystalline silica or the means by which employers attempt to control such exposures? Describe in detail these technological changes and their effects on respirable crystalline silica exposures and methods of control. 12. Has there been a trend within your industry or an effort in your firm to reduce or eliminate respirable crystalline silica from production processes, products, and services? If so, please describe the methods used and provide an estimate of the percentage reduction in respirable crystalline silica, and the extent to which respirable crystalline silica is still necessary in specific processes within product lines or production activities. If you have substituted another substance(s) for crystalline silica, identify the substance(s) and any adverse health effects associated with exposure to the substitute substances, and the cost impact of substitution (cost of materials, productivity impact). OSHA also E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56286 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules requests that responders describe any health hazards or technical, economic, or other deterrents to substitution. 13. Has your industry or firm used outsourcing or subcontracting, or concentrated high exposure tasks inhouse, in order to expose fewer workers to respirable crystalline silica? An example would be subcontracting for the removal of hardened concrete from concrete mixing trucks, a task done typically 2–4 times a year, to a specialty subcontractor. What methods have you used to reduce the number of workers exposed to respirable crystalline silica and how were they implemented? Describe any trends related to concentration of high exposure tasks and provide any supporting information. 14. Does any job category or employee in your workplace have exposures to respirable crystalline silica that air monitoring data do not adequately portray due to the short duration, intermittent or non-routine nature, or other unique characteristics of the exposure? Explain your response and indicate peak levels, duration, and frequency of exposures for employees in these job categories. 15. OSHA requests the following information regarding engineering and work practice controls to control exposure to crystalline silica in your workplace or industry: a. Describe the operations and tasks in which the proposed PEL is being achieved most of the time by means of engineering and work practice controls. b. What engineering and work practice controls have been implemented in these operations and tasks? c. For all operations and tasks in facilities where respirable crystalline silica is used, what engineering and work practice controls have been implemented to control respirable crystalline silica? If you have installed engineering controls or adopted work practices to reduce exposure to respirable crystalline silica, describe the exposure reduction achieved and the cost of these controls. d. Where current work practices include the use of regulated areas and hygiene facilities, provide data on the implementation of these controls, including data on the costs of installation, operation, and maintenance associated with these controls. e. Describe additional engineering and work practice controls that could be implemented in each operation where exposure levels are currently above the proposed PEL to further reduce exposure levels. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 f. When these additional controls are implemented, to what levels can exposure be expected to be reduced, or what percent reduction is expected to be achieved? g. What amount of time is needed to develop, install, and implement these additional controls? Will the added controls affect productivity? If so, how? h. Are there any processes or operations for which it is not reasonably possible to implement engineering and work practice controls within one year to achieve the proposed PEL? If so, how much additional time would be necessary? 16. OSHA requests information on whether there are any specific conditions or job tasks involving exposure to respirable crystalline silica where engineering and work practice controls are not available or are not capable of reducing exposure levels to or below the proposed PEL most of the time. Provide data and evidence to support your response. 17. OSHA has made a preliminary determination that compliance with the proposed PEL can be achieved in most operations most of the time through the use of engineering and work practice controls. OSHA has further made a preliminary determination that the proposed rule is technologically feasible. OSHA solicits comments on the reasonableness of these preliminary determinations. Compliance Costs 18. In its PEA (summarized in Section VIII.3 of this preamble), OSHA developed its estimate of the costs of the proposed rule. The Agency requests comment on the methodological and analytical assumptions applied in the cost analysis. Of particular importance are the unit cost estimates provided in tables and text in Chapter V of the PEA for all major provisions of the proposed rule. OSHA requests the following information regarding unit and total compliance costs: a. If you have installed engineering controls or adopted work practices to reduce exposure to respirable crystalline silica, describe these controls and their costs. If you have substituted another substance(s) for crystalline silica, what has been the cost impact of substitution (cost of materials, productivity impact)? b. OSHA has proposed to limit the prohibition on dry sweeping to situations where this activity could contribute to exposure that exceeds the PEL and estimated the costs for the use of wet methods to control dust. OSHA requests comment on the use of wet methods as a substitute for dry sweeping and whether the prohibition PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 on dry sweeping is feasible and costeffective. c. In its PEA, OSHA presents estimated baseline levels of use of personal protective equipment (PPE) and the incremental PPE costs associated with the proposed rule. Are OSHA’s estimated PPE compliance rates reasonable? Are OSHA’s estimates of PPE costs, and the assumptions underlying these estimates, consistent with current industry practice? If not, provide data and evidence describing current industry PPE practices. d. Do you currently conduct exposure monitoring for respirable crystalline silica? Are OSHA’s estimates of exposure assessment costs reasonable? Would your company require outside consultants to perform exposure monitoring? e. Are OSHA’s estimates for medical surveillance costs—including direct medical costs, the opportunity cost of worker time for offsite travel and for the health screening, and recordkeeping costs—reasonable? f. In its PEA, OSHA presents estimated baseline levels of training and information concerning respirable crystalline silica-related hazards and the incremental costs associated with the additional requirements for training and information in the proposed rule. OSHA requests information on information and training programs addressing respirable crystalline silica that are currently being implemented by employers and any necessary additions to those programs that are anticipated in response to the proposed rule. Are OSHA’s baseline estimates and unit costs for training reasonable and consistent with current industry practice? g. Are OSHA’s estimated costs for regulated areas and written access control plans reasonable? h. The cost estimates in the PEA take the much higher labor turnover rates in construction into account when calculating costs. For the proposed rule, OSHA used the most recent BLS turnover rate of 64 percent for construction (versus a turnover rate of 27.2 percent for general industry). OSHA believes that the estimates in the PEA capture the effect of high turnover rates in construction and solicits comments on this issue. i. Has OSHA omitted any costs that would be incurred to comply with the proposed rule? Effects on Small Entities 19. OSHA has considered the effects on small entities raised during its SBREFA process and addressed these concerns in Chapter VIII of the PEA. Are there additional difficulties small E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules entities may encounter when attempting to comply with requirements of the proposed rule? Can any of the proposal’s requirements be deleted or simplified for small entities, while still providing equivalent protection of the health of employees? Would allowing additional time for small entities to comply make a difference in their ability to comply? How much additional time would be necessary? Economic Impacts 20. OSHA, in its PEA, has estimated compliance costs per affected entity and the likely impacts on revenues and profits. OSHA requests that affected employers provide comment on OSHA’s estimate of revenue, profit, and the impacts of costs for their industry or application group. The Agency also requests that employers provide data on their revenues, profits, and the impacts of cost, if available. Are there special circumstances—such as unique cost factors, foreign competition, or pricing constraints—that OSHA needs to consider when evaluating economic impacts for particular applications and industry groups? 21. OSHA seeks comment as to whether establishments will be able to finance first-year compliance costs from cash flow, and under what circumstances a phase-in approach will assist firms in complying with the proposed rule. 22. The Agency invites comment on potential employment impacts of the proposed silica rule, and on Inforum’s estimates of the employment impacts of the proposed silica rule on the U.S. economy. c. The choice of discount rate for annualizing the monetized benefits of the proposed rule. d. Increasing the monetary value of a statistical life over time resulting from an increase in real per capita income and the estimated income elasticity of the value of life. e. Extending the benefits analysis beyond the 60-year period used in the PEA. f. The magnitude of non-quantified health benefits arising from the proposed rule and methods for better measuring these effects. An example would be diagnosing latent tuberculosis (TB) in the silica-exposed population and thereby reducing the risk of TB being spread to the population at large. Overlapping and Duplicative Regulations 25. Do any federal regulations duplicate, overlap, or conflict with the proposed respirable crystalline silica rule? If so, provide or cite to these regulations. Benefits and Net Benefits Alternatives/Ways to Simplify a New Standard 26. Comment on the alternative to new comprehensive standards (which have ancillary provisions in addition to a permissible exposure limit) that would be simply improved outreach and enforcement of the existing standards (which is only a permissible exposure limit with no ancillary provisions). Do you believe that improved outreach and enforcement of the existing permissible exposure limits would be sufficient to reduce significant risks of material health impairment in workers exposed to respirable crystalline silica? Provide information to support your position. 27. OSHA solicits comments on ways to simplify the proposed rule without compromising worker protection from exposure to respirable crystalline silica. In particular, provide detailed recommendations on ways to simplify the proposed standard for construction. Provide evidence that your recommended simplifications would result in a standard that was effective, to the extent feasible, in reducing significant risks of material health impairment in workers exposed to respirable crystalline silica. 24. OSHA requests comments on any aspect of its estimation of benefits and net benefits from the proposed rule, including the following: a. The use of willingness-to-pay measures and estimates based on compensating wage differentials. b. The data and methods used in the benefits calculations. Environmental Impacts 28. Submit data, information, or comments pertaining to possible environmental impacts of adopting this proposal, including any positive or negative environmental effects and any irreversible commitments of natural resources that would be involved. In particular, consideration should be Outreach and Compliance Assistance mstockstill on DSK4VPTVN1PROD with PROPOSALS2 23. If the proposed rule is promulgated, OSHA will provide outreach materials on the provisions of the standards in order to encourage and assist employers in complying. Are there particular materials that would make compliance easier for your company or industry? What materials would be especially useful for small entities? Submit recommendations or samples. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 56287 given to the potential direct or indirect impacts of the proposal on water and air pollution, energy use, solid waste disposal, or land use. Would compliance with the silica rule require additional actions to comply with federal, state, or local environmental requirements? 29. Some small entity representatives advised OSHA that the use of water as a control measure is limited at their work sites due to potential water and soil contamination. OSHA believes these limits may only apply in situations where crystalline silica is found with other toxic substances such as during abrasive blasting of metal or painted metal structures, or in locations where state and local requirements are more restrictive than EPA requirements. OSHA seeks comments on this issue, including cites to applicable requirements. a. Are there limits on the use of water controls in your operations due to environmental regulations? If so, are the limits due to the non-silica components of the waste stream? What are these non-silica components? b. What metals or other toxic chemicals are in your silica waste streams and what are the procedures and costs to filter out these metals or other toxic chemicals from your waste streams? Provide documentation to support your cost estimates. Provisions of the Standards Scope 30. OSHA’s Advisory Committee on Construction Safety and Health (ACCSH) has historically advised the Agency to take into consideration the unique nature of construction work environments by either setting separate standards or making accommodations for the differences in work environments in construction as compared to general industry. ASTM, for example, has separate silica standards of practice for general industry and construction, E 1132–06 and E 2625–09, respectively. To account for differences in the workplace environments for these different sectors, OSHA has proposed separate standards for general industry/maritime and construction. Is this approach necessary and appropriate? What other approaches, if any, should the Agency consider? Provide a rationale for your response. 31. OSHA has proposed that the scope of the construction standard include all occupational exposures to respirable crystalline silica in construction work as defined in 29 CFR 1910.12(b) and covered under 29 CFR part 1926, rather E:\FR\FM\12SEP2.SGM 12SEP2 56288 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 than restricting the application of the rule to specific construction operations. Should OSHA modify the scope to limit what is covered? What should be included and what should be excluded? Provide a rationale for your position. Submit your proposed language for the scope and application provision. 32. OSHA has not proposed to cover agriculture because the Agency does not have data sufficient to determine the feasibility of the proposed PEL in agricultural operations. Should OSHA cover respirable crystalline silica exposure in agriculture? Provide evidence to support your position. OSHA seeks information on agricultural operations that involve respirable crystalline silica exposures, including information that identifies particular activities or crops (e.g., hand picking fruit and vegetables, shaking branches and trees, harvesting with combines, loading storage silos, planting) associated with exposure, information indicating levels of exposure, and information relating to available control measures and their effectiveness. OSHA also seeks information related to the development of respirable crystalline silica-related adverse health effects and diseases among workers in the agricultural sector. 33. Should OSHA limit coverage of the rule to materials that contain a threshold concentration (e.g., 1%) of crystalline silica? For example, OSHA’s Asbestos standard defines ‘‘asbestoscontaining material’’ as any material containing more than 1% asbestos, for consistency with EPA regulations. OSHA has not proposed a comparable limitation to the definition of respirable crystalline silica. Is this approach appropriate? Provide the rationale for your position. 34. OSHA has proposed to cover shipyards under the general industry standard. Are there any unique circumstances in shipyard employment that would justify development of different provisions or a separate standard for the shipyard industry? What are the circumstances and how would they not be adequately covered by the general industry standard? Definitions 35. Competent person. OSHA has proposed limited duties for a competent person relating to establishment of an access control plan. The Agency did not propose specific requirements for training of a competent person. Is this approach appropriate? Should OSHA include a competent person provision? If so, should the Agency add to, modify, or delete any of the duties of a competent person as described in the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 proposed standard? Provide the basis for your recommendations. 36. Has OSHA defined ‘‘respirable crystalline silica’’ appropriately? If not, provide the definition that you believe is appropriate. Explain the basis for your response, and provide any data that you believe are relevant. 37. The proposed rule defines ‘‘respirable crystalline silica’’ in part as ‘‘airborne particles that contain quartz, cristobalite, and/or tridymite.’’ OSHA believes that tridymite is rarely found in nature or in the workplace. Please describe any instances of occupational exposure to tridymite of which you are aware. Please provide supporting evidence, or explain the basis of your knowledge. Should tridymite be included in the scope of this proposed rule? Please provide any evidence to support your position. PEL and Action Level 38. OSHA has proposed a TWA PEL for respirable crystalline silica of 50 mg/ m3 for general industry, maritime, and construction. The Agency has made a preliminary determination that this is the lowest level that is technologically feasible. The Agency has also determined that a PEL of 50 mg/m3 will substantially reduce, but not eliminate, significant risk of material health impairment. Is this PEL appropriate, given the Agency’s obligation to reduce significant risk of material health impairment to the extent feasible? If not, what PEL would be more appropriate? The Agency also solicits comment on maintaining the existing PELs for respirable crystalline silica. Provide evidence to support your response. 39. OSHA has proposed a single PEL for respirable crystalline silica (quartz, cristobalite, and tridymite). Is a single PEL appropriate, or should the Agency maintain separate PELs for the different forms of respirable crystalline silica? Provide the rationale for your position. 40. OSHA has proposed an action level for respirable crystalline silica exposure of 25 mg/m3 in general industry, maritime, and construction. Is this an appropriate approach and level, and if not, what approach or level would be more appropriate and why? Should an action level be included in the final rule? Provide the rationale for your position. 41. If an action level is included in the final rule, which provisions, if any, should be triggered by exposure above or below the action level? Provide the basis for your position and include supporting information. 42. If no action level is included in the final rule, which provisions should apply to all workers exposed to PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 respirable crystalline silica? Which provisions should be triggered by the PEL? Are there any other appropriate triggers for the requirements of the rule? Exposure Assessment 43. OSHA is proposing to allow employers to initially assess employee exposures using air monitoring or objective data. Has OSHA defined ‘‘objective data’’ sufficiently for an employer to know what data may be used? If not, submit an alternative definition. Is it appropriate to allow employers to use objective data to perform exposure assessments? Explain why or why not. 44. The proposed rule provides two options for periodic exposure assessment: (1) A fixed schedule option, and (2) a performance option. The performance option provides employers flexibility in the methods used to determine employee exposures, but requires employers to accurately characterize employee exposures. The proposed approach is explained in the Summary and Explanation for paragraph (d) Exposure Assessment. OSHA solicits comments on this proposed exposure assessment provision. Is the wording of the performance option in the regulatory text understandable and does it clearly indicate what would constitute compliance with the provision? If not, suggest alternative language that would clarify the provision, enabling employers to more easily understand what would constitute compliance. 45. Do you conduct initial air monitoring or do you rely on objective data to determine respirable crystalline silica exposures? If objective data, what data do you use? Have you conducted historical exposure monitoring of your workforce that is representative of current process technology and equipment use? Describe any other approaches you have implemented for assessing an employee’s initial exposure to respirable crystalline silica. 46. OSHA is proposing specific requirements for laboratories that perform analyses of respirable crystalline silica samples. The rationale is to improve the precision in individual laboratories and reduce the variability of results between laboratories, so that sampling results will be more reliable. Are these proposed requirements appropriate? Will the laboratory requirements add necessary reliability and reduce inter-lab variability, or might they be overly proscriptive? Provide the basis for your response. 47. Has OSHA correctly described the accuracy and precision of existing methods of sampling and analysis for E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules respirable crystalline silica at the proposed action level and PEL? Can worker exposures be accurately measured at the proposed action level and PEL? Explain the basis for your response, and provide any data that you believe are relevant. 48. OSHA has not addressed the performance of the analytical method with respect to tridymite since we have found little available data. Please comment on the performance of the analytical method with respect to tridymite and provide any data to support your position. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Regulated Areas and Access Control 49. Where exposures exceed the PEL, OSHA has proposed to provide employers with the option of either establishing a regulated area or establishing a written access control plan. For which types of work operations would employers be likely to establish a written access control plan? Will employees be protected by these options? Provide the basis for your position and include supporting information. 50. The Summary and Explanation for paragraph (e) Regulated Areas and Access Control clarifies how the regulated area requirements would apply to multi-employer worksites in the proposed standard. OSHA solicits comments on this issue. 51. OSHA is proposing limited requirements for protective clothing in the silica rule. Is this appropriate? Are you aware of any situations where more or different protective clothing would be needed for silica exposures? If so, what type of protective clothing and equipment should be required? Are there additional provisions related to protective clothing that should be incorporated into this rule that will enhance worker protection? Provide the rationale and data that support your conclusions. Methods of Compliance 52. In OSHA’s cadmium standard (29 CFR 1910.1027(f)(1)(ii),(iii), and (iv)), the Agency established separate engineering control air limits (SECALs) for certain processes in selected industries. SECALs were established where compliance with the PEL by means of engineering and work practice controls was infeasible. For these industries, a SECAL was established at the lowest feasible level that could be achieved by engineering and work practice controls. The PEL was set at a lower level, and could be achieved by any allowable combination of controls, including respiratory protection. In OSHA’s chromium (VI) standard (29 VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 CFR 1910.1026), an exception similar to SECALs was made for painting airplanes and airplane parts. Should OSHA follow this approach for respirable crystalline silica in any industries or processes? If so, in what industries or processes, and at what exposure levels, should the SECALs be established? Provide the basis for your position and include supporting information. 53. The proposed standards do not contain a requirement for a written exposure control program. The two ASTM standards for general industry and construction (E 1132–06, section 4.2.6, and E 2626–09, section 4.2.5) state that, where overexposures are persistent (such as in regulated areas or abrasive blasting operations), a written exposure control plan shall establish engineering and administrative controls to bring the area into compliance, if feasible. In addition, the proposed regulatory language developed by the Building and Construction Trades Department, AFL– CIO contains provisions for a written program. The ASTM standards recommend that, where there are regulated areas with persistent exposures or tasks, tools, or operations that tend to cause respirable crystalline silica exposure, the employer will conduct a formal analysis and implement a written control plan (an abatement plan) on how to bring the process into compliance. If that is not feasible, the employer is to indicate the respiratory protection and other protective procedures that will be used to protect employee(s) permanently or until compliance will be achieved. Should OSHA require employers to develop and implement a written exposure control plan and, if so, what should be required to be in the plans? 54. Table 1 in the proposed construction standard specifies engineering and work practice controls and respiratory protection for selected construction operations, and exempts employers who implement these controls from exposure assessment requirements. Is this approach appropriate? Are there other operations that should be included, or listed operations that should not be included? Are the specified control measures effective? Should any other changes be made in Table 1? How should OSHA update Table 1 in the future to account for development of new technologies? Provide data and information to support your position. 55. OSHA requests comments on the degree of specificity used for the engineering and work practice controls for tasks identified in Table 1, including maintenance requirements. Should PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 56289 OSHA require an evaluation or inspection checklist for controls? If so, how frequently should evaluations or inspections be conducted? Provide any examples of such checklists, along with information regarding their frequency of use and effectiveness. 56. In the proposed construction standard, when employees perform an operation listed in Table 1 and the employer fully implements the engineering controls, work practices, and respiratory protection described in Table 1 for that operation, the employer is not required to assess the exposure of the employees performing such operations. However, the employer must still ensure compliance with the proposed PEL for that operation. OSHA seeks comment on whether employers fully complying with Table 1 for an operation should still need to comply with the proposed PEL for that operation. Instead, should OSHA treat compliance with Table 1 as automatically meeting the requirements of the proposed PEL? 57. Are the descriptions of the operations (specific task or tool descriptions) and control technologies in Table 1 clear and precise enough so that employers and workers will know what controls they should be using for the listed operations? Identify the specific operation you are addressing and whether your assessment is based on your anecdotal experience or research. For each operation, are the data and other supporting information sufficient to predict the range of expected exposures under the controlled conditions? Identify operations, if any, where you believe the data are not sufficient. Provide the reasoning and data that support your position. 58. In one specific example from Table 1, OSHA has proposed the option of using a wet method for hand-operated grinders, with respirators required only for operations lasting four hours or more. Please comment and provide OSHA with additional information regarding wet grinding and the adequacy of this control strategy. OSHA is also seeking additional information on the second option (commercially available shrouds and dust collection systems) to confirm that this control strategy (including the use of half-mask respirators) will reduce workers’ exposure to or below the PEL. 59. For impact drilling operations lasting four hours or less, OSHA is proposing in Table 1 to allow workers to use water delivery systems without the use of respiratory protection, as the Agency believes that this dust suppression method alone will provide E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56290 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules consistent, sufficient protection. Is this control strategy appropriate? Please provide the basis for your position and any supporting evidence or additional information that addresses the appropriateness of this control strategy. 60. In the case of rock drilling, in order to ensure that workers are adequately protected from the higher exposures that they would experience working under shrouds, OSHA is proposing in Table 1 that employers ensure that workers use half-mask respirators when working under shrouds at the point of operation. Is this specification appropriate? Please provide the basis for your position and any supporting evidence or additional information that addresses the appropriateness of this specification. 61. OSHA has specified a control strategy for concrete drilling in Table 1 that includes use of a dust collection system as well as a low-flow water spray. Please provide to OSHA any data that you have that describes the efficacy of these controls. Is the control strategy in Table 1 adequate? Please provide the basis for your position and any supporting evidence or additional information regarding the adequacy of this control strategy. 62. One of the control options in Table 1 in the proposed construction standard for rock-crushing operations is local exhaust ventilation. However, OSHA is aware of difficulties in applying this control to this operation. Is this control strategy appropriate and practical for rock-crushing operations? Please provide any information that you have addressing this issue. 63. OSHA has not proposed to prohibit the use of crystalline silica as an abrasive blasting agent. Abrasive blasting, similar to other operations that involve respirable crystalline silica exposures, must follow the hierarchy of controls, which means, if feasible, that substitution, engineering, or administrative controls or a combination of these controls must be used to minimize or eliminate the exposure hazard. Is this approach appropriate? Provide the basis for your position and any supporting evidence. 64. The technological feasibility study (PEA, Chapter 4) indicates that employers use substitutes for crystalline silica in a variety of operations. If you are aware of substitutes for crystalline silica that are currently being used in any operation not considered in the feasibility study, please provide to OSHA relevant information that contains data supporting the effectiveness, in reducing exposure to crystalline silica, of those substitutes. Provide any information you may have VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 on the health hazards associated with exposure to these substitutes. 65. Information regarding the effectiveness of dust control kits that incorporate local exhaust ventilation in the railroad transportation industry in reducing worker exposure to crystalline silica is not available from the manufacturer. If you have any relevant information on the effectiveness of such kits, please provide it to OSHA. 66. The proposed rule prohibits the use of compressed air and dry brushing and sweeping for cleaning of surfaces and clothing in general industry, maritime, and construction and promotes the use of wet methods and HEPA-filter vacuuming as alternatives. Are there any circumstances in general industry, maritime, or construction work where dry sweeping is the only kind of sweeping that can be done? Have you done dry sweeping and, if so, what has been your experience with it? What methods have you used to minimize dust when dry sweeping? Can exposure levels be kept below the proposed PEL when dry sweeping is conducted? How? Provide exposure data for periods when you conducted dry sweeping. If silica respirable dust samples are not available, provide real time respirable dust or gravimetric respirable dust data. Is water available at most sites to wet down dust prior to sweeping? How effective is the use of water? Does the use of water cause other problems for the worksite? Are there other substitutes that are effective? 67. A 30-day exemption from the requirement to implement engineering and work practice controls was not included in the proposed standard for construction, and has been removed from the proposed standard for general industry and maritime. OSHA requests comment on this issue. 68. The proposed prohibition on employee rotation is explained in the Summary and Explanation for paragraph (f) Methods of Compliance. OSHA solicits comment on the prohibition of employee rotation to achieve compliance when exposure levels exceed the PEL. Medical Surveillance 69. Is medical surveillance being provided for respirable crystalline silica-exposed employees at your worksite? If so: a. How do you determine which employees receive medical surveillance (e.g., by exposure level or other factors)? b. Who administers and implements the medical surveillance (e.g., company doctor or nurse, outside doctor or nurse)? PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 c. What examinations, tests, or evaluations are included in the medical surveillance program? Does your medical surveillance program include testing for latent TB? Do you include pulmonary function testing in your medical surveillance program? d. What benefits (e.g., health, reduction in absenteeism, or financial) have been achieved from the medical surveillance program? e. What are the costs of your medical surveillance program? How do your costs compare with OSHA’s estimated unit costs for the physical examination and employee time involved in the medical surveillance program? Are OSHA’s baseline assumptions and cost estimates for medical surveillance consistent with your experiences providing medical surveillance to your employees? f. How many employees are included in your medical surveillance program? g. What NAICS code describes your workplace? 70. Is the content and frequency of proposed examinations appropriate? If not, how should content and frequency be modified? 71. Is the specified content of the physician or other licensed health care professional’s (PLHCP) written medical opinion sufficiently detailed to enable the employer to address the employee’s needs and potential workplace improvements, and yet appropriately limited so as to protect the employee’s medical privacy? If not, how could the medical opinion be improved? 72. Is the requirement for latent TB testing appropriate? Does the proposed rule implement this requirement in a cost-effective manner? Provide the data or cite references that support your position. 73. Is the requirement for pulmonary function testing initially and at threeyear intervals appropriate? Is there an alternate strategy or schedule for conducting follow-up testing that is better? Provide data or cite references to support your position. 74. Is the requirement for chest X-rays initially and at three-year intervals appropriate? Is there an alternate strategy or schedule for conducting follow-up chest X-rays that you believe would be better? Provide data or cite references to support your position. 75. Are there other tests that should be included in medical surveillance? 76. Do you provide medical surveillance to employees under another OSHA standard or as a matter of company policy? If so, describe your program in terms of what standards the program addresses and such factors as content and frequency of examinations E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules and referrals, and reports to the employer. 77. Is exposure for 30 days at or above the PEL the appropriate number of days to trigger medical surveillance? Should the appropriate reference for medical monitoring be the PEL or the action level? Is 30 days from initial assignment a reasonable amount of time to provide a medical exam? Indicate the basis for your position. 78. Are PLHCPs available in your geographic area to provide medical surveillance to workers who are covered by the proposed rule? For example, do you have access to qualified X-ray technicians, NIOSH-certified B-readers, and pulmonary specialists? Describe any difficulties you may have with regard to access to PLHCPs to provide surveillance for the rule. Note what you consider your ‘‘geographic area’’ in responding to this question. 79. OSHA is proposing to allow an ‘‘equivalent diagnostic study’’ in place of requirements to use a chest X-ray (posterior/anterior view; no less than 14 x 17 inches and no more than 16 x 17 inches at full inspiration; interpreted and classified according to the International Labour Organization (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified ‘‘B’’ reader). Two other radiological test methods, computed tomography (CT) and high resolution computed tomography (HRCT), could be considered ‘‘equivalent diagnostic studies’’ under paragraph (h)(2)(iii) of the proposal. However, the benefits of CT or HRCT should be balanced with risks, including higher radiation doses. Also, standardized methods for interpreting and reporting results of CT or HRCT are not currently available. The Agency requests comment on whether CT and HRCT should be considered ‘‘equivalent diagnostic studies’’ under the rule. Provide a rationale and evidence to support your position. 80. OSHA has not included requirements for medical removal protection (MRP) in the proposed rule, because OSHA has made a preliminary determination that there are few instances where temporary worker removal and MRP will be useful. The Agency requests comment as to whether the respirable crystalline silica rule should include provisions for the temporary removal and extension of MRP benefits to employees with certain respirable crystalline silica-related health conditions. In particular, what medical conditions or findings should trigger temporary removal and for what maximum amount of time should MRP benefits be extended? OSHA also seeks information on whether or not MRP is VerDate Mar<15>2010 20:46 Sep 11, 2013 Jkt 229001 currently being used by employers with respirable crystalline silica-exposed workers, and the costs of such programs. Hazard Communication and Training 81. OSHA has proposed that employers provide hazard information to employees in accordance with the Agency’s Hazard Communication standard (29 CFR 1910.1200). Compliance with the Hazard Communication standard would mean that there would be a requirement for a warning label for substances that contain more than 0.1 percent crystalline silica. Should this requirement be changed so that warning labels would only be required of substances more than 1 percent by weight of silica? Provide the rationale for your position. The Agency also has proposed additional training specific to work with respirable crystalline silica. Should OSHA include these additional requirements in the final rule, or are the requirements of the Hazard Communication standard sufficient? 82. OSHA is providing an abbreviated training section in this proposal as compared to ASTM consensus standards (see ASTM E 1132–06, sections 4.8.1–5). The Hazard Communication standard is comprehensive and covers most of the training requirements traditionally included in an OSHA health standard. Do you concur with OSHA that performance-based training specified in the Hazard Communication standard, supplemented by the few training requirements of this section, is sufficient in its scope and depth? Are there any other training provisions you would add? 83. The proposed rule does not alter the requirements for substances to have warning labels, specify wording for labels, or otherwise modify the provisions of the OSHA’s Hazard Communication standard. OSHA invites comment on these issues. Recordkeeping 84. OSHA is proposing to require recordkeeping for air monitoring data, objective data, and medical surveillance records. The proposed rule’s recordkeeping requirements are discussed in the Summary and Explanation for paragraph (j) Recordkeeping. The Agency seeks comment on the utility of these recordkeeping requirements as well as the costs of making and maintaining these records. Provide evidence to support your position. PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 56291 Dates 85. OSHA requests comment on the time allowed for compliance with the provisions of the proposed rule. Is the time proposed appropriate, or should there be a longer or shorter phase-in of requirements? In particular, should requirements for engineering controls and/or medical surveillance be phased in over a longer period of time (e.g., over 1, 2, 3, or more years)? Should an extended phase-in period be provided for specific industries (e.g., industries where first-year or annualized cost impacts are highest), specific sizeclasses of employers (e.g., employers with fewer than 20 employees), combinations of these factors, or all firms covered by the rule? Identify any industries, processes, or operations that have special needs for additional time, the additional time required, and the reasons for the request. 86. OSHA is proposing a two-year start-up period to allow laboratories time to achieve compliance with the proposed requirements, particularly with regard to requirements for accreditation and round robin testing. OSHA also recognizes that requirements for monitoring in the proposed rule will increase the required capacity for analysis of respirable crystalline silica samples. Do you think that this start-up period is enough time for laboratories to achieve compliance with the proposed requirements and to develop sufficient analytic capacity? If you think that additional time is needed, please tell OSHA how much additional time is required and give your reasons for this request. Appendices 87. Some OSHA health standards include appendices that address topics such as the hazards associated with the regulated substance, health screening considerations, occupational disease questionnaires, and PLHCP obligations. In this proposed rule, OSHA has included a non-mandatory appendix to clarify the medical surveillance provisions of the rule. What would be the advantages and disadvantages of including such an appendix in the final rule? If you believe it should be included, comment on the appropriateness of the information included. What additional information, if any, should be included in the appendix? II. Pertinent Legal Authority The purpose of the Occupational Safety and Health Act, 29 U.S.C. 651 et seq. (‘‘the Act’’), is to ‘‘. . . assure so far as possible every working man and E:\FR\FM\12SEP2.SGM 12SEP2 56292 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules woman in the nation safe and healthful working conditions and to preserve our human resources.’’ 29 U.S.C. 651(b). To achieve this goal Congress authorized the Secretary of Labor (the Secretary) to promulgate and enforce occupational safety and health standards. 29 U.S.C. 654(b) (requiring employers to comply with OSHA standards), 655(a) (authorizing summary adoption of existing consensus and federal standards within two years of the Act’s enactment), and 655(b) (authorizing promulgation, modification or revocation of standards pursuant to notice and comment). The Act provides that in promulgating health standards dealing with toxic materials or harmful physical agents, such as this proposed standard regulating occupational exposure to respirable crystalline silica, the Secretary, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. 29 U.S.C. 655(b)(5). The Supreme Court has held that before the Secretary can promulgate any permanent health or safety standard, she must make a threshold finding that significant risk is present and that such risk can be eliminated or lessened by a change in practices. Industrial Union Dept., AFL–CIO v. American Petroleum Institute, 448 U.S. 607, 641–42 (1980) (plurality opinion) (‘‘The Benzene case’’). Thus, section 6(b)(5) of the Act requires health standards to reduce significant risk to the extent feasible. Id. The Court further observed that what constitutes ‘‘significant risk’’ is ‘‘not a mathematical straitjacket’’ and must be ‘‘based largely on policy considerations.’’ The Benzene case, 448 U.S. at 655. The Court gave the example that if, mstockstill on DSK4VPTVN1PROD with PROPOSALS2 . . . the odds are one in a billion that a person will die from cancer . . . the risk clearly could not be considered significant. On the other hand, if the odds are one in one thousand that regular inhalation of gasoline vapors that are 2% benzene will be fatal, a reasonable person might well consider the risk significant. [Id.] OSHA standards must be both technologically and economically feasible. United Steelworkers v. Marshall, 647 F.2d 1189, 1264 (D.C. Cir. 1980) (‘‘The Lead I case’’). The Supreme Court has defined feasibility as ‘‘capable of being done.’’ Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 509–510 (1981) (‘‘The Cotton Dust case’’). The VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 courts have further clarified that a standard is technologically feasible if OSHA proves a reasonable possibility, . . . within the limits of the best available evidence . . . that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations. [See The Lead I case, 647 F.2d at 1272] With respect to economic feasibility, the courts have held that a standard is feasible if it does not threaten massive dislocation to or imperil the existence of the industry. Id. at 1265. A court must examine the cost of compliance with an OSHA standard, . . . in relation to the financial health and profitability of the industry and the likely effect of such costs on unit consumer prices . . . [T]he practical question is whether the standard threatens the competitive stability of an industry, . . . or whether any intraindustry or inter-industry discrimination in the standard might wreck such stability or lead to undue concentration. [Id. (citing Indus. Union Dep’t, AFL–CIO v. Hodgson, 499 F.2d 467 (D.C. Cir. 1974))] The courts have further observed that granting companies reasonable time to comply with new PELs may enhance economic feasibility. The Lead I case at 1265. While a standard must be economically feasible, the Supreme Court has held that a cost-benefit analysis of health standards is not required by the Act because a feasibility analysis is required. The Cotton Dust case, 453 U.S. at 509. Finally, sections 6(b)(7) and 8(c) of the Act authorize OSHA to include among a standard’s requirements labeling, monitoring, medical testing, and other information-gathering and -transmittal provisions. 29 U.S.C. 655(b)(7), 657(c). III. Events Leading to the Proposed Standards OSHA’s current standards for workplace exposure to respirable crystalline silica were adopted in 1971, pursuant to section 6(a) of the OSH Act (36 FR 10466, May 29, 1971). Section 6(a) provided that in the first two years after the effective date of the Act, OSHA had to promulgate ‘‘start-up’’ standards, on an expedited basis and without public hearing or comment, based on national consensus or established Federal standards that improved employee safety or health. Pursuant to that authority, OSHA in 1971 promulgated approximately 425 permissible exposure limits (PELs) for air contaminants, including silica, derived principally from Federal standards applicable to government contractors under the Walsh-Healey Public Contracts Act, 41 U.S.C. 35, and PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 the Contract Work Hours and Safety Standards Act (commonly known as the Construction Safety Act), 40 U.S.C. 333. The Walsh-Healey Act and Construction Safety Act standards, in turn, had been adopted primarily from recommendations of the American Conference of Governmental Industrial Hygienists (ACGIH). For general industry (see 29 CFR 1910.1000, Table Z–3), the PEL for crystalline silica in the form of respirable quartz is based on two alternative formulas: (1) A particlecount formula, PELmppcf = 250/(% quartz + 5); and (2) a mass formula proposed by ACGIH in 1968, PEL = (10 mg/m3)/ (% quartz + 2). The general industry PELs for cristobalite and tridymite are one-half of the value calculated from either of the above two formulas. For construction (29 CFR 1926.55, Appendix A) and shipyards (29 CFR 1915.1000, Table Z), the formula for the PEL for crystalline silica in the form of quartz (PELmppcf = 250/(% quartz + 5)), which requires particle counting, is derived from the 1970 ACGIH threshold limit value (TLV).2 The formula based on particle-counting technology used in the general industry, construction, and shipyard PELs is now considered obsolete. In 1974, the National Institute for Occupational Safety and Health (NIOSH) evaluated crystalline silica as a workplace hazard and issued criteria for a recommended standard on occupational exposure to crystalline silica (NIOSH, 1974). NIOSH recommended that occupational exposure to crystalline silica be controlled so that no worker is exposed to a time-weighted average (TWA) of free (respirable crystalline) silica greater than 50 mg/m3 as determined by a fullshift sample for up to a 10-hour workday, 40-hour workweek. The document also recommended a number of ancillary provisions for a standard, such as exposure monitoring and medical surveillance. In December 1974, OSHA published an Advanced Notice of Proposed Rulemaking (ANPRM) based on the recommendations in the NIOSH criteria document (39 FR 44771, Dec. 27, 1974). In the ANPRM, OSHA solicited ‘‘public participation on the issues of whether a new standard for crystalline silica 2 The Mineral Dusts tables that contain the silica PELs for construction and shipyards do not clearly express PELs for cristobalite and tridymite. 29 CFR 1926.55; 29 CFR 1915.1000. This lack of textual clarity likely results from a transcription error in the Code of Federal Regulations. OSHA’s current proposal provides the same PEL for quartz, cristobalite, and tridymite, in general industry, construction, and shipyards. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules should be issued on the basis of the [NIOSH] criteria or any other information, and, if so, what should be the contents of a proposed standard for crystalline silica.’’ OSHA also set forth the particular issues of concern on which comments were requested. The Agency did not pursue a final rule for crystalline silica at that time. As information developed during the 1980s and 1990s, national and international classification organizations came to recognize crystalline silica as a human carcinogen. In June 1986, the International Agency for Research on Cancer (IARC) evaluated the available evidence regarding crystalline silica carcinogenicity and concluded that it was ‘‘probably carcinogenic to humans’’ (IARC, 1987). An IARC working group met again in October 1996 to evaluate the complete body of research, including research that had been conducted since the initial 1986 evaluation. IARC concluded that ‘‘crystalline silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to humans’’ (IARC, 1997). In 1991, in the Sixth Annual Report on Carcinogens, the U.S. National Toxicology Program (NTP) concluded that respirable crystalline silica was ‘‘reasonably anticipated to be a human carcinogen’’ (NTP, 1991). NTP reevaluated the available evidence and concluded, in the Ninth Report on Carcinogens (NTP, 2000), 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 RCS and increased lung cancer rates in workers exposed to crystalline silica dust’’ (NTP, 2000). ACGIH listed respirable crystalline silica (in the form of quartz) as a suspected human carcinogen in 2000, while lowering the TLV to 0.05 mg/m3 (ACGIH, 2001). ACGIH subsequently lowered the TLV for crystalline silica to 0.025 mg/m3 in 2006, which is the current value (ACGIH, 2010). In 1989, OSHA established 8-hour TWA PELs of 0.1 for quartz and 0.05 mg/m3 for cristobalite and tridymite, as part of the Air Contaminants final rule for general industry (54 FR 2332, Jan. 19, 1989). OSHA stated that these limits presented no substantial change from VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the Agency’s former formula limits, but would simplify sampling procedures. In providing comments on the proposed rule, NIOSH recommended that crystalline silica be considered a potential carcinogen. In 1992, OSHA, as part of the Air Contaminants proposed rule for maritime, construction, and agriculture, proposed the same PELs as for general industry, to make the PELs consistent across all the OSHA-regulated sectors (57 FR 26002, June 12, 1992). However, on July 7 of the same year, the U.S. Court of Appeals for the Eleventh Circuit vacated the 1989 Air Contaminants final rule for general industry (Am. Fed’n of Labor and Cong. of Indus. Orgs. v. OSHA, 965 F.2d 962 (1992)), which also mooted the proposed rule for maritime, construction, and agriculture. The Court’s decision to vacate the rule forced the Agency to return to the PELs adopted in the 1970s. In 1994, OSHA launched a process to determine which safety and health hazards in the U.S. needed most attention. A priority planning committee included safety and health experts from OSHA, NIOSH, and the Mine Safety and Health Administration (MSHA). The committee reviewed available information on occupational deaths, injuries, and illnesses and held an extensive dialogue with representatives of labor, industry, professional and academic organizations, the States, voluntary standards organizations, and the public. The National Advisory Committee on Occupational Safety and Health and the Advisory Committee on Construction Safety and Health also made recommendations. Rulemaking for crystalline silica exposure was one of the priorities designated by this process. OSHA indicated that crystalline silica would be added to the Agency’s regulatory agenda as other standards were completed and resources became available. In August 1996, the Agency initiated enforcement efforts under a Special Emphasis Program (SEP) on crystalline silica. The SEP was intended to reduce worker silica dust exposures that can cause silicosis. It included extensive outreach as well as inspections. Among the outreach materials available were slides presenting information on hazard recognition and crystalline silica control technology, a video on crystalline silica PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 56293 and silicosis, and informational cards for workers explaining crystalline silica, health effects related to exposure, and methods of control. The SEP provided guidance for targeting inspections of worksites with employees at risk of developing silicosis. As a follow-up to the SEP, OSHA undertook numerous non-regulatory actions to address silica exposures. For example, in October of 1996, OSHA launched a joint silicosis prevention effort with MSHA, NIOSH, and the American Lung Association (DOL, 1996). This public education campaign involved distribution of materials on how to prevent silicosis, including a guide for working safely with silica and stickers for hard hats to remind workers of crystalline silica hazards. Spanish language versions of these materials were also made available. OSHA and MSHA inspectors distributed materials at mines, construction sites, and other affected workplaces. The joint silicosis prevention effort included a National Conference to Eliminate Silicosis in Washington, DC, in March of 1997, which brought together approximately 650 participants from labor, business, government, and the health and safety professions to exchange ideas and share solutions to reach the goal of eliminating silicosis. The conference highlighted the best methods of eliminating silicosis and included problem-solving workshops on how to prevent the disease in specific industries and job operations; plenary sessions with senior government, labor, and corporate officials; and opportunities to meet with safety and health professionals who had implemented successful silicosis prevention programs. In 2003, OSHA examined enforcement data for the years between 1997 and 2002 and identified high rates of noncompliance with the OSHA respirable crystalline silica PEL, particularly in construction. This period covers the first five years of the SEP. These enforcement data, presented in Table 1, indicate that 24 percent of silica samples from the construction industry and 13 percent from general industry were at least three times the OSHA PEL. The data indicate that 66 percent of the silica samples obtained during inspections in general industry were in compliance with the PEL, while only 58 percent of the samples collected in construction were in compliance. E:\FR\FM\12SEP2.SGM 12SEP2 56294 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE III–1—RESULTS OF TIME-WEIGHTED AVERAGE (TWA) EXPOSURE RESPIRABLE CRYSTALLINE SILICA SAMPLES FOR CONSTRUCTION AND GENERAL INDUSTRY [January 1, 1997–December 31, 2002] Construction Exposure (severity relative to the PEL) Number of samples < 1 PEL ............................................................................................................ 1 × PEL to < 2 × PEL ...................................................................................... 2 × PEL to < 3 × PEL ...................................................................................... ≥ 3 × PEL and higher (3+) ............................................................................... Number of samples Percent 424 86 48 180 Total # of samples .................................................................................... Other than construction 58 12 6 24 738 Percent 2226 469 215 453 66 14 6 13 3363 Source: OSHA Integrated Management Information System. In an effort to expand the 1996 SEP, on January 24, 2008, OSHA implemented a National Emphasis Program (NEP) to identify and reduce or eliminate the health hazards associated with occupational exposure to crystalline silica (OSHA, 2008). The NEP targeted worksites with elevated exposures to crystalline silica and included new program evaluation procedures designed to ensure that the goals of the NEP were measured as accurately as possible, detailed procedures for conducting inspections, updated information for selecting sites for inspection, development of outreach programs by each Regional and Area Office emphasizing the formation of voluntary partnerships to share information, and guidance on calculating PELs in construction and shipyards. In each OSHA Region, at least two percent of inspections every year are silica-related inspections. Additionally, the silica-related inspections are conducted at a range of facilities reasonably representing the distribution of general industry and construction work sites in that region. A recent analysis of OSHA enforcement data from January 2003 to December 2009 (covering the period of continued implementation of the SEP and the first two years of the NEP) shows that considerable noncompliance with the PEL continues to occur. These enforcement data, presented in Table 2, indicate that 14 percent of silica samples from the construction industry and 19 percent for general industry were at least three times the OSHA PEL during this period. The data indicate that 70 percent of the silica samples obtained during inspections in general industry were in compliance with the PEL, and 75 percent of the samples collected in construction were in compliance. TABLE III–2—RESULTS OF TIME-WEIGHTED AVERAGE (TWA) EXPOSURE RESPIRABLE CRYSTALLINE SILICA SAMPLES FOR CONSTRUCTION AND GENERAL INDUSTRY [January 1, 2003–December 31, 2009] Construction Exposure (severity relative to the PEL) Number of samples < 1 PEL ............................................................................................................ 1 × PEL to < 2 × PEL ...................................................................................... 2 × PEL to < 3 × PEL ...................................................................................... ≥ 3 × PEL and higher (3+) ............................................................................... Number of samples Percent 548 49 32 103 Total # of samples .................................................................................... Other than construction 75 7 4 14 732 948 107 46 254 Percent 70 8 3 19 1355 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Source: OSHA Integrated Management Information System. Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to respirable crystalline silica. For example, ASTM (originally known as the American Society for Testing and Materials) has published recommended standards for addressing the hazards of crystalline silica, and the Building and Construction Trades Department, AFL– CIO also has recommended a comprehensive program standard. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance. The National Industrial Sand Association has also VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 developed exposure assessment, medical surveillance, and training guidance products. In 1997, OSHA announced in its Unified Agenda under Long-Term Actions that it planned to publish a proposed rule on crystalline silica ‘‘because the agency has concluded that there will be no significant progress in the prevention of silica-related diseases without the adoption of a full and comprehensive silica standard, including provisions for product substitution, engineering controls, training and education, respiratory protection and medical screening and surveillance. A full standard will PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 improve worker protection, ensure adequate prevention programs, and further reduce silica-related diseases.’’ (62 FR 57755, 57758, Oct. 29, 1997). In November 1998, OSHA moved ‘‘Occupational Exposure to Crystalline Silica’’ to the pre-rule stage in the Regulatory Plan (63 FR 61284, 61303– 304, Nov. 9, 1998). OSHA held a series of stakeholder meetings in 1999 and 2000 to get input on the rulemaking. Stakeholder meetings for all industry sectors were held in Washington, Chicago, and San Francisco. A separate stakeholder meeting for the construction sector was held in Atlanta. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules OSHA initiated Small Business Regulatory Enforcement Fairness Act (SBREFA) proceedings in 2003, seeking the advice of small business representatives on the proposed rule (68 FR 30583, 30584, May 27, 2003). The SBREFA panel, including representatives from OSHA, the Small Business Administration (SBA), and the Office of Management and Budget (OMB), was convened on October 20, 2003. The panel conferred with small entity representatives (SERs) from general industry, maritime, and construction on November 10 and 12, 2003, and delivered its final report, which included comments from the SERs and recommendations to OSHA for the proposed rule, to OSHA’s Assistant Secretary on December 19, 2003 (OSHA, 2003). Throughout the crystalline silica rulemaking process, OSHA has presented information to, and has consulted with, the Advisory Committee on Construction Safety and Health (ACCSH) and the Maritime Advisory Committee on Occupational Safety and Health (MACOSH). In December of 2009, OSHA representatives met with ACCSH to discuss the rulemaking and receive their comments and recommendations. On December 11, ACCSH passed motions supporting the concept of Table 1 in the draft proposed construction rule and recognizing that the controls listed in Table 1 are effective. (As discussed with regard to paragraph (f) of the proposed rule, Table 1 presents specified control measures for selected construction operations.) ACCSH also recommended that OSHA maintain the protective clothing provision found in the SBREFA panel draft regulatory text and restore the ‘‘competent person’’ requirement and responsibilities to the proposed rule. Additionally, the group recommended that OSHA move forward expeditiously with the rulemaking process. In January 2010, OSHA completed a peer review of the draft Health Effects analysis and Preliminary Quantitative Risk Assessment following procedures set forth by OMB in the Final Information Quality Bulletin for Peer Review, published on the OMB Web site on December 16, 2004 (see 70 FR 2664, Jan. 14, 2005). Each peer reviewer submitted a written report to OSHA. The Agency revised its draft documents as appropriate and made the revised documents available to the public as part of this Notice of Proposed Rulemaking. OSHA also made the written charge to the peer reviewers, the peer reviewers’ names, the peer reviewers’ reports, and the Agency’s response to the peer reviewers’ reports VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 publicly available with publication of this proposed rule. OSHA will schedule time during the informal rulemaking hearing for participants to testify on the Health Effects analysis and Preliminary Quantitative Risk Assessment in the presence of peer reviewers and will request the peer reviewers to submit any amended final comments they may wish to add to the record. The Agency will consider amended final comments received from the peer reviewers during development of a final rule and will make them publicly available as part of the silica rulemaking record. IV. Chemical Properties and Industrial Uses Silica is a compound composed of the elements silicon and oxygen (chemical formula SiO2). Silica has a molecular weight of 60.08, and exists in crystalline and amorphous states, both in the natural environment and as produced during manufacturing or other processes. These substances are odorless solids, have no vapor pressure, and create non-explosive dusts when particles are suspended in air (IARC, 1997). Silica is classified as part of the ‘‘silicate’’ class of minerals, which includes compounds that are composed of silicon and oxygen and which may also be bonded to metal ions or their oxides (Hurlbut, 1966). The basic structural units of silicates are silicon tetrahedrons (SiO4), pyramidal structures with four triangular sides where a silicon atom is located in the center of the structure and an oxygen atom is located at each of the four corners. When silica tetrahedrons bond exclusively with other silica tetrahedrons, each oxygen atom is bonded to the silicon atom of its original ion, as well as to the silicon atom from another silica ion. This results in a ratio of one atom of silicon to two atoms of oxygen, expressed as SiO2. The siliconoxygen bonds within the tetrahedrons use only one-half of each oxygen’s total bonding energy. This leaves negatively charged oxygen ions available to bond with available positively charged ions. When they bond with metal and metal oxides, commonly of iron, magnesium, aluminum, sodium, potassium, and calcium, they form the silicate minerals commonly found in nature (Bureau of Mines, 1992). In crystalline silica, the silicon and oxygen atoms are arranged in a threedimensional repeating pattern. Silica is said to be polymorphic, as different forms are created when the silica tetrahedrons combine in different crystalline structures. The primary forms of crystalline silica are quartz, PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 56295 cristobalite, and tridymite. In an amorphous state, silicon and oxygen atoms are present in the same proportions but are not organized in a repeating pattern. Amorphous silica includes natural and manufactured glasses (vitreous and fused silica, quartz glass), biogenic silica, and opals which are amorphous silica hydrates (IARC, 1997). Quartz is the most common form of crystalline silica and accounts for almost 12% by volume of the earth’s crust. Alpha quartz, the quartz form that is stable below 573 °C, is the most prevalent form of crystalline silica found in the workplace. It accounts for the overwhelming majority of naturally found silica and is present in varying amounts in almost every type of mineral. Alpha quartz is found in igneous, sedimentary, and metamorphic rock, and all soils contain at least a trace amount of quartz (Bureau of Mines, 1992). Alpha quartz is used in many products throughout various industries and is a common component of building materials (Madsen et al., 1995). Common trade names for commercially available quartz include: CSQZ, DQ 12, Min-U-Sil, Sil-Co-Sil, Snowit, Sykron F300, and Sykron F600 (IARC, 1997). Cristobalite is a form of crystalline silica that is formed at high temperatures (>1470 °C). Although naturally occurring cristobalite is relatively rare, volcanic eruptions, such as Mount St. Helens, can release cristobalite dust into the air. Cristobalite can also be created during some processes conducted in the workplace. For example, flux-calcined diatomaceous earth is a material used as a filtering aid and as a filler in other products (IARC, 1997). It is produced when diatomaceous earth (diatomite), a geological product of decayed unicellular organisms called diatoms, is heated with flux. The finished product can contain between 40 and 60 percent cristobalite. Also, high temperature furnaces are often lined with bricks that contain quartz. When subjected to prolonged high temperatures, this quartz can convert to cristobalite. Tridymite is another material formed at high temperatures (>870 °C) that is associated with volcanic activity. The creation of tridymite requires the presence of a flux such as sodium oxide. Tridymite is rarely found in nature and rarely reported in the workplace (Smith, 1998). When heated or cooled sufficiently, crystalline silica can transition between the polymorphic forms, with specific transitions occurring at different temperatures. At higher temperatures the linkages between the silica E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56296 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules tetrahedrons break and reform, resulting in new crystalline structures. Quartz converts to cristobalite at 1470 °C, and at 1723 °C cristobalite loses its crystalline structure and becomes amorphous fused silica. These high temperature transitions reverse themselves at extremely slow rates, with different forms co-existing for a long time after the crystal cools. Other types of transitions occur at lower temperatures when the silicaoxygen bonds in the silica tetrahedron rotate or stretch, resulting in a new crystalline structure. These lowtemperature, or alpha to beta, transitions are readily and rapidly reversed as the crystal cools. At temperatures encountered by workers, only the alpha form of crystalline silica exists (IARC, 1997). Crystalline silica minerals produce distinct X-ray diffraction patterns, specific to their crystalline structure. The patterns can be used to distinguish the crystalline polymorphs from each other and from amorphous silica (IARC, 1997). The specific gravity and melting point of silica vary between polymorphs. Silica is insoluble in water at 20 °C and in most acids, but its solubility increases with higher temperatures and pH, and it dissolves readily in hydrofluoric acid. Solubility is also affected by the presence of trace metals and by particle size. Under humid conditions water vapor in the air reacts with the surface of silica particles to form an external layer of silinols (SiOH). When these silinols are present the crystalline silica becomes more hydrophilic. Heating or acid washing reduces the amount of silinols on the surface area of crystalline silica particles. There is an external amorphous layer found in aged quartz, called the Beilby layer, which is not found on freshly cut quartz. This amorphous layer is more water soluble than the underlying crystalline core. Etching with hydrofluoric acid removes the Beilby layer as well as the principal metal impurities on quartz. Crystalline silica has limited chemical reactivity. It reacts with alkaline aqueous solutions, but does not readily react with most acids, with the exception of hydrofluoric acid. In contrast, amorphous silica and most silicates react with most mineral acids and alkaline solutions. Analytical chemists relied on this difference in acid reactivity to develop the silica point count analytical method that was widely used prior to the current X-ray diffraction and infrared methods (Madsen et al., 1995). VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Crystalline silica is used in industry in a wide variety of applications. Sand and gravel are used in road building and concrete construction. Sand with greater than 98% silica is used in the manufacture of glass and ceramics. Silica sand is used to form molds for metal castings in foundries, and in abrasive blasting operations. Silica is also used as a filler in plastics, rubber, and paint, and as an abrasive in soaps and scouring cleansers. Silica sand is used to filter impurities from municipal water and sewage treatment plants, and in hydraulic fracturing for oil and gas recovery. Silica is also used to manufacture artificial stone products used as bathroom and kitchen countertops, and the silica content in those products can exceed 93 percent (Kramer et al., 2012). There are over thirty major industries and operations where exposures to crystalline silica can occur. They include such diverse workplaces as foundries, dental laboratories, concrete products and paint and coating manufacture, as well as construction activities including masonry cutting, grinding and tuckpointing, operating heavy equipment, and road work. A more detailed discussion of the industries affected by the proposed standard is presented in Section VIII of this preamble. Crystalline silica exposures can also occur in mining, and in agriculture during plowing and harvesting. V. Health Effects Summary This section presents a summary of OSHA’s review of the health effects literature for respirable crystalline silica. OSHA’s full analysis is contained in Section I of the background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment,’’ which has been placed in rulemaking docket OSHA–2010–0034. OSHA’s review of the literature on the adverse effects associated with exposure to crystalline silica covers the following topics: (1) Silicosis (including relevant data from U.S. disease surveillance efforts); (2) Lung cancer and cancer at other sites; (3) Non-malignant respiratory disease (other than silicosis); (4) Renal and autoimmune effects; and (5) Physical factors affecting the toxicity of crystalline silica. The purpose of the Agency’s scientific review is to present OSHA’s preliminary findings on the nature of the hazards presented by exposure to respirable crystalline silica, and to present an PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 adequate basis for the quantitative risk assessment section to follow. OSHA’s review reflects the relevant literature identified by the Agency through previously published reviews, literature searches, and contact with outside experts. Most of the evidence that describes the health risks associated with exposure to silica consists of epidemiological studies of worker populations; in addition, animal and in vitro studies on mode of action and molecular toxicology are also described. OSHA’s review of the silicosis literature focused on a few particular issues, such as the factors that affect progression of the disease and the relationship between the appearance of radiological abnormalities indicative of silicosis and pulmonary function decline. Exposure to respirable crystalline silica is the only known cause of silicosis and there are literally thousands of research papers and case studies describing silicosis among working populations. OSHA did not review every one of these studies, because many of them do not relate to the issues that are of interest to OSHA. OSHA’s health effects literature review addresses exposure only to airborne respirable crystalline silica since there is no evidence that dermal or oral exposure presents a hazard to workers. This review is also confined to issues related to inhalation of respirable dust, which is generally defined as particles that are capable of reaching the gas-exchange region of the lung (i.e., particles less than 10 mm in aerodynamic diameter). The available studies include populations exposed to quartz or cristobalite, the two forms of crystalline silica most often encountered in the workplace. OSHA was unable to identify any relevant epidemiological literature concerning a third polymorph, tridymite, which is also currently regulated by OSHA and included in the scope of OSHA’s proposed crystalline silica standard. OSHA’s approach in this review is based on a weight-of-evidence approach, in which studies (both positive and negative) are evaluated for their overall quality, and causal inferences are drawn based on a determination of whether there is substantial evidence that exposure increases the risk of a particular effect. Factors considered in assessing the quality of studies include size of the cohort studied and power of the study to detect a sufficiently low level of disease risk; duration of follow-up of the study population; potential for study bias (such as selection bias in casecontrol studies or survivor effects in cross-sectional studies); and adequacy of underlying exposure information for E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules examining exposure-response relationships. Studies were deemed suitable for inclusion in OSHA’s Preliminary Quantitative Risk Assessment where there was adequate quantitative information on exposure and disease risks and the study was judged to be sufficiently high quality according to the criteria described above. The Preliminary Quantitative Risk Assessment is included in Section II of the background document and is summarized in Section VI of this preamble. A draft health effects review document was submitted for external scientific peer review in accordance with the Office of Management and Budget’s ‘‘Final Information Quality Bulletin for Peer Review’’ (OMB, 2004). A summary of OSHA’s responses to the peer reviewers’ comments appears in Section III of the background document. Since the draft health effects review document was submitted for external scientific peer review, new studies or reviews examining possible associations between occupational exposure to respirable crystalline silica and lung cancer have been published. OSHA’s analysis of that new information is presented in a supplemental literature review and is available in the docket (OSHA, 2013). mstockstill on DSK4VPTVN1PROD with PROPOSALS2 A. Silicosis and Disease Progression 1. Pathology and Diagnosis Silicosis is a progressive disease in which accumulation of respirable crystalline silica particles causes an inflammatory reaction in the lung, leading to lung damage and scarring, and, in some cases, progresses to complications resulting in disability and death. Three types of silicosis have been described: an acute form following intense exposure to respirable dust of high crystalline silica content for a relatively short period (i.e., a few months or years); an accelerated form, resulting from about 5 to 15 years of heavy exposure to respirable dusts of high crystalline silica content; and, most commonly, a chronic form that typically follows less intense exposure of usually more than 20 years (Becklake, 1994; Balaan and Banks, 1992). In both the accelerated and chronic form of the disease, lung inflammation leads to the formation of excess connective tissue, or fibrosis, in the lung. The hallmark of the chronic form of silicosis is the silicotic islet or nodule, one of the few agentspecific lesions in pathology (Balaan and Banks, 1992). As the disease progresses, these nodules, or fibrotic lesions, increase in density and can develop into large fibrotic masses, VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 resulting in progressive massive fibrosis (PMF). Once established, the fibrotic process of chronic silicosis is thought to be irreversible (Becklake, 1994), and there is no specific treatment for silicosis (Davis, 1996; Banks, 2005). Unlike chronic silicosis, the acute form of the disease almost certainly arises from exposures well in excess of current OSHA standards and presents a different pathological picture, one of pulmonary alveolar proteinosis. Chronic silicosis is the most frequently observed type of silicosis in the U.S. today. Affected workers may have a dry chronic cough, sputum production, shortness of breath, and reduced pulmonary function. These symptoms result from airway restriction and/or obstruction caused by the development of fibrotic scarring in the alveolar sacs and lower region of the lung. The scarring can be detected by chest x-ray or computerized tomography (CT) when the lesions become large enough to appear as visible opacities. The result is restriction of lung volumes and decreased pulmonary compliance with concomitant reduced gas transfer (Balaan and Banks, 1992). Early stages of chronic silicosis can be referred to as either simple or nodular silicosis; later stages are referred to as either pulmonary massive fibrosis (PMF), complicated, or advanced silicosis. The clinical diagnosis of silicosis has three requisites (Balaan and Banks, 1992; Banks, 2005). The first is the recognition by the physician that exposure to crystalline silica adequate to cause this disease has occurred. The second is the presence of chest radiographic abnormalities consistent with silicosis. The third is the absence of other illnesses that could resemble silicosis on chest radiograph, e.g., pulmonary fungal infection or miliary tuberculosis. To describe the presence and severity of silicosis from chest x-ray films or digital radiographic images, a standardized system exists to classify the opacities seen on chest radiographs (the International Labor Organization (ILO) International Classification of Radiographs of the Pneumoconioses (ILO, 1980, 2002, 2011; Merchant and Schwartz, 1998; NIOSH, 2011). This system standardizes the description of chest x-ray films or digital radiographic images with respect to the size, shape, and density of opacities, which together indicate the severity and extent of lung involvement. The density of opacities seen on chest x-ray films or digital radiographic images is classified on a 4point major category scale (0, 1, 2, or 3), with each major category divided into three subcategories, giving a 12-point scale between 0/0 and 3/+. (For each PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 56297 subcategory, the top number indicates the major category that the profusion most closely resembles, and the bottom number indicates the major category that was given secondary consideration.) Major category 0 indicates the absence of visible opacities and categories 1 to 3 reflect increasing profusion of opacities and a concomitant increase in severity of disease. Biopsy is not necessary to make a diagnosis and a diagnosis does not require that chest x-ray films or digital radiographic images be rated using the ILO system (NIOSH, 2002). In addition, an assessment of pulmonary function, though not itself necessary to confirm a diagnosis of silicosis, is important to evaluate whether the individual has impaired lung function. Although chest x-ray is typically used to examine workers exposed to respirable crystalline silica for the presence of silicosis, it is a fairly insensitive tool for detecting lung fibrosis (Hnizdo et al., 1993; Craighead and Vallyathan, 1980; Rosenman et al., 1997). To address the low sensitivity of chest x-rays for detecting silicosis, Hnizdo et al. (1993) recommended that radiographs consistent with an ILO category of 0/1 or greater be considered indicative of silicosis among workers exposed to a high concentration of silica-containing dust. In like manner, to maintain high specificity, chest x-rays classified as category 1/0 or 1/1 should be considered as a positive diagnosis of silicosis. Newer imaging technologies with both research and clinical applications include computed tomography, and high resolution tomography. Highresolution computed tomography (HRCT) uses thinner image slices and a different reconstruction algorithm to improve spatial resolution over CT. Recent studies of high-resolution computerized tomography (HRCT) have found HRCT to be superior to chest xray imaging for detecting small opacities and for identifying PMF (Sun et al., 2008; Lopes et al., 2008; Blum et al., 2008). The causal relationship between exposure to crystalline silica and silicosis has long been accepted in the scientific and medical communities. Of greater interest to OSHA is the quantitative relationship between exposure to crystalline silica and development of silicosis. A large number of cross-sectional and retrospective studies have been conducted to evaluate this relationship (Kreiss and Zhen, 1996; Love et al., 1999; Ng and Chan, 1994; Rosenman et al., 1996; Hughes et al., 1998; Muir et al., 1989a, 1989b; Park et al., 2002; Chen E:\FR\FM\12SEP2.SGM 12SEP2 56298 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 et al., 2001; Hnizdo and Sluis-Cremer, 1993; Miller et al., 1998; Buchanan et al., 2003; Steenland and Brown, 1995b). In general, these studies, particularly those that included retirees, have found a risk of radiological silicosis (usually defined as x-ray films classified ILO major category 1 or greater) among workers exposed near the range of cumulative exposure permitted by current exposure limits. These studies are presented in detail in OSHA’s Preliminary Quantitative Risk Assessment (Section II of the background document and summarized in Section VI of this preamble). 2. Silicosis in the United States Unlike most occupational diseases, surveillance statistics are available that provide information on the prevalence of silicosis mortality and morbidity in the U.S. The most comprehensive and current source of surveillance data in the U.S. related to occupational lung diseases, including silicosis, is the National Institute for Occupational Safety and Health (NIOSH) WorkRelated Lung Disease (WoRLD) Surveillance System; the WoRLD Surveillance Report is compiled from the most recent data from the WoRLD System (NIOSH, 2008c). National statistics on mortality associated with occupational lung diseases are also compiled in the National Occupational Respiratory Mortality System (NORMS, available on the Internet at http:// webappa.cdc.gov/ords/norms.html), a searchable database administered by NIOSH. In addition, NIOSH published a recent review of mortality statistics in its MMWR Report Silicosis Mortality, Prevention, and Control—United States, 1968–2002 (CDC, 2005). For each of these sources, data are compiled from death certificates reported to state vital statistics offices, which are collected by the National Center for Health Statistics (NCHS). Data on silicosis morbidity are available from only a few states that administer occupational disease surveillance systems, and from data on hospital discharges. OSHA believes that the mortality and morbidity statistics compiled in these sources and summarized below indicate that silicosis remains a significant occupational health problem in the U.S. today. From 1968 to 2002, silicosis was recorded as an underlying or contributing cause of death on 16,305 death certificates; of these, a total of 15,944 (98 percent) deaths occurred in males (CDC, 2005). From 1968 to 2002, the number of silicosis deaths decreased from 1,157 (8.91 per million persons aged ≥15 years) to 148 (0.66 per VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 million), corresponding to a 93-percent decline in the overall mortality rate. In its most recent WoRLD Report (NIOSH, 2008c), NIOSH reported that the number of silicosis deaths in 2003, 2004, and 2005 were 179, 166, and 161, respectively, slightly higher than that reported in 2002. The number of silicosis deaths identified each year has remained fairly constant since the late 1990’s. NIOSH cited two main factors that were likely responsible for the declining trend in silicosis mortality since 1968. First, many of the deaths in the early part of the study period occurred among persons whose main exposure to crystalline silica dust probably occurred before introduction of national standards for silica dust exposure established by OSHA and the Mine Safety and Health Administration (MSHA) (i.e., permissible exposure limits (PELs)) that likely led to reduced silica dust exposure. Second, there has been declining employment in heavy industries (e.g., foundries) where silica exposure was prevalent (CDC, 2005). Although the factors described by NIOSH are reasonable explanations for the steep reduction in silicosis-related mortality, it should be emphasized that the surveillance data are insufficient for the analysis of residual risk associated with current occupational exposure limits for crystalline silica. Analyses designed to explore this question must make use of appropriate exposureresponse data, as is presented in OSHA’s Preliminary Quantitative Risk Assessment (summarized in Section VI of this preamble). Although the number of deaths from silicosis overall has declined since 1968, the number of silicosis-associated deaths reported among persons aged 15 to 44 had not declined substantially prior to 1995 (CDC 1998). Unfortunately, it is not known to what extent these deaths among younger workers were caused by acute or accelerated forms of silicosis. Silicosis deaths among workers of all ages result in significant premature mortality; between 1996 and 2005, a total of 1,746 deaths resulted in a total of 20,234 years of life lost from life expectancy, with an average of 11.6 years of life lost. For the same period, among 307 decedents who died before age 65, or the end of a working life, there were 3,045 years of life lost to age 65, with an average of 9.9 years of life lost from a working life (NIOSH, 2008c). Data on the prevalence of silicosis morbidity are available from only three states (Michigan, Ohio, and New Jersey) that have administered disease surveillance programs over the past PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 several years. These programs rely primarily on hospital discharge records, reporting of cases from the medical community, workers’ compensation programs, and death certificate data. For the reporting period 1993–2002, the last year for which data are available, three states (Michigan, New Jersey and Ohio) recorded 879 cases of silicosis (NIOSH 2008c). Hospital discharge records represent the primary ascertainment source for all three states. It should be noted that hospital discharge records most likely include cases of acute silicosis or very advance chronic silicosis since it is unlikely that there would be a need for hospitalization in cases with early radiographic signs of silicosis, such as for an ILO category 1/0 x-ray. Nationwide hospital discharge data compiled by NIOSH (2008c) and the Council of State and Territorial Epidemiologists (CSTE, 2005) indicates that there are at least 1,000 hospitalizations each year due to silicosis. Data on silicosis mortality and morbidity are likely to understate the true impact of exposure of U.S. workers to crystalline silica. This is in part due to underreporting that is characteristic of passive case-based disease surveillance systems that rely on the health care community to generate records (Froines et al., 1989). Health care professionals play the main role in such surveillance by virtue of their unique role in recognizing and diagnosing diseases, but most health care professionals do not take occupational histories (Goldman and Peters, 1981; Rutstein et al., 1983). In addition to the lack of information about exposure histories, difficulty in recognizing occupational illnesses that have long latency periods, like silicosis, contributes to under-recognition and underreporting by health care providers. Based on an analysis of data from Michigan’s silicosis surveillance activities, Rosenman et al. (2003) estimated that the true incidence of silicosis mortality and morbidity were understated by a factor of between 2.5 and 5, and that there were estimated to be from 3,600 to 7,300 new cases of silicosis occurring in the U.S. annually between 1987 and 1996. Taken with the surveillance data presented above, OSHA believes that exposure to crystalline silica remains a cause of significant mortality and morbidity in the U.S. 3. Progression of Silicosis and Its Associated Impairment As described above, silicosis is a progressive lung disease that is usually first detected by the appearance of a E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules diffuse nodular fibrosis on chest x-ray films. To evaluate the clinical significance of radiographic signs of silicosis, OSHA reviewed several studies that have examined how exposure affects progression of the disease (as seen by chest radiography) as well as the relationship between radiologic findings and pulmonary function. The following summarizes OSHA’s preliminary findings from this review. Of the several studies reviewed by OSHA that documented silicosis progression in populations of workers, four studies (Hughes et al., 1982; Hessel et al., 1988; Miller et al., 1998; Ng et al., 1987a) included quantitative exposure data that were based on either current or historical measurements of respirable quartz. The exposure variable most strongly associated in these studies with progression of silicosis was cumulative respirable quartz (or silica) exposure (Hessel et al., 1988; Hughes et al., 1982; Miller et al., 1998; Ng et al., 1987a), though both average concentration of respirable silica (Hughes et al., 1982; Ng et al., 1987a) and duration of employment in dusty jobs have also been found to be associated with the progression of silicosis (Hughes et al., 1982; Ogawa et al., 2003). The study reflecting average exposures most similar to current exposure conditions is that of Miller et al. (1998), which followed a group of 547 British coal miners in 1990–1991 to evaluate chest x-ray changes that had occurred after the mines closed in 1981. This study had data available from chest x-rays taken during health surveys conducted between 1954 and 1978, as well as data from extensive exposure monitoring conducted between 1964 and 1978. The mean and maximum cumulative exposure reported in the study correspond to average concentrations of 0.12 and 0.55 mg/m3, respectively, over the 15-year sampling period. However, between 1971 and 1976, workers experienced unusually high concentrations of respirable quartz in one of the two coal seams in which the miners worked. For some occupations, quarterly mean quartz concentrations ranged from 1 to 3 mg/ m3, and for a brief period, concentrations exceeded 10 mg/m3 for one job. Some of these high exposures likely contributed to the extent of disease progression seen in these workers; in its Preliminary Quantitative Risk Assessment, OSHA reviewed a study by Buchanan et al. (2003), who found that short-term exposures to high (>2 mg/m3) concentrations of silica can increase the silicosis risk by 3-fold over VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 what would be predicted by cumulative exposure alone (see Section VI). Among the 504 workers whose last chest x-ray was classified as ILO 0/0 or 0/1, 20 percent had experienced onset of silicosis (i.e., chest x-ray was classified as ILO 1/0 by the time of follow up in 1990–1991), and 4.8 percent progressed to at least category 2. However, there are no data available to continue following the progression of this group because there have been no follow-up surveys of this cohort since 1991. In three other studies examining the progression of silicosis, (Hessel et al., 1988; Hughes et al., 1982; Ng et al., 1987a) cohorts were comprised of silicotics (individuals already diagnosed with silicosis) that were followed further to evaluate disease progression. These studies reflect exposures of workers to generally higher average concentrations of respirable quartz than are permitted by OSHA’s current exposure limit. Some general findings from this body of literature follow. First, size of opacities on initial radiograph is a determinant for further progression. Individuals with large opacities on initial chest radiograph have a higher probability of further disease progression than those with small opacities (Hughes et al., 1982; Lee, et al., 2001; Ogawa et al., 2003). Second, although silicotics who continue to be exposed are more likely to progress than silicotics who are not exposed (Hessel et al., 1988), once silicosis has been detected there remains a likelihood of progression in the absence of additional exposure to silica (Hessel et al., 1988; Miller et al., 1998; Ogawa, et al., 2003; Yang et al., 2006). There is some evidence in the literature that the probability of progression is likely to decline over time following the end of the exposure, although this observation may also reflect a survivor effect (Hughes et al., 1982; Lee et al., 2001). In addition, of borderline statistical significance was the association of tuberculosis with increased likelihood of silicosis progression (Lee et al., 2001). Of the four studies reviewed by OSHA that provided quantitative exposure information, two studies (Miller et al., 1998; Ng et al., 1987a) provide the information most relevant to current exposure conditions. The range of average concentration of respirable crystalline silica to which workers were exposed in these studies (0.12 to 0.48 mg/m3, respectively) is relatively narrow and is of particular interest to OSHA because current enforcement data indicate that exposures in this range or not much lower are common today, especially in construction and foundries, and sandblasting operations. PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 56299 These studies reported the percentage of workers whose chest x-rays show signs of progression at the time of follow-up; the annual rate at which workers showed disease progression were similar, 2 percent and 6 percent, respectively. Several cross-sectional and longitudinal studies have examined the relationship between progressive changes observed on radiographs and corresponding declines in lung-function parameters. In general, the results are mixed: some studies have found that pulmonary function losses correlate with the extent of fibrosis seen on chest x-ray films, and others have not found such correlations. The lack of a correlation in some studies between degree of fibrotic profusion seen on chest x-rays and pulmonary function have led some to suggest that pulmonary function loss is an independent effect of exposure to respirable crystalline silica, or may be a consequence of emphysematous changes that have been seen in conjunction with radiographic silicosis. Among studies that have reported finding a relationship between pulmonary function and x-ray abnormalities, Ng and Chan (1992) found that forced expiratory volume (FEV1) and forced vital capacity (FVC) were statistically significantly lower for workers whose x-ray films were classified as ILO profusion categories 2 and 3, but not among workers with ILO category 1 profusion compared to those with a profusion score of 0/0. As expected, highly significant reductions in FEV1, FVC, and FEV1/FVC were noted in subjects with large opacities. The authors concluded that chronic simple silicosis, except that classified as profusion category 1, is associated with significant lung function impairment attributable to fibrotic disease. Similarly, Moore et al. (1988) also found chronic silicosis to be associated with significant lung function loss, especially among workers with chest xrays classified as ILO profusion categories 2 and 3. For those classified as category 1, lung function was not ´ diminished. Begin et al. (1988) also found a correlation between decreased lung function (FVC and the ratio of FEV1/FVC) and increased profusion and coalescence of opacities as determined by CT scan. This study demonstrated increased impairment among workers with higher imaging categories (3 and 4), as expected, but also impairment (significantly reduced expiratory flow rates) among persons with more moderate pulmonary fibrosis (group 2). In a population of gold miners, Cowie (1998) found that lung function E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56300 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules declined more rapidly in men with silicosis than those without. In addition to the 24 ml./yr. decrements expected due to aging, this study found an additional loss of 8 ml. of FEV1 per year would be expected from continued exposure to dust in the mines. An earlier cross-sectional study by these authors (Cowie and Mabena, 1991), which examined 1,197 black underground gold miners who had silicosis, found that silicosis (analyzed as a continuous variable based on chest x-ray film classification) was associated with reductions in FVC, FEV1, FEV1/ FVC, and carbon monoxide diffusing capacity (DLco), and these relationships persisted after controlling for duration and intensity of exposure and smoking. In contrast to these studies, other investigators have reported finding pulmonary function decrements in exposed workers independent of radiological evidence of silicosis. Hughes et al. (1982) studied a representative sample of 83 silicotic sandblasters, 61 of whom were followed for one to seven years. A multiple regression analysis showed that the annual reductions in FVC, FEV1 and DLco were related to average silica concentrations but not duration of exposure, smoking, stage of silicosis, or time from initial exposure. Ng et al. (1987b) found that, among male gemstone workers in Hong Kong with xrays classified as either Category 0 or 1, declines in FEV1 and FVC were not associated with radiographic category of silicosis after adjustment for years of employment. The authors concluded that there was an independent effect of respirable dust exposure on pulmonary function. In a population of 61 gold miners, Wiles et al. (1992) also found that radiographic silicosis was not associated with lung function decrements. In a re-analysis and followup of an earlier study, Hnizdo (1992) found that silicosis was not a significant predictor of lung function, except for FEV1 for non-smokers. Wang et al. (1997) observed that silica-exposed workers (both nonsmokers and smokers), even those without radiographic evidence of silicosis, had decreased spirometric parameters and diffusing capacity (DLco). Pulmonary function was further decreased in the presence of silicosis, even those with mild to moderate disease (ILO categories 1 and 2). The authors concluded that functional abnormalities precede radiographic changes of silicosis. A number of studies were conducted to examine the role of emphysematous changes in the presence of silicosis in reducing lung function; these have been VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 reviewed by Gamble et al. (2004), who concluded that there is little evidence that silicosis is related to development of emphysema in the absence of PMF. In addition, Gamble et al. (2004) found that, in general, studies found that the lung function of those with radiographic silicosis in ILO category 1 was indistinguishable from those in category 0, and that those in category 2 had small reductions in lung function relative to those with category 0 and little difference in the prevalence of emphysema. There were slightly greater decrements in lung function with category 3 and more significant reductions with progressive massive fibrosis. In studies for which information was available on both silicosis and emphysema, reduced lung function was more strongly related to emphysema than to silicosis. In conclusion, many studies reported finding an association between pulmonary function decrements and ILO category 2 or 3 background profusion of small opacities; this appears to be consistent with the histopathological view, in which individual fibrotic nodules conglomerate to form a massive fibrosis (Ng and Chan, 1992). Emphysema may also play a role in reducing lung function in workers with higher grades of silicosis. Pulmonary function decrements have not been reported in some studies among workers with silicosis scored as ILO category 1. However, a number of other studies have documented declines in pulmonary function in persons exposed to silica and whose radiograph readings are in the major ILO category 1 (i.e. 1/ 0, 1/1, 1/2), or even before changes were ´ seen on chest x-ray (Begin et al., 1988; Cowie, 1998; Cowie and Mabena, 1991; Ng et al., 1987a; Wang et al., 1997). It may also be that studies designed to relate x-ray findings with pulmonary function declines are further confounded by pulmonary function declines caused by chronic obstructive pulmonary disease (COPD) seen among silica-exposed workers absent radiological silicosis, as has been seen in many investigations of COPD. OSHA’s review of the literature on crystalline silica exposure and development of COPD appears in section II.D of the background document and is summarized in section V.D below. OSHA believes that the literature reviewed above demonstrates decreased lung function among workers with radiological evidence of silicosis consistent with an ILO classification of major category 2 or higher. Also, given the evidence of functional impairment PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 in some workers prior to radiological evidence of silicosis, and given the low sensitivity of radiography, particularly in detecting early silicosis, OSHA believes that exposure to silica impairs lung function in at least some individuals before silicosis can be detected on chest radiograph. 4. Pulmonary Tuberculosis As silicosis progresses, it may be complicated by severe mycobacterial infections, the most common of which is pulmonary tuberculosis (TB). Active tuberculosis infection is a wellrecognized complication of chronic silicosis, and such infections are known as silicotuberculosis (IARC, 1997; NIOSH, 2002). The risk of developing TB infection is higher in silicotics than non-silicotics (Balmes, 1990; Cowie, 1994; Hnizdo and Murray, 1998; Kleinschmidt and Churchyard, 1997; and Murray et al., 1996). There also is evidence that exposure to silica increases the risk for pulmonary tuberculosis independent of the presence of silicosis (Cowie, 1994; Hnizdo and Murray, 1998; teWaterNaude et al., 2006). In a summary of the literature on silicarelated disease mechanisms, Ding et al. (2002) noted that it is well documented that exposure to silica can lead to impaired cell-mediated immunity, increasing susceptibility to mycobacterial infection. Reduced numbers of T-cells, increased numbers of B-cells, and alterations of serum immunoglobulin levels have been observed in workers with silicosis. In addition, according to Ng and Chan (1991), silicosis and TB act synergistically to increase fibrotic scar tissue (leading to massive fibrosis) or to enhance susceptibility to active mycobacterial infection. Lung fibrosis is common to both diseases and both diseases decrease the ability of alveolar macrophages to aid in the clearance of dust or infectious particles. B. Carcinogenic Effects of Silica (Cancer of the Lung and Other Sites) OSHA conducted an independent review of the epidemiological literature on exposure to respirable crystalline silica and lung cancer, covering more than 30 occupational groups in over a dozen industrial sectors. In addition, OSHA reviewed a pooled case-control study, a large national death certificate study, two national cancer registry studies, and six meta-analyses. In all, OSHA’s review included approximately 60 primary epidemiological studies. Based on its review, OSHA preliminarily concludes that the human data summarized in this section E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules provides ample evidence that exposure to respirable crystalline silica increases the risk of lung cancer among workers. The strongest evidence comes from the worldwide cohort and case-control studies reporting excess lung cancer mortality among workers exposed to respirable crystalline silica dust as quartz in various industrial sectors, including the granite/stone quarrying and processing, industrial sand, mining, and pottery and ceramic industries, as well as to cristobalite in diatomaceous earth and refractory brick industries. The 10-cohort pooled case-control analysis by Steenland et al. (2001a) confirms these findings. A more recent clinic-based pooled case-control analysis of seven European countries by Cassidy et al. (2007) as well as two national death certificate registry studies (Pukkala et al., 2005 in Finland; Calvert et al., 2003 in the United States) support the findings from the cohort and case-control analysis. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 1. Overall and Industry Sector-Specific Findings Associations between exposure to respirable crystalline silica and lung cancer have been reported in worker populations from many different industrial sectors. IARC (1997) concluded that crystalline silica is a confirmed human carcinogen based largely on nine studies of cohorts in four industry sectors that IARC considered to be the least influenced by confounding factors (sectors included quarries and granite works, gold mining, ceramic/ pottery/refractory brick industries, and the diatomaceous earth industry). IARC (2012) recently reaffirmed that crystalline silica is a confirmed human carcinogen. NIOSH (2002) also determined that crystalline silica is a human carcinogen after evaluating updated literature. OSHA believes that the strongest evidence for carcinogenicity comes from studies in five industry sectors. These are: • Diatomaceous Earth Workers (Checkoway et al., 1993, 1996, 1997, and 1999; Seixas et al., 1997); • British Pottery Workers (Cherry et al., 1998; McDonald et al., 1995); • Vermont Granite Workers (Attfield and Costello, 2004; Graham et al., 2004; Costello and Graham, 1988; Davis et al., 1983); • North American Industrial Sand Workers (Hughes et al., 2001; McDonald et al., 2001, 2005; Rando et al., 2001; Sanderson et al., 2000; Steenland and Sanderson, 2001); and • British Coal Mining (Miller et al., 2007; Miller and MacCalman, 2009). VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 The studies above were all retrospective cohort or case-control studies that demonstrated positive, statistically significant exposureresponse relationships between exposure to crystalline silica and lung cancer mortality. Except for the British pottery studies, where exposureresponse trends were noted for average exposure only, lung cancer risk was found to be related to cumulative exposure. OSHA credits these studies because in general, they are of sufficient size and have adequate years of follow up, and have sufficient quantitative exposure data to reliably estimate exposures of cohort members. As part of their analyses, the authors of these studies also found positive exposureresponse relationships for silicosis, indicating that underlying estimates of worker exposures were not likely to be substantially misclassified. Furthermore, the authors of these studies addressed potential confounding due to other carcinogenic exposures through study design or data analysis. A series of studies of the diatomaceous earth industry (Checkoway et al., 1993, 1996, 1997, 1999) demonstrated positive exposureresponse trends between cristobalite exposures and lung cancer as well as non-malignant respiratory disease mortality (NMRD). Checkoway et al. (1993) developed a ‘‘semi-quantitative’’ cumulative exposure estimate that demonstrated a statistically significant positive exposure-response trend (p = 0.026) between duration of employment or cumulative exposure and lung cancer mortality. The quartile analysis showed a monotonic increase in lung cancer mortality, with the highest exposure quartile having a RR of 2.74 for lung cancer mortality. Checkoway et al. (1996) conducted a re-analysis to address criticisms of potential confounding due to asbestos and again demonstrated a positive exposure response risk gradient when controlling for asbestos exposure and other variables. Rice et al. (2001) conducted a re-analysis and quantitative risk assessment of the Checkoway et al. (1997) study, which OSHA has included as part of its assessment of lung cancer mortality risk (See Section II, Preliminary Quantitative Risk Assessment). In the British pottery industry, excess lung cancer risk was found to be associated with crystalline silica exposure among workers in a PMR study (McDonald et al., 1995) and in a cohort and nested case-control study (Cherry et al., 1998). In the PMR study, elevated PMRs for lung cancer were found after adjusting for potential PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 56301 confounding by asbestos exposure. In the study by Cherry et al., odds ratios for lung cancer mortality were statistically significantly elevated after adjusting for smoking. Odds ratios were related to average, but not cumulative, exposure to crystalline silica. The findings of the British pottery studies are supported by other studies within their industrial sector. Studies by Winter et al. (1990) of British pottery workers and by McLaughlin et al. (1992) both reported finding suggestive trends of increased lung cancer mortality with increasing exposure to respirable crystalline silica. Costello and Graham (1988) and Graham et al. (2004) in a follow-up study found that Vermont granite workers employed prior to 1930 had an excess risk of lung cancer, but lung cancer mortality among granite workers hired after 1940 (post-implementation of controls) was not elevated in the Costello and Graham (1988) study and was only somewhat elevated (not statistically significant) in the Graham et al. (2004) study. Graham et al. (2004) concluded that their results did not support a causal relationship between granite dust exposure and lung cancer mortality. Looking at the same population, Attfield and Costello (2004) developed a quantitative estimate of cumulative exposure (8 exposure categories) adapted from a job exposure matrix developed by Davis et al. (1983). They found a statistically significant trend with log-transformed cumulative exposure. Lung cancer mortality rose reasonably consistently through the first seven increasing exposure groups, but fell in the highest cumulative exposure group. With the highest exposure group omitted, a strong positive dose-response trend was found for both untransformed and log-transformed cumulative exposures. Attfield and Costello (2004) concluded that exposure to crystalline silica in the range of cumulative exposures typically experienced by contemporarily exposed workers causes an increased risk of lung cancer mortality. The authors explained that the highest exposure group would have included the most unreliable exposure estimates being reconstructed from exposures 20 years prior to study initiation when exposure estimation was less precise. Also, even though the highest exposure group consisted of only 15 percent of the study population, it had a disproportionate effect on dampening the exposure-response relationship. OSHA believes that the study by Attfield and Costello (2004) is of superior design in that it was a categorical analysis that used E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56302 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules quantitative estimates of exposure and evaluated lung cancer mortality rates by exposure group. In contrast, the findings by Graham et al. (2004) are based on a dichotomous comparison of risk among high- versus low-exposure groups, where date-of-hire before and after implementation of ventilation controls is used as a surrogate for exposure. Consequently, OSHA believes that the study by Attfield and Costello is the more convincing study, and is one of the studies used by OSHA for quantitative risk assessment of lung cancer mortality due to crystalline silica exposure. The conclusions of the Vermont granite worker study (Attfield and Costello, 2004) are supported by the findings in studies of workers in the U.S. crushed stone industry (Costello et al., 1995) and Danish stone industry ´ (Guenel et al., 1989a, 1989b). Costello et al. (1995) found a non-statistically significant increase in lung cancer mortality among limestone quarry workers and a statistically significant increased lung cancer mortality in granite quarry workers who worked 20 years or more since first exposure. ´ Guenel et al. (1989b), in a Danish cohort study, found statistically significant increases in lung cancer incidence among skilled stone workers and skilled granite stone cutters. A study of Finnish granite workers that initially showed increasing risk of lung cancer with increasing silica exposure, upon extended follow-up, did not show an association and is therefore considered a negative study (Toxichemica, Inc., 2004). Studies of two overlapping cohorts in the industrial sand industry (Hughes et al., 2001; McDonald et al., 2001, 2005; Rando et al., 2001; Sanderson et al., 2000; Steenland and Sanderson, 2001) reported comparable results. These studies found a statistically significantly increased risk of lung cancer mortality with increased cumulative exposure in both categorical and continuous analyses. McDonald et al. (2001) examined a cohort that entered the workforce, on average, a decade earlier than the cohorts that Steenland and Sanderson (2001) examined. The McDonald cohort, drawn from eight plants, had more years of exposure in the industry (19 versus 8.8 years). The Steenland and Sanderson (2001) cohort worked in 16 plants, 7 of which overlapped with the McDonald, et al. (2001) cohort. McDonald et al. (2001), Hughes et al. (2001), and Rando et al. (2001) had access to smoking histories, plant records, and exposure measurements that allowed for historical reconstruction and the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 development of a job exposure matrix. Steenland and Sanderson (2001) had limited access to plant facilities, less detailed historic exposure data, and used MSHA enforcement records for estimates of recent exposure. These studies (Hughes et al., 2001; McDonald et al., 2005; Steenland and Sanderson, 2001) show very similar exposure response patterns of increased lung cancer mortality with increased exposure. OSHA included the quantitative exposure-response analysis from the Hughes et al. (2001) study in its Preliminary Quantitative Risk Assessment (Section II). Brown and Rushton (2005a, 2005b) found no association between risk of lung cancer mortality and exposure to respirable crystalline silica among British industrial sand workers. However, the small sample size and number of years of follow-up limited the statistical power of the analysis. Additionally, as Steenland noted in a letter review (2005a), the cumulative exposures of workers in the Brown and Ruston (2005b) study were over 10 times lower than the cumulative exposures experienced by the cohorts in the pooled analysis that Steenland et al. (2001b) performed. The low exposures experienced by this cohort would have made detecting a positive association with lung cancer mortality even more difficult. Excess lung cancer mortality was reported in a large cohort study of British coal miners (Miller et al., 2007; Miller and MacCalman, 2009). These studies examined the mortality experience of 17,800 miners through the end of 2005. By that time, the cohort had accumulated 516,431 person years of observation (an average of 29 years per miner), with 10,698 deaths from all causes. Overall lung cancer mortality was elevated (SMR=115.7, 95% C.I. 104.8–127.7), and a positive exposureresponse relationship with crystalline silica exposure was determined from Cox regression after adjusting for smoking history. Three of the strengths of this study are the detailed timeexposure measurements of both quartz and total mine dust, detailed individual work histories, and individual smoking histories. For lung cancer, analyses based on the Cox regression provide strong evidence that, for these coal miners, quartz exposures were associated with increased lung cancer risk but that simultaneous exposures to coal dust did not cause increased lung cancer risk. Because of these strengths, OSHA included the quantitative analysis from this study in its Preliminary Quantitative Risk Assessment (Section II). PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 Studies of lung cancer mortality in metal ore mining populations reflect mixed results. Many of these mining studies were subject to confounding due to exposure to other potential carcinogens such as radon and arsenic. IARC (1997) noted that in only a few ore mining studies was confounding from other occupational carcinogens taken into account. IARC (1997) also noted that, where confounding was absent or accounted for in the analysis (gold miners in the U.S., tungsten miners in China, and zinc and lead miners in Sardinia, Italy), an association between silica exposure and lung cancer was absent. Many of the studies conducted since IARC’s (1997) review more strongly implicate crystalline silica as a human carcinogen. Pelucchi et al. (2006), in a meta-analysis of studies conducted since IARC’s (1997) review, reported statistically significantly elevated relative risks of lung cancer mortality in underground and surface miners in three cohort and four casecontrol studies (See Table I–15). Cassidy et al. (2007), in a pooled case-control analysis, showed a statistically significant increased risk of lung cancer mortality among miners (OR = 1.48). Cassidy et al. (2007) also demonstrated a clear linear trend of increasing odds ratios for lung cancer with increasing exposures. Among workers in Chinese tungsten and iron mines, mortality from lung cancer was not found to be statistically significantly increased (Chen et al., 1992; McLaughlin et al., 1992). In contrast, studies of Chinese tin miners found increased lung cancer mortality rates and positive exposure-response associations with increased silica exposure (Chen et al., 1992). Unfortunately, in many of these Chinese tin mines, there was potential confounding from arsenic exposure, which was highly correlated with exposure to crystalline silica (Chen and Chen, 2002; Chen et al., 2006). Two other studies (Carta et al. (2001) of Sardinian miners and stone quarrymen; Finkelstein (1998) primarily of Canadian miners) were limited to silicotics. The Sardinian study found a non-statistically significant association between crystalline silica exposure and lung cancer mortality but no apparent exposure-response trend with silica exposure. The authors attributed the increased lung cancer to increased radon exposure and smoking among cases as compared to controls. Finkelstein (1998) found a positive association between silica exposure and lung cancer. Gold mining has been extensively studied in the United States, South E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Africa, and Australia in four cohort and associated nested case-control studies, and in two separate case-control studies conducted in South Africa. As with metal ore mining, gold mining involves exposure to radon and other carcinogenic agents, which may confound the relationship between silica exposure and lung cancer. The U.S. gold miner study (Steenland and Brown, 1995a) did not find an increased risk of lung cancer, while the western Australian gold miner study (de Klerk and Musk, 1998) showed a SMR of 149 (95% CI 1.26–1.76) for lung cancer. Logistic regression analysis of the western Australian case control data showed that lung cancer mortality was statistically significantly associated with log cumulative silica exposure after adjusting for smoking and bronchitis. After additionally adjusting for silicosis, the relative risk remained elevated but was no longer statistically significant. The authors concluded that their findings showed statistically significantly increased lung cancer mortality in this cohort but that the increase in lung cancer mortality was restricted to silicotic members of the cohort. Four studies of gold miners were conducted in South Africa. Two case control studies (Hessel et al., 1986, 1990) reported no significant association between silica exposure and lung cancer, but these two studies may have underestimated risk, according to Hnizdo and Sluis-Cremer (1991). Two cohort studies (Reid and Sluis-Cremer, 1996; Hnizdo and Sluis-Cremer, 1991) and their associated nested case-control studies found elevated SMRs and odds ratios, respectively, for lung cancer. Reid and Sluis-Cremer (1996) attributed the increased mortality due to lung cancer and other non-malignant respiratory diseases to cohort members’ lifestyle choices (particularly smoking and alcohol consumption). However, OSHA notes that the study reported finding a positive, though not statistically significant, association between cumulative crystalline silica exposure and lung cancer, as well as statistically significant association with renal failure, COPD, and other respiratory diseases that have been implicated with silica exposure. In contrast, Hnizdo and Sluis-Cremer (1991) found a positive exposureresponse relationship between cumulative exposure and lung cancer mortality among South African gold miners after accounting for smoking. In a nested case-control study from the same cohort, Hnizdo et al. (1997) found a statistically significant increase in lung cancer mortality that was VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 associated with increased cumulative dust exposure and time spent underground. Of the studies examining silica and lung cancer among South African gold miners, these two studies were the least likely to have been affected by exposure misclassification, given their rigorous methodologies and exposure measurements. Although not conclusive in isolation, OSHA considers the mining study results, particularly the gold mining and the newer mining studies, as supporting evidence of a causal relationship between exposure to silica and lung cancer risk. OSHA has preliminarily determined that the results of the studies conducted in three industry sectors (foundry, silicon carbide, and construction sectors) were confounded by the presence of exposures to other carcinogens. Exposure data from these studies were not sufficient to distinguish between exposure to silica dust and exposure to other occupational carcinogens. Thus, elevated rates of lung cancer found in these industries could not be attributed to silica. IARC previously made a similar determination in reference to the foundry industry. However, with respect to the construction industry, Cassidy et al. (2007), in a large, European community-based casecontrol study, reported finding a clear linear trend of increasing odds ratio with increasing cumulative exposure to crystalline silica (estimated semiquantitatively) after adjusting for smoking and exposure to insulation and wood dusts. Similar trends were found for workers in the manufacturing and mining industries as well. This study was a very large multi-national study that utilized information on smoking histories and exposure to silica and other occupational carcinogens. OSHA believes that this study provides further evidence that exposure to crystalline silica increases the risk of lung cancer mortality and, in particular, in the construction industry. In addition, a recent analysis of 4.8 million death certificates from 27 states within the U.S. for the years 1982 to 1995 showed statistically significant excesses in lung cancer mortality, silicosis mortality, tuberculosis, and NMRD among persons with occupations involving medium and high exposure to respirable crystalline silica (Calvert et al., 2003). A national records and death certificate study was also conducted in Finland by Pukkala et al. (2005), who found a statistically significant excess of lung cancer incidence among men and women with estimated medium and heavy exposures. OSHA believes that these large national death certificate PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 56303 studies and the pooled European community-based case-control study are strongly supportive of the previously reviewed epidemiologic data and supports the conclusion that occupational exposure to crystalline silica is a risk factor for lung cancer mortality. One of the more compelling studies evaluated by OSHA is the pooled analysis of 10 occupational cohorts (5 mines and 5 industrial facilities) conducted by Steenland et al. (2001a), which demonstrated an overall positive exposure-response relationship between cumulative exposure to silica and lung cancer mortality. These ten cohorts included 65,980 workers and 1,072 lung cancer deaths, and were selected because of the availability of raw data on exposure to crystalline silica and health outcomes. The investigators used a nested case control design and found lung cancer risk increased with increasing cumulative exposure, log cumulative exposure, and average exposure. Exposure-response trends were similar between mining and nonmining cohorts. From their analysis, the authors concluded that ‘‘[d]espite this relatively shallow exposure–response trend, overall our results tend to support the recent conclusion by IARC (1997) that inhaled crystalline silica in occupational settings is a human carcinogen, and suggest that existing permissible exposure limits for silica need to be lowered (Steenland et al., 2001a). To evaluate the potential effect of random and systematic errors in the underlying exposure data from these 10 cohort studies, Steenland and Bartell (Toxichemica, Inc., 2004) conducted a series of sensitivity analyses at OSHA’s request. OSHA’s Preliminary Quantitative Risk Assessment (Section II) presents additional information on the Steenland et al. (2001a) pooled cohort study and the sensitivity analysis performed by Steenland and Bartell (Toxichemica, Inc., 2004). 2. Smoking, Silica Exposure, and Lung Cancer Smoking is known to be a major risk factor for lung cancer. However, OSHA believes it is unlikely that smoking explains the observed exposureresponse trends in the studies described above, particularly the retrospective cohort or nested case-control studies of diatomaceous earth, British pottery, Vermont granite, British coal, South African gold, and industrial sand workers. Also, the positive associations between silica exposure and lung cancer in multiple studies in multiple sectors indicates that exposure to crystalline E:\FR\FM\12SEP2.SGM 12SEP2 56304 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 silica independently increases the risk of lung cancer. Studies by Hnizdo et al. (1997), McLaughlin et al. (1992), Hughes et al. (2001), McDonald et al. (2001, 2005), Miller and MacCalman (2009), and Cassidy et al. (2007) had detailed smoking histories with sufficiently large populations and a sufficient number of years of follow-up time to quantify the interaction between crystalline silica exposure and cigarette smoking. In a cohort of white South African gold miners (Hnizdo and Sluis-Cremer, 1991) and in the follow-up nested case-control study (Hnizdo et al., 1997) found that the combined effect of exposure to respirable crystalline silica and smoking was greater than additive, suggesting a multiplicative effect. This synergy appeared to be greatest for miners with greater than 35 pack-years of smoking and higher cumulative exposure to silica. In the Chinese nested casecontrol studies reported by McLaughlin et al. (1992), cigarette smoking was associated with lung cancer, but control for smoking did not influence the association between silica and lung cancer in the mining and pottery cohorts studied. The studies of industrial sand workers by Hughes et al. (2001) and British coal workers by Miller and MacCalman (2009) found positive exposure-response trends after adjusting for smoking histories, as did Cassidy et al. (2007) in their community-based case-control study of exposed European workers. In reference to control of potential confounding by cigarette smoking in crystalline silica studies, Stayner (2007), in an invited journal commentary, stated: Of particular concern in occupational cohort studies is the difficulty in adequately controlling for confounding by cigarette smoking. Several of the cohort studies that adjusted for smoking have demonstrated an excess of lung cancer, although the control for smoking in many of these studies was less than optimal. The results of the article by Cassidy et al. presented in this journal appear to have been well controlled for smoking and other workplace exposures. It is quite implausible that residual confounding by smoking or other risk factors for lung cancer in this or other studies could explain the observed excess of lung cancer in the wide variety of populations and study designs that have been used. Also, it is generally considered very unlikely that confounding by smoking could explain the positive exposureresponse relationships observed in these studies, which largely rely on comparisons between workers with similar socioeconomic backgrounds. Given the findings of investigators who have accounted for the impact of smoking, the weight of the evidence VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 reviewed here implicates respirable crystalline silica as an independent risk factor for lung cancer mortality. This finding is further supported by animal studies demonstrating that exposure to silica alone can cause lung cancer (e.g., Muhle et al., 1995). 3. Silicosis and Lung Cancer Risk In general, studies of workers with silicosis, as well as meta-analyses that include these studies, have shown that workers with radiologic evidence of silicosis have higher lung cancer risk than those without radiologic abnormalities or mixed cohorts. Three meta-analyses attempted to look at the association of increasing ILO radiographic categories of silicosis with increasing lung cancer mortality. Two of these analyses (Kurihara and Wada, 2004; Tsuda et al., 1997) showed no association with increasing lung cancer mortality, while Lacasse et al. (2005) demonstrated a positive dose-response for lung cancer with increasing ILO radiographic category. A number of other studies, discussed above, found increased lung cancer risk among exposed workers absent radiological evidence of silicosis (Cassidy et al., 2007; Checkoway et al., 1999; Cherry et al., 1998; Hnizdo et al., 1997; McLaughlin et al., 1992). For example, the diatomaceous earth study by Checkoway et al. (1999) showed a statistically significant exposureresponse for lung cancer among nonsilicotics. Checkoway and Franzblau (2000), reviewing the international literature, found all epidemiological studies conducted to that date were insufficient to conclusively determine the role of silicosis in the etiology of lung cancer. OSHA preliminarily concludes that the more recent pooled and meta-analyses do not provide compelling evidence that silicosis is a necessary precursor to lung cancer. The analyses that do suggest an association between silicosis and lung cancer may simply reflect that more highly exposed individuals are at a higher risk for lung cancer. Animal and in vitro studies have demonstrated that the early steps in the proposed mechanistic pathways that lead to silicosis and lung cancer seem to share some common features. This has led some of these researchers to also suggest that silicosis is a prerequisite to lung cancer. Some have suggested that any increased lung cancer risk associated with silica may be a consequence of the inflammation (and concomitant oxidative stress) and increased epithelial cell proliferation associated with the development of silicosis. However, other researchers PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 have noted that other key factors and proposed mechanisms, such as direct damage to DNA by silica, inhibition of p53, loss of cell cycle regulation, stimulation of growth factors, and production of oncogenes, may also be involved in carcinogenesis induced by silica (see Section II.F of the background document for more information on these studies). Thus, OSHA preliminarily concludes that available animal and in vitro studies do not support the hypothesis that development of silicosis is necessary for silica exposure to cause lung cancer. 4. Relationship Between Silica Polymorphs and Lung Cancer Risk OSHA’s current PELs for respirable crystalline silica reflects a once-held belief that cristobalite is more toxic than quartz (i.e., the existing general industry PEL for cristobalite is one-half the general industry PEL for quartz). Available evidence indicates that this does not appear to be the case with respect to the carcinogenicity of crystalline silica. A comparison between cohorts having principally been exposed to cristobalite (the diatomaceous earth study and the Italian refractory brick study) with other well conducted studies of quartz-exposed cohorts suggests no difference in the toxicity of cristobalite versus quartz. The data indicates that the SMRs for lung cancer mortality among workers in the diatomaceous earth (SMR = 141) and refractory brick (SMR=151) cohort studies are within the range of the SMR point estimates of other cohort studies with principally quartz exposures (quartz exposure of Vermont granite workers yielding an SMR of 117; quartz and possible post-firing cristobalite exposure of British pottery workers yielding an SMR of 129; quartz exposure among industrial sand workers yielding SMRs of 129, (McDonald et al., 2001) and 160 (Steenland and Sanderson, 2001)). Also, the SMR point estimates for the diatomaceous earth and refractory brick studies are similar to, and fall within the 95 percent confidence interval of, the odds ratio (OR=1.37, 95% CI 1.14–1.65) of the recently conducted multi-center casecontrol study in Europe (Cassidy et al., 2007). OSHA believes that the current epidemiological literature provides little, if any, support for treating cristobalite as presenting a greater lung cancer risk than comparable exposure to respirable quartz. Furthermore, the weight of the available toxicological literature no longer supports the hypothesis that cristobalite has a higher toxicity than quartz, and quantitative E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules estimates of lung cancer risk do not suggest that cristobalite is more carcinogenic than quartz. (See Section I.F of the background document, Physical Factors that May Influence Toxicity of Crystalline Silica, for a fuller discussion of this issue.) OSHA preliminary concludes that respirable cristobalite and quartz dust have similar potencies for increasing lung cancer risk. Both IARC (1997) and NIOSH (2002) reached similar conclusions. 5. Cancers of Other Sites Respirable crystalline silica exposure has also been investigated as a potential risk factor for cancer at other sites such as the larynx, nasopharynx and the digestive system including the esophagus and stomach. Although many of these studies suggest an association between exposure to crystalline silica and an excess risk of cancer mortality, most are too limited in terms of size, study design, or potential for confounding to be conclusive. Other than for lung cancer, cancer mortality studies demonstrating a dose-response relationship are quite limited. In their silica hazard review, NIOSH (2002) concluded that, exclusive of the lung, an association has not been established between silica exposure and excess mortality from cancer at other sites. A brief summary of the relevant literature is presented below. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 a. Cancer of the Larynx and Nasopharynx Several studies, including three of the better-quality lung cancer studies (Checkoway et al., 1997; Davis et al., 1983; McDonald et al., 2001) suggest an association between exposure to crystalline silica and increased mortality from laryngeal cancer. However, the evidence for an association is not strong due to the small number of cases reported and lack of statistical significance of most of the findings. b. Gastric (Stomach) Cancer In their 2002 hazard review of respirable crystalline silica, NIOSH identified numerous epidemiological studies and reported statistically significant increases in death rates due to gastric or stomach cancer. OSHA preliminarily concurs with observations made previously by Cocco et al. (1996) and the NIOSH (2002) crystalline silica hazard review that the vast majority of epidemiology studies of silica and stomach cancer have not sufficiently adjusted for the effects of confounding factors or have not been sufficiently designed to assess a dose-response relationship (e.g., Finkelstein and VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Verma, 2005; Moshammer and Neuberger, 2004; Selikoff, 1978, Stern et al., 2001). Other studies did not demonstrate a statistically significant dose-response relationship (e.g., Calvert et al., 2003; Tsuda et al., 2001). Therefore, OSHA believes the evidence is insufficient to conclude that silica is a gastric carcinogen. c. Esophageal Cancer Three well-conducted nested casecontrol studies of Chinese workers indicated an increased risk of esophageal cancer mortality attributed by the study’s authors to respirable crystalline silica exposure in refractory brick production, boiler repair, and foundry workers (Pan et al., 1999; Wernli et al., 2006) and caisson construction work (Yu et al., 2005). Each study demonstrated a doseresponse association with some surrogate measure of exposure, but confounding due to other occupational exposures is possible in all three work settings (heavy metal exposure in the repair of boilers in steel plants, PAH exposure in foundry workers, radon and radon daughter exposure in Hong Kong caisson workers). Other less wellconstructed studies also indicated elevated rates of esophageal cancer mortality with silica exposure (Tsuda et al., 2001; Xu et al., 1996a). In contrast, two large national mortality studies in Finland and the United States, using qualitatively ranked exposure estimates, did not show a positive association between silica exposure and esophageal cancer mortality (Calvert et al., 2003; Weiderpass et al., 2003). OSHA preliminarily concludes that the epidemiological literature is not sufficiently robust to attribute increased esophageal cancer mortality to exposure to respirable crystalline silica. d. Other Miscellaneous Cancers In 2002, NIOSH conducted a thorough literature review of the health effects potentially associated with crystalline silica exposure including a review of lung cancer and other carcinogens. NIOSH noted that for workers who may have been exposed to crystalline silica, there have been infrequent reports of statistically significant excesses of deaths for other cancers. A summary of these cancer studies as cited in NIOSH (2002) have been reported in the following organ systems (see NIOSH, 2002 for full bibliographic references): salivary gland; liver; bone; pancreatic; skin; lymphopoetic or hematopoietic; brain; and bladder. According to NIOSH (2002), an association has not been established PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 56305 between these cancers and exposure to crystalline silica. OSHA believes that these isolated reports of excess cancer mortality at these sites are not sufficient to draw any inferences about the role of silica exposure. The findings have not been consistently seen among epidemiological studies and there is no evidence of an exposure response relationship. C. Other Nonmalignant Respiratory Disease In addition to causing silicosis, exposure to crystalline silica has been associated with increased risks of other non-malignant respiratory diseases (NMRD), primarily chronic obstructive pulmonary disease (COPD). COPD is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases. In patients with COPD, either chronic bronchitis or emphysema may be present or both conditions may be present together. The following presents OSHA’s discussion of the literature describing the relationships between silica exposure and non-malignant respiratory disease. 1. Emphysema OSHA has considered a series of longitudinal studies of white South African gold miners conducted by Hnizdo and co-workers. Hnizdo et al. (1991) found a significant association between emphysema (both panacinar and centriacinar) and years of employment in a high dust occupation (respirable dust was estimated to contain 30 percent free silica). There was no such association found for nonsmokers, as there were only four nonsmokers with a significant degree of emphysema found in the cohort. A further study by Hnizdo et al. (1994) looked at only life-long non-smoking South African gold miners. In this population, no significant degree of emphysema or association with years of exposure or cumulative dust exposure was found. However, the degree of emphysema was significantly associated with the degree of hilar gland nodules, which the authors suggested might act as a surrogate for exposure to silica. The authors concluded that the minimal degree of emphysema seen in nonsmoking miners exposed to the cumulative dust levels found in this study (mean 6.8 mg/m3, SD 2.4, range 0.5 to 20.2, 30 percent crystalline silica) was unlikely to cause meaningful impairment of lung function. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56306 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules From the two studies above, Hnizdo et al. (1994) concluded that the statistically significant association between exposure to silica dust and the degree of emphysema in smokers suggests that tobacco smoking potentiates the effect of silica dust. In contrast to their previous studies, a later study by Hnizdo et al. (2000) of South African gold miners found that emphysema prevalence was decreased in relation to dust exposure. The authors suggested that selection bias was responsible for this finding. The findings of several cross-sectional and case-control studies were more mixed. Becklake et al. (1987), in an unmatched case-control study of white South African gold miners, determined that a miner who had worked in high dust for 20 years had a greater chance of getting emphysema than a miner who had never worked in high dust. A reanalysis of this data (de Beer et al., 1992) including added-back cases and controls (because of possible selection bias in the original study), still found an increased risk for emphysema, although the reported odds ratio was smaller than previously reported by Becklake et al. (1987). Begin et al. (1995), in a study of the prevalence of emphysema in silicaexposed workers with and without silicosis, found that silica-exposed smokers without silicosis had a higher prevalence of emphysema than a group of asbestos-exposed workers with similar smoking history. In nonsmokers, the prevalence of emphysema was much higher in those with silicosis than in those without silicosis. A study of black underground gold miners found that the presence and grade of emphysema were statistically significantly associated with the presence of silicosis but not with years of mining (Cowie et al., 1993). Several of the above studies (Becklake et al., 1987; Begin et al., 1995; Hnizdo et al., 1994) found that emphysema can occur in silica-exposed workers who do not have silicosis and suggest that a causal relationship may exist between exposure to silica and emphysema. The findings of experimental (animal) studies that emphysema occurs at lower silica doses than does fibrosis in the airways or the appearance of early silicotic nodules (e.g., Wright et al., 1988) tend to support the findings in human studies that silica-induced emphysema can occur absent signs of silicosis. Others have also concluded that there is a relationship between emphysema and exposure to crystalline silica. Green and Vallyathan (1996) reviewed several studies of emphysema in workers exposed to silica. The authors stated VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 that these studies show an association between cumulative dust exposure and death from emphysema. IARC (1997) has also briefly reviewed studies on emphysema in its monograph on crystalline silica carcinogenicity and concluded that exposure to crystalline silica increases the risk of emphysema. In their 2002 Hazard Review, NIOSH concluded that occupational exposure to respirable crystalline silica is associated with emphysema but that some epidemiologic studies suggested that this effect may be less frequent or absent in non-smokers. Hnizdo and Vallyathan (2003) also conducted a review of studies addressing COPD due to occupational silica exposure and concluded that chronic exposure to silica dust at levels that do not cause silicosis may cause emphysema. Based on these findings, OSHA preliminarily concludes that exposure to respirable crystalline silica or silicacontaining dust can increase the risk of emphysema, regardless of whether silicosis is present. This appears to be clearly the case for smokers. It is less clear whether nonsmokers exposed to silica would also be at higher risk and if so, at what levels of exposure. It is also possible that smoking potentiates the effect of silica dust in increasing emphysema risk. 2. Chronic Bronchitis There were no longitudinal studies available designed to investigate the relationship between silica exposure and bronchitis. However, several crosssectional studies provide useful information. Studies are about equally divided between those that have reported a relationship between silica exposure and bronchitis and those that have not. Several studies demonstrated a qualitative or semiquantitative relationship between silica exposure and chronic bronchitis. Sluis-Cremer et al. (1967) found a significant difference between the prevalence of chronic bronchitis in dust-exposed and non-dust exposed male residents of a South African gold mining town who smoked, but found no increased prevalence among non-smokers. In contrast, a different study of South African gold miners found that the prevalence of chronic bronchitis increased significantly with increasing dust concentration and cumulative dust exposure in smokers, nonsmokers, and ex-smokers (Wiles and Faure, 1977). Similarly, a study of Western Australia gold miners found that the prevalence of chronic bronchitis, as indicated by odds ratios (controlled for age and smoking), was significantly increased in those that PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 had worked in the mines for 1 to 9 years, 10 to 19 years, and more than 20 years, as compared to lifetime nonminers (Holman et al., 1987). Chronic bronchitis was present in 62 percent of black South African gold miners and 45 percent of those who had never smoked in a study by Cowie and Mabena (1991). The prevalence of what the researchers called ‘‘chronic bronchitic symptom complex’’ reflected the intensity of dust exposure. A higher prevalence of respiratory symptoms, independent of smoking and age, was also found for granite quarry workers in Singapore in a high exposure group as compared to low exposure and control groups, even after excluding those with silicosis from the analysis (Ng et al., 1992b). Other studies found no relationship between silica exposure and the prevalence of chronic bronchitis. Irwig and Rocks (1978) compared silicotic and non-silicotic South African gold miners and found no significant difference in symptoms of chronic bronchitis. The prevalence of symptoms of chronic bronchitis were also not found to be associated with years of mining, after adjusting for smoking, in a population of current underground uranium miners (Samet et al., 1984). Silica exposure was described in the study to be ‘‘on occasion’’ above the TLV. It was not possible to determine, however, whether miners with respiratory diseases had left the workforce, making the remaining population unrepresentative. Hard-rock (molybdenum) miners, with 27 and 49 percent of personal silica samples greater than 100 and 55 mg/m3, respectively, also showed no increase in prevalence of chronic bronchitis in association with work in that industry (Kreiss et al., 1989). However, the authors thought that differential outmigration of symptomatic miners and retired miners from the industry and town might explain that finding. Finally, grinders of agate stones (with resulting dust containing 70.4 percent silica) in India also had no increase in the prevalence of chronic bronchitis compared to controls matched by socioeconomic status, age and smoking, although there was a significantly higher prevalence of acute bronchitis in female grinders. A significantly higher prevalence and increasing trend with exposure duration for pneumoconiosis in the agate workers indicated that had an increased prevalence in chronic bronchitis been present, it would have been detected (Rastogi et al., 1991). However, control workers in this study may also have been exposed to silica and the study and control workers both E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules had high tuberculosis prevalence, possibly masking an association of exposure with bronchitis (NIOSH, 2002). Furthermore, exposure durations were very short. Thus, some prevalence studies supported a finding of increased bronchitis in workers exposed to silicacontaining dust, while other studies did not support such a finding. However, OSHA believes that many of the studies that did not find such a relationship were likely to be biased towards the null. For example, some of the molybdenum miners studied by Kreiss et al. (1989), particularly retired and symptomatic miners, may have left the town and the industry before the time that the cross-sectional study was conducted, resulting in a survivor effect that could have interfered with detection of a possible association between silica exposure and bronchitis. This survivor effect may also have been operating in the study of uranium miners in New Mexico (Samet et al., 1984). In two of the negative studies, members of comparison and control groups were also exposed to crystalline silica (Irwig and Rocks, 1978; Rastogi et al., 1991), creating a potential bias toward the null. Additionally, tuberculosis in both exposed and control groups in the agate worker study (Rastogi et al., 1991)) may have masked an effect (NIOSH, 2002), and the exposure durations were very short. Several of the positive studies demonstrated a qualitative or semiquantitative relationship between silica exposure and chronic bronchitis. Others have reviewed relevant studies and also concluded that there is a relationship between exposure to crystalline silica and the development of bronchitis. The American Thoracic Society (ATS) (1997) published an official statement on the adverse effects of crystalline silica exposure that included a section that discussed studies on chronic bronchitis (defined by chronic sputum production). According to the ATS review, chronic bronchitis was found to be common among worker groups exposed to dusty environments contaminated with silica. In support of this conclusion, ATS cited studies with what they viewed as positive findings of South African (Hnizdo et al., 1990) and Australian (Holman et al., 1987) gold miners, Indonesian granite workers (Ng et al., 1992b), and Indian agate workers (Rastogi et al., 1991). ATS did not mention studies with negative findings. A review published by NIOSH in 2002 discussed studies related to silica exposure and development of chronic bronchitis. NIOSH concluded, based on VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the same studies reviewed by OSHA, that occupational exposure to respirable crystalline silica is associated with bronchitis, but that some epidemiologic studies suggested that this effect may be less frequent or absent in non-smokers. Hnizdo and Vallyathan (2003) also reviewed studies addressing COPD due to occupational silica exposure and concluded that chronic exposure to silica dust at levels that do not cause silicosis may cause chronic bronchitis. They based this conclusion on studies that they cited as showing that the prevalence of chronic bronchitis increases with intensity of exposure. The cited studies were also reviewed by OSHA (Cowie and Mabena, 1991; Holman et al., 1987; Kreiss et al., 1989; Sluis-Cremer et al., 1967; Wiles and Faure, 1977). OSHA preliminarily concludes that exposure to respirable crystalline silica may cause chronic bronchitis and an exposure-response relationship may exist. Smokers may be at increased risk as compared to non-smokers. Chronic bronchitis may occur in silica-exposed workers who do not have silicosis. 3. Pulmonary Function Impairment OSHA has reviewed numerous studies on the relationship of silica exposure to pulmonary function impairment as measured by spirometry. There were several longitudinal studies available. Two groups of researchers conducted longitudinal studies of lung function impairment in Vermont granite workers and reached opposite conclusions. Graham et al (1981, 1994) examined stone shed workers, who had the highest exposures to respirable crystalline silica (between 50 and 100 mg/m3), along with quarry workers (presumed to have lower exposure) and office workers (expected to have negligible exposure). The longitudinal losses of FVC and FEV1 were not correlated with years employed, did not differ among shed, quarry, and office workers, and were similar, according to the authors, to other blue collar workers not exposed to occupational dust. Eisen et al. (1983, 1995) found the opposite. They looked at lung function in two groups of granite workers: ‘‘survivors’’, who participated in each of five annual physical exams, and ‘‘dropouts’’, who did not participate in the final exam. There was a significant exposure-response relationship between exposure to crystalline silica and FEV1 decline among the dropouts but not among the survivors. The dropout group had a steeper FEV1 loss, and this was true for each smoking category. The authors concluded that exposures of about 50 ug/m3 produced a measurable PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 56307 effect on pulmonary function in the dropouts. Eisen et al. (1995) felt that the ‘‘healthy worker effect’’ was apparent in this study and that studies that only looked at ‘‘survivors’’ would be less likely to see any effect of silica on pulmonary function. A 12-year follow-up of age- and smoking-matched granite crushers and referents in Sweden found that over the follow-up period, the granite crushers had significantly greater decreases in FEV1, FEV1/FVC, maximum expiratory flow, and FEF50 than the referents (Malmberg et al., 1993). A longitudinal study of South African gold miners conducted by Hnizdo (1992) found that cumulative dust exposure was a significant predictor of most indices of decreases in lung function, including FEV1 and FVC. A multiple linear regression analysis showed that the effects of silica exposure and smoking were additive. Another study of South African gold miners (Cowie, 1998) also found a loss of FEV1 in those without silicosis. Finally, a study of U.S. automotive foundry workers (Hertzberg et al., 2002) found a consistent association with increased pulmonary function abnormalities and estimated measures of cumulative silica exposure within 0.1 mg/m3. The Hnizdo (1992), Cowie et al. (1993), and Cowie (1998) studies of South African gold miners and the Malmberg et al. (1993) study of Swedish granite workers found very similar reductions in FEV1 attributable to silica dust exposure. A number of prevalence studies have described relationships between lung function loss and silica exposure or exposure measurement surrogates (e.g., duration of exposure). These findings support those of the longitudinal studies. Such results have been found in studies of white South African gold miners (Hnizdo et al., 1990; Irwig and Rocks, 1978), black South African gold miners (Cowie and Mabena, 1991), Quebec silica-exposed workers (Begin, et al., 1995), Singapore rock drilling and crushing workers (Ng et al., 1992b), Vermont granite shed workers (Theriault et al., 1974a, 1974b), aggregate quarry workers and coal miners in Spain (Montes et al., 2004a, 2004b), concrete workers in The Netherlands (Meijer et al., 2001), Chinese refractory brick manufacturing workers in an iron-steel plant (Wang et al., 1997), Chinese gemstone workers (Ng et al., 1987b), hard-rock miners in Manitoba, Canada (Manfreda et al., 1982) and Colorado (Kreiss et al., 1989), pottery workers in France (Neukirch et al., 1994), potato sorters exposed to diatomaceous earth containing crystalline silica in The Netherlands E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56308 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules (Jorna et al., 1994), slate workers in Norway (Suhr et al., 2003), and men in a Norwegian community (Humerfelt et al., 1998). Two of these prevalence studies also addressed the role of smoking in lung function impairment associated with silica exposure. In contrast to the longitudinal study of South African gold miners discussed above (Hnizdo, 1992), another study of South African gold miners (Hnizdo et al., 1990) found that the joint effect of dust and tobacco smoking on lung function impairment was synergistic, rather than additive. Also, Montes et al. (2004b) found that the criteria for dusttobacco interactions were satisfied for FEV1 decline in a study of Spanish aggregate quarry workers. One of the longitudinal studies and many of the prevalence studies discussed above directly addressed the question of whether silica-exposed workers can develop pulmonary function impairment in the absence of silicosis. These studies found that pulmonary function impairment: (1) Can occur in silica-exposed workers in the absence of silicosis, (2) was still evident when silicosis was controlled for in the analysis, and (3) was related to the magnitude and duration of silica exposure rather than to the presence or severity of silicosis. Many researchers have concluded that a relationship exists between exposure to silica and lung function impairment. IARC (1997) has briefly reviewed studies on airways disease (i.e., chronic airflow limitation and obstructive impairment of lung function) in its monograph on crystalline silica carcinogenicity and concluded that exposure to crystalline silica causes these effects. In its official statement on the adverse effects of crystalline silica exposure, the American Thoracic Society (ATS) (1997) included a section on airflow obstruction. The ATS noted that, in most of the studies reviewed, airflow limitation was associated with chronic bronchitis. The review of Hnizdo and Vallyathan (2003) also addressed COPD due to occupational silica exposure. They examined the epidemiological evidence for an exposure-response relationship for airflow obstruction in studies where silicosis was present or absent. Hnizdo and Vallyathan (2003) concluded that chronic exposure to silica dust at levels that do not cause silicosis may cause airflow obstruction. Based on the evidence discussed above from a number of longitudinal studies and numerous cross-sectional studies, OSHA preliminarily concludes that there is an exposure-response relationship between exposure to VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 respirable crystalline silica and the development of impaired lung function. The effect of tobacco smoking on this relationship may be additive or synergistic. Also, pulmonary function impairment has been shown to occur among silica-exposed workers who do not show signs of silicosis. 4. Non-malignant Respiratory Disease Mortality In this section, OSHA reviews studies on NMRD mortality that focused on causes of death other than from silicosis. Two studies of gold miners, a study of diatomaceous earth workers, and a case-control analysis of death certificate data provide useful information. Wyndham et al. (1986) found a significant excess mortality for chronic respiratory diseases in a cohort of white South African gold miners. Although these data did include silicosis mortality, the authors found evidence demonstrating that none of the miners certified on the death certificate as dying from silicosis actually died from that disease. Instead, pneumoconiosis was always an incidental finding in those dying from some other cause, the most common of which was chronic obstructive lung disease. A case-referent analysis found that, although the major risk factor for chronic respiratory disease was smoking, there was a statistically significant additional effect of cumulative dust exposure, with the relative risk estimated to be 2.48 per ten units of 1000 particle years of exposure. A synergistic effect of smoking and cumulative dust exposure on mortality from COPD was found in another study of white South African gold miners (Hnizdo, 1990). Analysis of various combinations of dust exposure and smoking found a trend in odds ratios that indicated this synergism. There was a statistically significant increasing trend for dust particle-years and for cigarette-years of smoking. For cumulative dust exposure, an exposureresponse relationship was found, with the analysis estimating that those with exposures of 10,000, 17,500, or 20,000 particle-years of exposure had a 2.5-, 5.06-, or 6.4-times higher mortality risk for COPD, respectively, than those with the lowest dust exposure of less than 5000 particle-years. The authors concluded that dust alone would not lead to increased COPD mortality but that dust and smoking act synergistically to cause COPD and were thus the main risk factor for death from COPD in their study. Park et al. (2002) analyzed the California diatomaceous earth cohort data originally studied by Checkoway et PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 al. (1997), consisting of 2,570 diatomaceous earth workers employed for 12 months or more from 1942 to 1994, to quantify the relationship between exposure to cristobalite and mortality from chronic lung disease other than cancer (LDOC). Diseases in this category included pneumoconiosis (which included silicosis), chronic bronchitis, and emphysema, but excluded pneumonia and other infectious diseases. Smoking information was available for about 50 percent of the cohort and for 22 of the 67 LDOC deaths available for analysis, permitting Park et al. (2002) to at least partially adjust for smoking. Using the exposure estimates developed for the cohort by Rice et al. (2001) in their exposure-response study of lung cancer risks, Park et al. (2002) evaluated the quantitative exposure-response relationship for LDOC mortality and found a strong positive relationship with exposure to respirable crystalline silica. OSHA finds this study particularly compelling because of the strengths of the study design and availability of smoking history data on part of the cohort and high-quality exposure and job history data; consequently, OSHA has included this study in its Preliminary Quantitative Risk Assessment. In a case-control analysis of death certificate data drawn from 27 U.S. states, Calvert et al. (2003) found increased mortality odds ratios among those in the medium and higher crystalline silica exposure categories, a significant trend of increased risk for COPD mortality with increasing silica exposures, and a significantly increased odds ratio for COPD mortality in silicotics as compared to those without silicosis. Green and Vallyathan (1996) also reviewed several studies of NMRD mortality in workers exposed to silica. The authors stated that these studies showed an association between cumulative dust exposure and death from the chronic respiratory diseases. Based on the evidence presented in the studies above, OSHA preliminarily concludes that respirable crystalline silica increases the risk for mortality from non-malignant respiratory disease (not including silicosis) in an exposurerelated manner. However, it appears that the risk is strongly influenced by smoking, and the effects of smoking and silica exposure may be synergistic. D. Renal and Autoimmune Effects In recent years, evidence has accumulated that suggests an association between exposure to crystalline silica and an increased risk E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules of renal disease. Over the past 10 years, epidemiologic studies have been conducted that provide evidence of exposure-response trends to support this association. There is also suggestive evidence that silica can increase the risk of rheumatoid arthritis and other autoimmune diseases (Steenland, 2005b). In fact, an autoimmune mechanism has been postulated for some silica-associated renal disease (Calvert et al., 1997). This section will discuss the evidence supporting an association of silica exposure with renal and autoimmune diseases. Overall, there is substantial evidence suggesting an association between exposure to crystalline silica and increased risks of renal and autoimmune diseases. In addition to a number of case reports, epidemiologic studies have found statistically significant associations between occupational exposure to silica dust and chronic renal disease (e.g., Calvert et al., 1997), subclinical renal changes (e.g., Ng et al., 1992c), end-stage renal disease morbidity (e.g., Steenland et al., 1990), chronic renal disease mortality (Steenland et al., 2001b, 2002a), and Wegener’s granulomatosis (Nuyts et al., 1995). In other findings, silica-exposed individuals, both with and without silicosis, had an increased prevalence of abnormal renal function (Hotz et al., 1995), and renal effects have been reported to persist after cessation of silica exposure (Ng et al., 1992c). Possible mechanisms suggested for silica-induced renal disease include a direct toxic effect on the kidney, deposition in the kidney of immune complexes (IgA) following silica-related pulmonary inflammation, or an autoimmune mechanism (Calvert et al., 1997; Gregorini et al., 1993). Several studies of exposed worker populations reported finding excess renal disease mortality and morbidity. Wyndham et al. (1986) reported finding excess mortality from acute and chronic nephritis among South African goldminers that had been followed for 9 years. Italian ceramic workers experienced an overall increase in the prevalence of end-stage renal disease (ESRD) cases compared to regional rates; the six cases that occurred among the workers had cumulative exposures to crystalline silica of between 0.2 and 3.8 mg/m3-years (Rapiti et al., 1999). Calvert et al. (1997) found an increased incidence of non-systemic ESRD cases among 2,412 South Dakota gold miners exposed to a median crystalline silica concentration of 0.09 mg/m3. In another study of South Dakota gold miners, Steenland and Brown (1995a) reported a positive trend VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 of chronic renal disease mortality risk and cumulative exposure to respirable crystalline silica, but most of the excess deaths were concentrated among workers hired before 1930 when exposures were likely higher than in more recent years. Excess renal disease mortality has also been described among North American industrial sand workers. McDonald et al., (2001, 2005) found that nephritis/nephrosis mortality was elevated overall among 2,670 industrial sand workers hired 20 or more years prior to follow-up, but there was no apparent relationship with either cumulative or average exposure to crystalline silica. However, Steenland et al. (2001b) did find that increased mortality from acute and chronic renal disease was related to increasing quartiles of cumulative exposure among a larger cohort of 4,626 industrial sand workers. In addition, they also found a positive trend for ESRD case incidence and quartiles of cumulative exposure. In a pooled cohort analysis, Steenland et al. (2002a) combined the industrial sand cohort from Steenland et al. (2001b), gold mining cohort from Steenland and Brown (1995a), and the Vermont granite cohort studies by Costello and Graham (1988). In all, the combined cohort consisted of 13,382 workers with exposure information available for 12,783. The exposure estimates were validated by the monotonically increasing exposureresponse trends seen in analyses of silicosis, since cumulative silica levels are known to predict silicosis risk. The mean duration of exposure, cumulative exposure, and concentration of respirable silica for the cohort were 13.6 years, 1.2 mg/m3-years, and 0.07 mg/m3, respectively. The analysis demonstrated statistically significant exposureresponse trends for acute and chronic renal disease mortality with quartiles of cumulative exposure to respirable crystalline silica. In a nested casecontrol study design, a positive exposure-response relationship was found across the three cohorts for both multiple-cause mortality (i.e., any mention of renal disease on the death certificate) and underlying cause mortality. Renal disease risk was most prevalent among workers with cumulative exposures of 0.5 mg/m3 or more (Steenland et al., 2002a). Other studies failed to find an excess renal disease risk among silica-exposed workers. Davis et al. (1983) found an elevated, but not a statistically significant increase, in mortality from diseases of the genitourinary system among Vermont granite shed workers. PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 56309 There was no observed relationship between mortality from this cause and cumulative exposure. A similar finding was reported by Koskela et al. (1987) among Finnish granite workers, where there were 4 deaths due to urinary tract disease compared to 1.8 expected. Both Carta et al. (1994) and Cocco et al. (1994) reported finding no increased mortality from urinary tract disease among workers in an Italian lead mine and a zinc mine. However, Cocco et al. (1994) commented that exposures to respirable crystalline silica were low, averaging 0.007 and 0.09 mg/m3 in the two mines, respectively, and that their study in particular had low statistical power to detect excess mortality. There are many case series, casecontrol, and cohort studies that provide support for a causal relationship between exposure to respirable crystalline silica and an increased renal disease risk (Kolev et al., 1970; Osorio et al., 1987; Steenland et al., 1990; Gregorini et al., 1993; Nuyts et al., 1995). In addition, a number of studies have demonstrated early clinical signs of renal dysfunction (i.e., urinary excretion of low- and high-molecular weight proteins and other markers of renal glomerular and tubular disruption) in workers exposed to crystalline silica, both with and without silicosis (Ng et al., 1992c; Hotz et al., 1995; Boujemaa, 1994; Rosenman et al., 2000). OSHA believes that there is substantial evidence on which to base a finding that exposure to respirable crystalline silica increases the risk of renal disease mortality and morbidity. In particular, OSHA believes that the 3cohort pooled analysis conducted by Steenland et al. (2002a) is particularly convincing. OSHA believes that the findings of this pooled analysis seem credible because the analysis involved a large number of workers from three cohorts with well-documented, validated job-exposure matrices and found a positive and monotonic increase in renal disease risk with increasing exposure for both underlying and multiple cause data. However, there are considerably less data, and thus the findings based on them are less robust, than what is available for silicosis mortality or lung cancer mortality. Nevertheless, OSHA preliminarily concludes that the underlying data are sufficient to provide useful estimates of risk and has included the Steenland et al. (2002a) analysis in its Preliminary Quantitative Risk Assessment. Several studies of different designs, including case series, cohort, registry linkage and case-control, conducted in a variety of exposed groups suggest an association between silica exposure and E:\FR\FM\12SEP2.SGM 12SEP2 56310 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules increased risk of systemic autoimmune disease (Parks et al., 1999). Studies have found that the most common autoimmune diseases associated with silica exposure are scleroderma (e.g., Sluis-Cremer et al., 1985); rheumatoid arthritis (e.g. Klockars et al., 1987; Rosenman and Zhu, 1995); and systemic lupus erythematosus (e.g., Brown et al., 1997). Mechanisms suggested for silicarelated autoimmune disease include an adjuvant effect of silica (Parks et al., 1999), activation of the immune system by the fibrogenic proteins and growth factors released as a result of the interaction of silica particles with macrophages (e.g., Haustein and Anderegg, 1998), and a direct local effect of non-respirable silica particles penetrating the skin and producing scleroderma (Green and Vallyathan, 1996). However, there are no quantitative exposure-response data available at this time on which to base a quantitative risk assessment for autoimmune diseases. Therefore, OSHA preliminarily concludes that there is substantial evidence that silica exposure increases the risks of renal and autoimmune disease. The positive and monotonic exposure-response trends demonstrated for silica exposure and renal disease risk more strongly suggest a causal link. The studies by Steenland et al. (2001b, 2002a) and Steenland and Brown (1995a) provide evidence of a positive exposure-response relationship. For autoimmune diseases, the available data did not provide an adequate basis for assessing exposure-response relationships. However, OSHA believes that the available exposure-response data on silica exposure and renal disease is sufficient to allow for quantitative estimates of risk. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 E. Physical Factors That May Influence Toxicity of Crystalline Silica Much research has been conducted to investigate the influence of various physical factors on the toxicologic potency of crystalline silica. Such factors examined include crystal polymorphism; the age of fractured surfaces of the crystal particle; the presence of impurities, particularly metals, on particle surfaces; and clay occlusion of the particle. These factors likely vary among different workplace settings suggesting that the risk to workers exposed to a given level of respirable crystalline silica may not be equivalent in different work environments. In this section, OSHA examines the research demonstrating the effects of these factors on the toxicologic potency of silica. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 The modification of surface characteristics by the physical factors noted above may alter the toxicity of silica by affecting the physical and biochemical pathways of the mechanistic process. Thus, OSHA has reviewed the proposed mechanisms by which silica exposure leads to silicosis and lung cancer. It has been proposed that silicosis results from a cycle of cell damage, oxidant generation, inflammation, scarring and fibrosis. A silica particle entering the lung can cause lung damage by two major mechanisms: direct damage to lung cells due to the silica particle’s unique surface properties or by the activation or stimulation of alveolar macrophages (after phagocytosis) and/or alveolar epithelial cells. In either case, an elevated production of reactive oxygen and nitrogen species (ROS/RNS) results in oxidant damage to lung cells. The oxidative stress and lung injury stimulates alveolar macrophages and/or alveolar epithelial cells to produce growth factors and fibrogenic mediators, resulting in fibroblast activation and pulmonary fibrosis. A continuous ingestion-reingestion cycle, with cell activation and death, is established. OSHA has examined evidence on the comparative toxicity of the silica polymorphs (quartz, cristobalite, and tridymite). A number of animal studies appear to suggest that cristobalite and tridymite are more toxic to the lung than quartz and more tumorigenic (e.g., King et al., 1953; Wagner et al., 1980). However, in contrast to these findings, several authors have reviewed the studies done in this area and concluded that cristobalite and tridymite are not more toxic than quartz (e.g., Bolsaitis and Wallace, 1996; Guthrie and Heaney, 1995). Furthermore, a difference in toxicity between cristobalite and quartz has not been observed in epidemiologic studies (tridymite has not been studied) (NIOSH, 2002). In an analysis of exposure-response for lung cancer, Steenland et al. (2001a) found similar exposure-response trends between cristobalite-exposed workers and other cohorts exposed to quartz. A number of studies have compared the toxicity of freshly fractured versus aged silica. Although animal studies have demonstrated that freshly fractured silica is more toxic than aged silica, aged silica still retains significant toxicity (Porter et al., 2002; Shoemaker et al., 1995; Vallyathan et al., 1995). Studies of workers exposed to freshly fractured silica have demonstrated that these workers exhibit the same cellular effects as seen in animals exposed to freshly fractured silica (Castranova et al., 1998; Goodman et al., 1992). There PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 have been no studies, however, comparing workers exposed to freshly fractured silica to those exposed to aged silica. Animal studies also suggest that pulmonary reactions of rats to shortduration exposure to freshly fractured silica mimic those seen in acute silicosis in humans (Vallyathan et al., 1995). Surface impurities, particularly metals, have been shown to alter silica toxicity. Iron, depending on its state and quantity, has been shown to either increase or decrease toxicity. Aluminum has been shown to decrease toxicity (Castranova et al., 1997; Donaldson and Borm, 1998; Fubini, 1998). Silica coated with aluminosilicate clay exhibits lower toxicity, possibly as a result of reduced bioavailability of the silica particle surface (Donaldson and Borm, 1998; Fubini, 1998). This reduced bioavailability may be due to aluminum ions left on the silica surface by the clay (Bruch et al., 2004; Cakmak et al., 2004; Fubini et al., 2004). Aluminum and other metal ions are thought to modify silanol groups on the silica surface, thus decreasing the membranolytic and cytotoxic potency and resulting in enhanced particle clearance from the lung before damage can take place (Fubini, 1998). An epidemiologic study found that the risk of silicosis was less in pottery workers than in tin and tungsten miners (Chen et al., 2005; Harrison et al., 2005), possibly reflecting that pottery workers were exposed to silica particles having less biologically available, non-clay-occluded surface area than was the case for miners. The authors concluded that clay occlusion of silica particles can be a factor in reducing disease risk. Although it is evident that a number of factors can act to mediate the toxicological potency of crystalline silica, it is not clear how such considerations should be taken into account to evaluate lung cancer and silicosis risks to exposed workers. After evaluating many in vitro studies that had been conducted to investigate the surface characteristics of crystalline silica particles and their influence on fibrogenic activity, NIOSH (2002) concluded that further research is needed to associate specific surface characteristics that can affect toxicity with specific occupational exposure situations and consequent health risks to workers. According to NIOSH (2002), such exposures may include work processes that produce freshly fractured silica surfaces or that involve quartz contaminated with trace elements such as iron. NIOSH called for further in vitro and in vivo studies of the toxicity and pathogenicity of alpha quartz compared with its polymorphs, quartz E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules contaminated with trace elements, and further research on the association of surface properties with specific work practices and health effects. In discussing the ‘‘considerable’’ heterogeneity shown across the 10 studies used in the pooled lung cancer risk analysis, Steenland et al. (2001a) pointed to hypotheses that physical differences in silica exposure (e.g., freshness of particle cleavage) between cohorts may be a partial explanation of observed differences in exposureresponse coefficients derived from those cohort studies. However, the authors did not have specific information on whether or how these factors might have actually influenced the observed differences. Similarly, in the pooled analysis and risk assessments for silicosis mortality conducted by Mannetje et al. (2002b), differences in biological activity of different types of silica dust could not be specifically taken into account. Mannetje et al. (2002b) determined that the exposureresponse relationship between silicosis and log-transformed cumulative exposure to crystalline silica was comparable between studies and no significant heterogeneity was found. The authors therefore concluded that their findings were relevant for different circumstances of occupational exposure to crystalline silica. Both the Steenland et al. (2001a) and Mannetje et al. (2002b) studies are discussed in detail in OSHA’s Preliminary Quantitative Risk Assessment (section II of the background document and summarized in section VI of this preamble). OSHA preliminarily concludes that there is considerable evidence to support the hypothesis that surface activity of crystalline silica particles plays an important role in producing disease, and that several environmental influences can modify surface activity to either enhance or diminish the toxicity of silica. However, OSHA believes that the available information is insufficient to determine in any quantitative way how these influences may affect disease risk to workers in any particular workplace setting. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VI. Summary of OSHA’s Preliminary Quantitative Risk Assessment A. Introduction The Occupational Safety and Health Act (OSH Act or Act) and some landmark court cases have led OSHA to rely on quantitative risk assessment, to the extent possible, to support the risk determinations required to set a permissible exposure limit (PEL) for a toxic substance in standards under the OSH Act. A determining factor in the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 decision to perform a quantitative risk assessment is the availability of suitable data for such an assessment. In the case of crystalline silica, there has been extensive research on its health effects, and several quantitative risk assessments have been published in the peer-reviewed scientific literature that describe the risk to exposed workers of lung cancer mortality, silicosis mortality and morbidity, non-malignant respiratory disease mortality, and renal disease mortality. These assessments were based on several studies of occupational cohorts in a variety of industry sectors, the underlying studies of which are described in OSHA’s review of the health effects literature (see section V of this preamble). In this section, OSHA summarizes its Preliminary Quantitative Risk Assessment (QRA) for crystalline silica, which is presented in Section II of the background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ (placed in Docket OSHA– 2010–0034). OSHA has done what it believes to be a comprehensive review of the literature to provide quantitative estimates of risk for crystalline silica-related diseases. Quantitative risk assessments for lung cancer and silicosis mortality were published after the International Agency for Research on Cancer (IARC) determined more than a decade ago that there was sufficient evidence to regard crystalline silica as a human carcinogen (IARC, 1997). This finding was based on several studies of worker cohorts demonstrating associations between exposure to crystalline silica and an increased risk of lung cancer. Although IARC judged the overall evidence as being sufficient to support this conclusion, IARC also noted that some studies of crystalline silica-exposed workers did not demonstrate an excess risk of lung cancer and that exposureresponse trends were not always consistent among studies that were able to describe such trends. These findings led Steenland et al. (2001a) and Mannetje et al. (2002b) to conduct comprehensive exposure-response analyses of the risk of lung cancer and silicosis mortality associated with exposure to crystalline silica. These studies, referred to as the IARC multicenter studies of lung cancer and silicosis mortality, relied on all available cohort data from previously published epidemiological studies for which there were adequate quantitative data on worker exposures to crystalline silica to derive pooled estimates of PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 56311 disease risk. In addition, OSHA identified four single-cohort studies of lung cancer mortality that it judged suitable for quantitative risk assessment; two of these cohorts (Attfield and Costello, 2004; Rice et al., 2001) were included among the 10 used in the IARC multi-center study and studies of two other cohorts appeared later (Hughes et al., 2001; McDonald et al., 2001, 2005; Miller and MacCalman, 2009). For nonmalignant respiratory disease mortality, in addition to the silicosis mortality study by Mannetje et al. (2002b), Park et al. (2002) conducted an exposureresponse analysis of non-malignant respiratory disease mortality (including silicosis and other chronic obstructive pulmonary diseases) among diatomaceous earth workers. Exposureresponse analyses for silicosis morbidity have been published in several singlecohort studies (Chen et al., 2005; Hnizdo and Sluis-Cremer, 1993; Steenland and Brown, 1995b; Miller et al., 1998; Buchanan et al., 2003). Finally, a quantitative assessment of end-stage renal disease mortality based on data from three worker cohorts was developed by Steenland et al. (2002a). In addition to these published studies, OSHA’s contractor, Toxichemica, Inc., commissioned Drs. Kyle Steenland and Scott Bartell of Emory University to perform an uncertainty analysis to examine the effect on lung cancer and silicosis mortality risk estimates of uncertainties that exist in the exposure assessments underlying the two IARC multi-center analyses (Toxichemica, Inc., 2004). OSHA’s Preliminary QRA presents estimates of the risk of silica-related diseases assuming exposure over a working life (45 years) to the proposed 8-hour time-weighted average (TWA) PEL and action level of 0.05 and 0.025 mg/m3, respectively, of respirable crystalline silica, as well as to OSHA’s current PELs. OSHA’s current general industry PEL for respirable quartz is expressed both in terms of a particle count formula and a gravimetric concentration formula, while the current construction and shipyard employment PELs for respirable quartz are only expressed in terms of a particle count formula. The current PELs limit exposure to respirable dust; the specific limit in any given instance depends on the concentration of crystalline silica in the dust. For quartz, the gravimetric general industry PEL approaches a limit of 0.1 mg/m3 as respirable quartz as the quartz content increases (see discussion in Section XVI of this preamble, Summary and Explanation for paragraph (c)). OSHA’s Preliminary QRA presents risk estimates for E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56312 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules exposure over a working lifetime to 0.1 mg/m3 to represent the risk associated with exposure to the current general industry PEL. OSHA’s current PEL for construction and shipyard employment is a formula PEL that limits exposure to respirable dust expressed as a respirable particle count concentration. As with the gravimetric general industry PEL, the limit varies depending on quartz content of the dust. There is no single mass concentration equivalent for the construction and shipyard PELs; OSHA’s Preliminary QRA reviews several studies that suggest that the current construction/shipyard PEL likely lies in the range between 0.25 and 0.5 mg/m3 respirable quartz, and OSHA presents risk estimates for this range of exposure to represent the risks associated with exposure to the current construction/shipyard PEL. In general industry, for both the gravimetric and particle count PELs, OSHA’s current PEL for cristobalite and tridymite are half the value for quartz. Thus, OSHA’s Preliminary QRA presents risk estimates associated with exposure over a working lifetime to 0.025, 0.05, 0.1, 0.25, and 0.5 mg/m3 respirable silica (corresponding to cumulative exposures over 45 years to 1.125, 2.25, 4.5, 11.25, and 22.5 mg/ m3-years). Risk estimates for lung cancer mortality, silicosis and non-malignant respiratory disease mortality, and renal disease mortality are presented in terms of lifetime (up to age 85) excess risk per 1,000 workers for exposure over an 8hour working day, 250 days per year, and a 45-year working life. For silicosis morbidity, OSHA based its risk estimates on cumulative risk models used by the various investigators to develop quantitative exposure-response relationships. These models characterized the risk of developing silicosis (as detected by chest radiography) up to the time that cohort members (including both active and retired workers) were last examined. Thus, risk estimates derived from these studies represent less-than-lifetime risks of developing radiographic silicosis. OSHA did not attempt to estimate lifetime risk (i.e., up to age 85) for silicosis morbidity because the relationships between age, time, and disease onset post-exposure have not been well characterized. A draft preliminary quantitative risk assessment document was submitted for external scientific peer review in accordance with the Office of Management and Budget’s ‘‘Final Information Quality Bulletin for Peer Review’’ (OMB, 2004). A summary of OSHA’s responses to the peer reviewers’ VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 comments appears in Section III of the background document. In the sections below, OSHA describes the studies and the published risk assessments it uses to estimate the occupational risk of crystalline silicarelated disease. (The Preliminary QRA itself also discusses several other available studies that OSHA does not include and OSHA’s reasons for not including these studies.) B. Lung Cancer Mortality 1. Summary of Studies In its Preliminary QRA, OSHA discusses risk assessments from six published studies that quantitatively analyzed exposure-response relationships for crystalline silica and lung cancer; some of these also provided estimates of risks associated with exposure to OSHA’s current PEL or NIOSH’s Recommended Exposure Limit (REL) of 0.05 mg/m3. These studies include: (1) A quantitative analysis by Steenland et al. (2001a) of worker cohort data pooled from ten studies; (2) an exposure-response analysis by Rice et al. (2001) of a cohort of diatomaceous earth workers primarily exposed to cristobalite; (3) an analysis by Attfield and Costello (2004) of U.S. granite workers; (4) a risk assessment by Kuempel et al. (2001), who employed a kinetic rat lung model to describe the relationship between quartz lung burden and cancer risk, then calibrated and validated that model using the diatomaceous earth worker and granite worker cohort mortality data; (5) an exposure-response analysis by Hughes et al., (2001) of U.S. industrial sand workers; and (6) a risk analysis by Miller et al. (2007) and Miller and MacCalman (2009) of British coal miners. These six studies are described briefly below and are followed by a summary of the lung cancer risk estimates derived from these studies. a. Steenland et al. (2001a) Pooled Cohort Analysis OSHA considers the lung cancer analysis conducted by Steenland et al. (2001a) to be of prime importance for risk estimation because of its size, incorporation of data from multiple cohorts, and availability of detailed exposure and job history data. Subsequent to its publication, Steenland and Bartell (Toxichemica, Inc., 2004) conducted a quantitative uncertainty analysis on the pooled data set to evaluate the potential impact on the risk estimates of random and systematic exposure misclassification, and Steenland (personal communication, PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 2010) conducted additional exposureresponse modeling. The original study consisted of a pooled exposure-response analysis and risk assessment based on raw data obtained from ten cohorts of silicaexposed workers (65,980 workers, 1,072 lung cancer deaths). Steenland et al. (2001a) initially identified 13 cohort studies as containing exposure information sufficient to develop a quantitative exposure assessment; the 10 studies included in the pooled analysis were those for which data on exposure and health outcome could be obtained for individual workers. The cohorts in the pooled analysis included U.S. gold miners (Steenland and Brown, 1995a), U.S. diatomaceous earth workers (Checkoway et al., 1997), Australian gold miners (de Klerk and Musk, 1998), Finnish granite workers (Koskela et al., 1994), U.S. industrial sand employees (Steenland and Sanderson, 2001), Vermont granite workers (Costello and Graham, 1988), South African gold miners (Hnizdo and Sluis-Cremer, 1991; Hnizdo et al., 1997), and Chinese pottery workers, tin miners, and tungsten miners (Chen et al., 1992). The exposure assessments developed for the pooled analysis are described by Mannetje et al. (2002a). The exposure information and measurement methods used to assess exposure from each of the 10 cohort studies varied by cohort and by time and included dust measurements representing particle counts, mass of total dust, and respirable dust mass. All exposure information was converted to units of mg/m3 respirable crystalline silica by generating cohort-specific conversion factors based on the silica content of the dust to which workers were exposed. A case-control study design was employed for which cases and controls were matched for race, sex, age (within 5 years) and study; 100 controls were matched to each case. To test the reasonableness of the cumulative exposure estimates for cohort members, Mannetje et al. (2002a) examined exposure-response relationships for silicosis mortality by performing a nested case-control analysis for silicosis or unspecified pneumoconiosis using conditional logistic regression. Each cohort was stratified into quartiles by cumulative exposure, and standardized rate ratios (SRR) for silicosis were calculated using the lowest-exposure quartile as the baseline. Odds ratios (OR) for silicosis were also calculated for the pooled data set overall, which was stratified into quintiles based on cumulative exposure. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules For the pooled data set, the relationship between odds ratio for silicosis mortality and increasing cumulative exposure was ‘‘positive and reasonably monotonic’’, ranging from 3.1 for the lowest quartile of exposure to 4.8 for the highest. In addition, in seven of the ten individual cohorts, there were statistically significant trends between silicosis mortality rate ratios (SRR) and cumulative exposure. For two of the cohorts (U.S. granite workers and U.S. gold miners), the trend test was not statistically significant (p=0.10). A trend analysis could not be performed on the South African gold miner cohort since silicosis was not coded as an underlying cause of death in that country. A more rigorous analysis of silicosis mortality on pooled data from six of these cohorts also showed a strong, statistically significant increasing trend with increasing decile of cumulative exposure (Mannetje et al., 2002b), providing additional evidence for the reasonableness of the exposure assessment used for the Steenland et al (2001a) lung cancer analysis. For the pooled lung cancer mortality analysis, Steenland et al. (2001a) conducted a nested case-control analysis via Cox regression, in which there were 100 controls chosen for each case randomly selected from among cohort members who survived past the age at which the case died, and matched on age (the time variable in Cox regression), study, race/ethnicity, sex, and date of birth within 5 years (which, in effect, matched on calendar time given the matching on age). Using alternative continuous exposure variables in a log-linear relative risk model (log RR=bx, where x represents the exposure variable and b the coefficient to be estimated), Steenland et al. (2001a) found that the use of either 1) cumulative exposure with a 15-year lag, 2) the log of cumulative exposure with a 15-year lag, or 3) average exposure resulted in positive statistically significant (p≤0.05) exposure-response coefficients. The models that provided the best fit to the data were those that used cumulative exposure and log-transformed cumulative exposure. The fit of the loglinear model with average exposure was clearly inferior to those using cumulative and log-cumulative exposure metrics. There was significant heterogeneity among studies (cohorts) using either cumulative exposure or average exposure. The authors suggested a number of possible reasons for such heterogeneity, including errors in measurement of high exposures (which tends to have strong influence on the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 exposure-response curve when untransformed exposure measures are used), the differential toxicity of silica depending on the crystalline polymorph, the presence of coatings or trace minerals that alter the reactivity of the crystal surfaces, and the age of the fractured surfaces. Models that used the log transform of cumulative exposure showed no statistically significant heterogeneity among cohorts (p=0.36), possibly because they are less influenced by very high exposures than models using untransformed cumulative exposure. For this reason, as well as the good fit of the model using logcumulative exposure, Steenland et al. (2001a) conducted much of their analysis using log-transformed cumulative exposure. The sensitivity analysis by Toxichemica, Inc. (2004) repeated this analysis after correcting some errors in the original coding of the data set. At OSHA’s request, Steenland (2010) also conducted a categorical analysis of the pooled data set and additional analyses using linear relative risk models (with and without logtransformation of cumulative exposure) as well as a 2-piece spline model. The cohort studies included in the pooled analysis relied in part on particle count data and the use of conversion factors to estimate exposures of workers to mass respirable quartz. A few studies were able to include at least some respirable mass sampling data. OSHA believes that uncertainty in the exposure assessments that underlie each of the 10 studies included in the pooled analysis is likely to represent one of the most important sources of uncertainty in the risk estimates. To evaluate the potential impact of uncertainties in the underlying exposure assessments on estimates of the risk, OSHA’s contractor, Toxichemica, Inc. (2004), commissioned Drs. Kyle Steenland and Scott Bartell of Emory University to conduct an uncertainty analysis using the raw data from the pooled cancer risk assessment. The uncertainty analysis employed a Monte Carlo technique in which two kinds of random exposure measurement error were considered; these were (1) random variation in respirable dust measurements and (2) random error in estimating respirable quartz exposures from historical data on particle count concentration, total dust mass concentration, and respirable dust mass concentration measurements. Based on the results of this uncertainty analysis, OSHA does not have reason to believe that random error in the underlying exposure estimates in the Steenland et al. (2001a) pooled cohort study of lung cancer is likely to have substantially PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 56313 influenced the original findings, although a few individual cohorts (particularly the South African and Australian gold miner cohorts) appeared to be sensitive to measurement errors. The sensitivity analysis also examined the potential effect of systematic bias in the use of conversion factors to estimate respirable crystalline silica exposures from historical data. Absent a priori reasons to suspect bias in a specific direction (with the possible exception of the South African cohort), Toxichemica, Inc. (2004) considered possible biases in either direction by assuming that exposure was underestimated by 100% (i.e., the true exposure was twice the estimated) or over-estimated by 100% (i.e., the true exposure was half the estimated) for any given cohort in the original pooled dataset. For the conditional logistic regression model using log cumulative exposure with a 15-year lag, doubling or halving the exposure for a specific study resulted in virtually no change in the exposure-response coefficient for that study or for the pooled analysis overall. Therefore, based on the results of the uncertainty analysis, OSHA believes that misclassification errors of a reasonable magnitude in the estimation of historical exposures for the 10 cohort studies were not likely to have substantially biased risk estimates derived from the exposure-response model used by Steenland et al. (2001a). b. Rice et al. (2001) Analysis of Diatomaceous Earth Workers Rice et al. (2001) applied a variety of exposure-response models to the same California diatomaceous earth cohort data originally reported on by Checkoway et al. (1993, 1996, 1997) and included in the pooled analysis conducted by Steenland et al. (2001a) described above. The cohort consisted of 2,342 white males employed for at least one year between 1942 and 1987 in a California diatomaceous earth mining and processing plant. The cohort was followed until 1994, and included 77 lung cancer deaths. Rice et al. (2001) relied on the dust exposure assessment developed by Seixas et al. (1997) from company records of over 6,000 samples collected from 1948 to 1988; cristobalite was the predominate form of crystalline silica to which the cohort was exposed. Analysis was based on both Poisson regression models Cox’s proportional hazards models with various functions of cumulative silica exposure in mg/m3years to estimate the relationship between silica exposure and lung cancer mortality rate. Rice et al. (2001) reported that exposure to crystalline silica was a significant predictor of lung cancer E:\FR\FM\12SEP2.SGM 12SEP2 56314 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 mortality for nearly all of the models employed, with the linear relative risk model providing the best fit to the data in the Poisson regression analysis. c. Attfield and Costello (2004) Analysis of Granite Workers Attfield and Costello (2004) analyzed the same U.S. granite cohort originally studied by Costello and Graham (1988) and Davis et al. (1983) and included in the Steenland et al. (2001a) pooled analysis, consisting of 5,414 male granite workers who were employed in the Vermont granite industry between 1950 and 1982 and who had received at least one chest x-ray from the surveillance program of the Vermont Department of Industrial Hygiene. Their 2004 report extended follow-up from 1982 to 1994, and found 201 deaths. Workers’ cumulative exposures were estimated by Davis et al. (1983) based on historical exposure data collected in six environmental surveys conducted between 1924 and 1977, plus work history information. Using Poisson regression models and seven cumulative exposure categories, the authors reported that the results of the categorical analysis showed a generally increasing trend of lung cancer rate ratios with increasing cumulative exposure, with seven lung cancer death rate ratios ranging from 1.18 to 2.6. A complication of this analysis was that the rate ratio for the highest exposure group in the analysis (cumulative exposures of 6.0 mg/m3years or higher) was substantially lower than those for other exposure groups. Attfield and Costello (2004) reported that the best-fitting model was based on a 15-year lag, use of untransformed cumulative exposure, and omission of the highest exposure group. The authors argued that it was appropriate to base their risk estimates on a model that was fitted without the highest exposure group for several reasons. They believed the underlying exposure data for the high-exposure group was weaker than for the others, and that there was a greater likelihood that competing causes of death and misdiagnoses of causes of death attenuated the lung cancer death rate. Second, all of the remaining groups comprised 85 percent of the deaths in the cohort and showed a strong linear increase in lung cancer mortality with increasing exposure. Third, Attfield and Costello (2004) believed that the exposure-response relationship seen in the lower exposure groups was more relevant given that the exposures of these groups were within the range of current occupational standards. Finally, the authors stated that risk estimates VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 derived from the model after excluding the highest exposure group were more consistent with other published risk estimates than was the case for estimates derived from the model using all exposure groups. Because of these reasons, OSHA believes it is appropriate to rely on the model employed by Attfield and Costello (2004) after omitting the highest exposure group. d. Kuempel et al. (2001) Rat-Based Model for Human Lung Cancer Kuempel et al. (2001) published a ratbased toxicokinetic/toxicodynamic model for silica exposure for predicting human lung cancer, based on lung burden concentrations necessary to cause the precursor events that can lead to adverse physiological effects in the lung. These adverse physiological effects can then lead to lung fibrosis and an indirect genotoxic cause of lung cancer. The hypothesized first step, or earliest expected response, in these disease processes is chronic lung inflammation, which the authors consider as a disease limiting step. Since the NOAEL of lung burden associated with this inflammation, based on the authors’ rat-to-human lung model conversion, is the equivalent of exposure to 0.036 mg/m3 (Mcrit) for 45 years, exposures below this level would presumably not lead to (based on an indirect genotoxic mechanism) lung cancer, at least in the ‘‘average individual.’’ Since silicosis also is inflammation mediated, this exposure could also be considered to be an average threshold level for that disease as well. Kuempel et al. (2001) have used their rat-based lung cancer model with human data, both to validate their model and to estimate the lung cancer risk as a function of quartz lung burden. First they ‘‘calibrated’’ human lung burdens from those in rats based on exposure estimates and lung autopsy reports of U.S. coal miners. Then they validated these lung burden estimates using quartz exposure data from U.K. coal miners. Using these human lung burden/exposure concentration equivalence relationships, they then converted the cumulative exposure-lung cancer response slope estimates from both the California diatomaceous earth workers (Rice et al., 2001) and Vermont granite workers (Attfield and Costello, 2001) to lung burden-lung cancer response slope estimates. Finally, they used these latter slope estimates in a life table program to estimate lung cancer risk associated with their ‘‘threshold’’ exposure of 0.036 mg/m3 and to the OSHA PEL and NIOSH REL. Comparing the estimates from the two PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 epidemiology studies with those based on a male rat chronic silica exposure study the authors found that, ’’ the lung cancer excess risk estimates based on male rat data are approximately three times higher than those based on the male human data.’’ Based on this modeling and validation exercise, Keumpel et al. concluded, ‘‘the ratbased estimates of excess lung cancer risk in humans exposed to crystalline silica are reasonably similar to those based on two human occupational epidemiology studies.’’ Toxichemica, Inc. (2004) investigated whether use of the dosimetry model would substantially affect the results of the pooled lung cancer data analysis initially conducted by Steenland et al. (2001a). They replicated the lung dosimetry model using Kuempel et al.’s (2001) reported median fit parameter values, and compared the relationship between log cumulative exposure and 15-year lagged lung burden at the age of death in case subjects selected for the pooled case-control analysis. The two dose metrics were found to be highly correlated (r=0.99), and models based on either log silica lung burden or log cumulative exposure were similarly good predictors of lung cancer risk in the pooled analysis (nearly identical log-likelihoods of –4843.96 and— 4843.996, respectively). OSHA believes that the Kuempel et al. (2001) analysis is a credible attempt to quantitatively describe the retention and accumulation of quartz in the lung, and to relate the external exposure and its associated lung burden to the inflammatory process. However, using the lung burden model to convert the cumulative exposure coefficients to a different exposure metric appears to add little additional information or insight to the risk assessments conducted on the diatomaceous earth and granite cohort studies. Therefore, for the purpose of quantitatively evaluating lung cancer risk in exposed workers, OSHA has chosen to rely on the epidemiology studies themselves and the cumulative exposure metrics used in those studies. e. Hughes et al. (2001), McDonald et al. (2001), and McDonald et al. (2005) Study of North American Industrial Sand Workers McDonald et al. (2001), Hughes et al. (2001) and McDonald et al. (2005) followed up on a cohort study of North American industrial sand workers that overlapped with the industrial sand cohort (18 plants, 4,626 workers) studied by Steenland and Sanderson (2001) and included in Steenland et al.’s (2001a) pooled cohort analysis. The McDonald et al. (2001) follow-up cohort E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules included 2,670 men employed before 1980 for three years or more in one of nine North American (8 U.S. and 1 Canadian) sand-producing plants, including 1 large associated office complex. Information on cause of death was obtained, from 1960 through 1994, for 99 percent of the deceased workers for a total 1,025 deaths representing 38 percent of the cohort. A nested casecontrol study and analysis based on 90 lung cancer deaths from this cohort was also conducted by Hughes et al. (2001). A later update through 2000, of both the cohort and nested case-control studies by McDonald et al. (2005), eliminated the Canadian plant, following 2,452 men from the eight U.S. plants. For the lung cancer case-control part of the study the update included 105 lung cancer deaths. Both the initial and updated case control studies used up to two controls per case. Although the cohort studies provided evidence of increased risk of lung cancer (SMR = 150, p = 0.001, based on U.S. rates) for deaths occurring 20 or more years from hire, the nested casecontrol studies, Hughes et al. (2001) and McDonald et al. (2005), allowed for individual job, exposure, and smoking histories to be taken into account in the exposure-response analysis for lung cancer. Both of these case-control analyses relied on an analysis of exposure information reported by Sanderson et al. (2000) and by Rando et al. (2001) to provide individual estimates of average and cumulative exposure. Statistically significant positive exposure-response trends for lung cancer were found for both cumulative exposure (lagged 15 years) and average exposure concentration, but not for duration of employment, after controlling for smoking. A monotonic increase was seen for both lagged and unlagged cumulative exposure when the four upper exposure categories were collapsed into two. With exposure lagged 15 years and after adjusting for smoking, increasing quartiles of cumulative silica exposure were associated with lung cancer mortality (odds ratios of 1.00, 0.84, 2.02 and 2.07, p-value for trend=0.04). There was no indication of an interaction effect of smoking and cumulative silica exposure (Hughes et al., 2001). OSHA considers this Hughes et al. (2001) study and analysis to be of high enough quality to provide risk estimates for excess lung cancer for silica exposure to industrial sand workers. Using the median cumulative exposure levels of 0, 0.758, 2.229 and 6.183 mg/ m3-years, Hughes et al. estimated lung cancer odds ratios, ORs (no. of deaths), for these categories of 1.00 (14), 0.84 VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 (15), 2.02 (31), and 2.07 (30), respectively, on a 15-year lag basis (pvalue for trend=0.04.) For the updated nested case control analysis, McDonald et al. (2005) found very similar results, with exposure lagged 15 years and, after adjusting for smoking, increasing quartiles of cumulative silica exposure were associated with lung cancer ORs (no. of deaths) of 1.00 (13), 0.94 (17), 2.24 (38), and 2.66 (37) (p-value for trend=0.006). Because the Hughes et al. (2001) report contained information that allowed OSHA to better calculate exposure-response estimates and because of otherwise very similar results in the two papers, OSHA has chosen to base its lifetime excess lung cancer risk estimate for these industrial sand workers on the Hughes et al. (2001) case-control study. Using the median exposure levels of 0, 0.758, 2.229 and 6.183 mg-years/m3, respectively, for each of the four categories described above, and using the model: ln OR = a + b × Cumulative Exposure, the coefficient for the exposure estimate was b = 0.13 per (mg/m3-years), with a standard error of b = 0.074 (calculated from the trend test p-value in the same paper). In this model, with background lung cancer risks of about 5 percent, the OR provides a suitable estimate of the relative risk. f. Miller et al. (2007) and Miller and MacCalman (2009) Study of British Coal Workers Exposed to Respirable Quartz Miller et al. (2007) and Miller and MacCalman (2009) continued a followup mortality study, begun in 1970, of 18,166 coalminers from 10 British coalmines initially followed through the end of 1992 (Miller et al., 1997). The two recent reports on mortality analyzed the cohort of 17,800 miners and extended the analysis through the end of 2005. By that time there were 516,431 person years of observation, an average of 29 years per miner, with 10,698 deaths from all causes. Causes of deaths of interest included pneumoconiosis, other non-malignant respiratory diseases (NMRD), lung cancer, stomach cancer, and tuberculosis. Three of the strengths of this study are its use of detailed time-exposure measurements of both quartz and total mine dust, detailed individual work histories, and individual smoking histories. However, the authors noted that no additional exposure measurements were included in the updated analysis, since all the mines had closed by the mid 1980’s. For this cohort mortality study there were analyses using both external (regional age-time and cause specific mortality rates) internal controls. For the analysis from external mortality PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 56315 rates, the all-cause mortality SMR from 1959 through 2005 was 100.9 (95% C.I., 99.0–102.8), based on all 10,698 deaths. However, these death ratios were not uniform over time. For the period from 1990 to 2005, the all-cause SMR was 109.6 (95% C.I., 106.5–112.8), while the ratios for previous periods were less than 100. This pattern of recent increasing SMRs was also seen in the recent cause-specific death rate for lung cancer, SMR=115.7 (95% C.I., 104.8– 127.7). For the analysis based on internal rates and using Cox regression methods, the relative risk for lung cancer risk based on a cumulative quartz exposure equivalent to approximately 0.055 mg/m3 for 45 years was RR = 1.14 (95% C.I., 1.04 to 1.25). This risk is adjusted for concurrent coal dust exposure and smoking status, and incorporated a 15-year lag in quartz exposures. The analysis showed a strong effect for smoking (independent of quartz exposure) on lung cancer. For lung cancer, OSHA believes that the analyses based on the Cox regression method provides strong evidence that for these coal miners’ quartz exposures were associated with increased lung cancer risk, but that simultaneous exposures to coal dust did not cause increased lung cancer risk. To estimate lung cancer risk from this study, OSHA estimated the regression slope for a loglinear relative risk model based on the Miller and MacCalman’s (2009) finding of a relative risk of 1.14 for a cumulative exposure of 0.055 mg/m3-years. 2. Summary of OSHA’s Estimates of Lung Cancer Mortality Risk Tables VI–1 and VI–2 summarize the excess lung cancer risk estimates from occupational exposure to crystalline silica, based on five of the six lung cancer risk assessments discussed above. OSHA’s estimates of lifetime excess lung cancer risk associated with 45 years of exposure to crystalline silica at 0.1 mg/m3 (approximately the current general industry PEL) range from 13 to 60 deaths per 1,000 workers. For exposure to the proposed PEL of 0.05 mg/m3, the lifetime risk estimates calculated by OSHA are in the range of 6 to 26 deaths per 1,000 workers. For a 45-year exposure at the proposed action level of 0.025 mg/m3, OSHA estimates the risk to range from 3 to 23 deaths per 1,000 workers. The results from these assessments are reasonably consistent despite the use of data from different cohorts and the reliance on different analytical techniques for evaluating dose-response relationships. Furthermore, OSHA notes that in this range of exposure, 0.025—0.1 mg/m3, there is statistical consistency between E:\FR\FM\12SEP2.SGM 12SEP2 56316 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules the risk estimates, as evidenced by the considerable overlap in the 95-percent confidence intervals of the risk estimates presented in Table VI–1. OSHA also estimates the lung cancer risk associated with 45 years of exposure to the current construction/ shipyard PEL (in the range of 0.25 to 0.5 mg/m3) to range from 37 to 653 deaths per 1,000 workers. Exposure to 0.25 or 0.5 mg/m3 over 45 years represents cumulative exposures of 11.25 and 22.5 mg-years/m3, respectively. This range of cumulative exposure is well above the median cumulative exposure for most of the cohorts used in the risk assessment, primarily because most of the individuals in these cohorts had not been exposed for as long as 45 years. Thus, estimating lung cancer excess risks over this higher range of cumulative exposures of interest to OSHA required some degree of extrapolation and adds uncertainty to the estimates. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 C. Silicosis and Non-Malignant Respiratory Disease Mortality There are two published quantitative risk assessment studies of silicosis and non-malignant respiratory disease (NMRD) mortality; a pooled analysis of silicosis mortality by Mannetje et al. (2002b) of data from six epidemiological studies, and an exposure-response analysis of NMRD mortality among diatomaceous earth workers (Park et al., 2002). 1. Mannetje et al. (2002b) Six Cohort Pooled Analysis The Mannetje et al. (2002b) silicosis analysis was part of the IARC ten cohort pooled study included in the Steenland et al. (2001a) lung cancer mortality analysis above. These studies included 18,634 subjects and 170 silicosis deaths (n = 150 for silicosis, and n = 20 unspecified pneumoconiosis). The silicosis deaths had a median duration of exposure of 28 years, a median cumulative exposure of 7.2 mg/m3years, and a median average exposure of 0.26 mg/m3, while the respective values of the whole cohort were 10 years, 0.62 mg/m3-years, and 0.07 mg/m3. Rates for silicosis adjusted for age, calendar time, and study were estimated by Poisson regression; rates increased nearly monotonically with deciles of cumulative exposure, from a mortality rate of 5/100,000 person-years in the lowest exposure category (0–0.99 mg/ m3-years) to 299/100,000 person-years in the highest category (>28.10 mg/m3years). Quantitative estimates of exposure to respirable silica (mg/m3) were available for all six cohorts (Mannetje et al. 2002a). Lifetime risk of VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 silicosis mortality was estimated by accumulating mortality rates over time using the formula Risk = 1 ¥ exp(¥ètime * rate). To estimate the risk of silicosis mortality at the current and proposed PELs, OSHA used the model described by Mannetje et al. (2002b) to estimate risk to age 85 but used rate ratios that were estimated from a nested casecontrol design that was part of a sensitivity analysis conducted by Toxichemica, Inc. (2004), rather than the Poisson regression originally conducted by Mannetje et al. (2002b). The case-control design was selected because it was expected to better control for age; in addition, the rate ratios derived from the case-control study reflect exposure measurement uncertainty via conduct of a Monte Carlo analysis (Toxichemica, Inc., 2004). 2. Park et al. (2002) Study of Diatomaceous Earth Workers Park et al. (2002) analyzed the California diatomaceous earth cohort data originally studied by Checkoway et al. (1997), consisting of 2,570 diatomaceous earth workers employed for 12 months or more from 1942 to 1994, to quantify the relationship between exposure to cristobalite and mortality from chronic lung disease other than cancer (LDOC). Diseases in this category included pneumoconiosis (which included silicosis), chronic bronchitis, and emphysema, but excluded pneumonia and other infectious diseases. Industrial hygiene data for the cohort were available from the employer for total dust, silica (mostly cristobalite), and asbestos. Park et al. (2002) used the exposure assessment previously reported by Seixas et al. (1997) and used by Rice et al. (2001) to estimate cumulative crystalline silica exposures for each worker in the cohort based on detailed work history files. The mean silica concentration for the cohort overall was 0.29 mg/m3 over the period of employment (Seixas et al., 1997). The mean cumulative exposure values for total respirable dust and respirable crystalline silica were 7.31 and 2.16 mg/ m3-year, respectively. Similar cumulative exposure estimates were made for asbestos. Smoking information was available for about 50 percent of the cohort and for 22 of the 67 LDOC deaths available for analysis, permitting Park et al. (2002) to at least partially adjust for smoking. Estimates of LDOC mortality risks were derived via Poisson and Cox’s proportional hazards models; a variety of relative rate model forms were fit to the data, with a linear relative rate model being selected for risk estimation. PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 3. Summary Risk Estimates for Silicosis and NMRD Mortality Table VI–2 presents OSHA’s risk estimates for silicosis and NMRD mortality derived from the Mannetje et al. (2002b) and Park et al. (2002) studies, respectively. For 45 years of exposure to the current general industry PEL (approximately 0.1 mg/m3 respirable crystalline silica), OSHA’s estimates of excess lifetime risk are 11 deaths per 1,000 workers for the pooled analysis and 83 deaths per 1,000 workers based on Park et al.’s (2002) estimates. At the proposed PEL, estimates of silicosis and NMRD mortality are 7 and 43 deaths per 1,000, respectively. For exposures up to 0.25 mg/m3, the estimates based on Park et al. are about 5 to 11 times as great as those calculated for the pooled analysis of silicosis mortality (Mannetje et al., 2002b). However, these two sets of risk estimates are not directly comparable. First, the Park et al. analysis used untransformed cumulative exposure as the exposure metric, whereas the Mannertje et al. analysis used log cumulative exposure, which causes the exposure-response to flatten out in the higher exposure ranges. Second, the mortality endpoint for the Park et al. (2002) analysis is death from all noncancer lung diseases, including pneumoconiosis, emphysema, and chronic bronchitis, whereas the pooled analysis by Mannetje et al. (2002b) included only deaths coded as silicosis or other pneumoconiosis. Less than 25 percent of the LDOC deaths in the Park et al. (2002) analysis were coded as silicosis or other pneumoconiosis (15 of 67). As noted by Park et al. (2002), it is likely that silicosis as a cause of death is often misclassified as emphysema or chronic bronchitis; thus, Mannetje et al.’s (2002b) selection of deaths may tend to underestimate the true risk of silicosis mortality, and Park et al.’s (2002) analysis would more fairly capture the total respiratory mortality risk from all non-malignant causes, including silicosis and chronic obstructive pulmonary disease. D. Renal Disease Mortality Steenland et al. (2002a) examined renal disease mortality in three cohorts and evaluated exposure-response relationships from the pooled cohort data. The three cohorts included U.S. gold miners (Steenland and Brown, 1995a), U.S. industrial sand workers (Steenland et al., 2001b), and Vermont granite workers (Costello and Graham, 1988), all three of which are included in both the lung cancer mortality and silicosis mortality pooled analyses reported above. Follow up for the U.S. E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 gold miners study was extended six years from that in the other pooled analyses. Steenland et al. (2002a) reported that these cohorts were chosen because data were available for both underlying cause mortality and multiple cause mortality; this was believed important because renal disease is often listed on death certificates without being identified as an underlying cause of death. In the three cohorts, there were 51 total renal disease deaths using underlying cause, and 204 total renal deaths using multiple cause mortality. The combined cohort for the pooled analysis (Steenland et al., 2002a) consisted of 13,382 workers with exposure information available for 12,783 (95 percent). Exposure matrices for the three cohorts had been used in previous studies (Steenland and Brown, 1995a; Attfield and Costello, 2001; Steenland et al., 2001b). The mean duration of exposure, the mean cumulative exposure, and the mean concentration of respirable silica for the pooled cohort were 13.6 years, 1.2 mg/ m3-years, and 0.07 mg/m3, respectively. SMRs (compared to the U.S. population) for renal disease (acute and chronic glomerulonephritis, nephrotic syndrome, acute and chronic renal failure, renal sclerosis, and nephritis/ nephropathy) were statistically significantly elevated using multiple cause data (SMR 1.29, 95% CI 1.10– 1.47, 193 deaths) and underlying cause data (SMR 1.41, 95% CI 1.05–1.85, 51 observed deaths). OSHA’s estimates of renal disease mortality appear in Table VI–2. Based on the life table analysis, OSHA estimates that exposure to the current (0.10 mg/m3) and proposed general industry PEL (0.0.05 mg/m3) over a working life would result in a lifetime excess renal disease risk of 39 (95% CI 2–200) and 32 (95% CI 1.7–147) deaths per 1,000, respectively. For exposure to the current construction/shipyard PEL, OSHA estimates the excess lifetime risk to range from 52 (95% CI 2.2–289) to 63 (95% CI 2.5–368) deaths per 1,000 workers. E. Silicosis Morbidity OSHA’s Preliminary QRA summarizes the principal cross-sectional and cohort studies that have quantitatively characterized relationships between exposure to crystalline silica and development of radiographic evidence of silicosis. Each of these studies relied on estimates of cumulative exposure to evaluate the relationship between exposure and silicosis prevalence in the worker populations examined. The health endpoint of interest in these studies is the appearance of opacities on VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 chest roentgenograms indicative of pulmonary fibrosis. The International Labour Organization’s (ILO) 1980 International Classification of Radiographs of the Pneumoconioses is accepted as the standard against which chest radiographs are measured in epidemiologic studies, for medical surveillance and for clinical evaluation. According to this standard, if radiographic findings are or may be consistent with pneumoconiosis, then the size, shape, and extent of profusion of opacities are characterized by comparing the radiograph to standard films. Classification by shape (rounded vs. irregular) and size involves identifying primary and secondary types of small opacities on the radiograph and classifying them into one of six size/ shape categories. The extent of profusion is judged from the concentrations of opacities as compared with that on the standard radiographs and is graded on a 12-point scale of four major categories (0–3, with Category 0 representing absence of opacities), each with three subcategories. Most of the studies reviewed by OSHA considered a finding consistent with an ILO classification of 1/1 to be a positive diagnosis of silicosis, although some also considered an x-ray classification of 1/0 or 0/1 to be positive. Chest radiography is not the most sensitive tool used to diagnose or detect silicosis. In 1993, Hnizdo et al. reported the results of a study that compared autopsy and radiological findings of silicosis in a cohort of 557 white South African gold miners. The average period from last x-ray to autopsy was 2.7 years. Silicosis was not diagnosed radiographically for over 60 percent of the miners for whom pathological examination of lung tissue showed slight to marked silicosis. The likelihood of false negatives (negative by x-ray, but silicosis is actually present) increased with years of mining and average dust exposure of the miners. The low sensitivity seen for radiographic evaluation suggests that risk estimates derived from radiographic evidence likely understate the true risk of developing fibrotic lesions as a result of exposure to crystalline silica. OSHA’s Preliminary QRA examines multiple studies from which silicosis occupational morbidity risks can be estimated. The studies evaluated fall into three major types. Some are crosssectional studies in which radiographs taken at a point in time were examined to ascertain cases (Kreiss and Zhen, 1996; Love et al., 1999; Ng and Chan, 1994; Rosenman et al., 1996; Churchyard et al., 2003, 2004); these PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 56317 radiographs may have been taken as part of a health survey conducted by the investigators or represent the most recent chest x-ray available for study subjects. Other studies were designed to examine radiographs over time in an effort to determine onset of disease. Some of these studies examined primarily active, or current, workers (Hughes et al., 1998; Muir et al., 1989a, 1989b; Park et al., 2002), while others included both active and retired workers (Chen et al., 2001, 2005; Hnizdo and Sluis-Cremer, 1993; Miller et al., 1998; Buchanan et al., 2003; Steenland and Brown, 1995b). Even though OSHA has presented silicosis risk estimates for all of the studies identified, the Agency is relying primarily on those studies that examined radiographs over time and included both active and retired workers. It has been pointed out by others (Chen et al., 2001; Finkelstein, 2000; NIOSH, 2002) that lack of followup of retired workers consistently resulted in lower risk estimates compared to studies that included retired workers. OSHA believes that the most reliable estimates of silicosis morbidity, as detected by chest radiographs, come from the studies that evaluated radiographs over time, included radiographic evaluation of workers after they left employment, and derived cumulative or lifetime estimates of silicosis disease risk. Brief descriptions of these cumulative risk studies used to estimate silicosis morbidity risks are presented below. 1. Hnizdo and Sluis Cremer (1993) Study of South African White Gold Miners Hnizdo and Sluis-Cremer (1993) described the results of a retrospective cohort study of 2,235 white gold miners in South Africa. These workers had received annual examinations and chest x-rays while employed; most returned for occasional examinations after employment. A case was defined as one with an x-ray classification of ILO 1/1 or greater. A total of 313 miners had developed silicosis and had been exposed for an average of 27 years at the time of diagnosis. Forty-three percent of the cases were diagnosed while employed and the remaining 57 percent were diagnosed an average of 7.4 years after leaving the mines. The average latency for the cohort was 35 years (range of 18–50 years) from start of exposure to diagnosis. The average respirable dust exposure for the cohort overall was 0.29 mg/m3 (range 0.11–0.47), corresponding to an estimated average respirable silica concentration of 0.09 mg/m3 (range E:\FR\FM\12SEP2.SGM 12SEP2 56318 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 0.033–0.14). The average cumulative dust exposure for the overall cohort was 6.6 mg/m3-years (range 1.2–18.7), or an average cumulative silica exposure of 1.98 mg/m3-years (range 0.36–5.61). OSHA believes that the exposure estimates for the cohort are uncertain given the need to rely on particle count data generated over a fairly narrow production period. Silicosis risk increased exponentially with cumulative exposure to respirable dust and was modeled using log-logistic regression. Using the exposure-response relationship developed by Hnizdo and Sluis-Cremer (1993), and assuming a quartz content of 30 percent in respirable dust, Rice and Stayner (1995) and NIOSH (2002) estimated the risk of silicosis to be 70 percent and 13 percent for a 45-year exposure to 0.1 and 0.05 mg/m3 respirable crystalline silica, respectively. 2. Steenland and Brown (1995b) Study of South Dakota Gold Miners Three thousand three hundred thirty South Dakota gold miners who had worked at least a year underground between 1940 and 1965 were studied by Steenland and Brown (1995b). Workers were followed though 1990 with 1,551 having died; loss to follow up was low (2 percent). Chest x-rays taken in crosssectional surveys in 1960 and 1976 and death certificates were used to ascertain cases of silicosis. One hundred twenty eight cases were found via death certificate, 29 by x-ray (defined as ILO 1/1 or greater), and 13 by both. Nine percent of deaths had silicosis mentioned on the death certificate. Inclusion of death certificate diagnoses probably increases the risk estimates from this study compared to those that rely exclusively on radiographic findings to evaluate silicosis morbidity risk (see discussion of Hnizdo et al. (1993) above). Exposure was estimated by conversion of impinger (particle count) data and was based on measurements indicating an average of 13 percent silica in the dust. Based on these data, the authors estimated the mean exposure concentration to be 0.05 mg/ m3 for the overall cohort, with those hired before 1930 exposed to an average of 0.15 mg/m3. The average duration of exposure for cases was 20 years (s.d = 8.7) compared to 8.2 years (s.d = 7.9) for the rest of the cohort. This study found that cumulative exposure was the best disease predictor, followed by duration of exposure and average exposure. Lifetime risks were estimated from Poisson regression models using standard life table techniques. The authors estimated a risk of 47 percent VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 associated with 45 years of exposure to 0.09 mg/m3 respirable crystalline silica, which reduced to 35 percent after adjustment for age and calendar time. 3. Miller et al. (1995, 1998) and Buchanan et al. (2003) Study of Scottish Coal Miners Miller et al. (1995, 1998) and Buchanan et al. (2003) reported on a 1990/1991 follow-up study of 547 survivors of a 1,416 member cohort of Scottish coal workers from a single mine. These men had all worked in the mine during a period between early 1971 and mid 1976, during which they had experienced ‘‘unusually high concentrations of freshly cut quartz in mixed coalmine dust. The population’s exposures to both coal and quartz dust had been measured in unique detail, for a substantial proportion of the men’s working lives.’’ Thus, this cohort allowed for the study of the effects of both higher and lower silica concentrations, and exposure-rate effects on the development of silicosis. The 1,416 men had all had previous radiographs dating from before, during, or just after this high concentration period, and the 547 participating survivors received their follow-up chest x-rays between November 1990 and April 1991. Follow-up interviews consisted of questions on current and past smoking habits, and occupational history since leaving the coal mine, which closed in 1981. Silicosis cases were identified as such if the median classification of the three readers indicated an ILO (1980) classification of 1/0 or greater, plus a progression from the earlier reading. Of the 547 men, 203 (38 percent) showed progression of at least one ILO category from the 1970’s surveys to the 1990–91 survey; in 128 of these (24 percent) there was progression of two or more steps. In the 1970’s survey 504 men had a profusion score of 0; of these, 120 (24 percent) progressed to an ILO classification of 1/0 or greater. Of the 36 men who had shown earlier profusions of 1/0 or greater, 27 (75 percent) showed further progression at the 1990/1991 follow-up. Only one subject showed a regression from any earlier reading, and that was slight, from ILO 1/0 to 0/1. To study the effects of exposure to high concentrations of quartz dust, the Buchanan et al. (2003) analysis presented the results of logistic regression modeling that incorporated two independent terms for cumulative exposure, one arising from exposure to concentrations less than 2 mg/m3 respirable quartz and the other from exposure to concentrations greater than or equal to 2 mg/m3. Both of the PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 cumulative quartz exposure concentration variables were ‘‘highly statistically significant in the presence of the other,’’ and independent of the presence of coal dust. Since these quartz variables were in the same units, g–hr/ m3, the authors noted that coefficient for exposure concentrations equal to or above 2.0 mg/m3 was 3 times that of the coefficient for concentrations less than 2.0 mg/m3. From this, the authors concluded that their analysis showed that ‘‘the risk of silicosis over a working lifetime can rise dramatically with exposure to such high concentrations over a timescale of merely a few months.’’ Buchanan et al., (2003) provided analysis and risk estimates only for silicosis cases defined as having an xray classified as ILO 2/1+, after adjusting for the disproportionately severe effect of exposure to high concentrations on silicosis risk. Estimating the risk of acquiring a chest x-ray classified as ILO 1/0+ from the Buchanan (2003) or the earlier Miller et al. (1995, 1998) publications can only be roughly approximated because of the limited summary information included; this information suggests that the risk of silicosis defined as an ILO classification of 1/0+ could be about three times higher than the risk of silicosis defined as an ILO 2/1+ x-ray. OSHA has a high degree of confidence in the estimates of progression to stages 2/1+ from this Scotland coal mine study, mainly because of the highly detailed and extensive exposure measurements, the radiographic records, and the detailed analyses of high exposure-rate effects. 4. Chen et al. (2001) Study of Tin Miners Chen et al. (2001) reported the results of a retrospective study of a Chinese cohort of 3,010 underground miners who had worked in tin mines at least one year between 1960 and 1965. They were followed through 1994, by which time 2,426 (80.6%) workers had either retired or died, and only 400 (13.3%) remained employed at the mines. The study incorporated occupational histories, dust measurements and medical examination records. Exposure data consisted of high-flow, short-term gravimetric total dust measurements made routinely since 1950; the authors used data from 1950 to represent earlier exposures since dust control measures were not implemented until 1958. Results from a 1998–1999 survey indicated that respirable silica measurements were 3.6 percent (s.d = 2.5 percent) of total dust measurements. Annual radiographs were taken since 1963 and all cohort members continued E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 to have chest x-rays taken every 2 or 3 years after leaving work. Silicosis was diagnosed when at least 2 of 3 radiologists classified a radiograph as being a ‘‘suspected case’’ or at Stage I, II, or III under the 1986 Chinese pneumoconiosis roentgen diagnostic criteria. According to Chen et al. (2001), these four categories under the Chinese system were found to agree closely with ILO categories 0/1, Category 1, Category 2, and Category 3, respectively, based on studies comparing the Chinese and ILO classification systems. Silicosis was observed in 33.7 percent of the group; 67.4 percent of the cases developed after exposure ended. 5. Chen et al. (2005) Study of Chinese Pottery Workers, Tin Miners, and Tungsten Miners In a later study, Chen et al. (2005) investigated silicosis morbidity risks among three cohorts to determine if the risk varied among workers exposed to silica dust having different characteristics. The cohorts consisted of 4,547 pottery workers, 4,028 tin miners, and 14,427 tungsten miners selected from a total of 20 workplaces. Cohort members included all males employed after January 1, 1950 and who worked for at least one year between 1960 and 1974. Radiological follow-up was through December 31, 1994 and x-rays were scored according to the Chinese classification system as described above by Chen et al. (2001) for the tin miner study. Exposure estimates of cohort members to respirable crystalline silica were based on the same data as described by Chen et al. (2001). In addition, the investigators measured the extent of surface occlusion of crystalline silica particles by alumino-silicate from 47 dust samples taken at 13 worksites using multiple-voltage scanning electron microscopy and energy dispersive X-ray spectroscopy (Harrison et al., 2005); this method yielded estimates of the percent of particle surface that is occluded. Compared to tin and tungsten miners, pottery workers were exposed to significantly higher mean total dust concentrations (8.2 mg/m3, compared to 3.9 mg/m3 for tin miners and 4.0 mg/m3 for tungsten miners), worked more net years in dusty occupations (mean of 24.9 years compared to 16.4 years for tin miners and 16.5 years for tungsten miners), and had higher mean cumulative dust exposures (205.6 mg/ m3-years compared to 62.3 mg/m3-years for tin miners and 64.9 mg/m3-years for tungsten miners) (Chen et al., 2005). Applying the authors’ conversion factors to estimate respirable crystalline silica from Chinese total dust VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 measurements, the approximate mean cumulative exposures to respirable silica for pottery, tin, and tungsten workers are 6.4 mg/m3-years, 2.4 mg/ m3-years, and 3.2 mg/m3-years, respectively. Measurement of particle surface occlusion indicated that, on average, 45 percent of the surface area of respirable particles collected from pottery factory samples was occluded, compared to 18 percent of the particle surface area for tin mine samples and 13 percent of particle surface area for tungsten mines. Based on Chen et al. (2005), OSHA estimated the cumulative silicosis risk associated with 45 years of exposure to 0.1 mg/m3 respirable crystalline silica (a cumulative exposure of 4.5 mg/m3years) to be 6 percent for pottery workers, 12 percent for tungsten miners, and 40 percent for tin miners. For a cumulative exposure of 2.25 mg/m3years (i.e., 45 years of exposure to 0.05 mg/m3), cumulative silicosis morbidity risks were estimated to be 2, 2, and 10 percent for pottery workers, tungsten miners, and tin miners, respectively. When cumulative silica exposure was adjusted to reflect exposure to surfaceactive quartz particles (i.e., not occluded), the estimated cumulative risk among pottery workers more closely approximated those of the tin and tungsten miners, suggesting to the authors that alumino-silicate occlusion of the crystalline particles in pottery factories at least partially explained the lower risk seen among workers, despite their having been more heavily exposed. 6. Summary of Silicosis Morbidity Risk Estimates. Table VI–2 presents OSHA’s risk estimates for silicosis morbidity that are derived from each of the studies described above. Estimates of silicosis morbidity derived from the seven cohorts in cumulative risk studies with post-employment follow-up range from 60 to 773 per 1,000 workers for 45-year exposures to the current general industry PEL of 0.10 mg/m3, and from 20 to 170 per 1,000 workers for a 45year exposure to the proposed PEL of 0.05 mg/m3. The study results provide substantial evidence that the disease can progress for years after exposure ends. Results from an autopsy study (Hnizdo et al., 1993), which found pathological evidence of silicosis absent radiological signs, suggest that silicosis cases based on radiographic diagnosis alone tend to underestimate risk since pathological evidence of silicosis. Other results (Chen et al., 2005) suggest that surface properties among various types of silica dusts can have different silicosis potencies. Results from the Buchanan et PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 56319 al. (2003) study of Scottish coal miners suggest that short-term exposures to >2 mg/m3 silica can cause a disproportionately higher risk of silicosis than would be predicted by cumulative exposure alone, suggesting a dose-rate effect for exposures to concentrations above this level. OSHA believes that, given the consistent finding of a monotonic exposureresponse relationship for silicosis morbidity with cumulative exposure in the studies reviewed, that cumulative exposure is a reasonable exposure metric upon which to base risk estimates in the exposure range of interest to OSHA (i.e., between 0.025 and 0.5 mg/m3 respirable crystalline silica). F. Other Considerations in OSHA’s Risk Analysis Uncertainties are inherent to any risk modeling process and analysis; assessing risk and associated complexities of silica exposure among workers is no different. However, the Agency has a high level of confidence that the preliminary risk assessment results reasonably reflect the range of risks experienced by workers exposed to silica in all occupational settings. First, the preliminary assessment is based on an analysis of a wide range of studies, conducted in multiple industries across a wide range of exposure distributions, which included cumulative exposures equivalent to 45 years of exposure to and below the current PEL. Second, risk models employed in this assessment are based on a cumulative exposure metric, which is the product of average daily silica concentration and duration of worker exposure for a specific job. Consequently, these models predict the same risk for a given cumulative exposure regardless of the pattern of exposure. For example, a manufacturing plant worker exposed to silica at 0.05 mg/m3 for eight hours per day will have the same cumulative exposure over a given period of time as a construction worker who is exposed each day to silica at 0.1 mg/m3 for one hour, at 0.075 mg/m3 for four hours and not exposed to silica for three hours. The cumulative exposure metric thus reflects a worker’s long-term average exposure without regard to the pattern of exposure experienced by the worker, and is therefore generally applicable to all workers who are exposed to silica in the various industries. For example, at construction sites, conditions may change often since the nature of work can be intermittent and involve working with a variety of materials that contain different concentrations of quartz. Additionally, workers may perform E:\FR\FM\12SEP2.SGM 12SEP2 56320 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules cumulative exposures exhibited in these studies are equivalent to the cumulative exposure that would result from 45 years of exposure to the current and proposed PELs (i.e., 4.5 and 2,25 mg/m3, respectively). For this reason, OSHA has a high degree of confidence in the risk estimates associated with exposure to the current and proposed PELs; additionally, the risk assessment does not require significant low-dose extrapolation of the model beyond the observed range of exposures. OSHA acknowledges there is greater uncertainty in the risk estimates for the proposed action level of 0.025 mg/m3, particularly given some evidence of a threshold for silicosis between the proposed PEL and action level. Given the Agency’s findings that controlling exposures below the proposed PEL would not be technologically feasible for employers, OSHA believes that estimating risk for exposures below the proposed action level, which becomes increasingly more uncertain, is not construction operations for relatively short periods of time where they are exposed to concentrations of silica that may be significantly higher than many continuous operations in general industry. However, these differences are taken into account by the use of the cumulative exposure metric that relates exposure to disease risk. OSHA believes that use of cumulative exposure is the most appropriate dose-metric because each of the studies that provide the basis for the risk assessment demonstrated strong exposure-response relationships between cumulative exposure and disease risk. This metric is especially important in terms of progression of silica-related disease, as discussed in Section VII of the preamble, Significance of Risk, in section B.1.a. OSHA’s risk assessment relied upon many studies that utilized cumulative exposures of cohort members. Table VI– 3 summarizes these lung cancer studies, including worker exposure quartile data across a number of industry sectors. The necessary to further inform the Agency’s regulatory action. Although the Agency believes that the results of its risk assessment are broadly relevant to all occupational exposure situations involving crystalline silica, OSHA acknowledges that differences exist in the relative toxicity of crystalline silica particles present in different work settings due to factors such as the presence of mineral or metal impurities on quartz particle surfaces, whether the particles have been freshly fractured or are aged, and size distribution of particles. At this time, however, OSHA preliminarily concludes that it is not yet possible to use available information on factors that mediate the potency of silica to refine available quantitative estimates of the lung cancer and silicosis mortality risks, and that the estimates from the studies and analyses relied upon are fairly representative of a wide range of workplaces reflecting differences in silica polymorphism, surface properties, and impurities. TABLE VI–1—ESTIMATES OF LIFETIME A LUNG CANCER MORTALITY RISK RESULTING FROM 45-YEARS OF EXPOSURE TO CRYSTALLINE SILICA [Deaths per 1,000 workers (95% confidence interval)] Cohort Exposure lag (years) Model Exposure level (mg/m3) Model parameters (standard error) 0.025 0.05 0.10 0.25 0.50 ............ 15 b = 0.60 (0.015) .... 22 (11–36) 26 (12–41) 29 (13–48) 34 (15–56) 38 (17–63) .................. 15 23 (9–38) 26 (10–43) 29 (11–47) 33 (12–53) 36 (14–58) Linear .................... Ten pooled cohorts (see Table II–1). 15 9 (2–16) 18 (4–31) 22 (6–38) 27 (12–43) 36 (20–51) 0.21–13 0.41–28 0.83–69 2.1–298 4.2–687 Log-linear b ........................... 15 b = 0.074950 (0.024121). b1 = 0.16498 (0.0653) and. b2 = ¥0.1493 (0.0657). Various .................. Log-linear c ............ Linear c .................. 10 b = 0.1441 e ........... 9 (2–21) 17 (5–41) 34 (10–79) 81 (24–180) 152 (46–312) Log-linear c ............ 15 b = 0.19 e ............... 11 (4–18) 25 (9–42) 60 (19–111) 250 (59–502) 653 (167–760) Log-linear c ............ 15 b = 0.13 (0.074) f ... 7 (0–16) 15 (0–37) 34 (0–93) 120 (0–425) 387 (0–750) Log-linear c ............ 15 B = 0.0524 (0.0188). 3 (1–5) 6 (2–11) 13 (4–23) 37 (9–75) 95 (20–224) Linear b Spline§c d Range from 10 cohorts. Diatomaceous earth workers. U.S.Granite workers. North American industrial sand workers. British coal miners ............... a Risk to age 85 and based on 2006 background mortality rates for all males (see Appendix for life table method). with log cumulative exposure (mg/m3-days + 1). with cumulative exposure (mg/m3-years). d 95% confidence interval calculated as follows (where CE = cumulative exposure in mg/m3-years and SE is standard error of the parameter estimate): For CE ≤ 2.19: 1 + [(b1 ± (1.96*SE1)) * CE]. For CE > 2.19: 1 + [(b1 * CE) + (b2 * (CE–2.19))] ± 1.96 * SQRT[ (CE2 * SE12) + ((CE–2.19)2* SE22) + (2*CE*(CE–3.29)*-0.00429)]. e Standard error not reported, upper and lower confidence limit on beta estimated from confidence interval of risk estimate reported in original article. f Standard error of the coefficient was estimated from the p-value for trend. b Model mstockstill on DSK4VPTVN1PROD with PROPOSALS2 c Model TABLE VI–2—SUMMARY OF LIFETIME OR CUMULATIVE RISK ESTIMATES FOR CRYSTALLINE SILICA Risk associated with 45 years of occupational exposure (per 1,000 workers) Health endpoint (source) Respirable crystalline silica exposure level (mg/m3) 0.025 Lung Cancer Mortality (Lifetime Risk): Pooled Analysis, Toxichemica, Inc (2004) a b ............... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00048 0.05 9–23 Fmt 4701 Sfmt 4702 0.100 18–26 E:\FR\FM\12SEP2.SGM 22–29 12SEP2 0.250 27–34 0.500 36–38 56321 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VI–2—SUMMARY OF LIFETIME OR CUMULATIVE RISK ESTIMATES FOR CRYSTALLINE SILICA—Continued Risk associated with 45 years of occupational exposure (per 1,000 workers) Health endpoint (source) Respirable crystalline silica exposure level (mg/m3) 0.025 Diatomaceous Earth Worker study (Rice et al., 2001) a c ..................................................................... U.S. Granite Worker study (Attfield and Costello, 2004) a d ..................................................................... North American Industrial Sand Worker study (Hughes et al., 2001) a e ............................................ British Coal Miner study (Miller and MacCalman, 2009) a f ...................................................................... Silicosis and Non-Malignant Lung Disease Mortality (Lifetime Risk): Pooled Analysis (Toxichemica, Inc., 2004) (silicosis) g Diatomaceous Earth Worker study (Park et al., 2002) (NMRD) h ................................................................... Renal Disease Mortality (Lifetime Risk): Pooled Cohort study (Steenland et al., 2002a) ............ Silicosis Morbidity (Cumulative Risk): Chest x-ray category of 2/1 or greater (Buchanan et al., 2003) j .................................................................. Silicosis mortality and/or x-ray of 1/1 or greater (Steenland and Brown, 1995b) k ............................... Chest x-ray category of 1/1 or greater (Hnizdo and Sluis-Cremer, 1993) l ................................................. Chest x-ray category of 1 or greater (Chen et al., 2001) m ...................................................................... Chest x-ray category of 1 or greater (Chen et al., 2005) n Tin miners .............................................................. Tungsten miners .................................................... Pottery workers ...................................................... 0.05 0.100 0.250 0.500 9 17 34 81 152 11 25 60 250 653 7 15 34 120 387 3 6 13 37 95 4 7 11 17 22 22 43 83 188 321 25 32 39 52 63 21 55 301 994 1000 31 74 431 593 626 6 127 773 995 1000 40 170 590 1000 1000 40 5 5 100 20 20 400 120 60 950 750 300 1000 1000 700 From Table II–12, ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ (Docket OSHA–2010–0034). TABLE VI–3—EXPOSURE DISTRIBUTION IN LUNG CANCER STUDIES mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Study U.S. diatomaceous earth workers 1 (Checkoway et al., 1997). S. African gold miners 1 (Hnizdo and Sluis-cremer, 1991 & Hnizdo et al., 1997). U.S. gold miners 1 (Steenland and Brown, 1995a). Australian gold miners 1 (de Klerk and Musk, 1998). U.S. granite workers (Costello and Graham, 1988). Finnish granite workers (Koskela et al., 1994). VerDate Mar<15>2010 Cum(exp) (mg/m3-y) Primary exposure (as described in study) No. of deaths from lung cancer 2,342 cristobalite 77 0.37 1.05 2.48 2,260 quartz and other silicates. 77 n/a 4.23 3,328 silica dust 156 0.1 2,297 silica dust 135 5,414 silica dust from granite. 1,026 quartz dust Average* exposure (mg/m3) n 19:12 Sep 11, 2013 Jkt 229001 25th (q1) median (q2) 75th (q3) 62.52 0.11 0.18 0.46 2.43 n/a n/a n/a 0.15 0.19 0.22 0.31 n/a 0.23 0.74 6.2 0.02 0.05 0.1 0.24 n/a 6.52 11.37 17.31 50.22 0.25 0.43 0.65 1.55 n/a 124 0.14 0.71 2.19 50 0.02 0.05 0.08 1.01 n/a 38 0.84 4.63 15.42 100.98 0.39 0.59 1.29 3.6 n/a PO 00000 median (q2) Mean respirable crystalline silica exposure over employment period (mg/m∧3) q1 Frm 00049 Fmt 4701 q3 max Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 max 56322 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VI–3—EXPOSURE DISTRIBUTION IN LUNG CANCER STUDIES—Continued Study U.S. industrial sand workers 1 (Steenland et al., 2001b). North American industrial sand workers 1 (Hughes et al., 2001). Ch. Tungsten (Chen et al., 1992). Ch. Pottery (Chen et al., 1992). Ch. Tin (Chen et al., 1992). British coal workers 1 (Miller and MacCalman, 2009). Cum(exp) (mg/m3-y) Primary exposure (as described in study) No. of deaths from lung cancer 4,626 silica dust 85 0.03 0.13 5.2 90 crystalline silica. 95 1.11 2.73 28,442 silica dust 174 3.49 13,719 silica dust 81 7,849 silica dust quartz ....... Average* exposure (mg/m3) n 17,820 Mean respirable crystalline silica exposure over employment period (mg/m∧3) 25th (q1) median (q2) 75th (q3) 8.265 0.02 0.04 0.06 0.4 n/a 5.20 n/a 0.069 0.15 0.025 n/a n/a 8.56 29.79 232.26 0.15 0.32 1.28 4.98 6.1 3.89 6.07 9.44 63.15 0.18 0.22 0.34 2.1 11.4 119 2.79 5.27 5.29 83.09 0.12 0.19 0.49 1.95 7.7 973 n/a n/a n/a n/a n/a n/a n/a n/a n/a median (q2) q1 q3 max max 1 Study adjusted for effects smoking. * Average exposure is cumulative exposure averaged over the entire exposure period. n/a Data not available. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VII. Significance of Risk A. Legal Requirements To promulgate a standard that regulates workplace exposure to toxic materials or harmful physical agents, OSHA must first determine that the standard reduces a ‘‘significant risk’’ of ‘‘material impairment.’’ The first part of this requirement, ‘‘significant risk,’’ refers to the likelihood of harm, whereas the second part, ‘‘material impairment,’’ refers to the severity of the consequences of exposure. The Agency’s burden to establish significant risk derives from the OSH Act, 29 U.S.C. 651 et seq. Section 3(8) of the Act requires that workplace safety and health standards be ‘‘reasonably necessary and appropriate to provide safe or healthful employment.’’ 29 U.S.C. 652(8). The Supreme Court, in the ‘‘benzene’’ decision, stated that section 3(8) ‘‘implies that, before promulgating any standard, the Secretary must make a finding that the workplaces in question are not safe.’’ Indus. Union Dep’t, AFL–CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980). Examining section 3(8) more closely, the Court described OSHA’s obligation to demonstrate significant risk: ‘‘[S]afe’’ is not the equivalent of ‘‘risk-free.’’ A workplace can hardly be considered ‘‘unsafe’’ unless it threatens the workers with a significant risk of harm. Therefore, before the Secretary can promulgate any permanent VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 health or safety standard, he must make a threshold finding that the place of employment is unsafe in the sense that significant risks are present and can be eliminated or lessened by a change in practices. Id. While clarifying OSHA’s responsibilities, the Court emphasized the Agency’s discretion in determining what constitutes significant risk, stating, ‘‘[the Agency’s] determination that a particular level of risk is ‘significant’ will be based largely on policy considerations.’’ Benzene, 448 U.S. at 655, n. 62. The Court explained that significant risk is not a ‘‘mathematical straitjacket,’’ and maintained that OSHA could meet its burden without ‘‘wait[ing] for deaths to occur before taking any action.’’ Benzene, 448 U.S. at 655. Because section 6(b)(5) of the Act requires that the Agency base its findings on the ‘‘best available evidence,’’ a reviewing court must ‘‘give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge.’’ Benzene, 448 U.S. at 656. Thus, while OSHA’s significant risk determination must be supported by substantial evidence, the Agency ‘‘is not required to support the finding that a significant risk exists with anything approaching scientific certainty.’’ Id. Furthermore, ‘‘the Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 error on the side of over protection rather than under protection,’’ so long as such assumptions are based in ‘‘a body of reputable scientific thought.’’ Id. The Act also requires that the Agency make a finding that the toxic material or harmful physical agent at issue causes material impairment to workers’ health. Section 6(b)(5) of the Act directs the Secretary of Labor to ‘‘set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard . . . for the period of his working life.’’ 29 U.S.C. 655(b)(5). As with significant risk, what constitutes material impairment in any given case is a policy determination for which OSHA is given substantial leeway. ‘‘OSHA is not required to state with scientific certainty or precision the exact point at which each type of [harm] becomes a material impairment.’’ AFL– CIO v. OSHA, 965 F.2d 962, 975 (11th Cir. 1992). Courts have also noted that OSHA should consider all forms and degrees of material impairment—not just death or serious physical harm— and that OSHA may act with a ‘‘pronounced bias towards worker safety.’’ Id; Bldg & Constr. Trades Dep’t v. Brock, 838 F.2d 1258, 1266 (D.C. Cir. 1988). It is the Agency’s practice to estimate risk to workers by using quantitative E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules risk assessment and determining the significance of that risk based on judicial guidance, the language of the OSH Act, and Agency policy considerations. Thus, using the best available evidence, OSHA identifies material health impairments associated with potentially hazardous occupational exposures, and, when possible, provides a quantitative assessment of exposed workers’ risk of these impairments. The Agency then evaluates whether these risks are severe enough to warrant regulatory action and determines whether a new or revised rule will substantially reduce these risks. In this case, OSHA has reviewed extensive toxicological, epidemiological, and experimental research pertaining to adverse health effects of occupational exposure to respirable crystalline silica, including silicosis, other non-malignant respiratory disease, lung cancer, and autoimmune and renal diseases. As a result of this review, the Agency has developed preliminary quantitative estimates of the excess risk of mortality and morbidity that is attributable to currently allowable respirable crystalline silica exposure concentrations. The Agency is proposing a new PEL of 0.05 mg/m3 because exposures at and above this level present a significant risk to workers’ health. Even though OSHA’s preliminary risk assessment indicates that a significant risk exists at the proposed action level of 0.025 mg/m3, the Agency is not proposing a PEL below the proposed 0.05 mg/m3 limit because OSHA must also consider technological and economic feasibility in determining exposure limits. As explained in the Summary and Explanation for paragraph (c), Permissible Exposure Limit (PEL), OSHA has preliminary determined that the proposed PEL of 0.05 mg/m3 is technologically and economically feasible, but that a lower PEL of 0.025 mg/m3 is not technologically feasible. OSHA has preliminarily determined that long-term exposure at the current PEL presents a significant risk of material harm to workers’ health, and that adoption of the proposed PEL will substantially reduce this risk to the extent feasible. As discussed in Section V of this preamble (Health Effects Summary), inhalation exposure to respirable crystalline silica increases the risk of a variety of adverse health effects, including silicosis, chronic obstructive pulmonary disease (COPD), lung cancer, immunological effects, kidney disease, and infectious tuberculosis (TB). OSHA considers each of these conditions to be VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 a material impairment of health. These diseases result in significant discomfort, permanent functional limitations including permanent disability or reduced ability to work, reduced quality of life, and decreased life expectancy. When these diseases coexist, as is common, the effects are particularly debilitating (Rice and Stayner, 1995; Rosenman et al., 1999). Based on these findings and on the scientific evidence that respirable crystalline silica substantially increases the risk of each of these conditions, OSHA preliminarily concludes that workers who are exposed to respirable crystalline silica at the current PEL are at significant risk of material impairment of health or functional capacity. B. OSHA’s Preliminary Findings 1. Material Impairments of Health Section I of OSHA’s Health Effects Literature Review and Preliminary Quantitative Risk Assessment (available in Docket OSHA–2010–0034) describes in detail the adverse health conditions that workers who are exposed to respirable crystalline silica are at risk of developing. The Agency’s findings are summarized in Section V of this preamble (Health Effects Summary). The adverse health effects discussed include lung cancer, silicosis, other nonmalignant respiratory disease (NMRD), and immunological and renal effects. a. Silicosis Silicosis refers to a spectrum of lung diseases attributable to the inhalation of respirable crystalline silica. As described in Section V (Health Effects Summary), the three types of silicosis are acute, accelerated, and chronic. Acute silicosis can occur within a few weeks to months after inhalation exposure to extremely high levels of respirable crystalline silica. Death from acute silicosis can occur within months to a few years of disease onset, with the exposed person drowning in their own lung fluid (NIOSH, 1996). Accelerated silicosis results from exposure to high levels of airborne respirable crystalline silica, and disease usually occurs within 5 to 10 years of initial exposure (NIOSH, 1996). Both acute and accelerated silicosis are associated with exposures that are substantially above the current general industry PEL, although precise information on the relationships between exposure and occurrence of disease are not available. Chronic silicosis is the most common form of silicosis seen today, and is a progressive and irreversible condition characterized as a diffuse nodular pulmonary fibrosis (NIOSH, 1996). PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 56323 Chronic silicosis generally occurs after 10 years or more of inhalation exposure to respirable crystalline silica at levels below those associated with acute and accelerated silicosis. Affected workers may have a dry chronic cough, sputum production, shortness of breath, and reduced pulmonary function. These symptoms result from airway restriction caused by the development of fibrotic scarring in the alveolar sacs and the ends of the lung tissue. The scarring can be detected in chest x-ray films when the lesions become large enough to appear as visible opacities. The result is restriction of lung volumes and decreased pulmonary compliance with concomitant reduced gas transfer (Balaan and Banks, 1992). Chronic silicosis is characterized by small, rounded opacities that are symmetrically distributed in the upper lung zones on chest radiograph. The diagnosis of silicosis is based on a history of exposure to respirable crystalline silica, chest radiograph findings, and the exclusion of other conditions, including tuberculosis (TB). Because workers affected by early stages of chronic silicosis are often asymptomatic, the finding of opacities in the lung is key to detecting silicosis and characterizing its severity. The International Labour Organization (ILO) International Classification of Radiographs of Pneumoconioses (ILO, 1980, 2002, 2011) is the currently accepted standard against which chest radiographs are evaluated in epidemiologic studies, for medical surveillance, and for clinical evaluation. The ILO system standardizes the description of chest x-rays, and is based on a 12-step scale of severity and extent of silicosis as evidenced by the size, shape, and density of opacities seen on the x-ray film. Profusion (frequency) of small opacities is classified on a 4-point major category scale (0–3), with each major category divided into three, giving a 12-point scale between 0/¥ and 3/+. Large opacities are defined as any opacity greater than 1 cm that is present in a film. The small rounded opacities seen in early stage chronic silicosis (i.e., ILO major category 1 profusion) may progress (through ILO major categories 2 and/or 3) and develop into large fibrotic masses that destroy the lung architecture, resulting in progressive massive fibrosis (PMF). This stage of advanced silicosis is usually characterized by impaired pulmonary function, disability, and premature death. In cases involving PMF, death is commonly attributable to progressive respiratory insufficiency (Balaan and Banks, 1992). E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56324 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules The appearance of ILO category 2 or 3 background profusion of small opacities has been shown to increase the risk of developing large opacities characteristic of PMF. In one study of silicosis patients in Hong Kong, Ng and Chan (1991) found the risk of PMF increased by 42 and 64 percent among patients whose chest x-ray films were classified as ILO major category 2 or 3, respectively. Research has shown that people with silicosis advanced beyond ILO major category 1 have reduced median survival times compared to the general population (Infante-Rivard et al., 1991; Ng et al., 1992a; Westerholm, 1980). Silicosis is the oldest known occupational lung disease and is still today the cause of significant premature mortality. In 2005, there were 161 deaths in the U.S. where silicosis was recorded as an underlying or contributing cause of death on a death certificate (NIOSH, 2008c). Between 1996 and 2005, deaths attributed to silicosis resulted in an average of 11.6 years of life lost by affected workers (NIOSH, 2007). In addition, exposure to respirable crystalline silica remains an important cause of morbidity and hospitalizations. State-based hospital discharge data show that in the year 2000, 1,128 silicosis-related hospitalizations occurred, indicating that silicosis continues to be a significant health issue in the U.S. (CSTE, 2005). Although there is no national silicosis disease surveillance system in the U.S., a published analysis of state-based surveillance data from the time period 1987–1996 estimated that between 3,600–7,000 new cases of silicosis occurred in the U.S. each year (Rosenman et al., 2003). It has been widely reported that available statistics on silicosis-related mortality and morbidity are likely to be understated due to misclassification of causes of death (for example, as tuberculosis, chronic bronchitis, emphysema, or cor pulmonale), errors in recording occupation on death certificates, or misdiagnosis of disease by health care providers (Goodwin, 2003; Windau et al., 1991; Rosenman et al., 2003). Furthermore, reliance on chest x-ray findings may miss cases of silicosis because fibrotic changes in the lung may not be visible on chest radiograph; thus, silicosis may be present absent x-ray signs or may be more severe than indicated by x-ray (Hnizdo et al., 1993; Craighead and Vallyathan, 1980; Rosenman et al., 1997). Although most workers with earlystage silicosis (ILO categories 0/1 or 1/ 0) typically do not experience respiratory symptoms, the primary risk VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 to the affected worker is progression of disease with progressive decline of lung function. Several studies of workers exposed to crystalline silica have shown that, once silicosis is detected by x-ray, a substantial proportion of affected workers can progress beyond ILO category 1 silicosis, even after exposure has ceased (for example, Hughes et al., 1982; Hessel et al., 1988; Miller et al., 1998; Ng et al., 1987a; Yang et al., 2006). In a population of coal miners whose last chest x-ray while employed was classified as major category 0, and who were examined again 10 years after the mine had closed, 20 percent had developed opacities consistent with a classification of at least 1/0, and 4 percent progressed further to at least 2/ 1 (Miller et al., 1998). Although there were periods of extremely high exposure to respirable quartz in the mine (greater than 2 mg/m3 in some jobs between 1972 and 1976, and more than 10 percent of exposures between 1969 and 1977 were greater than 1 mg/m3), the mean cumulative exposure for the cohort over the period 1964–1978 was 1.8 mg/m3-years, corresponding to an average silica concentration of 0.12 mg/ m3. In a population of granite quarry workers exposed to an average respirable silica concentration of 0.48 mg/m3 (mean length of employment was 23.4 years), 45 percent of those diagnosed with simple silicosis showed radiological progression of disease after 2 to 10 years of follow up (Ng et al., 1987a). Among a population of gold miners, 92 percent progressed in 14 years; exposures of high-, medium-, and low-exposure groups were 0.97, 0.45, and 0.24 mg/m3, respectively (Hessel et al., 1988). Chinese mine and factory workers categorized under the Chinese system of x-ray classification as ‘‘suspected’’ silicosis cases (analogous to ILO 0/1) had a progression rate to stage I (analogous to ILO major category 1) of 48.7 percent and the average interval was about 5.1 years (Yang et al., 2006). These and other studies discussed in the Health Effects section are of populations of workers exposed to average concentrations of respirable crystalline silica above those permitted by OSHA’s current general industry PEL. The studies, however, are of interest to OSHA because the Agency’s current enforcement data indicate that exposures in this range are still common in some industry sectors. Furthermore, the Agency’s preliminary risk assessment is based on use of an exposure metric that is less influenced by exposure pattern and, instead, characterizes the accumulated exposure of workers over time. Further, the use of PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 a cumulative exposure metric reflects the progression of silica-related diseases: While it is not known that silicosis is a precursor to lung cancer, continued exposure to respirable crystalline silica among workers with silicosis has been shown to be associated with malignant respiratory disease (Chen et al., 1992). The Chinese pottery workers study offers an example of silicosis-associated lung cancer among workers in the clay industry, reflecting the variety of health outcomes associated with diverse silica exposures across industrial settings. The risk of silicosis, and particularly its progression, carries with it an increased risk of reduced lung function. There is strong evidence in the literature for the finding that lung function deteriorates more rapidly in workers exposed to silica, especially those with silicosis, than what is expected from a normal aging process (Cowie 1998; Hughes et al., 1982; Malmberg et al., 1993; Ng and Chan, 1992). The rates of decline in lung function are greater in those whose disease showed evidence of ´ radiologic progression (Begin et al., 1987a; Cowie 1998; Ng and Chan, 1992; Ng et al., 1987a). Additionally, the average deterioration of lung function exceeds that in smokers (Hughes et al., 1982). Several studies have reported no decrease in pulmonary function with an ILO category 1 level of profusion of small opacities but found declines in pulmonary function with categories 2 and 3 (Ng et al., 1987a; Begin et al., 1988; Moore et al., 1988). A study by Cowie (1998), however, found a statistically significantly greater annual loss in FVC and FEV1 among those with category 1 profusion compared to category 0. In another study, Cowie and Mabena (1991) found that the degree of profusion of opacities was associated with reductions in several pulmonary function metrics. Still, other studies have reported no associations between radiographic silicosis and decreases in pulmonary function (Ng et al., 1987a; Wiles et al., 1992; Hnizdo, 1992), with some studies (Ng et al., 1987a; Wang et al., 1997) finding that measurable changes in pulmonary function are evident well before the changes seen on chest x-ray. This may reflect the general insensitivity of chest radiography in detecting lung fibrosis, and/or may reflect that exposure to respirable silica has also been shown to increase the risk of chronic obstructive pulmonary disease (COPD) (see Section V, Health Effects Summary). Finally, silicosis, and exposure to respirable crystalline silica in and of itself, increases the risk that latent E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules tuberculosis infection can convert to active disease. Early descriptions of dust diseases of the lung did not distinguish between TB and silicosis, and most fatal cases described in the first half of this century were a combination of silicosis and TB (Castranova et al., 1996). More recent findings demonstrate that exposure to silica, even without silicosis, increases the risk of infectious (i.e., active) pulmonary TB (Sherson et al., 1990; Cowie, 1994; Hnizdo and Murray, 1998; WaterNaude et al., 2006). Both conditions together can hasten the development of respiratory impairment and increase mortality risk even beyond that experienced by unexposed persons with active TB (Banks, 2005). Based on the information presented above and in its review of the health literature, OSHA preliminarily concludes that silicosis remains a significant cause of early mortality and of serious morbidity, despite the existence of an enforceable exposure limit over the past 40 years. Silicosis in its later stages of progression (i.e., with chest x-ray findings of ILO category 2 or 3 profusion of small opacities, or the presence of large opacities) is characterized by the likely appearance of respiratory symptoms and decreased pulmonary function, as well as increased risk of progression to PMF, disability, and early mortality. Earlystage silicosis, although without symptoms among many who are affected, nevertheless reflects the formation of fibrotic lesions in the lung and increases the risk of progression to later stages, even after exposure to respirable crystalline silica ceases. In addition, the presence of silicosis increases the risk of pulmonary infections, including conversion of latent TB infection to active TB. Silicosis is not a reversible condition and there is no specific treatment for the disease, other than administration of drugs to alleviate inflammation and maintain open airways, or administration of oxygen therapy in severe cases. Based on these considerations, OSHA preliminarily finds that silicosis of any form, and at any stage, is a material impairment of health and that fibrotic scarring of the lungs represents loss of functional respiratory capacity. b. Lung Cancer OSHA considers lung cancer, an irreversible and usually fatal disease, to be a clear material impairment of health. According to the National Cancer Institute (Horner et al., 2009), the fiveyear survival rate for all forms of lung cancer is only 15.6 percent, a rate that has not improved in nearly two decades. OSHA’s preliminary finding that respirable crystalline silica exposure substantially increases the risk of lung cancer mortality is based on the best available toxicological and epidemiological data, reflects substantial supportive evidence from 56325 animal and mechanistic research, and is consistent with the conclusions of other government and public health organizations, including the International Agency for Research on Cancer (IARC, 1997), the National Toxicology Program (NTP, 2000), the National Institute for Occupational Safety and Health (NIOSH, 2002), the American Thoracic Society (1997), and the American Conference of Governmental Industrial Hygienists (ACGIH, 2001). The Agency’s primary evidence comes from evaluation of more than 50 studies of occupational cohorts from many different industry sectors in which exposure to respirable crystalline silica occurs, including granite and stone quarrying; the refractory brick industry; gold, tin, and tungsten mining; the diatomaceous earth industry; the industrial sand industry; and construction. Studies key to OSHA’s risk assessment are outlined in Table VII–1, which summarizes exposure characterization and related lung cancer risk across several different industries. In addition, the association between exposure to respirable crystalline silica and lung cancer risk was reported in a national mortality surveillance study (Calvert et al., 2003) and in two community-based studies (Pukkala et al., 2005; Cassidy et al., 2007), as well as in a pooled analysis of 10 occupational cohort studies (Steenland et al., 2001a). TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES Industry sector/population Type of study and description of population Exposure characterization No. of lung cancer deaths/cases Risk ratios (95% CI) Additional information U.S. Diatomaceous earth workers. Cohort study. Same as Checkoway et al., 1993, excluding 317 workers whose exposures could not be characterized, and including 89 workers with asbestos exposure who were previously excluded from the 1993 study. Follow up through 1994. Cohort study. N=2,209 white male miners employed between 1936 and 1943. Followed from 1968– 1986. Assessment based on almost 6,400 samples taken from 1948–1988; about 57 percent of samples represented particle counts, 17 percent were personal respirable dust samples. JEM included 135 jobs over 4 time periods (Seixas et al., 1997). Particle count data from Beadle (1971). 77 ................................ SMR 129 (CI 101– 161) based on national rates, and SMR 144 (CI 114– 180) based on local rates. Risk ratios by exposure quintile were 1.00, 0.96, 0.77, 1.26, and 2.15, with the latter being stat. sig. RR= 2.15 and 1.67. Smoking history available for half cohort. Under worst-case assumptions, the risk ratio for the high-exposure group would be reduced to 1.67 after accounting for smoking. Checkoway et al., 1997. 77 ................................ RR 1.023 (CI 1.005– 1.042) per 1,000 particle-years of exposure based on Cox proportional hazards model. Model adjusted for smoking and year of birth. Lung cancer was associated with silicosis of the hilar glands not silicosis of lung or pleura. Possible confounding by radon exposure among miners with 20 or more years experience. Hnizdo and SluisCremer, 1991. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 South African gold miners. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Source 56326 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES—Continued Industry sector/population Type of study and description of population Exposure characterization South African gold miners. Nested case-control study from population study by Hnizdo and SluisCremer,1991. N=78 cases, 386 controls. Particle count data converted to respirable dust mass (Beadle and Bradley, 1970, and Page-Shipp and Harris, 1972). 78 ................................ RR 2.45 (CI 1.2–5.2) when silicosis was included in model. US gold miners. Cohort and nested case-control study, same population as Brown et al. (1986); workers with at least 1 year underground work between 1940 and 1965. Follow up through 1990. 115 .............................. Australian gold miners. Cohort and nested case-control study. N=2,297, follow up of Armstrong et al. (1979). Follow up through 1993. Particle count data, conversion to mass concentration based on Vt. Granite study, construction of JEM. Median quartz exposures were 0.15, 0.07, and 0.02 mg/ m3 prior to 1930, from 1930–1950, and after 1950 respectively. Expert ranking of dustiness by job. SMR 113 (CI 94–136) overall. SMRs increased for workers with 30 or more years of latency, and when local cancer rates used as referents. Case-control study showed no relationship of risk to cumulative exposure to dust. SMR 126 (CI 107– 159) lower bound; SMR 149 (CI 126– 176) upper bound. From case-control, RR 1.31 (CI 1.10– 1.7) per unit exposure score. U.S. (Vermont) granite shed and quarry workers –. Cohort study. N=5,414 employed at least 1 year between 1950 and 1982. Exposure data not used in analysis. 53 deaths among those hired before 1930; 43 deaths among those hired after 1940. Finnish granite workers. Cohort and nested case-control studies. N=1,026, follow up from 1972–1981, extended to 1985 (Koskella et al., 1990) and 1989 (Koskella et al., 1994). Case-control study from McDonald et al. (2001) cohort. Personal sampling data collected from 1970–1972 included total and respirable dust and respirable silica sampling. Average silica concentrations ranged form 0.3–4.9 mg/m3. Assessment based on 14,249 respirable dust and silica samples taken from 1974 to 1998. Exposures prior to this based on particle count data. Adjustments made for respirator use (Rando et al., 2001). 31 through 1989 ......... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 North American industrial sand workers. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 No. of lung cancer deaths/cases Nested case control of 138 lung cancer deaths. 95 cases, two controls per case. Frm 00054 Fmt 4701 Risk ratios (95% CI) SMR 129 for pre-1930 hires (not stat. sig.); SMR 95 for post1940 hires (not stat. sig). SMR 181 (stat. sig) for shed workers hired before 1930 and with long tenure and latency. Through 1989, SMR 140 (CI 98–193). For workers in two regions where silica content of rock was highest, SMRs were 126 (CI 71–208) and 211 (CI 120–342), respectively. OR 1.00, 0.84, 2.02 and 2.07 for increasing quartiles of exposure p for trend=0.04). Sfmt 4702 Additional information Source Lung cancer mortality Hnizdo et al., 1997. associated with smoking, cumulative dust exposure, and duration of underground work. Latter two factors were most significantly associated with lung cancer with exposure lagged 20 years. Smoking data availSteenland and Brown, able for part of co1995a, 1995b hort, habits comparable to general US population; attributable smokingrelated cancer risk estimated to be 1.07. Association between exposure and lung cancer mortality not stat. sig. after adjusting for smoking, bronchitis, and silicosis. Authors concluded lung cancer restricted to miners who received compensation for silicosis.. Dust controls employed between 1938 and 1940 with continuing improvement afterwards. de Klerk and Musk, 1998 Smoking habits similar to other Finnish occupational groups. Minimal work-related exposures to other carcinogens. Koskela et al., 1987, 1990, 1994. Adjusted for smoking. Positive association between silica exposure and lung cancer. Median exposure for cases and controls were 0.148 and 0.110 mg/m3 respirable silica, respectively. Hughes et al., 2001. E:\FR\FM\12SEP2.SGM 12SEP2 Costello and Graham, 1988. Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56327 TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES—Continued Type of study and description of population Exposure characterization No. of lung cancer deaths/cases Risk ratios (95% CI) Additional information U.S. industrial sand workers. Cohort and nested case-control study. N=4,626 workers. Follow up from 1960–1996. SMR 160 (CI 131– 193) overall. Positive trends seen with cumulative silica exposure (p=0.04 for unlagged, p=0.08 for lagged). Smoking data from 358 workers suggested that smoking could not explain the observed increase in lung cancer mortality rates. Steenland and Sanderson, 2001. Cohort study. N=54,522 workers employed 1 yr. or more between 1972 and 1974. Follow up through 1989. ..................................... SMRs 198 for tin workers (no CI reported but stat. sig.). No stat. sig. increased SMR for tungsten or copper miners. Non-statistically significantly increased risk ratio for lung cancer among silicotics. No increased gradient in risk observed with exposure. Chen et al., 1992. Chinese Pottery workers. Cohort study. N=13,719 workers employed in 1972– 1974. Follow up through 1989. ..................................... SMR 58 (p<0.05) overall. RR 1.63 (CI 0.8– 3.4) among silicotics compared to nonsilicotics. No reported increase in lung cancer with increasing exposure. Chen et al., 1992. British Coal workers. Cohort study. N=17,820 miners from 10 collieries.. Exposure assessment based on 4,269 compliance dust samples taken from 1974–1996 and analyzed for respirable quartz. Exposures prior to 1974 based on particle count data and quartz analysis of settled dust and dust collected by high-volume air samplers, and use of a conversion factor (1 mppcf=0.1 mg/m3). Measurements for total dust, quartz content, and particle size taken from 1950’s1980’s. Exposures categorized as high, medium, low, or non-exposed. Measurements of jobspecific total dust and quartz content of settled dust used to classify workers into one of four total dust exposure groups. Quartz exposure assessed from personal respirable dust samples. 109 deaths overall ...... Chinese Tin, Tungsten, and Copper miners. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Industry sector/population 973 .............................. Significant relationship between cumulative silica exposure (lagged 15 years) and lung cancer mortality VIA Cox regression. Adjusted for smoking .. Miller et al, 2007; Miller and MacCalman, 2009 Toxicity studies provide additional evidence of the carcinogenic potential of crystalline silica (Health Effects Summary, Section V). Acellular studies using DNA exposed directly to freshly fractured crystalline silica demonstrate the direct effect silica has on DNA breakage. Cell culture research has investigated the processes by which crystalline silica disrupts normal gene expression and replication (Section V). Studies demonstrate that chronic inflammatory and fibrotic processes resulting in oxidative and cellular damage set up another possible mechanism that leads to neoplastic changes in the lung (Goldsmith, 1997; see also Health Effects discussion in Section V). In addition, the biologically damaging physical characteristics of crystalline silica, and the direct and indirect genotoxicity of crystalline silica (Schins, 2002; Borm and Driscoll, 1996), support the Agency’s preliminary position that respirable crystalline silica should be considered as an occupational carcinogen that causes lung cancer, a clear material impairment of health. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 c. Non-Malignant Respiratory Disease (Other Than Silicosis) Exposure to respirable crystalline silica increases the risk of developing chronic obstructive pulmonary disease (COPD), in particular chronic bronchitis and emphysema. COPD results in loss of pulmonary function that restricts normal activity in individuals afflicted with these conditions (ATS, 2003). Both chronic bronchitis and emphysema can occur in conjunction with development of silicosis. Several studies have documented increased prevalence of chronic bronchitis and emphysema among silica-exposed workers even absent evidence of silicosis (see Section I of the Health Effects Literature Review and Preliminary Quantitative Risk Assessment; NIOSH, 2002; ATS, 1997). There is evidence that smoking may have an additive or synergistic effect on silica-related COPD morbidity or mortality (Hnizdo, 1990; Hnizdo et al., 1990; Wyndham et al., 1986; NIOSH, 2002). In a study of diatomaceous earth workers, Park et al. (2002) found a positive exposure-response relationship between exposure to respirable PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 Source cristobalite and increased mortality from non-malignant respiratory disease. Decrements in pulmonary function have often been found among workers exposed to respirable crystalline silica absent radiologic evidence of silicosis. Several cross-sectional studies have reported such findings among granite workers (Theriault, 1974a, 1974b; Ng et al., 1992b; Montes et al., 2004b), South African gold miners (Irwig and Rocks, 1978; Hnizdo et al., 1990; Cowie and Mabena, 1991), gemstone cutters (Ng et al., 1987b), concrete workers (Meijer et al., 2001), refractory brick workers (Wang et al., 1997), hard rock miners (Manfreda et al., 1982; Kreiss et al., 1989), pottery workers (Neukirch et al., 1994), slate workers (Suhr et al., 2003), and potato sorters (Jorna et al., 1994). OSHA also evaluated several longitudinal studies where exposed workers were examined over a period of time to track changes in pulmonary function. Among both active and retired Vermont granite workers exposed to an average of 60 mg/m3, Graham did not find exposure-related decrements in pulmonary function (Graham et al., 1981, 1994). However, Eisen et al. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56328 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules (1995) did find significant pulmonary decrements among a subset of granite workers (termed ‘‘dropouts’’) who left work and consequently did not voluntarily participate in the last of a series of annual pulmonary function tests. This group of workers experienced steeper declines in FEV1 compared to the subset of workers who remained at work and participated in all tests (termed ‘‘survivors’’), and these declines were significantly related to dust exposure. Thus, in this study, workers who had left work had exposure-related declines in pulmonary function to a greater extent than did workers who remained on the job, clearly demonstrating a survivor effect among the active workers. Exposure-related changes in lung function were also reported in a 12-year study of granite workers (Malmberg et al., 1993), in two 5-year studies of South African miners (Hnizdo, 1992; Cowie, 1998), and in a study of foundry workers whose lung function was assessed between 1978 and 1992 (Hertzberg et al., 2002). Each of these studies reported their findings in terms of rates of decline in any of several pulmonary function measures, such as FVC, FEV1, and FEV1/ FVC. To put these declines in perspective, Eisen et al. (1995), reported that the rate of decline in FEV1 seen among the dropout subgroup of Vermont granite workers was 4 ml per mg/m3-year of exposure to respirable granite dust; by comparison, FEV1 declines at a rate of 10 ml/year from smoking one pack of cigarettes daily. From their study of foundry workers, Hertzberg et al., (2002) reported finding a 1.1 ml/year decline in FEV1 and a 1.6 ml/year decline in FVC for each mg/m3year of respirable silica exposure after controlling for ethnicity and smoking. From these rates of decline, they estimated that exposure to the current OSHA quartz standard of 0.1 mg/m3 for 40 years would result in a total loss of FEV1 and FVC that is less than but still comparable to smoking a pack of cigarettes daily for 40 years. Hertzberg et al. (2002) also estimated that exposure to the current standard for 40 years would increase the risk of developing abnormal FEV1 or FVC by factors of 1.68 and 1.42, respectively. OSHA believes that this magnitude of reduced pulmonary function, as well as the increased morbidity and mortality from non-malignant respiratory disease that has been documented in the studies summarized above, constitute material impairments of health and loss of functional respiratory capacity. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 d. Renal and Autoimmune Effects OSHA’s review of the literature summarized in Section V, Health Effects Summary, reflects substantial evidence that exposure to crystalline silica increases the risk of renal and autoimmune diseases. Epidemiologic studies have found statistically significant associations between occupational exposure to silica dust and chronic renal disease (e.g., Calvert et al., 1997), subclinical renal changes including proteinurea and elevated serum creatinine (e.g., Ng et al., 1992c; Rosenman et al., 2000; Hotz et al., 1995), end-stage renal disease morbidity (e.g., Steenland et al., 1990), chronic renal disease mortality (Steenland et al., 2001b, 2002a), and Wegener’s granulomatosis (Nuyts et al., 1995), the latter of which represents severe injury to the glomeruli that, if untreated, rapidly leads to renal failure. Possible mechanisms suggested for silicainduced renal disease include a direct toxic effect on the kidney, deposition in the kidney of immune complexes (IgA) following silica-related pulmonary inflammation, or an autoimmune mechanism (Calvert et al., 1997; Gregorini et al., 1993). Steenland et al. (2002a) demonstrated a positive exposure-response relationship between exposure to respirable crystalline silica and end-stage renal disease mortality. In addition, there are a number of studies that show exposure to be related to increased risks of autoimmune disease, including scleroderma (e.g., Sluis-Cremer et al., 1985), rheumatoid arthritis (e.g. Klockars et al., 1987; Rosenman and Zhu, 1995), and systemic lupus erythematosus (e.g., Brown et al., 1997). Scleroderma is a degenerative disorder that leads to over-production of collagen in connective tissue that can cause a wide variety of symptoms including skin discoloration and ulceration, joint pain, swelling and discomfort in the extremities, breathing problems, and digestive problems. Rheumatoid arthritis is characterized by joint pain and tenderness, fatigue, fever, and weight loss. Systemic lupus erythematosus is a chronic disease of connective tissue that can present a wide range of symptoms including skin rash, fever, malaise, joint pain, and, in many cases, anemia and iron deficiency. OSHA believes that chronic renal disease, end-stage renal disease mortality, Wegener’s granulomatosis, scleroderma, rheumatoid arthritis, and systemic lupus erythematosus clearly represent material impairments of health. PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 2. Significance of Risk To evaluate the significance of the health risks that result from exposure to hazardous chemical agents, OSHA relies on toxicological, epidemiological, and experimental data, as well as statistical methods. The Agency uses these data and methods to characterize the risk of disease resulting from workers’ exposure to a given hazard over a working lifetime at levels of exposure reflecting both compliance with current standards and compliance with the new standard being proposed. In the case of crystalline silica, the current general industry, construction, and shipyard PELs are formulas that limit 8-hour TWA exposures to respirable dust; the limit on exposure decreases with increasing crystalline silica content of the dust. OSHA’s current general industry PEL for respirable quartz is expressed both in terms of a particle count as well as a gravimetric concentration, while the current construction and shipyard employment PELs for respirable quartz are only expressed in terms of a particle count formula. For general industry, the gravimetric formula PEL for quartz approaches 0.1 mg/m3 (100 mg/m3) of respirable crystalline silica when the quartz content of the dust is about 10 percent or greater. For the construction and shipyard industries, the current PEL is a formula that is based on concentration of respirable particles in the air; on a mass concentration basis, it is believed by OSHA to lie within a range of between about 0.25 mg/m3 (250 mg/m3) to 0.5 mg/m3 (500 mg/m3) expressed as respirable quartz (see Section VI). In general industry, the current PELs for cristobalite and tridymite are one-half the PEL for quartz. OSHA is proposing to revise the current PELs for general industry, construction, and shipyards to 0.05 mg/ m3 (50 mg/m3) of respirable crystalline silica. OSHA is also proposing an action level of 0.025 mg/m3 (25 mg/m3). In the Summary of the Preliminary Quantitative Risk Assessment (Section VI of the preamble), OSHA presents estimates of health risks associated with 45 years of exposure to 0.025, 0.05, and 0.1 mg/m3 respirable crystalline silica to represent the risks associated with exposure over a working lifetime to the proposed action level, proposed PEL, and current general industry PEL, respectively. OSHA also presents estimates associated with exposure to 0.25 and 0.5 mg/m3 to represent a range of risks likely to be associated with exposure to the current construction and shipyard PELs. Risk estimates are E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 presented for mortality due to lung cancer, silicosis and other nonmalignant lung disease, and end-stage renal disease, as well as silicosis morbidity. The preliminary findings from this assessment are summarized below. a. Summary of Excess Risk Estimates for Excess Lung Cancer Mortality For preliminary estimates of lung cancer risk from crystalline silica exposure, OSHA has relied upon studies of exposure-response relationships presented in a pooled analysis of 10 cohort studies (Steenland, et al. 2001a; Toxichemica, Inc., 2004) as well as on individual studies of granite (Attfield and Costello, 2004), diatomaceous earth (Rice et al., 2001), and industrial sand (Hughes et al., 2001) worker cohorts, and a study of coal miners exposed to respirable quartz (Miller et al., 2007; Miller and MacCalman, 2009). OSHA believes these studies are suitable for use to quantitatively characterize health risks to exposed workers because (1) study populations were of sufficient size to provide adequate power to detect low levels of risk, (2) sufficient quantitative exposure data were available to characterize cumulative exposures of cohort members to respirable crystalline silica, (3) the studies either adjusted for or otherwise adequately addressed confounding factors such as smoking and exposure to other carcinogens, and (4) investigators developed quantitative assessments of exposure-response relationships using appropriate statistical models or otherwise provided sufficient information that permits OSHA to do so. Where investigators estimated excess lung cancer risks associated with exposure to the current PEL or NIOSH recommended exposure limit, OSHA provided these estimates in its Preliminary Quantitative Risk Assessment. However, OSHA implemented all risk models in its own life table analysis so that the use of background lung cancer rates and assumptions regarding length of exposure and lifetime were constant across each of the models, and so OSHA could estimate lung cancer risks associated with exposure to specific levels of silica of interest to the Agency. The Steenland et al. (2001a) study consisted of a pooled exposure-response analysis and risk assessment based on raw data obtained for ten cohorts of silica-exposed workers (65,980 workers, 1,072 lung cancer deaths). The cohorts in this pooled analysis include U.S. gold miners (Steenland and Brown, 1995a), U.S. diatomaceous earth workers (Checkoway et al., 1997), Australian gold miners (deKlerk and Musk, 1998), VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Finnish granite workers (Koskela et al., 1994), South African gold miners (Hnizdo et al., 1997), U.S. industrial sand employees (Steenland et al., 2001b), Vermont granite workers (Costello and Graham, 1988), and Chinese pottery workers, tin miners, and tungsten miners (Chen et al., 1992). The investigators used a nested casecontrol design with cases and controls matched for race, sex, age (within five years) and study; 100 controls were matched for each case. An extensive exposure assessment for this pooled analysis was developed and published by Mannetje et al. (2002a). Exposure measurement data were available for all 10 cohorts and included measurements of particle counts, total dust mass, respirable dust mass, and, for one cohort, respirable quartz. Cohortspecific conversion factors were used to estimate cumulative exposures to respirable crystalline silica. A casecontrol analysis of silicosis mortality (Mannetje et al., 2002b) showed a strong positive exposure-response trend, indicating that cumulative exposure estimates for the cohorts were not subject to random misclassification errors of such a magnitude so as to obscure observing an exposure-response relationship between silica and silicosis despite the variety of dust measurement metrics relied upon and the need to make assumptions to convert the data to a single exposure metric (i.e., mass concentration of respirable crystalline silica). In effect, the known relationship between exposure to respirable silica and silicosis served as a positive control to assess the validity of exposure estimates. Quantitative assessment of lung cancer risks were based on use of a log-linear model (log RR = bx, where x represents the exposure variable and b the coefficient to be estimated) with a 15-year exposure lag providing the best fit. Models based on untransformed or log-transformed cumulative dose metrics provided an acceptable fit to the pooled data, with the model using untransformed cumulative dose providing a slightly better fit. However, there was substantial heterogeneity among the exposure-response coefficients derived from the individual cohorts when untransformed cumulative dose was used, which could result in one or a few of the cohorts unduly influencing the pooled exposure-response coefficient. For this reason, the authors preferred the use of log-transformed cumulative exposure in the model to derive the pooled coefficient since heterogeneity was substantially reduced. PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 56329 OSHA’s implementation of this model is based on a re-analysis conducted by Steenland and Bartow (Toxichemica, 2004), which corrected small errors in the assignment of exposure estimates in the original analysis. In addition, subsequent to the Toxichemica report, and in response to suggestions made by external peer reviewers, Steenland and Bartow conducted additional analyses based on use of a linear relative risk model having the general form RR = 1 + bx, as well as a categorical analysis (personal communication, Steenland 2010). The linear model was implemented with both untransformed and log-transformed cumulative exposure metrics, and was also implemented as a 2-piece spline model. The categorical analysis indicates that, for the pooled data set, lung cancer relative risks increase steeply at low exposures, after which the rate of increase in relative risk declines and the exposure-response curve becomes flat (see Figure II–2 of the Preliminary Quantitative Risk Assessment). Use of either the linear relative risk or loglinear relative risk model with untransformed cumulative exposure (with or without a 15-year lag) failed to capture this initial steep slope, resulting in an underestimate of the relative risk compared to that suggested by the categorical analysis. In contrast, use of log-transformed cumulative exposure with the linear or log-linear model, and use of the 2-piece linear spline model with untransformed exposure, better reflected the initial rise and subsequent leveling out of the exposure-response curve, with the spline model fitting somewhat better than either the linear or log-linear models (all models incorporated a 15-year exposure lag). Of the three models that best reflect the shape of the underlying exposureresponse curve suggested by the categorical analysis, there is no clear rationale to prefer one over the other. Use of log-transformed cumulative exposure in either the linear or loglinear models has the advantage of reducing heterogeneity among the 10 pooled studies, lessening the likelihood that the pooled coefficient would be overtly influenced by outliers; however, use of a log-transformed exposure metric complicates comparing results with those from other risk analyses considered by OSHA that are based on untransformed exposure metrics. Since all three of these models yield comparable estimates of risk the choice of model is not critical for the purpose of assessing significance of the risk, and therefore OSHA believes that the risk estimates derived from the pooled study E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56330 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules are best represented as a range of estimates based on all three of these models. From these models, the estimated lung cancer risk associated with 45 years of exposure to 0.1 mg/m3 (about equal to the current general industry PEL) is between 22 and 29 deaths per 1,000 workers. The estimated risk associated with exposure to silica concentrations in the range of 0.25 and 0.5 mg/m3 (about equal to the current construction and shipyard PELs) is between 27 and 38 deaths per 1,000. At the proposed PEL of 0.05 mg/m3, the estimated excess risk ranges from 18 to 26 deaths per 1,000, and, at the proposed action level of 0.025 mg/m3, from 9 to 23 deaths per 1,000. As previously discussed, the exposure-response coefficients derived from each of the 10 cohorts exhibited significant heterogeneity; risk estimates based on the coefficients derived from the individual studies for untransformed cumulative exposure varied by almost two orders of magnitude, with estimated risks associated with exposure over a working lifetime to the current general industry PEL ranging from a low of 0.8 deaths per 1,000 (from the Chinese pottery worker study) to a high of 69 deaths per 1,000 (from the South African miner study). It is possible that the differences seen in the slopes of the exposure-response relationships reflect physical differences in the nature of crystalline silica particles generated in these workplaces and/or the presence of different substances on the crystal surfaces that could mitigate or enhance their toxicity (see Section V, Health Effects Summary). It may also be that exposure estimates for some cohorts were subject to systematic misclassification errors resulting in under- or over-estimation of exposures due to the use of assumptions and conversion factors that were necessary to estimate mass respirable crystalline silica concentrations from exposure samples analyzed as particle counts or total and respirable dust mass. OSHA believes that, given the wide range of risk estimates derived from these 10 studies, use of log-transformed cumulative exposure or the 2-piece spline model is a reasonable approach for deriving a single summary statistic that represents the lung cancer risk across the range of workplaces and exposure conditions represented by the studies. However, use of these approaches results in a non-linear exposure-response and suggests that the relative risk of silica-related lung cancer begins to attenuate at cumulative exposures in the range of those represented by the current PELs. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Although such exposure-response relationships have been described for some carcinogens (for example, from metabolic saturation or a healthy worker survivor effect, see Staynor et al., 2003), OSHA is not aware of any specific evidence that would suggest that such a result is biologically plausible for silica, except perhaps the possibility that lung cancer risks increase more slowly with increasing exposure because of competing risks from other silica-related diseases. Attenuation of the exposureresponse can also result from misclassification of exposure estimates for the more highly-exposed cohort members (Staynor et al., 2003). OSHA’s evaluation of individual cohort studies discussed below indicates that, with the exception of the Vermont granite cohort, attenuation of exposure-related lung cancer response has not been directly observed. In addition to the pooled cohort study, OSHA’s Preliminary Quantitative Risk Assessment presents risk estimates derived from four individual studies where investigators presented either lung cancer risk estimates or exposureresponse coefficients. Two of these studies, one on diatomaceous earth workers (Rice et al., 2001) and one on Vermont granite workers (Attfield and Costello, 2004), were included in the 10cohort pooled study (Steenland et al., 2001a; Toxichemica, 2004). The other two were of British coal miners (Miller et al., 2007; Miller and MacCalman, 2010) and North American industrial sand workers (Hughes et al., 2001). Rice et al. (2001) presents an exposure-response analysis of the diatomaceous worker cohort studied by Checkoway et al. (1993, 1996, 1997), who found a significant relationship between exposure to respirable cristobalite and increased lung cancer mortality. The cohort consisted of 2,342 white males employed for at least one year between 1942 and 1987 in a California diatomaceous earth mining and processing plant. The cohort was followed until 1994, and included 77 lung cancer deaths. The risk analysis relied on an extensive job-specific exposure assessment developed by Sexias et al. (1997), which included use of over 6,000 samples taken during the period 1948 through 1988. The mean cumulative exposure for the cohort was 2.16 mg/m3-years for respirable crystalline silica dust. Rice et al. (2001) evaluated several model forms for the exposure-response analysis and found exposure to respirable cristobalite to be a significant predictor of lung cancer mortality with the best-fitting model being a linear relative risk model (with a 15-year exposure lag). From this PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 model, the estimates of the excess risk of lung cancer mortality are 34, 17, and 9 deaths per 1,000 workers for 45-years of exposure to 0.1, 0.05, and 0.025 mg/ m3, respectively. For exposures in the range of the current construction and shipyard PELs over 45 years, estimated risks lie in a range between 81 and 152 deaths per 1,000 workers. Somewhat higher risk estimates are derived from the analysis presented by Attfield and Costello (2004) of Vermont granite workers. This study involved a cohort of 5,414 male granite workers who were employed in the Vermont granite industry between 1950 and 1982 and who were followed through 1994. Workers’ cumulative exposures were estimated by Davis et al. (1983) based on historical exposure data collected in six environmental surveys conducted between 1924 and 1977. A categorical analysis showed an increasing trend of lung cancer risk ratios with increasing exposure, and Poisson regression was used to evaluate several exposureresponse models with varying exposure lags and use of either untransformed or log-transformed exposure metrics. The best-fitting model was based on use of a 15-year lag, use of untransformed cumulative exposure, and omission of the highest exposure group. The investigators believed that the omission of the highest exposure group was appropriate since: (1) The underlying exposure data for the high-exposure group was weaker than for the others; (2) there was a greater likelihood that competing causes of death and misdiagnoses of causes of death attenuated the lung cancer death rate in the highest exposure group; (3) all of the remaining groups comprised 85 percent of the deaths in the cohort and showed a strong linear increase in lung cancer mortality with increasing exposure; and (4) the exposure-response relationship seen in the lower exposure groups was more relevant given that the exposures of these groups were within the range of current occupational standards. OSHA’s use of the exposure coefficient from this analysis in a log-linear relative risk model yielded a risk estimate of 60 deaths per 1,000 workers for 45 years of exposure to the current general industry PEL of 0.1 mg/m3, 25 deaths per 1,000 for 45 years of exposure to the proposed PEL of 0.05 mg/m3, and 11 deaths per 1,000 for 45 years of exposure at the proposed action level of 0.025 mg/m3. Estimated risks associated with 45 years of exposure at the current construction PEL range from 250 to 653 deaths per 1,000. Hughes et al. (2001) conducted a nested case-control study of 95 lung cancer deaths from a cohort of 2,670 E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules industrial sand workers in the U.S. and Canada studied by McDonald et al. (2001). (This cohort overlaps with the cohort studied by Steenland and Sanderson (2001), which was included in the 10-cohort pooled study by Steenland et al., 2001a). Both categorical analyses and conditional logistic regression were used to examine relationships with cumulative exposure, log of cumulative exposure, and average exposure. Exposure levels over time were estimated via a job-exposure matrix developed for this study (Rando et al., 2001). The 50th percentile (median) exposure level of cases and controls for lung cancer were 0.149 and 0.110 mg/m3 respirable crystalline silica, respectively, slightly above the current OSHA general industry standard. There did not appear to be substantial misclassification of exposures, as evidenced by silicosis mortality showing a positive exposureresponse trend with cumulative exposure and average exposure concentration. Statistically significant positive exposure-response trends for lung cancer were found for both cumulative exposure (lagged 15 years) and average exposure concentration, but not for duration of employment, after controlling for smoking. There was no indication of an interaction effect of smoking and cumulative silica exposure. Hughes et al. (2001) reported the exposure coefficients for both lagged and unlagged cumulative exposure; there was no significant difference between the two (0.13 per mg/m3-year for lagged vs. 0.14 per mg/m3-year for unlagged). Use of the coefficient from Hughes et al. (2001) that incorporated a 15-year lag generates estimated cancer risks of 34, 15, and 7 deaths per 1,000 for 45 years exposure to the current general industry PEL of 0.1, the proposed PEL of 0.05 mg/m3, and the proposed action level of 0.025 mg/m3 respirable silica, respectively. For 45 years of exposure to the construction PEL, estimated risks range from 120 to 387 deaths per 1,000 workers. Miller and MacCalman (2010, also reported in Miller et al., 2007) extended the follow-up of a previously published cohort mortality study (Miller and Buchanan, 1997). The follow-up study included 17,800 miners from 10 coal mines in the U.K. who were followed through the end of 2005; observation in the original study began in 1970. By 2005, there were 516,431 person years of observation, an average of 29 years per miner, with 10,698 deaths from all causes. Exposure estimates of cohort members were not updated from the earlier study since the mines closed in VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the 1980s; however, some of these men might have had additional exposure at other mines or facilities. An analysis of cause-specific mortality was performed using external controls; it demonstrated that lung cancer mortality was statistically significantly elevated for coal miners exposed to silica. An analysis using internal controls was performed via Cox proportional hazards regression methods, which allowed for each individual miner’s measurements of age and smoking status, as well as the individual’s detailed dust and quartz time-dependent exposure measurements. From the Cox regression, Miller and MacCalman (2009) estimated that cumulative exposure of 5 g-h/m3 respirable quartz (incorporating a 15year lag) was associated with a relative risk of 1.14 for lung cancer. This cumulative exposure is about equivalent to 45 years of exposure to 0.055 mg/m3 respirable quartz, or a cumulative exposure of 2.25 mg/m3-yr, assuming 2,000 hours of exposure per year. OSHA applied this slope factor in a log-relative risk model and estimated the lifetime lung cancer mortality risk to be 13 per 1,000 for 45 years of exposure to 0.1 mg/ m3 respirable crystalline silica. For the proposed PEL of 0.05 mg/m3 and proposed action level of 0.025 mg/m3, the lifetime risks are estimated to be 6 and 3 deaths per 1,000, respectively. The range of risks estimated to result from 45 years of exposure to the current construction and shipyard PELs is from 37 to 95 deaths per 1,000 workers. The analysis from the Miller and MacCalman (2009) study yields risk estimates that are lower than those obtained from the other cohort studies described above. Possible explanations for this include: (1) Unlike the studies on diatomaceous earth workers and granite workers, the mortality analysis of the coal miners was adjusted for smoking; (2) lung cancer risks might have been lower among the coal miners due to high competing mortality risks observed in the cohort (mortality was significantly increased for several diseases, including tuberculosis, chronic bronchitis, and non-malignant respiratory disease); and (3) the lower risk estimates derived from the coal miner study could reflect an actual difference in the cancer potency of the quartz dust in the coal mines compared to that present in the work environments studied elsewhere. OSHA believes that the risk estimates derived from this study are credible. In terms of design, the cohort was based on union rolls with very good participation rates and good reporting. The study group was the largest of any of the individual PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 56331 cohort studies reviewed here (over 17,000 workers) and there was an average of nearly 30 years of follow-up, with about 60 percent of the cohort having died by the end of follow-up. Just as important were the high quality and detail of the exposure measurements, both of total dust and quartz. b. Summary of Risk Estimates for Silicosis and Other Chronic Lung Disease Mortality OSHA based its quantitative assessment of silicosis mortality risks on a pooled analysis conducted by Mannetje et al. (2002b) of data from six of the ten epidemiological studies in the Steenland et al. (2001a) pooled analysis of lung cancer mortality. Cohorts included in the silicosis study were U.S. diatomaceous earth workers (Checkoway et al., 1997); Finnish granite workers (Koskela et al., 1994); U.S. granite workers (Costello and Graham, 1988); U.S. industrial sand workers (Steenland and Sanderson, 2001); U.S. gold miners (Steenland and Brown, 1995b); and Australian gold miners (deKlerk and Musk, 1998). These six cohorts contained 18,634 subjects and 170 silicosis deaths, where silicosis mortality was defined as death from silicosis (ICD–9 502, n=150) or from unspecified pneumoconiosis (ICD–9 505, n = 20). Analysis of exposureresponse was performed in a categorical analysis where the cohort was divided into cumulative exposure deciles and Poisson regression was used to estimate silicosis rate ratios for each category, adjusted for age, calendar period, and study. Exposure-response was examined in more detail using a nested casecontrol design and logistic regression. Although Mannetje et al. (2002b) estimated silicosis risks at the current OSHA PEL from the Poisson regression, a subsequent analysis based on the casecontrol design was conducted by Steenland and Bartow (Toxichemica, 2004), which resulted in slightly lower estimates of risk. Based on the Toxichemica analysis, OSHA estimates that the lifetime risk (over 85 years) of silicosis mortality associated with 45 years of exposure to the current general industry PEL of 0.1 mg/m3 is 11 deaths per 1,000 workers. Exposure for 45 years to the proposed PEL of 0.05 mg/m3 and action level of 0.025 mg/m3 results in an estimated 7 and 4 silicosis deaths per 1,000, respectively. Lifetime risks associated with exposure at the current construction and shipyard PELs range from 17 to 22 deaths per 1,000 workers. To study non-malignant respiratory diseases, of which silicosis is one, Park et al. (2002) analyzed the California E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56332 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules diatomaceous earth cohort data originally studied by Checkoway et al. (1997), consisting of 2,570 diatomaceous earth workers employed for 12 months or more from 1942 to 1994. The authors quantified the relationship between exposure to cristobalite and mortality from chronic lung disease other than cancer (LDOC). Diseases in this category included pneumoconiosis (which included silicosis), chronic bronchitis, and emphysema, but excluded pneumonia and other infectious diseases. Less than 25 percent of the LDOC deaths in the analysis were coded as silicosis or other pneumoconiosis (15 of 67). As noted by Park et al. (2002), it is likely that silicosis as a cause of death is often misclassified as emphysema or chronic bronchitis. Exposure-response relationships were explored using both Poisson regression models and Cox’s proportional hazards models fit to the same series of relative rate exposureresponse models that were evaluated by Rice et al. (2001) for lung cancer (i.e., log-linear, log-square root, log-quadratic, linear relative rate, a power function, and a shape function). Relative or excess rates were modeled using internal controls and adjusting for age, calendar time, ethnicity (Hispanic versus white), and time since first entry into the cohort, or using age- and calendar timeadjusted external standardization to U.S. population mortality rates. There were no LDOC deaths recorded among workers having cumulative exposures above 32 mg/m3-years, causing the response to level off or decline in the highest exposure range; possible explanations considered included survivor selection, depletion of susceptible populations in high dust areas, and/or a higher degree of misclassification of exposures in the earlier years where exposure data were lacking and when exposures were presumably the highest. Therefore, Park et al. (2002) performed exposureresponse analyses that restricted the dataset to observations where cumulative exposures were below 10 mg/m3-years, a level more than four times higher than that resulting from 45 years of exposure to the current general industry PEL for cristobalite (which is about 0.05 mg/m3), as well as analyses using the full dataset. Among the models based on the restricted dataset, the best-fitting model with a single exposure term was the linear relative rate model using external adjustment. OSHA’s estimates of the lifetime chronic lung disease mortality risk based on this model are substantially higher than those that OSHA derived from the Mannetje et al. (2002b) silicosis VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 analysis. For the current general industry PEL of 0.1 mg/m3, exposure for 45 years is estimated to result in 83 deaths per 1,000 workers. At the proposed PEL of 0.05 mg/m3 and action level of 0.025 mg/m3, OSHA estimates the lifetime risk from 45 years of exposure to be 43 and 22 deaths per 1,000, respectively. The range of risks associated with exposure at the construction and shipyard PELs over a working lifetime is from 188 to 321 deaths per 1,000 workers. It should be noted that the Mannetje study (2002b) was not adjusted for smoking while the Park study (2002) had data on smoking habits for about one-third of the workers who died from LDOC and about half of the entire cohort. The Poisson regression on which the risk model is based was partially stratified on smoking. Furthermore, analyses without adjustment for smoking suggested to the authors that smoking was acting as a negative confounder. c. Summary of Risk Estimates for Renal Disease Mortality OSHA’s analysis of the health effects literature included several studies that have demonstrated that exposure to crystalline silica increases the risk of renal and autoimmune disease (see Section V, Health Effects Summary). Studies have found statistically significant associations between occupational exposure to silica dust and chronic renal disease, sub-clinical renal changes, end-stage renal disease morbidity, chronic renal disease mortality, and Wegener’s granulomatosis. A strong exposureresponse association for renal disease mortality and silica exposure has also been demonstrated. OSHA’s assessment of the renal disease risks that result from exposure to respirable crystalline silica are based on an analysis of pooled data from three cohort studies (Steenland et al., 2002a). The combined cohort for the pooled analysis (Steenland et al., 2002a) consisted of 13,382 workers and included industrial sand workers (Steenland et al., 2001b), U.S. gold miners (Steenland and Brown, 1995a), and Vermont granite workers (Costello and Graham, 1998). Exposure data were available for 12,783 workers and analyses conducted by the original investigators demonstrated monotonically increasing exposureresponse trends for silicosis, indicating that exposure estimates were not likely subject to significant random misclassification. The mean duration of exposure, cumulative exposure, and concentration of respirable silica for the combined cohort were 13.6 years, 1.2 PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 mg/m3-years, and 0.07 mg/m3, respectively. There were highly statistically significant trends for increasing renal disease mortality with increasing cumulative exposure for both multiple cause analysis of mortality (p<0.000001) and underlying cause analysis (p = 0.0007). Exposureresponse analysis was also conducted as part of a nested case-control study, which showed statistically significant monotonic trends of increasing risk with increasing exposure again for both multiple cause (p = 0.004 linear trend, 0.0002 log trend) and underlying cause (p = 0.21 linear trend, 0.03 log trend) analysis. The authors found that use of log-cumulative dose in a log relative risk model fit the pooled data better than cumulative exposure, average exposure, or lagged exposure. OSHA’s estimates of renal disease mortality risk, which are based on the log relative risk model with log cumulative exposure, are 39 deaths per 1,000 for 45 years of exposure at the current general industry PEL of 0.1 mg/m3, 32 deaths per 1,000 for exposure at the proposed PEL of 0.05 mg/m3, and 25 deaths per 1,000 at the proposed action level of 0.025 mg/m3. OSHA also estimates that 45 years of exposure at the current construction and shipyard PELs would result in a renal disease mortality risk ranging from 52 to 63 deaths per 1,000 workers. d. Summary of Risk Estimates for Silicosis Morbidity OSHA’s Preliminary Quantitative Risk Assessment reviewed several crosssectional studies designed to characterize relationships between exposure to respirable crystalline silica and development of silicosis as determined by chest radiography. Several of these studies could not provide information on exposure or length of employment prior to disease onset. Others did have access to sufficient historical medical data to retrospectively determine time of disease onset but included medical examination at follow up of primarily active workers with little or no postemployment follow-up. Although OSHA presents silicosis risk estimates that were reported by the investigators of these studies, OSHA believes that such estimates are likely to understate lifetime risk of developing radiological silicosis; in fact, the risk estimates reported in these studies are generally lower than those derived from studies that included retired workers in follow up medical examinations. Therefore, OSHA believes that the most useful studies for characterizing lifetime risk of silicosis morbidity are retrospective cohort studies that E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules included a large proportion of retired workers in the cohort and that were able to evaluate disease status over time, including post-retirement. OSHA identified studies of six cohorts for which the inclusion of retirees was deemed sufficient to adequately characterize silicosis morbidity risks well past employment (Hnizdo and Sluis-Cremer, 1993; Steenland and Brown, 1995b; Miller et al., 1998; Buchanan et al., 2003; Chen et al., 2001; Chen et al., 2005). Study populations included five mining cohorts and a Chinese pottery worker cohort. Except for the Chinese studies (Chen et al., 2001; Chen et al., 2005), chest radiographs were interpreted in accordance with the ILO system described earlier in this section, and xray films were read by panels of Breaders. In the Chinese studies, films were evaluated using a Chinese system of classification that is analogous to the ILO system. In addition, the Steenland and Brown (1995b) study of U.S. gold miners included silicosis mortality as well as morbidity in its analysis. OSHA’s estimates of silicosis morbidity risks are based on implementing the various exposure-response models reported by the investigators; these are considered to be cumulative risk models in the sense that they represent the risk observed in the cohort at the time of the last medical evaluation and do not reflect all of the risk that may become manifest over a lifetime. With the exception of a coal miner study (Buchanan et al., 2003), risk estimates reflect the risk that a worker will acquire an abnormal chest x-ray classified as ILO major category 1 or greater; the coal miner study evaluated the risk of acquiring an abnormal chest x-ray classified as major category 2 or higher. For miners exposed to freshly cut crystalline silica, the estimated risk of developing lesions consistent with an ILO classification of category 1 or greater is estimated to range from 120 to 773 cases per 1,000 workers exposed at the current general industry PEL of 0.1 mg/m3 for 45 years. For 45 years of exposure to the proposed PEL of 0.05 mg/m3, the range in estimated risk is from 20 to 170 cases per 1,000 workers. The risk predicted from exposure to the proposed action level of 0.025 mg/m3 ranges from 5 to 40 cases per 1,000. From the coal miner study of Buchanan et al. (2003), the estimated risks of acquiring an abnormal chest x-ray classified as ILO category 2 or higher are 301, 55, and 21 cases per 1,000 workers exposed for 45 years to 0.1, 0.05, and 0.025 mg/m3, respectively. These estimates are within the range of risks obtained from the other mining studies. At exposures at or above 0.25 mg/m3 for 45 years (equivalent to the current construction and shipyard PELs), the risk of acquiring an abnormal chest xray approaches unity. Risk estimates based on the pottery cohort are 60, 20, and 5 cases per 1,000 workers exposed for 45 years to 0.1, 0.05, and 0.025 mg/ m3, respectively, which is generally below the range of risks estimated from the other studies and may reflect a lower toxicity of quartz particles in that work environment due to the presence of alumino-silicates on the particle surfaces. According to Chen et al. (2005), adjustment of the exposure metric to reflect the unoccluded surface area of silica particles resulted in an exposure-response of pottery workers that was similar to the mining cohorts. The finding of a reduced silicosis risk among pottery workers is consistent with other studies of clay and brick industries that have reported finding a lower prevalence of silicosis compared to that experienced in other industry sectors (Love et al., 1999; Hessel, 2006; Miller and Soutar, 2007) as well as a lower silicosis risk per unit of cumulative exposure (Love et al., 1999; Miller and Soutar, 2007). 3. Significance of Risk and Risk Reduction The Supreme Court’s benzene decision of 1980, discussed above in this section, states that ‘‘before he can promulgate any permanent health or safety standard, the Secretary [of Labor] is required to make a threshold finding that a place of employment is unsafe— 56333 in the sense that significant risks are present and can be eliminated or lessened by a change in practices.’’ Benzene, 448 U.S. at 642. While making it clear that it is up to the Agency to determine what constitutes a significant risk, the Court offered general guidance on the level of risk OSHA might determine to be significant. It is the Agency’s responsibility to determine in the first instance what it considers to be a ‘‘significant’’ risk. Some risks are plainly acceptable and others are plainly unacceptable. If, for example, the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, the risk clearly could not be considered significant. On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are 2% benzene will be fatal, a reasonable person might well consider the risk significant and take appropriate steps to decrease or eliminate it. Benzene, 448 U.S. at 655. The Court further stated that the determination of significant risk is not a mathematical straitjacket and that ‘‘the Agency has no duty to calculate the exact probability of harm.’’ Id. In this section, OSHA presents its preliminary findings with respect to the significance of the risks summarized above, and the potential of the proposed standard to reduce those risks. Findings related to mortality risk will be presented first, followed by silicosis morbidity risks. a. Mortality Risks OSHA’s Preliminary Quantitative Risk Assessment (and the Summary of the Preliminary Quantitative Risk Assessment in section VI) presents risk estimates for four causes of excess mortality: Lung cancer, silicosis, nonmalignant respiratory disease (including silicosis and COPD), and renal disease. Table VII–2 presents the estimated excess lifetime risks (i.e., to age 85) of these fatal diseases associated with various levels of crystalline silica exposure allowed under the current rule, based on OSHA’s risk assessment and assuming 45 years of occupational exposure to crystalline silica. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 TABLE VII–2—EXPECTED EXCESS DEATHS PER 1,000 WORKERS Current general industry PEL (0.1 mg/m3) Fatal health outcome Lung Cancer: 10-cohort pooled analysis ........................................................................................ Single cohort study-lowest estimate ......................................................................... Single cohort study-highest estimate ....................................................................... Silicosis ............................................................................................................................ Non-Malignant Respiratory Disease (including silicosis) ................................................ VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 Current construction/ shipyard PEL (0.25–0.5 mg/m3) 22–29 13 60 11 83 E:\FR\FM\12SEP2.SGM 27–38 37–95 250–653 17–22 188–321 12SEP2 Proposed PEL (0.05 mg/m3) 18–26 6 25 7 43 56334 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VII–2—EXPECTED EXCESS DEATHS PER 1,000 WORKERS—Continued Current general industry PEL (0.1 mg/m3) Fatal health outcome Renal Disease ................................................................................................................. The purpose of the OSH Act, as stated in Section 6(b), is to ensure ‘‘that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard . . . for the period of his working life.’’ 29 U.S.C. 655(b)(5). Assuming a 45-year working life, as OSHA has done in significant risk determinations for previous standards, the Agency preliminarily finds that the excess risk of disease mortality related to exposure to respirable crystalline silica at levels permitted by current OSHA standards is clearly significant. The Agency’s estimate of such risk falls well above the level of risk the Supreme Court indicated a reasonable person might consider unacceptable. Benzene, 448 U.S. at 655. For lung cancer, OSHA estimates the range of risk at the current general industry PEL to be between 13 and 60 deaths per 1,000 workers. The estimated risk for silicosis mortality is lower, at 11 deaths per 1,000 workers; however, the estimated lifetime risk for non-malignant respiratory disease mortality, including silicosis, is about 8fold higher than that for silicosis alone, at 83 deaths per 1,000. OSHA believes that the estimate for non-malignant respiratory disease mortality is better than the estimate for silicosis mortality at capturing the total respiratory disease burden associated with exposure to crystalline silica dust. The former captures deaths related to COPD, for which there is strong evidence of a causal relationship with exposure to silica, and is also more likely to capture those deaths where silicosis was a contributing factor but where the cause of death was misclassified. Finally, there is an estimated lifetime risk of renal disease mortality of 39 deaths per 1,000. Exposure for 45 years at levels of respirable crystalline silica in the range of the current limits for construction and shipyards result in even higher risk estimates, as presented in Table VII–2. To further demonstrate significant risk, OSHA compares the risk from currently permissible crystalline silica exposures to risks found across a broad variety of occupations. The Agency has used similar occupational risk comparisons in the significant risk determination for substance-specific standards promulgated since the benzene decision. This approach is supported by evidence in the legislative record, with regard to Section 6(b)(5) of the Act (29 U.S.C. 655(b)(5)), that Congress intended the Agency to regulate unacceptably severe occupational hazards, and not ‘‘to establish a utopia free from any hazards’’ or to address risks comparable to those that exist in virtually any occupation or workplace. 116 Cong. Rec. 37614 (1970), Leg. Hist. 480–82. It is also consistent with Section 6(g) of the OSH Act, which states: ‘‘In determining the priority for establishing standards under this section, the Secretary shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments.’’ 29 U.S.C. 655(g). Fatal injury rates for most U.S. industries and occupations may be obtained from data collected by the Bureau of Labor Statistics. Table VII–3 shows annual fatality rates per 1,000 employees for several industries for Current construction/ shipyard PEL (0.25–0.5 mg/m3) 39 52–63 Proposed PEL (0.05 mg/m3) 32 2007, as well as projected fatalities per 1,000 employees assuming exposure to workplace hazards for 45 years based on these annual rates (BLS, 2010). While it is difficult to meaningfully compare aggregate industry fatality rates to the risks estimated in the quantitative risk assessment for crystalline silica, which address one specific hazard (inhalation exposure to respirable crystalline silica) and several health outcomes (lung cancer, silicosis, NMRD, renal disease mortality), these rates provide a useful frame of reference for considering risk from inhalation exposure to crystalline silica. For example, OSHA’s estimated range of 6–60 excess lung cancer deaths per 1,000 workers from regular occupational exposure to respirable crystalline silica in the range of 0.05— 0.1 mg/m3 is roughly comparable to, or higher than, the expected risk of fatal injuries over a working life in high-risk occupations such as mining and construction (see Table VII–3). Regular exposures at higher levels, including the current construction and shipyard PELs for respirable crystalline silica, are expected to cause substantially more deaths per 1,000 workers from lung cancer (ranging from 37 to 653 per 1,000) than result from occupational injuries in most private industry. At the proposed PEL of 0.05 mg/m3 respirable crystalline silica, the Agency’s estimate of excess lung cancer mortality, from 6 to 26 deaths per 1,000 workers, is still 3- to10-fold or more higher than private industry’s average fatal injury rate, given the same employment time, and substantially exceeds those rates found in lower-risk industries such as finance and educational and health services. TABLE VII–3—FATAL INJURIES PER 1000 EMPLOYEES, BY INDUSTRY OR SECTOR mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Over 1 year All Private Industry ................................................................................................................................................... Mining (General) ...................................................................................................................................................... Construction ............................................................................................................................................................. Manufacturing .......................................................................................................................................................... Wholesale Trade ...................................................................................................................................................... Transportation and Warehousing ............................................................................................................................ Financial Activities ................................................................................................................................................... Educational and Health Services ............................................................................................................................ Source: BLS (2010). VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 0.043 0.214 0.108 0.024 0.045 0.165 0.012 0.008 Over 45 years 1.9 9.6 4.8 1.1 2.0 7.4 0.5 0.4 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Because there is little available information on the incidence of occupational cancer across all industries, risk from crystalline silica exposure cannot be compared with overall risk from other workplace carcinogens. However, OSHA’s previous risk assessments provide estimates of 56335 from 45 years of occupational exposure to several carcinogens, as published in the preambles to final rules promulgated since the benzene decision in 1980. These risks were judged by the Agency to be significant. risk from exposure to certain carcinogens. These risk assessments, as with the current assessment for crystalline silica, were based on animal or human data of reasonable or high quality and used the best information then available. Table VII–4 shows the Agency’s best estimates of cancer risk TABLE VII–4—SELECTED OSHA RISK ESTIMATES FOR PRIOR AND CURRENT PELS [Excess Cancers per 1000 workers] Standard Risk at prior PEL Risk at current PEL Federal Register date Ethylene Oxide .................................................................. Asbestos ............................................................................ Benzene ............................................................................. Formaldehyde .................................................................... Methylenedianiline ............................................................. Cadmium ............................................................................ 1,3-Butadiene ..................................................................... Methylene Chloride ............................................................ Chromium VI ...................................................................... Crystalline Silica: General Industry PEL ................................................. Construction/Shipyard PEL ........................................ 63–109 per 1000 ................. 64 per 1000 ......................... 95 per 1000 ......................... 0.4–6.2 per 1000 ................. *6–30 per 1000 ................... 58–157 per 1000 ................. 11.2–59.4 per 1000 ............. 126 per 1000 ....................... 101–351 per 1000 ............... 1.2–2.3 per 1000 ................. 6.7 per 1000 ........................ 10 per 1000 ......................... 0.0056 per 1000 .................. 0.8 per 1000 ........................ 3–15 per 1000 ..................... 1.3–8.1 per 1000 ................. 3.6 per 1000 ........................ 10–45 per 1000 ................... June 22, 1984. June 20, 1986. September 11, 1987. December 4, 1987. August 10, 1992. September 14, 1992. November 4, 1996. January 10, 1997. February 28, 2006 **13–60 per 1000 ................ **27–653 per 1000 .............. ***6–26 per 1000 ................. ***6–26 per 1000 ................. N/A mstockstill on DSK4VPTVN1PROD with PROPOSALS2 * no prior standard; reported risk is based on estimated exposures at the time of the rulemaking ** estimated excess lung cancer risks at the current PEL *** estimated excess lung cancer risks at the proposed new PEL The estimated excess lung cancer risks associated with respirable crystalline silica at the current general industry PEL, 13–60 deaths per 1,000 workers, are comparable to, and in some cases higher than, the estimated excess cancer risks for many other workplace carcinogens for which OSHA made a determination of significant risk (see Table VII–4, ‘‘Selected OSHA Risk Estimates for Prior and Current PELs’’). The estimated excess lung cancer risks associated with exposure to the current construction and shipyard PELs are even higher. The estimated risk from lifetime occupational exposure to respirable crystalline silica at the proposed PEL is 6–26 excess lung cancer deaths per 1,000 workers, a range still higher than the risks from exposure to many other carcinogens regulated by OSHA (see Table VII–4, ‘‘Selected OSHA Risk Estimates for Prior and Current PELs’’). OSHA’s preliminary risk assessment also shows that reduction of the current PELs to the proposed level of 0.05 mg/ m3 will result in substantial reduction in risk, although quantification of that reduction is subject to model uncertainty. Risk models that reflect attenuation of the risk with increasing exposure, such as those relating risk to a log transformation of cumulative exposure, will result in lower estimates of risk reduction compared to linear risk models. Thus, for lung cancer risks, the assessment based on the 10-cohort pooled analysis by Steenland et al. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 (2001; also Toxichemica, 2004; Steenland 2010) suggests risk will be reduced by about 14 percent from the current general industry PEL and by 28– 41 percent from the current construction/shipyard PEL (based on the midpoint of the ranges of estimated risk derived from the three models used for the pooled cohort data). These risk reduction estimates, however, are much lower than those derived from the single cohort studies (Rice et al., 2001; Attfield and Costello, 2004; Hughes et al., 2001; Miller and MacCalman, 2009), which used linear or log-linear relative risk models with untransformed cumulative exposure as the dose metric. These single cohort studies suggest that reducing the current PELs to the proposed PEL will reduce lung cancer risk by more than 50 percent in general industry and by more than 80 percent in construction and shipyards. For silicosis mortality, OSHA’s assessment indicates that risk will be reduced by 36 percent and by 58–68 percent as a result of reducing the current general industry and construction/shipyard PELs, respectively. Non-malignant respiratory disease mortality risks will be reduced by 48 percent and by 77–87 percent from reducing the general industry and construction/shipyard PELs, respectively, to the proposed PEL. There is also a substantial reduction in renal disease mortality risks; an 18-percent reduction associated with reducing the general industry PEL and a 38- to 49- PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 percent reduction associated with reducing the construction/shipyard PEL. Thus, OSHA believes that the proposed PEL of 0.05 mg/m3 respirable crystalline silica will substantially reduce the risk of material health impairments associated with exposure to silica. However, even at the proposed PEL, as well as the action level of 0.025 mg/m3, the risk posed to workers with 45 years of regular exposure to respirable crystalline silica is greater than 1 per 1,000 workers and is still clearly significant. b. Silicosis Morbidity Risks OSHA’s Preliminary Risk Assessment characterizes the risk of developing lung fibrosis as detected by chest x-ray. For 45 years of exposure at the current general industry PEL, OSHA estimates that the risk of developing lung fibrosis consistent with an ILO category 1+ degree of small opacity profusion ranges from 60 to 773 cases per 1,000. For exposure at the construction and shipyard PELs, the risk approaches unity. The wide range of risk estimates derived from the underlying studies relied on for the risk assessment may reflect differences in the relative toxicity of quartz particles in different workplaces; nevertheless, OSHA believes that each of these risk estimates clearly represent a significant risk of developing fibrotic lesions in the lung. Exposure to the proposed PEL of 0.05 mg/m3 respirable crystalline silica for 45 years yields an estimated risk of E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56336 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules between 20 and 170 cases per 1,000 for developing fibrotic lesions consistent with an ILO category of 1+. These risk estimates indicate that promulgation of the proposed PEL would result in a reduction in risk by about two-thirds or more, which the Agency believes is a substantial reduction of the risk of developing abnormal chest x-ray findings consistent with silicosis. One study of coal miners also permitted the agency to evaluate the risk of developing lung fibrosis consistent with an ILO category 2+ degree of profusion of small opacities (Buchanan et al., 2003). This level of profusion has been shown to be associated with a higher prevalence of lung function decrement and an increased rate of early mortality (Ng et al., 1987a; Begin et al., 1998; Moore et al., 1988; Ng et al., 1992a; Infante-Rivard et al., 1991). From this study, OSHA estimates that the risk associated with 45 years of exposure to the current general industry PEL is 301 cases per 1,000 workers, again a clearly significant risk. Exposure to the proposed PEL of 0.05 mg/m3 respirable crystalline silica for 45 years yields an estimated risk of 55 cases per 1,000 for developing lesions consistent with an ILO category 2+ degree of small opacity profusion. This represents a reduction in risk of over 80 percent, again a clearly substantial reduction of the risk of developing radiologic silicosis consistent with ILO category 2+ degree of small opacity profusion. As is the case for other health effects addressed in the preliminary risk assessment (i.e., lung cancer, silicosis morbidity defined as ILO 1+ level of profusion), there is some evidence that this risk will vary according to the nature of quartz particles present in different workplaces. In particular, risk may vary depending on whether quartz is freshly fractured during work operations and the co-existence of other minerals and substances that could alter the biological activity of quartz. Using medical and exposure data taken from a cohort of heavy clay workers first studied by Love et al. (1999), Miller and Soutar (2007) compared the silicosis prevalence within the cohort to that predicted by the exposure-response model derived by Buchanan et al. (2003) and used by OSHA to estimate the risk of radiologic silicosis with a classification of ILO 2+. They found that the model predicted about a 4-fold higher prevalence of workers having an abnormal x-ray than was actually seen in the clay cohort (31 cases predicted vs. 8 observed). Unlike the coal miner study, the clay worker cohort included only active workers and not retirees (Love et al., 1999); however, Miller and VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Soutar believed this could not explain the magnitude of the difference between the model prediction and observed silicosis prevalence in the clay worker cohort. OSHA believes that the result obtained by Miller and Soutar (2007) likely does reflect differences in the toxic potency of quartz particles in different work settings. Nevertheless, even if the risk estimates predicted by the model derived from the coal worker study were reduced substantially, even by more than a factor of 10, the resulting risk estimate would still reflect the presence of a significant risk. The Preliminary Quantitative Risk Assessment also discusses the question of a threshold exposure level for silicosis. There is little quantitative data available with which to estimate a threshold exposure level for silicosis or any of the other silica-related diseases addressed in the risk assessment. The risk assessment discussed one study that perhaps provides the best information. This is an analysis by Kuempel et al. (2001) who used a ratbased toxicokinetic/toxicodynamic model along with a human lung deposition/clearance model to estimate a minimum lung burden necessary to cause the initial inflammatory events that can lead to lung fibrosis and an indirect genotoxic cause of lung cancer. They estimated that the threshold effect level of lung burden associated with this inflammation (Mcrit) is the equivalent of exposure to 0.036 mg/m3 for 45 years; thus, exposures below this level would presumably not lead to an excess lung cancer risk (based on an indirect genotoxic mechanism) nor to silicosis, at least in the ‘‘average individual.’’ This might suggest that exposures to a concentration of silica at the proposed action level would not be associated with a risk of silicosis, and possibly not of lung cancer. However, OSHA does not believe that the analysis by Kuemple et al. is definitive with respect to a threshold for silica-related disease. First, since the critical quartz burden is a mean value derived from the model, the authors estimated that a 45-year exposure to a concentration as low as 0.005 mg/m3, or 5 times below the proposed action level, would result in a lung quartz burden that was equal to the 95-percent lower confidence limit on Mcrit. Due to the statistical uncertainty in Kuemple et al.’s estimate of critical lung burden, OSHA cannot rule out the existence of a threshold lung burden that is below that resulting from exposure to the proposed action level. In addition, with respect to silicarelated lung cancer, if at least some of the risk is from a direct genotoxic PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 mechanism (see section II.F of the Health Effects Literature Review), then this threshold value is not relevant to the risk of lung cancer. Supporting evidence comes from Steenland and Deddens (2002), who found that, for the 10-cohort pooled data set, a risk model that incorporated a threshold did fit better than a no-threshold model, but the estimated threshold was very low, 0.010 mg/m3 (10 mg/m3). OSHA acknowledges that a threshold exposure level might lie within the range of the proposed action level, as suggested by the work of Kuempel et al. (2001) and that this possibility adds uncertainty to the estimated risks associated with exposure to the action level. However, OSHA believes that available information cannot firmly establish a threshold exposure level for silicarelated effects, and there is no empirical evidence that a threshold exists at or above the proposed PEL of 0.05 mg/m3 for respirable crystalline silica. VIII. Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis A. Introduction and Summary OSHA’s Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA) addresses issues related to the costs, benefits, technological and economic feasibility, and the economic impacts (including impacts on small entities) of this proposed respirable crystalline silica rule and evaluates regulatory alternatives to the proposed rule. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The full PEA has been placed in OSHA rulemaking docket OSHA–2010–0034. This rule is an economically significant regulatory action under Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by executive order. The purpose of the PEA is to: • Identify the establishments and industries potentially affected by the proposed rule; E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules • Estimate current exposures and the technologically feasible methods of controlling these exposures; • Estimate the benefits resulting from employers coming into compliance with the proposed rule in terms of reductions in cases of silicosis, lung cancer, other forms of chronic obstructive pulmonary disease, and renal failure; • Evaluate the costs and economic impacts that establishments in the regulated community will incur to achieve compliance with the proposed rule; • Assess the economic feasibility of the proposed rule for affected industries; and • Assess the impact of the proposed rule on small entities through an Initial Regulatory Flexibility Analysis (IRFA), to include an evaluation of significant regulatory alternatives to the proposed rule that OSHA has considered. The Preliminary Economic Analysis contains the following chapters: Chapter I. Introduction Chapter II. Assessing the Need for Regulation Chapter III. Profile of Affected Industries Chapter IV. Technological Feasibility Chapter V. Costs of Compliance Chapter VI. Economic Impacts Chapter VII. Benefits and Net Benefits Chapter VIII. Regulatory Alternatives Chapter IX. Initial Regulatory Flexibility Analysis Chapter X. Environmental Impacts Key findings of these chapters are summarized below and in sections VIII.B through VIII.I of this PEA summary. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Profile of Affected Industries The proposed rule would affect employers and employees in many different industries across the economy. As described in Section VIII.C and reported in Table VIII–3 of this preamble, OSHA estimates that a total of 2.1 million employees in 550,000 establishments and 533,000 firms (entities) are potentially at risk from exposure to respirable crystalline silica. This total includes 1.8 million employees in 477,000 establishments and 486,000 firms in the construction industry and 295,000 employees in 56,000 establishments and 47,000 firms in general industry and maritime. Technological Feasibility As described in more detail in Section VIII.D of this preamble and in Chapter IV of the PEA, OSHA assessed, for all affected sectors, the current exposures and the technological feasibility of the proposed PEL of 50 mg/m3 and, for analytic purposes, an alternative PEL of 25 mg/m3. Tables VIII–6 and VIII–7 in section VIII.D of this preamble summarize all VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the industry sectors and construction activities studied in the technological feasibility analysis and show how many operations within each can achieve levels of 50 mg/m3 through the implementation of engineering and work practice controls. The table also summarizes the overall feasibility finding for each industry sector or construction activity based on the number of feasible versus infeasible operations. For the general industry sector, OSHA has preliminarily concluded that the proposed PEL of 50 mg/m3 is technologically feasible for all affected industries. For the construction activities, OSHA has determined that the proposed PEL of 50 mg/m3 is feasible in 10 out of 12 of the affected activities. Thus, OSHA preliminarily concludes that engineering and work practices will be sufficient to reduce and maintain silica exposures to the proposed PEL of 50 mg/m3 or below in most operations most of the time in the affected industries. For those few operations within an industry or activity where the proposed PEL is not technologically feasible even when workers use recommended engineering and work practice controls (seven out of 108 operations, see Tables VIII–6 and VIII– 7), employers can supplement controls with respirators to achieve exposure levels at or below the proposed PEL. Based on the information presented in the technological feasibility analysis, the Agency believes that 50 mg/m3 is the lowest feasible PEL. An alternative PEL of 25 mg/m3 would not be feasible because the engineering and work practice controls identified to date will not be sufficient to consistently reduce exposures to levels below 25 mg/m3 in most operations most of the time. OSHA believes that an alternative PEL of 25 mg/m3 would not be feasible for many industries, and that the use of respiratory protection would be necessary in most operations most of the time to achieve compliance. Additionally, the current methods of sampling analysis create higher errors and lower precision in measurement as concentrations of silica lower than the proposed PEL are analyzed. However, the Agency preliminarily concludes that these sampling and analytical methods are adequate to permit employers to comply with all applicable requirements triggered by the proposed action level and PEL. Costs of Compliance As described in more detail in Section VIII.E and reported by industry in Table VIII–8 of this preamble, the total annualized cost of compliance with the proposed standard is estimated to be PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 56337 about $658 million. The major cost elements associated with the revisions to the standard are costs for engineering controls, including controls for abrasive blasting ($344 million); medical surveillance ($79 million); exposure monitoring ($74 million); respiratory protection ($91 million); training ($50 million) and regulated areas or access control ($19 million). Of the total cost, $511 million would be borne by firms in the construction industry and $147 million would be borne by firms in general industry and maritime. The compliance costs are expressed as annualized costs in order to evaluate economic impacts against annual revenue and annual profits, to be able to compare the economic impact of the rulemaking with other OSHA regulatory actions, and to be able to add and track Federal regulatory compliance costs and economic impacts in a consistent manner. Annualized costs also represent a better measure for assessing the longer-term potential impacts of the rulemaking. The annualized costs were calculated by annualizing the one-time costs over a period of 10 years and applying discount rates of 7 and 3 percent as appropriate. The estimated costs for the proposed silica standard rule include the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that has already been achieved with regard to the new requirements or costs necessary to achieve compliance with existing silica requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements. OSHA’s exposure profile represents the Agency’s best estimate of current exposures (i.e., baseline exposures). OSHA did not attempt to determine the extent to which current exposures in compliance with the current silica PELs are the result of baseline engineering controls or the result of circumstances leading to low exposures. This information is not needed to estimate the costs of (additional) engineering controls needed to comply with the proposed standard. Because of the severe health hazards involved, the Agency expects that the estimated 15,446 abrasive blasters in the construction sector and the estimated 4,550 abrasive blasters in the maritime sector are currently wearing respirators in compliance with OSHA’s abrasive blasting provisions. Furthermore, for the construction baseline, an estimated 241,269 workers, including abrasive blasters, will need to use respirators to achieve compliance with the proposed E:\FR\FM\12SEP2.SGM 12SEP2 56338 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 rule, and, based on the NIOSH/BLS respirator use survey (NIOSH/BLS, 2003), an estimated 56 percent of construction employers currently require such respiratory use and have respirator programs that meet OSHA’s respirator standard. OSHA has not taken any costs for employers and their workers currently in compliance with the respiratory provisions in the proposed rule. In addition, under both the general industry and construction baselines, an estimated 50 percent of employers have pre-existing training programs that address silica-related risks (as required under OSHA’s hazard communication standard) and partially satisfy the proposed rule’s training requirements (for costing purposes, estimated to satisfy 50 percent of the training requirements in the proposed rule). These employers will need fewer resources to achieve full compliance with the proposed rule than those employers without pre-existing training programs that address silica-related risks. Other than respiratory protection and worker training concerning silicarelated risks, OSHA did not assume baseline compliance with any ancillary provisions, even though some employers have reported that they do currently monitor silica exposure and some employers have reported conducting medical surveillance. Economic Impacts To assess the nature and magnitude of the economic impacts associated with compliance with the proposed rule, OSHA developed quantitative estimates of the potential economic impact of the new requirements on entities in each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide an assessment of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. As described in greater detail in Section VIII.F of this preamble, the costs of compliance with the proposed rulemaking are not large in relation to the corresponding annual financial flows associated with each of the affected industry sectors. The estimated annualized costs of compliance represent about 0.02 percent of annual revenues and about 0.5 percent of annual profits, on average, across all firms in general industry and maritime, and about 0.05 percent of annual revenues and about 1.0 percent of VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 annual profits, on average, across all firms in construction. Compliance costs do not represent more than 0.39 percent of revenues or more than 8.8 percent of profits in any affected industry in general industry or maritime, or more than 0.13 percent of revenues or more than 3 percent of profits in any affected industry in construction. Based on its analysis of international trade effects, OSHA concluded that most or all costs arising from this proposed silica rule would be passed on in higher prices rather than absorbed in lost profits and that any price increases would result in minimal loss of business to foreign competition. Given the minimal potential impact on prices or profits in the affected industries, OSHA has preliminarily concluded that compliance with the requirements of the proposed rulemaking would be economically feasible in every affected industry sector. In addition, OSHA directed Inforum— a not-for-profit corporation with over 40 years of experience in the design and application of macroeconomic models— to run its LIFT (Long-term Interindustry Forecasting Tool) model of the U.S. economy to estimate the industry and aggregate employment effects of the proposed silica rule. Inforum developed estimates of the employment impacts over the ten-year period from 2014– 2023 by feeding OSHA’s year-by-year and industry-by-industry estimates of the compliance costs of the proposed rule into its LIFT model. The most important Inforum result is that the proposed silica rule would have a negligible—albeit slightly positive—net effect on aggregate U.S. employment. Based on its analysis of the costs and economic impacts associated with this rulemaking and on Inforum’s estimates of associated employment and other macroeconomic impacts, OSHA preliminarily concludes that the effect of the proposed standard on employment, wages, and economic growth for the United States would be negligible. Benefits, Net Benefits, and CostEffectiveness As described in more detail in Section VIII.G of this preamble, OSHA estimated the benefits, net benefits, and incremental benefits of the proposed silica rule. That section also contains a sensitivity analysis to show how robust the estimates of net benefits are to changes in various cost and benefit parameters. A full explanation of the PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 derivation of the estimates presented there is provided in Chapter VII of the PEA for the proposed rule. OSHA invites comments on any aspect of its estimation of the benefits and net benefits of the proposed rule. OSHA estimated the benefits associated with the proposed PEL of 50 mg/m3 and, for analytical purposes to comply with OMB Circular A–4, with an alternative PEL of 100 mg/m3 for respirable crystalline silica by applying the dose-response relationship developed in the Agency’s quantitative risk assessment—summarized in Section VI of this preamble—to current exposure levels. OSHA determined current exposure levels by first developing an exposure profile (presented in Chapter IV of the PEA) for industries with workers exposed to respirable crystalline silica, using OSHA inspection and site-visit data, and then applying this exposure profile to the total current worker population. The industry-by-industry exposure profile is summarized in Table VIII–5 in Section VIII.C of this preamble. By applying the dose-response relationship to estimates of current exposure levels across industries, it is possible to project the number of cases of the following diseases expected to occur in the worker population given current exposure levels (the ‘‘baseline’’): • Fatal cases of lung cancer, • fatal cases of non-malignant respiratory disease (including silicosis), • fatal cases of end-stage renal disease, and • cases of silicosis morbidity. Table VIII–1 provides a summary of OSHA’s best estimate of the costs and benefits of the proposed rule using a discount rate of 3 percent. As shown, the proposed rule is estimated to prevent 688 fatalities and 1,585 silicarelated illnesses annually once it is fully effective, and the estimated cost of the rule is $637 million annually. Also as shown in Table VIII–1, the discounted monetized benefits of the proposed rule are estimated to be $5.3 billion annually, and the proposed rule is estimated to generate net benefits of $4.6 billion annually. Table VIII–1 also presents the estimated costs and benefits of the proposed rule using a discount rate of 7 percent. The estimated costs and benefits of the proposed rule, disaggregated by industry sector, were previously presented in Table SI–3 in this preamble. E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56339 TABLE VIII–1—ANNUALIZED BENEFITS, COSTS AND NET BENEFITS OF OSHA’S PROPOSED SILICA STANDARD OF 50 μG/M3 Discount rate 3% Annualized Costs Engineering Controls (includes Abrasive Blasting) .................................................. Respirators ............................................................................................................... Exposure Assessment .............................................................................................. Medical Surveillance ................................................................................................. Training ..................................................................................................................... Regulated Area or Access Control ........................................................................... $329,994,068 90,573,449 72,504,999 76,233,932 48,779,433 19,243,500 3,203,485,869 1,986,214,921 2,101,980,475 1,363,727,104 5,189,700,790 4,552,371,410 688 1,585 657,892,211 3,465,707,579 2,807,815,368 162 375 151 Silica-Related Mortality ............................................................................................. Silicosis Morbidity ..................................................................................................... $343,818,700 90,918,741 74,421,757 79,069,527 50,266,744 19,396,743 637,329,380 Total Annualized Costs (point estimate) ........................................................... Annual Benefits: Number of Cases Prevented Fatal Lung Cancers (midpoint estimate) .................................................................. Fatal Silicosis & other Non-Malignant Respiratory Diseases .................................. Fatal Renal Disease ................................................................................................. Monetized Annual Benefits (midpoint estimate) ............................................... Net Benefits ....................................................................................................... Initial Regulatory Flexibility Analysis OSHA has prepared an Initial Regulatory Flexibility Analysis (IRFA) in accordance with the requirements of the Regulatory Flexibility Act, as amended in 1996. Among the contents of the IRFA are an analysis of the potential impact of the proposed rule on small entities and a description and discussion of significant alternatives to the proposed rule that OSHA has considered. The IRFA is presented in its entirety both in Chapter IX of the PEA and in Section VIII.I of this preamble. The remainder of this section (Section VIII) of the preamble is organized as follows: B. The Need for Regulation C. Profile of Affected Industry D. Technological Feasibility E. Costs of Compliance F. Economic Feasibility Analysis and Regulatory Flexibility Determination G. Benefits and Net Benefits H. Regulatory Alternatives I. Initial Regulatory Flexibility Analysis. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 7% B. Need for Regulation Employees in work environments addressed by the proposed silica rule are exposed to a variety of significant hazards that can and do cause serious injury and death. As described in Chapter II of the PEA in support of the proposed rule, the risks to employees are excessively large due to the existence of various types of market failure, and existing and alternative methods of overcoming these negative consequences—such as workers’ compensation systems, tort liability options, and information dissemination programs—have been shown to provide insufficient worker protection. After carefully weighing the various potential advantages and disadvantages VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 of using a regulatory approach to improve upon the current situation, OSHA concludes that, in the case of silica exposure, the proposed mandatory standards represent the best choice for reducing the risks to employees. In addition, rulemaking is necessary in this case in order to replace older existing standards with updated, clear, and consistent health standards. C. Profile of Affected Industries 1. Introduction Chapter III of the PEA presents profile data for industries potentially affected by the proposed silica rule. The discussion below summarizes the findings in that chapter. As a first step, OSHA identifies the North American Industrial Classification System (NAICS) industries, both in general industry and maritime and in the construction sector, with potential worker exposure to silica. Next, OSHA provides summary statistics for the affected industries, including the number of affected entities and establishments, the number of at-risk workers, and the average revenue for affected entities and establishments. 3 Finally, OSHA presents silica exposure profiles for at-risk workers. These data are presented by sector and job category. Summary data are also provided for the number of workers in each affected industry who are currently exposed above the proposed silica PEL of 50 mg/ m3, as well as above an alternative PEL 3 An establishment is a single physical location at which business is conducted or services or industrial operations are performed. An entity is an aggregation of all establishments owned by a parent company within an industry with some annual payroll. PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 of 100 mg/m3 for economic analysis purposes. The methodological basis for the industry and at-risk worker data presented here comes from ERG (2007a, 2007b, 2008a, and 2008b). The actual data presented here comes from the technological feasibility analyses presented in Chapter IV of the PEA and from ERG (2013), which updated ERG’s earlier spreadsheets to reflect the most recent industry data available. The technological feasibility analyses identified the job categories with potential worker exposure to silica. ERG (2007a, 2007b) matched the BLS Occupational Employment Survey (OES) occupational titles in NAICS industries with the at-risk job categories and then calculated the percentages of production employment represented by each at-risk job title.4 These percentages were then used to project the number of employees in the at-risk job categories by NAICS industry. OSHA welcomes additional information and data that might help improve the accuracy and usefulness of the industry profile presented here and in Chapter III of the PEA. 2. Selection of NAICS Industries for Analysis The technological feasibility analyses presented in Chapter IV of the PEA identify the general industry and maritime sectors and the construction activities potentially affected by the proposed silica standard. 4 Production employment includes workers in building and grounds maintenance; forestry, fishing, and farming; installation and maintenance; construction; production; and material handling occupations. E:\FR\FM\12SEP2.SGM 12SEP2 56340 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 a. General Industry and Maritime Employees engaged in various activities in general industry and maritime routinely encounter crystalline silica as a molding material, as an inert mineral additive, as a refractory material, as a sandblasting abrasive, or as a natural component of the base materials with which they work. Some industries use various forms of silica for multiple purposes. As a result, employers are challenged to limit worker exposure to silica in dozens of job categories throughout the general industry and maritime sectors. Job categories in general industry and maritime were selected for analysis based on data from the technical industrial hygiene literature, evidence from OSHA Special Emphasis Program (SEP) results, and, in several cases, information from ERG site visit reports. These data sources provided evidence of silica exposures in numerous sectors. While the available data are not entirely comprehensive, OSHA believes that silica exposures in other sectors are quite limited. The 25 industry subsectors in the overall general industry and maritime VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 sectors that OSHA identified as being potentially affected by the proposed silica standard are as follows: • Asphalt Paving Products • Asphalt Roofing Materials • Industries with Captive Foundries • Concrete Products • Cut Stone • Dental Equipment and Supplies • Dental Laboratories • Flat Glass • Iron Foundries • Jewelry • Mineral Processing • Mineral Wool • Nonferrous Sand Casting Foundries • Non-Sand Casting Foundries • Other Ferrous Sand Casting Foundries • Other Glass Products • Paint and Coatings • Porcelain Enameling • Pottery • Railroads • Ready-Mix Concrete • Refractories • Refractory Repair • Shipyards • Structural Clay In some cases, affected industries presented in the technological PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 feasibility analysis have been disaggregated to facilitate the cost and economic impact analysis. In particular, flat glass, mineral wool, and other glass products are subsectors of the glass industry described in Chapter IV of the PEA, and captive foundries,5 iron foundries, nonferrous sand casting foundries, non-sand cast foundries, and other ferrous sand casting foundries are subsectors of the overall foundries industry presented in Chapter IV of the PEA. As described in ERG (2008b), OSHA identified the six-digit NAICS codes for these subsectors to develop a list of industries potentially affected by the proposed silica standard. Table VIII–2 presents the sectors listed above with their corresponding six-digit NAICS industries. BILLING CODE 4510–26–P 5 Captive foundries include establishments in other industries with foundry processes incidental to the primary products manufactured. ERG (2008b) provides a discussion of the methodological issues involved in estimating the number of captive foundries and in identifying the industries in which they are found. E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56341 Table VIII-2 General Industry and Martime Sectors and Industries Potentially Affected by OSHA's Proposed Silica Rule VerDate Mar<15>2010 NAICS Industry 324121 324122 331111 331112 331210 331221 331222 331314 331423 331492 332111 332112 332115 332116 332117 332211 332212 332213 332214 332439 332510 332611 332612 332618 332710 332911 332912 332913 332919 332991 332996 332997 332998 332999 333319 333411 333412 333414 333511 333512 333513 333514 333515 333516 333518 333612 333613 333911 333912 333991 333992 333993 333994 333995 333996 333997 333999 334518 336111 336112 336120 336211 336212 Asphalt paving mixture and block mfg Asphalt shingle and roofing materials Iron & steel mills Electrometallurgical ferroalloy product mfg Iron & steel pipes & tubes mfg from purchased steel Cold-rolled steel shape mfg Steel wire drawing Secondary smelting & alloying of aluminum Secondary smelting, refining, & alloying of copper Other nonferrous metal secondary smelting, refining, & alloying Iron & steel forging Nonferrous forging Crown & closure mfg Metal stamping Powder metallurgy part mfg Cutlery & flatware (except precious) mfg Hand & edge tool mfg Saw blade & handsaw mfg Kitchen utensil, pot, & pan mfg Other metal container mfg Hardware mfg Spring (heavy gauge) mfg Spring (light gauge) mfg Other fabricated wire product mfg Machine shops Industrial valve mfg Fluid power valve & hose fitting mfg Plumbing fixture fitting & trim mfg Other metal valve & pipe fitting mfg Ball & roller bearing mfg Fabricated pipe & pipe fitting mfg Industrial pattern mfg Enameled iron & metal sanitary ware mfg All other miscellaneous fabricated metal product mfg Other commercial & service industry machinery mfg Air purification equipment mfg Industrial & commercial fan & blower mfg Heating equipment (except warm air furnaces) mfg Industrial mold mfg Machine tool (metal cutting types) mfg Machine tool (metal forming types) mfg Special die & tool, die set, jig, & fixture mfg Cutting tool & machine tool accessory mfg Rolling mill machinery & equipment mfg Other metalworking machinery mfg Speed changer, industrial high-speed drive, & gear mfg Mechanical power transmission equipment mfg Pump & pumping equipment mfg Air & gas compressor mfg Power-driven handtool mfg Welding & soldering equipment mfg Packaging machinery mfg Industrial process furnace & oven mfg Fluid power cylinder & actuator mfg Fluid power pump & motor mfg Scale & balance (except laboratory) mfg All other miscellaneous general-purpose machinery mfg Watch, clock, & part mfg Automobile mfg Light truck & utility vehicle mfg Heavy duty truck mfg Motor vehicle body mfg Truck trailer mfg 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00069 Fmt 4701 Sfmt 4725 E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.004</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Sector Asphalt Paving Products Asphalt Roofing Materials Captive Foundries 56342 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Table VIII-2 General Industry and Martime Sectors and Industries Potentially Affected by OSHA's Proposed Silica Rule (Continued) Concrete Products Cut Stone Dental Equipment and Supplies Dental Laboratories Flat Glass Iron Foundries Jewelry Mineral Processing Mineral Wool Nonferrous Sand Casting Foundries Non-Sand Casting Foundries Other Ferrous Sand Casting Foundries Other Glass Products Paint and Coatings Porcelain Enameling Pottery Railraods Ready-Mix Concrete Refractories Refractory Repair Shipyards Carburetor, piston, piston ring, & vallA3 mfg Gasoline engine & engine parts mfg Other motor IA3hicle electrical & electronic equipment mfg Motor IA3hicle steering & suspension component (except spring) mfg Motor IA3hicie brake system mfg Motor IA3hicie transmission & power train parts mfg Motor IA3hicie metal stamping All other motor IA3hicie parts mfg Military armored IA3hicle, tank, & tank component mfg Showcase, partition, shellhng, & locker mfg Costume jewelry & nOlA3lty mfg Concrete block & brick mfg Concrete pipe mfg Other concrete product mfg All other miscellaneous nonmetallic mineral product mfg Cut stone & stone product mfg Dental equipment and supplies, manufacturing Dental laboratories Offices of dentists Flat glass mfg Iron foundries Jewelry (except costume) mfg Jewelers' material & lapidary work mfg Costume jewelry & nOlA3lty mfg Ground or treated mineral and earth manufacturing Mineral wool mfg Aluminum foundries (except die-casting) Copper foundries (except die-casting) Other nonferrous foundries (except die-casting) Steel inlA3stment foundries Aluminum foundries (except die-casting) Copper foundries (except die-casting) Other nonferrous foundries (except die-casting) Steel foundries (except inlA3stment) Other pressed & blown glass & glassware mfg Glass container mfg Paint & coating mfg tel Metal coating and allied serlhces Enameled iron & metal sanitary ware mfg Electric housewares and household fans Household cooking appliance manufactruing Household refrigerator and home freezer manufacturing Ornamental and architectural metal work Household laundry equipment manufacturing Other major household appliance manufacturing Sign manufacturing Vitreous china plumbing fixture & bathroom accessories mfg Vitreous china, fine earthenware, & other pottery product mfg Porcelain electrical supply mfg Rail transportation Ready-mix concrete mfg Clay refractory mfg Nonclay refractory mfg Industrial supplies - wholesale Ship building & repairing Boat building Brick & structural clay tile mfg Ceramic wall & floor tile mfg Other structural clay product mfg Source: ERG, 2013 BILLING CODE 4510–26–C VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.005</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Structural Clay 336311 336312 336322 336330 336340 336350 336370 336399 336992 337215 339914 327331 327332 327390 327999 327991 339114 339116 621210 327211 331511 339911 339913 339914 327992 327993 331524 331525 331528 331512 331524 331525 331528 331513 327212 327213 325510 332812 332998 335211 335221 335222 332323 335224 335228 339950 327111 327112 327113 482110 327320 327124 327125 423840 336611 336612 327121 327122 327123 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules b. Construction mstockstill on DSK4VPTVN1PROD with PROPOSALS2 The construction sector is an integral part of the nation’s economy, accounting for almost 6 percent of total employment. Establishments in this industry are involved in a wide variety of activities, including land development and subdivision, homebuilding, construction of nonresidential buildings and other structures, heavy construction work (including roadways and bridges), and a myriad of special trades such as plumbing, roofing, electrical, excavation, and demolition work. Construction activities were selected for analysis based on historical data of recorded samples of construction worker exposures from the OSHA Integrated Management Information System (IMIS) and the National Institute for Occupational Safety and Health (NIOSH). In addition, OSHA reviewed the industrial hygiene literature across the full range of construction activities, and focused on dusty operations where silica sand was most likely to be fractured or abraded by work operations. These physical processes have been found to cause the silica exposures that pose the greatest risk of silicosis for workers. The 12 construction activities, by job category, that OSHA identified as being potentially affected by the proposed silica standard are as follows: • Abrasive Blasters • Drywall Finishers • Heavy Equipment Operators • Hole Drillers Using Hand-Held Drills • Jackhammer and Impact Drillers • Masonry Cutters Using Portable Saws • Masonry Cutters Using Stationary Saws • Millers Using Portable or Mobile Machines • Rock and Concrete Drillers • Rock-Crushing Machine Operators and Tenders • Tuckpointers and Grinders VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 • Underground Construction Workers As shown in ERG (2008a) and in Chapter IV of the PEA, these construction activities occur in the following construction industries, accompanied by their four-digit NAICS codes: 6 7 • 2361 Residential Building Construction • 2362 Nonresidential Building Construction • 2371 Utility System Construction • 2372 Land Subdivision • 2373 Highway, Street, and Bridge Construction • 2379 Other Heavy and Civil Engineering Construction • 2381 Foundation, Structure, and Building Exterior Contractors • 2382 Building Equipment Contractors • 2383 Building Finishing Contractors • 2389 Other Specialty Trade Contractors Characteristics of Affected Industries Table VIII–3 provides an overview of the industries and estimated number of workers affected by the proposed rule. Included in Table VIII–3 are summary statistics for each of the affected industries, subtotals for construction and for general industry and maritime, and grand totals for all affected industries combined. The first five columns in Table VIII– 3 identify each industry in which workers are routinely exposed to 6 ERG and OSHA used the four-digit NAICS codes for the construction sector both because the BLS’s Occupational Employment Statistics survey only provides data at this level of detail and because, unlike the case in general industry and maritime, job categories in the construction sector are taskspecific, not industry-specific. Furthermore, as far as economic impacts are concerned, IRS data on profitability are reported only at the four-digit NAICS code level of detail. 7 In addition, some public employees in state and local governments are exposed to elevated levels of respirable crystalline silica. These exposures are included in the construction sector because they are the result of construction activities. PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 56343 respirable crystalline silica (preceded by the industry’s NAICS code) and the total number of entities, establishments, and employees for that industry. Note that not all entities, establishments, and employees in these affected industries necessarily engage in activities involving silica exposure. The next three columns in Table VIII– 3 show, for each affected industry, OSHA’s estimate of the number of affected entities, establishments, and workers—that is, the number of entities and establishments in which workers are actually exposed to silica and the total number of workers exposed to silica. Based on ERG (2007a, 2007b), OSHA’s methodology focused on estimation of the number of affected workers. The number of affected establishments was set equal to the total number of establishments in an industry (based on Census data) unless the number of affected establishments would exceed the number of affected employees in the industry. In that case, the number of affected establishments in the industry was set equal to the number of affected employees, and the number of affected entities in the industry was reduced so as to maintain the same ratio of entities to establishments in the industry.8 8 OSHA determined that removing this assumption would have a negligible impact on total costs and would reduce the cost and economic impact on the average affected establishment or entity. E:\FR\FM\12SEP2.SGM 12SEP2 VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ 327113 327121 327122 327123 327124 327125 327211 327212 327213 327320 327331 327332 327390 327991 327992 327993 327999 331111 331112 331210 331221 331222 331314 331423 331492 331511 331512 331513 331524 331525 331528 332111 332112 332115 332116 332117 332211 332212 332213 332214 332323 332439 327112 ........ 324121 324122 325510 327111 236100 236200 237100 237200 237300 237900 238100 238200 238300 238900 999000 NAICS 197,600 43,634 20,236 12,383 11,081 5,326 116,836 179,051 132,219 73,922 14,397 Total entities a Frm 00072 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 457 115 208 441 251 119 358 67 50 1,556 111 138 1,056 127 64 2,408 364 150 232 119 29 195 110 104 180 45 108 81 56 457 32 2,470 599 194 1,934 1,885 171 195 350 686 22 186 728 480 121 1,093 31 Subtotals—Construction .................................................... Asphalt paving mixture and block manufacturing .................... Asphalt shingle and roofing materials ...................................... Paint and coating manufacturing e ........................................... Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg ................................................. Brick and structural clay mfg .................................................... Ceramic wall and floor tile mfg ................................................. Other structural clay product mfg ............................................. Clay refractory manufacturing .................................................. Nonclay refractory manufacturing ............................................ Flat glass manufacturing .......................................................... Other pressed and blown glass and glassware manufacturing Glass container manufacturing ................................................. Ready-mixed concrete manufacturing ...................................... Concrete block and brick mfg .................................................. Concrete pipe mfg .................................................................... Other concrete product mfg ..................................................... Cut stone and stone product manufacturing ............................ Ground or treated mineral and earth manufacturing ............... Mineral wool manufacturing ..................................................... All other misc. nonmetallic mineral product mfg ...................... Iron and steel mills ................................................................... Electrometallurgical ferroalloy product manufacturing ............. Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ............................................ Steel wire drawing .................................................................... Secondary smelting and alloying of aluminum ........................ Secondary smelting, refining, and alloying of copper .............. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ............................................................................ Steel investment foundries ....................................................... Steel foundries (except investment) ......................................... Aluminum foundries (except die-casting) ................................. Copper foundries (except die-casting) ..................................... Other nonferrous foundries (except die-casting) ...................... Iron and steel forging ............................................................... Nonferrous forging .................................................................... Crown and closure manufacturing ........................................... Metal stamping ......................................................................... Powder metallurgy part manufacturing .................................... Cutlery and flatware (except precious) manufacturing ............ Hand and edge tool manufacturing .......................................... Saw blade and handsaw manufacturing .................................. Kitchen utensil, pot, and pan manufacturing ............................ Ornamental and architectural metal work ................................ Other metal container manufacturing ....................................... 806,685 Residential Building Construction ............................................. Nonresidential Building Construction ....................................... Utility System Construction ...................................................... Land Subdivision ...................................................................... Highway, Street, and Bridge Construction ............................... Other Heavy and Civil Engineering Construction .................... Foundation, Structure, and Building Exterior Contractors ....... Building Equipment Contractors ............................................... Building Finishing Contractors .................................................. Other Specialty Trade Contractors ........................................... State and local governments d ................................................. Industry 13,101,738 966,198 741,978 496,628 77,406 325,182 90,167 1,167,986 1,940,281 975,335 557,638 5,762,939 485,859 54,973 43,634 20,236 6,466 11,081 5,326 116,836 19,988 119,000 73,922 14,397 Total affected entities b Construction Total employment a 527 132 222 466 256 124 398 77 59 1,641 129 141 1,155 136 70 2,450 401 170 288 150 31 217 125 204 193 49 129 105 83 499 72 6,064 951 385 2,281 1,943 271 321 465 805 22 240 731 1,431 224 1,344 41 59,209 16,429 17,722 26,565 6,120 4,710 26,596 8,814 3,243 64,724 8,362 5,779 36,622 7,304 3,928 39,947 15,195 10,857 14,669 7,381 1,278 9,383 6,168 13,509 7,094 1,603 4,475 5,640 11,003 20,625 14,392 107,190 22,738 14,077 66,095 30,633 6,629 19,241 10,028 108,592 2,198 21,543 9,178 14,471 12,631 46,209 5,854 457 115 208 441 251 119 135 43 15 347 41 32 189 39 20 53 78 54 67 33 7 48 110 104 180 45 108 81 56 457 32 2,470 599 194 1,934 1,885 171 195 350 523 12 94 728 480 121 1,093 31 General Industry and Maritime 802,349 198,912 44,702 21,232 12,469 11,860 5,561 117,456 182,368 133,343 74,446 N/A Total establish-ments a 527 132 222 466 256 124 150 50 18 366 47 33 207 41 22 54 86 61 83 42 7 53 125 204 193 49 129 105 83 499 72 6,064 951 385 2,281 1,943 271 321 465 614 12 122 731 1,431 224 1,344 41 477,476 55,338 44,702 21,232 6,511 11,860 5,561 117,456 20,358 120,012 74,446 NA Total affected establishments b 22,111 5,934 6,618 9,633 2,219 1,708 150 50 18 366 47 33 207 41 22 54 86 61 83 42 7 53 2,953 5,132 2,695 609 1,646 2,075 271 1,034 722 43,920 10,962 6,787 31,865 12,085 5,051 1,090 4,835 614 12 122 4,394 5,043 4,395 3,285 2,802 1,849,175 55,338 173,939 217,070 6,511 204,899 46,813 559,729 20,358 120,012 274,439 170,068 Total affected employment b ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ 652,029 27,669 34,788 96,181 3,255 66,916 18,835 111,946 10,179 60,006 137,219 85,034 Total FTE affected employees b 9,753,093 2,290,472 3,640,441 3,614,233 747,437 821,327 5,702,872 2,080,000 905,206 10,418,233 1,178,698 1,198,675 6,382,593 1,450,781 1,226,230 6,402,565 2,817,120 4,494,254 3,496,143 4,139,263 765,196 3,012,985 951,475 2,195,641 1,217,597 227,406 955,377 1,453,869 3,421,674 3,395,635 4,365,673 27,904,708 5,127,518 2,861,038 10,336,178 3,507,209 2,205,910 5,734,226 2,538,560 53,496,748 1,027,769 7,014,894 827,296 8,909,030 7,168,591 24,113,682 818,725 1,548,247,709 $374,724,410 313,592,140 98,129,343 24,449,519 96,655,241 19,456,230 157,513,197 267,537,377 112,005,298 84,184,953 N/A Total revenues ($1,000) c 21,341,560 19,917,147 17,502,121 8,195,541 2,977,835 6,901,910 15,929,811 31,044,783 18,104,119 6,695,523 10,618,900 8,686,049 6,044,123 11,423,474 19,159,850 2,658,873 7,739,340 29,961,696 15,069,584 34,783,724 26,386,082 15,451,203 8,649,776 21,111,931 6,764,429 5,053,461 8,846,082 17,948,999 61,101,328 7,430,274 136,427,289 11,297,453 8,560,131 14,747,620 5,344,456 1,860,588 12,900,061 29,406,287 7,253,028 77,983,597 46,716,774 37,714,484 1,136,395 18,560,480 59,244,556 22,061,923 26,410,479 1,954,148 $1,896,379 7,186,876 4,849,246 1,974,442 8,722,610 3,653,066 1,348,156 1,494,196 847,120 1,138,835 N/A Revenues per entity TABLE VIII–3—CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA’S PROPOSED STANDARD FOR SILICA—ALL ENTITIES mstockstill on DSK4VPTVN1PROD with PROPOSALS2 18,506,818 17,352,060 16,398,383 7,755,866 2,919,674 6,623,607 14,328,825 27,012,993 15,342,473 6,348,710 9,137,193 8,501,240 5,526,055 10,667,509 17,517,577 2,613,292 7,025,236 26,436,790 12,139,387 27,595,088 24,683,755 13,884,721 7,611,802 10,762,945 6,308,794 4,640,933 7,406,022 13,846,371 41,224,993 6,804,880 60,634,351 4,601,700 5,391,712 7,431,268 4,531,424 1,805,048 8,139,891 17,863,633 5,459,268 66,455,587 46,716,774 29,228,725 1,131,731 6,225,737 32,002,640 17,941,728 19,968,899 1,929,644 $1,883,870 7,015,170 4,621,766 1,960,824 8,149,683 3,498,693 1,341,040 1,467,019 839,979 1,130,819 N/A Revenues per establishment 56344 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules VerDate Mar<15>2010 19:12 Sep 11, 2013 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ Jkt 229001 PO 00000 Frm 00073 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ 333613 333911 333912 333991 333992 333993 333994 333995 333996 333997 333999 334518 335211 335221 335222 335224 335228 336111 336112 336120 336211 336212 336213 336311 336312 336322 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ 336370 336399 336611 336612 336992 337215 339114 339116 339911 339913 339914 336340 ........ 336350 ........ 336330 ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ 333411 333412 333414 333511 333512 333513 333514 333515 333516 333518 333612 333319 ........ 332510 332611 332612 332618 332710 332812 332911 332912 332913 332919 332991 332996 332997 332998 332999 Hardware manufacturing .......................................................... Spring (heavy gauge) manufacturing ....................................... Spring (light gauge) manufacturing .......................................... Other fabricated wire product manufacturing ........................... Machine shops ......................................................................... Metal coating and allied services ............................................. Industrial valve manufacturing .................................................. Fluid power valve and hose fitting manufacturing ................... Plumbing fixture fitting and trim manufacturing ........................ Other metal valve and pipe fitting manufacturing .................... Ball and roller bearing manufacturing ...................................... Fabricated pipe and pipe fitting manufacturing ........................ Industrial pattern manufacturing ............................................... Enameled iron and metal sanitary ware manufacturing .......... All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing ................................. Industrial and commercial fan and blower manufacturing ....... Heating equipment (except warm air furnaces) manufacturing Industrial mold manufacturing .................................................. Machine tool (metal cutting types) manufacturing ................... Machine tool (metal forming types) manufacturing .................. Special die and tool, die set, jig, and fixture manufacturing .... Cutting tool and machine tool accessory manufacturing ......... Rolling mill machinery and equipment manufacturing ............. Other metalworking machinery manufacturing ......................... Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing ..... Pump and pumping equipment manufacturing ........................ Air and gas compressor manufacturing ................................... Power-driven handtool manufacturing ...................................... Welding and soldering equipment manufacturing .................... Packaging machinery manufacturing ....................................... Industrial process furnace and oven manufacturing ................ Fluid power cylinder and actuator manufacturing .................... Fluid power pump and motor manufacturing ........................... Scale and balance (except laboratory) manufacturing ............ All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing ...................................... Electric housewares and household fans ................................ Household cooking appliance manufacturing .......................... Household refrigerator and home freezer manufacturing ........ Household laundry equipment manufacturing .......................... Other major household appliance manufacturing .................... Automobile manufacturing ........................................................ Light truck and utility vehicle manufacturing ............................ Heavy duty truck manufacturing ............................................... Motor vehicle body manufacturing ........................................... Truck trailer manufacturing ....................................................... Motor home manufacturing ...................................................... Carburetor, piston, piston ring, and valve manufacturing ........ Gasoline engine and engine parts manufacturing ................... Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing ............................. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping .................................................. All other motor vehicle parts manufacturing ............................ Ship building and repair ........................................................... Boat building ............................................................................. Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing ........ Dental equipment and supplies manufacturing ........................ Dental laboratories ................................................................... Jewelry (except costume) manufacturing ................................. Jewelers’ materials and lapidary work manufacturing ............. Costume jewelry and novelty manufacturing ........................... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 1,647 740 7,028 1,760 261 590 635 1,189 575 1,066 47 188 432 214 104 99 116 18 17 39 167 63 77 728 353 79 102 810 643 196 413 272 137 250 583 312 269 146 95 1,630 303 142 377 2,084 514 274 3,172 1,482 70 362 197 1,253 734 109 270 1,103 21,135 2,363 394 306 126 240 107 711 459 72 3,043 1,733 763 7,261 1,777 264 590 781 1,458 635 1,129 57 241 535 257 106 105 125 26 23 45 181 94 95 820 394 91 116 876 697 231 490 318 150 275 619 335 319 178 102 1,725 351 163 407 2,126 530 285 3,232 1,552 73 383 226 1,349 828 113 340 1,198 21,356 2,599 488 381 144 268 180 765 461 76 3,123 59,080 15,550 47,088 25,280 5,199 6,775 110,578 149,251 87,352 54,705 6,899 33,782 83,756 39,390 2,188 7,425 16,033 17,121 16,269 12,806 75,225 103,815 32,122 47,566 32,260 21,533 10,537 66,112 62,016 15,645 30,764 21,417 8,714 15,853 21,179 10,720 19,887 13,631 3,748 52,454 14,883 10,506 20,577 39,917 17,220 8,556 57,576 34,922 3,020 12,470 12,374 53,012 45,282 4,059 15,336 36,364 266,597 56,978 38,330 35,519 11,513 18,112 27,197 27,201 5,281 5,655 72,201 317 399 7,028 1,760 261 590 508 687 575 1,066 32 149 382 185 12 20 43 18 17 32 167 63 77 239 163 79 52 345 323 75 147 104 45 82 113 56 95 63 20 280 72 52 108 221 94 46 319 188 17 67 61 278 227 22 69 189 1,490 2,363 175 161 57 91 91 143 30 72 397 334 411 7,261 1,777 264 590 624 843 635 1,129 39 191 473 223 12 22 47 26 23 37 181 94 95 269 182 91 60 373 350 88 174 121 49 90 120 61 112 77 21 296 84 59 116 226 97 48 325 197 17 70 70 299 256 23 87 205 1,506 2,599 216 201 65 102 154 154 30 76 408 334 411 33,214 7,813 1,607 1,088 624 843 2,798 1,752 39 191 473 223 12 22 47 50 47 37 425 587 181 269 182 122 60 373 350 88 174 121 49 90 120 61 112 77 21 296 84 59 116 226 97 48 325 197 17 70 70 299 256 23 87 205 1,506 4,695 216 201 65 102 154 154 30 96 408 ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ 8,059,533 3,397,252 3,852,293 6,160,238 934,387 751,192 24,461,822 42,936,991 14,650,189 10,062,908 2,406,966 11,675,801 31,710,273 10,244,934 491,114 2,175,398 4,461,008 4,601,594 4,792,444 4,549,859 87,308,106 139,827,543 17,387,065 11,581,029 6,313,133 5,600,569 2,327,226 30,440,351 22,222,133 3,256,010 7,872,517 6,305,944 3,115,514 4,257,678 4,294,579 1,759,938 3,991,832 3,019,188 694,419 9,791,511 2,428,159 1,962,040 4,266,536 4,963,915 3,675,264 1,398,993 7,232,706 4,941,932 652,141 2,605,582 2,280,825 12,744,730 9,268,800 825,444 2,618,283 5,770,701 32,643,382 11,010,624 8,446,768 8,044,008 3,276,413 3,787,626 6,198,871 4,879,023 486,947 1,036,508 12,944,345 4,893,462 4,590,881 548,135 3,500,135 3,580,028 1,273,206 38,522,554 36,111,851 25,478,589 9,439,876 51,212,047 62,105,323 73,403,409 47,873,524 4,722,250 21,973,717 38,456,968 255,644,105 281,908,445 116,663,058 522,803,033 2,219,484,812 225,806,042 15,908,007 17,884,229 70,893,283 22,815,945 37,580,680 34,560,082 16,612,294 19,061,785 23,183,616 22,740,979 17,030,713 7,366,345 5,640,828 14,839,523 20,679,367 7,309,671 6,007,062 8,013,727 13,817,181 11,317,071 2,381,917 7,150,320 5,105,812 2,280,172 3,334,637 9,316,299 7,197,740 11,577,790 10,171,373 12,627,793 7,572,882 9,697,344 5,231,823 1,544,518 4,659,595 21,438,497 26,287,608 26,003,281 15,781,773 57,933,374 6,862,198 1,060,887 14,395,940 4,253,811 4,650,625 4,452,493 530,546 3,466,650 3,539,346 1,273,206 31,321,154 29,449,239 23,071,163 8,913,116 42,227,477 48,447,306 59,271,538 39,863,557 4,633,151 20,718,076 35,688,066 176,984,380 208,367,112 101,107,984 482,365,229 1,487,527,055 183,021,739 14,123,206 16,023,179 61,544,718 20,062,296 34,749,259 31,882,544 14,095,280 16,066,362 19,830,011 20,770,094 15,482,466 6,937,931 5,253,548 12,513,579 16,961,728 6,808,027 5,676,238 6,917,833 12,037,053 10,482,888 2,334,861 6,934,461 4,908,746 2,237,842 3,184,235 8,933,437 6,803,086 10,092,145 9,447,539 11,194,203 7,304,815 7,700,832 4,816,946 1,528,534 4,236,485 17,308,951 21,112,882 22,752,871 14,132,931 34,438,172 6,377,808 1,056,285 13,638,259 4,144,843 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56345 VerDate Mar<15>2010 ........ ........ ........ ........ 6,291 7,016 N/A 119,471 219,203 1,025,888 Subtotals—General Industry and maritime ....................... Totals—All Industries ........................................................ Total entities a Sign manufacturing ................................................................... Industrial supplies, wholesalers ................................................ Rail transportation .................................................................... Dental offices ............................................................................ Industry 1,041,291 238,942 6,415 10,742 N/A 124,553 Total establish-ments a 17,508,728 4,406,990 89,360 111,198 N/A 817,396 Total employment a 532,866 47,007 487 250 N/A 7,655 Total affected entities b 533,597 56,121 496 383 N/A 7,980 Total affected establishments b 2,144,061 294,886 496 383 16,895 7,980 Total affected employment b 652,029 ........................ ........................ ........................ ........................ ........................ Total FTE affected employees b $2,649,803,698 1,101,555,989 11,299,429 19,335,522 N/A 88,473,742 Total revenues ($1,000) c $2,619,701 5,025,278 1,796,126 2,755,918 N/A 740,546 Revenues per entity $2,544,729 4,610,140 1,761,407 1,799,993 N/A 710,330 Revenues per establishment a U.S. Census Bureau, Statistics of U.S. Businesses, 2006. b OSHA estimates of employees potentially exposed to silica and associated entities and establishments. Affected entities and establishments constrained to be less than or equal to the number of affected employees. c Estimates based on 2002 receipts and payroll data from U.S. Census Bureau, Statistics of U.S. Businesses, 2002, and payroll data from the U.S. Census Bureau, Statistics of U.S. Businesses, 2006. Receipts are not reported for 2006, but were estimated assuming the ratio of receipts to payroll remained unchanged from 2002 to 2006. d State-plan states only. State and local governments are included under the construction sector because the silica risks for public employees are the result of construction-related activities. e OSHA estimates that only one-third of the entities and establishments in this industry, as reported above, use silica-containing inputs. Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG, 2013. 339950 423840 482110 621210 NAICS TABLE VIII–3—CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA’S PROPOSED STANDARD FOR SILICA—ALL ENTITIES—Continued mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56346 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00074 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules As shown in Table VIII–3, OSHA estimates that a total of 533,000 entities (486,000 in construction; 47,000 in general industry and maritime), 534,000 establishments (477,500 in construction; 56,100 in general industry and maritime), and 2.1 million workers (1.8 million in construction; 0.3 million in general industry and maritime) would be affected by the proposed silica rule. Note that only slightly more than 50 percent of the entities and establishments, and about 12 percent of the workers in affected industries, actually engage in activities involving silica exposure.9 The ninth column in Table VIII–3, with data only for construction, shows for each affected NAICS construction industry the number of full-timeequivalent (FTE) affected workers that corresponds to the total number of affected construction workers in the previous column.10 This distinction is necessary because affected construction workers may spend large amounts of time working on tasks with no risk of silica exposure. As shown in Table VIII– 3, the 1.8 million affected workers in construction converts to approximately 652,000 FTE affected workers. In contrast, OSHA based its analysis of the affected workers in general industry and maritime on the assumption that they were engaged full time in activities with some silica exposure. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 9 It should be emphasized that these percentages vary significantly depending on the industry sector and, within an industry sector, depending on the NAICS industry. For example, about 14 percent of the workers in construction, but only 7 percent of workers in general industry, actually engage in activities involving silica exposure. As an example within construction, about 63 percent of workers in highway, street, and bridge construction, but only 3 percent of workers in state and local governments, actually engage in activities involving silica exposure. 10 FTE affected workers becomes a relevant variable in the estimation of control costs in the construction industry. The reason is that, consistent with the costing methodology, control costs depend only on how many worker-days there are in which exposures are above the PEL. These are the workerdays in which controls are required. For the derivation of FTEs, see Tables IV–8 and IV–22 and the associated text in ERG (2007a). VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 The last three columns in Table VIII– 3 show combined total revenues for all entities (not just affected entities) in each affected industry, and the average revenue per entity and per establishment in each affected industry. Because OSHA did not have data to distinguish revenues for affected entities and establishments in any industry, average revenue per entity and average revenue per affected entity (as well as average revenue per establishment and average revenue per affected establishment) are estimated to be equal in value. Silica Exposure Profile of At-Risk Workers The technological feasibility analyses presented in Chapter IV of the PEA contain data and discussion of worker exposures to silica throughout industry. Exposure profiles, by job category, were developed from individual exposure measurements that were judged to be substantive and to contain sufficient accompanying description to allow interpretation of the circumstance of each measurement. The resulting exposure profiles show the job categories with current overexposures to silica and, thus, the workers for whom silica controls would be implemented under the proposed rule. Chapter IV of the PEA includes a section with a detailed description of the methods used to develop the exposure profile and to assess the technological feasibility of the proposed standard. That section documents how OSHA selected and used the data to establish the exposure profiles for each operation in the affected industry sectors, and discusses sources of uncertainly including the following: • Data Selection—OSHA discusses how exposure samples with sample durations of less than 480 minutes (an 8-hour shift) are used in the analysis. • Use of IMIS data—OSHA discusses the limitations of data from its Integrated Management Information System. • Use of analogous information— OSHA discusses how information from one industry or operation is used to PO 00000 Frm 00075 Fmt 4701 Sfmt 4702 56347 describe exposures in other industries or operations with similar characteristics. • Non-Detects—OSHA discusses how exposure data that is identified as ‘‘less than the LOD (limit of detection)’’ is used in the analysis. OSHA seeks comment on the assumptions and data selection criteria the Agency used to develop the exposure profiles shown in Chapter IV of the PEA. Table VIII–4 summarizes, from the exposure profiles, the total number of workers at risk from silica exposure at any level, and the distribution of 8-hour TWA respirable crystalline silica exposures by job category for general industry and maritime sectors and for construction activities. Exposures are grouped into the following ranges: less than 25 mg/m3; ≥ 25 mg/m3 and ≤ 50 mg/ m3; > 50 mg/m3 and ≤ 100 mg/m3; > 100 mg/m3 and ≤ 250 mg/m3; and greater than 250 mg/m3. These frequencies represent the percentages of production employees in each job category and sector currently exposed at levels within the indicated range. Table VIII–5 presents data by NAICS code—for each affected general, maritime, and construction industry— on the estimated number of workers currently at risk from silica exposure, as well as the estimated number of workers at risk of silica exposure at or above 25 mg/m3, above 50 mg/m3, and above 100 mg/m3. As shown, an estimated 1,026,000 workers (851,000 in construction; 176,000 in general industry and maritime) currently have silica exposures at or above the proposed action level of 25 mg/m3; an estimated 770,000 workers (648,000 in construction; 122,000 in general industry and maritime) currently have silica exposures above the proposed PEL of 50 mg/m3; and an estimated 501,000 workers (420,000 in construction; 81,000 in general industry and maritime) currently have silica exposures above 100 mg/m3—an alternative PEL investigated by OSHA for economic analysis purposes. BILLING CODE 4510–26–P E:\FR\FM\12SEP2.SGM 12SEP2 56348 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Table VIII-4 Distribution of Silica Exposures by Sector and Job Category or Activity Silica Exposure Range <25 Job Category/Activity Sector ~g/m3 25-50 ~g/m3 50-100 ~g/m3 100-250 >250 ~g/m3 ~g/m3 Total Construction 18.6% 86.7% 79.2% 14.3% 18.3% 24.2% 11.9% 6.7% 8.3% 28.6% 8.3% 9.9% 16.9% 6.7% 8.3% 35.7% 15.6% 12.1% 20.3% 0.0% 4.2% 14.3% 24.8% 38.5% 32.2% 0.0% 0.0% 7.1% 33.0% 15.4% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% Masonry Cutters Using Stationary Saws 21.4% 25.0% 25.0% 3.6% 25.0% 100.0% Millers Using Portable or Mobile Machines Rock and Concrete Drillers 54.3% 35.9% 20.0% 17.9% 200% 17.9% 2.9% 17.9% 2.9% 10.3% 100.0% 100.0% Rock-Crushing Machine Operators and Tenders Tuckpointers and Grinders Underground Construction Workers 0.0% 10.0% 59.3% 0.0% 8.5% 18.5% 0.0% 11.9% 11.1% 20.0% 18.4% 7.4% 80.0% 51.2% 3.7% 100.0% 100.0% 100.0% 50.0% 100.0% 100.0% 0.0% 16.7% 28.1% 26.3% 25.0% 172% 14.4% 13.3% 45.9% 83.3% 41.9% 46.2% 33.3% 14.3% 16.7% 11.8% 17.4% 17.2% 33.3% 83.9% 50.0% 0.0% 6.6% 15.5% 25.5 0/0 37.5% 14.3% 10.8% 16.7% 28.1% 26.3% 25.0% 17.2% 14.4% 37.5% 0.0% 50.0% 0.0% 6.6% 0.0% 0.0% 0.0% 28.6% 60.0% 24.6% 21.6% 32.1% 25.0% 14.3% 35.1% 25.0% 18.8% 24.3% 25.0% 15.5% 25.8% 6.7% 16.2% 7.1% 22.6% 15.4% 0.0% 28.6% 33.3% 17.6% 26.1% 13.8% 0.0% 12.9% 0.0% 16,7% 24.6% 21.6% 32.1% 25.0% 14.3% 35.1% 25.0% 18.8% 24.3% 25.0% 15.5% 25.8% 18.8% 82.4% 0<0% 16.7% 24.6% 50.0% 0.0% 0.0% 42.9% 200% 27.9% 19.2% 29.2% 0.0% 429% 18.9% 25.0% 31.3% 28.9% 16.7% 25.9% 29.9% 20.0% 10.8% 7.1% 19.4% 0.0% 33.3% 14.3% 8.3% 23.5% 39.1% 20.7% 33.3% 3.2% 33.3% 33.3% 27.9% 19.2% 29.2% 0.0% 42.9% 18.9% 25.0% 31.3% 28.9% 16.7% 25.9% 29.9% 12.5% 11.8% 33.3% 33.3% 27.9% 0.0% 0.0% 0.0% 28.6% 20.0% 27.9% 21.1% 9.4% 12.5% 14.3% 24.3% 12.5% 21.9% 19.1% 29.2% 27.6% 17.5% 26.7% 16.2% 2.4% 9.7% 30.8% 16.7% 14.3% 25.0% 35.3% 17.4% 48.3% 33.3% 0.0% 0.0% 33.3% 27.9% 21.1% 9.4% 12.5% 14.3% 24.3% 12.5% 21.9% 19.1% 29.2% 27.6% 17.5% 18.8% 5.9% 0.0% 33.3% 27.9% 0.0% 0.0% 0.0% 0.0% 0.0% 13.1% 22.5% 3.8% 25.0% 14.3% 10.8% 20.8% 0.0% 1.3% 4.2% 13.8% 12.4% 33.3% 10.8% 0.0% 6.5% 7.7% 16.7% 28.6% 16.7% 11.8% 0.0% 0.0% 0.0% 0.0% 16.7% 16.7% 13.1% 22.5% 3.8% 25.0% 14.3% 10.8% 20.8% 0.0% 1.3% 4.2% 13.8% 12.4% 12.5% 0.0% 16.7% 16.7% 13.1% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 1000% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 1000% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 1000% 100.0% 100.0% 100.0% 15.5% 25.5% 21.6% 321% 19.2% 29.2% 21.1% 9.4% 22.5% 3.8% 100.0% 100.0% mstockstill on DSK4VPTVN1PROD with PROPOSALS2 General Industry/Maritime Asphalt Paving Products Front-end loader operator Maintenance worker Plant operator Asphalt Roofing Materials Material handler Production operator Abrasive blasting operator Captive Foundries Cleaning/Finishing operator Coremaker Furnace operator Housekeeping worker Knockout operator Maintenance operator Material handler Molder Pouring operator Sand systems operator Shakeout operator Abrasive blasting operator Concrete Products Finishing operator Forming Line operator Material handler Mixer Operator Packaging operator Abrasive blasting ops Cut Stone Fabricator Machine operator Sawyer Splitter/chipper Production operator Dental Equipment Dental technician Dental Laboratories Batch operator FlalGlass Material handler Abrasive blasting operator Iron Foundries Cleaning/Finishing operator Coremaker Furnace operator Housekeeping worker Knockout operator Maintenance operator Material handler Molder Pouring operator Sand systems operator Shakeout operator Jewelry workers Jewelry Production worker Mineral Processing Batch operator Mineral Wool Materia! handler Abrasive blasting operator Nonferrous Sand Casling Foundries Cleaning/Finishing operator Coremaker VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00076 0.0% 6.6% 15.5% 25.5% 37.5% 14.3% 10.8% Fmt 4701 Sfmt 4725 E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.006</GPH> Abrasive Blasters Drywall Finishers Heavy Equipment Operators Hole Drillers Using Hand-Held Drills Jackhammer and Impact Drillers Masonry Cutters Using Portable Saws Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56349 Table VIII-4 Distribution of Silica Exposures by Sector and Job Category or Activity (Continued) Silica Exposure Range Sector <25 ~g/m3 ~g/m3 100-250 >250 ~g/m3 Total ~g/m3 37.5% 14.3% 10.8% 16.7% 28.1% 26.3% 25.0% 17.2% 14.4% 6.6% Maintenance operator Materia! handler Molder Pouring operator Sand systems operator Shakeout operator Non-Sand Casting Foundries Abrasive blasting operator Cleaning/Finishing operator Coremaker Furnace operator Housekeeping worker Knockout operator Maintenance operator Material handler Molder Pouring operator Sand systems operator Shakeout operator Abrasive blasting operator 0.0% 42.9% 18.9% 25.0% 31.3% 28.9% 16.7% 25.9% 29.9% 27.9% 12.5% 14.3% 24.3% 12.5% 21.9% 19.1% 29.2% 27.6% 17.5% 27.9% 25.0% 14.3% 10.8% 20.8% 0.0% 1.3% 4.2% 13.8% 12.4% 13.1% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 1000% 100.0% 100.0% 21.6% 32.1% 25.0% 14.3% 35.1% 25.0% 18.8% 24.3% 25.0% 15.5% 25.8% 24.6% 19.2% 29.2% 0.0% 42.9% 18.9% 25.0% 31.3% 28.9% 16.7% 25.9% 29.9% 27.9% 21.1% 9.4% 12.5% 14.3% 24.3% 12.5% 21.9% 19.1% 29.2% 27.6% 17.5% 27.9% 22.5% 3.8% 25.0% 14.3% 10.8% 20.8% 0.0% 1.3% 42% 13.8% 12.4% 13.1% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 15.5% 25.5% 37.5% 14.3% 10.8% 16.7% 28.1% 26.3% 25.0% 17.2% 14.4% 50.0% 0.0% 100.0% 800% 33.3% 52.2% 18.9% 5.3% 15.4% 25.6% 38.1% 50.0% 21.0% 100.0% 60.0% 75.0% 100.0% 0.0% 100.0% 100.0% 45.5% 33.3% 50.0% 20.0% 0.0% 10.0% 27.0% 0.0% 21.4% 42.9% 70.3% 30.0% Knockout operator 25.0% 14.3% 35.1% 25.0% 18.8% 24.3% 25.0% 15.5% 25.8% 24.6% 15.5% 25.5% 37.5% 14.3% 10.8% 16.7% 28.1% 26.3% 25.0% 172% 14.4% 6.6% Furnace operator Housekeeping worker Other Ferrous Sand Casting 50-100 ~glm3 Job Category/Activity 25-50 21.6% 32.1% 25.0% 14.3% 35.1% 250% 18.8% 24.3% 25.0% 15.5% 25.8% 0.0% 16.7% 0.0% 0.0% 33.3% 13.0% 10.8% 5.3% 34.6% 40.0% 19.0% 26.9% 380% 0.0% 20.0% 0.0% 0.0% 0.0% 0.0% 0.0% 27.3% 22.2% 41.7% 40.0% 28.6% 10.0% 16.2% 14.3% 7.1% 0.0% 16.2% 20.0% 19.2% 29.2% 0.0% 42.9% 18.9% 25.0% 31.3% 28.9% 16.7% 25.9% 29.9% 33.3% 33.3% 0.0% 0.0% 33.3% 21.7% 16.2% 31.6% 19.2% 14.4% 19.0% 7.7% 23.0% 0.0% 20.0% 25.0% 0.0% 0.0% 0.0% 0.0% 13.6% 22.2% 0.0% 20.0% 14.3% 50.0% 16.2% 14.3% 21.4% 28.6% 10.8% 30.0% 21.1% 9.4% 12.5% 14.3% 24.3% 12.5% 21.9% 19.1% 29.2% 27.6% 17.5% 0.0% 33.3% 0.0% 0.0% 0.0% 0.0% 32.4% 26.3% 30.8% 20.0% 9.5% 7.7% 11.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 13.6% 18.5% 8.3% 20.0% 14.3% 30.0% 29.7% 28.6% 28.6% 28.6% 2.7% 15.0% 22.5% 3.8% 25.0% 14.3% 10.8% 20.8% 0.0% 1.3% 4.2% 13.8% 12.4% 16.7% 16.7% 0.0% 20.0% 0.0% 13.0% 21.6% 31.6% 0.0% 0.0% 14.3% 7.7% 7.0% 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 3.7% 0.0% 0.0% 42.9% 0.0% 10.8% 42.9% 21.4% 0.0% 0.0% 5.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% Foundries Cleaning/Finishing operator Coremaker Furnace operator Housekeeping worker Knockout operator Maintenance operator Material handler Molder Other Glass Products Paint and Coatings Porcelain Enameling Pottery Railroads Ready mix Refractories Refractory Repair Shipyards Structural Clay Pouring operator Sand systems operator Shakeout operator Batch operator Material handler Material handler Mixer operator Enamel preparer Porcelain applicator Coatings operator Coatings preparer Finishing operator Forming line operator Material handler Ballast dumper Machine operator Batch operator Maintenance operator Materia! handler Quality control technician Truck driver Ceramic fiber furnace operator Finishing operator Forming operator Material handler Packaging operator Production operator Abrasive blasters Forming line operator/Coatings blender Forming line operator/Formers Forming line operator/Pug mill operator Grinding operator Material handler/Loader operator Materia! handler/post-production Material handler/production Source: Technological feasibillty analysis in Chapter IV of the PEA BILLING CODE 4510–26–C NAICS Number of establishments Industry Number of employees Numbers exposed to Silica >=0 >=25 >=50 >=100 >=250 Construction 236100 236200 237100 237200 .............. .............. .............. .............. VerDate Mar<15>2010 Residential Building Construction .......... Nonresidential Building Construction ..... Utility System Construction .................... Land Subdivision .................................... 19:12 Sep 11, 2013 Jkt 229001 PO 00000 198,912 44,702 21,232 12,469 Frm 00077 Fmt 4701 966,198 741,978 496,628 77,406 Sfmt 4702 55,338 173,939 217,070 6,511 32,260 83,003 76,687 1,745 E:\FR\FM\12SEP2.SGM 12SEP2 24,445 63,198 53,073 1,172 14,652 39,632 28,667 560 7,502 20,504 9,783 186 EP12SE13.007</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3)) 56350 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))— Continued NAICS 237300 .............. 237900 .............. 238100 .............. 238200 238300 238900 999000 .............. .............. .............. .............. Subtotals— Construction. Number of establishments Industry Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors ............ Building Finishing Contractors ............... Other Specialty Trade Contractors ........ State and local governments [d] ............ ................................................................ Number of employees Numbers exposed to Silica >=0 >=25 >=50 >=100 >=250 11,860 325,182 204,899 58,441 39,273 19,347 7,441 5,561 90,167 46,813 12,904 8,655 4,221 1,369 117,456 1,167,986 559,729 396,582 323,119 237,537 134,355 182,368 133,343 74,446 NA 1,940,281 975,335 557,638 5,762,939 20,358 120,012 274,439 170,068 6,752 49,202 87,267 45,847 4,947 37,952 60,894 31,080 2,876 24,662 32,871 15,254 1,222 14,762 13,718 5,161 802,349 13,101,738 1,849,175 850,690 647,807 420,278 216,003 General Industry and Maritime 324121 .............. 324122 .............. 325510 .............. 327111 .............. 327112 .............. 327113 327121 327122 327123 327124 327125 327211 327212 .............. .............. .............. .............. .............. .............. .............. .............. 327213 327320 327331 327332 327390 327991 .............. .............. .............. .............. .............. .............. 327992 .............. 327993 .............. 327999 .............. 331111 .............. 331112 .............. 331210 .............. 331221 .............. 331222 .............. 331314 .............. 331423 .............. 331492 .............. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 331511 331512 331513 331524 331525 331528 .............. .............. .............. .............. .............. .............. 332111 332112 332115 332116 332117 332211 .............. .............. .............. .............. .............. .............. 332212 .............. 332213 .............. 332214 .............. VerDate Mar<15>2010 Asphalt paving mixture and block manufacturing. Asphalt shingle and roofing materials .... Paint and coating manufacturing ........... Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg .............. Brick and structural clay mfg ................. Ceramic wall and floor tile mfg .............. Other structural clay product mfg .......... Clay refractory manufacturing ................ Nonclay refractory manufacturing .......... Flat glass manufacturing ........................ Other pressed and blown glass and glassware manufacturing. Glass container manufacturing .............. Ready-mixed concrete manufacturing ... Concrete block and brick mfg ................ Concrete pipe mfg .................................. Other concrete product mfg ................... Cut stone and stone product manufacturing. Ground or treated mineral and earth manufacturing. Mineral wool manufacturing ................... All other misc. nonmetallic mineral product mfg. Iron and steel mills ................................. Electrometallurgical ferroalloy product manufacturing. Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ......... Steel wire drawing .................................. Secondary smelting and alloying of aluminum. Secondary smelting, refining, and alloying of copper. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ......................................... Steel investment foundries ..................... Steel foundries (except investment) ...... Aluminum foundries (except die-casting) Copper foundries (except die-casting) ... Other nonferrous foundries (except diecasting). Iron and steel forging ............................. Nonferrous forging ................................. Crown and closure manufacturing ......... Metal stamping ....................................... Powder metallurgy part manufacturing .. Cutlery and flatware (except precious) manufacturing. Hand and edge tool manufacturing ....... Saw blade and handsaw manufacturing Kitchen utensil, pot, and pan manufacturing. 19:12 Sep 11, 2013 Jkt 229001 PO 00000 1,431 14,471 5,043 48 48 0 0 224 1,344 41 12,631 46,209 5,854 4,395 3,285 2,802 4,395 404 2,128 1,963 404 1,319 935 404 853 0 404 227 731 9,178 4,394 3,336 2,068 1,337 356 125 204 193 49 129 105 83 499 6,168 13,509 7,094 1,603 4,475 5,640 11,003 20,625 2,953 5,132 2,695 609 1,646 2,075 271 1,034 2,242 3,476 1,826 412 722 910 164 631 1,390 2,663 1,398 316 364 459 154 593 898 1,538 808 182 191 241 64 248 239 461 242 55 13 17 45 172 72 6,064 951 385 2,281 1,943 14,392 107,190 22,738 14,077 66,095 30,633 722 43,920 10,962 6,787 31,865 12,085 440 32,713 5,489 3,398 15,957 10,298 414 32,110 3,866 2,394 11,239 7,441 173 29,526 2,329 1,442 6,769 4,577 120 29,526 929 575 2,700 1,240 271 6,629 5,051 5,051 891 297 0 321 465 19,241 10,028 1,090 4,835 675 2,421 632 1,705 268 1,027 182 410 805 22 108,592 2,198 614 12 456 9 309 6 167 3 57 1 240 21,543 122 90 61 33 11 170 288 150 10,857 14,669 7,381 61 83 42 46 62 31 31 42 21 17 23 11 6 8 4 31 1,278 7 5 4 2 1 217 9,383 53 39 27 14 5 527 132 222 466 256 124 59,209 16,429 17,722 26,565 6,120 4,710 22,111 5,934 6,618 9,633 2,219 1,708 16,417 4,570 4,914 7,418 1,709 1,315 11,140 3,100 3,334 5,032 1,159 892 6,005 1,671 1,797 2,712 625 481 2,071 573 620 931 214 165 398 77 59 1,641 129 141 26,596 8,814 3,243 64,724 8,362 5,779 150 50 18 366 47 33 112 37 14 272 35 24 76 25 9 184 24 16 41 13 5 99 13 9 14 5 2 34 4 3 1,155 136 70 36,622 7,304 3,928 207 41 22 154 31 17 104 21 11 56 11 6 19 4 2 Frm 00078 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56351 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))— Continued NAICS 332323 .............. 332439 332510 332611 332612 332618 .............. .............. .............. .............. .............. 332710 332812 332911 332912 .............. .............. .............. .............. 332913 .............. 332919 .............. 332991 .............. 332996 .............. 332997 .............. 332998 .............. 332999 .............. 333319 .............. 333411 .............. 333412 .............. 333414 .............. 333511 .............. 333512 .............. 333513 .............. 333514 .............. 333515 .............. 333516 .............. 333518 .............. 333612 .............. 333613 .............. 333911 .............. 333912 .............. 333991 .............. 333992 .............. 333993 .............. 333994 .............. 333995 .............. 333996 .............. 333997 .............. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 333999 .............. 334518 .............. 335211 .............. 335221 .............. 335222 .............. 335224 .............. 335228 .............. 336111 .............. VerDate Mar<15>2010 Number of establishments Industry Ornamental and architectural metal work. Other metal container manufacturing .... Hardware manufacturing ........................ Spring (heavy gauge) manufacturing ..... Spring (light gauge) manufacturing ........ Other fabricated wire product manufacturing. Machine shops ....................................... Metal coating and allied services ........... Industrial valve manufacturing ............... Fluid power valve and hose fitting manufacturing. Plumbing fixture fitting and trim manufacturing. Other metal valve and pipe fitting manufacturing. Ball and roller bearing manufacturing .... Fabricated pipe and pipe fitting manufacturing. Industrial pattern manufacturing ............ Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing ................ Machine tool (metal cutting types) manufacturing. Machine tool (metal forming types) manufacturing. Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing. Other metalworking machinery manufacturing. Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing. Air and gas compressor manufacturing Power-driven handtool manufacturing ... Welding and soldering equipment manufacturing. Packaging machinery manufacturing ..... Industrial process furnace and oven manufacturing. Fluid power cylinder and actuator manufacturing. Fluid power pump and motor manufacturing. Scale and balance (except laboratory) manufacturing. All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing ... Electric housewares and household fans. Household cooking appliance manufacturing. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing. Other major household appliance manufacturing. Automobile manufacturing ..................... 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Number of employees Numbers exposed to Silica >=0 >=25 >=50 >=100 >=250 2,450 39,947 54 26 19 7 7 401 828 113 340 1,198 15,195 45,282 4,059 15,336 36,364 86 256 23 87 205 64 190 17 64 153 43 129 12 44 104 23 69 6 24 56 8 24 2 8 19 21,356 2,599 488 381 266,597 56,978 38,330 35,519 1,506 4,695 216 201 1,118 2,255 161 149 759 1,632 109 101 409 606 59 55 141 606 20 19 144 11,513 65 48 33 18 6 268 18,112 102 76 51 28 10 180 765 27,197 27,201 154 154 114 114 77 77 42 42 14 14 461 76 5,281 5,655 30 96 22 56 15 38 8 16 3 11 3,123 72,201 408 303 205 111 38 1,349 53,012 299 222 151 81 28 351 163 14,883 10,506 84 59 62 44 42 30 23 16 8 6 407 20,577 116 86 59 32 11 2,126 530 39,917 17,220 226 97 168 72 114 49 61 26 21 9 285 8,556 48 36 24 13 5 3,232 57,576 325 241 164 88 30 1,552 34,922 197 146 99 54 18 73 3,020 17 13 9 5 2 383 12,470 70 52 35 19 7 226 12,374 70 52 35 19 7 231 15,645 88 66 44 24 8 490 30,764 174 129 88 47 16 318 150 275 21,417 8,714 15,853 121 49 90 90 37 67 61 25 45 33 13 24 11 5 8 619 335 21,179 10,720 120 61 89 45 60 31 32 16 11 6 319 19,887 112 83 57 31 11 178 13,631 77 57 39 21 7 102 3,748 21 16 11 6 2 1,725 52,454 296 220 149 80 28 106 105 2,188 7,425 12 22 9 10 6 8 3 3 1 3 125 16,033 47 22 16 6 6 26 17,121 50 24 17 7 7 23 16,269 47 23 17 6 6 45 12,806 37 18 13 5 5 181 75,225 425 316 214 115 40 Frm 00079 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56352 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))— Continued NAICS 336112 .............. 336120 336211 336212 336213 336311 .............. .............. .............. .............. .............. 336312 .............. 336322 .............. 336330 .............. 336340 .............. 336350 .............. 336370 .............. 336399 .............. 336611 .............. 336612 .............. 336992 .............. 337215 .............. 339114 .............. 339116 .............. 339911 .............. 339913 .............. 339914 .............. 339950 423840 482110 621210 .............. .............. .............. .............. Subtotals— General Industry and Maritime. Totals Number of establishments Industry Light truck and utility vehicle manufacturing. Heavy duty truck manufacturing ............ Motor vehicle body manufacturing ......... Truck trailer manufacturing .................... Motor home manufacturing .................... Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing. Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping ................ All other motor vehicle parts manufacturing. Ship building and repair ......................... Boat building .......................................... Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing. Dental laboratories ................................. Jewelry (except costume) manufacturing. Jewelers’ materials and lapidary work manufacturing. Costume jewelry and novelty manufacturing. Sign manufacturing ................................ Industrial supplies, wholesalers ............. Rail transportation .................................. Dental offices ......................................... Number of employees Numbers exposed to Silica >=0 >=25 >=50 >=100 >=250 94 103,815 587 436 296 159 55 95 820 394 91 116 32,122 47,566 32,260 21,533 10,537 181 269 182 122 60 135 200 135 90 44 91 135 92 61 30 49 73 50 33 16 17 25 17 11 6 876 66,112 373 277 188 101 35 697 62,016 350 260 176 95 33 257 39,390 223 165 112 60 21 241 33,782 191 142 96 52 18 535 83,756 473 351 238 128 44 781 1,458 110,578 149,251 624 843 464 626 315 425 170 229 58 79 635 1,129 57 87,352 54,705 6,899 2,798 1,752 39 2,798 1,752 29 1,998 1,252 20 1,599 1,001 11 1,199 751 4 1,733 59,080 334 248 168 91 31 763 15,550 411 274 274 137 0 7,261 1,777 47,088 25,280 33,214 7,813 5,357 4,883 1,071 3,418 0 2,442 0 977 264 5,199 1,607 1,004 703 502 201 590 6,775 1,088 685 479 338 135 6,415 10,742 NA 124,553 89,360 111,198 NA 817,396 496 383 16,895 7,980 249 306 11,248 1,287 172 153 5,629 257 57 77 2,852 0 57 0 1,233 0 ................................................................ 238,942 4,406,990 294,886 175,801 122,472 80,731 48,956 ................................................................ 1,041,291 17,508,728 2,144,061 1,026,491 770,280 501,009 264,959 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on Table III–5 and the technological feasibility analysis presented in Chapter IV of the PEA. D. Technological Feasibility Analysis of the Proposed Permissible Exposure Limit to Crystalline Silica Exposures Chapter IV of the Preliminary Economic Analysis (PEA) provides the technological feasibility analysis that guided OSHA’s selection of the proposed PEL, consistent with the requirements of the Occupational Safety and Health Act (‘‘OSH Act’’), 29 U.S.C. 651 et seq. Section 6(b)(5) of the OSH Act requires that OSHA ‘‘set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity.’’ 29 U.S.C. 655(b)(5) (emphasis added). The Court of Appeals for the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 D.C. Circuit has clarified the Agency’s obligation to demonstrate the technological feasibility of reducing occupational exposure to a hazardous substance: OSHA must prove a reasonable possibility that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations . . . The effect of such proof is to establish a presumption that industry can meet the PEL without relying on respirators . . . Insufficient proof of technological feasibility for a few isolated operations within an industry, or even OSHA’s concession that respirators will be necessary in a few such operations, will not undermine this general presumption in favor of feasibility. Rather, in such operations firms will remain responsible for installing PO 00000 Frm 00080 Fmt 4701 Sfmt 4702 engineering and work practice controls to the extent feasible, and for using them to reduce . . . exposure as far as these controls can do so. United Steelworkers of America, AFL– CIO–CIC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980). Additionally, the D.C. Circuit has explained that ‘‘[f]easibility of compliance turns on whether exposure levels at or below [the PEL] can be met in most operations most of the time. . . .’’ American Iron & Steel Inst. v. OSHA, 939 F.2d 975, 990 (D.C. Cir. 1991). To demonstrate the limits of feasibility, OSHA’s analysis examines the technological feasibility of the proposed PEL of 50 mg/m3, as well as E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 the technological feasibility of an alternative PEL of 25 mg/m3. In total, OSHA analyzed technological feasibility in 108 operations in general industry, maritime, and construction industries. This analysis addresses two different aspects of technological feasibility: (1) The extent to which engineering controls can reduce and maintain exposures; and (2) the capability of existing sampling and analytical methods to measure silica exposures. The discussion below summarizes the findings in Chapter IV of the PEA (see Docket No. OSHA–2010–0034). Methodology The technological feasibility analysis relies on information from a wide variety of sources. These sources include published literature, OSHA inspection reports, NIOSH reports and engineering control feasibility studies, and information from other federal agencies, state agencies, labor organizations, industry associations, and other groups. OSHA has limited the analysis to job categories that are associated with substantial direct silica exposure. The technological feasibility analyses group the general industry and maritime workplaces into 23 industry sectors.11 The Agency has divided each industry sector into specific job categories on the basis of common materials, work processes, equipment, and available exposure control methods. OSHA notes that these job categories are intended to represent job functions; actual job titles and responsibilities might differ depending on the facility. OSHA has organized the construction industry by grouping workers into 12 general construction activities. The Agency organized construction workers into general activities that create silica exposures rather than organizing them by job titles because construction workers often perform multiple activities and job titles do not always coincide with the sources of exposure. In organizing construction worker activity this way, OSHA was able to create a more accurate exposure profile and apply control methods to workers who perform these activities in any segment of the construction industry. The exposure profiles include silica exposure data only for workers in the United States. Information on international exposure levels is occasionally referenced for perspective 11 Note that OSHA’s technological feasibility analysis contains 21 general industry sections. The number is expanded to 23 in this summary because Table VIII.D–1 describes the foundry industry as three different sectors (ferrous, nonferrous, and non-sand casting foundries) to provide a more detailed analysis of exposures. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 or in discussions of control options. It is important to note that the vast majority of crystalline silica encountered by workers in the United States is in the quartz form, and the terms crystalline silica and quartz are often used interchangeably. Unless specifically indicated otherwise, all silica exposure data, samples, and results discussed in the technological feasibility analysis refer to measurements of personal breathing zone (PBZ) respirable crystalline silica. In general and maritime industries, the exposure profiles in the technological feasibility analysis consist mainly of full-shift samples, collected over periods of 360 minutes or more. By using full-shift sampling results, OSHA minimizes the number of results that are less than the limit of detection (LOD) and eliminates the ambiguity associated with the LOD for low air volume samples. Thus, results that are reported in the original data source as below the LOD are included without contributing substantial uncertainty regarding their relationship to the proposed PEL. This is particularly important for general industry samples, which on average have lower silica levels than typical results for many tasks in the construction industry. In general and maritime industries, the exposure level for the period sampled is assumed to have continued over any unsampled portion of the worker’s shift. OSHA has preliminarily determined that this sample criterion is valid because workers in these industries are likely to work at the same general task or same repeating set of tasks over most of their shift; thus, unsampled periods generally are likely to be similar to the sampled periods. In the construction industry, much of the data analyzed for the defined activities consisted of full-shift samples collected over periods of 360 minutes or more. Construction workers are likely to spend a shift working at multiple discrete tasks, independent of occupational titles, and do not normally engage in those discrete tasks for the entire duration of a shift. Therefore, the Agency occasionally included partialshift samples (periods of less than 360 minutes), but has limited the use of partial-shift samples with results below the LOD, giving preference to data covering a greater part of the workers’ shifts. OSHA believes that the partial-shift samples were collected for the entire duration of the task and that the exposure to silica ended when the task was completed. Therefore, OSHA assumes that the exposure to silica was zero for the remaining unsampled time. PO 00000 Frm 00081 Fmt 4701 Sfmt 4702 56353 OSHA understands that this may not always be the case, and that there may be activities other than the sampled tasks that affect overall worker exposures, but the documentation regarding these factors is insufficient to use in calculating a time-weighted average. It is important to note, however, that the Agency has identified to the best of its ability the construction activities that create significant exposures to respirable crystalline silica. In cases where exposure information from a specific job category is not available, OSHA has based that portion of the exposure profile on surrogate data from one or more similar job categories in related industries. The surrogate data is selected based on strong similarities of raw materials, equipment, worker activities, and exposure duration between the job categories. When used, OSHA has clearly identified the surrogate data and the relationship between the industries or job categories. 1. Feasibility Determination of Sampling and Analytical Methods As part of its technological feasibility analysis, OSHA examined the capability of currently available sampling methods and sensitivity 12 and precision of currently available analytical methods to measure respirable crystalline silica (please refer to the ‘‘Feasibility of Measuring Respirable Crystalline Silica Exposures at The Proposed PEL’’ section in Chapter IV of the PEA). The Agency understands that several commercially available personal sampling cyclones exist that can be operated at flow rates that conform to the ISO/CEN particle size selection criteria with an acceptable level of bias. Some of these sampling devices are the Dorr-Oliver, HiggensDowel, BGI GK 2.69, and the SKC G–3 cyclones. Bias against the ISO/CEN criteria will fall within ±20 percent, and often is within ±10 percent. Additionally, the Agency preliminarily concludes that all of the mentioned cyclones are capable of allowing a sufficient quantity of quartz to be collected from atmospheric concentrations as low as 25 mg/m3 to exceed the limit of quantification for the OSHA ID–142 analytical method, provided that a sample duration is at least 4 hours. Furthermore, OSHA believes that these devices are also capable of collecting more than the minimum amount of cristobalite at the proposed PEL and action level 12 Note that sensitivity refers to the smallest quantity that can be measured with a specified level of accuracy, expressed either as the limit of detection or limit of quantification. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56354 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules necessary for quantification with OSHA’s method ID–142 for a full shift. One of these cyclones (GK 2.69) can also collect an amount of cristobalite exceeding OSHA’s limit of quantification (LOQ) with a 4-hour sample at the proposed PEL and action level. Regarding analytical methods to measure silica, OSHA investigated the sensitivity and precision of available methods. The Agency preliminarily concludes that the X-Ray Diffraction (XRD) and Infrared Spectroscopy (IR) methods of analysis are both sufficiently sensitive to quantify levels of quartz and cristobalite that would be collected on air samples taken from concentrations at the proposed PEL and action level. Available information shows that poor inter-laboratory agreement and lack of specificity render colorimetric spectrophotometry (another analytical method) inferior to XRD or IR techniques. As such, OSHA is proposing not to permit employers to rely on exposure monitoring results based on analytical methods that use colorimetric methods. For the OSHA XRD Method ID–142 (revised December 1996), precision is ±23 percent at a working range of 50 to 160 mg crystalline silica, and the SAE (sampling and analytical error) is ±19 percent. The NIOSH and MSHA XRD and IR methods report a similar degree of precision. OSHA’s Salt Lake Technical Center (SLTC) evaluated the precision of ID–142 at lower filter loadings and has shown an acceptable level of precision is achieved at filter loadings of approximately 40 mg and 20 mg corresponding to the amounts collected from full-shift sampling at the proposed PEL and action level, respectively. This analysis showed that at filter loadings corresponding to the proposed PEL, the precision and SAE for quartz are ±17 and ±14 percent, respectively. For cristobalite, the precision and SAE are ±19 and ±16 percent, respectively. These results indicate that employers can have confidence in sampling results for the purpose of assessing compliance with the PEL and identifying when additional engineering and work practice controls and/or respiratory protection are needed. For example, given an SAE for quartz of 0.14 at a filter load of 40 mg, employers can be virtually certain that the PEL is not exceeded where exposures are less than 43 mg/m3, which represents the lower 95-percent confidence limit (i.e., 50 mg/m3 minus 50*0.14). At 43 mg/m3, a full-shift sample that collects 816 L of air will result in a filter load of 35 mg of quartz, VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 or more than twice the LOQ for Method ID–142. Thus, OSHA believes that the method is sufficiently sensitive and precise to allow employers to distinguish between operations that have sufficient dust control to comply with the PEL from those that do not. Finally, OSHA’s analysis of PAT data indicates that most laboratories achieve good agreement in results for samples having filter loads just above 40 mg quartz (49–70 mg). At the proposed action level, the study by SLTC found the precision and SAE of the method for quartz at 20 mg to be ±19 and ±16 percent, respectively. For cristobalite, the precision and SAE at 20 mg were also ±19 and ±16 percent, respectively. OSHA believes that these results show that Method ID–142 can achieve a sufficient degree of precision for the purpose of identifying those operations where routine exposure monitoring should be conducted. However, OSHA also believes that limitations in the characterization of the precision of the analytical method in this range of filter load preclude the Agency from proposing a PEL of 25 mg/ m3 at this time. First, the measurement error increases by about 4 to 5 percent for a full-shift sample taken at 25 mg/m3 compared to one taken at 50 mg/m3, and the error would be expected to increase further as filter loads approach the limit of detection. Second, for an employer to be virtually certain that an exposure to quartz did not exceed 25 mg/m3 as an exposure limit, the exposure would have to be below 21 mg/m3 given the SAE of ±16 percent calculated from the SLTC study. For a full-shift sample of 0.816 L of air, only about 17 mg of quartz would be collected at 21 mg/m3, which is near the LOQ for Method ID–142 and at the maximum acceptable LOD that would be required by the proposed rule. Thus, given a sample result that is below a laboratory’s reported LOD, employers might not be able to rule out whether a PEL of 25 mg/m3 was exceeded. Finally, there are no available data that describe the total variability seen between laboratories at filter loadings in the range of 20 mg crystalline silica since the lowest filter loading used in PAT samples is about 50 mg. Given these considerations, OSHA believes that a PEL of 50 mg/m3 is more appropriate in that employers will have more confidence that sampling results are properly informing them where additional dust controls and respiratory protection is needed. Based on the evaluation of the nationally recognized sampling and analytical methods for measuring respirable crystalline silica presented in PO 00000 Frm 00082 Fmt 4701 Sfmt 4702 the section titled ‘‘Feasibility of Measuring Respirable Crystalline Silica Exposures at The Proposed PEL’’ in Chapter IV of the PEA, OSHA preliminarily concludes that it is technologically feasible to reliably measure exposures of workers at the proposed PEL of 50 mg/m3 and action level of 25 mg/m3. OSHA notes that the sampling and analytical error is larger at the proposed action level than that for the proposed PEL. In the ‘‘Issues’’ section of this preamble (see Provisions of the Standards—Exposure Assessment), OSHA solicits comments on whether measurements of exposures at the proposed action level and PEL are sufficiently precise to permit employers to adequately determine when additional exposure monitoring is necessary under the standard, when to provide workers with the required medical surveillance, and when to comply with all other requirements of the proposed standard. OSHA also solicits comments on the appropriateness of specific requirements in the proposed standard for laboratories that perform analyses of respirable crystalline silica samples to reduce the variability between laboratories. 2. Feasibility Determination of Control Technologies The Agency has conducted a feasibility analysis for each of the identified 23 general industry sectors and 12 construction industry activities that are potentially affected by the proposed silica standard. Additionally, the Agency identified 108 operations within those sectors/activities and developed exposure profiles for each operation, except for two industries, engineered stone products and landscape contracting industries. For these two industries, data satisfying OSHA’s criteria for inclusion in the exposure profile were unavailable (refer to the Methodology section in Chapter 4 of the PEA for criteria). However, the Agency obtained sufficient information in both of these industries to make feasibility determinations (see Chapter IV Sections C.7 and C.11 of the PEA). Each feasibility analysis contains a description of the applicable operations, the baseline conditions for each operation (including the respirable silica samples collected), additional controls necessary to reduce exposures, and final feasibility determinations for each operation. 3. Feasibility Findings for the Proposed Permissible Exposure Limit of 50 mg/m3 Tables VIII–6 and VIII–7 summarize all the industry sectors and construction E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules activities studied in the technological feasibility analysis and show how many operations within each can achieve levels of 50 mg/m3 through the implementation of engineering and work practice controls. The tables also summarize the overall feasibility finding for each industry sector or construction activity based on the number of feasible versus not feasible operations. For the general industry sector, OSHA has preliminarily concluded that the proposed PEL of 50 mg/m3 is technologically feasible for all affected industries. For the construction activities, OSHA has determined that the proposed PEL of 50 mg/m3 is feasible in 10 out of 12 of the affected activities. Thus, OSHA preliminarily concludes that engineering and work practices will be sufficient to reduce and maintain silica exposures to the proposed PEL of 50 mg/m3 or below in most operations most of the time in the affected industries. For those few operations within an industry or activity where the proposed PEL is not technologically feasible even when workers use recommended engineering and work practice controls (seven out of 108 operations, see Tables VIII–6 and VIII– 7), employers can supplement controls with respirators to achieve exposure levels at or below the proposed PEL. 4. Feasibility Findings for an Alternative Permissible Exposure Limit of 25 mg/m3 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Based on the information presented in the technological feasibility analysis, OSHA believes that engineering and work practice controls identified to date will not be sufficient to consistently reduce exposures to PELs lower than 50 mg/m3. The Agency believes that a proposed PEL of 25 mg/m3, for example, would not be feasible for many industries, and to use respiratory protection would have to be required in most operations and most of the time to achieve compliance. However, OSHA has data indicating that an alternative PEL of 25 mg/m3 has already been achieved in several industries (e.g. asphalt paving products, dental laboratories, mineral processing, and paint and coatings manufacturing in general industry, and drywall finishers and heavy equipment operators in VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 construction). In these industries, airborne respirable silica concentrations are inherently low because either small amounts of silica containing materials are handled or these materials are not subjected to high energy processes that generate large amounts of respirable dust. For many of the other industries, OSHA believes that engineering and work practice controls will not be able to reduce and maintain exposures to an alternative PEL of 25 mg/m3 in most operations and most of the time. This is especially the case in industries that use silica containing material in substantial quantities and industries with high energy operations. For example, in general industry, the ferrous foundry industry would not be able to comply with an alternative PEL of 25 mg/m3 without widespread respirator use. In this industry, silica containing sand is transported, used, and recycled in significant quantities to create castings, and as a result, workers can be exposed to high levels of silica in all steps of the production line. Additionally, some high energy operations in foundries create airborne dust that causes high worker exposures to silica. One of these operations is the shakeout process, where operators monitor equipment that separates castings from mold materials by mechanically vibrating or tumbling the casting. The dust generated from this process causes elevated silica exposures for shakeout operators and often contributes to exposures for other workers in a foundry. For small, medium, and large castings, exposure information with engineering controls in place show that exposures below 50 mg/m3 can be consistently achieved, but exposures above an alternative PEL of 25 mg/m3 still occur. With engineering controls in place, exposure data for these operations range from 13 mg/m3 to 53 mg/m3, with many of the reported exposures above 25 mg/m3. In the construction industry, OSHA estimates that an alternative PEL of 25 mg/m3 would be infeasible in most operations because most of them are high energy operations that produce significant levels of dust, causing workers to have elevated exposures, and available engineering controls would PO 00000 Frm 00083 Fmt 4701 Sfmt 4702 56355 not be able to maintain exposures at or below the alternative PEL most of the time. For example, jackhammering is a high energy operation that creates a large volume of silica containing dust, which disburses rapidly in highly disturbed air. OSHA estimates that the exposure levels of most workers operating jackhammers outdoors will be reduced to less that 100 mg/m3 as an 8hour TWA, by using either wet methods or LEV paired with a suitable vacuum. OSHA believes that typically, the majority of jackhammering is performed for less than four hours of a worker’s shift, and in these circumstances the Agency estimates that most workers will experience levels below 50 mg/m3. Jackhammer operators who work indoors or with multiple jackhammers will achieve similar results granted that the same engineering controls are used and that fresh air circulation is provided to prevent accumulation of respirable dust in a worker’s vicinity. OSHA does not have any data indicating that these control strategies would reduce exposures of most workers to levels of 25 mg/m3 or less. 5. Overall Feasibility Determination Based on the information presented in the technological feasibility analysis, the Agency believes that 50 mg/m3 is the lowest feasible PEL. An alternative PEL of 25 mg/m3 would not be feasible because the engineering and work practice controls identified to date will not be sufficient to consistently reduce exposures to levels below 25 mg/m3 in most operations most of the time. OSHA believes that an alternative PEL of 25 mg/m3 would not be feasible for many industries, and that the use of respiratory protection would be necessary in most operations most of the time to achieve compliance. Additionally, the current methods of sampling analysis create higher errors and lower precision in measurement as concentrations of silica lower than the proposed PEL are analyzed. However, the Agency preliminarily concludes that these sampling and analytical methods are adequate to permit employers to comply with all applicable requirements triggered by the proposed action level and PEL. E:\FR\FM\12SEP2.SGM 12SEP2 56356 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–6—SUMMARY OF TECHNOLOGICAL FEASIBILITY OF CONTROL TECHNOLOGIES IN GENERAL AND MARITIME INDUSTRIES AFFECTED BY SILICA EXPOSURES Total number of affected operations Industry sector Number of operations for which the proposed PEL is achievable with engineering controls and work practice controls Number of operations for which the proposed PEL is NOT achievable with engineering controls and work practice controls Asphalt Paving Products ......................................................... Asphalt Roofing Materials ........................................................ Concrete Products ................................................................... Cut Stone ................................................................................. Dental Equipment and Suppliers ............................................. Dental Laboratories ................................................................. Engineered Stone Products ..................................................... Foundries: Ferrous* ................................................................. Foundries: Nonferrous* ............................................................ Foundries: Non-Sand Casting* ................................................ Glass ........................................................................................ Jewelry ..................................................................................... Landscape Contracting ............................................................ Mineral Processing .................................................................. Paint and Coatings .................................................................. Porcelain Enameling ................................................................ Pottery ...................................................................................... Railroads .................................................................................. Ready-Mix Concrete ................................................................ Refractories .............................................................................. Refractory Repair ..................................................................... Shipyards (Maritime Industry) .................................................. Structural Clay ......................................................................... 3 2 6 5 1 1 1 12 12 11 2 1 1 1 2 2 5 5 5 5 1 2 3 3 2 5 5 1 1 1 12 12 11 2 1 1 1 2 2 5 5 4 5 1 1 3 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 Totals ................................................................................ 89 96.6% Overall feasibility finding for industry sector Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. 3.4% * Section 8 of the Technological Feasibility Analysis includes four subsectors of the foundry industry. Each subsector includes its own exposure profile and feasibility analysis in that section. This table lists three of those four subsectors individually based on the difference in casting processes used and subsequent potential for silica exposure. The table does not include captive foundries because the captive foundry operations are incorporated into the larger manufacturing process of the parent foundry. TABLE VIII–7—SUMMARY OF TECHNOLOGICAL FEASIBILITY OF CONTROL TECHNOLOGIES IN CONSTRUCTION ACTIVITIES AFFECTED BY SILICA EXPOSURES Total number of affected operations Construction activity Number of operations for which the proposed PEL is achievable with engineering controls and work practice controls Number of operations for which the proposed PEL is NOT achievable with engineering controls and work practice controls mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Abrasive Blasters ..................................................................... Drywall Finishers ...................................................................... Heavy Equipment Operators ................................................... Hole Drillers Using Hand-Held Drills ....................................... Jackhammer and Impact Drillers ............................................. Masonry Cutters Using Portable Saws .................................... Masonry Cutters Using Stationary Saws ................................. Millers Using Portable and Mobile Machines .......................... Rock and Concrete Drillers ...................................................... Rock-Crushing Machine Operators and Tenders .................... Tuckpointers and Grinders ...................................................... Underground Construction Workers ........................................ 2 1 1 1 1 3 1 3 1 1 3 1 0 1 1 1 1 3 1 3 1 1 1 1 2 0 0 0 0 0 0 0 0 0 2 0 Totals ................................................................................ 19 78.9% Overall feasibility finding for activity 21.1% E. Costs of Compliance Chapter V of the PEA in support of the proposed silica rule provides a detailed assessment of the costs to establishments in all affected industry VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 sectors of reducing worker exposures to silica to an eight-hour time-weighted average (TWA) permissible exposure limit (PEL) of 50 mg/m3 and of complying with the proposed standard’s PO 00000 Frm 00084 Fmt 4701 Sfmt 4702 Not Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Feasible. Not Feasible. Feasible. ancillary requirements. The discussion below summarizes the findings in the PEA cost chapter. OSHA’s preliminary cost assessment is based on the Agency’s technological feasibility E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules analysis presented in Chapter IV of the PEA (2013); analyses of the costs of the proposed standard conducted by OSHA’s contractor, Eastern Research Group (ERG, 2007a, 2007b, and 2013); and the comments submitted to the docket as part of the SBREFA panel process. OSHA estimates that the proposed rule will cost $657.9 million per year in 2009 dollars. Costs originally estimated for earlier years were adjusted to 2009 dollars using the appropriate price indices. All costs are annualized using a discount rate of 7 percent. (A sensitivity analysis using discount rates of 3 percent and 0 percent is presented in the discussion of net benefits.) Onetime costs are annualized over 10-year annualization period, and capital goods are annualized over the life of the equipment. OSHA has historically annualized one-time costs over at least a 10-year period, which approximately reflects the average life of a business in the United States. (The Agency has chosen a longer annualization period under special circumstances, such as when a rule involves longer and more complex phase-in periods. In general, a longer annualization period, in such cases, will tend to reduce annualized costs slightly.) The estimated costs for the proposed silica standard rule include the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that has already been achieved with regard to the new requirements or costs necessary to achieve compliance with existing silica requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements. Table VIII–8 provides the annualized costs of the proposed rule by cost category for general industry, maritime, and construction. As shown in Table VIII–8, of the total annualized costs of the proposed rule, $132.5 million would be incurred by general industry, $14.2 million by maritime, and $511.2 million by construction. Table VIII–9 shows the annualized costs of the proposed rule by cost category and by industry for general industry and maritime, and Table VIII– 10 shows the annualized costs similarly disaggregated for construction. These tables show that engineering control costs represent 69 percent of the costs of the proposed standard for general industry and maritime and 47 percent of the costs of the proposed standard for construction. Considering other leading cost categories, costs for exposure assessment and respirators represent, VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 respectively, 20 percent and 5 percent of the costs of the proposed standard for general industry and maritime; costs for respirators and medical surveillance represent, respectively, 16 percent and 15 percent of the costs of the proposed standard for construction. While the costs presented here represent the Agency’s best estimate of the costs to industry of complying with the proposed rule under static conditions (that is, using existing technology and the current deployment of workers), OSHA recognizes that the actual costs could be somewhat higher or lower, depending on the Agency’s possible overestimation or underestimation of various cost factors. In Chapter VII of the PEA, OSHA provides a sensitivity analysis of its cost estimates by modifying certain critical unit cost factors. Beyond the sensitivity analysis, however, OSHA believes its cost estimates may significantly overstate the actual costs of the proposed rule because, in response to the rule, industry may be able to take two types of actions to reduce compliance costs. First, in construction, 53 percent of the estimated costs of the proposed rule (all costs except engineering controls) vary directly with the number of workers exposed to silica. However, as shown in Table VIII–3 of this preamble, almost three times as many construction workers would be affected by the proposed rule as would the number of full-time-equivalent construction workers necessary to do the work. This is because most construction workers currently do work involving silica exposure for only a portion of their workday. In response to the proposed rule, many employers are likely to assign work so that fewer construction workers perform tasks involving silica exposure; correspondingly, construction work involving silica exposure will tend to become a full-time job for some construction workers.13 Were this approach fully implemented in construction, the actual cost of the proposed rule would decline by over 25 percent, or by $180 million annually, to under $480 million annually.14 13 There are numerous instances of job reassignments and job specialties arising in response to OSHA regulation. For example, asbestos removal and confined space work in construction have become activities performed by well-trained specialized employees, not general laborers (whose only responsibility is to identify the presence of asbestos or a confined space situation and then to notify the appropriate specialist). 14 OSHA expected that such a structural change in construction work assignments would not have a significant effect on the benefits of the proposed rule. As discussed in Chapter VII of the PEA, the benefits of the proposed rule are relatively PO 00000 Frm 00085 Fmt 4701 Sfmt 4702 56357 Second, the costs presented here do not take into account the likely development and dissemination of costreducing compliance technology in response to the proposed rule.15 One possible example is the development of safe substitutes for silica sand in abrasive blasting operations, repair and replacement of refractory materials, foundry operations, and the railroad transportation industry. Another is expanded uses of automated processes, which would allow workers to be isolated from the points of operation that involve silica exposure (such as tasks between the furnace and the pouring machine in foundries and at sand transfer stations in structural clay production facilities). Yet another example is the further development and use of bags with valves that seal effectively when filled, thereby preventing product leakage and worker exposure (for example, in mineral processing and concrete products industries). Probably the most pervasive and significant technological advances, however, will likely come from the integration of compliant control technology into production equipment as standard equipment. Such advances would both increase the effectiveness and reduce the costs of silica controls retrofitted to production equipment. Possible examples include local exhaust ventilation (LEV) systems attached to portable tools used by grinders and tuckpointers; enclosed operator cabs equipped with air filtration and air conditioning in industries that mechanically transfer silica or silicacontaining materials; and machineintegrated wet dust suppression systems used, for example, in road milling operations. Of course, all the possible technological advances in response to the proposed rule and their effects on costs are difficult to predict.16 OSHA has decided at this time not to create a more dynamic and predictive analysis of possible cost-reducing insensitive to changes in average occupational tenure or how total silica exposure in an industry is distributed among individual workers. 15 Evidence of such technological responses to regulation is widespread (see for example Ashford, Ayers, and Stone (1985), OTA (1995), and OSHA’s regulatory reviews of existing standards under § 610 of the Regulatory Flexibility Act (‘‘610 lookback reviews’’)). 16 A dramatic example from OSHA’s 610 lookback review of its 1984 ethylene oxide (EtO) standard is the use of EtO as a sterilant. OSHA estimated the costs of add-on controls for EtO sterilization, but in response to the standard, improved EtO sterilizers with built-in controls were developed and widely disseminated at about half the cost of the equipment with add-on controls. (See OSHA, 2005.) Lower-cost EtO sterilizers with built-in controls did not exist, and their development had not been predicted by OSHA, at the time the final rule was published in 1984. E:\FR\FM\12SEP2.SGM 12SEP2 56358 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules technological advances or worker specialization because the technological and economic feasibility of the proposed rule can easily be demonstrated using existing technology and employment patterns. However, OSHA believes that actual costs, if future developments of this type were fully accounted for, would be lower than those estimated here. OSHA invites comment on this discussion concerning the costs of the proposed rule. TABLE VIII–8—ANNUALIZED COMPLIANCE COSTS FOR EMPLOYERS IN GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA STANDARD [2009 dollars] Industry Engineering controls (includes abrasive blasting) Respirators Exposure assessment Medical surveillance Regulated areas or access control Training Total General Industry .......... Maritime ....................... Construction ................. $88,442,480 12,797,027 242,579,193 $6,914,225 NA 84,004,516 $29,197,633 671,175 44,552,948 $2,410,253 646,824 76,012,451 $2,952,035 43,865 47,270,844 $2,580,728 70,352 16,745,663 $132,497,353 14,229,242 511,165,616 Total ...................... 343,818,700 90,918,741 74,421,757 79,069,527 50,266,744 19,396,743 657,892,211 U.S. Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2007a, 2007b, and 2013). TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS AFFECTED BY THE PROPOSED SILICA STANDARD Engineering controls (includes abrasive blasting) NAICS Industry 324121 ..... Asphalt paving mixture and block manufacturing. Asphalt shingle and roofing materials .. Paint and coating manufacturing .......... Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg ............. Brick and structural clay mfg ................ Ceramic wall and floor tile mfg ............. Other structural clay product mfg ......... Clay refractory manufacturing .............. Nonclay refractory manufacturing ........ Flat glass manufacturing ...................... Other pressed and blown glass and glassware manufacturing. Glass container manufacturing ............. Ready-mixed concrete manufacturing .. Concrete block and brick mfg .............. Concrete pipe mfg ................................ Other concrete product mfg ................. Cut stone and stone product manufacturing. Ground or treated mineral and earth manufacturing. Mineral wool manufacturing ................. All other misc. nonmetallic mineral product mfg. Iron and steel mills ............................... Electrometallurgical ferroalloy product manufacturing. Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ........ Steel wire drawing ................................ Secondary smelting and alloying of aluminum. Secondary smelting, refining, and alloying of copper. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ........................................ Steel investment foundries ................... Steel foundries (except investment) ..... Aluminum foundries (except die-casting). Copper foundries (except die-casting) 324122 ..... 325510 ..... 327111 ..... 327112 ..... 327113 327121 327122 327123 327124 327125 327211 327212 ..... ..... ..... ..... ..... ..... ..... ..... 327213 327320 327331 327332 327390 327991 ..... ..... ..... ..... ..... ..... 327992 ..... 327993 ..... 327999 ..... 331111 ..... 331112 ..... 331210 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 331221 ..... 331222 ..... 331314 ..... 331423 ..... 331492 ..... 331511 331512 331513 331524 ..... ..... ..... ..... 331525 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Exposure assessment Respirators Medical surveillance Regulated areas Training Total $179,111 $2,784 $8,195 $962 $49,979 $1,038 $242,070 2,194,150 0 1,128,859 113,924 23,445 76,502 723,761 70,423 369,478 39,364 8,179 26,795 43,563 33,482 29,006 42,495 8,752 28,554 3,157,257 144,281 1,659,194 1,769,953 119,948 579,309 42,012 45,479 44,770 2,601,471 1,189,482 6,966,654 3,658,389 826,511 304,625 383,919 227,805 902,802 80,610 154,040 80,982 18,320 21,108 26,602 8,960 34,398 389,320 554,322 306,500 72,312 124,390 156,769 29,108 111,912 28,234 53,831 28,371 6,417 7,393 9,318 3,138 12,048 30,564 51,566 27,599 6,302 17,043 21,479 2,800 10,708 30,087 57,636 30,266 6,838 7,878 9,929 3,344 12,839 1,748,297 7,838,050 4,132,107 936,699 482,438 608,017 275,155 1,084,706 629,986 7,029,710 2,979,495 1,844,576 8,660,830 5,894,506 24,003 1,862,221 224,227 138,817 651,785 431,758 78,093 5,817,205 958,517 593,408 2,786,227 1,835,498 8,374 652,249 78,536 48,621 228,290 151,392 7,472 454,630 113,473 70,250 329,844 126,064 8,959 695,065 83,692 51,813 243,276 161,080 756,888 16,511,080 4,437,939 2,747,484 12,900,251 8,600,298 3,585,439 51,718 867,728 18,134 52,692 19,295 4,595,006 897,980 1,314,066 36,654 98,936 122,015 431,012 12,852 34,691 11,376 50,435 13,675 36,911 1,094,552 1,966,052 315,559 6,375 17,939 362 72,403 1,463 6,129 124 5,836 118 6,691 135 424,557 8,577 62,639 3,552 14,556 1,239 1,222 1,328 84,537 31,618 42,648 21,359 1,793 2,419 1,213 7,348 9,911 4,908 625 843 419 617 832 406 670 904 453 42,672 57,557 28,757 3,655 207 857 72 71 78 4,940 27,338 1,551 6,407 539 531 580 36,946 11,372,127 3,175,862 3,403,790 5,155,172 645,546 179,639 193,194 291,571 2,612,775 739,312 794,973 1,220,879 223,005 62,324 67,027 101,588 216,228 58,892 65,679 97,006 241,133 67,110 72,174 108,935 15,310,815 4,283,138 4,596,837 6,975,150 1,187,578 67,272 309,403 23,668 23,448 25,095 1,636,463 PO 00000 Frm 00086 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56359 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS AFFECTED BY THE PROPOSED SILICA STANDARD—Continued Engineering controls (includes abrasive blasting) NAICS Industry 331528 ..... Other nonferrous foundries (except die-casting). Iron and steel forging ........................... Nonferrous forging ................................ Crown and closure manufacturing ....... Metal stamping ..................................... Powder metallurgy part manufacturing Cutlery and flatware (except precious) manufacturing. Hand and edge tool manufacturing ...... Saw blade and handsaw manufacturing. Kitchen utensil, pot, and pan manufacturing. Ornamental and architectural metal work. Other metal container manufacturing ... Hardware manufacturing ...................... Spring (heavy gauge) manufacturing ... Spring (light gauge) manufacturing ...... Other fabricated wire product manufacturing. Machine shops ..................................... Metal coating and allied services ......... Industrial valve manufacturing .............. Fluid power valve and hose fitting manufacturing. Plumbing fixture fitting and trim manufacturing. Other metal valve and pipe fitting manufacturing. Ball and roller bearing manufacturing .. Fabricated pipe and pipe fitting manufacturing. Industrial pattern manufacturing ........... Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing. Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing .............. Machine tool (metal cutting types) manufacturing. Machine tool (metal forming types) manufacturing. Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing. Other metalworking machinery manufacturing. Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing. Air and gas compressor manufacturing Power-driven handtool manufacturing .. Welding and soldering equipment manufacturing. Packaging machinery manufacturing ... Industrial process furnace and oven manufacturing. Fluid power cylinder and actuator manufacturing. Fluid power pump and motor manufacturing. 332111 332112 332115 332116 332117 332211 ..... ..... ..... ..... ..... ..... 332212 ..... 332213 ..... 332214 ..... 332323 ..... 332439 332510 332611 332612 332618 ..... ..... ..... ..... ..... 332710 332812 332911 332912 ..... ..... ..... ..... 332913 ..... 332919 ..... 332991 ..... 332996 ..... 332997 ..... 332998 ..... 332999 ..... 333319 ..... 333411 ..... 333412 ..... 333414 ..... 333511 ..... 333512 ..... 333513 ..... 333514 ..... 333515 ..... 333516 ..... 333518 ..... 333612 ..... 333613 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 333911 ..... 333912 ..... 333991 ..... 333992 ..... 333993 ..... 333994 ..... 333995 ..... 333996 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure assessment Respirators Medical surveillance Training Regulated areas Total 914,028 51,701 212,778 17,937 16,949 19,314 1,232,708 77,324 25,529 9,381 188,102 24,250 16,763 4,393 1,451 532 10,676 1,375 952 19,505 6,440 2,236 45,595 5,727 4,229 1,538 508 186 3,734 481 333 1,555 513 186 3,736 479 337 1,640 541 199 3,988 514 355 105,955 34,982 12,720 255,832 32,828 22,970 106,344 21,272 6,041 1,209 26,356 5,090 2,110 418 2,118 411 2,255 451 145,223 28,851 11,442 650 2,886 228 230 243 15,678 28,010 1,089 4,808 383 572 406 35,267 44,028 131,574 11,792 44,511 105,686 2,502 7,476 670 2,529 6,005 11,106 33,190 2,974 11,228 26,659 876 2,617 235 885 2,102 885 2,646 237 895 2,125 934 2,790 250 944 2,241 60,330 180,292 16,158 60,992 144,819 774,529 2,431,996 111,334 103,246 44,074 94,689 6,316 5,863 211,043 395,206 25,894 24,854 15,533 33,145 2,197 2,040 16,157 48,563 2,159 2,021 16,423 35,337 2,361 2,189 1,077,759 3,038,935 150,261 140,213 33,484 1,901 8,060 661 655 710 45,472 52,542 2,984 12,648 1,038 1,028 1,114 71,354 79,038 78,951 4,488 4,483 19,027 19,006 1,561 1,560 1,547 1,545 1,676 1,674 107,338 107,219 15,383 46,581 874 2,225 3,703 9,304 304 774 301 969 326 831 20,891 60,684 209,692 11,915 53,603 4,181 4,256 4,446 288,093 154,006 8,741 37,161 3,053 3,046 3,266 209,273 43,190 2,453 10,037 847 823 916 58,265 30,549 1,735 7,099 599 582 648 41,212 59,860 3,399 13,911 1,174 1,141 1,269 80,754 116,034 49,965 6,597 2,839 30,348 12,313 2,317 988 2,375 985 2,460 1,059 160,131 68,151 24,850 1,411 6,157 495 500 527 33,940 167,204 9,513 44,922 3,346 3,458 3,545 231,988 101,385 5,764 26,517 2,025 2,075 2,150 139,916 8,897 506 2,327 178 182 189 12,279 36,232 2,060 9,476 724 742 768 50,002 35,962 2,043 8,308 702 674 763 48,452 45,422 2,581 10,493 886 852 963 61,197 89,460 5,077 21,139 1,767 1,746 1,897 121,086 62,241 25,377 46,136 3,534 1,441 2,622 14,975 6,105 10,882 1,230 501 904 1,219 497 879 1,320 538 978 84,518 34,459 62,401 61,479 31,154 3,491 1,768 15,004 7,694 1,219 620 1,218 626 1,304 661 83,714 42,523 57,771 3,280 13,532 1,137 1,113 1,225 78,057 39,598 2,247 9,296 782 772 840 53,535 Frm 00087 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56360 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS AFFECTED BY THE PROPOSED SILICA STANDARD—Continued Engineering controls (includes abrasive blasting) NAICS Industry 333997 ..... Scale and balance (except laboratory) manufacturing. All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing .. Electric housewares and household fans. Household cooking appliance manufacturing. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing. Other major household appliance manufacturing. Automobile manufacturing .................... Light truck and utility vehicle manufacturing. Heavy duty truck manufacturing ........... Motor vehicle body manufacturing ....... Truck trailer manufacturing ................... Motor home manufacturing .................. Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing. Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping .............. All other motor vehicle parts manufacturing. Ship building and repair ....................... Boat building ......................................... Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing. Dental laboratories ............................... Jewelry (except costume) manufacturing. Jewelers’ materials and lapidary work manufacturing. Costume jewelry and novelty manufacturing. Sign manufacturing ............................... Industrial supplies, wholesalers ............ Rail transportation ................................ Dental offices ........................................ 333999 ..... 334518 ..... 335211 ..... 335221 ..... 335222 ..... 335224 ..... 335228 ..... 336111 ..... 336112 ..... 336120 336211 336212 336213 336311 ..... ..... ..... ..... ..... 336312 ..... 336322 ..... 336330 ..... 336340 ..... 336350 ..... 336370 ..... 336399 ..... 336611 ..... 336612 ..... 336992 ..... 337215 ..... 339114 ..... 339116 ..... 339911 ..... 339913 ..... 339914 ..... 339950 423840 482110 621210 ..... ..... ..... ..... Total ...................................................... Exposure assessment Respirators Medical surveillance Training Regulated areas Total 10,853 616 2,688 216 218 230 14,822 152,444 8,657 36,677 3,012 2,985 3,232 207,006 6,389 11,336 363 437 1,596 1,641 127 149 129 203 135 163 8,740 13,928 24,478 944 3,543 321 438 352 30,077 26,139 1,009 3,784 343 468 376 32,118 24,839 958 3,596 326 444 357 30,521 19,551 754 2,830 256 350 281 24,023 218,635 301,676 12,444 17,170 49,525 68,335 4,203 5,799 3,914 5,400 4,636 6,397 293,357 404,778 93,229 138,218 93,781 62,548 30,612 5,303 7,849 5,325 3,557 1,739 21,179 32,738 21,786 14,284 7,044 1,800 2,722 1,841 1,212 598 1,692 2,674 1,791 1,147 576 1,977 2,931 1,989 1,326 649 125,181 187,131 126,512 84,073 41,219 192,076 10,910 44,198 3,753 3,616 4,073 258,625 180,164 10,233 41,457 3,520 3,392 3,820 242,586 114,457 6,504 26,216 2,228 2,128 2,427 153,960 98,118 5,573 22,578 1,917 1,847 2,080 132,114 243,348 13,832 55,796 4,730 4,510 5,160 327,377 321,190 433,579 18,237 24,628 73,408 99,769 6,282 8,472 6,057 8,162 6,810 9,194 431,985 583,803 7,868,944 4,928,083 20,097 NA NA 1,142 412,708 258,467 4,786 397,735 249,089 394 26,973 16,892 383 43,259 27,092 426 8,749,619 5,479,624 27,227 171,563 9,741 41,962 3,405 3,412 3,638 233,720 272,308 15,901 48,135 5,524 4,157 5,930 351,955 103,876 260,378 62,183 198,421 892,167 876,676 21,602 69,472 335,984 81,414 23,193 73,992 1,439,004 1,560,353 53,545 40,804 180,284 14,287 16,742 15,216 320,878 54,734 27,779 122,885 9,726 11,337 10,359 236,821 227,905 97,304 0 24,957 9,972 8,910 327,176 14,985 44,660 60,422 1,738,398 251,046 3,491 3,149 110,229 5,286 5,173 4,199 154,412 87,408 3,718 3,315 121,858 5,572 294,919 177,299 2,452,073 389,256 101,239,507 6,914,225 29,868,808 3,057,076 2,995,900 2,651,079 146,726,595 Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013). TABLE VIII–10—ANNUALIZED COMPLIANCE COSTS FOR CONSTRUCTION EMPLOYERS AFFECTED BY OSHA’S PROPOSED SILICA STANDARD mstockstill on DSK4VPTVN1PROD with PROPOSALS2 [2009 dollars] NAICS 236100 236200 237100 237200 237300 ..... ..... ..... ..... ..... Engineering controls (includes abrasive blasting) Industry Residential Building Construction ......... Nonresidential Building Construction ... Utility System Construction .................. Land Subdivision .................................. Highway, Street, and Bridge Construction. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 $14,610,121 16,597,147 30,877,799 676,046 16,771,688 PO 00000 Frm 00088 Exposure assessment Respirators $2,356,507 7,339,394 2,808,570 59,606 2,654,815 Fmt 4701 $1,949,685 4,153,899 4,458,900 128,183 3,538,146 Sfmt 4702 Medical surveillance $2,031,866 6,202,842 2,386,139 51,327 2,245,164 E:\FR\FM\12SEP2.SGM Training $1,515,047 4,349,517 5,245,721 173,183 4,960,966 12SEP2 Regulated areas and access control $825,654 1,022,115 941,034 22,443 637,082 Total $23,288,881 39,664,913 46,718,162 1,110,789 30,807,861 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56361 TABLE VIII–10—ANNUALIZED COMPLIANCE COSTS FOR CONSTRUCTION EMPLOYERS AFFECTED BY OSHA’S PROPOSED SILICA STANDARD—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 237900 ..... Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors ........... Building Finishing Contractors .............. Other Specialty Trade Contractors ....... State and Local Governments [c] ......... Total—Construction .............................. 238100 ..... 238200 238300 238900 999000 ..... ..... ..... ..... Exposure assessment Respirators Medical surveillance Training Regulated areas and access control Total 4,247,372 430,127 825,247 367,517 1,162,105 131,843 7,164,210 66,484,670 59,427,878 17,345,127 50,179,152 14,435,854 8,034,530 215,907,211 3,165,237 34,628,392 43,159,424 11,361,299 366,310 2,874,918 4,044,680 1,641,712 394,270 2,623,763 5,878,597 3,257,131 316,655 5,950,757 4,854,336 1,426,696 526,555 3,156,004 7,251,924 4,493,968 133,113 1,025,405 2,815,017 1,157,427 4,902,138 50,259,239 68,003,978 23,338,234 242,579,193 84,004,516 44,552,948 76,012,451 47,270,844 16,745,663 511,165,616 Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013). 1. Unit Costs, Other Cost Parameters, and Methodological Assumptions by Major Provision Below, OSHA summarizes its methodology for estimating unit and total costs for the major provisions required under the proposed silica standard. For a full presentation of the cost analysis, see Chapter V of the PEA and ERG (2007a, 2007b, 2011, 2013). OSHA invites comment on all aspects of its preliminary cost analysis. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 a. Engineering Controls Engineering controls include such measures as local exhaust ventilation, equipment hoods and enclosures, dust suppressants, spray booths and other forms of wet methods, high efficient particulate air (HEPA) vacuums, and control rooms. Following ERG’s (2011) methodology, OSHA estimated silica control costs on a per-worker basis, allowing the costs to be related directly to the estimates of the number of overexposed workers. OSHA then multiplied the estimated control cost per worker by the numbers of overexposed workers for both the proposed PEL of 50 mg/m3 and the alternative PEL of 100 mg/m3, introduced for economic analysis purposes. The numbers of workers needing controls (i.e., workers overexposed) are based on the exposure profiles for at-risk occupations developed in the technological feasibility analysis in Chapter IV of the PEA and estimates of the number of workers employed in these occupations developed in the industry profile in Chapter III of the PEA. This workerbased method is necessary because, even though the Agency has data on the number of firms in each affected industry, on the occupations and industrial activities with worker exposure to silica, on exposure profiles of at-risk occupations, and on the costs VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 of controlling silica exposure for specific industrial activities, OSHA does not have a way to match up these data at the firm level. Nor does OSHA have facility-specific data on worker exposure to silica or even facilityspecific data on the level of activity involving worker exposure to silica. Thus, OSHA could not directly estimate per-affected-facility costs, but instead, first had to estimate aggregate compliance costs and then calculate the average per-affected-facility costs by dividing aggregate costs by the number of affected facilities. In general, OSHA viewed the extent to which exposure controls are already in place to be reflected in the distribution of overexposures among the affected workers. Thus, for example, if 50 percent of workers in a given occupation are found to be overexposed relative to the proposed silica PEL, OSHA judged this equivalent to 50 percent of facilities lacking the relevant exposure controls. The remaining 50 percent of facilities are expected either to have installed the relevant controls or to engage in activities that do not require that the exposure controls be in place. OSHA recognizes that some facilities might have the relevant controls in place but are still unable, for whatever reason, to achieve the PEL under consideration. ERG’s review of the industrial hygiene literature and other source materials (as noted in ERG, 2007b), however, suggest that the large majority of overexposed workers lack relevant controls. Thus, OSHA has generally assumed that overexposures occur due to the absence of suitable controls. This assumption results in an overestimate of costs since, in some cases, employers may merely need to upgrade or better maintain existing controls or to improve work practices rather than to install and maintain new controls. PO 00000 Frm 00089 Fmt 4701 Sfmt 4702 There are two situations in which the proportionality assumption may oversimplify the estimation of the costs of the needed controls. First, some facilities may have the relevant controls in place but are still unable, for whatever reason, to achieve the PEL under consideration for all employees. ERG’s review of the industrial hygiene literature and other source materials (as noted in ERG, 2007b, pg. 3–4), however, suggest that the large majority of overexposed workers lack relevant controls. Thus, OSHA has generally assumed that overexposures occur due to the absence of suitable controls. This assumption could, in some cases, result in an overestimate of costs where employers merely need to upgrade or better maintain existing controls or to improve work practices rather than to install and maintain new controls. Second, there may be situations where facilities do not have the relevant controls in place but nevertheless have only a fraction of all affected employees above the PEL. If, in such situations, an employer would have to install all the controls necessary to meet the PEL, OSHA may have underestimated the control costs. However, OSHA believes that, in general, employers could come into compliance by such methods as checking the work practices of the employee who is above the PEL or installing smaller amounts of LEV at costs that would be more or less proportional to the costs for all employees. Nevertheless there may be situations in which a complete set of controls would be necessary if even one employee in a work area is above the PEL. OSHA welcomes comment on the extent to which this approach may yield underestimates or overestimates of costs. At many workstations, employers must improve ventilation to reduce silica exposures. Ventilation improvements will take a variety of E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56362 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules forms at different workstations and in different facilities and industries. The cost of ventilation enhancements generally reflects the expense of ductwork and other equipment for the immediate workstation or individual location and, potentially, the cost of incremental capacity system-wide enhancements and increased operation costs for the heating, ventilation, and air conditioning (HVAC) system for the facility. For a number of occupations, the technological feasibility analysis indicates that, in addition to ventilation, the use of wet methods, improved housekeeping practices, and enclosure of process equipment are needed to reduce silica exposures. The degree of incremental housekeeping depends upon how dusty the operations are and the applicability of HEPA vacuums or other equipment to the dust problem. The incremental costs for most such occupations arise due to the labor required for these additional housekeeping efforts. Because additional labor for housekeeping will be required on virtually every work shift by most of the affected occupations, the costs of housekeeping are substantial. Employers also need to purchase HEPA vacuums and must incur the ongoing costs of HEPA vacuum filters. To reduce silica exposures by enclosure of process equipment, such as in the use of conveyors near production workers in mineral processing, covers can be particularly effective where silicacontaining materials are transferred (and notable quantities of dust become airborne), or, as another example, where dust is generated, such as in sawing or grinding operations. For construction, ERG (2007a) defined silica dust control measures for each representative job as specified in Table 1 of the proposed rule. Generally, these controls involve either a dust collection system or a water-spray approach (wet method) to capture and suppress the release of respirable silica dust. Wetmethod controls require a water source (e.g., tank) and hoses. The size of the tank varies with the nature of the job and ranges from a small handpressurized tank to a large tank for earth drilling operations. Depending on the tool, dust collection methods entail vacuum equipment, including a vacuum unit and hoses, and either a dust shroud or an extractor. For example, concrete grinding operations using hand-held tools require dust shroud adapters for each tool and a vacuum. The capacity of the vacuum depends on the type and size of tool being used. Some equipment, such as concrete floor grinders, comes with a dust collection VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 system and a port for a vacuum hose. The estimates of control costs for those jobs using dust collection methods assume that an HEPA filter will be required. For each job, ERG estimated the annual cost of the appropriate controls and translated this cost to a daily charge. The unit costs for control equipment were based on price information collected from manufacturers and vendors. In some cases, control equipment costs were based on data on equipment rental charges. As noted above, included among the engineering controls in OSHA’s cost model are housekeeping and dustsuppression controls in general industry. For the maritime industry and for construction, abrasive blasting operations are expected to require the use of wet methods to control silica dust. Tables V–3, V–4, V–21, V–22, and V– 31 in Chapter V of the PEA and Tables V–A–1 and V–A–2 in Appendix V–A provide details on the unit costs, other unit parameters, and methodological assumptions applied by OSHA to estimate engineering control costs. OSHA’s cost estimates assume that implementation of the recommended silica controls prevents workers in general industry and maritime from being exposed over the PEL in most cases. Specifically, based on its technological feasibility analysis, OSHA expects that the technical controls are adequate to keep silica exposures at or below the PEL for an alternative PEL of 100 mg/m3 (introduced for economic analysis purposes).17 For the proposed 50 mg/m3 PEL, OSHA’s feasibility analysis suggests that the controls that employers use, either because of technical limitations or imperfect implementation, might not be adequate in all cases to ensure that worker exposures in all affected job categories are at or below 50 mg/m3. For this preliminary cost analysis, OSHA estimates that ten percent of the at-risk workers in general industry would require respirators, at least occasionally, after the implementation of engineering controls to achieve compliance with the proposed PEL of 50 mg/m3. For workers in maritime, the only activity with silica exposures above the proposed PEL of 50 mg/m3 is abrasive blasting, and maritime workers engaged in abrasive blasting are already required to use respirators under the existing OSHA ventilation standard (29 CFR 1910.94(a)). Therefore, OSHA has estimated no additional costs for maritime workers to use respirators as a result of the proposed silica rule. For construction, employers whose workers receive exposures above the PEL are assumed to adopt the appropriate task-specific engineering controls and, where required, respirators prescribed in Table 1 and under paragraph (g)(1) in the proposed standard. Respirator costs in the construction industry have been adjusted to take into account OSHA’s estimate (consistent with the findings from the NIOSH Respiratory Survey, 2003) that 56 percent of establishments in the construction industry are already using respirators that would be in compliance with the proposed silica rule. ERG (2013) used respirator cost information from a 2003 OSHA respirator study to estimate the annual cost of $570 (in 2009 dollars) for a halfmask, non-powered, air-purifying respirator and $638 per year (in 2009 dollars) for a full-face non-powered airpurifying respirator (ERG, 2003). These unit costs reflect the annualized cost of respirator use, including accessories (e.g., filters), training, fit testing, and cleaning. In addition to bearing the costs associated with the provision of respirators, employers will incur a cost burden to establish respirator programs. OSHA projects that this expense will involve an initial 8 hours for establishments with 500 or more employees and 4 hours for all other firms. After the first year, OSHA estimates that 20 percent of establishments would revise their respirator program every year, with the largest establishments (500 or more employees) expending 4 hours for program revision, and all other employers expending two hours for program revision. Consistent with the findings from the NIOSH Respiratory Survey (2003), OSHA estimates that 56 percent of establishments in the construction industry that would require respirators to achieve compliance with the proposed PEL already have a respirator program.18 OSHA further estimates that 50 percent of firms in general industry and all maritime firms that would require 17 As a result, OSHA expects that establishments in general industry do not currently use respirators to comply with the current OSHA PEL for quartz of approximately 100 mg/m3. 18 OSHA’s derivation of the 56 percent current compliance rate in construction, in the context of the proposed silica rule, is described in Chapter V in the PEA. b. Respiratory Protection PO 00000 Frm 00090 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 respirators to achieve compliance already have a respirator program. c. Exposure Assessment Most establishments wishing to perform exposure monitoring will require the assistance of an outside consulting industrial hygienist (IH) to obtain accurate results. While some firms might already employ or train qualified staff, ERG (2007b) judged that the testing protocols are fairly challenging and that few firms have sufficiently skilled staff to eliminate the need for outside consultants. Table V–8 in the PEA shows the unit costs and associated assumptions used to estimate exposure assessment costs. Unit costs for exposure sampling include direct sampling costs, the costs of productivity losses, and recordkeeping costs, and, depending on establishment size, range from $225 to $412 per sample in general industry and maritime and from $228 to $415 per sample in construction. For costing purposes, based on ERG (2007b), OSHA estimated that there are four workers per work area. OSHA interpreted the initial exposure assessment as requiring first-year testing of at least one worker in each distinct job classification and work area who is, or may reasonably be expected to be, exposed to airborne concentrations of respirable crystalline silica at or above the action level. This may result in overestimated exposure assessment costs in construction because OSHA anticipates that many employers, aware that their operations currently expose their workers to silica levels above the PEL, will simply choose to comply with Table 1 and avoid the costs of conducting exposure assessments. For periodic monitoring, the proposed standard provides employers an option of assessing employee exposures either under a fixed schedule (paragraph (d)(3)(i)) or a performance-based schedule (paragraph (d)(3)(ii)). Under the fixed schedule, the proposed standard requires semi-annual sampling for exposures at or above the action level and quarterly sampling for exposures above the 50 mg/m3 PEL. Monitoring must be continued until the employer can demonstrate that exposures are no longer at or above the action level. OSHA used the fixed schedule option under the frequency-ofmonitoring requirements to estimate, for costing purposes, that exposure monitoring will be conducted (a) twice a year where initial or subsequent exposure monitoring reveals that employee exposures are at or above the action level but at or below the PEL, and (b) four times a year where initial or VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 subsequent exposure monitoring reveals that employee exposures are above the PEL. As required under paragraph (d)(4) of the proposed rule, whenever there is a change in the production, process, control equipment, personnel, or work practices that may result in new or additional exposures at or above the action level or when the employer has any reason to suspect that a change may result in new or additional exposures at or above the action level, the employer must conduct additional monitoring. Based on ERG (2007a, 2007b), OSHA estimated that approximately 15 percent of workers whose initial exposure or subsequent monitoring was at or above the action level would undertake additional monitoring. A more detailed description of unit costs, other unit parameters, and methodological assumptions for exposure assessments is presented in Chapter V of the PEA. d. Medical Surveillance Paragraph (h) of the proposed standard requires an initial health screening and then triennial periodic screenings for workers exposed above the proposed PEL of 50 mg/m3 for 30 days or more per year. ERG (2013) assembled information on representative unit costs for initial and periodic medical surveillance. Separate costs were estimated for current employees and for new hires as a function of the employment size (i.e., 1– 19, 20–499, or 500+ employees) of affected establishments. Table V–10 in the PEA presents ERG’s unit cost data and modeling assumptions used by OSHA to estimate medical surveillance costs. In accordance with the paragraph (h)(2) of the proposed rule, the initial (baseline) medical examination would consist of (1) a medical and work history, (2) a physical examination with special emphasis on the respiratory system, (3) a chest X-ray that is interpreted according to guidelines of the International Labour Organization, (4) a pulmonary function test that meets certain criteria and is administered by spirometry technician with current certification from a NIOSH-approved spirometry course, (5) testing for latent tuberculosis (TB) infection, and (6) any other tests deemed appropriate by the physician or licensed health care professional (PLHCP). As shown in Table V–10 in the PEA, the estimated unit cost of the initial health screening for current employees in general industry and maritime ranges from approximately $378 to $397 and includes direct medical costs, the PO 00000 Frm 00091 Fmt 4701 Sfmt 4702 56363 opportunity cost of worker time (i.e., lost work time, evaluated at the worker’s 2009 hourly wage, including fringe benefits) for offsite travel and for the initial health screening itself, and recordkeeping costs. The variation in the unit cost of the initial health screening is due entirely to differences in the percentage of workers expected to travel offsite for the health screening. In OSHA’s experience, the larger the establishment the more likely it is that the selected PLHCP would provide the health screening services at the establishment’s worksite. OSHA estimates that 20 percent of establishments with fewer than 20 employees, 75 percent of establishments with 20–499 employees, and 100 percent of establishments with 500 or more employees would have the initial health screening for current employees conducted onsite. The unit cost components of the initial health screening for new hires in general industry and maritime are identical to those for existing employees with the exception that the percentage of workers expected to travel offsite for the health screening would be somewhat larger (due to fewer workers being screened annually, in the case of new hires, and therefore yielding fewer economies of onsite screening). OSHA estimates that 10 percent of establishments with fewer than 20 employees, 50 percent of establishments with 20–499 employees, and 90 percent of establishments with 500 or more employees would have the initial health screening for new hires conducted onsite. As shown in Chapter V in the PEA, the estimated unit cost of the initial health screening for new hires in general industry and maritime ranges from approximately $380 to $399. The unit costs of medical surveillance in construction were derived using identical methods. As shown in Table V–39 of the PEA, the estimated unit costs of the initial health screening for current employees in construction range from approximately $389 to $425; the estimated unit costs of the initial health screening for new hires in construction range from approximately $394 to $429. In accordance with paragraph (h)(3) of the proposed rule, the periodic medical examination (every third year after the initial health screening) would consist of (1) a medical and work history review and update, (2) a physical examination with special emphasis on the respiratory system, (3) a chest X-ray that meets certain standards of the International Labour Organization, (4) a pulmonary function test that meets certain criteria and is administered by a spirometry technician with current certification E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56364 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules from a NIOSH-approved spirometry course, (5) testing for latent TB infection, if recommended by the PLHCP, and (6) any other tests deemed appropriate by the PLHCP. The estimated unit cost of periodic health screening also includes direct medical costs, the opportunity cost of worker time, and recordkeeping costs. As shown in Table V–10 in the PEA, these triennial unit costs in general industry and maritime vary from $378 to $397. For construction, as shown in Table V–39 in the PEA, the triennial unit costs for periodic health screening vary from roughly $389 to $425. The variation in the unit cost (with or without the chest X-ray and pulmonary function test) is due entirely to differences in the percentage of workers expected to travel offsite for the periodic health screening. OSHA estimated that the share of workers traveling offsite, as a function of establishment size, would be the same for the periodic health screening as for the initial health screening for existing employees. ERG (2013) estimated a turnover rate of 27.2 percent in general industry and maritime and 64.0 percent in construction, based on estimates of the separations rate (layoffs, quits, and retirements) provided by the Bureau of Labor Statistics (BLS, 2007). However, not all new hires would require initial medical testing. As specified in paragraph (h)(2) of the proposed rule, employees who had received a qualifying medical examination within the previous twelve months would be exempt from the initial medical examination. OSHA estimates that 25 percent of new hires in general industry and maritime and 60 percent of new hires in construction would be exempt from the initial medical examination. Although OSHA believes that some affected establishments in general industry, maritime, and construction currently provide some medical testing to their silica-exposed employees, the Agency doubts that many provide the comprehensive health screening required under the proposed rule. Therefore for costing purposes for the proposed rule, OSHA has assumed no current compliance with the proposed health screening requirements. OSHA requests information from interested parties on the current levels and the comprehensiveness of health screening in general industry, maritime, and construction. Finally, OSHA estimated the unit cost of a medical examination by a pulmonary specialist for those employees found to have signs or symptoms of silica-related disease or are otherwise referred by the PLHCP. OSHA VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 estimates that a medical examination by a pulmonary specialist costs approximately $307 for workers in general industry and maritime and $333 for workers in construction. This cost includes direct medical costs, the opportunity cost of worker time, and recordkeeping costs. In all cases, OSHA anticipates that the worker will travel offsite to receive the medical examination by a pulmonary specialist. See Chapter V in the PEA for a full discussion of OSHA’s analysis of medical surveillance costs under the proposed standard. e. Information and Training As specified in paragraph (i) of the proposed rule and 29 CFR 1910.1200, training is required for all employees in jobs where there is potential exposure to respirable crystalline silica. In addition, new hires would require training before starting work. As previously noted, ERG (2013) provided an estimate of the newhire rate in general industry and maritime, based on the BLS-estimated separations rate of 27.2 percent in manufacturing, and an estimate of the new-hire rate in construction, based on the BLS-estimated separations rate in construction of 64.0 percent. OSHA estimated separate costs for initial training of current employees and for training new hires. Given that newhire training might need to be performed frequently during the year, OSHA estimated a smaller class size for new hires. OSHA anticipates that training, in accordance with the requirements of the proposed rule, will be conducted by in-house safety or supervisory staff with the use of training modules or videos and will last, on average, one hour. ERG (2007b) judged that establishments could purchase sufficient training materials at an average cost of $2 per worker, encompassing the cost of handouts, video presentations, and training manuals and exercises. ERG (2013) included in the cost estimates for training the value of worker and trainer time as measured by 2009 hourly wage rates (to include fringe benefits). ERG also developed estimates of average class sizes as a function of establishment size. For initial training, ERG estimated an average class size of 5 workers for establishments with fewer than 20 employees, 10 workers for establishments with 20 to 499 employees, and 20 workers for establishments with 500 or more employees. For new hire training, ERG estimated an average class size of 2 workers for establishments with fewer than 20 employees, 5 workers for establishments with 20 to 499 PO 00000 Frm 00092 Fmt 4701 Sfmt 4702 employees, and 10 workers for establishments with 500 or more employees. The unit costs of training are presented in Tables V–14 (for general industry/maritime) and V–43 (for construction) in the PEA. Based on ERG’s work, OSHA estimated the annualized cost (annualized over 10 years) of initial training per current employee at between $3.02 and $3.57 and the annual cost of new-hire training at between $22.50 and $32.72 per employee in general industry and maritime, depending on establishment size. For construction, OSHA estimated the annualized cost of initial training per employee at between $3.68 and $4.37 and the annual cost of new hire training at between $27.46 and $40.39 per employee, depending on establishment size. OSHA recognizes that many affected establishments currently provide training on the hazards of respirable crystalline silica in the workplace. Consistent with some estimates developed by ERG (2007a and 2007b), OSHA estimates that 50 percent of affected establishments already provide such training. However, some of the training specified in the proposed rule requires that workers be familiar with the training and medical surveillance provisions in the rule. OSHA expects that these training requirements in the proposed rule are not currently being provided. Therefore, for costing purposes for the proposed rule, OSHA has estimated that 50 percent of affected establishments currently provide their workers, and would provide new hires, with training that would comply with approximately 50 percent of the training requirements. In other words, OSHA estimates that those 50 percent of establishments currently providing training on workplace silica hazards would provide an additional 30 minutes of training to comply with the proposed rule; the remaining 50 percent of establishments would provide 60 minutes of training to comply with the proposed rule. OSHA also recognizes that many new hires may have been previously employed in the same industry, and in some cases by the same establishment, so that they might have already received (partial) silica training. However, for purposes of cost estimation, OSHA estimates that all new hires will receive the full silica training from the new employer. OSHA requests comments from interested parties on the reasonableness of these assumptions. f. Regulated Areas and Access Control Paragraph (e)(1) of the proposed standard requires that wherever an E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules employee’s exposure to airborne concentrations of respirable crystalline silica is, or can reasonably be expected to be, in excess of the PEL, each employer shall establish and implement either a regulated area in accordance with paragraph (e)(2) or an access control plan in accordance with paragraph (e)(3). For costing purposes, OSHA estimated that employers in general industry and maritime would typically prefer and choose option (e)(2) and would therefore establish regulated areas when an employee’s exposure to airborne concentrations of silica exceeds, or can reasonably be expected to exceed, the PEL. OSHA believes that general industry and maritime employers will prefer this option as it is expected to be the most practical alternative in fixed worksites. Requirements in the proposed rule for a regulated area include demarcating the boundaries of the regulated area (as separate from the rest of the workplace), limiting access to the regulated area, providing an appropriate respirator to each employee entering the regulated area, and providing protective clothing as needed in the regulated area. Based on ERG (2007b), OSHA derived unit cost estimates for establishing and maintaining regulated areas to comply with these requirements and estimated that one area would be necessary for every eight workers in general industry and maritime exposed above the PEL. Unit costs include planning time (estimated at eight hours of supervisor time annually); material costs for signs and boundary markers (annualized at $63.64 in 2009 dollars); and costs of $500 annually for two disposable respirators per day to be used by authorized persons (other than those who regularly work in the regulated area) who might need to enter the area in the course of their job duties. In addition, for costing purposes, OSHA estimates that, in response to the protective work clothing requirements in regulated areas, ten percent of employees in regulated areas would wear disposable protective clothing daily, estimated at $5.50 per suit, for an annual clothing cost of $1,100 per regulated area. Tables V–16 in the PEA shows the cost assumptions and unit costs applied in OSHA’s cost model for regulated areas in general industry and maritime. Overall, OSHA estimates that each regulated area would, on average, cost employers $1,732 annually in general industry and maritime. For construction, OSHA estimated that some employers would select the (e)(2) option concerning regulated areas while other employers would prefer the (e)(3) option concerning written access VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 control plans whenever an employee’s exposure to airborne concentrations of respirable crystalline silica exceeds, or can reasonably be expected to exceed, the PEL. Based on the respirator specifications developed by ERG (2007a) and shown in Table V–34 in the PEA, ERG derived the full-time-equivalent number of workers engaged in construction tasks where respirators are required and estimated the costs of establishing a regulated area for these workers. Under the second option for written access control plans, the employer must include the following elements in the plan: competent person provisions; notification and demarcation procedures; multi-employer workplace procedures; provisions for limiting access; provisions for supplying respirators; and protective clothing procedures. OSHA anticipates that employers will incur costs for labor, materials, respiratory protection, and protective clothing to comply with the proposed access control plan requirements. Table V–45 in the PEA shows the unit costs and assumptions for developing costs for regulated areas and for access control plans in construction. ERG estimated separate development and implementation costs. ERG judged that developing either a regulated area or an access control plan would take approximately 4 hours of a supervisor’s time. The time allowed to set up a regulated area or an access control plan is intended to allow for the communication of access restrictions and locations at multi-employer worksites. ERG estimated a cost of $116 per job based on job frequency and the costs for hazard tape and warning signs (which are reusable). ERG estimated a labor cost of $27 per job for implementing a written access control plan (covering the time expended for revision of the access control plan for individual jobs and communication of the plan). In addition, OSHA estimated that there would be annual disposable clothing costs of $333 per crew for employers who implement either regulated areas or the access control plan option. In addition, OSHA estimated that there would be annual respirator costs of $60 per crew for employers who implement either option. ERG aggregated costs by estimating an average crew size of four in construction and an average job length of ten days. ERG judged that employers would choose to establish regulated areas in 75 percent of the instances where either regulated areas or an access control plan is required, and that written access PO 00000 Frm 00093 Fmt 4701 Sfmt 4702 56365 control plans would be established for the remaining 25 percent. See Chapter V in the PEA for a full discussion of OSHA’s analysis of costs for regulated areas and written access control plans under the proposed standard. F. Economic Feasibility Analysis and Regulatory Flexibility Determination Chapter VI of the PEA presents OSHA’s analysis of the economic impacts of its proposed silica rule on affected employers in general industry, maritime, and construction. The discussion below summarizes the findings in that chapter. As a first step, the Agency explains its approach for achieving the two major objectives of its economic impact analysis: (1) To establish whether the proposed rule is economically feasible for all affected industries, and (2) to determine if the Agency can certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. Next, this approach is applied to industries with affected employers in general industry and maritime and then to industries with affected employers in construction. Finally, OSHA directed Inforum—a not-for-profit corporation (based at the University of Maryland) specializing in the design and application of macroeconomic models of the United States (and other countries)—to estimate the industry and aggregate employment effects of the proposed silica rule. The Agency invites comment on any aspect of the methods and data presented here or in Chapter VI of the PEA. 1. Analytic Approach a. Economic Feasibility The Court of Appeals for the D.C. Circuit has long held that OSHA standards are economically feasible so long as their costs do not threaten the existence of, or cause massive economic dislocations within, a particular industry or alter the competitive structure of that industry. American Iron and Steel Institute. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991); United Steelworkers of America, AFL–CIO–CLC v. Marshall, 647 F.2d 1189, 1265 (D.C. Cir. 1980); Industrial Union Department v. Hodgson, 499 F.2d 467, 478 (D.C. Cir. 1974). In practice, the economic burden of an OSHA standard on an industry—and whether the standard is economically feasible for that industry—depends on the magnitude of compliance costs incurred by establishments in that industry and the extent to which they E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56366 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules are able to pass those costs on to their customers. That, in turn, depends, to a significant degree, on the price elasticity of demand for the products sold by establishments in that industry. The price elasticity of demand refers to the relationship between the price charged for a product and the demand for that product: the more elastic the relationship, the less an establishment’s compliance costs can be passed through to customers in the form of a price increase and the more it has to absorb compliance costs in the form of reduced profits. When demand is inelastic, establishments can recover most of the costs of compliance by raising the prices they charge; under this scenario, profit rates are largely unchanged and the industry remains largely unaffected. Any impacts are primarily on those customers using the relevant product. On the other hand, when demand is elastic, establishments cannot recover all compliance costs simply by passing the cost increase through in the form of a price increase; instead, they must absorb some of the increase from their profits. Commonly, this will mean reductions both in the quantity of goods and services produced and in total profits, though the profit rate may remain unchanged. In general, ‘‘[w]hen an industry is subjected to a higher cost, it does not simply swallow it; it raises its price and reduces its output, and in this way shifts a part of the cost to its consumers and a part to its suppliers,’’ in the words of the court in American Dental Association v. Secretary of Labor (984 F.2d 823, 829 (7th Cir. 1993)). The court’s summary is in accord with microeconomic theory. In the long run, firms can remain in business only if their profits are adequate to provide a return on investment that ensures that investment in the industry will continue. Over time, because of rising real incomes and productivity increases, firms in most industries are able to ensure an adequate profit. As technology and costs change, however, the long-run demand for some products naturally increases and the long-run demand for other products naturally decreases. In the face of additional compliance costs (or other external costs), firms that otherwise have a profitable line of business may have to increase prices to stay viable. Increases in prices typically result in reduced quantity demanded, but rarely eliminate all demand for the product. Whether this decrease in the total production of goods and services results in smaller output for each establishment within the industry or the closure of some plants within the industry, or a combination of the two, is dependent on VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the cost and profit structure of individual firms within the industry. If demand is perfectly inelastic (i.e., the price elasticity of demand is zero), then the impact of compliance costs that are 1 percent of revenues for each firm in the industry would result in a 1 percent increase in the price of the product, with no decline in quantity demanded. Such a situation represents an extreme case, but might be observed in situations in which there were few if any substitutes for the product in question, or if the products of the affected sector account for only a very small portion of the revenue or income of its customers. If the demand is perfectly elastic (i.e., the price elasticity of demand is infinitely large), then no increase in price is possible and before-tax profits would be reduced by an amount equal to the costs of compliance (net of any cost savings—such as reduced workers’ compensation insurance premiums— resulting from the proposed standard) if the industry attempted to maintain production at the same level as previously. Under this scenario, if the costs of compliance are such a large percentage of profits that some or all plants in the industry could no longer operate in the industry with hope of an adequate return on investment, then some or all of the firms in the industry would close. This scenario is highly unlikely to occur, however, because it can only arise when there are other products—unaffected by the proposed rule—that are, in the eyes of their customers, perfect substitutes for the products the affected establishments make. A common intermediate case would be a price elasticity of demand of one (in absolute terms). In this situation, if the costs of compliance amount to 1 percent of revenues, then production would decline by 1 percent and prices would rise by 1 percent. As a result, industry revenues would remain the same, with somewhat lower production, but with similar profit rates (in most situations where the marginal costs of production net of regulatory costs would fall as well). Customers would, however, receive less of the product for their (same) expenditures, and firms would have lower total profits; this, as the court described in American Dental Association v. Secretary of Labor, is the more typical case. A decline in output as a result of an increase in price may occur in a variety of ways: individual establishments could each reduce their levels of production; some marginal plants could close; or, in the case of an expanding industry, new entry may be delayed PO 00000 Frm 00094 Fmt 4701 Sfmt 4702 until demand equals supply. In many cases it will be a combination of all three kinds of reductions in output. Which possibility is most likely depends on the form that the costs of the regulation take. If the costs are variable costs (i.e., costs that vary with the level of production at a facility), then economic theory suggests that any reductions in output will take the form of reductions in output at each affected facility, with few if any plant closures. If, on the other hand, the costs of a regulation primarily take the form of fixed costs (i.e., costs that do not vary with the level of production at a facility), then reductions in output are more likely to take the form of plant closures or delays in new entry. Most of the costs of this regulation, as estimated in Chapter V of the PEA, are variable costs. Almost all of the major costs of program elements, such as medical surveillance and training, will vary in proportion to the number of employees (which is a rough proxy for the amount of production). Exposure monitoring costs will vary with the number of employees, but do have some economies of scale to the extent that a larger firm need only conduct representative sampling rather than sample every employee. The costs of engineering controls in construction also vary by level of production because almost all necessary equipment can readily be rented and the productivity costs of using some of these controls vary proportionally to the level of production. Finally, the costs of operating engineering controls in general industry (the majority of the annualized costs of engineering controls in general industry) vary by the number of hours the establishment works, and thus vary by the level of production and are not fixed costs in the strictest sense. This leaves two kinds of costs that are, in some sense, fixed costs—capital costs of engineering controls in general industry and certain initial costs that new entries to the industry will not have to bear. Capital costs of engineering controls in general industry due to this standard are relatively small as compared to the total costs, representing less than 8 percent of total annualized costs and approximately $362 per year per affected establishment in general industry. Some initial costs are fixed in the sense that they will only be borne by firms in the industry today—these include initial costs for general training not currently required and initial costs of medical surveillance. Both of these costs will disappear after the initial year of the standard and thus would be E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules difficult to pass on. These costs, however, represent less than 4 percent of total costs and less than $55 per affected establishment. As a result of these considerations, OSHA expects that it is somewhat more likely that reductions in industry output will be met by reductions in output at each affected facility rather than as a result of plant closures. However, closures of some marginal plants or poorly performing facilities are always possible. To determine whether a rule is economically feasible, OSHA begins with two screening tests to consider minimum threshold effects of the rule under two extreme cases: (1) all costs are passed through to customers in the form of higher prices (consistent with a price elasticity of demand of zero), and (2) all costs are absorbed by the firm in the form of reduced profits (consistent with an infinite price elasticity of demand). In the former case, the immediate impact of the rule would be observed in increased industry revenues. While there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of one percent of annual revenues. Retrospective studies of previous OSHA regulations have shown that potential impacts of such a small magnitude are unlikely to eliminate an industry or significantly alter its competitive structure,19 particularly since most industries have at least some ability to raise prices to reflect increased costs and, as shown in the PEA, normal price variations for products typically exceed three percent a year. Of course, OSHA recognizes that even when costs are within this range, there could be unusual circumstances requiring further analysis. In the latter case, the immediate impact of the rule would be observed in reduced industry profits. OSHA uses the ratio of annualized costs to annual profits as a second check on economic feasibility. Again, while there is no hard and fast rule, in the absence of evidence to the contrary, OSHA has historically considered a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of ten percent of annual profits. In the context of economic feasibility, the Agency believes this threshold level to 19 See OSHA’s Web page, http://www.osha.gov/ dea/lookback.html#Completed, for a link to all completed OSHA lookback reviews. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 be fairly modest, given that—as shown in the PEA—normal year-to-year variations in profit rates in an industry can exceed 40 percent or more. OSHA’s choice of a threshold level of ten percent of annual profits is low enough that even if, in a hypothetical worst case, all compliance costs were upfront costs, then upfront costs would still equal seventy-one percent of profits and thus would be affordable from profits without resort to credit markets. If the threshold level were first-year costs of ten percent of annual profits, firms could even more easily expect to cover first-year costs at the threshold level out of current profits without having to access capital markets and otherwise being threatened with short-term insolvency. In general, because it is usually the case that firms would able to pass on some or all of the costs of the proposed rule, OSHA will tend to give much more weight to the ratio of industry costs to industry revenues than to the ratio of industry costs to industry profits. However, if costs exceed either the threshold percentage of revenue or the threshold percentage of profits for an industry, or if there is other evidence of a threat to the viability of an industry because of the standard, OSHA will examine the effect of the rule on that industry more closely. Such an examination would include market factors specific to the industry, such as normal variations in prices and profits, international trade and foreign competition, and any special circumstances, such as close domestic substitutes of equal cost, which might make the industry particularly vulnerable to a regulatory cost increase. The preceding discussion focused on the economic viability of the affected industries in their entirety. However, even if OSHA found that a proposed standard did not threaten the survival of affected industries, there is still the question of whether the industries’ competitive structure would be significantly altered. For this reason, OSHA also examines the differential costs by size of firm. b. Regulatory Flexibility Screening Analysis The Regulatory Flexibility Act (RFA), Pub. L. No. 96–354, 94 Stat. 1164 (codified at 5 U.S.C. 601), requires Federal agencies to consider the economic impact that a proposed rulemaking will have on small entities. The RFA states that whenever a Federal agency is required to publish general notice of proposed rulemaking for any proposed rule, the agency must prepare and make available for public comment PO 00000 Frm 00095 Fmt 4701 Sfmt 4702 56367 an initial regulatory flexibility analysis (IRFA). 5 U.S.C. 603(a). Pursuant to section 605(b), in lieu of an IRFA, the head of an agency may certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. A certification must be supported by a factual basis. If the head of an agency makes a certification, the agency shall publish such certification in the Federal Register at the time of publication of general notice of proposed rulemaking or at the time of publication of the final rule. 5 U.S.C. 605(b). To determine if the Assistant Secretary of Labor for OSHA can certify that the proposed silica rule will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the proposed rule on small entities. These screening tests are similar in concept to those OSHA developed above to identify minimum threshold effects for purposes of demonstrating economic feasibility. There are, however, two differences. First, for each affected industry, the screening tests are applied, not to all establishments, but to small entities (defined as ‘‘small business concerns’’ by SBA) and also to very small entities (defined by OSHA as entities with fewer than 20 employees). Second, although OSHA’s regulatory flexibility screening test for revenues also uses a minimum threshold level of annualized costs equal to one percent of annual revenues, OSHA has established a minimum threshold level of annualized costs equal to five percent of annual profits for the average small entity or very small entity. The Agency has chosen a lower minimum threshold level for the profitability screening analysis and has applied its screening tests to both small entities and very small entities in order to ensure that certification will be made, and an IRFA will not be prepared, only if OSHA can be highly confident that a proposed rule will not have a significant economic impact on a substantial number of small entities in any affected industry. 2. Impacts in General Industry and Maritime a. Economic Feasibility Screening Analysis: All Establishments To determine whether the proposed rule’s projected costs of compliance would threaten the economic viability of affected industries, OSHA first compared, for each affected industry, annualized compliance costs to annual revenues and profits per (average) E:\FR\FM\12SEP2.SGM 12SEP2 56368 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 affected establishment. The results for all affected establishments in all affected industries in general industry and maritime are presented in Table VIII–11, using annualized costs per establishment for the proposed 50 mg/m3 PEL. Shown in the table for each affected industry are total annualized costs, the total number of affected establishments, annualized costs per affected establishment, annual revenues per establishment, the profit rate, annual profits per establishment, annualized compliance costs as a percentage of annual revenues, and annualized compliance costs as a percentage of annual profits. The annualized costs per affected establishment for each affected industry were calculated by distributing the industry-level (incremental) annualized compliance costs among all affected establishments in the industry, where costs were annualized using a 7 percent VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 discount rate. The annualized cost of the proposed rule for the average establishment in all of general industry and maritime is estimated at $2,571 in 2009 dollars. It is clear from Table VIII– 11 that the estimates of the annualized costs per affected establishment in general industry and maritime vary widely from industry to industry. These estimates range from $40,468 for NAICS 327111 (Vitreous china plumbing fixtures and bathroom accessories manufacturing) and $38,422 for NAICS 327121 (Brick and structural clay manufacturing) to $107 for NAICS 325510 (Paint and coating manufacturing) and $49 for NAICS 621210 (Dental offices). Table VIII–11 also shows that, within the general industry and maritime sectors, there are no industries in which the annualized costs of the proposed rule exceed 1 percent of annual revenues or 10 percent of annual profits. PO 00000 Frm 00096 Fmt 4701 Sfmt 4702 NAICS 327123 (Other structural clay product manufacturing) has both the highest cost impact as a percentage of revenues, of 0.39 percent, and the highest cost impact as a percentage of profits, of 8.78 percent. Based on these results, even if the costs of the proposed rule were 50 percent higher than OSHA has estimated, the highest cost impact as a percentage of revenues in any affected industry in general industry or maritime would be less than 0.6 percent. Furthermore, the costs of the proposed rule would have to be more than 150 percent higher than OSHA has estimated for the cost impact as a percentage of revenues to equal 1 percent in any affected industry. For all affected establishments in general industry and maritime, the estimated annualized cost of the proposed rule is, on average, equal to 0.02 percent of annual revenue and 0.5 percent of annual profit. E:\FR\FM\12SEP2.SGM 12SEP2 VerDate Mar<15>2010 ..... ..... ..... ..... 19:12 Sep 11, 2013 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 327113 327121 327122 327123 327124 327125 327211 327212 327213 327320 327331 327332 327390 327991 327992 327993 327999 331111 331112 331210 331221 331222 331314 331423 331492 331511 331512 331513 331524 331525 331528 332111 332112 332115 332116 332117 332211 332212 332213 332214 332323 332439 332510 332611 332612 332618 332710 332812 332911 327112 ..... 324121 324122 325510 327111 NAICS Asphalt paving mixture and block manufacturing ........ Asphalt shingle and roofing materials .......................... Paint and coating manufacturing ................................. Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg .................................... Brick and structural clay mfg ....................................... Ceramic wall and floor tile mfg .................................... Other structural clay product mfg ................................ Clay refractory manufacturing ...................................... Nonclay refractory manufacturing ................................ Flat glass manufacturing .............................................. Other pressed and blown glass and glassware manufacturing. Glass container manufacturing .................................... Ready-mixed concrete manufacturing ......................... Concrete block and brick mfg ...................................... Concrete pipe mfg ........................................................ Other concrete product mfg ......................................... Cut stone and stone product manufacturing ............... Ground or treated mineral and earth manufacturing ... Mineral wool manufacturing ......................................... All other misc. nonmetallic mineral product mfg .......... Iron and steel mills ....................................................... Electrometallurgical ferroalloy product manufacturing Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ............................... Steel wire drawing ........................................................ Secondary smelting and alloying of aluminum ............ Secondary smelting, refining, and alloying of copper .. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ............................................................... Steel investment foundries ........................................... Steel foundries (except investment) ............................ Aluminum foundries (except die-casting) ..................... Copper foundries (except die-casting) ......................... Other nonferrous foundries (except die-casting) ......... Iron and steel forging ................................................... Nonferrous forging ....................................................... Crown and closure manufacturing ............................... Metal stamping ............................................................. Powder metallurgy part manufacturing ........................ Cutlery and flatware (except precious) manufacturing Hand and edge tool manufacturing ............................. Saw blade and handsaw manufacturing ...................... Kitchen utensil, pot, and pan manufacturing ............... Ornamental and architectural metal work .................... Other metal container manufacturing .......................... Hardware manufacturing .............................................. Spring (heavy gauge) manufacturing ........................... Spring (light gauge) manufacturing .............................. Other fabricated wire product manufacturing .............. Machine shops ............................................................. Metal coating and allied services ................................. Industrial valve manufacturing ..................................... Industry Jkt 229001 PO 00000 Frm 00097 Fmt 4701 Sfmt 4702 15,310,815 4,283,138 4,596,837 6,975,150 1,636,463 1,232,708 105,955 34,982 12,720 255,832 32,828 22,970 145,223 28,851 15,678 35,267 60,330 180,292 16,158 60,992 144,819 1,077,759 3,038,935 150,261 42,672 57,557 28,757 4,940 36,946 756,888 16,511,080 4,437,939 2,747,484 12,900,251 8,600,298 4,595,006 1,094,552 1,966,052 424,557 8,577 84,537 1,748,297 7,838,050 4,132,107 936,699 482,438 608,017 275,155 1,084,706 2,601,471 $242,070 3,157,257 144,281 1,659,194 Total annualized costs 527 132 222 466 256 124 150 50 18 366 47 33 207 41 22 54 86 256 23 87 205 1,506 2,599 216 61 83 42 7 53 72 6,064 951 385 2,281 1,943 271 321 465 614 12 122 125 204 193 49 129 105 83 499 731 1,431 224 1,344 41 Number of affected establishments 29,053 32,448 20,706 14,968 6,392 9,941 705 705 697 700 696 705 702 698 705 654 705 705 705 705 705 716 1,169 694 694 694 692 695 695 10,512 2,723 4,667 7,136 5,656 4,426 16,956 3,410 4,228 692 692 694 13,986 38,422 21,410 19,116 3,740 5,791 3,315 2,174 3,559 $169 14,095 107 40,468 Annualized costs per affected establishment 19,672,534 18,445,040 17,431,292 8,244,396 3,103,580 7,040,818 15,231,376 28,714,500 16,308,872 6,748,606 9,712,731 9,036,720 5,874,133 11,339,439 18,620,983 2,777,899 7,467,745 11,899,309 7,764,934 8,185,896 5,120,358 1,624,814 4,503,334 18,399,215 28,102,003 12,904,028 29,333,260 26,238,546 14,759,299 64,453,615 4,891,554 5,731,328 7,899,352 4,816,851 1,918,745 8,652,610 18,988,835 5,803,139 70,641,523 49,659,392 31,069,797 8,091,258 11,440,887 6,706,175 4,933,258 7,872,516 14,718,533 43,821,692 7,233,509 1,203,017 $6,617,887 34,018,437 19,071,850 21,226,709 Revenues per establishment 4.11 4.11 4.11 4.11 4.11 4.11 4.71 4.71 4.71 4.71 4.71 5.22 5.22 5.22 5.22 4.70 3.58 5.22 5.22 5.22 5.22 5.80 4.85 6.81 4.49 4.49 4.46 4.42 4.42 3.42 6.64 6.64 6.64 6.64 5.49 5.49 5.49 5.49 4.49 4.49 4.49 4.41 4.41 4.41 4.41 4.41 4.41 3.42 3.42 4.41 7.50 7.50 5.38 4.41 Profit rate a (percent) 809,290 758,794 717,090 339,159 127,675 289,646 716,646 1,351,035 767,343 317,526 456,990 472,045 306,843 592,331 972,693 130,669 267,613 621,577 405,612 427,602 267,469 94,209 218,618 1,252,418 1,262,339 579,647 1,309,709 1,158,438 651,626 2,204,903 324,706 380,451 524,366 319,747 105,320 474,944 1,042,303 318,536 3,173,209 2,230,694 1,395,652 357,222 505,105 296,072 217,799 347,565 649,810 1,499,102 247,452 53,112 $496,420 2,551,788 1,026,902 937,141 Profits per establishment 0.15 0.18 0.12 0.18 0.21 0.14 0.00 0.00 0.00 0.01 0.01 0.01 0.01 0.01 0.00 0.02 0.01 0.01 0.01 0.01 0.01 0.04 0.03 0.00 0.00 0.01 0.00 0.00 0.00 0.02 0.06 0.08 0.09 0.12 0.23 0.20 0.02 0.07 0.00 0.00 0.00 0.17 0.34 0.32 0.39 0.05 0.04 0.01 0.03 0.30 0.00 0.04 0.00 0.19 Costs as a percentage of revenues 3.59 4.28 2.89 4.41 5.01 3.43 0.10 0.05 0.09 0.22 0.15 0.15 0.23 0.12 0.07 0.50 0.26 0.11 0.17 0.16 0.26 0.76 0.53 0.06 0.05 0.12 0.05 0.06 0.11 0.48 0.84 1.23 1.36 1.77 4.20 3.57 0.33 1.33 0.02 0.03 0.05 3.92 7.61 7.23 8.78 1.08 0.89 0.22 0.88 6.70 0.03 0.55 0.01 4.32 Costs as a percentage of profits TABLE VIII–11—SCREENING ANALYSIS FOR ESTABLISHMENTS IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules E:\FR\FM\12SEP2.SGM 12SEP2 56369 VerDate Mar<15>2010 19:12 Sep 11, 2013 ..... ..... ..... ..... ..... ..... ..... Jkt 229001 PO 00000 Frm 00098 ..... ..... ..... ..... Fmt 4701 Sfmt 4702 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... E:\FR\FM\12SEP2.SGM 12SEP2 ..... ..... ..... ..... ..... ..... ..... ..... ..... 334518 335211 335221 335222 335224 335228 336111 336112 336120 336211 336212 336213 336311 336312 ..... ..... ..... ..... ..... 333911 333912 333991 333992 333993 333994 333995 333996 333997 333999 333613 ..... 333516 ..... 333518 ..... 333612 ..... 333515 ..... 333511 333512 333513 333514 333414 ..... 333411 ..... 333412 ..... 333319 ..... 332999 ..... 332912 332913 332919 332991 332996 332997 332998 NAICS Fluid power valve and hose fitting manufacturing ....... Plumbing fixture fitting and trim manufacturing ........... Other metal valve and pipe fitting manufacturing ........ Ball and roller bearing manufacturing .......................... Fabricated pipe and pipe fitting manufacturing ........... Industrial pattern manufacturing .................................. Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing .................... Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing ...................................... Machine tool (metal cutting types) manufacturing ....... Machine tool (metal forming types) manufacturing ..... Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing Other metalworking machinery manufacturing ............ Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing ............ Air and gas compressor manufacturing ....................... Power-driven handtool manufacturing ......................... Welding and soldering equipment manufacturing ....... Packaging machinery manufacturing ........................... Industrial process furnace and oven manufacturing .... Fluid power cylinder and actuator manufacturing ........ Fluid power pump and motor manufacturing ............... Scale and balance (except laboratory) manufacturing All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing ......................... Electric housewares and household fans .................... Household cooking appliance manufacturing .............. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing ............. Other major household appliance manufacturing ........ Automobile manufacturing ........................................... Light truck and utility vehicle manufacturing ................ Heavy duty truck manufacturing .................................. Motor vehicle body manufacturing ............................... Truck trailer manufacturing .......................................... Motor home manufacturing .......................................... Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing ....... Industry 258,625 30,521 24,023 293,357 404,778 125,181 187,131 126,512 84,073 41,219 8,740 13,928 30,077 32,118 121,086 84,518 34,459 62,401 83,714 42,523 78,057 53,535 14,822 207,006 61,197 12,279 50,002 48,452 139,916 160,131 68,151 33,940 231,988 80,754 58,265 41,212 209,273 288,093 140,213 45,472 71,354 107,338 107,219 20,891 60,684 Total annualized costs 373 23 37 181 94 95 269 182 91 60 12 22 47 26 174 121 49 90 120 61 112 77 21 296 88 17 70 70 197 226 97 48 325 116 84 59 299 408 201 65 102 154 154 30 76 Number of affected establishments 693 1,327 643 1,621 4,306 1,318 696 694 924 693 703 643 643 1,235 696 698 698 696 700 702 695 695 702 698 693 710 710 693 710 710 702 702 714 694 694 694 699 707 698 698 698 698 698 698 798 Annualized costs per affected establishment 36,938,061 221,491,837 107,476,620 512,748,675 1,581,224,101 194,549,998 15,012,805 17,032,455 65,421,325 21,325,990 4,924,986 22,023,076 37,936,003 188,132,355 17,078,357 21,079,073 22,078,371 16,457,683 7,374,940 5,584,460 13,301,790 18,030,122 7,236,854 6,033,776 14,983,120 9,496,141 7,231,602 10,727,834 3,384,805 2,481,931 7,371,252 5,217,940 2,378,801 11,143,189 7,353,577 12,795,249 10,042,625 4,405,921 22,442,750 24,186,039 15,023,143 36,607,380 6,779,536 1,122,819 14,497,312 Revenues per establishment 2.04 4.21 4.21 2.04 2.04 2.04 2.04 2.04 2.04 2.04 5.94 4.21 4.21 4.21 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 2.63 5.29 5.29 2.63 5.29 5.29 5.29 5.29 5.29 4.55 4.55 4.55 4.86 6.81 6.81 6.81 6.81 6.81 6.81 6.81 6.81 Profit rate a (percent) 753,709 9,331,875 4,528,196 10,462,470 32,264,364 3,969,729 306,331 347,542 1,334,901 435,150 292,667 927,874 1,598,316 7,926,376 781,566 964,653 1,010,384 753,162 337,503 255,565 608,737 825,122 331,184 276,127 393,597 502,283 382,504 281,813 179,034 131,278 389,890 275,994 125,823 507,342 334,804 582,559 487,919 299,907 1,527,658 1,646,322 1,022,612 2,491,832 461,477 76,429 986,819 Profits per establishment 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.01 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.01 0.01 0.01 0.00 0.01 0.01 0.00 0.01 0.01 0.01 0.02 0.03 0.01 0.01 0.03 0.01 0.01 0.01 0.01 0.02 0.00 0.00 0.00 0.00 0.01 0.06 0.01 Costs as a percentage of revenues 0.09 0.01 0.01 0.02 0.01 0.03 0.23 0.20 0.07 0.16 0.24 0.07 0.04 0.02 0.09 0.07 0.07 0.09 0.21 0.27 0.11 0.08 0.21 0.25 0.18 0.14 0.19 0.25 0.40 0.54 0.18 0.25 0.57 0.14 0.21 0.12 0.14 0.24 0.05 0.04 0.07 0.03 0.15 0.91 0.08 Costs as a percentage of profits TABLE VIII–11—SCREENING ANALYSIS FOR ESTABLISHMENTS IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD— Continued mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56370 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules VerDate Mar<15>2010 19:12 Sep 11, 2013 ..... ..... ..... ..... ..... Jkt 229001 PO 00000 Frm 00099 ..... ..... ..... ..... ..... ..... ..... ..... ..... 242,586 146,726,595 Total ............................................................................. 233,720 431,985 583,803 8,749,619 5,479,624 27,227 132,114 327,377 153,960 351,955 1,439,004 1,560,353 320,878 236,821 294,919 177,299 2,452,073 389,256 Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing ................. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping ...................................... All other motor vehicle parts manufacturing ................ Ship building and repair ............................................... Boat building ................................................................ Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing ........... Dental laboratories ....................................................... Jewelry (except costume) manufacturing .................... Jewelers’ materials and lapidary work manufacturing Costume jewelry and novelty manufacturing ............... Sign manufacturing ...................................................... Industrial supplies, wholesalers ................................... Rail transportation ........................................................ Dental offices ............................................................... 56,121 411 7,261 1,777 264 590 496 383 N/A 7,980 334 624 843 635 1,129 39 191 473 223 350 2,571 856 198 878 1,215 401 594 463 N/A 49 701 692 693 13,779 4,854 697 693 692 692 693 .......................... 4,732,949 563,964 3,685,009 3,762,284 1,353,403 1,872,356 1,913,371 N/A 755,073 4,943,560 33,294,026 31,304,202 24,524,381 9,474,540 44,887,321 51,498,927 63,004,961 42,374,501 33,890,776 .......................... 10.77 10.77 5.80 5.80 5.80 5.80 3.44 N/A 7.34 4.54 2.04 2.04 5.86 5.86 6.31 2.04 2.04 2.04 2.04 .......................... 509,695 60,734 213,566 218,045 78,437 108,513 65,736 N/A 55,429 224,593 679,354 638,752 1,437,564 555,376 2,832,073 1,050,819 1,285,596 864,638 691,530 .......................... 0.02 0.04 0.02 0.03 0.03 0.03 0.02 N/A 0.01 0.01 0.00 0.00 0.06 0.05 0.00 0.00 0.00 0.00 0.00 .......................... 0.17 0.33 0.41 0.56 0.51 0.55 0.70 N/A 0.09 0.31 0.10 0.11 0.96 0.87 0.02 0.07 0.05 0.08 0.10 rates were calculated by ERG (2013) as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). [a] Profit 339114 339116 339911 339913 339914 339950 423840 482110 621210 337215 ..... 336370 336399 336611 336612 336992 336340 ..... 336350 ..... 336330 ..... 336322 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56371 56372 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 b. Normal Year-to-Year Variations in Prices and Profit Rates The United States has a dynamic and constantly changing economy in which an annual percentage increase in industry revenues or prices of one percent or more are common. Examples of year-to-year changes in an industry that could cause such an increase in revenues or prices include increases in fuel, material, real estate, or other costs; tax increases; and shifts in demand. To demonstrate the normal year-toyear variation in prices for all the manufacturers in general industry and maritime affected by the proposed rule, OSHA developed in the PEA year-toyear producer price indices and year-toyear percentage changes in producer prices, by industry, for the years 1998– 2009. For the combined affected manufacturing industries in general industry and maritime over the 12-year period, the average change in producer prices was 3.8 percent a year. For the three industries in general industry and maritime with the largest estimated potential annual cost impact as a percentage of revenue (of approximately 0.35 percent, on average), the average annual changes in producer prices in these industries over the 12-year period averaged 3.5 percent. Based on these data, it is clear that the potential price impacts of the proposed rule in general industry and maritime are all well within normal year-to-year variations in prices in those industries. Thus, OSHA preliminarily concludes that the potential price impacts of the proposed would not threaten the economic viability of any industries in general industry and maritime. Changes in profit rates are also subject to the dynamics of the U.S. economy. A recession, a downturn in a particular industry, foreign competition, or the increased competitiveness of producers of close domestic substitutes are all easily capable of causing a decline in profit rates in an industry of well in excess of ten percent in one year or for several years in succession. To demonstrate the normal year-toyear variation in profit rates for all the manufacturers in general industry and maritime affected by the proposed rule, OSHA presented data in the PEA on year-to-year profit rates and year-to-year percentage changes in profit rates, by industry, for the years 2000–2006. For the combined affected manufacturing industries in general industry and maritime over the 7-year period, the average change in profit rates was 38.9 percent a year. For the 7 industries in general industry and maritime with the largest estimated potential annual cost VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 impacts as a percentage of profit— ranging from 4 percent to 9 percent—the average annual changes in profit rates in these industries over the 7-year period averaged 35 percent. Nevertheless, a longer-term reduction in profit rates in excess of 10 percent a year could be problematic for some affected industries and might conceivably, under sufficiently adverse circumstances, threaten an industry’s economic viability. In OSHA’s view, however, affected industries would generally be able to pass on most or all of the costs of the proposed rule in the form of higher prices rather than to bear the costs of the proposed rule in reduced profits. After all, it defies common sense to suggest that the demanded quantities of brick and structural clay, vitreous china, ceramic wall and floor tile, other structural clay products (such as clay sewer pipe), and the various other products manufactured by affected industries would significantly contract in response to a 0.4 percent (or lower) price increase for these products. It is of course possible that such price changes will result in some reduction in output, and the reduction in output might be met through the closure of a small percentage of the plants in the industry. However, the only realistic circumstance such that an entire industry would be significantly affected by small potential price increases would be the availability in the market of a very close or perfect substitute product not subject to OSHA regulation. The classic example, in theory, would be foreign competition. Below, OSHA examines the threat of foreign competition for affected U.S. establishments in general industry and maritime. c. International Trade Effects The magnitude and strength of foreign competition is a critical factor in determining the ability of firms in the U.S. to pass on (part or all of) the costs of the proposed rule. If firms are unable to do so, they would likely absorb the costs of the proposed rule out of profits, possibly resulting in the business failure of individual firms or even, if the cost impacts are sufficiently large and pervasive, causing significant dislocations within an affected industry. In the PEA, OSHA examined how likely such an outcome is. The analysis there included a review of trade theory and empirical evidence and the estimation of impacts. Throughout, the Agency drew on ERG (2007c), which was prepared specifically to help analyze the international trade impacts of OSHA’s proposed silica rule. A PO 00000 Frm 00100 Fmt 4701 Sfmt 4702 summary of the PEA results is presented below. ERG (2007c) focused its analysis on eight of the industries likely to be most affected by the proposed silica rule and for which import and export data were available. ERG combined econometric estimates of the elasticity of substitution between foreign and domestic products, Annual Survey of Manufactures data, and assumptions concerning the values for key parameters to estimate the effect of a range of hypothetical price increases on total domestic production. In particular, ERG estimated the domestic production that would be replaced by imported products and the decrease in exported products that would result from a 1 percent increase in prices—under the assumption that firms would attempt to pass on all of a 1 percent increase in costs arising from the proposed rule. The sum of the increase in imports and decrease in exports represents the total loss to industry attributable to the rule. These projected losses are presented as a percentage of baseline domestic production to provide some context for evaluating the relative size of these impacts. The effect of a 1 percent increase in the price of a domestic product is derived from the baseline level of U.S. domestic production and the baseline level of imports. The baseline ratio of import values to domestic production for the eight affected industries ranges from 0.04 for iron foundries to 0.547 for ceramic wall and floor tile manufacturing—that is, baseline import values range from 4 percent to more than 50 percent of domestic production in these eight industries. ERG’s estimates of the percentage reduction in U.S. production for the eight affected industries due to increased domestic imports (arising from a 1 percent increase in the price of domestic products) range from 0.013 percent for iron foundries to 0.237 percent for cut stone and stone product manufacturing. ERG also estimated baseline ratio of U.S. exports to consumption in the rest of the world for the sample of eight affected industries. The ratios range from 0.001 for other concrete manufacturing to 0.035 percent for nonclay refractory manufacturing. The estimated percentage reductions in U.S. production due to reduced U.S. exports (arising from a 1 percent increase in the price of domestic products) range from 0.014 percent for ceramic wall and floor tile manufacturing to 0.201 percent for nonclay refractory manufacturing. The total percentage change in U.S. production for the eight affected industries is the sum of the loss of E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 increased imports and the loss of exports. The total percentage reduction in U.S. production arising from a 1 percent increase in the price of domestic products range from a low of 0.085 percent for other concrete product manufacturing to a high of 0.299 percent for porcelain electrical supply manufacturing. These estimates suggest that the proposed rule would have only modest international trade effects. It was previously hypothesized that if price increases resulted in a substantial loss of revenue to foreign competition, then the increased costs of the proposed rule would have to come out of profits. That possibility has been contradicted by the results reported in this section. The maximum loss to foreign competition in any affected industry due to a 1 percent price increase was estimated at approximately 0.3 percent of industry revenue. Because, as reported earlier in this section, the maximum cost impact of the proposed rule for any affected industry would be 0.39 percent of revenue, this means that the maximum loss to foreign competition in any affected industry as a result of the proposed rule would be 0.12 percent of industry revenue—which, even for the most affected industry, would hardly qualify as a substantial loss to foreign competition. This analysis cannot tell us whether the resulting change in revenues will lead to a small decline in the number of establishments in the industry or slightly less revenue for each establishment. However it can reasonably be concluded that revenue changes of this magnitude will not lead to the elimination of industries or significantly alter their competitive structure. Based on the Agency’s preceding analysis of economic impacts on revenues, profits, and international trade, OSHA preliminarily concludes VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 that the annualized costs of the proposed rule are below the threshold level that could threaten the economic viability of any industry in general industry or maritime. OSHA further notes that while there would be additional costs (not attributable to the proposed rule) for some employers in general industry and maritime to come into compliance with the current silica standard, these costs would not affect the Agency’s preliminary determination of the economic feasibility of the proposed rule. d. Economic Feasibility Screening Analysis: Small and Very Small Businesses The preceding discussion focused on the economic viability of the affected industries in their entirety and found that the proposed standard did not threaten the survival of these industries. Now OSHA wishes to demonstrate that the competitive structure of these industries would not be significantly altered. To address this issue, OSHA examined the annualized costs per affected small entity and per very small entity for each affected industry in general industry and maritime. Again, OSHA used a minimum threshold level of annualized costs equal to one percent of annual revenues—and, secondarily, annualized costs equal to ten percent of annual profits—below which the Agency has concluded that the costs are unlikely to threaten the survival of small entities or very small entities or, consequently, to alter the competitive structure of the affected industries. As shown in Table VIII–12 and Table VIII–13, the annualized cost of the proposed rule is estimated to be $2,103 for the average small entity in general industry and maritime and $616 for the average very small entity in general industry and maritime. These tables also show that there are no industries in PO 00000 Frm 00101 Fmt 4701 Sfmt 4702 56373 general industry and maritime in which the annualized costs of the proposed rule for small entities or very small entities exceed one percent of annual revenues. NAICS 327111 (Vitreous china plumbing fixtures & bathroom accessories manufacturing) has the highest potential cost impact as a percentage of revenues, of 0.61 percent, for small entities, and NAICS 327112 (Vitreous china, fine earthenware, & other pottery product manufacturing) has the highest potential cost impact as a percentage of revenues, of 0.75 percent, for very small entities. Small entities in two industries in general industry and maritime—NAICS 327111 and NAICS 327123 (Other structural clay product mfg.)—have annualized costs in excess of 10 percent of annual profits (13.91 percent and 10.63 percent, respectively). NAICS 327112 is the only industry in general industry and maritime in which the annualized costs of the proposed rule for very small entities exceed ten percent of annual profits (16.92 percent). In general, cost impacts for affected small entities or very small entities will tend to be somewhat higher, on average, than the cost impacts for the average business in those affected industries. That is to be expected. After all, smaller businesses typically suffer from diseconomies of scale in many aspects of their business, leading to less revenue per dollar of cost and higher unit costs. Small businesses are able to overcome these obstacles by providing specialized products and services, offering local service and better service, or otherwise creating a market niche for themselves. The higher cost impacts for smaller businesses estimated for this rule generally fall within the range observed in other OSHA regulations and, as verified by OSHA’s lookback reviews, have not been of such a magnitude to lead to their economic failure. E:\FR\FM\12SEP2.SGM 12SEP2 VerDate Mar<15>2010 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 327113 327121 327122 327123 327124 327125 327211 327212 327213 327320 327331 327332 327390 327991 327992 327993 327999 331111 331112 331210 331221 331222 331314 331423 331492 331511 331512 331513 331524 331525 331528 332111 332112 332115 332116 332117 332211 332212 332213 332214 332323 332439 332510 332611 332612 332618 332710 332812 332911 332912 327112 ..... 324121 324122 325510 327111 NAICS Asphalt paving mixture and block manufacturing ........ Asphalt shingle and roofing materials .......................... Paint and coating manufacturing ................................. Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg .................................... Brick and structural clay mfg ........................................ Ceramic wall and floor tile mfg .................................... Other structural clay product mfg ................................. Clay refractory manufacturing ...................................... Nonclay refractory manufacturing ................................ Flat glass manufacturing .............................................. Other pressed and blown glass and glassware manufacturing. Glass container manufacturing .................................... Ready-mixed concrete manufacturing ......................... Concrete block and brick mfg ...................................... Concrete pipe mfg ........................................................ Other concrete product mfg ......................................... Cut stone and stone product manufacturing ................ Ground or treated mineral and earth manufacturing ... Mineral wool manufacturing ......................................... All other misc. nonmetallic mineral product mfg .......... Iron and steel mills ....................................................... Electrometallurgical ferroalloy product manufacturing Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ................................ Steel wire drawing ........................................................ Secondary smelting and alloying of aluminum ............ Secondary smelting, refining, and alloying of copper .. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ............................................................... Steel investment foundries ........................................... Steel foundries (except investment) ............................. Aluminum foundries (except die-casting) ..................... Copper foundries (except die-casting) ......................... Other nonferrous foundries (except die-casting) ......... Iron and steel forging ................................................... Nonferrous forging ........................................................ Crown and closure manufacturing ............................... Metal stamping ............................................................. Powder metallurgy part manufacturing ........................ Cutlery and flatware (except precious) manufacturing Hand and edge tool manufacturing .............................. Saw blade and handsaw manufacturing ...................... Kitchen utensil, pot, and pan manufacturing ............... Ornamental and architectural metal work .................... Other metal container manufacturing ........................... Hardware manufacturing .............................................. Spring (heavy gauge) manufacturing ........................... Spring (light gauge) manufacturing .............................. Other fabricated wire product manufacturing ............... Machine shops ............................................................. Metal coating and allied services ................................. Industrial valve manufacturing ..................................... Fluid power valve and hose fitting manufacturing ....... Industry 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00102 Fmt 4701 Sfmt 4702 5,312,382 1,705,373 2,521,998 4,316,135 1,596,288 620,344 47,376 13,056 5,080 212,110 17,537 10,419 87,599 9,221 10,475 28,608 43,857 78,538 14,071 36,826 113,603 1,032,483 2,492,357 53,520 41,712 42,672 57,557 15,277 4,206 18,357 57,797 10,490,561 2,862,910 1,441,766 8,826,516 8,028,431 2,108,649 291,145 1,130,230 424,557 4,987 84,537 1,004,480 3,062,272 2,189,278 510,811 212,965 211,512 275,155 243,132 1,854,472 $140,305 872,614 71,718 231,845 Total annualized costs 408 101 192 412 246 112 63 17 7 279 23 14 113 12 13 42 56 104 19 44 148 1,399 2,301 71 55 54 67 20 6 25 24 2,401 567 181 1,876 1,874 132 175 326 523 7 94 97 93 173 42 96 68 56 228 717 431 106 1,042 25 Number of affected small entities 13,021 16,885 13,135 10,476 6,489 5,539 756 760 732 759 762 738 772 752 798 673 784 756 754 834 765 738 1,083 752 757 787 862 777 722 741 2,408 4,369 5,049 7,966 4,705 4,284 15,975 1,664 3,467 812 692 896 10,355 32,928 12,655 12,162 2,218 3,110 4,913 1,068 2,586 $326 8,232 69 9,274 Annualized cost per affected entity 5,865,357 8,489,826 11,977,647 4,039,244 2,847,376 2,640,180 8,310,925 21,892,338 6,697,995 5,360,428 6,328,522 2,852,835 3,399,782 5,385,465 10,355,293 2,069,492 5,260,693 4,442,699 6,621,896 4,500,760 3,440,489 1,464,380 2,904,851 5,841,019 6,486,405 31,848,937 16,018,794 18,496,524 20,561,614 9,513,728 10,181,980 7,245,974 6,318,185 7,852,099 3,521,965 1,730,741 6,288,188 6,181,590 4,299,551 82,895,665 24,121,503 40,090,061 4,574,464 9,265,846 3,236,635 2,592,114 6,026,297 7,346,739 64,950,007 935,353 693,637 $10,428,583 14,067,491 6,392,803 1,509,677 Revenues per entity 4.11 4.11 4.11 4.11 4.11 4.11 4.71 4.71 4.71 4.71 4.71 5.22 5.22 5.22 5.22 4.70 3.58 5.22 5.22 5.22 5.22 5.80 4.85 6.81 6.81 4.49 4.49 4.46 4.42 4.42 3.42 6.64 6.64 6.64 6.64 5.49 5.49 5.49 5.49 4.49 4.49 4.49 4.41 4.41 4.41 4.41 4.41 4.41 3.42 3.42 4.41 7.50 7.50 5.38 4.41 Profit rate [a] (percent) 241,290 349,255 492,738 166,167 117,136 108,612 391,034 1,030,048 315,145 252,211 297,761 149,022 177,592 281,317 540,923 97,346 188,521 232,070 345,904 235,103 179,719 84,907 141,018 397,593 441,524 1,430,651 719,562 825,857 907,800 420,033 348,317 480,994 419,407 521,229 233,791 95,001 345,160 339,309 236,004 3,723,664 1,083,535 1,800,841 201,959 409,079 142,895 114,440 266,056 324,352 2,221,884 31,998 30,623 $782,268 1,055,229 344,213 66,651 Profits per entity 0.22 0.20 0.11 0.26 0.23 0.21 0.01 0.00 0.01 0.01 0.01 0.03 0.02 0.01 0.01 0.03 0.01 0.02 0.01 0.02 0.02 0.05 0.04 0.01 0.01 0.00 0.01 0.00 0.00 0.01 0.02 0.06 0.08 0.10 0.13 0.25 0.25 0.03 0.08 0.00 0.00 0.00 0.23 0.36 0.39 0.47 0.04 0.04 0.01 0.11 0.37 0.00 0.06 0.00 0.61 Costs as a percentage of revenues 5.40 4.83 2.67 6.30 5.54 5.10 0.19 0.07 0.23 0.30 0.26 0.50 0.43 0.27 0.15 0.69 0.42 0.33 0.22 0.35 0.43 0.87 0.77 0.19 0.17 0.05 0.12 0.09 0.08 0.18 0.69 0.91 1.20 1.53 2.01 4.51 4.63 0.49 1.47 0.02 0.06 0.05 5.13 8.05 8.86 10.63 0.83 0.96 0.22 3.34 8.45 0.04 0.78 0.02 13.91 Costs as a percentage of profits TABLE VIII–12—SCREENING ANALYSIS FOR SMALL ENTITIES IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56374 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules E:\FR\FM\12SEP2.SGM 12SEP2 VerDate Mar<15>2010 ..... ..... ..... ..... ..... ..... 19:12 Sep 11, 2013 Jkt 229001 ..... ..... ..... ..... PO 00000 Frm 00103 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 334518 335211 335221 335222 335224 335228 336111 336112 336120 336211 336212 336213 336311 336370 ..... 336399 ..... 336611 ..... 336340 ..... 336350 ..... 336330 ..... 336312 ..... 336322 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 333911 333912 333991 333992 333993 333994 333995 333996 333997 333999 333613 ..... 333516 ..... 333518 ..... 333612 ..... 333515 ..... 333511 333512 333513 333514 333414 ..... 333411 ..... 333412 ..... 333319 ..... 332999 ..... 332913 332919 332991 332996 332997 332998 Plumbing fixture fitting and trim manufacturing ........... Other metal valve and pipe fitting manufacturing ........ Ball and roller bearing manufacturing .......................... Fabricated pipe and pipe fitting manufacturing ............ Industrial pattern manufacturing ................................... Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing ..................... Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing ...................................... Machine tool (metal cutting types) manufacturing ....... Machine tool (metal forming types) manufacturing ...... Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing Other metalworking machinery manufacturing ............ Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing ............ Air and gas compressor manufacturing ....................... Power-driven handtool manufacturing ......................... Welding and soldering equipment manufacturing ........ Packaging machinery manufacturing ........................... Industrial process furnace and oven manufacturing .... Fluid power cylinder and actuator manufacturing ........ Fluid power pump and motor manufacturing ............... Scale and balance (except laboratory) manufacturing All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing ......................... Electric housewares and household fans .................... Household cooking appliance manufacturing .............. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing ............. Other major household appliance manufacturing ........ Automobile manufacturing ............................................ Light truck and utility vehicle manufacturing ................ Heavy duty truck manufacturing .................................. Motor vehicle body manufacturing ............................... Truck trailer manufacturing .......................................... Motor home manufacturing .......................................... Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing ....... Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing ................. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping ...................................... All other motor vehicle parts manufacturing ................ Ship building and repair ............................................... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 159,156 169,401 8,749,619 32,886 46,869 25,492 65,767 71,423 30,521 1,917 293,357 404,778 125,181 187,131 54,137 84,073 10,269 6,646 3,326 6,521 32,118 41,360 23,948 9,867 23,144 54,872 34,418 32,249 15,258 12,129 123,384 26,182 9,604 38,359 25,087 104,313 143,216 44,845 30,365 203,742 45,308 27,021 27,149 123,816 230,825 19,037 30,618 13,624 74,633 20,767 13,779 201 235 575 46 66 36 94 101 17 3 167 63 77 239 72 79 14 9 5 10 18 54 32 13 31 74 45 43 20 16 166 35 13 50 32 140 193 60 40 274 61 36 34 165 311 25 40 18 99 28 22 792 721 15,217 710 710 708 703 706 1,795 671 1,757 6,425 1,626 784 748 1,064 748 732 643 649 1,784 762 758 732 745 742 757 756 772 764 745 754 744 765 777 746 743 746 758 743 741 748 791 750 742 752 764 741 754 736 630 11,477,248 6,985,145 27,083,446 6,554,128 6,058,947 7,742,773 4,245,230 6,746,386 299,665,426 8,269,046 555,733,594 2,359,286,755 240,029,218 16,910,028 9,018,164 75,358,742 2,242,044 2,878,581 6,088,365 10,460,359 271,746,735 6,220,799 6,290,845 3,816,319 5,635,771 4,240,165 4,470,378 5,830,077 4,401,836 4,987,858 3,262,128 9,094,798 8,330,543 5,680,062 6,028,137 2,082,357 2,121,298 4,136,962 4,358,035 2,083,166 5,667,272 4,449,669 7,928,953 4,960,861 2,904,500 9,183,477 9,432,914 5,892,239 4,377,576 1,127,301 3,195,173 2.04 2.04 5.86 2.04 2.04 2.04 2.04 2.04 4.21 4.21 2.04 2.04 2.04 2.04 2.04 2.04 2.04 5.94 4.21 4.21 4.21 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 4.58 2.63 5.29 5.29 2.63 5.29 5.29 5.29 5.29 5.29 4.55 4.55 4.55 4.86 6.81 6.81 6.81 6.81 6.81 6.81 6.81 234,190 142,530 1,587,570 133,735 123,631 157,989 86,623 137,658 12,625,478 348,391 11,339,563 48,140,479 4,897,718 345,044 184,013 1,537,671 45,748 171,059 256,514 440,715 11,449,210 284,686 287,891 174,648 257,913 194,045 204,580 266,805 201,444 228,262 149,287 238,915 440,630 300,438 158,355 110,143 112,203 218,818 230,511 110,186 258,027 202,591 361,000 241,023 197,707 625,111 642,090 401,079 297,978 76,734 217,493 0.01 0.01 0.06 0.01 0.01 0.01 0.02 0.01 0.00 0.01 0.00 0.00 0.00 0.00 0.01 0.00 0.03 0.03 0.01 0.01 0.00 0.01 0.01 0.02 0.01 0.02 0.02 0.01 0.02 0.02 0.02 0.01 0.01 0.01 0.01 0.04 0.04 0.02 0.02 0.04 0.01 0.02 0.01 0.02 0.03 0.01 0.01 0.01 0.02 0.07 0.02 0.34 0.51 0.96 0.53 0.57 0.45 0.81 0.51 0.01 0.19 0.02 0.01 0.03 0.23 0.41 0.07 1.64 0.43 0.25 0.15 0.02 0.27 0.26 0.42 0.29 0.38 0.37 0.28 0.38 0.33 0.50 0.32 0.17 0.25 0.49 0.68 0.66 0.34 0.33 0.67 0.29 0.37 0.22 0.31 0.38 0.12 0.12 0.18 0.25 0.96 0.29 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56375 VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 ..... ..... ..... ..... ..... ..... ..... ..... ..... 86,520,059 Total ............................................................................. 176,800 261,393 1,397,271 1,392,054 257,285 242,158 264,810 143,614 N/A 370,174 2,612,088 27,227 Total annualized costs Boat building ................................................................. Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing ............ Dental laboratories ....................................................... Jewelry (except costume) manufacturing .................... Jewelers’ materials and lapidary work manufacturing Costume jewelry and novelty manufacturing ............... Sign manufacturing ...................................................... Industrial supplies, wholesalers ................................... Rail transportation ........................................................ Dental offices ................................................................ Industry 41,136 292 7,011 1,751 258 588 428 226 N/A 7,423 235 814 32 Number of affected small entities 2,103 895 199 795 997 412 618 636 N/A 50 751 3,209 845 Annualized cost per affected entity 2,619,222 532,828 2,615,940 2,775,717 971,681 1,642,826 5,001,467 N/A 663,948 3,637,716 5,304,212 54,437,815 Revenues per entity 10.77 10.77 5.80 5.80 5.80 5.80 3.44 N/A 7.34 4.54 5.86 6.31 Profit rate [a] (percent) 282,066 57,381 151,608 160,868 56,314 95,211 171,830 N/A 48,739 165,266 310,921 3,434,642 Profits per entity 0.03 0.04 0.03 0.04 0.04 0.04 0.01 N/A 0.01 0.02 0.06 0.00 Costs as a percentage of revenues 0.32 0.35 0.52 0.62 0.73 0.65 0.37 N/A 0.10 0.45 1.03 0.02 Costs as a percentage of profits Frm 00104 Fmt 4701 Sfmt 4702 ..... ..... ..... ..... E:\FR\FM\12SEP2.SGM 12SEP2 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 327213 327320 327331 327332 327390 327991 327992 327993 327999 331111 331112 331210 331221 ..... ..... ..... ..... ..... ..... ..... ..... ..... 327113 327121 327122 327123 327124 327125 327211 327212 327112 ..... 324121 324122 325510 327111 NAICS Asphalt paving mixture and block manufacturing ........ Asphalt shingle and roofing materials .......................... Paint and coating manufacturing ................................. Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg .................................... Brick and structural clay mfg ........................................ Ceramic wall and floor tile mfg .................................... Other structural clay product mfg ................................. Clay refractory manufacturing ...................................... Nonclay refractory manufacturing ................................ Flat glass manufacturing .............................................. Other pressed and blown glass and glassware manufacturing. Glass container manufacturing .................................... Ready-mixed concrete manufacturing ......................... Concrete block and brick mfg ...................................... Concrete pipe mfg ........................................................ Other concrete product mfg ......................................... Cut stone and stone product manufacturing ................ Ground or treated mineral and earth manufacturing ... Mineral wool manufacturing ......................................... All other misc. nonmetallic mineral product mfg .......... Iron and steel mills ....................................................... Electrometallurgical ferroalloy product manufacturing Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ................................ Industry 1,612 4,798 1,897,131 544,975 116,670 1,885,496 2,753,051 389,745 48,575 311,859 9,342 0 1,706 79,824 76,696 382,871 67,176 29,861 34,061 4,450 87,895 747,902 $27,770 85,253 18,910 26,606 Total annualized costs 2 4 1,429 339 67 1,326 1,471 78 46 235 12 0 2 57 31 136 25 55 40 4 79 645 260 57 324 19 Number of affected entities with <20 employees 774 1,107 1,328 1,608 1,741 1,422 1,872 4,997 1,061 1,327 777 N/A 774 1,400 2,474 2,815 2,687 543 852 1,075 1,107 1,160 $107 1,496 58 1,400 Annualized costs per affected entities 2,108,498 2,690,032 1,922,659 1,995,833 2,375,117 974,563 946,566 1,635,092 1,398,274 1,457,181 4,177,841 1,202,610 2,113,379 601,316 715,098 807,291 782,505 1,521,469 1,506,151 905,562 370,782 155,258 $4,335,678 4,013,780 1,871,296 327,368 Revenues per entity 4.49 3.42 6.64 6.64 6.64 6.64 5.49 5.49 5.49 5.49 4.49 4.49 4.49 4.41 4.41 4.41 4.41 4.41 4.41 3.42 3.42 4.41 7.50 7.50 5.38 4.41 Profit rate [a] (percent) 94,713 92,024 127,628 132,485 157,662 64,692 51,957 89,751 76,752 79,985 187,668 54,021 94,933 26,548 31,571 35,641 34,547 67,172 66,495 30,978 12,684 6,855 $325,227 301,081 100,758 14,453 Profits per entity 0.04 0.04 0.07 0.08 0.07 0.15 0.20 0.31 0.08 0.09 0.02 N/A 0.04 0.23 0.35 0.35 0.34 0.04 0.06 0.12 0.30 0.75 0.00 0.04 0.00 0.43 Costs as a percentage of revenues 0.82 1.20 1.04 1.21 1.10 2.20 3.60 5.57 1.38 1.66 0.41 N/A 0.82 5.28 7.84 7.90 7.78 0.81 1.28 3.47 8.73 16.92 0.03 0.50 0.06 9.69 Costs as a percentage of profits TABLE VIII–13—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD [a] Profit rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). 339114 339116 339911 339913 339914 339950 423840 482110 621210 337215 ..... 336612 ..... 336992 ..... NAICS TABLE VIII–12—SCREENING ANALYSIS FOR SMALL ENTITIES IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD— Continued mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56376 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules ..... ..... ..... ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00105 Fmt 4701 331511 331512 331513 331524 331525 331528 332111 332112 332115 332116 332117 332211 332212 332213 332214 332323 332439 332510 332611 332612 332618 332710 332812 332911 332912 332913 332919 332991 332996 332997 332998 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 ..... ..... ..... ..... 333911 333912 333991 333992 333993 333994 333995 ..... ..... ..... ..... ..... ..... ..... 333613 ..... 333516 ..... 333518 ..... 333612 ..... 333515 ..... 333511 333512 333513 333514 333414 ..... 333411 ..... 333412 ..... 333319 ..... 332999 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 331222 331314 331423 331492 Steel wire drawing ........................................................ Secondary smelting and alloying of aluminum ............ Secondary smelting, refining, and alloying of copper .. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ............................................................... Steel investment foundries ........................................... Steel foundries (except investment) ............................. Aluminum foundries (except die-casting) ..................... Copper foundries (except die-casting) ......................... Other nonferrous foundries (except die-casting) ......... Iron and steel forging ................................................... Nonferrous forging ........................................................ Crown and closure manufacturing ............................... Metal stamping ............................................................. Powder metallurgy part manufacturing ........................ Cutlery and flatware (except precious) manufacturing Hand and edge tool manufacturing .............................. Saw blade and handsaw manufacturing ...................... Kitchen utensil, pot, and pan manufacturing ............... Ornamental and architectural metal work .................... Other metal container manufacturing ........................... Hardware manufacturing .............................................. Spring (heavy gauge) manufacturing ........................... Spring (light gauge) manufacturing .............................. Other fabricated wire product manufacturing ............... Machine shops ............................................................. Metal coating and allied services ................................. Industrial valve manufacturing ..................................... Fluid power valve and hose fitting manufacturing ....... Plumbing fixture fitting and trim manufacturing ........... Other metal valve and pipe fitting manufacturing ........ Ball and roller bearing manufacturing .......................... Fabricated pipe and pipe fitting manufacturing ............ Industrial pattern manufacturing ................................... Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing ..................... Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing ...................................... Machine tool (metal cutting types) manufacturing ....... Machine tool (metal forming types) manufacturing ...... Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing Other metalworking machinery manufacturing ............ Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing ............ Air and gas compressor manufacturing ....................... Power-driven handtool manufacturing ......................... Welding and soldering equipment manufacturing ........ Packaging machinery manufacturing ........................... Industrial process furnace and oven manufacturing .... Fluid power cylinder and actuator manufacturing ........ mstockstill on DSK4VPTVN1PROD with PROPOSALS2 7,209 4,228 2,212 3,835 9,742 5,631 3,955 3,114 1,361 6,766 3,318 31,406 43,738 8,756 4,666 65,867 6,087 4,745 1,675 19,776 55,981 330,543 47,902 162,670 503,027 370,110 162,043 4,089 784 992 27,154 2,072 2,217 19,535 2,296 0 9,527 5,279 11,863 1,927 4,960 19,946 416,115 613,903 5,886 4,491 1,505 2,710 1,132 12,453 8,917 3,287 2,939 1,254 0 2,897 9 5 3 5 13 7 5 4 2 9 4 41 56 11 6 85 8 6 2 26 72 201 27 102 235 164 77 5 1 1 35 3 3 25 3 0 14 7 15 2 6 26 537 885 8 6 2 3 1 16 12 5 4 2 0 4 774 774 774 774 774 774 774 774 774 774 774 775 774 776 774 774 777 774 774 774 774 1,644 1,774 1,595 2,141 2,257 2,104 774 774 774 775 774 774 774 774 N/A 694 788 777 786 774 774 774 694 774 774 774 781 774 774 774 690 774 774 N/A 774 1,343,868 1,644,664 2,158,268 1,331,521 809,474 1,324,790 916,613 2,113,156 2,243,812 965,694 1,393,898 771,162 716,506 911,891 1,308,768 816,990 901,560 1,152,661 1,454,305 1,127,993 933,734 1,031,210 1,831,394 1,577,667 874,058 814,575 837,457 1,175,666 1,431,874 1,715,882 1,146,408 1,580,975 391,981 770,858 975,698 826,410 695,970 1,027,511 776,986 1,774,584 1,085,302 778,870 649,804 602,598 1,294,943 1,350,501 811,318 2,164,960 1,808,246 1,237,265 503,294 725,491 835,444 2,039,338 2,729,146 1,546,332 4.58 4.58 4.58 4.58 4.58 4.58 4.58 2.63 5.29 5.29 2.63 5.29 5.29 5.29 5.29 5.29 4.55 4.55 4.55 4.86 6.81 4.11 4.11 4.11 4.11 4.11 4.11 4.71 4.71 4.71 4.71 4.71 5.22 5.22 5.22 5.22 4.70 3.58 5.22 5.22 5.22 5.22 5.80 4.85 6.81 6.81 6.81 6.81 6.81 6.81 6.81 6.81 4.49 4.46 4.42 4.42 61,500 75,266 98,770 60,935 37,044 60,627 41,947 55,511 118,683 51,079 36,617 40,789 37,898 48,233 69,225 43,213 41,047 52,480 66,214 54,803 63,558 42,422 75,340 64,902 35,957 33,510 34,451 55,316 67,371 80,733 53,939 74,386 20,476 40,267 50,967 43,169 32,737 36,822 40,587 92,698 56,692 40,685 37,677 29,254 88,146 91,927 55,226 147,367 123,086 84,220 34,259 49,384 37,528 91,055 120,492 68,271 0.06 0.05 0.04 0.06 0.10 0.06 0.08 0.04 0.03 0.08 0.06 0.10 0.11 0.09 0.06 0.09 0.09 0.07 0.05 0.07 0.08 0.16 0.10 0.10 0.24 0.28 0.25 0.07 0.05 0.05 0.07 0.05 0.20 0.10 0.08 N/A 0.10 0.08 0.10 0.04 0.07 0.10 0.12 0.12 0.06 0.06 0.10 0.04 0.04 0.06 0.15 0.10 0.09 0.04 N/A 0.05 1.26 1.03 0.78 1.27 2.09 1.28 1.84 1.39 0.65 1.51 2.11 1.90 2.04 1.61 1.12 1.79 1.89 1.47 1.17 1.41 1.22 3.88 2.35 2.46 5.95 6.73 6.11 1.40 1.15 0.96 1.44 1.04 3.78 1.92 1.52 N/A 2.12 2.14 1.92 0.85 1.36 1.90 2.06 2.37 0.88 0.84 1.40 0.53 0.63 0.92 2.26 1.40 2.06 0.85 N/A 1.13 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56377 VerDate Mar<15>2010 20:46 Sep 11, 2013 Jkt 229001 PO 00000 ..... ..... ..... ..... ..... ..... ..... ..... ..... 335224 335228 336111 336112 336120 336211 336212 336213 336311 Frm 00106 Fmt 4701 Sfmt 4702 ..... ..... ..... ..... ..... E:\FR\FM\12SEP2.SGM 12SEP2 ..... ..... ..... ..... ..... ..... ..... ..... ..... Total annualized costs 79,876 1,040,112 533,353 86,465 100,556 89,586 50,612 N/A 320,986 15,745,425 Total ............................................................................. 28,216 5,759 16,021 212,021 391,950 0 2,386 6,390 2,876 11,683 8,618 0 0 2,147 795 943 12,371 5,147 1,193 1,329 1,322 0 722 0 2,670 1,947 32,637 Fluid power pump and motor manufacturing ............... Scale and balance (except laboratory) manufacturing All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing ......................... Electric housewares and household fans .................... Household cooking appliance manufacturing .............. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing ............. Other major household appliance manufacturing ........ Automobile manufacturing ............................................ Light truck and utility vehicle manufacturing ................ Heavy duty truck manufacturing .................................. Motor vehicle body manufacturing ............................... Truck trailer manufacturing .......................................... Motor home manufacturing .......................................... Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing ....... Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing ................. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping ...................................... All other motor vehicle parts manufacturing ................ Ship building and repair ............................................... Boat building ................................................................. Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing ............ Dental laboratories ....................................................... Jewelry (except costume) manufacturing .................... Jewelers’ materials and lapidary work manufacturing Costume jewelry and novelty manufacturing ............... Sign manufacturing ...................................................... Industrial supplies, wholesalers ................................... Rail transportation ........................................................ Dental offices ................................................................ Industry 25,544 87 6,664 1,532 218 368 140 95 N/A 6,506 36 7 21 65 121 0 3 8 4 15 11 0 0 3 1 1 16 7 2 2 2 0 1 0 3 3 42 Number of affected entities with <20 employees 616 922 156 348 397 274 639 531 N/A 49 774 778 774 3,252 3,247 N/A 774 774 774 774 774 N/A N/A 774 774 774 774 774 774 774 774 N/A 698 N/A 774 774 774 Annualized costs per affected entities 657,192 326,740 673,857 919,422 454,292 521,518 2,432,392 N/A 562,983 866,964 1,519,875 1,369,097 770,896 1,101,324 1,145,870 1,378,684 864,746 1,543,436 867,703 1,383,831 1,767,776 1,706,991 1,507,110 1,089,801 4,371,350 1,720,545 2,706,375 2,184,388 870,496 586,350 847,408 2,228,319 4,917,513 1,417,549 1,527,651 871,700 Revenues per entity 10.77 10.77 5.80 5.80 5.80 5.80 3.44 N/A 7.34 4.54 2.04 2.04 5.86 5.86 6.31 2.04 2.04 2.04 2.04 2.04 4.21 4.21 2.04 2.04 2.04 2.04 2.04 2.04 2.04 5.94 4.21 4.21 4.21 4.58 4.58 4.58 Profit rate [a] (percent) 70,773 35,187 39,054 53,285 26,329 30,225 83,567 N/A 41,328 39,387 31,013 27,936 45,188 64,557 72,296 28,132 17,645 31,493 17,705 28,237 74,480 71,919 30,752 22,237 89,196 35,107 55,223 44,572 17,762 34,844 35,703 93,883 207,184 64,872 69,911 39,892 Profits per entity 0.14 0.05 0.05 0.04 0.06 0.12 0.02 N/A 0.01 0.09 0.05 0.06 0.42 0.29 N/A 0.06 0.09 0.05 0.09 0.06 N/A N/A 0.05 0.07 0.02 0.04 0.03 0.04 0.09 0.13 N/A 0.03 N/A 0.05 0.05 0.09 Costs as a percentage of revenues 1.30 0.44 0.89 0.74 1.04 2.12 0.64 N/A 0.12 1.96 2.51 2.77 7.20 5.03 N/A 2.75 4.38 2.46 4.37 2.74 N/A N/A 2.52 3.48 0.87 2.20 1.40 1.74 4.36 2.22 N/A 0.74 N/A 1.19 1.11 1.94 Costs as a percentage of profits rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). a Profit 339114 339116 339911 339913 339914 339950 423840 482110 621210 337215 ..... 336370 336399 336611 336612 336992 336340 ..... 336350 ..... 336330 ..... 336312 ..... 336322 ..... ..... ..... ..... ..... 334518 335211 335221 335222 333996 ..... 333997 ..... 333999 ..... NAICS TABLE VIII–13—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD—Continued mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56378 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules As a point of clarification, OSHA would like to draw attention to industries with captive foundries. There are three industries with captive foundries whose annualized costs for very small entities approach five percent of annual profits: NAICS 336311 (Carburetor, piston ring, and valve manufacturing); NAICS 336312 (Gasoline engine and engine parts manufacturing); and NAICS 336350 (Motor vehicle transmission and power train parts manufacturing). For very small entities in all three of these industries, the annualized costs as a percentage of annual profits are approximately 4.4 percent. OSHA believes, however, that very small entities in industries with captive foundries are unlikely to actually have captive foundries and that the captive foundries allocated to very small entities in fact belong in larger entities. This would have the result that the costs as percentage of profits for these larger entities would be lower than the 4.4 percent reported above. Instead, OSHA assumed that the affected employees would be distributed among entities of different size according to each entity size class’s share of total employment. In other words, if 15 percent of employees in an industry worked in very small entities (those with fewer than 20 employees), then OSHA assumed that 15 percent of affected employees in the industry would work in very small entities. However, in reality, OSHA anticipates that in industries with captive foundries, none of the entities with fewer than 20 employees have captive foundries or, if they do, that the impacts are much smaller than estimated here. OSHA invites comment about whether and to what extent very small entities have captive foundries (in industries with captive foundries). Regardless of whether the cost estimates have been inflated for very small entities in the three industries with captive foundries listed above, there are two reasons why OSHA is confident that the competitive structure of these industries would not be threatened by adverse competitive conditions for very small entities. First, as shown in Appendix VI–B of the PEA, very small entities in NAICS 336311, NAICS 336312, and NAICS 336350 account for 3 percent, 2 percent, and 3 percent, respectively, of the total number of establishments in the industry. Although it is possible that some of these very small entities could exit the industry in response to the proposed rule, courts interpreting the OSH Act have historically taken the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 view that losing at most 3 percent of the establishments in an industry would alter the competitive structure of that industry. Second, very small entities in industries with captive foundries, when confronted with higher foundry costs as a result of the proposed rule, have the option of dropping foundry activities, purchasing foundry products and services from businesses directly in the foundry industry, and focusing on the main goods and services produced in the industry. This, after all, is precisely what the rest of the establishments in these industries do. e. Regulatory Flexibility Screening Analysis To determine if the Assistant Secretary of Labor for OSHA can certify that the proposed silica rule will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the proposed rule on small entities. The minimum threshold effects for this purpose are annualized costs equal to one percent of annual revenues and annualized costs equal to five percent of annual profits applied to each affected industry. OSHA has applied these screening tests both to small entities and to very small entities. For purposes of certification, the threshold level cannot be exceeded for affected small entities or very small entities in any affected industry. Table VIII–12 and Table VIII–13 show that, in general industry and maritime, the annualized costs of the proposed rule do not exceed one percent of annual revenues for small entities or for very small entities in any industry. These tables also show that the annualized costs of the proposed rule exceed five percent of annual profits for small entities in 10 industries and for very small entities in 13 industries. OSHA is therefore unable to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities in general industry and maritime and must prepare an Initial Regulatory Flexibility Analysis (IRFA). The IRFA is presented in Section VIII.I of this preamble. 3. Impacts in Construction a. Economic Feasibility Screening Analysis: All Establishments To determine whether the proposed rule’s projected costs of compliance would threaten the economic viability of affected construction industries, OSHA used the same data sources and methodological approach that were used earlier in this chapter for general PO 00000 Frm 00107 Fmt 4701 Sfmt 4702 56379 industry and maritime. OSHA first compared, for each affected construction industry, annualized compliance costs to annual revenues and profits per (average) affected establishment. The results for all affected establishments in all affected construction industries are presented in Table VIII–14, using annualized costs per establishment for the proposed 50 mg/m3 PEL. The annualized cost of the proposed rule for the average establishment in construction, encompassing all construction industries, is estimated at $1,022 in 2009 dollars. It is clear from Table VIII– 14 that the estimates of the annualized costs per affected establishment in the 10 construction industries vary widely. These estimates range from $2,598 for NAICS 237300 (Highway, street, and bridge construction) and $2,200 for NAICS 237100 (Utility system construction) to $241 for NAICS 238200 (Building finishing contractors) and $171 for NAICS 237200 (Land subdivision). Table VIII–14 shows that in no construction industry do the annualized costs of the proposed rule exceed one percent of annual revenues or ten percent of annual profits. NAICS 238100 (Foundation, structure, and building exterior contractors) has both the highest cost impact as a percentage of revenues, of 0.13 percent, and the highest cost impact as a percentage of profits, of 2.97 percent. Based on these results, even if the costs of the proposed rule were 50 percent higher than OSHA has estimated, the highest cost impact as a percentage of revenues in any affected construction industry would be less than 0.2 percent. Furthermore, the costs of the proposed rule would have to be more than 650 percent higher than OSHA has estimated for the cost impact as a percentage of revenues to equal 1 percent in any affected construction industry. For all affected establishments in construction, the estimated annualized cost of the proposed rule is, on average, equal to 0.05 percent of annual revenue and 1.0 percent of annual profit. Therefore, even though the annualized costs of the proposed rule incurred by the construction industry as a whole are almost four times the combined annualized costs incurred by general industry and maritime, OSHA preliminarily concludes, based on its screening analysis, that the annualized costs as a percentage of annual revenues and as a percentage of annual profits are below the threshold level that could threaten the economic viability of any of the construction industries. OSHA further notes that while there would be E:\FR\FM\12SEP2.SGM 12SEP2 56380 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules additional costs (not attributable to the proposed rule) for some employers in construction industries to come into compliance with the current silica standard, these costs would not affect the Agency’s preliminary determination of the economic feasibility of the proposed rule. Below, OSHA provides additional information to further support the Agency’s conclusion that the proposed rule would not threaten the economic viability of any construction industry. TABLE VIII–14—SCREENING ANALYSIS FOR ESTABLISHMENTS IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA STANDARD NAICS Industry 236100 ..... Residential Building Construction. Nonresidential Building Construction. Utility System Construction. Land Subdivision ........ Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors. Building Finishing Contractors. Other Specialty Trade Contractors. State and local governments d. Total ............................ 236200 ..... 237100 ..... 237200 ..... 237300 ..... 237900 ..... 238100 ..... 238200 ..... 238300 ..... 238900 ..... 999000 ..... Affected establishments Annualized costs per affected establishment Revenues per establishment $23,288,881 55,338 $421 $2,002,532 39,664,913 44,702 887 46,718,162 21,232 1,110,789 30,807,861 Total annualized costs Profits per establishment Costs as a percentage of revenues Costs as a percentage of profits 4.87 $97,456 0.02 0.43 7,457,045 4.87 362,908 0.01 0.24 2,200 4,912,884 5.36 263,227 0.04 0.84 6,511 11,860 171 2,598 2,084,334 8,663,019 11.04 5.36 230,214 464,156 0.01 0.03 0.07 0.56 7,164,210 5,561 1,288 3,719,070 5.36 199,264 0.03 0.65 215,907,211 117,456 1,838 1,425,510 4.34 61,832 0.13 2.97 4,902,138 20,358 241 1,559,425 4.34 67,640 0.02 0.36 50,259,239 120,012 419 892,888 4.34 38,729 0.05 1.08 68,003,978 74,446 913 1,202,048 4.48 53,826 0.08 1.70 23,338,234 N/A N/A N/A N/A N/A N/A N/A 511,165,616 477,476 1,022 ...................... ...................... ...................... ...................... ...................... Profit rate a (percent) a Profit rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). mstockstill on DSK4VPTVN1PROD with PROPOSALS2 b. Normal Year-to-Year Variations in Profit Rates As previously noted, the United States has a dynamic and constantly changing economy in which large yearto-year changes in industry profit rates are commonplace. A recession, a downturn in a particular industry, foreign competition, or the increased competitiveness of producers of close domestic substitutes are all easily capable of causing a decline in profit rates in an industry of well in excess of ten percent in one year or for several years in succession. To demonstrate the normal year-toyear variation in profit rates for all the manufacturers in construction affected by the proposed rule, OSHA presented data in the PEA on year-to-year profit rates and year-to-year percentage changes in profit rates, by industry, for the years 2000—2006. For the combined affected manufacturing industries in general industry and maritime over the 7-year period, the average change in profit rates was 15.4 percent a year. What these data indicate is that, even if, theoretically, the annualized costs of the proposed rule for the most significantly affected construction VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 industries were completely absorbed in reduced annual profits, the magnitude of reduced annual profit rates are well within normal year-to-year variations in profit rates in those industries and do not threaten their economic viability. Of course, a permanent loss of profits would present a greater problem than a temporary loss, but it is unlikely that all costs of the proposed rule would be absorbed in lost profits. Given that, as discussed in Chapter VI of the PEA, the overall price elasticity of demand for the outputs of the construction industry is fairly low and that almost all of the costs estimated in Chapter V of the PEA are variable costs, there is a reasonable chance that most firms will see small declines in output rather than that any but the most extremely marginal firms would close. Considering the costs of the proposed rule relative to the size of construction activity in the United States, OSHA preliminarily concludes that the price and profit impacts of the proposed rule on construction industries would, in practice, be quite limited. Based on ERG (2007a), on an annual basis, the cost of the proposed rule would be equal to approximately 2 percent of the value of PO 00000 Frm 00108 Fmt 4701 Sfmt 4702 affected, silica-generating construction activity, and silica-generating construction activity accounts for approximately 4.8 percent of all construction spending in the U.S. Thus, the annualized cost of the proposed rule would be equal to approximately 0.1 percent of the value of annual construction activity in the U.S. On top of that, construction activity in the U.S. is not subject to any meaningful foreign competition, and any foreign firms performing construction activities in the United States would be subject to OSHA regulations. c. Impacts by Type of Construction Demand The demand for construction services originates in three independent sectors: residential building construction, nonresidential building construction, and nonbuilding construction. Residential Building Construction: Residential housing demand is derived from the household demand for housing services. These services are provided by the stock of single and multi-unit residential housing units. Residential housing construction represents changes to the housing stock and includes construction of new units and E:\FR\FM\12SEP2.SGM 12SEP2 56381 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules modifications, renovations, and repairs to existing units. A number of studies have examined the price sensitivity of the demand for housing services. Depending on the data source and estimation methodologies, these studies have estimated the demand for housing services at price elasticity values ranging from –0.40 to –1.0, with the smaller (in absolute value) less elastic values estimated for short-run periods. In the long run, it is reasonable to expect the demand for the stock of housing to reflect similar levels of price sensitivity. Since housing investments include changes in the existing stock (renovations, depreciation, etc.) as well as new construction, it is likely that the price elasticity of demand for new residential construction will be lower than that for residential construction as a whole. OSHA judges that many of the silicagenerating construction activities affected by the proposed rule are not widely used in single-family construction. This assessment is consistent with the cost estimates that show relatively low impacts for residential building contractors. Multifamily residential construction might have more substantial impacts, but, based on census data, this type of construction represents a relatively small share of net investment in residential buildings. Nonresidential Building Construction: Nonresidential building construction consists of industrial, commercial, and other nonresidential structures. As such, construction demand is derived from the demand for the output of the industries that use the buildings. For example, the demand for commercial office space is derived from the demand for the output produced by the users of the office space. The price elasticity of demand for this construction category will depend, among other things, on the price elasticity of demand for the final products produced, the importance of the costs of construction in the total cost of the final product, and the elasticity of substitution of other inputs that could substitute for nonresidential building construction. ERG (2007c) found no studies that attempted to quantify these relationships. But given the costs of the proposed rule relative to the size of construction spending in the United States, the resultant price or revenue effects are likely to be so small as to be barely detectable. Nonbuilding Construction: Nonbuilding construction includes roads, bridges, and other infrastructure projects. Utility construction (power lines, sewers, water mains, etc.) and a variety of other construction types are also included. A large share of this construction (63.8 percent) is publicly financed (ERG, 2007a). For this reason, a large percentage of the decisions regarding the appropriate level of such investments is not made in a private market setting. The relationship between the costs and price of such investments and the level of demand might depend more on political considerations than the factors that determine the demand for privately produced goods and services. While a number of studies have examined the factors that determine the demand for publicly financed construction projects, these studies have focused on the ability to finance such projects (e.g., tax receipts) and sociodemographic factors (e.g., population growth) to the exclusion of cost or price factors. In the absence of budgetary constraints, OSHA believes, therefore, that the price elasticity of demand for public investment is probably quite low. On the other hand, budget-imposed limits might constrain public construction spending. If the dollar value of public investments were fixed, a price elasticity of demand of 1 (in absolute terms) would be implied. Any percentage increase in construction costs would be offset with an equal percentage reduction in investment (measured in physical units), keeping public construction expenditures constant. Public utility construction comprises the remainder of nonbuilding construction. This type of construction is subject to the same derived-demand considerations discussed for nonresidential building construction, and for the same reasons, OSHA expects the price and profit impacts to be quite small. d. Economic Feasibility Screening Analysis: Small and Very Small Businesses The preceding discussion focused on the economic viability of the affected construction industries in their entirety and found that the proposed standard did not threaten the survival of these construction industries. Now OSHA wishes to demonstrate that the competitive structure of these industries would not be significantly altered. To address this issue, OSHA examined the annualized costs per affected small and very small entity for each affected construction industry. Table VIII–15 and Table VIII–16 show that in no construction industries do the annualized costs of the proposed rule exceed one percent of annual revenues or ten percent of annual profits either for small entities or for very small entities. Therefore, OSHA preliminarily concludes, based on its screening analysis, that the annualized costs as a percentage of annual revenues and as a percentage of annual profits are below the threshold level that could threaten the competitive structure of any of the construction industries. TABLE VIII–15—SCREENING ANALYSIS FOR SMALL ENTITIES IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA STANDARD NAICS Industry 236100 ..... Residential Building Construction. Nonresidential Building Construction. Utility System Construction. Land Subdivision ........ Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 236200 ..... 237100 ..... 237200 ..... 237300 ..... 237900 ..... 238100 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Total annualized costs Affected small entities Annualized costs per affected entities Revenues per entities Profit rate a (percent) Profits per entities Costs as a percentage of revenues Costs as a percentage of profits $18,527,934 44,212 $419 $1,303,262 4.87 $67,420 0.03 0.62 24,443,185 42,536 575 4,117,755 4.87 200,396 0.01 0.29 30,733,201 20,069 1,531 3,248,053 5.36 174,027 0.05 0.88 546,331 13,756,992 3,036 10,350 180 1,329 1,215,688 3,851,971 11.04 5.36 134,272 206,385 0.01 0.03 0.13 0.64 5,427,484 5,260 1,032 2,585,858 5.36 138,548 0.04 0.74 152,160,159 115,345 1,319 991,258 4.34 42,996 0.13 3.07 Jkt 229001 PO 00000 Frm 00109 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56382 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–15—SCREENING ANALYSIS FOR SMALL ENTITIES IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA STANDARD—Continued NAICS Industry 238200 ..... Building Equipment Contractors. Building Finishing Contractors. Other Specialty Trade Contractors. State and local governments [d]. 238300 ..... 238900 ..... 999000 ..... Total ............................ Total annualized costs Affected small entities Annualized costs per affected entities Revenues per entities Profit rate a (percent) Profits per entities Costs as a percentage of revenues Costs as a percentage of profits 3,399,252 13,933 244 1,092,405 4.34 47,383 0.02 0.51 36,777,673 87,362 421 737,930 4.34 32,008 0.06 1.32 53,432,213 73,291 729 1,006,640 4.48 45,076 0.07 1.62 2,995,955 13,482 222 N/A N/A N/A N/A N/A 342,200,381 428,876 798 ...................... ...................... ...................... ...................... ...................... a Profit rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). TABLE VIII–16—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA STANDARD NAICS Industry 236100 ..... Residential Building Construction. Nonresidential Building Construction. Utility System Construction. Land Subdivision ........ Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors. Building Finishing Contractors. Other Specialty Trade Contractors. State and local governments [d]. Total ............................ 236200 ..... 237100 ..... 237200 ..... 237300 ..... 237900 ..... 238100 ..... 238200 ..... 238300 ..... 238900 ..... 999000 ..... Affected entities with <20 employees Annualized costs per affected entities $13,837,293 32,042 $432 $922,275 4.87 10,777,269 35,746 301 1,902,892 8,578,771 16,113 532 546,331 4,518,038 3,036 8,080 1,650,007 Total annualized costs Costs as a percentage of revenues Costs as a percentage of profits $44,884 0.05 0.96 4.87 92,607 0.02 0.33 991,776 5.36 53,138 0.05 1.00 180 559 1,215,688 1,649,324 11.04 5.36 134,272 88,369 0.01 0.03 0.13 0.63 4,436 372 834,051 5.36 44,688 0.04 0.83 81,822,550 105,227 778 596,296 4.34 25,864 0.13 3.01 1,839,588 7,283 253 579,724 4.34 25,146 0.04 1.00 21,884,973 50,749 431 429,154 4.34 18,615 0.10 2.32 30,936,078 68,075 454 600,658 4.48 26,897 0.08 1.69 N/A N/A N/A N/A N/A N/A N/A N/A 176,390,899 330,786 533 ...................... ...................... ...................... ...................... ...................... Revenues per entities Profit rate [a] (percent) Profits per entities a Profit rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007). Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013). mstockstill on DSK4VPTVN1PROD with PROPOSALS2 e. Differential Impacts on Small Entities and Very Small Entities Below, OSHA provides some additional information about differential compliance costs for small and very small entities that might influence the magnitude of differential impacts for these smaller businesses. The distribution of impacts by size of business is affected by the characteristics of the compliance measures. For silica controls in construction, the dust control measures consist primarily of equipment modifications and additions made to individual tools, rather than large, discrete investments, such as might be applied in a manufacturing setting. As VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 a result, compliance advantages for large firms through economies of scale are limited. It is possible that some large construction firms might derive purchasing power by buying dust control measures in bulk. Given the simplicity of many control measures, however, such as the use of wet methods on machines already manufactured to accommodate them, such differential purchasing power appears to be of limited consequence. The greater capital resources of large firms will give them some advantage in making the relatively large investments for some control measures. For example, cab enclosures on heavy construction equipment or foam-based dust control systems on rock crushers might be PO 00000 Frm 00110 Fmt 4701 Sfmt 4702 particularly expensive for some small entities with an unusual number of heavy equipment pieces. Nevertheless, where differential investment capabilities might exist, small construction firms might also have the capability to achieve compliance with lower-cost measures, such as by modifying work practices. In the case of rock crushing, for example, simple water spray systems can be arranged without large-scale investments in the best commercially available systems. In the program area, large firms might have a slight advantage in the delivery of training or in arranging for health screenings. Given the likelihood that small firms can, under most circumstances, call upon independent E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules training specialists at competitive prices, and the widespread availability of medical services for health screenings, the advantage for large firms is, again, expected to be fairly modest. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 f. Regulatory Flexibility Screening Analysis To determine if the Assistant Secretary of Labor for OSHA can certify that the proposed silica rule will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the proposed rule on small entities. The minimum threshold effects for this purpose are annualized costs equal to one percent of annual revenues and annualized costs equal to five percent of annual profits applied to each affected industry. OSHA has applied these screening tests both to small entities and to very small entities. For purposes of certification, the threshold levels cannot be exceeded for affected small or very small entities in any affected industry. Table VIII–15 and Table VIII–16 show that in no construction industries do the annualized costs of the proposed rule exceed one percent of annual revenues or five percent of annual profits either for small entities or for very small entities. However, as previously noted in this section, OSHA is unable to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities in general industry and maritime and must prepare an Initial Regulatory Flexibility Analysis (IRFA). The IRFA is presented in Section VIII.I of this preamble. 4. Employment Impacts on the U.S. Economy In October 2011, OSHA directed Inforum—a not-for-profit Maryland corporation (based at the University of Maryland)—to run its macroeconomic model to estimate the employment impacts of the costs of the proposed silica rule.20 The specific model of the U.S. economy that Inforum used—called the LIFT model—is particularly suitable for this work because it combines the industry detail of a pure input-output model (which shows, in matrix form, how the output of each industry serves as inputs in other industries) with macroeconomic modeling of demand, investment, and other macroeconomic parameters.21 The Inforum model can 20 Inforum has over 40 years experience designing and using macroeconomic models of the United States (and other countries). 21 LIFT stands for Long-Term Interindustry Forecasting Tool. This model combines a dynamic input-output core for 97 productive sectors with a VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 thus both trace changes in particular industries through their effect on other industries and also examine the effects of these changes on aggregate demand, imports, exports, and investment, and in turn determine net changes to GDP, employment, prices, etc. In order to estimate the possible macroeconomic impacts of the proposed rule, Inforum had to run its model twice: once to establish a baseline and then again with changes in industry expenditures to reflect the year-by-year costs of the proposed silica rule as estimated by OSHA in its Preliminary Economic Analysis (PEA).22 The difference in employment, GDP, etc. between the two runs of the model revealed the estimated economic impacts of the proposed rule.23 OSHA selected 2014 as the starting year for running the Inforum model under the assumption that that would be the earliest that a final silica rule could take effect. Inforum ran the model through the year 2023 and reported its annual and cumulative results for the ten-year period 2014–2023. The most important Inforum result is that the proposed silica rule cumulatively generates an additional 8,625 job-years over the period 2014–2023, or an additional 862.5 job-years annually, on full macroeconomic model with more than 800 macroeconomic variables. LIFT employs a ‘‘bottoms-up’’ regression approach to macroeconomic modeling (so that aggregate investment, employment, and exports, for example, are the sum of investment and employment by industry and exports by commodity). Unlike some simpler forecasting models, price effects are embedded in the model and the results are timedependent (that is, they are not static or steadystate, but present year-by-year estimates of impacts consistent with economic conditions at the time). 22 OSHA worked with Inforum to disaggregate compliance costs into categories that mapped into specific LIFT production sectors. Inforum also established a mapping between OSHA’s NAICSbased industries and the LIFT production sectors. OSHA’s compliance cost estimates were based on production and employment levels in affected industries in 2006 (although the costs were then inflated to 2009 dollars). Therefore, Inforum benchmarked compliance cost estimates in future years to production and employment conditions in 2006 (that is, compliance costs in a future year were proportionately adjusted to production and employment changes from 2006 to that future year). See Inforum (2011) for a discussion of these and other transformations of OSHA’s cost estimates to conform to the specifications of the LIFT model. 23 Because OSHA’s analysis of the hydraulic fracturing industry for the proposed silica rule was not conducted until after the draft PEA had been completed, OSHA’s estimates of the compliance costs for this industry were not included in Inforum’s analysis of the rule’s employment and other macroeconomic impacts on the U.S. economy. It should be noted that, according to the Agency’s estimates, compliance costs for the hydraulic fracturing industry represent only about 4 percent of the total compliance costs for all affected industries. PO 00000 Frm 00111 Fmt 4701 Sfmt 4702 56383 average, over the period (Inforum, 2011).24 For a fuller discussion of the employment and other macroeconomic impacts of the silica rule, see Inforum (2011) and Chapter VI of the PEA for the proposed rule. G. Benefits and Net Benefits In this section, OSHA presents a summary of the estimated benefits, net benefits, and incremental benefits of the proposed silica rule. This section also contains a sensitivity analysis to show how robust the estimates of net benefits are to changes in various cost and benefit parameters. A full explanation of the derivation of the estimates presented here is provided in Chapter VII of the PEA for the proposed rule. OSHA invites comments on any aspect of its estimation of the benefits and net benefits of the proposed rule. 1. Estimation of the Number of SilicaRelated Diseases Avoided OSHA estimated the benefits associated with the proposed PEL of 50 mg/m3 and, for economic analysis purposes, with an alternative PEL of 100 mg/m3 for respirable crystalline silica by applying the dose-response relationship developed in the Agency’s quantitative risk assessment (QRA)—summarized in Section VI of this preamble—to exposures at or below the current PELs. OSHA determined exposures at or below the current PELs by first developing an exposure profile (presented in Chapter IV of the PEA) for industries with workers exposed to respirable crystalline silica, using OSHA inspection and site-visit data, and then applying this exposure profile to the total current worker population. The industry-by-industry exposure profile was previously presented in Section VIII.C of this preamble. By applying the dose-response relationship to estimates of exposures at or below the current PELs across industries, it is possible to project the number of cases of the following diseases expected to occur in the worker population given exposures at or below the current PELs (the ‘‘baseline’’): • Fatal cases of lung cancer, • fatal cases of non-malignant respiratory disease (including silicosis), • fatal cases of end-stage renal disease, and • cases of silicosis morbidity. In addition, it is possible to project the number of these cases that would be avoided under alternative, lower PELs. 24 A ‘‘job-year’’ is the term of art used to reflect the fact that an additional person is employed for a year, not that a new job has necessarily been permanently created. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56384 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules As a simplified example, suppose that the risk per worker of a given health endpoint is 2 in 1,000 at 100 mg/m3 and 1 in 1,000 at 50 mg/m3 and that there are 100,000 workers currently exposed at 100 mg/m3. In this example, the proposed PEL would lower exposures to 50 mg/m3, thereby cutting the risk in half and lowering the number of expected cases in the future from 200 to 100. The estimated benefits for the proposed silica rule represent the additional benefits derived from employers achieving full compliance with the proposed PEL relative to the current PELs. They do not include benefits associated with current compliance that has already been achieved with regard to the new requirements or benefits obtained from future compliance with existing silica requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements. The technological feasibility analysis, described earlier in this section of the preamble, demonstrated the effectiveness of controls in meeting or exceeding the proposed OSHA PEL. For purposes of estimating the benefit of reducing the PEL, OSHA has made some simplifying assumptions. On the one hand, given the lack of background information on respirator use related to existing exposure data, OSHA used existing personal exposure measurement information, unadjusted for potential respirator use.25 On the other hand, OSHA assumed that compliance with the existing and proposed rule would result in reductions in exposure levels to exactly the existing standard and proposed PEL, respectively. However, in many cases, indivisibilities in the application of respirators, as well as certain types of engineering controls, may cause employers to reduce exposures to some point below the existing standard or the proposed PEL. This is particularly true in the construction sector for employers who opt to follow Table 1, which specifies particular controls. In order to examine the effect of simply changing the PEL, OSHA compared the number of various kinds of cases that would occur if a worker were exposed for an entire working life to PELs of 50 mg/m3 or 100 mg/m3 to the number of cases that would occur at levels of exposure at or below the 25 Based on available data, the Agency estimated the weighted average for the relevant exposure groups to match up with the quantitative risk assessment. For the 50–100 mg/m3 exposure range, the Agency estimated an average exposure of 62.5 mg/m3. For the 100–250 mg/m3 range, the Agency estimated an average exposure of 125 mg/m3. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 current PELs. The number of avoided cases over a hypothetical working life of exposure for the current population at a lower PEL is then equal to the difference between the number of cases at levels of exposure at or below the current PEL for that population minus the number of cases at the lower PEL. This approach represents a steady-state comparison based on what would hypothetically happen to workers who received a specific average level of occupational exposure to silica during an entire working life. (In order to incorporate the element of timing to assess the economic value of the health benefits, OSHA presents a modified approach later in this section.) Based on OSHA’s application of the Steenland et al. (2001) log-linear and the Attfield and Costello (2004) models, Table VIII–17 shows the estimated number of avoided fatal lung cancers for PELs of 50 mg/m3 and 100 mg/m3. At the proposed PEL of 50 mg/m3, an estimated 2,404 to 12,173 lung cancers would be prevented over the lifetime of the current worker population, with a midpoint estimate of 7,289 fatal cancers prevented. This is the equivalent of between 53 and 271 cases avoided annually, with a midpoint estimate of 162 cases avoided annually, given a 45year working life of exposure. Following Park (2002), as discussed in summary of the Agency’s QRA in Section VI of this preamble, OSHA also estimates that the proposed PEL of 50 mg/m3 would prevent an estimated 16,878 fatalities over a lifetime from non-malignant respiratory diseases arising from silica exposure. This is equivalent to 375 fatal cases prevented annually. Some of these fatalities would be classified as silicosis, but most would be classified as other pneumoconioses and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. As also discussed in the summary of the Agency’s QRA in Section VI of this preamble, OSHA finds that workers with large exposures to silica are at elevated risk of end-stage renal disease (ESRD). Based on Steenland, Attfield, and Mannetje (2002), OSHA estimates that the proposed PEL of 50 mg/m3 would prevent 6,774 cases of end-stage renal disease over a working life of exposure, or about 151 cases annually. Combining the three major fatal health endpoints—for lung cancer, nonmalignant respiratory diseases, and endstage renal disease—OSHA estimates that the proposed PEL would prevent between 26,055 and 35,825 premature fatalities over a lifetime, with a midpoint estimate of 30,940 fatalities prevented. This is the equivalent of PO 00000 Frm 00112 Fmt 4701 Sfmt 4702 between 579 and 796 premature fatalities avoided annually, with a midpoint estimate of 688 premature fatalities avoided annually, given a 45year working life of exposure. In addition, the rule would prevent a large number of cases of silicosis morbidity. Based on Rosenman et al. (2003), the Agency estimates that between 2,700 and 5,475 new cases of silicosis, at an ILO X-ray rating of 1/0 or higher, occur annually at the present PELs as a result of silica exposure at establishments within OSHA’s jurisdiction. Based on the studies summarized in OSHA’s QRA, OSHA expects that the proposed rule will eliminate the large majority of these cases. The Agency has not included the elimination of the less severe silicosis cases in its estimates of the monetized benefits and net benefits of the proposed rule. Instead, OSHA separately estimated the number of silicosis cases reaching the more severe levels of 2/1 and above. Based on a study by Buchannan et al. (2003) of a cohort of coal miners (as discussed in the Agency’s QRA), OSHA estimates that the proposed PEL of 50 mg/m3 would prevent 71,307 cases of moderate-tosevere silicosis (registering 2/1 or more, using the ILO method for assessing severity) over a working life, or about 1,585 cases of moderate-to-severe silicosis prevented annually. Note that the Agency based its estimates of reductions in the number of silica-related diseases over a working life of constant exposure for workers who are employed in a respirable crystalline silica-exposed occupation for their entire working lives, from ages 20 to 65. While the Agency is legally obligated to examine the effect of exposures from a working lifetime of exposure,26 in an alternative analysis purely for informational purposes, the Agency examined, in Chapter VII of the PEA, the effect of assuming that workers are exposed for only 25 working years, as opposed to the 45 years assumed in the main analysis. While all workers are assumed to have less cumulative exposure under the 25-years-of26 Section (6)(b)(5) of the OSH Act states: ‘‘The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.’’ Given that it is necessary for OSHA to reach a determination of significant risk over a working life, it is a logical extension to estimate what this translates into in terms of estimated benefits for the affected population over the same period. E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 exposure assumption, the effective exposed population over time is proportionately increased. Estimated prevented cases of end-stage renal disease and silicosis morbidity are lower in the 25-year model, whereas cases of fatal non-malignant lung disease are higher. In the case of lung cancer, the effect varies by model, with a lower high-end estimate (Attfield & Costello, 2004) and a higher low-end estimate (Steenland et. al., 2001 loglinear model). Overall, however, the 45year-working-life assumption yields larger estimates of the number of cases of avoided fatalities and illnesses than does the 25-years-of-exposure assumption. For example, the midpoint estimates of the number of avoided fatalities and illnesses under the proposed PEL of 50 mg/m3 would decline from 688 and 1,585, respectively, under the 45-year-workinglife assumption to 683 and 642, respectively, under the 25-year-workinglife assumption. Note the effect, in this case, of going from a 45-year-workinglife assumption to a 25-year-working-life assumption would be a 1 percent reduction in the number of avoided fatalities and a 59 percent reduction in the number of avoided illnesses. The divergence reflects differences in the mathematical structure of the risk assessment models that are the basis for these estimates.27 OSHA believes that 25 years of worker exposure to respirable crystalline silica may be a reasonable alternative estimate for informational purposes. However, to accommodate the possibility that average worker exposure to silica over a working life may be shorter, at least in certain industries (see the following paragraph), the Agency also examined the effect of assuming only 13 years of exposure for the average worker. The results were broadly similar to the 25 years of exposure—annual fatalities prevented were higher (788), but illnesses prevented lower (399), with the lower average cumulative exposure being offset to a substantial degree by a larger exposed population. The same effect is seen if one assumes only 6.6 years of cumulative exposure to silica for the average worker: estimated fatalities rise to 832 cases annually, with 385 cases of 27 Technically, this analysis assumes that workers receive 25 years worth of silica exposure, but that they receive it over 45 working years, as is assumed by the risk models in the QRA. It also accounts for the turnover implied by 25, as opposed to 45, years of work. However, it is possible that an alternate analysis, which accounts for the larger number of post-exposure worker-years implied by workers departing their jobs before the end of their working lifetime, might find larger health effects for workers receiving 25 years worth of silica exposure. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 silicosis morbidity. In short, the aggregate estimated benefits of the rule appear to be relatively insensitive to implicit assumptions of average occupational tenure. Nonetheless, the Agency is confident that the typical affected worker sustains an extended period of exposure to silica. Even in the construction industry, which has an extremely high rate of job turnover, the mean job tenure with one’s current employer is 6.6 years (BLS, 2010a), and the median age of construction workers in the U.S. is 41.6 years (BLS, 2010b). OSHA is unaware of any data on job tenure within an industry, but the Agency would expect job tenure in the construction industry would be at least twice the job tenure with one’s current employer. Furthermore, many workers may return to the construction industry after unemployment or work in another industry. Of course, job tenure is longer in the other industries affected by the proposed rule. The proposed rule also contains specific provisions for diagnosing latent tuberculosis (TB) in the silica-exposed population and thereby reducing the risk of TB being spread to the population at large. The Agency currently lacks good methods for quantifying these benefits. Nor has the Agency attempted to assess benefits directly stemming from enhanced medical surveillance in terms of reducing the severity of symptoms from the illnesses that do result from present or future exposure to silica. However, the Agency welcomes comment on the likely magnitude of these currently nonquantified health benefits arising from the proposed rule and on methods for better measuring these effects. OSHA’s risk estimates are based on application of exposure-response models derived from several individual epidemiological studies as well as the pooled cohort studies of Steenland et al. (2001) and Mannetje et al. (2002). OSHA recognizes that there is uncertainty around any of the point estimates of risk derived from any single study. In its preliminary risk assessment (summarized in Section VI of this preamble), OSHA has made efforts to characterize some of the more important sources of uncertainty to the extent that available data permit. This specifically includes characterizing statistical uncertainty by reporting the confidence intervals around each of the risk estimates; by quantitatively evaluating the impact of uncertainties in underlying exposure data used in the cohort studies; and by exploring the use of alternative exposure-response model forms. OSHA believes that these efforts PO 00000 Frm 00113 Fmt 4701 Sfmt 4702 56385 reflect much, but not necessarily all, of the uncertainties associated with the approaches taken by investigators in their respective risk analyses. However, OSHA believes that characterizing the risks and benefits as a range of estimates derived from the full set of available studies, rather than relying on any single study as the basis for its estimates, better reflects the uncertainties in the estimates and more fairly captures the range of risks likely to exist across a wide range of industries and exposure situations. Another source of uncertainty involves the degree to which OSHA’s risk estimates reflect the risk of disease among workers with widely varying exposure patterns. Some workers are exposed to fairly high concentrations of crystalline silica only intermittently, while others experience more regular and constant exposure. Risk models employed in the quantitative assessment are based on a cumulative exposure metric, which is the product of average daily silica concentration and duration of worker exposure for a specific job. Consequently, these models predict the same risk for a given cumulative exposure regardless of the pattern of exposure, reflecting a worker’s longterm average exposure without regard to intermittencies or other variances in exposure, and are therefore generally applicable to all workers who are exposed to silica in the various industries. Section VI of this preamble provides evidence supporting the use of cumulative exposure as the preferred dose metric. Although the Agency believes that the results of its risk assessment are broadly relevant to all occupational exposure situations involving crystalline silica, OSHA acknowledges that differences exist in the relative toxicity of crystalline silica particles present in different work settings due to factors such as the presence of mineral or metal impurities on quartz particle surfaces, whether the particles have been freshly fractured or are aged, and size distribution of particles. However, in its preliminary risk assessment, OSHA preliminarily concludes that the estimates from the studies and analyses relied upon are fairly representative of a wide range of workplaces reflecting differences in silica polymorphism, surface properties, and impurities. Thus, OSHA has a high degree of confidence in the risk estimates associated with exposure to the current and proposed PELs. OSHA acknowledges there is greater uncertainty in the risk estimates for the proposed action level of 0.025 mg/m3 than exists at the current (0.1 mg/m3) E:\FR\FM\12SEP2.SGM 12SEP2 56386 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 and proposed (0.05 mg/m3) PELs, particularly given some evidence of a threshold for silicosis between the proposed PEL and action level. Given the Agency’s findings that controlling exposures below the proposed PEL VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 would not be technologically feasible for employers, OSHA believes that a precise estimate of the risk for exposures below the proposed action level is not necessary to further inform the Agency’s regulatory action. OSHA PO 00000 Frm 00114 Fmt 4701 Sfmt 4702 requests comment on remaining sources of uncertainties in its risk and benefits estimates that have not been specifically characterized by OSHA in its analysis. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VerDate Mar<15>2010 Jkt 229001 Estimated Number of Avoided Fatal & Nonfatal Illnesses Resulting from a Reduction in Crystalline Silica Exposure of At-Risk Workers over a 45-Year Working Life Due to Proposed PEL of 50 3 PO 00000 IJg/m and Alternative PEL of 100 IJg/m 3 Total Number of Avoided Cases Frm 00115 50 Fmt 4701 Sfmt 4725 E:\FR\FM\12SEP2.SGM Construction 2,636 1,437 238 6,563 3,719 875 6,277 3,573 869 13,944 2,934 8,490 6,774 5,722 1,052 35,825 30,940 26,055 29,203 25,517 21,831 71,307 48,617 Construction 12,173 7,289 2,404 9,537 5,852 2,166 Silicosis & Other Non-Malignant Respiratory Diseases 16,878 End Stage Renal Disease Total Number of Fatal Illnesses Prevented High Midpoint Low Total Number of Silicosis Morbidity Cases Prevented' GI& Total Total Lung Cancers High Midpoint Low 100 50 GI& Annual Number of Avoided Cases 100 Total Construction 286 146 6 271 162 53 212 130 48 8,403 87 375 2,684 2,655 29 6,622 5,423 4,224 17,737 14,893 12,049 17,335 14,631 11,927 22,689 42,881 41,375 Maritime GI& GI& Total Construction 59 32 5 146 83 19 139 79 19 6 3 0 310 65 189 187 2 151 127 23 60 59 1 402 262 122 796 688 579 649 567 485 147 121 94 394 331 268 385 325 265 9 6 3 1,506 1,585 1,080 504 953 919 33 Maritime *Assessed at 2/1 or higher X-ray, following ILO criteria 12SEP2 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis. Office of Regulatory Analysis Maritime Maritime Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Table VIII-17 56387 EP12SE13.008</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56388 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 2. Estimating the Stream of Benefits Over Time Risk assessments in the occupational environment are generally designed to estimate the risk of an occupationally related illness over the course of an individual worker’s lifetime. As previously discussed, the current occupational exposure profile for a particular substance for the current cohort of workers can be matched up against the expected profile after the proposed standard takes effect, creating a ‘‘steady state’’ estimate of benefits. However, in order to annualize the benefits for the period of time after the silica rule takes effect, it is necessary to create a timeline of benefits for an entire active workforce over that period. In order to characterize the magnitude of benefits before the steady state is reached, OSHA created a linear phasein model to reflect the potential timing of benefits. Specifically, OSHA estimated that, for all non-cancer cases, while the number of cases would gradually decline as a result of the proposed rule, they would not reach the steady-state level until 45 years had passed. The reduction in cases estimated to occur in any given year in the future was estimated to be equal to the steady-state reduction (the number of cases in the baseline minus the number of cases in the new steady state) times the ratio of the number of years since the standard was implemented and a working life of 45 years. Expressed mathematically: Nt=(C—S) × (t/45), where Nt is the number of nonmalignant silica-related diseases avoided in year t; C is the current annual number of non-malignant silicarelated diseases; S is the steady-state annual number of non-malignant silicarelated diseases; and t represents the number of years after the proposed standard takes effect, with t≤45. In the case of lung cancer, the function representing the decline in the number of cases as a result of the proposed rule is similar, but there would be a 15-year lag before any reduction in cancer cases would be achieved. Expressed mathematically, for lung cancer: Lt=(Cm—Sm) x ((t-15)/45)), where 15 ≤ t ≤ 60 and Lt is the number of lung cancer cases avoided in year t as a result of the proposed rule; Cm is the current annual number of silicarelated lung cancers; and Sm is the steady-state annual number of silicarelated lung cancers. A more complete discussion of the functioning and results of this model is presented in Chapter VII of the PEA. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 This model was extended to 60 years for all the health effects previously discussed in order to incorporate the 15year lag, in the case of lung cancer, and a 45-year working life. As a practical matter, however, there is no overriding reason for stopping the benefits analysis at 60 years. An internal analysis by OSHA indicated that, both in terms of cases prevented, and even with regard to monetized benefits, particularly when lower discount rates are used, the estimated benefits of the standard are noticeably larger on an annualized basis if the analysis extends further into the future. The Agency welcomes comment on the merit of extending the benefits analysis beyond the 60 years analyzed in the PEA. In order to compare costs to benefits, OSHA assumes that economic conditions remain constant and that annualized costs—and the underlying costs—will repeat for the entire 60-year time horizon used for the benefits analysis (as discussed in Chapter V of the PEA). OSHA welcomes comments on the assumption for both the benefit and cost analysis that economic conditions remain constant for sixty years. OSHA is particularly interested in what assumptions and time horizon should be used instead and why. 3. Monetizing the Benefits To estimate the monetary value of the reductions in the number of silicarelated fatalities, OSHA relied, as OMB recommends, on estimates developed from the willingness of affected individuals to pay to avoid a marginal increase in the risk of fatality. While a willingness-to-pay (WTP) approach clearly has theoretical merit, it should be noted that an individual’s willingness to pay to reduce the risk of fatality would tend to underestimate the total willingness to pay, which would include the willingness of others— particularly the immediate family—to pay to reduce that individual’s risk of fatality.28 For estimates using the willingnessto-pay concept, OSHA relied on existing studies of the imputed value of fatalities avoided based on the theory of compensating wage differentials in the labor market. These studies rely on certain critical assumptions for their accuracy, particularly that workers 28 See, for example, Thaler and Rosen (1976), pp. 265–266. In addition, see Sunstein (2004), p. 433. ‘‘This point demonstrates a general and badly neglected problem for WTP as it is currently used: agencies consider people’s WTP to eliminate statistical risks, without taking account of the fact that others—especially family members and close friends—would also be willing to pay something to eliminate those risks.’’ PO 00000 Frm 00116 Fmt 4701 Sfmt 4702 understand the risks to which they are exposed and that workers have legitimate choices between high- and low-risk jobs. These assumptions are far from obviously met in actual labor markets.29 A number of academic studies, as summarized in Viscusi & Aldy (2003), have shown a correlation between higher job risk and higher wages, suggesting that employees demand monetary compensation in return for a greater risk of injury or fatality. The estimated trade-off between lower wages and marginal reductions in fatal occupational risk—that is, workers’ willingness to pay for marginal reductions in such risk—yields an imputed value of an avoided fatality: the willingness-to-pay amount for a reduction in risk divided by the reduction in risk.30 OSHA has used this approach in many recent proposed and final rules. Although this approach has been found to yield results that are less than statistically robust (see, for example, Hintermann, Alberini and Markandya, 2010), OSHA views these estimates as the best available, and will use them for its basic estimates. OSHA welcomes comments on the use of willingness-to-pay measures and estimates based on compensating wage differentials. Viscusi & Aldy (2003) conducted a meta-analysis of studies in the economics literature that use a willingness-to-pay methodology to estimate the imputed value of lifesaving programs and found that each fatality avoided was valued at approximately $7 million in 2000 dollars. This $7 million base number in 2000 dollars yields an estimate of $8.7 million in 2009 dollars for each fatality avoided.31 In addition to the benefits that are based on the implicit value of fatalities avoided, workers also place an implicit value on occupational injuries or illnesses avoided, which reflect their 29 On the former assumption, see the discussion in Chapter II of the PEA on imperfect information. On the latter, see, for example, the discussion of wage compensation for risk for union versus nonunion workers in Dorman and Hagstrom (1998). 30 For example, if workers are willing to pay $50 each for a 1/100,000 reduction in the probability of dying on the job, then the imputed value of an avoided fatality would be $50 divided by 1/100,000, or $5,000,000. Another way to consider this result would be to assume that 100,000 workers made this trade-off. On average, one life would be saved at a cost of $5,000,000. 31 An alternative approach to valuing an avoided fatality is to monetize, for each year that a life is extended, an estimate from the economics literature of the value of that statistical life-year (VSLY). See, for instance, Aldy and Viscusi (2007) for discussion of VSLY theory and FDA (2003), pp. 41488–9, for an application of VSLY in rulemaking. OSHA has not investigated this approach, but welcomes comment on the issue. E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 willingness to pay to avoid monetary costs (for medical expenses and lost wages) and quality-of-life losses as a result of occupational illness. Silicosis, lung cancer, and renal disease can adversely affect individuals for years or even decades in non-fatal cases, or before ultimately proving fatal. Because measures of the benefits of avoiding these illnesses are rare and difficult to find, OSHA has included a range based on a variety of estimation methods. Consistent with Buchannan et al. (2003), OSHA estimated the total number of moderate to severe silicosis cases prevented by the proposed rule, as measured by 2/1 or more severe X-rays (based on the ILO rating system). However, while radiological evidence of moderate to severe silicosis is evidence of significant material impairment of health, placing a precise monetary value on this condition is difficult, in part because the severity of symptoms may vary significantly among individuals. For that reason, for this preliminary analysis, the Agency employed a broad range of valuation, which should encompass the range of severity these individuals may encounter. Using the willingness-to-pay approach, discussed in the context of the imputed value of fatalities avoided, OSHA has estimated a range in valuations (updated and reported in 2009 dollars) that runs from approximately $62,000 per case—which reflects estimates developed by Viscusi and Aldy (2003), based on a series of studies primarily describing simple accidents—to upwards of $5.1 million per case—which reflects work developed by Magat, Viscusi & Huber (1996) for non-fatal cancer. The latter number is based on an approach that places a willingness-to-pay value to avoid serious illness that is calibrated relative to the value of an avoided fatality. OSHA (2006) previously used this approach in the Final Economic Analysis (FEA) supporting its VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 hexavalent chromium final rule, and EPA (2003) used this approach in its Stage 2 Disinfection and Disinfection Byproducts Rule concerning regulation of primary drinking water. Based on Magat, Viscusi & Huber (1996), EPA used studies on the willingness-to-pay to avoid nonfatal lymphoma and chronic bronchitis as a basis for valuing a case of nonfatal cancer at 58.3 percent of the value of a fatal cancer. OSHA’s estimate of $5.1 million for an avoided case of non-fatal cancer is based on this 58.3 percent figure. The Agency believes this range of estimates is descriptive of the value of preventing morbidity associated with moderate to severe silicosis, as well as the morbidity preceding mortality due to other causes enumerated here—lung cancer, lung diseases other than cancer, and renal disease.32 OSHA therefore is applying these values to those situations as well. The Agency is interested in public input on the issue of valuing the cost to society of non-fatal cases of moderate to severe silicosis, as well as the morbidity associated with other related diseases of the lung, and with renal disease. a. The Monetized Benefits of the Proposed Rule Table VIII–18 presents the estimated annualized (over 60 years, using a 0 percent discount rate) benefits from each of these components of the valuation, and the range of estimates, based on risk model uncertainty (notably in the case of lung cancer), and the range of uncertainty regarding valuation of morbidity. (Mid-point estimates of the undiscounted benefits for each of the first 60 years are 32 There are several benchmarks for valuation of health impairment due to silica exposure, using a variety of techniques, which provide a number of mid-range estimates between OSHA’s high and low estimates. For a fuller discussion of these estimates, see Chapter VII of the PEA. PO 00000 Frm 00117 Fmt 4701 Sfmt 4702 56389 provided in the middle columns of Table VII–A–1 in Appendix VII–A in the PEA. The estimates by year reach a peak of $11.9 billion in the 60th year.) As shown, the full range of monetized benefits, undiscounted, for the proposed PEL of 50 mg/m3 runs from $3.2 billion annually, in the case of the lowest estimate of lung cancer risk and the lowest valuation for morbidity, up to $10.9 billion annually, for the highest of both. Note that the value of total benefits is more sensitive to the valuation of morbidity (ranging from $3.5 billion to $10.3 billion, given estimates at the midpoint of the lung cancer models) than to the lung cancer model used (ranging from $6.4 to $7.4 billion, given estimates at the midpoint of the morbidity valuation).33 This comports with the very wide range of valuation for morbidity. At the low end of the valuation range, the total value of benefits is dominated by mortality ($3.4 billion out of $3.5 billion at the case frequency midpoint), whereas at the high end the majority of the benefits are related to morbidity ($6.9 billion out of $10.3 billion at the case frequency midpoint). Also, the analysis illustrates that most of the morbidity benefits are related to silicosis cases that are not ultimately fatal. At the valuation and case frequency midpoint, $3.4 billion in benefits are related to mortality, $1.0 billion are related to morbidity preceding mortality, and $2.4 billion are related to morbidity not preceding mortality. 33 As previously indicated, these valuations include all the various estimated health endpoints. In the case of mortality this includes lung cancer, non-malignant respiratory disease and end-stage renal disease. The Agency highlighted lung cancers in this discussion due to the model uncertainty. In calculating the monetized benefits, the Agency is typically referring to the midpoint of the high and low ends of potential valuation—in this case, the undiscounted midpoint of $3.2 billion and $10.9 billion.. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56390 Estimated Annualized Undiscounted Monetized Benefits of the Silica Proposal for Morbidity and Mortality Low 3 Frm 00118 Fmt 4701 Sfmt 4702 12SEP2 imputed value of avoided fatalities and avoided diseases will tend to increase over time. Two related factors suggest such an increase in value over time. First, economic theory suggests that the value of reducing life-threatening E:\FR\FM\12SEP2.SGM disease. To this point, these imputed values have been assumed to remain constant over time. OSHA now would like to suggest that an adjustment be made to monetized benefits to reflect the fact that the PO 00000 Hi h Low 100 j.Jg/m Valuation Midpoint $3,074,165,270 $3,436,186,835 $3,798,208,401 $3,074,165,270 $3,436,186,835 $3,798,208,401 $1,433,022,347 $1,643,786,936 $1,643,786,936 $1,433,022,347 $1,643,786,936 $1,643,786,936 $1,433,022,347 $1,643,786,936 $1,643,786,936 $912,002,363 $1,019,402,094 $1,126,801,826 $1,802,096,882 $2,014,316,421 $2,226,535,959 $10,212,343 $11,714,344 $11,714,344 $425,129,963 $487,656,791 $487,656,791 $840,047,583 $963,599,238 $963,599,238 $2,449,641,696 $4,840,438,842 $35,733,901 $1,487,567,728 $2,939,401,554 $6,435,809,329 $9,716,700,994 $6,905,230,626 $10,290,942,098 $7,374,651,923 $10,865,183,202 $1,478,968,592 $1,691,235,181 $1,691,235,181 $3,345,720,038 $3,619,011,454 $3,619,011,454 $5,212,471,484 $5,546,787,728 $5,546,787,728 50 j.Jg/m Valuation Mid oint Hiah Cases Fatalities - Total Low Midpoint High $3,074,165,270 $3,436,186,835 $3,798,208,401 Morbidity Preceding Mortality Low Midpoint High $21,907,844 $24,487,768 $27,067,692 Morbidity Not Preceding Mortality Total EP12SE13.009</GPH> 3 PEL TOTAL Low Midpoint High $58,844,551 $3,154,917,665 $3,519,519,154 $3,884,120,643 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Jkt 229001 b. A Suggested Adjustment to Monetized Benefits 19:12 Sep 11, 2013 OSHA’s estimates of the monetized benefits of the proposed rule are based on the imputed value of each avoided fatality and each avoided silica-related VerDate Mar<15>2010 TABLE VIII-18 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 and health-threatening risks will increase as real per capita income increases. With increased income, an individual’s health and life become more valuable relative to other goods because, unlike other goods, they are without close substitutes and in relatively fixed or limited supply. Expressed differently, as income increases, consumption will increase but the marginal utility of consumption will decrease. In contrast, added years of life (in good health) is not subject to the same type of diminishing returns— implying that an effective way to increase lifetime utility is by extending one’s life and maintaining one’s good health (Hall and Jones, 2007). Second, real per capita income has broadly been increasing throughout U.S. history, including recent periods. For example, for the period 1950 through 2000, real per capita income grew at an average rate of 2.31 percent a year (Hall and Jones, 2007) 34 although real per capita income for the recent 25 year period 1983 through 2008 grew at an average rate of only 1.3 percent a year (U.S. Census Bureau, 2010). More important is the fact that real U.S. per capita income is projected to grow significantly in future years. For example, the Annual Energy Outlook (AEO) projections, prepared by the Energy Information Administration (EIA) in the Department of Energy (DOE), show an average annual growth rate of per capita income in the United States of 2.7 percent for the period 2011–2035.35 The U.S. Environmental Protection Agency prepared its economic analysis of the Clean Air Act using the AEO projections. Although these estimates may turn out to be somewhat higher or lower than predicted, OSHA believes that it is reasonable to use the same AEO projections employed by DOE and EPA, and correspondingly projects that per capita income in the United States will increase by 2.7 percent a year. On the basis of the predicted increase in real per capita income in the United States over time and the expected resulting increase in the value of avoided fatalities and diseases, OSHA is considering adjusting its estimates of 34 The results are similar if the historical period includes a major economic downturn (such as the United States has recently experienced). From 1929 through 2003, a period in U.S. history that includes the Great Depression, real per capita income still grew at an average rate of 2.22 percent a year (Gomme and Rupert, 2004). 35 The EIA used DOE’s National Energy Modeling System (NEMS) to produce the Annual Energy Outlook (AEO) projections (EIA, 2011). Future per capita GDP was calculated by dividing the projected real gross domestic product each year by the projected U.S. population for that year. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 the benefits of the proposed rule to reflect the anticipated increase in their value over time. This type of adjustment has been recognized by OMB (2003), supported by EPA’s Science Advisory Board (EPA, 2000), and applied by EPA.36 OSHA proposes to accomplish this adjustment by modifying benefits in year i from [Bi] to [Bi * (1 + h)i], where ‘‘h’’ is the estimated annual increase in the magnitude of the benefits of the proposed rule. What remains is to estimate a value for ‘‘h’’ with which to increase benefits annually in response to annual increases in real per capita income. Probably the most direct evidence of the value of ‘‘h’’ comes from the work of Costa and Kahn (2003, 2004). They estimate repeated labor market compensating wage differentials from cross-sectional hedonic regressions using census and fatality data from the Bureau of Labor Statistics for 1940, 1950, 1960, 1970, and 1980. In addition, with the imputed income elasticity of the value of life on per capita GNP of 1.7 derived from the 1940–1980 data, they then predict the value of an avoided fatality in 1900, 1920, and 2000. Given the change in the value of an avoided fatality over time, it is possible to estimate a value of ‘‘h’’ of 3.4 percent a year from 1900–2000; of 4.3 percent a year from 1940–1980; and of 2.5 percent a year from 1980–2000. Other, more indirect evidence comes from estimates in the economics literature on the income elasticity for the value of a statistical life. Viscusi and Aldy (2003) performed a meta-analysis on 50 wage-risk studies and concluded that the point estimates across a variety of model specifications ranged between 0.5 and 0.6. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of ‘‘h’’ of about 1.5 percent a year. More recently, Kniesner, Viscusi, and Ziliak (2010), using panel data quintile regressions, developed an estimate of the overall income elasticity of the value of a statistical life of 1.44. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of ‘‘h’’ of about 3.9 percent a year. Based on the preceding discussion of these two approaches for estimating the annual increase in the value of the benefits of the proposed rule and the fact that, as previously noted, the projected increase in real per capita income in the United States has flattened in the most recent 25 year period, OSHA suggests a value of ‘‘h’’ of approximately 2 percent a year. The 36 See, PO 00000 for example, EPA (2003, 2008). Frm 00119 Fmt 4701 Sfmt 4702 56391 Agency invites comment on this estimate and on estimates of the income elasticity of the value of a statistical life. While the Agency believes that the rising value, over time, of health benefits is a real phenomenon that should be taken into account in estimating the annualized benefits of the proposed rule, OSHA is at this time only offering these adjusted monetized benefits as analytic alternatives for consideration. Table VIII–19, which follows the discussion on discounting monetized benefits, shows estimates of the monetized benefits of the proposed rule (under alternative discount rates) both with and without this suggested increase in monetized benefits over time. The Agency invites comment on this suggested adjustment to monetized benefits. 4. Discounting of Monetized Benefits As previously noted, the estimated stream of benefits arising from the proposed silica rule is not constant from year to year, both because of the 45-year delay after the rule takes effect until all active workers obtain reduced silica exposure over their entire working lives and because of, in the case of lung cancer, a 15-year latency period between reduced exposure and a reduction in the probability of disease. An appropriate discount rate 37 is needed to reflect the timing of benefits over the 60-year period after the rule takes effect and to allow conversion to an equivalent steady stream of annualized benefits. a. Alternative Discount Rates for Annualizing Benefits Following OMB (2003) guidelines, OSHA has estimated the annualized benefits of the proposed rule using separate discount rates of 3 percent and 7 percent. Consistent with the Agency’s own practices in recent proposed and final rules, OSHA has also estimated, for benchmarking purposes, undiscounted benefits—that is, benefits using a zero percent discount rate. The question remains, what is the ‘‘appropriate’’ or ‘‘preferred’’ discount rate to use to monetize health benefits? The choice of discount rate is a controversial topic, one that has been the source of scholarly economic debate for several decades. However, in simplest terms, the basic choices involve a social opportunity cost of capital approach or social rate of time preference approach. 37 Here and elsewhere throughout this section, unless otherwise noted, the term ‘‘discount rate’’ always refers to the real discount rate—that is, the discount rate net of any inflationary effects. E:\FR\FM\12SEP2.SGM 12SEP2 56392 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 The social opportunity cost of capital approach reflects the fact that private funds spent to comply with government regulations have an opportunity cost in terms of foregone private investments that could otherwise have been made. The relevant discount rate in this case is the pre-tax rate of return on the foregone investments (Lind, 1982b, pp. 24–32). The rate of time preference approach is intended to measure the tradeoff between current consumption and future consumption, or in the context of the proposed rule, between current benefits and future benefits. The individual rate of time preference is influenced by uncertainty about the availability of the benefits at a future date and whether the individual will be alive to enjoy the delayed benefits. By comparison, the social rate of time preference takes a broader view over a longer time horizon—ignoring individual mortality and the riskiness of individual investments (which can be accounted for separately) . The usual method for estimating the social rate of time preference is to calculate the post-tax real rate of return on long-term, risk-free assets, such as U.S. Treasury securities (OMB, 2003). A variety of studies have estimated these VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 rates of return over time and reported them to be in the range of approximately 1–4 percent. In accordance with OMB Circular A– 4 (2003), OSHA presents benefits and net benefits estimates using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach). The Agency is interested in any evidence, theoretical or applied, that would inform the application of discount rates to the costs and benefits of a regulation. b. Summary of Annualized Benefits Under Alternative Discount Rates Table VIII–19 presents OSHA’s estimates of the sum of the annualized benefits of the proposed rule, using alternative discount rates at 0, 3, and 7 percent, with a breakout between construction and general industry, and including the possible alternative of increasing monetized benefits in response to annual increases in per capita income over time. Given that the stream of benefits extends out 60 years, the value of future benefits is sensitive to the choice of discount rate. As previously established in Table VIII–18, the undiscounted benefits range from $3.2 billion to $10.9 PO 00000 Frm 00120 Fmt 4701 Sfmt 4702 billion annually. Using a 7 percent discount rate, the annualized benefits range from $1.6 billion to $5.4 billion. As can be seen, going from undiscounted benefits to a 7 percent discount rate has the effect of cutting the annualized benefits of the proposed rule approximately in half. The Agency’s best estimate of the total annualized benefits of the proposed rule—using a 3 percent discount rate with no adjustment for the increasing value of health benefits over time— is between $2.4 and $8.1 billion, with a mid-point value of $5.3 billion. As previously mentioned, OSHA has not attempted to estimate the monetary value of less severe silicosis cases, measured at 1/0 to 1/2 on the ILO scale. The Agency believes the economic loss to individuals with less severe cases of silicosis could be substantial, insofar as they may be accompanied by a lifetime of medical surveillance and lung damage, and potentially may require a change in career. However, many of these effects can be difficult to isolate and measure in economic terms, particularly in those cases where there is no obvious effect yet on physiological function or performance. The Agency invites public comment on this issue. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VerDate Mar<15>2010 Total Annual Monetized Benefits Resulting from a Reduction in Exposure to Crystalline Silica Jkt 229001 Due to Proposed PEL of 50 Ilg/m3 and Alternative PEL of 100 Ilg/m3 ($Billions) PO 00000 Frm 00121 Fmt 4701 Sfmt 4725 E:\FR\FM\12SEP2.SGM 12SEP2 Discount Rate Range Total Construction UndiscOlmted (0%) Low Midpoint High Low Midpoint High Low Midpoint High Low Midpoint High Low Midpoint High $3.2 $7.0 $lO.9 $2.9 $6.4 $9.9 $2.4 $5.3 $8.1 $2.0 $4.3 $6.6 $1.6 $3.5 $5.4 $2.6 $5.4 $8.2 $2.4 $5.0 $7.5 $2.0 $4.1 $6.1 $1.6 $3.3 $5.0 $1.3 $2.7 $4.1 Discounted at 3%, with a suggested increased in monetized benefits over time Discounted at 3% Discounted at 7%, with a suggested increased in monetized benefits over time Discounted at 7% 100 50 PEL GI& Maritime $0.5 $1.6 $2.7 $0.5 $1.5 $2.4 $0.4 $1.2 $2.0 $0.3 $1.0 $1.6 $0.3 $0.8 $1.3 Total Construction G I & Maritime $1.5 $3.7 $5.9 $1.4 $3.4 $5.4 $1.1 $2.8 $4.4 $0.9 $2.2 $3.6 $0.8 $1.8 $2.9 $1.5 $3.6 $5.7 $1.3 $3.3 $5.2 $1.1 $2.7 $4.3 $0.9 $2.2 $3.5 $0.8 $1.8 $2.8 $0.0 $0.1 $0.2 $0.0 $0.1 $0.1 $0.0 $0.1 $0.1 $0.0 $0.1 $0.1 $0.0 $0.0 $0.1 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Table VIII-19 56393 EP12SE13.010</GPH> 56394 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 5. Net Benefits of the Proposed Rule OSHA has estimated, in Table VIII– 20, the net benefits of the proposed rule (with a PEL of 50 mg/m3), based on the benefits and costs previously presented. Table VIII–20 also provides estimates of annualized net benefits for an alternative PEL of 100 mg/m3. Both the proposed rule and the alternative rule have the same ancillary provisions and an action level equal to half of the PEL in both cases. Table VIII–20 is being provided for informational purposes only. As previously noted, the OSH Act requires the Agency to set standards based on eliminating significant risk to the extent feasible. An alternative criterion of maximizing net (monetized) benefits may result in very different regulatory outcomes. Thus, this analysis of net benefits has not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for this proposed silica rule. Table VIII–20 shows net benefits using alternative discount rates of 0, 3, and 7 percent for benefits and costs and includes a possible adjustment to monetized benefits to reflect increases in real per capita income over time. (An expanded version of Tables VIII–20, with a breakout of net benefits between construction and general industry/ maritime, is provided in Table VII–B–1 in Appendix B, of the PEA.) OSHA has relied on a uniform discount rate applied to both costs and benefits. The Agency is interested in any evidence, theoretical or applied, that would support or refute the application of differential discount rates to the costs and benefits of a regulation. As previously noted, the choice of discount rate for annualizing benefits has a significant effect on annualized benefits. The same is true for net benefits. For example, the net benefits using a 7 percent discount rate for benefits are considerably smaller than the net benefits using a 0 percent discount rate, declining by more than half under all scenarios. (Conversely, as noted in Chapter V of the PEA, the choice of discount rate for annualizing costs has only a very minor effect on annualized costs.) Based on the results presented in Table VIII–20, OSHA finds: • While the net benefits of the proposed rule vary considerably— depending on the choice of discount rate used to annualize benefits and on whether the benefits being used are in the high, midpoint, or low range— benefits exceed costs for the proposed 50 mg/m3 PEL in all cases that OSHA considered. • The Agency’s best estimate of the net annualized benefits of the proposed rule—using a uniform discount rate for both benefits and costs of 3 percent—is between $1.8 billion and $7.5 billion, with a midpoint value of $4.6 billion. • The alternative of a 100 mg/m3 PEL was found to have lower net benefits under all assumptions, relative to the proposed 50 mg/m3 PEL. However, for this alternative PEL, benefits were found to exceed costs in all cases that OSHA considered. 6. Incremental Benefits of the Proposed Rule Incremental costs and benefits are those that are associated with increasing the stringency of the standard. A comparison of incremental benefits and costs provides an indication of the relative efficiency of the proposed PEL and the alternative PEL. Again, OSHA has conducted these calculations for informational purposes only and has not used this information as the basis for selecting the PEL for the proposed rule. OSHA provided, in Table VIII–20, estimates of the net benefits of an alternative 100 mg/m3 PEL. The incremental costs, benefits, and net benefits of going from a 100 mg/m3 PEL to a 50 mg/m3 PEL (as well as meeting a 50 mg/m3 PEL and then going to a 25 mg/m3 PEL—which the Agency has determined is not feasible), for alternative discount rates of 3 and 7 percent, are presented in Tables VIII–21 and VIII–22. Table VIII–21 breaks out costs by provision and benefits by type of disease and by morbidity/mortality, while Table VIII–22 breaks out costs and benefits by major industry sector. As Table VIII–21 shows, at a discount rate of 3 percent, a PEL of 50 mg/m3, relative to a PEL of 100 mg/m3, imposes additional costs of $339 million per year; additional benefits of $2.5 billion per year, and additional net benefits of $2.16 billion per year. The proposed PEL of 50 mg/m3 also has higher net benefits using either a 3 percent or 7 percent discount rate. Table VIII–22 continues this incremental analysis but with breakdowns between construction and general industry/maritime. This table shows that construction provides most of the incremental costs, but the incremental benefits are more evenly divided between the two sectors. Nevertheless, both sectors show strong positive net benefits, which are greater for the proposed PEL of 50 mg/m3 than the alternative of 100 mg/m3. Tables VIII–21 and VIII–22 demonstrate that, across all discount rates, there are net benefits to be achieved by lowering exposures to 100 mg/m3 and then, in turn, lowering them further to 50 mg/m3. However, the majority of the benefits and costs attributable to the proposed rule are from the initial effort to lower exposures to 100 mg/m3. Consistent with the previous analysis, net benefits decline across all increments as the discount rate for annualizing benefits increases. In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard. These alternatives are discussed in Section VIII.H of this preamble. TABLE VIII–20—ANNUAL MONETIZED NET BENEFITS RESULTING FROM A REDUCTION IN EXPOSURE TO CRYSTALLINE SILICA DUE TO PROPOSED PEL OF 50 μg/m3 AND ALTERNATIVE PEL OF 100 μg/m3 [$Billions] PEL 50 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Discount rate Undiscounted (0%) ................................................... Low ........................................................................... Midpoint .................................................................... High .......................................................................... Low ........................................................................... Midpoint .................................................................... High .......................................................................... Low ........................................................................... Midpoint .................................................................... High .......................................................................... 100 Range Discounted at 3%, with a suggested increased in monetized benefits over time. 3% ............................................................................. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00122 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM $2.5 6.4 10.2 2.3 5.8 9.3 1.8 4.6 7.5 12SEP2 $1.2 3.4 5.6 1.1 3.1 5.1 0.8 2.5 4.1 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56395 TABLE VIII–20—ANNUAL MONETIZED NET BENEFITS RESULTING FROM A REDUCTION IN EXPOSURE TO CRYSTALLINE SILICA DUE TO PROPOSED PEL OF 50 μg/m3 AND ALTERNATIVE PEL OF 100 μg/m3—Continued [$Billions] PEL 50 Discount rate Discounted at 7%, with a suggested increased in monetized benefits over time. Low ........................................................................... Midpoint .................................................................... High .......................................................................... Low ........................................................................... Midpoint .................................................................... High .......................................................................... 100 Range 7% ............................................................................. 1.3 3.6 5.9 1.0 2.8 4.7 0.6 1.9 3.3 0.5 1.5 2.6 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Standards and Guidance, Office of Regulatory Analysis. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00123 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56396 VerDate Mar<15>2010 Jkt 229001 25l!g/m3 PO 00000 Frm 00124 Fmt 4701 Sfmt 4725 E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.011</GPH> ~ Discount Rate Annualized Costs Engineering Controls (includes Abrasive Blasting) Respirators Exposure Assessment Medical Surveillance Training Regulated Area or Access Control ~ ~ ~ ~ $344 $422 $203 $227 $50 $86 $0 $330 $131 $143 $0 $66 $0 $331 $129 $148 $0 $66 $330 $91 $73 $76 $49 $19 ~ ~ $1,308 $1,332 $670 $674 $637 $658 $339 Cases Cases 100 ~gfm' Incremental Costs/Benefits ~ 3% $330 $421 $203 $219 $49 $85 Total Annualized Costs (point estimate) Annual Benefits: Number of Cases Prevented Fatal Lung Cancers (midpoint estimate) Fatal Silicosis & other Non-Malignant Respiratory Diseases Fatal Renal Disease 5Ol!g/m3 Incremental Costs/Benefits $344 $91 $74 $79 $50 Cases $187 $88 $26 $28 $0 ~ ~ 3% $197 $88 $26 $29 $0 $143 $2 $47 $48 $147 $3 $48 $50 $50 $49 $9 $351 ~ $299 ~ $307 Cases Cases """237 75 """"162 ~ 83 527 152 375 186 189 258 ~ 108 Silica-Related Mortality 1,023 $4,811 $3,160 335 $1,543 $1,028 Silicosis Morbidity 1,770 $2,219 $1,523 186 $233 $160 91 60 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 Monetized Annual Benefds (midpoint estimate) $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 Net Benefits $5722 $3352 $1105 $514 $4617 $2838 $2157 $1308 $2460 $1529 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis * Benefits are assessed over a 50-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming that economic conditions remain constant for the sixty year time horizon, Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Table VIII·21: Annualized Costs, Benefits and Incremental Benefds of OSHA's Proposed Silica Standard of 50 ~gfm3 and 100 ~gfm3 AUernative Millions ($2009) mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VerDate Mar<15>2010 25!,!s/m 3 ~ ~ Discount Rate Jkt 229001 PO 00000 Annualized Costs Construction General Industry/Maritime $1,043 $264 Total Annualized Costs $1,308 ~ ~ $1,062 $270 $548 $122 $1,332 ~ $551 $123 $670 Incremental Costs/Benefits 50 (!s/m' Incremental Costs/Benefits $495 $143 $674 ~ ~ 100 (!s/m' ~ 3% ~ $511 $147 $233 $106 $241 $110 $262 $36 $270 $37 $658 $339 $351 $299 $307 ---- Annual Benefits: Number of Cases Prevented Frm 00125 Silica-Related Mortality Construction Generallndustry/Maritime Fmt 4701 Total Sfmt 4725 Silicosis Morbidity Construction Generallndustry/Maritime Total E:\FR\FM\12SEP2.SGM Monetized Annual Benefits (midpoint estimate) Construction General Industry/Maritime Total Net Benefits Construction General Industry/Maritime 12SEP2 Total Cases Cases $637 Cases Cases Cases 802 221 $3,804 $1,007 $2,504 $657 235 100 $1,109 $434 $746 $283 567 121 $2,695 $573 $1,758 $374 242 115 $1,158 $545 $760 $356 325 6 $1,537 $27 $998 $18 1,023 $4,811 $3,160 335 $1,543 $1,028 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,157 613 $1,451 $768 $996 $528 77 109 $96 $136 $66 $94 1,080 504 $1,354 $632 $930 $434 161 471 $202 $590 $139 $405 919 33 $1,152 $42 $791 $29 1,770 $2,219 $1,523 186 $233 $160 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 $5,255 $1,775 $3,500 $1,164 $1,205 $570 $812 $377 $4,049 $1,205 $2,688 $808 $1,360 $1,135 $898 $761 $2,690 $69 $1,789 $47 $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 $4,211 $1,511 $2,437 $914 $657 $448 $261 $254 $3,555 $1,062 $2,177 $661 $1,127 $1,029 $658 $651 $2,427 $33 $1,519 $10 $5,722 $3,352 $1,105 $514 $4,617 $2,838 $2,157 $1,308 $2,460 $1,529 Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis * Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming that economic conditions remain constant for the sixty year time horizon, Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Table VIII-22: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 1l9/m' and 100 1l9/m' Alternative, by Major Industry Sector Millions ($2009) 56397 EP12SE13.012</GPH> 56398 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 7. Sensitivity Analysis In this section, OSHA presents the results of two different types of sensitivity analysis to demonstrate how robust the estimates of net benefits are to changes in various cost and benefit parameters. In the first type of sensitivity analysis, OSHA made a series of isolated changes to individual cost and benefit input parameters in order to determine their effects on the Agency’s estimates of annualized costs, annualized benefits, and annualized net benefits. In the second type of sensitivity analysis—a so-called ‘‘breakeven’’ analysis—OSHA also investigated isolated changes to individual cost and benefit input parameters, but with the objective of determining how much they would have to change for annualized costs to equal annualized benefits. Again, the Agency has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Analysis of Isolated Changes to Inputs The methodology and calculations underlying the estimation of the costs VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 and benefits associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to isolated variations a particular input parameter. For example, if the estimated time that employees need to travel to (and from) medical screenings were doubled, the corresponding labor costs would double as well. OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. OSHA first considered changes to input parameters that affected only costs and then changes to input parameters that affected only benefits. Each of the sensitivity tests on cost parameters had only a very minor effect on total costs or net costs. Much larger effects were observed when the benefits parameters were modified; however, in all cases, net benefits remained significantly positive. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the cost or benefit input parameters still show significant PO 00000 Frm 00126 Fmt 4701 Sfmt 4702 net benefits for the proposed rule. The results of the individual sensitivity tests are summarized in Table VIII–23 and are described in more detail below. In the first of these sensitivity test where OSHA doubled the estimated portion of employees in regulated areas requiring disposable clothing, from 10 to 20 percent, and estimates of other input parameters remained unchanged, Table VIII–23 shows that the estimated total costs of compliance would increase by $3.6 million annually, or by about 0.54 percent, while net benefits would also decline by $3.6 million, from $4,582 million to $4,528 million annually. In a second sensitivity test, OSHA decreased the estimated current prevalence of baseline silica training by half, from 50 percent to 25 percent. As shown in Table VIII–23, if OSHA’s estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $7.9 million annually, or by about 1.19 percent, while net benefits would also decline by $7.9 million annually, from $4,532 million to $4,524 million annually. E:\FR\FM\12SEP2.SGM 12SEP2 In a third sensitivity test, OSHA doubled the estimated travel time for employees to and from medical exams from 60 to 120 minutes. As shown in Table VIII–23, if OSHA’s estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $1.4 million annually, or by about 0.22 percent, while net benefits would also decline by $1.4 million annually, from VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 $4,532 million to $4,530 million annually. In a fourth sensitivity test, OSHA reduced its estimate of the number of workers who could be represented by an exposure monitoring sample from four to three. This would have the effect of increasing such costs by one-third. As shown in Table VIII–23, if OSHA’s estimates of other input parameters remained unchanged, the total PO 00000 Frm 00127 Fmt 4701 Sfmt 4702 56399 estimated costs of compliance would increase by $24.8 million annually, or by about 3.77 percent, while net benefits would also decline by $24.8 million annually, from $4,532 million to $4,507 million annually. In a fifth sensitivity test, OSHA increased by 50 percent the size of the productivity penalty arising from the use of engineering controls in construction. As shown in Table VIII– E:\FR\FM\12SEP2.SGM 12SEP2 EP12SE13.013</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56400 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 23, if OSHA’s estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $35.8 million annually, or by about 5.44 percent (and by 7.0 percent in construction), while net benefits would also decline by $35.8 million annually, from $4,532 million to $4,496 million annually. In a sixth sensitivity test, based on the discussion in Chapter V of this PEA, OSHA reduced the costs of respirator cartridges to reflect possible reductions in costs since the original costs per filter were developed in 2003, and inflated to current dollars. For this purpose, OSHA reduced respirator filter costs by 40 percent to reflect the recent lowerquartile estimates of costs relative to the costs used in OSHA’s primary analysis. As shown in Table VIII–23, the total estimated costs of compliance would be reduced by $21.2 million annually, or by about 3.23 percent, while net benefits would also increase by $21.2 million annually, from $4,532 million to $4,553 million annually. In a seventh sensitivity test, OSHA reduced the average crew size in general industry and maritime subject to a ‘‘unit’’ of engineering controls from 4 to 3. This would have the effect of increasing such costs by one-third. As shown in Table VIII–23, if OSHA’s estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $20.8 million annually, or by about 3.16 percent (and by 14.2 percent in general industry and VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 maritime), while net benefits would also decline by $20.8 million annually, from $4,532 million to $4,511 million annually. In an eighth sensitivity test, OSHA considered the effect on annualized net benefits of varying the discount rate for costs and the discount rate for benefits separately. In particular, the Agency examined the effect of reducing the discount rate for costs from 7 percent to 3 percent. As indicated in Table VIII–23, this parameter change lowers the estimated annualized cost by $20.6 million, or 3.13 percent. Total annualized net benefits would increase from $4,532 million annually to $4,552 million annually. The Agency also performed sensitivity tests on several input parameters used to estimate the benefits of the proposed rule. In the first two tests, in an extension of results previously presented in Table VIII–21, the Agency examined the effect on annualized net benefits of employing the high-end estimate of the benefits, as well as the low-end estimate. As discussed previously, the Agency examined the sensitivity of the benefits to both the number of different fatal lung cancer cases prevented, as well as the valuation of individual morbidity cases. Table VIII–23 presents the effect on annualized net benefits of using the extreme values of these ranges, the high mortality count and high morbidity valuation case, and the low mortality count and low morbidity valuation case. As indicated, using the high estimate of PO 00000 Frm 00128 Fmt 4701 Sfmt 4702 mortality cases prevented and morbidity valuation, the benefits rise by 56% to $8.1 billion, yielding net benefits of $7.5 billion. For the low estimate of both cases and valuation, the benefits decline by 54 percent, to $2.4 billion, yielding net benefits of $1.7 billion. In the third sensitivity test of benefits, the Agency examined the effect of raising the discount rate for benefits to 7 percent. The fourth sensitivity test of benefits examines the effect of adjusting monetized benefits to reflect increases in real per capita income over time. The results of these two sensitivity tests were previously shown in Table VIII–20 and are repeated in Table VIII–23. Raising the interest rate to 7 percent lowers the estimated benefits by 33 percent, to $3.5 billion, yielding annualized net benefits of $2.8 billion. Adjusting monetized benefits to reflect increases in real per capita income over time raises the benefits by 22 percent, to $6.3 billion, yielding net benefits of $5.7 billion. ‘‘Break-Even’’ Analysis OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the proposed rule. However, for these, the Agency performed a ‘‘break-even’’ analysis, asking how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits. The results are shown in Table VIII–24. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 19:12 Sep 11, 2013 $657,892,211 $5,189,700,790 $4,531,808,579 688.8% Engineering Control Costs $343,818,700 $4,875,627,279 $4,531,808,579 1318.1 % $8,700,000 $2,575,000 $1,102,889 $326,430 -$7,597, III -$2,248,570 -87.3% -87.3% 688 1,585 87 201 -600 -1,384 -87.3% -87.3% Frm 00129 Fmt 4701 Sfmt 4702 *Note: The total estimated value of prevented mortality or morbidity alone exceeds the estimated cost of the rule, providing no break-even point. Accordingly, these numbers represent a reduction in the composite valuation of an avoided fatality or illness or in the composite number of cases avoided. Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 12SEP2 56401 and morbidity are each estimated to exceed $1.9 billion, while the estimated costs are $0.6 billion, an independent break-even point for each is impossible. In other words, for example, if no value is attached to an avoided illness associated with the rule, but the estimated value of an avoided fatality is held constant, the rule still has substantial net benefits. Only through a E:\FR\FM\12SEP2.SGM would need to increase by $4.5 billion, or 1,318 percent, for costs to equal benefits. In a third sensitivity test, on benefits, OSHA examined how much its estimated monetary valuation of an avoided illness or an avoided fatality would need to be reduced in order for the costs to equal the benefits. Since the total valuation of prevented mortality PO 00000 Deaths Avoided* Illnesses Avoided* Factor Value at which Benefits Equal Costs OSHA's Best Estimate of Annualized Cost or Benefit Factor Jkt 229001 Cases Avoided Total Costs Benefits Valuation per Case Avoided Monetized Benefit per Fatality Avoided* Monetized Benefit per Illness Avoided* Required Factor Dollar/N umber Change Percentage Factor Change Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules Break-Even Sensitivity Analysis In one break-even test on cost estimates, OSHA examined how much costs would have to increase in order for costs to equal benefits. As shown in Table VIII–24, this point would be reached if costs increased by $4.5 billion, or 689 percent. In a second test, looking specifically at the estimated engineering control costs, the Agency found that these costs VerDate Mar<15>2010 EP12SE13.014</GPH> Table VIII-24 56402 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 reduction in the estimated net value of both components is a break-even point possible. The Agency, therefore, examined how large an across-the-board reduction in the monetized value of all avoided illnesses and fatalities would be necessary for the benefits to equal the costs. As shown in Table VIII–24, an 87 percent reduction in the monetized value of all avoided illnesses and fatalities would be necessary for costs to equal benefits, reducing the estimated value to $1.1 million per life saved, and an equivalent percentage reduction to about $0.3 million per illness prevented. In a fourth break-even sensitivity test, OSHA estimated how many fewer silicarelated fatalities and illnesses would be required for benefits to equal costs. Paralleling the previous discussion, eliminating either the prevented mortality or morbidity cases alone would be insufficient to lower benefits to the break-even point. The Agency therefore examined them as a group. As shown in Table VIII–24, a reduction of 87 percent, for both simultaneously, is required to reach the break-even point— 600 fewer mortality cases prevented annually, and 1,384 fewer morbidity cases prevented annually. Taking into account both types of sensitivity analysis the Agency performed on its point estimates of the annualized costs and annualized benefits of the proposed rule, the results demonstrate that net benefits would be positive in all plausible cases tested. In particular, this finding would hold even with relatively large variations in individual input parameters. Alternately, one would have to imagine extremely large changes in costs or benefits for the rule to fail to produce net benefits. OSHA concludes that its finding of significant net benefits resulting from the proposed rule is a robust one. OSHA welcomes input from the public regarding all aspects of this sensitivity analysis, including any data or information regarding the accuracy of the preliminary estimates of compliance costs and benefits and how the estimates of costs and benefits may be affected by varying assumptions and methodological approaches. H. Regulatory Alternatives This section discusses various regulatory alternatives to the proposed OSHA silica standard. OSHA believes that this presentation of regulatory alternatives serves two important functions. The first is to explore the possibility of less costly ways (than the proposed rule) to provide an adequate level of worker protection from VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 exposure to respirable crystalline silica. The second is tied to the Agency’s statutory requirement, which underlies the proposed rule, to reduce significant risk to the extent feasible. If, based on evidence presented during notice and comment, OSHA is unable to justify its preliminary findings of significant risk and feasibility as presented in this preamble to the proposed rule, the Agency must then consider regulatory alternatives that do satisfy its statutory obligations. Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency’s findings of significant risk and feasibility. To facilitate comment, the regulatory alternatives have been organized into four categories: (1) Alternative PELs to the proposed PEL of 50 mg/m3; (2) regulatory alternatives that affect proposed ancillary provisions; (3) a regulatory alternative that would modify the proposed methods of compliance; and (4) regulatory alternatives concerning when different provisions of the proposed rule would take effect. Alternative PELs OSHA is proposing a new PEL for respirable crystalline silica of 50 mg/m3 for all industry sectors covered by the rule. OSHA’s proposal is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so. See Section II of this preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements. OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. The Agency has also developed estimates of the risk of silica-related diseases assuming exposure over a working lifetime at the proposed PEL and action level, as well as at OSHA’s current PELs. These analyses are presented in a background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ and are summarized in this preamble in Section V, Health Effects Summary, and Section VI, Summary of OSHA’s Preliminary PO 00000 Frm 00130 Fmt 4701 Sfmt 4702 Quantitative Risk Assessment, respectively. 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. As discussed in Section VII, Significance of Risk, in this preamble, OSHA preliminarily finds that worker exposure to respirable crystalline silica constitutes a significant risk and that the proposed standard will substantially reduce this risk. Section 6(b) of the OSH Act (29 U.S.C. 655(b)) requires OSHA to determine that its standards are technologically and economically feasible. OSHA’s examination of the technological and economic feasibility of the proposed rule is presented in the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA), and is summarized in this section (Section VIII) of this preamble. For general industry and maritime, OSHA has preliminarily concluded that the proposed PEL of 50 mg/m3 is technologically feasible for all affected industries. For construction, OSHA has preliminarily determined that the proposed PEL of 50 mg/m3 is feasible in 10 out of 12 of the affected activities. Thus, OSHA preliminarily concludes that engineering and work practices will be sufficient to reduce and maintain silica exposures to the proposed PEL of 50 mg/m3 or below in most operations most of the time in the affected industries. For those few operations within an industry or activity where the proposed PEL is not technologically feasible even when workers use recommended engineering and work practice controls, employers can supplement controls with respirators to achieve exposure levels at or below the proposed PEL. OSHA developed quantitative estimates of the compliance costs of the proposed rule for each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has preliminarily concluded that compliance with the E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 requirements of the proposed rule would be economically feasible in every affected industry sector. OSHA has examined two regulatory alternatives (named Regulatory Alternatives #1 and #2) that would modify the PEL for the proposed rule. Under Regulatory Alternative #1, the proposed PEL would be changed from 50 mg/m3 to 100 mg/m3 for all industry sectors covered by the rule, and the action level would be changed from 25 mg/m3 to 50 mg/m3 (thereby keeping the action level at one-half of the PEL). Under Regulatory Alternative #2, the VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 proposed PEL would be lowered from 50 mg/m3 to 25 mg/m3 for all industry sectors covered by the rule, while the action level would remain at 25 mg/m3 (because of difficulties in accurately measuring exposure levels below 25 mg/ m3). Tables VIII–25 and VIII–26 present, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed PEL of 50 mg/m3 and for the regulatory alternatives of a PEL of 100 mg/m3 and a PEL of 25 mg/m3 (Regulatory Alternatives # 1 and #2), PO 00000 Frm 00131 Fmt 4701 Sfmt 4702 56403 using alternative discount rates of 3 and 7 percent. These two tables also present the incremental costs, the incremental benefits, and the incremental net benefits of going from a PEL of 100 mg/ m3 to the proposed PEL of 50 mg/m3 and then of going from the proposed PEL of 50 mg/m3 to a PEL of 25 mg/m3. Table VIII–25 breaks out costs by provision and benefits by type of disease and by morbidity/mortality, while Table VIII– 26 breaks out costs and benefits by major industry sector. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56404 VerDate Mar<15>2010 Jkt 229001 Millions ($2009) 25 ~g/m3 PO 00000 ~ Discount Rate 50 ~g/m3 Incremental Costs/Benefits ~ ~ ~ ~ 3% 100 ~g/m3 Incremental Costs/Benefits ~ ~ ~ 3% Annualized Costs Frm 00132 Engineering Controls (includes Abrasive Blastlng) Respirators Exposure Assessment Medical Surveillance Training Regulated Area or Access Control Fmt 4701 $330 $421 $203 $219 $49 $85 Annual Benefits: Number of Cases Prevented Sfmt 4725 Fatal Lung Cancers (midpoint estimate) Fatal Silicosis & other Non-Malignant Respiratory Diseases Fatal Renal Disease $0 $330 $131 $143 $0 $66 $0 $331 $129 $148 $0 $66 $330 $91 $73 $76 $49 $19 ~ ~ $1,308 Total Annualized Costs (point estimate) $344 $422 $203 $227 $50 $86 $1,332 $670 $674 $637 $658 $339 Cases Cases $344 $91 $74 $79 $50 Cases $187 $88 $26 $28 $0 $197 $88 $26 $29 $0 $143 $2 $47 $48 $49 $9 $351 Cases ~ $299 ~ $147 $3 $48 $50 $50 $307 Cases 237 ----ys ---w2 79 83 527 152 375 186 189 258 108 151 E:\FR\FM\12SEP2.SGM Silica-Related Mortality 1,023 $4,811 $3,160 335 $1,543 $1,028 Silicosis Morbidity 1,770 $2,219 $1,523 186 $233 $160 Monetized Annual Benefits (midpoint estimate) $7,030 $4,664 $1,776 Net Benefits $5722 $3352 $1105 91 60 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 $514 $4617 $2838 $2157 $1308 $2460 $1529 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 12SEP2 * Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming that economic conditions remain constant for the sixty year time horizon, Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 EP12SE13.015</GPH> Table VIII-25: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 !-191m3 and 100 !-191m3 Alternative mstockstill on DSK4VPTVN1PROD with PROPOSALS2 25!:19/m3 ~ ~ Discount Rate Jkt 229001 Annualized Costs Construction General Industry/Maritime $1,043 $264 Frm 00133 Fmt 4701 Sfmt 4702 12SEP2 $1,062 $270 $548 $122 Annual Benefits: Number of Cases Prevented Silica-Related Mortality Construction General Industry/Maritime Total Silicosis Morbidity Construction General Industry/Maritime Total Monetized Annual Benefits (midpoint estimate) Construction General Industry/Maritime Total Net Benefits Construction General Industry/Maritime Total $1,308 ~ $551 $123 $495 $143 ---- --- $1,332 Cases ~ $670 ~ ~ $511 $147 $233 $106 ---- --$637 $674 Cases Incremental Costs/Benefits ~ 3% $241 $110 $262 $36 --- --- $658 Cases 100 !:I9/m' $339 $270 $37 --- $351 Cases ~ $299 $307 Cases 802 221 $3,804 $1,007 $2,504 $657 235 100 $1,109 $434 $746 $283 567 121 $2,695 $573 $1,758 $374 242 115 $1,158 $545 $760 $356 325 6 $1,537 $27 $998 $18 1,023 $4,811 $3,160 335 $1,543 $1,028 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,157 613 $1,451 $768 $996 $528 77 109 $96 $136 $66 $94 1,080 504 $1,354 $632 $930 $434 161 471 $202 $590 $139 $405 919 33 $1,152 $42 $791 $29 1,770 $2,219 $1,523 186 $233 $160 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 $5,255 $1,775 $3,500 $1,184 $1,205 $570 $812 $377 $4,049 $1,205 $2,688 $808 $1,360 $1,135 $898 $761 $2,690 $69 $1,789 $47 $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 $4,211 $1,511 $2,437 $914 $657 $448 $261 $254 $3,555 $1,062 $2,177 $661 $1,127 $1,029 $658 $651 $2,427 $33 $1,519 $10 $5,722 $3352 $1.105 $514 $4,617 ill38 ~157 $1,308 $2~iM~L Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis * Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming that economic conditions remain constant for the sixty year time horizon. 56405 and an additional 632 cases of silicosis. Based on its preliminary findings that E:\FR\FM\12SEP2.SGM of 50 mg/m3 would prevent, annually, an additional 357 silica-related fatalities PO 00000 EP12SE13.016</GPH> ~ ---- --Total Annualized Costs 50 !:I9/m3 Incremental Costs/Benefits Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 As Tables VIII–25 and VIII–26 show, going from a PEL of 100 mg/m3 to a PEL VerDate Mar<15>2010 Table VIII-26: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 I'g/m' and 100 I'g/m' Alternative, by Major Industry Sector Millions ($2009) 56406 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 the proposed PEL of 50 mg/m3 significantly reduces worker risk from silica exposure (as demonstrated by the number of silica-related fatalities and silicosis cases avoided) and is both technologically and economically feasible, OSHA cannot propose a PEL of 100 mg/m3 (Regulatory Alternative #1) without violating its statutory obligations under the OSH Act. However, the Agency will consider evidence that challenges its preliminary findings. As previously noted, Tables VIII–25 and VIII–26 also show the costs and benefits of a PEL of 25 mg/m3 (Regulatory Alternative #2), as well as the incremental costs and benefits of going from the proposed PEL of 50 mg/ m3 to a PEL of 25 mg/m3. Because OSHA determined that a PEL of 25 mg/m3 would not be feasible (that is, engineering and work practices would not be sufficient to reduce and maintain silica exposures to a PEL of 25 mg/m3 or below in most operations most of the time in the affected industries), the Agency did not attempt to identify engineering controls or their costs for affected industries to meet this PEL. Instead, for purposes of estimating the costs of going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3, OSHA assumed that all workers exposed between 50 mg/ m3 and 25 mg/m3 would have to wear respirators to achieve compliance with the 25 mg/m3 PEL. OSHA then estimated the associated additional costs for respirators, exposure assessments, medical surveillance, and regulated areas (the latter three for ancillary requirements specified in the proposed rule). As shown in Tables VIII–25 and VIII– 26, going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3 would prevent, annually, an additional 335 silicarelated fatalities and an additional 186 cases of silicosis. These estimates support OSHA’s preliminarily finding that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has preliminarily determined that a PEL of 25 mg/m3 (Regulatory Alternative #2) is not technologically feasible, and for that reason, cannot propose it without violating its statutory obligations under the OSH Act. Regulatory Alternatives That Affect Ancillary Provisions The proposed rule contains several ancillary provisions (provisions other the PEL), including requirements for exposure assessment, medical VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 surveillance, silica training, and regulated areas or access control. As shown in Table VIII–25, these ancillary provisions represent approximately $223 million (or about 34 percent) of the total annualized costs of the rule of $658 million (using a 7 percent discount rate). The two most expensive of the ancillary provisions are the requirements for medical surveillance, with annualized costs of $79 million, and the requirements for exposure monitoring, with annualized costs of $74 million. As proposed, the requirements for exposure assessment are triggered by the action level. As described in this preamble, OSHA has defined the action level for the proposed standard as an airborne concentration of respirable crystalline silica of 25 mg/m3 calculated as an eight-hour time-weighted average. In this proposal, as in other standards, the action level has been set at one-half of the PEL. Because of the variable nature of employee exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the PEL on days when no exposure measurements are made. Even when all measurements on a given day may fall below the PEL (but are above the action level), there is some chance that on another day, when exposures are not measured, the employee’s actual exposure may exceed the PEL. When exposure measurements are above the action level, the employer cannot be reasonably confident that employees have not been exposed to respirable crystalline silica concentrations in excess of the PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring. The action level is also intended to encourage employers to lower exposure levels in order to avoid the costs associated with the exposure assessment provisions. Some employers would be able to reduce exposures below the action level in all work areas, and other employers in some work areas. As exposures are lowered, the risk of adverse health effects among workers decreases. PO 00000 Frm 00134 Fmt 4701 Sfmt 4702 OSHA’s preliminary risk assessment indicates that significant risk remains at the proposed PEL of 50 mg/m3. Where there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr.Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (DC Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA’s preliminary conclusion is that the requirements triggered by the action level will result in a very real and necessary, but non-quantifiable, further reduction in risk beyond that provided by the PEL alone. OSHA’s choice of proposing an action level for exposure monitoring of one-half of the PEL is based on the Agency’s successful experience with other standards, including those for inorganic arsenic (29 CFR 1910.1018), ethylene oxide (29 CFR 1910.1047), benzene (29 CFR 1910.1028), and methylene chloride (29 CFR 1910.1052). As specified in the proposed rule, all workers exposed to respirable crystalline silica above the PEL of 50 mg/ m3 are subject to the medical surveillance requirements. This means that the medical surveillance requirements would apply to 15,172 workers in general industry and 336,244 workers in construction. OSHA estimates that 457 possible silicosis cases will be referred to pulmonary specialists annually as a result of this medical surveillance. OSHA has preliminarily determined that these ancillary provisions will: (1) help to ensure the PEL is not exceeded, and (2) minimize risk to workers given the very high level of risk remaining at the PEL. OSHA did not estimate, and the benefits analysis does not include, monetary benefits resulting from early discovery of illness. Because medical surveillance and exposure assessment are the two most costly ancillary provisions in the proposed rule, the Agency has examined four regulatory alternatives (named Regulatory Alternatives #3, #4, #5, and #6) involving changes to one or the other of these ancillary provisions. These four regulatory alternatives are defined below and the incremental cost impact of each is summarized in Table VIII–27. In addition, OSHA is including a regulatory alternative (named Regulatory Alternative #7) that would remove all ancillary provisions. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 13% Discount Rate I Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GIIM Total Jkt 229001 Frm 00135 Fmt 4701 Sfmt 4702 12SEP2 $494,826,699 $142,502,681 $637,329,380 Option 3: PEL=50; AL=50 $457,686,162 $117,680,601 $575,366,763 -$37,140,537 -$24,822,080 -$61,962,617 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $606,697,624 $173,701,827 $780,399,451 $111,870,925 $31,199,146 $143,070,071 Option 5: PEL=50; AL=25, with medical exams annually $561,613,766 $145,088,559 $706,702,325 $66,787,067 $2,585,878 $69,372,945 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $775,334,483 $203,665,685 $979,000,168 $280,507,784 $61,163,004 $341,670,788 f7°7~bisc6unfRatel Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GIIM Total Proposed Rule $511,165,616 $146,726,595 $657,892,211 Option 3: PEL=50; AL=50 $473,638,698 $121,817,396 $595,456,093 -$37,526,918 -$24,909,200 -$62,436,118 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $627,197,794 $179,066,993 $806,264,787 $132,371,095 $36,564,312 $168,935,407 Option 5: PEL=50; AL=25, with medical exams annually $575,224,843 $149,204,718 $724,429,561 $64,059,227 $2,478,122 $66,537,350 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $791,806,358 $208,339,741 $1,000,146,099 $280,640,742 $61,613,145 $342,253,887 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 56407 monitoring requirements would be triggered only if workers were exposed E:\FR\FM\12SEP2.SGM m3 to 50 mg/m3 while keeping the PEL at 50 mg/m3. As a result, exposure PO 00000 Proposed Rule Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Under Regulatory Alternative #3, the action level would be raised from 25 mg/ VerDate Mar<15>2010 EP12SE13.017</GPH> Table VIII-27: Cost of Regulatory Alternatives Affecting Ancillary Provisions mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56408 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules above the proposed PEL of 50 mg/m3. As shown in Table VIII–27, Regulatory Option #3 would reduce the annualized cost of the proposed rule by about $62 million, using a discount rate of either 3 percent or 7 percent. Under Regulatory Alternative #4, the action level would remain at 25 mg/m3 but medical surveillance would now be triggered by the action level, not the PEL. As a result, medical surveillance requirements would be triggered only if workers were exposed at or above the proposed action level of 25 mg/m3. As shown in Table VIII–27, Regulatory Option #4 would increase the annualized cost of the proposed rule by about $143 million, using a discount rate of 3 percent (and by about $169 million, using a discount rate of 7 percent). Under Regulatory Alternative #5, the only change to the proposed rule would be to the medical surveillance requirements. Instead of requiring workers exposed above the PEL to have a medical check-up every three years, those workers would be required to have a medical check-up annually. As shown in Table VIII–27, Regulatory Option #5 would increase the annualized cost of the proposed rule by about $69 million, using a discount rate of 3 percent (and by about $66 million, using a discount rate of 7 percent). Regulatory Alternative #6 would essentially combine the modified requirements in Regulatory Alternatives #4 and #5. Under Regulatory Alternative #6, medical surveillance would be triggered by the action level, not the PEL, and workers exposed at or above the action level would be required to have a medical check-up annually rather than triennially. The exposure monitoring requirements in the proposed rule would not be affected. As shown in Table VIII–27, Regulatory Option #6 would increase the annualized cost of the proposed rule by about $342 million, using a discount rate of either 3 percent or 7 percent. OSHA is not able to quantify the effects of these preceding four regulatory alternatives on protecting workers exposed to respirable crystalline silica at levels at or below the proposed PEL of 50 mg/m3—where significant risk remains. The Agency solicits comment on the extent to which these regulatory options may improve or reduce the effectiveness of the proposed rule. The final regulatory alternative affecting ancillary provisions, Regulatory Alternative #7, would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 surveillance, training, and regulated areas or access control. However, it should be carefully noted that elimination of the ancillary provisions does not mean that all costs for ancillary provisions would disappear. In order to meet the PEL, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that employers would increasingly follow the many recommendations to provide medical surveillance for employees. OSHA has not attempted to estimate the extent to which the costs of these activities would be reduced if they were not formally required, but OSHA welcomes comment on the issue. As indicated previously, OSHA preliminarily finds that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has also preliminarily determined that 50 mg/m3 is the lowest feasible PEL. Therefore, the Agency believes that it is necessary to include ancillary provisions in the proposed rule to further reduce the remaining risk. OSHA anticipates that these ancillary provisions will reduce the risk beyond the reduction that will be achieved by a new PEL alone. OSHA’s reasons for including each of the proposed ancillary provisions are detailed in Section XVI of this preamble, Summary and Explanation of the Standards. In particular, OSHA believes that requirements for exposure assessment (or alternately, using specified exposure control methods for selected construction operations) would provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is particularly important because individuals exposed above the PEL (which triggers medical surveillance in the proposed rule) are at significant risk of death and illness. Medical surveillance would allow for identification of respirable crystalline silica-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA believes that regulated areas and access control are important because they serve to limit exposure to respirable crystalline silica to as few employees as possible. Finally, OSHA believes that worker training is necessary to inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize potential health hazards. Worker training on silicarelated work practices is particularly PO 00000 Frm 00136 Fmt 4701 Sfmt 4702 important in controlling silica exposures because engineering controls frequently require action on the part of workers to function effectively. OSHA expects that the benefits estimated under the proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed rule. For example, OSHA believes that the effectiveness of the proposed rule depends on regulated areas or access control to further limit exposures and on medical surveillance to identify disease cases when they do occur. Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to respirable crystalline silica. For example, the industry consensus standards for crystalline silica, ASTM E 1132–06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626–09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, as well as the draft proposed silica standard for construction developed by the Building and Construction Trades Department, AFL– CIO, have each included comprehensive programs. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance (ASTM, 2006; 2009; BCTD 2001). Moreover, as mentioned previously, where there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr. Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (DC Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA preliminarily concludes that the additional requirements in the ancillary provisions of the proposed standard clearly exceed this threshold. A Regulatory Alternative That Modifies the Methods of Compliance The proposed standard in general industry and maritime would require employers to implement engineering and work practice controls to reduce employees’ exposures to or below the PEL. Where engineering and/or work practice controls are insufficient, employers would still be required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. Under the proposed E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 construction standard, employers would be given two options for compliance. The first option largely follows requirements for the general industry and maritime proposed standard, while the second option outlines, in Table 1 (Exposure Control Methods for Selected Construction Operations) of the proposed rule, specific construction exposure control methods. Employers choosing to follow OSHA’s proposed control methods would be considered to be in compliance with the engineering and work practice control requirements of the proposed standard, and would not be required to conduct certain exposure monitoring activities. One regulatory alternative (Regulatory Alternative #8) involving methods of compliance would be to eliminate Table 1 as a compliance option in the construction sector. Under this regulatory alternative, OSHA estimates that there would be no effect on estimated benefits but that the annualized costs of complying with the proposed rule (without the benefit of the Table 1 option in construction) would increase by $175 million, totally in exposure monitoring costs, using a 3 percent discount rate (and by $178 million using a 7 percent discount rate), so that the total annualized compliance costs for all affected establishments in construction would increase from $495 to $670 million using a 3 percent discount rate (and from $511 to $689 million using a 7 percent discount rate). Regulatory Alternatives That Affect the Timing of the Standard The proposed rule would become effective 60 days following publication of the final rule in the Federal Register. Provisions outlined in the proposed standard would become enforceable 180 days following the effective date, with the exceptions of engineering controls and laboratory requirements. The proposed rule would require engineering controls to be implemented no later than one year after the effective date, and laboratory requirements would be required to begin two years after the effective date. One regulatory alternative (Regulatory Alternative #9) involving the timing of the standard would arise if, contrary to OSHA’s preliminary findings, a PEL of 50 mg/m3 with an action level of 25 mg/ m3 were found to be technologically and economically feasible some time in the future (say, in five years), but not feasible immediately. In that case, OSHA might issue a final rule with a PEL of 50 mg/m3 and an action level of 25 mg/m3 to take effect in five years, but at the same time issue an interim PEL of 100 mg/m3 and an action level of 50 VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 mg/m3 to be in effect until the final rule becomes feasible. Under this regulatory alternative, and consistent with the public participation and ‘‘look back’’ provisions of Executive Order 13563, the Agency could monitor compliance with the interim standard, review progress toward meeting the feasibility requirements of the final rule, and evaluate whether any adjustments to the timing of the final rule would be needed. Under Regulatory Alternative #9, the estimated costs and benefits would be somewhere between those estimated for a PEL of 100 mg/m3 with an action level of 50 mg/m3 and those estimated for a PEL of 50 mg/m3 with an action level of 25 mg/m3, the exact estimates depending on the length of time until the final rule is phased in. OSHA emphasizes that this regulatory alternative is contrary to the Agency’s preliminary findings of economic feasibility and, for the Agency to consider it, would require specific evidence introduced on the record to show that the proposed rule is not now feasible but would be feasible in the future. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), OSHA is soliciting comments on this issue. Such a particularized, multi-year phase-in would have several advantages, especially from the viewpoint of impacts on small businesses. First, it would reduce the one-time initial costs of the standard by spreading them out over time, a particularly useful mechanism for small businesses that have trouble borrowing large amounts of capital in a single year. A differential phase-in for smaller firms would also aid very small firms by allowing them to gain from the control experience of larger firms. A phase-in would also be useful in certain industries—such as foundries, for example—by allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However a phase-in would also postpone the benefits of the standard, recognizing, as described in Chapter VII of the PEA, that the full benefits of the proposal would take a number of years to fully materialize even in the absence of a phase-in. As previously discussed in the Introduction to this preamble, OSHA requests comments on these regulatory alternatives, including the Agency’s choice of regulatory alternatives (and PO 00000 Frm 00137 Fmt 4701 Sfmt 4702 56409 whether there are other regulatory alternatives the Agency should consider) and the Agency’s analysis of them. I. Initial Regulatory Flexibility Analysis The Regulatory Flexibility Act, as amended in 1996, requires the preparation of an Initial Regulatory Flexibility Analysis (IRFA) for proposed rules where there would be a significant economic impact on a substantial number of small entities. (5 U.S.C. 601– 612). Under the provisions of the law, each such analysis shall contain: 1. A description of the impact of the proposed rule on small entities; 2. A description of the reasons why action by the agency is being considered; 3. A succinct statement of the objectives of, and legal basis for, the proposed rule; 4. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply; 5. A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record; 6. An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the proposed rule; and 7. A description and discussion of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities, such as (a) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (b) The clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (c) The use of performance rather than design standards; and (d) An exemption from coverage of the rule, or any part thereof, for such small entities. 5 U.S.C. 603, 607. The Regulatory Flexibility Act further states that the required elements of the IRFA may be performed in conjunction with or as part of any other agenda or analysis required by any other law if such other analysis satisfies the provisions of the IRFA. 5 U.S.C. 605. While a full understanding of OSHA’s analysis and conclusions with respect to E:\FR\FM\12SEP2.SGM 12SEP2 56410 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules costs and economic impacts on small entities requires a reading of the complete PEA and its supporting materials, this IRFA will summarize the key aspects of OSHA’s analysis as they affect small entities. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 A Description of the Impact of the Proposed Rule on Small Entities Section VIII.F of this preamble summarized the impacts of the proposed rule on small entities. Tables VIII–12 and VIII–15 showed costs as a percentage of profits and revenues for small entities in general industry and maritime and in construction, respectively, classified as small by the Small Business Administration, and Tables VIII–13 and VIII–16 showed costs as a percentage of revenues and profits for business entities with fewer than 20 employees in general industry and maritime and in construction, respectively. (The costs in these tables were annualized using a discount rate of 7 percent.) A Description of the Reasons Why Action by the Agency Is Being Considered Exposure to crystalline silica has been shown to increase the risk of several serious diseases. Crystalline silica is the only known cause of silicosis, which is a progressive respiratory disease in which respirable crystalline silica particles cause an inflammatory reaction in the lung, leading to lung damage and scarring, and, in some cases, to complications resulting in disability and death. In addition, many wellconducted investigations of exposed workers have shown that exposure increases the risk of mortality from lung cancer, chronic obstructive pulmonary disease (COPD), and renal disease. OSHA’s detailed analysis of the scientific literature and silica-related health risks are presented in the background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ (placed in Docket OSHA– 2010–0034). Based on a review of over 60 epidemiological studies covering more than 30 occupational groups, OSHA preliminarily concludes that crystalline silica is a human carcinogen. Most of these studies documented that exposed workers experience higher lung cancer mortality rates than do unexposed workers or the general population, and that the increase in lung cancer mortality is related to cumulative exposure to crystalline silica. These exposure-related trends strongly implicate crystalline silica as a likely VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 causative agent. This is consistent with the conclusions of other government and public health organizations, including the International Agency for Research on Cancer (IARC), the Agency for Toxic Substance and Disease Registry (ATSDR), the World Health Organization (WHO), the U.S. Environmental Protection Agency (EPA), the National Toxicology Program (NTP), the National Academies of Science (NAS), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH). OSHA believes that the strongest evidence for carcinogenicity comes from studies in five industry sectors (diatomaceous earth, pottery, granite, industrial sand, and coal mining) as well as a study by Steenland et al. (2001) that analyzed pooled data from 10 occupational cohort studies; each of these studies found a positive relationship between exposure to crystalline silica and lung cancer mortality. Based on a variety of relative risk models fit to these data sets, OSHA estimates that the excess lifetime risk to workers exposed over a working life of 45 years at the current general industry permissible exposure limit (PEL) (approximately 100 mg/m3 respirable crystalline silica) is between 13 and 60 deaths per 1,000 workers. For exposure over a working life at the current construction and shipyard employment PELs (estimated to range between 250 and 500 mg/m3), the estimated risk lies between 37 and 653 deaths per 1,000. Reducing these PELs to the proposed PEL of 50 mg/m3 respirable crystalline silica results in a substantial reduction of these risks, to a range estimated to be between 6 and 26 deaths per 1,000 workers. OSHA has also quantitatively evaluated the mortality risk from nonmalignant respiratory disease, including silicosis and COPD. Risk estimates for silicosis mortality are based on a study by Mannetje et al. (2002), which pooled data from six worker cohort studies to derive a quantitative relationship between exposure and death rate for silicosis. For non-malignant respiratory disease, risk estimates are based on an epidemiologic study of diatomaceous earth workers, which included a quantitative exposure-response analysis (Park et al., 2002). For 45 years of exposure to the current general industry PEL, OSHA’s estimates of excess lifetime risk are 11 deaths per 1,000 workers for the pooled analysis and 83 deaths per 1,000 workers based on Park et al.’s (2002) estimates. At the proposed PEL, estimates of silicosis and non- PO 00000 Frm 00138 Fmt 4701 Sfmt 4702 malignant respiratory disease mortality are 7 and 43 deaths per 1,000, respectively. As noted by Park et al. (2002), it is likely that silicosis as a cause of death is often misclassified as emphysema or chronic bronchitis; thus, Mannetje et al.’s selection of deaths may tend to underestimate the true risk of silicosis mortality, while Park et al.’s (2002) analysis would more fairly capture the total respiratory mortality risk from all non-malignant causes, including silicosis and COPD. OSHA also identified seven studies that quantitatively described relationships between exposure to respirable crystalline silica and silicosis morbidity, as diagnosed from chest radiography (i.e., chest x-rays or computerized tomography). Estimates of silicosis morbidity derived from these cohort studies range from 60 to 773 cases per 1,000 workers for a 45-year exposure to the current general industry PEL, and approach unity for a 45-year exposure to the current construction/ shipyard PEL. Estimated risks of silicosis morbidity range from 20 to 170 cases per 1,000 workers for a 45-year exposure to the proposed PEL, reflecting a substantial reduction in the risk associated with exposure to the current PELs. OSHA’s estimates of crystalline silicarelated renal disease mortality risk are derived from an analysis by Steenland et al. (2002), in which data from three cohort studies were pooled to derive a quantitative relationship between exposure to silica and the relative risk of end-stage renal disease mortality. The cohorts included workers in the U.S. gold mining, industrial sand, and granite industries. From this study, OSHA estimates that exposure to the current general industry and proposed PELs over a working life would result in a lifetime excess renal disease risk of 39 and 32 deaths per 1,000 workers, respectively. For exposure to the current construction/shipyard PEL, OSHA estimates the excess lifetime risk to range from 52 to 63 deaths per 1,000 workers. A Statement of the Objectives of, and Legal Basis for, the Proposed Rule The objective of the proposed rule is to reduce the numbers of fatalities and illnesses occurring among employees exposed to respirable crystalline silica in general industry, maritime, and construction sectors. This objective will be achieved by requiring employers to install engineering controls where appropriate and to provide employees with the equipment, respirators, training, exposure monitoring, medical surveillance, and other protective E:\FR\FM\12SEP2.SGM 12SEP2 56411 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules measures to perform their jobs safely. The legal basis for the rule is the responsibility given the U.S. Department of Labor through the Occupational Safety and Health Act of 1970 (OSH Act). The OSH Act provides that, in promulgating health standards dealing with toxic materials or harmful physical agents, the Secretary ‘‘shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.’’ 29 U.S.C. Sec. 655(b)(5). See Section II of this preamble for a more detailed discussion of the Secretary’s legal authority to promulgate standards. A Description of and Estimate of the Number of Small Entities To Which the Proposed Rule Will Apply OSHA has completed a preliminary analysis of the impacts associated with this proposal, including an analysis of the type and number of small entities to which the proposed rule would apply, as described above. In order to determine the number of small entities potentially affected by this rulemaking, OSHA used the definitions of small entities developed by the Small Business Administration (SBA) for each industry. OSHA estimates that approximately 470,000 small business or government entities would be affected by the proposed standard. Within these small entities, roughly 1.3 million workers are exposed to crystalline silica and would be protected by the proposed standard. A breakdown, by industry, of the number of affected small entities is provided in Table III–3 in Chapter III of the PEA. OSHA estimates that approximately 356,000 very small entities would be affected by the proposed standard. Within these very small entities, roughly 580,000 workers are exposed to crystalline silica and would be protected by the proposed standard. A breakdown, by industry, of the number of affected very small entities is provided in Table III–4 in Chapter III of the PEA. A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule Tables VIII–28 and VIII–29 show the average costs of the proposed standard by NAICS code and by compliance requirement for, respectively, small entities (classified as small by SBA) and very small entities (fewer than 20 employees). For the average small entity in general industry and maritime, the estimated cost of the proposed rule would be about $2,103 annually, with engineering controls accounting for 67 percent of the costs and exposure monitoring accounting for 23 percent of the costs. For the average small entity in construction, the estimate cost of the proposed rule would be about $798 annually, with engineering controls accounting for 47 percent of the costs, exposure monitoring accounting for 17 percent of the costs, and medical surveillance accounting for 15 percent of the costs. For the average very small entity in general industry and maritime, the estimate cost of the proposed rule would be about $616 annually, with engineering controls accounting for 55 percent of the costs and exposure monitoring accounting for 33 percent of the costs. For the average very small entity in construction, the estimate cost of the proposed rule would be about $533 annually, with engineering controls accounting for 45 percent of the costs, exposure monitoring accounting for 16 percent of the costs, and medical surveillance accounting for 16 percent of the costs. Table VIII–30 shows the unit costs which form the basis for these cost estimates for the average small entity and very small entity. TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 324121 ..... Asphalt paving mixture and block manufacturing. Asphalt shingle and roofing materials .. Paint and coating manufacturing .......... Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg ............. Brick and structural clay mfg ................ Ceramic wall and floor tile mfg ............. Other structural clay product mfg ......... Clay refractory manufacturing .............. Nonclay refractory manufacturing ........ Flat glass manufacturing ...................... Other pressed and blown glass and glassware manufacturing. Glass container manufacturing ............. Ready-mixed concrete manufacturing .. Concrete block and brick mfg .............. Concrete pipe mfg ................................ Other concrete product mfg ................. Cut stone and stone product manufacturing. Ground or treated mineral and earth manufacturing. Mineral wool manufacturing ................. All other misc. nonmetallic mineral product mfg. Iron and steel mills ............................... 324122 ..... 325510 ..... 327111 ..... 327112 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 327113 327121 327122 327123 327124 327125 327211 327212 ..... ..... ..... ..... ..... ..... ..... ..... 327213 327320 327331 327332 327390 327991 ..... ..... ..... ..... ..... ..... 327992 ..... 327993 ..... 327999 ..... 331111 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total $232 $4 $13 $1 $74 $1 $326 5,721 0 6,310 297 10 428 1,887 36 2,065 103 3 150 114 15 162 111 4 160 8,232 69 9,274 1,679 114 663 41 47 42 2,586 6,722 28,574 10,982 10,554 1,325 1,964 4,068 889 458 636 245 235 92 136 160 34 2,656 3,018 1,160 1,115 653 802 520 110 162 226 87 83 33 48 56 12 188 237 91 87 81 110 50 11 170 236 91 87 34 51 60 13 10,355 32,928 12,655 12,162 2,218 3,110 4,913 1,068 2,004 1,728 3,236 5,105 3,016 2,821 76 460 245 386 228 207 248 1,726 1,257 1,983 1,171 1,040 27 163 87 137 81 74 24 121 134 211 125 65 29 171 91 143 85 77 2,408 4,369 5,049 7,966 4,705 4,284 12,034 174 3,449 62 191 65 15,975 1,365 2,222 56 168 185 863 20 60 17 92 21 62 1,664 3,467 604 34 138 12 11 13 812 Frm 00139 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56412 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 331112 ..... Electrometallurgical ferroalloy product manufacturing. Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ........ Steel wire drawing ................................ Secondary smelting and alloying of aluminum. Secondary smelting, refining, and alloying of copper. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ........................................ Steel investment foundries ................... Steel foundries (except investment) ..... Aluminum foundries (except die-casting). Copper foundries (except die-casting) Other nonferrous foundries (except die-casting). Iron and steel forging ........................... Nonferrous forging ................................ Crown and closure manufacturing ....... Metal stamping ..................................... Powder metallurgy part manufacturing Cutlery and flatware (except precious) manufacturing. Hand and edge tool manufacturing ...... Saw blade and handsaw manufacturing. Kitchen utensil, pot, and pan manufacturing. Ornamental and architectural metal work. Other metal container manufacturing ... Hardware manufacturing ...................... Spring (heavy gauge) manufacturing ... Spring (light gauge) manufacturing ...... Other fabricated wire product manufacturing. Machine shops ..................................... Metal coating and allied services ......... Industrial valve manufacturing .............. Fluid power valve and hose fitting manufacturing. Plumbing fixture fitting and trim manufacturing. Other metal valve and pipe fitting manufacturing. Ball and roller bearing manufacturing .. Fabricated pipe and pipe fitting manufacturing. Industrial pattern manufacturing ........... Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing. Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing .............. Machine tool (metal cutting types) manufacturing. Machine tool (metal forming types) manufacturing. Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. 331210 ..... 331221 ..... 331222 ..... 331314 ..... 331423 ..... 331492 ..... 331511 331512 331513 331524 ..... ..... ..... ..... 331525 ..... 331528 ..... 332111 332112 332115 332116 332117 332211 ..... ..... ..... ..... ..... ..... 332212 ..... 332213 ..... 332214 ..... 332323 ..... 332439 332510 332611 332612 332618 ..... ..... ..... ..... ..... 332710 332812 332911 332912 ..... ..... ..... ..... 332913 ..... 332919 ..... 332991 ..... 332996 ..... 332997 ..... 332998 ..... 332999 ..... 333319 ..... 333411 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 333412 ..... 333414 ..... 333511 ..... 333512 ..... 333513 ..... 333514 ..... 333515 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total 514 29 118 10 10 11 692 664 38 154 13 13 14 896 583 638 577 33 36 33 135 148 133 12 13 11 11 12 11 12 14 12 787 862 777 534 30 125 11 10 11 722 548 31 128 11 11 12 741 9,143 11,874 9,223 7,367 522 675 526 419 2,777 3,596 2,802 2,231 185 240 187 149 200 249 202 155 194 251 196 156 13,021 16,885 13,135 10,476 4,563 3,895 260 222 1,382 1,179 92 79 96 82 96 82 6,489 5,539 531 533 514 533 535 518 30 30 29 30 31 30 161 162 156 162 163 157 11 11 10 11 11 10 12 12 11 12 12 11 11 11 11 11 11 11 756 760 732 759 762 738 542 528 31 30 165 160 11 11 12 12 12 11 772 752 560 32 170 11 12 12 798 524 20 102 7 11 8 673 550 531 529 585 537 31 30 30 33 31 167 161 161 178 163 11 11 11 12 11 12 12 12 13 12 12 11 11 12 11 784 756 754 834 765 518 843 528 532 30 33 30 30 157 165 160 162 10 12 11 11 11 18 12 12 11 12 11 11 738 1,083 752 757 528 30 160 11 12 11 752 536 31 163 11 12 11 764 545 529 31 30 131 161 11 11 11 12 12 11 741 754 517 484 29 23 157 97 10 8 11 10 11 9 736 630 521 30 158 11 11 11 742 526 30 160 11 12 11 750 525 30 160 11 11 11 748 555 32 169 11 12 12 791 520 30 158 11 11 11 741 522 524 30 30 159 159 11 11 11 11 11 11 743 746 532 30 162 11 12 11 758 522 30 158 11 11 11 743 524 30 159 11 11 11 746 Frm 00140 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56413 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 333516 ..... Rolling mill machinery and equipment manufacturing. Other metalworking machinery manufacturing. Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing. Air and gas compressor manufacturing Power-driven handtool manufacturing .. Welding and soldering equipment manufacturing. Packaging machinery manufacturing ... Industrial process furnace and oven manufacturing. Fluid power cylinder and actuator manufacturing. Fluid power pump and motor manufacturing. Scale and balance (except laboratory) manufacturing. All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing .. Electric housewares and household fans. Household cooking appliance manufacturing. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing. Other major household appliance manufacturing. Automobile manufacturing .................... Light truck and utility vehicle manufacturing. Heavy duty truck manufacturing ........... Motor vehicle body manufacturing ....... Truck trailer manufacturing ................... Motor home manufacturing .................. Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing. Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping .............. All other motor vehicle parts manufacturing. Ship building and repair ....................... Boat building ......................................... Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing. Dental laboratories ............................... Jewelry (except costume) manufacturing. Jewelers’ materials and lapidary work manufacturing. Costume jewelry and novelty manufacturing. Sign manufacturing ............................... Industrial supplies, wholesalers ............ 333518 ..... 333612 ..... 333613 ..... 333911 ..... 333912 ..... 333991 ..... 333992 ..... 333993 ..... 333994 ..... 333995 ..... 333996 ..... 333997 ..... 333999 ..... 334518 ..... 335211 ..... 335221 ..... 335222 ..... 335224 ..... 335228 ..... 336111 ..... 336112 ..... 336120 336211 336212 336213 336311 ..... ..... ..... ..... ..... 336312 ..... 336322 ..... 336330 ..... 336340 ..... 336350 ..... 336370 ..... 336399 ..... 336611 ..... 336612 ..... 336992 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 337215 ..... 339114 ..... 339116 ..... 339911 ..... 339913 ..... 339914 ..... 339950 ..... 423840 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total 522 30 159 11 11 11 744 537 31 163 11 12 11 765 546 31 166 11 12 12 777 529 30 161 11 12 11 754 535 31 163 11 12 11 762 532 514 523 30 29 30 162 156 159 11 10 11 12 11 11 11 11 11 758 732 745 521 531 30 30 158 161 11 11 11 12 11 11 742 757 531 30 161 11 12 11 756 542 31 165 11 12 11 772 537 31 163 11 12 11 764 523 30 159 11 11 11 745 514 523 29 20 156 76 10 7 11 9 11 8 732 643 529 20 77 7 9 8 649 1,452 56 210 19 26 21 1,784 1,461 56 212 19 26 21 1,795 523 20 101 7 11 8 671 1,309 4,789 75 273 297 1,085 25 92 23 86 28 102 1,757 6,425 1,211 579 525 792 525 69 33 30 45 30 275 137 160 181 160 23 11 11 15 11 22 11 11 15 11 26 12 11 17 11 1,626 784 748 1,064 748 522 30 120 10 10 11 703 524 30 121 10 10 11 706 526 30 120 10 10 11 708 527 30 121 10 10 11 710 528 30 121 10 10 11 710 556 535 32 30 169 123 11 10 12 10 12 11 792 721 13,685 2,831 624 0 0 35 718 202 149 692 149 12 47 11 12 75 16 13 15,217 3,209 845 527 30 160 11 12 11 751 671 39 145 14 11 15 895 12 120 7 92 130 475 3 33 44 41 3 34 199 795 151 115 596 41 51 43 997 87 44 229 16 19 16 412 465 313 20 29 107 257 7 10 11 15 8 11 618 636 Frm 00141 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56414 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 482110 ..... 621210 ..... Rail transportation ................................ Dental offices ........................................ Total—General Industry and Maritime Residential Building Construction ......... Nonresidential Building Construction ... Utility System Construction .................. Land Subdivision .................................. Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors ........... Building Finishing Contractors .............. Other Specialty Trade Contractors ....... State and Local Governments [c] ......... Total—Construction .............................. 236100 236200 237100 237200 237300 ..... ..... ..... ..... ..... 237900 ..... 238100 ..... 238200 238300 238900 999000 ..... ..... ..... ..... Respirators Exposure monitoring Medical surveillance Training Regulated areas or access control Total ...................... 3 1,399 264 234 978 104 692 ...................... 2 93 43 104 89 9 109 ...................... 32 483 34 67 172 25 179 ...................... 1 46 37 89 78 8 95 ...................... 11 46 27 66 185 30 227 ...................... 1 36 15 14 30 3 26 ...................... 50 2,103 419 575 1,531 180 1,329 592 60 134 52 175 18 1,032 401 359 113 307 91 49 1,319 156 289 460 108 375 18 24 43 16 132 21 23 65 31 72 16 50 52 14 122 27 27 79 43 71 7 9 30 11 26 244 421 729 222 798 Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013). TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 324121 ..... Asphalt paving mixture and block manufacturing. Asphalt shingle and roofing materials .. Paint and coating manufacturing .......... Vitreous china plumbing fixtures & bathroom accessories manufacturing. Vitreous china, fine earthenware, & other pottery product manufacturing. Porcelain electrical supply mfg ............. Brick and structural clay mfg ................ Ceramic wall and floor tile mfg ............. Other structural clay product mfg ......... Clay refractory manufacturing .............. Nonclay refractory manufacturing ........ Flat glass manufacturing ...................... Other pressed and blown glass and glassware manufacturing. Glass container manufacturing ............. Ready-mixed concrete manufacturing .. Concrete block and brick mfg .............. Concrete pipe mfg ................................ Other concrete product mfg ................. Cut stone and stone product manufacturing. Ground or treated mineral and earth manufacturing. Mineral wool manufacturing ................. All other misc. nonmetallic mineral product mfg. Iron and steel mills ............................... Electrometallurgical ferroalloy product manufacturing. Iron and steel pipe and tube manufacturing from purchased steel. Rolled steel shape manufacturing ........ Steel wire drawing ................................ Secondary smelting and alloying of aluminum. Secondary smelting, refining, and alloying of copper. Secondary smelting, refining, and alloying of nonferrous metal (except cu & al). Iron foundries ........................................ Steel investment foundries ................... Steel foundries (except investment) ..... 324122 ..... 325510 ..... 327111 ..... 327112 ..... 327113 327121 327122 327123 327124 327125 327211 327212 ..... ..... ..... ..... ..... ..... ..... ..... 327213 327320 327331 327332 327390 327991 ..... ..... ..... ..... ..... ..... 327992 ..... 327993 ..... 327999 ..... 331111 ..... 331112 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 331210 ..... 331221 ..... 331222 ..... 331314 ..... 331423 ..... 331492 ..... 331511 ..... 331512 ..... 331513 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total $74 $1 $5 $0 $26 $0 $107 914 0 851 48 7 58 476 33 422 17 3 21 23 13 26 18 3 22 1,496 58 1,400 705 48 349 17 22 18 1,160 851 2,096 2,385 2,277 301 471 842 873 58 47 53 51 21 33 34 34 422 277 316 301 186 291 163 164 21 17 19 18 8 12 12 12 26 19 22 21 20 32 12 12 22 17 20 19 8 12 12 12 1,400 2,474 2,815 2,687 543 852 1,075 1,107 873 475 966 1,046 854 1,158 34 127 74 80 65 86 164 595 470 509 416 535 12 46 27 29 23 31 12 37 44 48 39 30 12 47 27 29 24 32 1,107 1,328 1,608 1,741 1,422 1,872 3,564 52 1,280 19 63 19 4,997 823 797 34 61 166 388 12 22 12 37 13 22 1,061 1,327 517 0 30 0 197 0 11 0 13 0 11 0 777 0 514 30 196 11 12 11 774 514 514 514 30 30 30 196 196 196 11 11 11 12 12 12 11 11 11 774 774 774 0 0 0 0 0 0 0 514 30 196 11 12 11 774 1,093 1,181 1,060 63 68 61 416 448 404 23 24 22 26 28 26 23 25 22 1,644 1,774 1,595 Frm 00142 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56415 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 331524 ..... Aluminum foundries (except die-casting). Copper foundries (except die-casting) Other nonferrous foundries (except die-casting). Iron and steel forging ........................... Nonferrous forging ................................ Crown and closure manufacturing ....... Metal stamping ..................................... Powder metallurgy part manufacturing Cutlery and flatware (except precious) manufacturing. Hand and edge tool manufacturing ...... Saw blade and handsaw manufacturing. Kitchen utensil, pot, and pan manufacturing. Ornamental and architectural metal work. Other metal container manufacturing ... Hardware manufacturing ...................... Spring (heavy gauge) manufacturing ... Spring (light gauge) manufacturing ...... Other fabricated wire product manufacturing. Machine shops ..................................... Metal coating and allied services ......... Industrial valve manufacturing .............. Fluid power valve and hose fitting manufacturing. Plumbing fixture fitting and trim manufacturing. Other metal valve and pipe fitting manufacturing. Ball and roller bearing manufacturing .. Fabricated pipe and pipe fitting manufacturing. Industrial pattern manufacturing ........... Enameled iron and metal sanitary ware manufacturing. All other miscellaneous fabricated metal product manufacturing. Other commercial and service industry machinery manufacturing. Air purification equipment manufacturing. Industrial and commercial fan and blower manufacturing. Heating equipment (except warm air furnaces) manufacturing. Industrial mold manufacturing .............. Machine tool (metal cutting types) manufacturing. Machine tool (metal forming types) manufacturing. Special die and tool, die set, jig, and fixture manufacturing. Cutting tool and machine tool accessory manufacturing. Rolling mill machinery and equipment manufacturing. Other metalworking machinery manufacturing. Speed changer, industrial high-speed drive, and gear manufacturing. Mechanical power transmission equipment manufacturing. Pump and pumping equipment manufacturing. Air and gas compressor manufacturing Power-driven handtool manufacturing .. Welding and soldering equipment manufacturing. Packaging machinery manufacturing ... Industrial process furnace and oven manufacturing. 331525 ..... 331528 ..... 332111 332112 332115 332116 332117 332211 ..... ..... ..... ..... ..... ..... 332212 ..... 332213 ..... 332214 ..... 332323 ..... 332439 332510 332611 332612 332618 ..... ..... ..... ..... ..... 332710 332812 332911 332912 ..... ..... ..... ..... 332913 ..... 332919 ..... 332991 ..... 332996 ..... 332997 ..... 332998 ..... 332999 ..... 333319 ..... 333411 ..... 333412 ..... 333414 ..... 333511 ..... 333512 ..... 333513 ..... 333514 ..... 333515 ..... 333516 ..... 333518 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 333612 ..... 333613 ..... 333911 ..... 333912 ..... 333991 ..... 333992 ..... 333993 ..... 333994 ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total 1,425 82 541 29 33 30 2,141 1,503 1,401 86 80 570 532 31 29 35 33 32 30 2,257 2,104 514 514 514 515 514 514 30 30 30 30 30 30 196 196 196 196 196 196 11 11 11 11 11 11 12 12 12 12 12 12 11 11 11 11 11 11 774 774 774 775 774 774 514 514 30 30 196 196 11 11 12 12 11 11 774 774 0 0 0 0 0 0 0 520 20 127 7 12 8 694 524 517 523 514 514 30 30 30 30 30 199 197 199 196 196 11 11 11 11 11 13 13 13 12 12 11 11 11 11 11 788 777 786 774 774 515 519 514 514 30 20 30 30 196 127 196 196 11 7 11 11 12 12 12 12 11 8 11 11 774 694 774 774 514 30 196 11 12 11 774 519 30 198 11 13 11 781 514 514 30 30 196 196 11 11 12 12 11 11 774 774 514 484 30 23 196 153 11 8 12 12 11 9 774 690 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 517 30 197 11 13 11 777 515 516 30 30 196 196 11 11 12 13 11 11 774 776 514 30 196 11 12 11 774 515 30 196 11 12 11 774 515 30 196 11 12 11 775 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 514 514 30 30 30 196 196 196 11 11 11 12 12 12 11 11 11 774 774 774 514 514 30 30 196 196 11 11 12 12 11 11 774 774 Frm 00143 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56416 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] Engineering controls (includes abrasive blasting) NAICS Industry 333995 ..... Fluid power cylinder and actuator manufacturing. Fluid power pump and motor manufacturing. Scale and balance (except laboratory) manufacturing. All other miscellaneous general purpose machinery manufacturing. Watch, clock, and part manufacturing .. Electric housewares and household fans. Household cooking appliance manufacturing. Household refrigerator and home freezer manufacturing. Household laundry equipment manufacturing. Other major household appliance manufacturing. Automobile manufacturing .................... Light truck and utility vehicle manufacturing. Heavy duty truck manufacturing ........... Motor vehicle body manufacturing ....... Truck trailer manufacturing ................... Motor home manufacturing .................. Carburetor, piston, piston ring, and valve manufacturing. Gasoline engine and engine parts manufacturing. Other motor vehicle electrical and electronic equipment manufacturing. Motor vehicle steering and suspension components (except spring) manufacturing. Motor vehicle brake system manufacturing. Motor vehicle transmission and power train parts manufacturing. Motor vehicle metal stamping .............. All other motor vehicle parts manufacturing. Ship building and repair ....................... Boat building ......................................... Military armored vehicle, tank, and tank component manufacturing. Showcase, partition, shelving, and locker manufacturing. Dental equipment and supplies manufacturing. Dental laboratories ............................... Jewelry (except costume) manufacturing. Jewelers’ materials and lapidary work manufacturing. Costume jewelry and novelty manufacturing. Sign manufacturing ............................... Industrial supplies, wholesalers ............ Rail transportation ................................ Dental offices ........................................ Total—General Industry and Maritime Residential Building Construction ......... Nonresidential Building Construction ... Utility System Construction .................. Land Subdivision .................................. Highway, Street, and Bridge Construction. Other Heavy and Civil Engineering Construction. Foundation, Structure, and Building Exterior Contractors. Building Equipment Contractors ........... Building Finishing Contractors .............. Other Specialty Trade Contractors ....... State and Local Governments [c] ......... 333996 ..... 333997 ..... 333999 ..... 334518 ..... 335211 ..... 335221 ..... 335222 ..... 335224 ..... 335228 ..... 336111 ..... 336112 ..... 336120 336211 336212 336213 336311 ..... ..... ..... ..... ..... 336312 ..... 336322 ..... 336330 ..... 336340 ..... 336350 ..... 336370 ..... 336399 ..... 336611 ..... 336612 ..... 336992 ..... 337215 ..... 339114 ..... 339116 ..... 339911 ..... 339913 ..... 339914 ..... mstockstill on DSK4VPTVN1PROD with PROPOSALS2 339950 423840 482110 621210 ..... ..... ..... ..... 236100 236200 237100 237200 237300 ..... ..... ..... ..... ..... 237900 ..... 238100 ..... 238200 238300 238900 999000 ..... ..... ..... ..... VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Exposure monitoring Respirators Medical surveillance Regulated areas or access control Training Total 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 0 30 0 196 0 11 0 12 0 11 0 774 0 523 20 127 7 12 8 698 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 514 514 30 30 196 196 11 11 12 12 11 11 774 774 514 514 514 514 514 30 30 30 30 30 196 196 196 196 196 11 11 11 11 11 12 12 12 12 12 11 11 11 11 11 774 774 774 774 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 514 30 196 11 12 11 774 517 514 30 30 197 196 11 11 13 12 11 11 778 774 2,820 2,816 0 0 0 0 253 252 0 151 151 0 13 12 0 16 15 0 3,252 3,247 0 514 30 196 11 12 11 774 663 39 180 14 12 14 922 8 45 5 35 107 225 2 13 32 17 2 13 156 348 52 40 256 14 19 15 397 50 26 166 9 12 10 274 459 262 20 24 132 215 7 9 12 13 7 9 639 531 3 337 264 117 326 104 275 2 29 43 52 30 9 44 32 205 42 42 71 25 89 1 12 38 46 27 8 39 11 23 30 37 69 30 102 1 11 15 7 10 3 10 49 616 432 301 532 180 559 202 20 57 18 67 6 372 228 204 80 180 58 28 778 156 289 276 N/A 18 24 26 N/A 26 28 49 N/A 16 51 32 N/A 30 30 53 N/A 7 9 18 N/A 253 431 454 N/A Frm 00144 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56417 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued [2009 dollars] NAICS Engineering controls (includes abrasive blasting) Industry Total—Construction .............................. Exposure monitoring Respirators 242 87 56 Medical surveillance Regulated areas or access control Training 83 49 17 Total 533 Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013). TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION Ventilation airflow (cfm) Description Saw enclosure ............ 8′ x 8′ x 8′ wood/plastic. N/A $487.70 $48.77 $118.95 Cab enclosures .......... Enclosed cabs ............ N/A 15,164.82 5,307.69 3,698.56 LEV for hand held grinders. Shrouds + vacuum ..... N/A 1,671.63 585.07 407.70 Upgraded abrasive blast cabinet. Improved maintenance and purchases for some. N/A 4,666.10 1,000.00 664.35 Improved spray booth for pottery. Maintenance time & materials. N/A 116.65 114.68 231.33 Improved LEV for ceramics spray booth. Exhaust for saw, cut stone industry. Increased air flow; per cfm. Based on saw LEV (e.g., pg. 10–158, 159, 160, ACGIH, 2001). Granite cutting and finishing; (pg. 10–94, ACGIH, 2001). Based on abrasive cut-off saw; (pg. 10– 134) (ACGIH, 2001). Bag opening station; (pg. 10–19, ACGIH, 2001). Conveyor belt ventilation; (pg. 10–70, ACGIH, 2001). Bucket elevator ventilation (pg. 10–68; ACGIH, 2001). N/A 3.21 0.88 3.21 450 5,774.30 1,577.35 822.13 600 7,699.06 2,103.14 1,096.17 500 6,415.89 1,752.61 913.48 1,513 19,414.48 5,303.41 2,764.18 700 8,982.24 2,453.66 1,278.87 1,600 20,530.84 5,608.36 2,923.13 1,050 13,473.36 3,680.49 1,918.30 1,200 15,398.13 4,206.27 2,192.35 4′ x 6′ screen; 50 cfm per ft2. 1,050 13,473.36 3,680.49 1,918.30 ERG estimate of cfm requirements. 3,750 48,119.16 13,144.60 6,851.09 ERG estimate of cfm requirements. LEV for hand chipping in cut stone. Exhaust trimming machine. Bag opening ............... Conveyor ventilation ... Bucket elevator ventilation. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Bin and hopper ventilation. Screen ventilation ....... Batch operator workstation. LEV for hand grinding operator (pottery). VerDate Mar<15>2010 Bin and hopper ventilation (pg. 10–69; ACGIH, 2001). Ventilated screen (pg. 10–173, ACGIH, 2001). Bin & hopper ventilation for unvented mixers (pg. 10–69, ACGIH, 2001). Hand grinding bench (pg. 10–135, ACGIH, 2001). 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00145 Capital cost [b] Annualized capital cost Control [a] Fmt 4701 Sfmt 4702 Operating cost E:\FR\FM\12SEP2.SGM 12SEP2 Comment or source Fabrication costs estimated by ERG, assuming in-plant work. Five-year life. ERG estimate based on vendor interviews. Vacuum plus shroud adapter (http://www. proventilation.com/ products/productDetail.asp?id=15); 35% for maintenance and operating costs. Assumes add. maintenance (of up to $2,000) or new cabinets ($8,000) (Norton, 2003). Annual: $100 materials plus 4 hours maintenance time. 25% of installed CFM price. ERG based on typical saw cfm requirements. ERG estimate of cfm requirements. Opening of 2 sq ft assumed, with 250 cfm/sq.ft. 3.5′ x 1.5′ opening; with ventilated bag crusher (200 cfm). Per take-off point, 2′ wide belt. 2′ x 3′ x 30′ casing; 4 take-offs @250 cfm; 100 cfm per sq ft of cross section. 350 cfm per ft2; 3’ belt width. 56418 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued Ventilation airflow (cfm) Capital cost [b] Annualized capital cost Control [a] Description LEV, mixer and muller hood. Mixer & muller hood (pg. 10–87, ACGIH, 2001). Bag filling station (pg. 10–15, ACGIH, 2001). Manual controls, system covers 100 ft of conveyor. 1,050 13,473.36 3,680.49 1,918.30 ERG estimate of cfm requirements. 1,500 19,247.66 5,257.84 2,740.43 Includes costs for air shower. N/A 10,207.09 1,020.71 1,453.26 Plumbing for hose installations, floor resloping and troughs. Ventilated shakeout conveyor enclosure. Shakeout double sidedraft table (pg. 10– 23, ACGIH, 2001). Ventilated enclosing hood (pg. 10–23, ACGIH, 2001); 4′ x 4′ openings. Portable grinding table pg. 10–136), ACGIH, 2001), 3′ x 3′ opening. Hand grinding table pg. 10–135), ACGIH, 2001), 4′ x 6′ surface. Ventilated cut-off saw (pg. 10–134, ACGIH, 2001, 2′ x 3′ opening. Bench with LEV (pg. 10–135, ACGIH, 2001); 3′ x 5′. Bench with LEV (pg. 10–149, ACGIH, 2001), 3′ x 4′. Bench with LEV (pg. 10–135, ACGIH, 2001); 3′ x 4′. Retrofit suction attachment. Clean air supplied directly to worker. N/A 36,412.40 3,258.87 5,184.31 10,000 128,317.75 35,052.26 18,269.56 National Environmental Services Company (Kestner, 2003). ERG estimate. Includes cost of water and labor time. ERG estimate. 28,800 369,555.11 100,950.52 52,616.33 ERG estimate of cfm requirements. 7,040 90,335.69 24,676.79 12,861.77 ERG estimate of opening size required. 1,350 17,322.90 4,732.06 2,466.39 ERG estimate of opening size required. 4,800 61,592.52 16,825.09 8,769.39 ERG estimate of bench surface area. 1,500 19,247.66 5,257.84 2,740.43 ERG estimate of opening size required. 3,750 48,119.16 13,144.60 6,851.09 1,400 17,964.48 4,907.32 2,557.74 2,400 30,796.26 8,412.54 4,384.69 200 464.21 701.05 66.09 2,500 32,079.44 8,763.07 4,567.39 ERG estimate of cfm requirements; 250 cfm/sq. ft. ERG estimate of cfm requirements; 125 cfm per linear foot. ERG estimate of cfm requirements; 200 cfm/sq. ft. ERG estimate of cfm requirements. ERG estimate of cfm requirements; 125 cfm/sq. ft. for 20 square feet. ERG estimate. $100 in annual costs. LEV for bag filling stations. Installed manual spray mister. Install cleaning hoses, reslope floor, drainage. Shakeout conveyor enclosure. Shakeout side-draft ventilation. Shakeout enclosing hood. Small knockout table .. Large knockout table .. Ventilated abrasive cutoff saw. Hand grinding bench (foundry). Forming operator bench (pottery). Hand grinding bench (pottery). Hand tool hardware .... Clean air island .......... Operating cost Shop-built water feed equipment. N/A 116.65 0.00 116.65 Ventilation blower and ducting. N/A 792.74 198.18 193.34 Control room .............. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Water fed chipping equipment drum cleaning. Ventilation for drum cleaning. 10′ x 10′ ventilated control room with HEPA filter. 200 19,556.79 701.05 2,784.45 Control room improvement. Repair and improve control room enclosure. N/A 2,240.00 N/A 318.93 Improved bag valves .. Bags with extended polyethylene valve, incremental cost per bag. N/A 0.01 N/A N/A VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00146 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Comment or source Electric blower (1,277 cfm) and 25 ft. of duct. Northern Safety Co. (p. 193). ERG estimate based on RSMeans (2003), ACGIH (2001). ERG estimate. Assumes repairs are 20% of new control room cost. Cecala et. al., (1986). Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56419 TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued Ventilation airflow (cfm) Capital cost [b] Annualized capital cost Control [a] Description Dust suppressants ..... Kleen Products 50 lb poly bag green sweeping compound. NILFISK VT60 wet/dry hepa vac, 15 gal. N/A N/A 634.54 0.00 N/A 3,494.85 511.20 852.36 HEPA vacuum for housekeeping. Yard dust suppression NILFISK, large capacity. 100 ft, 1’’ contractor hose and nozzle. N/A 7,699.06 988.90 1,877.73 N/A 204.14 0.00 112.91 Wet methods to clean concrete mixing equip.. HEPA vacuum substitute for compressed air. Spray system for wet concrete finishing. 10 mins per day per operator. N/A 0.00 916.82 0.00 Incremental time to remove dust by vacuum. Shop-built sprayer system. N/A N/A 494.54 0.00 5 min per day per affected worker. N/A 204.67 20.47 113.20 Substitute alt., non-silica, blasting media. Alternative media estimated to cost 22 percent more. N/A 0.00 33,646.00 0.00 Abrasive blasting cost per square foot (dry blasting). Half-mask, non-powered, air-purifying respirator. 125 blasting days per year. N/A N/A 2.00 N/A Assumes $100 in materials and 4 hours to fabricate. Also 10% for maintenance. Based on 212,000 square feet of coverage per year per crew. ERG estimate based on RSMeans (2009). Unit cost includes expenses for accessories, training, fit testing, and cleaning. Unit cost includes expenses for accessories, training, fit testing, and cleaning. Unit cost includes expenses for accessories, training, fit testing, and cleaning. Consulting IH technician—rate per sample. Assumes IH rate of $500 per day and samples per day of 2, 6, and 8 for small, medium, and large establishments, respectively. ..................................... N/A N/A 570.13 N/A N/A N/A 637.94 N/A N/A N/A 468.74 N/A N/A N/A 500 N/A N/A N/A 133.38 N/A Evaluation and office consultation including detailed examination. Tri-annual radiologic examination, chest; stereo, frontal. Costs include consultation and written report. N/A N/A 100.00 N/A N/A N/A 79.61 N/A HEPA vacuum for housekeeping. Full-face nonpowered air-purifying respirator. Half-face respirator (construction). Industrial Hygiene Fees/personal breathing zone. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Exposure assessment lab fees and shipping cost. Physical examination by knowledgeable Health Care Practitioner. Chest X-ray ................ VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00147 Fmt 4701 Sfmt 4702 Operating cost E:\FR\FM\12SEP2.SGM 12SEP2 Comment or source 0.28/lb, 2 lbs/day; 5 minutes/day (www.fastenal.com). Nilfisk, HEPA vacuum (http://www.sylvane. com/nilfisk.html). Nilfisk, HEPA vacuum (McCarthy, 2003). Contactor hose and nozzle; 2 year life; (www.pwmall.com). 10 mins per day per mixer operator. Lab fees (EMSL Laboratory, 2000) and OSHA estimates. Inflated to 2009 values. ERG, 2013. 56420 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued Control [a] Pulmonary function test. Ventilation airflow (cfm) Description Operating cost Annualized capital cost Comment or source N/A N/A 54.69 N/A N/A N/A 190.28 N/A N/A N/A 34.09 N/A Estimated cost of $2 per worker for the training/reading materials. ..................................... N/A N/A 2.00 N/A N/A N/A 17.94 N/A 1.00 per respirator per day, typical cost for N95 disposable respirator. Per suit, daily clothing costs for 10% of workers. Per regulated area for annual set-up (300 ft). 25.30 per sign ............ N/A N/A 1.00 N/A N/A N/A 5.50 N/A Lab Safety Supply, 2010. N/A N/A 5.80 N/A Lab Safety Supply, 2010. N/A N/A 151.80 N/A ..................................... N/A 226.73 [d] 0.18 125.40 Dust shrouds: grinder ..................................... N/A 97.33 [d] 0.14 97.33 Water tank, portable (unspecified capacity). Water tank, small capacity (hand pressurized). Hose (water), 20′, 2″ diameter. Custom water spray nozzle and attachments. Hose (water), 200′, 2″ diameter. Vacuum, 10–15 gal with HEPA. ..................................... N/A [e] 15.50 N/A Lab Safety Supply, 2010. Contractors Direct (2009); Berland House of Tools (2009); mytoolstore (2009). Contractors Direct (2009); Berland House of Tools (2009); Dust-Buddy (2009); Martin (2008). RSMeans—based on monthly rental cost. ..................................... N/A [d] 0.11 79.04 ..................................... N/A N/A [e] 1.65 N/A ..................................... N/A 363 [d] 0.54 388.68 ..................................... N/A N/A [e] 16.45 N/A ..................................... N/A 725 [d] 0.56 400.99 Vacuum, large capacity with HEPA. ..................................... N/A 2,108 [d] 1.63 1,165.92 Examination by a pulmonary specialist [c]. Training instructor cost per hour. Training materials for class per attendee. Value of worker time spent in class. Cost—disposable particulate respirator (N95). Disposable clothing .... Hazard tape ................ mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Warning signs (6 per regulated area). Wet kit, with water tank. VerDate Mar<15>2010 Tri-annual spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurements(s), and/or maximal voluntary ventilation. Office consultation and evaluation by a pulmonary specialist. ..................................... Capital cost [b] 20:46 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00148 Fmt 4701 N/A 73.87 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Based on supervisor wage, adjusted for fringe benefits (BLS, 2008, updated to 2009 dollars). Based on worker wage, adjusted for fringe benefits (BLS, 2008, updated to 2009 dollars). Lab Safety Supply, 2010. Contractors Direct (2009); mytoolstore (2009). RSMeans—based on monthly cost. New Jersey Laborers’ Health and Safety Fund (2007). RSMeans—based on monthly rental cost. ICS (2009); Dust Collection (2009); EDCO (2009); CS Unitec (2009). ICS (2009); EDCO (2009); Aramsco (2009). Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56421 TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued Ventilation airflow (cfm) Capital cost [b] Annualized capital cost Control [a] Description Dust extraction kit (rotary hammers). ..................................... N/A 215 [d] 0.30 214.81 Dust control/quarry drill. ..................................... N/A N/A [e] 17.33 N/A Dustless drywall sander. ..................................... N/A 133 [d] 0.19 133.33 Cab enclosure/w ventilation and air conditioning. Foam dust suppression system. Water tank, engine driven discharge, 5000 gal.. Tunnel dust suppression system supplement. Training instructor cost per hour (Construction). ..................................... N/A 13,000 [d] 2.59 1,850.91 ..................................... N/A 14,550 [e] 162.07 2,071.59 ..................................... N/A N/A [d] 121.50 N/A ..................................... N/A 7,928 [e] 2.71 1,933.47 ..................................... N/A N/A 43.12 N/A Value of worker time spent in class (Construction). ..................................... N/A N/A 22.22 N/A Warning signs (3 per regulated area) (Construction). Per-worker costs for written access control plan or regulated area setup implementation (Construction). 25.30 per sign ............ N/A N/A 75.90 N/A Weighted average annual cost per worker; Applies to workers with exposures above the PEL. Operating cost Comment or source Grainger (2009); mytoolstore (2009); Toolmart (2009). RSMeans Heavy Construction Cost Data (2008). Home Depot (2009); LSS (2009); Dustless Tech (2009). Estimates from equipment suppliers and retrofitters. Midyette (2003). RSMeans (2008)— based on monthly rental cost. Raring (2003). Based on supervisor wage, adjusted for fringe benefits (BLS, 2008, updated to 2009 dollars). Based on worker wage, adjusted for fringe benefits (BLS, 2008, updated to 2009 dollars). Lab Safety Supply, 2010. 175.56 [a] For mstockstill on DSK4VPTVN1PROD with PROPOSALS2 local exhaust ventilation (LEV), maintenance, and conveyor covers, OSHA applied the following estimates: LEV: capital cost = $12.83 per cfm; operating cost = $3.51 per cfm; annualized capital cost = $1.83 per cfm; based on current energy prices and the estimates of consultants to ERG (2013). Maintenance: estimated as 10% of capital cost. Conveyor Covers: estimated as $17.10 per linear foot for 100 ft. (Landola, 2003); capital cost = $19.95 per linear ft., including all hardware; annualized capital cost = $2.84 per linear ft. [b] Adjusted from 2003 price levels using an inflation factor of 1.166, calculated as the ratio of average annual GDP Implicit Price Deflator for 2009 and 2003. [c] Mean expense per office-based physician visit to a pulmonary specialist for diagnosis and treatment, based on data from the 2004 Medical Expenditure Panel Survey. Inflated to 2009 dollars using the consumer price inflator for medical services. Costs for physical exams and tests, chest X-ray, and pulmonary tests are direct medical costs used in bundling services under Medicare (Intellimed International, 2003). Costs are inflated by 30% to eliminate the effect of Medicare discounts that are unlikely to apply to occupational medicine environments. [d] Daily maintenance and operating cost. [e] Daily equipment costs derived from RS Means (2008) monthly rental rates, which include maintenance and operating costs. Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013). Federal Rules Which May Duplicate, Overlap, or Conflict With the Proposed Rule. OSHA has not identified any other Federal rules which may duplicate, overlap, or conflict with the proposal, and requests comments from the public regarding this issue. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 1. Alternatives to the Proposed Rule which Accomplish the Stated Objectives of Applicable Statutes and which Minimize any Significant Economic Impact of the Proposed Rule on Small Entities SBREFA Panel process or on recommendations made by the SBREFA Panel as potentially alleviating impacts on small entities. Then, the Agency presents various regulatory alternatives to the proposed OSHA silica standard. This section first discusses several provisions in the proposed standard that OSHA has adopted or modified based on comments from small entity representatives (SERs) during the a. Elements of Proposed Rule To Reduce Impacts on Small Entities PO 00000 Frm 00149 Fmt 4701 Sfmt 4702 The SBREFA Panel was concerned that changing work conditions in the construction industry would make it E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56422 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules difficult to apply some of the provisions that OSHA suggested at the time of the Panel. OSHA has preliminarily decided to change its approach in this sector. OSHA is proposing two separate standards, one for general industry and maritime and one for construction. As described earlier in this preamble, in construction, OSHA has provided a table—labeled Table 1, Exposure Control Methods for Selected Construction Operations—that for special operations enables the employer to implement engineering controls, work practices, and respiratory protection without the need for exposure assessment. Table 1 in the proposed construction standard presents engineering and work practice controls and respiratory protection options for special operations. Where employees perform the special operations listed in the table and the employer has fully implemented the engineering controls, work practices, and respiratory protection specified in the table, the employer is not required to assess the exposure of employees performing such operations. As an alternative to the regulated area provision, OSHA is proposing that employers be permitted the option of establishing written access control plans that must contain provisions for a competent person; procedures for notifying employees of the presence of exposure to respirable crystalline silica and demarcating such areas from the rest of the workplace; in multi-employer workplaces, the methods for informing other employers of the presence and location of areas where silica exposures may exceed the PEL; provisions for limiting access to areas where silica exposures are likely; and procedures for providing respiratory protection to employees entering areas with controlled access. Further discussion on this alternative is found in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control. OSHA believes that, although the estimated per-worker cost for written access control plans averages somewhat higher than the per-worker cost for regulated areas ($199.29 per worker for the control plans vs. $167.65 per worker for the regulated area), access control plans may be significantly less costly and more protective than regulated areas in certain work situations. Some SERs were already applying many of the protective controls and practices that would be required by the ancillary provisions of the standard. However, many SERs objected to the provisions regarding housekeeping, protective clothing, and hygiene facilities. For this proposed rule, OSHA VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 removed the requirement for hygiene facilities, which has resulted in the elimination of compliance costs for change rooms, shower facilities, lunch rooms, and hygiene-specific housekeeping requirements. OSHA also restricted the provision for protective clothing (or, alternatively, any other means to remove excessive silica dust from work clothing) to situations where there is the potential for employees’ work clothing to become grossly contaminated with finely divided material containing crystalline silica. b. Regulatory Alternatives For the convenience of those persons interested only in OSHA’s regulatory flexibility analysis, this section repeats the discussion of the various regulatory alternatives to the proposed OSHA silica standard presented in the Introduction and in Section VIII.H of this preamble. Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency’s findings of significant risk and feasibility. To facilitate comment, the regulatory alternatives have been organized into four categories: (1) Alternative PELs to the proposed PEL of 50 mg/m3; (2) regulatory alternatives that affect proposed ancillary provisions; (3) a regulatory alternative that would modify the proposed methods of compliance; and (4) regulatory alternatives concerning when different provisions of the proposed rule would take effect. Alternative PELs OSHA is proposing a new PEL for respirable crystalline silica of 50 mg/m3 for all industry sectors covered by the rule. OSHA’s proposal is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so. See Section II of this preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements. OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. The Agency has also developed estimates of the risk of silica-related diseases assuming exposure over a working PO 00000 Frm 00150 Fmt 4701 Sfmt 4702 lifetime at the proposed PEL and action level, as well as at OSHA’s current PELs. These analyses are presented in a background document entitled ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’ and are summarized in this preamble in Section V, Health Effects Summary, and Section VI, Summary of OSHA’s Preliminary Quantitative Risk Assessment, respectively. 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. As discussed in Section VII, Significance of Risk, in this preamble, OSHA preliminarily finds that worker exposure to respirable crystalline silica constitutes a significant risk and that the proposed standard will substantially reduce this risk. Section 6(b) of the OSH Act (29 U.S.C. 655(b)) requires OSHA to determine that its standards are technologically and economically feasible. OSHA’s examination of the technological and economic feasibility of the proposed rule is presented in the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA), and is summarized in this section (Section VIII) of this preamble. For general industry and maritime, OSHA has preliminarily concluded that the proposed PEL of 50 mg/m3 is technologically feasible for all affected industries. For construction, OSHA has preliminarily determined that the proposed PEL of 50 mg/m3 is feasible in 10 out of 12 of the affected activities. Thus, OSHA preliminarily concludes that engineering and work practices will be sufficient to reduce and maintain silica exposures to the proposed PEL of 50 mg/m3 or below in most operations most of the time in the affected industries. For those few operations within an industry or activity where the proposed PEL is not technologically feasible even when workers use recommended engineering and work practice controls, employers can supplement controls with respirators to achieve exposure levels at or below the proposed PEL. OSHA developed quantitative estimates of the compliance costs of the proposed rule for each of the affected industry sectors. The estimated compliance costs were compared with E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has preliminarily concluded that compliance with the requirements of the proposed rule would be economically feasible in every affected industry sector. OSHA has examined two regulatory alternatives (named Regulatory Alternatives #1 and #2) that would modify the PEL for the proposed rule. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 Under Regulatory Alternative #1, the proposed PEL would be changed from 50 mg/m3 to 100 mg/m3 for all industry sectors covered by the rule, and the action level would be changed from 25 mg/m3 to 50 mg/m3 (thereby keeping the action level at one-half of the PEL). Under Regulatory Alternative #2, the proposed PEL would be lowered from 50 mg/m3 to 25 mg/m3 for all industry sectors covered by the rule, while the action level would remain at 25 mg/m3 (because of difficulties in accurately measuring exposure levels below 25 mg/ m3). Tables VIII–31A and VIII–31B present, for informational purposes, the estimated costs, benefits, and net PO 00000 Frm 00151 Fmt 4701 Sfmt 4702 56423 benefits of the proposed rule under the proposed PEL of 50 mg/m3 and for the regulatory alternatives of a PEL of 100 mg/m3 and a PEL of 25 mg/m3 (Regulatory Alternatives # 1 and #2), using alternative discount rates of 3 and 7 percent. These two tables also present the incremental costs, the incremental benefits, and the incremental net benefits of going from a PEL of 100 mg/ m3 to the proposed PEL of 50 mg/m3 and then of going from the proposed PEL of 50 mg/m3 to a PEL of 25 mg/m3. Table VIII–31A breaks out costs by provision and benefits by type of disease and by morbidity/mortality, while Table VIII– 31B breaks out costs and benefits by major industry sector. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56424 VerDate Mar<15>2010 Jkt 229001 PO 00000 25~!!1m3 ~ Discount Rate 3 Incremental Costs/Benefits ~ ~ ~ ~ 3% 100~!!1m3 Incremental Costs/Benefits 501!g/m ~ ~ ~ 3% Frm 00152 Annualized Costs Fmt 4701 $330 $421 $203 $219 $49 $85 Total Annualized Costs (point estimate) Sfmt 4725 Annual Benefits: Number of Cases Prevented E:\FR\FM\12SEP2.SGM Fatal Lung Cancers (midpoint estimate) Fatal Silicosis & other Non-Malignant Respiratory Diseases Fatal Renal Disease $344 $422 $203 $227 $50 $86 $0 $330 $131 $143 $0 $66 $0 $331 $129 $148 $0 $66 $330 $91 $73 $76 $49 $1,308 Engineering Controls (includes Abrasive Blasting) Respirators Exposure Assessment Medical Surveillance Training Regulated Area or Access Control $1,332 $670 $674 $637 Cases Cases $344 $91 $74 $79 $50 $187 $88 $26 $28 $0 ~ ~ $658 $339 Cases $197 $88 $26 $29 $0 $143 $2 $47 $48 $49 ~ Cases $147 $3 $48 $50 $50 ~ $351 $299 $307 Cases 23'7 75 """""i62 79 83 527 152 375 186 189 258 108 151 91 Silica-Related Mortality 1,023 $4,811 $3,160 335 Silicosis Morbidity 1,770 186 $1,543 $1,028 688 $3,268 $2,132 357 1,585 632 60 $1,704 $1,116 331 $1.565 953 $1,016 $2,219 $1,523 $233 $160 $1,986 $1,364 $792 $544 $1,194 $820 Monetized Annual Benefits (midpoint estimate) $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 Net Benefits $5,722 $3,352 $1,105 $514 $4,617 $2,838 $2,157 $1,308 $2,460 $1,529 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 12SEP2 EP12SE13.018</GPH> 3 Millions ($2009) Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 3 Table VIII-31A: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 J.lg/m and 100 J.lg/m Alternative mstockstill on DSK4VPTVN1PROD with PROPOSALS2 3 Jkt 229001 ~ ~ Discount Rate 3 Incremental Costs/Benefits 251!g/m ~ Frm 00153 Fmt 4701 Sfmt 4702 12SEP2 $1,062 $270 $548 $122 $551 $123 Total Annualized Costs $1,308 $1,332 $670 $674 $495 $143 ~ ~ 100 I!g/m ~ 3% ~ $511 $147 $233 $106 $241 $110 $262 $36 $270 $37 $658 $339 $351 $299 $307 ---- Annual Benefits: Number of Cases Prevented Silica-Related Mortality Construction General Industry/Maritime Total Silicosis Morbidity Construction General Industry/Maritime Total Total Net Benefits Construction General Industry/Maritime Total Cases Cases $637 Cases Cases Cases 802 221 $3,804 $1,007 $2,504 $657 235 100 $1,109 $434 $746 $283 567 121 $2,695 $573 $1,758 $374 242 115 $1,158 $545 $760 $356 325 6 $1,537 $27 $998 $18 1,023 $4,811 $3,160 335 $1,543 $1,028 688 $3,268 $2,132 357 $1,704 $1,116 331 $1,565 $1,016 1,157 613 $1,451 $768 $996 $528 77 109 $96 $136 $66 $94 1,080 504 $1,354 $632 $930 $434 161 471 $202 $590 $139 $405 919 33 $1,152 $42 $791 $29 1,770 $2,219 $1,523 186 $233 $160 1,585 $1,986 $1,364 632 $792 $544 953 $1,194 $820 $5,255 $1,775 $3,500 $1.184 $1,205 $570 $812 $377 $4,049 $1,205 $2,688 $808 $1,360 $1,135 $898 $761 $2,690 $69 $1,789 $47 $7,030 $4,684 $1,776 $1,188 $5,254 $3,495 $2,495 $1,659 $2,759 $1,836 $4,211 $1,511 $2,437 $914 $657 $448 $261 $254 $3,555 $1,062 $2,177 $661 $1,127 $1,029 $658 $651 $2,427 $33 $1,519 $10 $5,722 $3,352 $1,105 $514 $4,617 $2,838 $2,157 $1,308 $2,460 $1,529 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 56425 related fatalities and an additional 632 cases of silicosis. Based on its E:\FR\FM\12SEP2.SGM a PEL of 50 mg/m3 would prevent, annually, an additional 357 silica- PO 00000 $1,043 $264 ~ 3 Incremental Costs/Benefits 50 I!g/m ~ Annualized Costs Construction General Industry/Maritime Monetized Annual Benefits (midpoint estimate) Construction Generallndustry/Maritime EP12SE13.019</GPH> 3 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 As Tables VIII–31A and VIII–31B show, going from a PEL of 100 mg/m3 to VerDate Mar<15>2010 3 Table VIII-31B: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 I'g/m and 100 I'g/m Alternative, by Major Industry Sector Millions ($2009) 56426 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 preliminary findings that the proposed PEL of 50 mg/m3 significantly reduces worker risk from silica exposure (as demonstrated by the number of silicarelated fatalities and silicosis cases avoided) and is both technologically and economically feasible, OSHA cannot propose a PEL of 100 mg/m3 (Regulatory Alternative #1) without violating its statutory obligations under the OSH Act. However, the Agency will consider evidence that challenges its preliminary findings. As previously noted, Tables VIII–31A and VIII–31B also show the costs and benefits of a PEL of 25 mg/m3 (Regulatory Alternative #2), as well as the incremental costs and benefits of going from the proposed PEL of 50 mg/ m3 to a PEL of 25 mg/m3. Because OSHA determined that a PEL of 25 mg/m3 would not be feasible (that is, engineering and work practices would not be sufficient to reduce and maintain silica exposures to a PEL of 25 mg/m3 or below in most operations most of the time in the affected industries), the Agency did not attempt to identify engineering controls or their costs for affected industries to meet this PEL. Instead, for purposes of estimating the costs of going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3, OSHA assumed that all workers exposed between 50 mg/ m3 and 25 mg/m3 would have to wear respirators to achieve compliance with the 25 mg/m3 PEL. OSHA then estimated the associated additional costs for respirators, exposure assessments, medical surveillance, and regulated areas (the latter three for ancillary requirements specified in the proposed rule). As shown in Tables VIII–31A and VIII–31B, going from a PEL of 50 mg/m3 to a PEL of 25 mg/m3 would prevent, annually, an additional 335 silicarelated fatalities and an additional 186 cases of silicosis. These estimates support OSHA’s preliminarily finding that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has preliminarily determined that a PEL of 25 mg/m3 (Regulatory Alternative #2) is not technologically feasible, and for that reason, cannot propose it without violating its statutory obligations under the OSH Act. Regulatory Alternatives That Affect Ancillary Provisions The proposed rule contains several ancillary provisions (provisions other the PEL), including requirements for exposure assessment, medical VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 surveillance, silica training, and regulated areas or access control. As shown in Table VIII–31A, these ancillary provisions represent approximately $223 million (or about 34 percent) of the total annualized costs of the rule of $658 million (using a 7 percent discount rate). The two most expensive of the ancillary provisions are the requirements for medical surveillance, with annualized costs of $79 million, and the requirements for exposure monitoring, with annualized costs of $74 million. As proposed, the requirements for exposure assessment are triggered by the action level. As described in the preamble, OSHA has defined the action level for the proposed standard as an airborne concentration of respirable crystalline silica of 25 mg/m3 calculated as an eight-hour time-weighted average. In this proposal, as in other standards, the action level has been set at one-half of the PEL. Because of the variable nature of employee exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the PEL on days when no exposure measurements are made. Even when all measurements on a given day may fall below the PEL (but are above the action level), there is some chance that on another day, when exposures are not measured, the employee’s actual exposure may exceed the PEL. When exposure measurements are above the action level, the employer cannot be reasonably confident that employees have not been exposed to respirable crystalline silica concentrations in excess of the PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring. The action level is also intended to encourage employers to lower exposure levels in order to avoid the costs associated with the exposure assessment provisions. Some employers would be able to reduce exposures below the action level in all work areas, and other employers in some work areas. As exposures are lowered, the risk of adverse health effects among workers decreases. PO 00000 Frm 00154 Fmt 4701 Sfmt 4702 OSHA’s preliminary risk assessment indicates that significant risk remains at the proposed PEL of 50 mg/m3. Where there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr.Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA’s preliminary conclusion is that the requirements triggered by the action level will result in a very real and necessary, but non-quantifiable, further reduction in risk beyond that provided by the PEL alone. OSHA’s choice of proposing an action level for exposure monitoring of one-half of the PEL is based on the Agency’s successful experience with other standards, including those for inorganic arsenic (29 CFR 1910.1018), ethylene oxide (29 CFR 1910.1047), benzene (29 CFR 1910.1028), and methylene chloride (29 CFR 1910.1052). As specified in the proposed rule, all workers exposed to respirable crystalline silica above the PEL of 50 mg/ m3 are subject to the medical surveillance requirements. This means that the medical surveillance requirements would apply to 15,172 workers in general industry and 336,244 workers in construction. OSHA estimates that 457 possible silicosis cases will be referred to pulmonary specialists annually as a result of this medical surveillance. OSHA has preliminarily determined that these ancillary provisions will: (1) Help to ensure the PEL is not exceeded, and (2) minimize risk to workers given the very high level of risk remaining at the PEL. OSHA did not estimate, and the benefits analysis does not include, monetary benefits resulting from early discovery of illness. Because medical surveillance and exposure assessment are the two most costly ancillary provisions in the proposed rule, the Agency has examined four regulatory alternatives (named Regulatory Alternatives #3, #4, #5, and #6) involving changes to one or the other of these ancillary provisions. These four regulatory alternatives are defined below and the incremental cost impact of each is summarized in Table VIII–32. In addition, OSHA is including a regulatory alternative (named Regulatory Alternative #7) that would remove all ancillary provisions. E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 13% Discount Rate I Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GIIM Total Jkt 229001 Frm 00155 Fmt 4701 Sfmt 4702 12SEP2 $494,826,699 $142,502,681 $637,329,380 Option 3: PEL=50; AL=50 $457,686,162 $117,680,601 $575,366,763 -$37,140,537 -$24,822,080 -$61,962,617 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $606,697,624 $173,701,827 $780,399,451 $111,870,925 $31,199,146 $143,070,071 Option 5: PEL=50; AL=25, with medical exams annually $561,613,766 $145,088,559 $706,702,325 $66,787,067 $2,585,878 $69,372,945 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $775,334,483 $203,665,685 $979,000,168 $280,507,784 $61,163,004 $341,670,788 (7%·biscountRatel Cost Construction GIIM Incremental Cost Relative to Proposal Total Construction GI/M Total Proposed Rule $511,165,616 $146,726,595 $657,892,211 Option 3: PEL=50; AL=50 $473,638,698 $121,817,396 $595,456,093 -$37,526,918 -$24,909,200 -$62,436,118 Option 4: PEL=50; AL =25, with medical surveillance triggered by AL $627,197,794 $179,066,993 $806,264,787 $132,371,095 $36,564,312 $168,935,407 Option 5: PEL=50; AL=25, with medical exams annually $575,224,843 $149,204,718 $724,429,561 $64,059,227 $2,478,122 $66,537,350 Option 6: PEL=50; AL=25, with surveillance triggered by AL and medical exams annually $791,806,358 $208,339,741 $1,000,146,099 $280,640,742 $61,613,145 $342,253,887 Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis 56427 monitoring requirements would be triggered only if workers were exposed E:\FR\FM\12SEP2.SGM m3 to 50 mg/m3 while keeping the PEL at 50 mg/m3. As a result, exposure PO 00000 Proposed Rule Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 19:12 Sep 11, 2013 Under Regulatory Alternative #3, the action level would be raised from 25 mg/ VerDate Mar<15>2010 EP12SE13.020</GPH> Table VIII-32: Cost of Regulatory Alternatives Affecting Ancillary Provisions mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56428 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules above the proposed PEL of 50 mg/m3. As shown in Table VIII–32, Regulatory Option #3 would reduce the annualized cost of the proposed rule by about $62 million, using a discount rate of either 3 percent or 7 percent. Under Regulatory Alternative #4, the action level would remain at 25 mg/m3 but medical surveillance would now be triggered by the action level, not the PEL. As a result, medical surveillance requirements would be triggered only if workers were exposed at or above the proposed action level of 25 mg/m3. As shown in Table VIII–32, Regulatory Option #4 would increase the annualized cost of the proposed rule by about $143 million, using a discount rate of 3 percent (and by about $169 million, using a discount rate of 7 percent). Under Regulatory Alternative #5, the only change to the proposed rule would be to the medical surveillance requirements. Instead of requiring workers exposed above the PEL to have a medical check-up every three years, those workers would be required to have a medical check-up annually. As shown in Table VIII–32, Regulatory Option #5 would increase the annualized cost of the proposed rule by about $69 million, using a discount rate of 3 percent (and by about $66 million, using a discount rate of 7 percent). Regulatory Alternative #6 would essentially combine the modified requirements in Regulatory Alternatives #4 and #5. Under Regulatory Alternative #6, medical surveillance would be triggered by the action level, not the PEL, and workers exposed at or above the action level would be required to have a medical check-up annually rather than triennially. The exposure monitoring requirements in the proposed rule would not be affected. As shown in Table VIII–32, Regulatory Option #6 would increase the annualized cost of the proposed rule by about $342 million, using a discount rate of either 3 percent or 7 percent. OSHA is not able to quantify the effects of these preceding four regulatory alternatives on protecting workers exposed to respirable crystalline silica at levels at or below the proposed PEL of 50 mg/m3—where significant risk remains. The Agency solicits comment on the extent to which these regulatory options may improve or reduce the effectiveness of the proposed rule. The final regulatory alternative affecting ancillary provisions, Regulatory Alternative #7, would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical VerDate Mar<15>2010 20:46 Sep 11, 2013 Jkt 229001 surveillance, training, and regulated areas or access control. However, it should be carefully noted that elimination of the ancillary provisions does not mean that all costs for ancillary provisions would disappear. In order to meet the PEL, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that employers would increasingly follow the many recommendations to provide medical surveillance for employees. OSHA has not attempted to estimate the extent to which the costs of these activities would be reduced if they were not formally required, but OSHA welcomes comment on the issue. As indicated previously, OSHA preliminarily finds that there is significant risk remaining at the proposed PEL of 50 mg/m3. However, the Agency has also preliminarily determined that 50 mg/m3 is the lowest feasible PEL. Therefore, the Agency believes that it is necessary to include ancillary provisions in the proposed rule to further reduce the remaining risk. OSHA anticipates that these ancillary provisions will reduce the risk beyond the reduction that will be achieved by a new PEL alone. OSHA’s reasons for including each of the proposed ancillary provisions are detailed in Section XVI of this preamble, Summary and Explanation of the Standards. In particular, OSHA believes that requirements for exposure assessment (or alternately, using specified exposure control methods for selected construction operations) would provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is particularly important because individuals exposed above the PEL (which triggers medical surveillance in the proposed rule) are at significant risk of death and illness. Medical surveillance would allow for identification of respirable crystalline silica-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA believes that regulated areas and access control are important because they serve to limit exposure to respirable crystalline silica to as few employees as possible. Finally, OSHA believes that worker training is necessary to inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize potential health hazards. Worker training on silicarelated work practices is particularly PO 00000 Frm 00156 Fmt 4701 Sfmt 4702 important in controlling silica exposures because engineering controls frequently require action on the part of workers to function effectively. OSHA expects that the benefits estimated under the proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed rule. For example, OSHA believes that the effectiveness of the proposed rule depends on regulated areas or access control to further limit exposures and on medical surveillance to identify disease cases when they do occur. Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to respirable crystalline silica. For example, the industry consensus standards for crystalline silica, ASTM E 1132–06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626–09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, as well as the draft proposed silica standard for construction developed by the Building and Construction Trades Department, AFL– CIO, have each included comprehensive programs. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance (ASTM, 2006; 2009; BCTD 2001). Moreover, as mentioned previously, where there is continuing significant risk, the decision in the Asbestos case (Bldg. and Constr. Trades Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 1274 (DC Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers’ health. OSHA preliminarily concludes that the additional requirements in the ancillary provisions of the proposed standard clearly exceed this threshold. A Regulatory Alternative That Modifies the Methods of Compliance The proposed standard in general industry and maritime would require employers to implement engineering and work practice controls to reduce employees’ exposures to or below the PEL. Where engineering and/or work practice controls are insufficient, employers would still be required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. Under the proposed E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules construction standard, employers would be given two options for compliance. The first option largely follows requirements for the general industry and maritime proposed standard, while the second option outlines, in Table 1 (Exposure Control Methods for Selected Construction Operations) of the proposed rule, specific construction exposure control methods. Employers choosing to follow OSHA’s proposed control methods would be considered to be in compliance with the engineering and work practice control requirements of the proposed standard, and would not be required to conduct certain exposure monitoring activities. One regulatory alternative (Regulatory Alternative #8) involving methods of compliance would be to eliminate Table 1 as a compliance option in the construction sector. Under this regulatory alternative, OSHA estimates that there would be no effect on estimated benefits but that the annualized costs of complying with the proposed rule (without the benefit of the Table 1 option in construction) would increase by $175 million, totally in exposure monitoring costs, using a 3 percent discount rate (and by $178 million using a 7 percent discount rate), so that the total annualized compliance costs for all affected establishments in construction would increase from $495 to $670 million using a 3 percent discount rate (and from $511 to $689 million using a 7 percent discount rate). Regulatory Alternatives That Affect the Timing of the Standard The proposed rule would become effective 60 days following publication of the final rule in the Federal Register. Provisions outlined in the proposed standard would become enforceable 180 days following the effective date, with the exceptions of engineering controls and laboratory requirements. The proposed rule would require engineering controls to be implemented no later than one year after the effective date, and laboratory requirements would be required to begin two years after the effective date. One regulatory alternative (Regulatory Alternative #9) involving the timing of the standard would arise if, contrary to OSHA’s preliminary findings, a PEL of 50 mg/m3 with an action level of 25 mg/ m3 were found to be technologically and economically feasible some time in the future (say, in five years), but not feasible immediately. In that case, OSHA might issue a final rule with a PEL of 50 mg/m3 and an action level of 25 mg/m3 to take effect in five years, but at the same time issue an interim PEL of 100 mg/m3 and an action level of 50 mg/m3 to be in effect until the final rule becomes feasible. Under this regulatory alternative, and consistent with the public participation and ‘‘look back’’ provisions of Executive Order 13563, the Agency could monitor compliance with the interim standard, review progress toward meeting the feasibility requirements of the final rule, and evaluate whether any adjustments to the timing of the final rule would be needed. Under Regulatory Alternative #9, the estimated costs and benefits would be somewhere between those estimated for a PEL of 100 mg/m3 with an action level of 50 mg/m3 and those estimated for a PEL of 50 mg/m3 with an action level of 25 mg/m3, the exact estimates depending on the length of time until the final rule is phased in. OSHA emphasizes that this regulatory alternative is contrary to the Agency’s preliminary findings of economic feasibility and, for the Agency to consider it, would require specific evidence introduced on the record to show that the proposed rule is not now 56429 feasible but would be feasible in the future. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), OSHA is soliciting comments on this issue. Such a particularized, multi-year phase-in would have several advantages, especially from the viewpoint of impacts on small businesses. First, it would reduce the one-time initial costs of the standard by spreading them out over time, a particularly useful mechanism for small businesses that have trouble borrowing large amounts of capital in a single year. A differential phase-in for smaller firms would also aid very small firms by allowing them to gain from the control experience of larger firms. A phase-in would also be useful in certain industries—such as foundries, for example—by allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However a phase-in would also postpone the benefits of the standard. As previous discussed in the Introduction and in Section VIII.H of this preamble, OSHA requests comments on these regulatory alternatives, including the Agency’s choice of regulatory alternatives (and whether there are other regulatory alternatives the Agency should consider) and the Agency’s analysis of them. SBREFA Panel Table VIII–33 lists all of the SBREFA Panel recommendations and OSHA’s responses to these recommendations. TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES mstockstill on DSK4VPTVN1PROD with PROPOSALS2 SBREFA Panel recommendation OSHA response The Panel recommended that OSHA give consideration to the alternative of improved enforcement of and expanded outreach for the existing rule rather than a new rule. In addition, the Panel recommended that OSHA carefully study the effects of existing compliance and outreach efforts, such as the Special Emphasis Program on silica, with a view to better delineating the effects of such efforts. This examination should include (1) a year-by-year analysis of the extent of noncompliance discovered in OSHA compliance inspections, and (2) the kinds of efforts OSHA made to improve enforcement and outreach. As discussed in Chapter II of the PEA, Need for Regulation (and summarized in Section VIII.B of this Preamble), OSHA has reviewed existing enforcement and outreach programs, as well as other legal and administrative remedies, and believes that a standard would be the most effective means to protect workers from exposure to silica. A review of OSHA’s compliance assistance efforts and an analysis of compliance with the current PELs for respirable crystalline silica are discussed in Section III of the preamble, Events Leading to the Proposed Standard. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00157 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56430 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response (General Industry) The Panel recommended that OSHA revise its economic and regulatory flexibility analyses as appropriate to reflect the SERs’ comments on underestimation of costs, and that the Agency compare OSHA’s revised estimates to alternative estimates provided and methodologies suggested by the SERs. For those SER estimates and methodological suggestions that OSHA does not adopt, the Panel recommends that OSHA explain its reasons for preferring an alternative estimate and solicit comment on the issue. OSHA has reviewed its cost estimates in response to the comments received from the SERs and evaluated the alternative estimates and methodologies suggested by the SERs. In some cases (such as for exposure monitoring and training) OSHA has revised its cost estimates in response to SER comments. However, OSHA has not made all cost changes suggested by the SERs, but has retained (or simply updated) those cost estimates that OSHA determined reflect sound methodology and reliable data. OSHA requests comments on the Agency’s estimated costs and on the assumptions applied in the cost analysis, and has included this topic in Section I. Issues (See Compliance Costs) and in Chapter V of the PEA. OSHA has extensively reviewed its costs estimates, changed many of them in response to SER comments, and solicits comments on these revised cost estimates. A few examples of OSHA’s cost changes are given in the responses to specific issues below (e.g., exposure monitoring, medical exams, training and familiarization). OSHA requests comments on the Agency’s estimated costs and on the assumptions applied in the cost analysis, and has included this topic in Section I. Issues (See Compliance Costs) and in Chapter V of the PEA. The PEA reflects OSHA’s judgment on technological feasibility and includes responses to specific issues raised by the Panel and SERs. OSHA solicits comment on the accuracy and reasonableness of these judgments and has included this topic in Section I. Issues (See Technological and Economic Feasibility of the Proposed PEL and Compliance Costs). Table 1 in the proposed standard is designed to relieve establishments in construction from requirements for exposure assessment when certain controls are established. OSHA developed cost estimates in the PEA for exposure monitoring as a function of the size of the establishment. OSHA’s cost estimates now reflect the fact that smaller entities will tend to experience larger unit costs. OSHA estimated higher exposure monitoring costs for small entities because an industrial hygienist could not take as many samples a day in a small establishment as in a large one. OSHA believes that its unit cost estimates for exposure monitoring are realistic but will raise that as an issue. See Chapter V of the PEA for details of OSHA’s unit costs for exposure monitoring in general industry and maritime. OSHA’s cost estimates for health screening are a function of the size of the establishment. OSHA’s cost estimates now reflect the fact that smaller entities will tend to experience larger unit costs. OSHA estimated higher medical surveillance costs (than was estimated in the Preliminary Initial Regulatory Flexibility Analysis (PIRFA)) for small entities because smaller establishments would be more likely to send the workers off-site for medical testing. In addition, OSHA significantly increased the total costs of exposure sampling and x-rays in medical surveillance by assuming no existing compliance with the those provisions in the proposed rule (as compared to an average of 32.6 percent and 34.8 percent existing compliance, respectively, in the PIRFA). OSHA removed the specific hygiene provisions in the proposed rule, which has resulted in the elimination of compliance costs for changing rooms, shower facilities, lunch rooms, and hygiene-specific housekeeping requirements. However, OSHA has retained requirements and cost estimates for disposable clothing (in regulated areas) where there is the potential for employees’ work clothing to become grossly contaminated with finely divided material containing crystalline silica. Dry sweeping remains a prohibited activity in the proposed standard and OSHA has estimated the costs for the use of wet methods to control dust (see Table VIII–30, above). OSHA requests comment on the use of wet methods as a substitute for dry sweeping and has included this topic in Section I. Issues (See Compliance Costs and Provisions of the Standards—Methods of compliance). The Panel recommended that, as time permits, OSHA revise its economic and regulatory flexibility analyses as appropriate to reflect the SERs’ comments on underestimation of costs and that the Agency compare the OSHA revised estimates to alternative estimates provided and methodologies suggested by the SERs. For those SER estimates and methodological suggestions that OSHA does not adopt, the Panel recommends that OSHA explain its reasons for preferring an alternative estimate and solicit comment on the issue. The Panel recommended that prior to publishing a proposed standard, OSHA should carefully consider the ability of each potentially affected industry to meet any proposed PEL for silica, and that OSHA should recognize, and incorporate in its cost estimates, specific issues or hindrances that different industries may have in implementing effective controls. The Panel recommended that OSHA carefully review the basis for its estimated exposure monitoring costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. The Panel recommended that OSHA carefully review the basis for its estimated health screening compliance costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (Construction) The Panel recommended that OSHA carefully review the basis for its estimated hygiene compliance costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. The Panel recommended that OSHA carefully review the issue of dry sweeping in the analysis, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00158 Fmt 4701 Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56431 TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response The Panel recommended that OSHA carefully review the basis for its training costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. One participant in the silica SBREFA process objected to ERG’s analytical assumption (used in OSHA’s Preliminary Initial Regulatory Flexibility Analysis) that training is needed only for those workers exposed above the action level and suggested that training might be necessary for all at-risk workers. For the proposed rule, the scope of this requirement was revised so that the provision now would apply to workers with any potential occupational exposure to respirable crystalline silica; OSHA has estimated training costs in the PEA accordingly. OSHA estimated higher training costs for small entities because of smaller-sized training classes and significantly increased training costs by assuming only half compliance for half of the affected establishments (compared to an average of 56 percent existing compliance for all establishments in the PIRFA). The cost estimates in the PEA reflect OSHA’s best judgment and take the much higher labor turnover rates in construction into account when calculating costs. For the proposed rule, OSHA used the most recent BLS turnover rate of 64 percent for construction (versus a turnover rate of 27.2 percent for general industry). OSHA believes that the estimates in the PEA capture the effect of high turnover rates in construction and solicits comments on this issue in Section I. Issues (See Compliance Costs). OSHA used the exposure profiles to estimate the number of full-timeequivalent (FTE) workers in construction who are exposed above the PEL. This would be the exposure profile if all exposed workers worked full-time only at the specified silica-generating tasks. In OSHA’s analysis, the actual number of workers exposed above the PEL is represented by two to five times the number of FTE workers, depending on the activity. The estimate of the total number of at-risk workers takes into account the fact that most workers, regardless of construction occupation, spend some time working on jobs where no silica contamination is present. For the control cost analysis, however, it matters only how many worker-days there are in which exposures are above the PEL. These are the worker-days in which controls are required. The control costs (as opposed to the program costs) are independent of the number of at-risk workers associated with these worker-days. OSHA emphasizes that the use of FTEs does not ‘‘discount’’ its estimates of aggregate control costs. A 30-day exemption from the requirement to implement engineering and work practice controls was not included in the proposed standard for construction, and has been removed from the proposed standard for general industry. OSHA requests comment on a 30-day exemption, and has included this topic in Section I. Issues (See Provisions of the Standards—Methods of compliance). (Construction) SERs raised cost issues similar to those in general industry, but were particularly concerned about the impact in construction, given the high turnover rates in the industry. The Panel recommended that OSHA carefully review the basis for its estimated compliance costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. (Construction) The Panel recommended that OSHA (1) carefully review the basis for its estimated labor costs, and issues related to the use of FTEs in the analysis, (2) consider the concerns raised by the SERs, and (3) ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (Construction) Some SERs requested that OSHA apply a 30-day exclusion for implementing engineering and work practice controls, as was reflected in the draft standard for general industry and maritime. The Panel recommended that OSHA consider this change and request comment on the appropriateness of exempting operations that are conducted fewer than 30 days per year from the hierarchy requirement. (Construction) The Panel recommended that OSHA consider and seek comment on the need to prohibit employee rotation as a means of complying with the PEL and the likelihood that employees would be exposed to other serious hazards if the Agency were to retain this provision. (Construction) Some SERs questioned the scientific and legal basis for the draft prohibitions on the use of compressed air, brushing, and dry sweeping of silica-containing debris. Others raised feasibility concerns such as in instances where water or electric power was unavailable or where use of wet methods could damage construction materials. The Panel recommended that OSHA carefully consider the need for and feasibility of these prohibitions given these concerns, and that OSHA seek comment on the appropriateness of such prohibitions. (Construction) The Panel recommended that OSHA carefully consider whether regulated area provisions should be included in the draft proposed standard, and, if so, where and how regulated areas are to be established. OSHA should also clarify in the preamble and in its compliance assistance materials how compliance is expected to be achieved in the various circumstances raised by the SERs. (Construction) The Panel recommended that OSHA clarify how the regulated area requirements would apply to multi-employer worksites in the draft standard or preamble, and solicit comments on site control issues. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00159 Fmt 4701 The proposed prohibition on rotation is explained in the Summary and Explanation for paragraph (f) Methods of Compliance. OSHA solicits comment on the prohibition of employee rotation to achieve compliance when exposure levels exceed the PEL, and has included this topic in Section I. Issues (See Provisions of the Standards—Methods of compliance). As discussed in the Summary and Explanation of paragraph (f) Methods of Compliance, the prohibition against the use of compressed air, brushing, and dry sweeping applies to situations where such activities could contribute to employee exposure that exceeds the PEL. OSHA solicits comment on this issue, and has included this topic in Section I. Issues (See Provisions of the Standards—Methods of compliance). As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, the proposed standard includes a provision for implementation of ‘‘access control plans’’ in lieu of establishing regulated areas. Clarification for establishing either a regulated area or an access control plan is provided in the Summary and Explanation. The Summary and Explanation for paragraph (e) Regulated Areas and Access Control clarifies this requirement. OSHA requests comment on this topic, and has included this topic in Section I. Issues (See Compliance Costs and Provisions of the Standards—Methods of compliance). Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56432 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response (Construction) Many SERs were concerned with the extent to which they felt the draft proposed standard would require the use of respirators in construction activities. The Panel recommended that OSHA carefully consider its respiratory protection requirements, the respiratory protection requirements in Table 1, and the PEL in light of this concern. OSHA has made a preliminary determination that compliance with the proposed PEL can be achieved in most operations most of the time through the use of engineering and work practice controls. However, as described in the Summary and Explanation of paragraphs (f) Methods of Compliance and (g) Respiratory Protection and in the Technological Feasibility chapter of the PEA, use of respiratory protection will be required for some operations. OSHA solicits comment on this issue in Section I. Issues (See Technological and Economic Feasibility of the Proposed PEL). OSHA discusses the reliability of measuring respirable crystalline silica in the Technological Feasibility chapter of the PEA. An exemption for monitoring is also provided where the employer uses Table 1. As discussed in the Summary and Explanation for paragraph (d) Exposure Assessment, the proposed standard also allows a performance option for exposure assessment that is expected to reduce the amount of monitoring needed. OSHA solicits comment on this topic in Section I. Issues (See Provisions of the Standards—Exposure Assessment). As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, OSHA has proposed a limited requirement for use of protective clothing or other means to remove silica dust from contaminated clothing. This requirement would apply only in regulated areas where there is the potential for work clothing to become grossly contaminated with silica dust. No requirement for hygiene facilities is included in the proposed standard. OSHA solicits comment regarding appropriate requirements for use of protective clothing and hygiene facilities in Section I. Issues (See Provisions of the Standards—Regulated areas and access control). The provisions requiring B-readers and pulmonary specialists are discussed in the Summary and Explanation of paragraph (n) Medical Surveillance, and the numbers of available specialists are reported. OSHA solicits comment on this issue in Section I. Issues (See Provisions of the Standards—Medical surveillance). As described in the Summary and Explanation for paragraph (n) Medical Surveillance, an initial examination is required within 30 days after initial assignment to a job with exposure above the action level for more than 30 days per year. OSHA solicits comment on this proposed requirement in Section I. Issues (See Provisions of the Standards—Medical surveillance). The proposed standard does not specify wording for labels. OSHA solicits comment on this issue in Section I. Issues (See Provisions of the Standards—Hazard communication). (Construction) The Panel recommended that OSHA carefully address the issues of reliability of exposure measurement for silica and laboratory requirements. The Panel also recommended that OSHA seek approaches to a construction standard that can mitigate the need for extensive exposure monitoring to the extent possible. (Construction) As in general industry, many SERs were concerned about all of these provisions because, they contended, silica is not recognized as either a take-home or dermal hazard. Further, many said that these provisions would be unusually expensive in the context of construction work. Other SERs pointed out that protective clothing could lead to heat stress problems in some circumstances. The Panel recommended that OSHA carefully re-examine the need for these provisions in the construction industry and solicit comment on this issue. (Construction) The Panel recommended that OSHA explicitly examine the issue of availability of specialists called for by these provisions, and re-examine the costs and feasibility of such requirements based on their findings with respect to availability, as needed. (Construction) The Panel recommended that OSHA carefully consider the need for pre-placement physicals in construction, the possibility of delayed initial screening (so only employees who had been on the job a certain number of days would be required to have initial screening), and solicit comment on this issue. (Construction) Like the general industry SERs, construction SERs raised the issue that they would prefer a warning label with wording similar to that used in asbestos and lead. The Panel recommended that OSHA consider this suggestion and solicit comment on it. (Construction) Some SERs questioned whether hazard communication requirements made sense on a construction site where there are tons of silica-containing dirt, bricks, and concrete. The Panel recommended OSHA consider how to address this issue in the context of hazard communication. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (Construction) The Panel recommended that OSHA carefully review the recordkeeping requirements with respect to both their utility and burden. The Panel recommended that OSHA, to the extent permitted by the availability of economic data, update economic data to better reflect recent changes in the economic status of the affected industries consistent with its statutory mandate. SERs in construction, and some in general industry, felt the estimate of affected small entities and employees did not give adequate consideration to workers who would be subject to exposure at a site but were not directly employed by firms engaged in silica-associated work, such as employees of other subcontractors at a construction site, visitors to a plant, etc. The Panel recommended that OSHA carefully examine this issue, considering both the possible costs associated with such workers, and ways of clarifying what workers are covered by the standard VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00160 Fmt 4701 The proposed standard requires hazard communication for employees who are potentially exposed to respirable crystalline silica. Many of the proposed requirements are already required by OSHA’s Hazard Communication Standard. The Agency requests comment on the proposed requirements in Section I. Issues (See Provisions of the Standards—Hazard communication). OSHA has reviewed the recordkeeping requirements as required by the Paperwork Reduction Act. Detailed analysis of the recordkeeping requirements can be found in OSHA’s information collection request submitted to OMB. The recordkeeping requirements are discussed in the Summary and Explanation for paragraph (j) Recordkeeping. OSHA solicits comment on these requirements in Section I. Issues (See Provisions of the Standards—Recordkeeping). OSHA has prepared the PEA using the most current economic data available. The scope of the proposed standard is discussed in the Summary and Explanation for paragraph (a) Scope and Application. Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56433 TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response The Panel recommended that OSHA clarify in any rulemaking action how its action is or is not related to designating silica-containing materials as hazardous wastes. Some SERs also noted the issue that the use of wet methods in some areas may violate EPA rules with respect to suspended solids in runoff unless provision is made for recycling or settling the suspended solids out of the water. The Panel recommended that OSHA investigate this issue, add appropriate costs if necessary, and solicit comment on this issue. The relationship between the proposed rule and EPA requirements is discussed in Section XVI, Environmental Impacts. The Panel recommended that OSHA (1) carefully consider and solicit comment on the alternative of improved outreach and support for the existing standard; (2) examine what has and has not been accomplished by existing outreach and enforcement efforts; and (3) examine and fully discuss the need for a new standard and if such a standard can accomplish more than improved outreach and enforcement. The Panel recommended, if there is to be a standard for construction, that OSHA: (1) seek ways to greatly simplify the standard and restrict the number of persons in respirators; (2) consider the alternative of a standard oriented to engineering controls and work practices in construction; and (3) analyze and solicit comment on ways to simplify the standard. The Panel recommended that, if there is to be a standard, OSHA consider and solicit comment on maintaining the existing PEL. The Panel also recommends that OSHA examine each of the ancillary provisions on a provision-by-provision basis in light of the comments of the SERs on the costs and lack of need for some of these provisions. (General Industry) The Panel recommended that OSHA carefully examine the technological and economic feasibility of the draft proposed standard in light of these SER comments. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (General Industry) Some SERs were concerned that the prohibition on dry sweeping was not feasible or cost effective in their industries. The Panel recommended that OSHA consider this issue and solicit comment on the costs and necessity of such a prohibition. (General Industry) The Panel recommended that OSHA carefully consider whether regulated area provisions should be included in the draft proposed standard, and, if so, where and how regulated areas are to be established. OSHA should also clarify in the preamble and in its compliance assistance materials how compliance is expected to be achieved in the various circumstances raised by the SERs. (General Industry) The Panel recommended that OSHA carefully examine the issues associated with reliability of monitoring and laboratory standards in light of the SER comments, and solicit comment on these issues. (General Industry) Some SERs preferred the more performance-oriented Option 2 provision included in the draft exposure assessment requirements, stating that fixed-frequency exposure monitoring can be unnecessary and wasteful. However, other SERs expressed concern over whether such a performance-oriented approach would be consistently interpreted by enforcement officers. The Panel recommended that OSHA continue to consider Option 2 but, should OSHA decide to include it in a proposed rule, clarify what would constitute compliance with the provision. Some SERs were also concerned about the wording of the exposure assessment provision. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00161 Fmt 4701 Silica wastes are not classified as hazardous. Therefore OSHA believes that the incremental disposal costs resulting from dust collected in vacuums and other sources are likely to be quite small. An analysis of wet methods for dust controls suggests that in most cases the amount of slurry discharged are not sufficient to cause a run off to storm drains. OSHA solicits comments on this topic in Section I. Issues (See Environmental Impacts). A review of OSHA’s outreach efforts is provided in Section III, Events Leading to the Proposed Standards. OSHA solicits comment on this topic in Section I. Issues (See Alternatives/Ways to Simplify a New Standard). OSHA has made a preliminary determination that compliance with the proposed PEL can be achieved in most operations most of the time through the use of engineering and work practice controls. However, as described in the Summary and Explanation of paragraphs (f) Methods of Compliance and (g) Respiratory Protection and in the Technological Feasibility chapter of the PEA, use of respiratory protection will be required for some operations. OSHA solicits comment on this topic in Section I. Issues (See Technological and Economic Feasibility of the Proposed PEL). OSHA also solicits comment on ways to simplify the standard in Section I. Issues (See Alternatives/ Ways to Simplify a New Standard). As discussed in the Summary and Explanation for paragraph (c) Permissible Exposure Limit (PEL), OSHA has made a preliminary determination that the proposed PEL is necessary to meet the legal requirements to reduce significant risk to the extent feasible. Because the proposed PEL is a fixed value, OSHA also believes it is easier to understand when compared to the current PEL. OSHA solicits comment on the proposed PEL in Section I. Issues (See Provisions of the Standards—PEL and action level). The PEA reflects OSHA’s judgment on the technological and economic feasibility of the proposed standard and includes responses to specific issues raised by the Panel. OSHA solicits comment on the accuracy and reasonableness of these judgments in Section I. Issues (See Technological and Economic Feasibility of the Proposed PEL). OSHA has proposed to limit the prohibition on dry sweeping to situations where this activity could contribute to exposure that exceeds the PEL. The Agency solicits comment on this topic in Section I. Issues (See Provisions of the Standards—Methods of compliance). Proposed regulated area provisions are explained in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control. The proposed standard also includes a provision for implementation of ‘‘access control plans’’ in lieu of establishing regulated areas. Clarification for establishing an access control plan is provided in the Summary and Explanation. OSHA has made a preliminary determination in the proposed rule that only certain sampling and analytical methods can be used to measure airborne crystalline silica at the proposed PEL. Issues related to sampling and analytical methods are discussed in the Technological Feasibility section of the PEA. OSHA solicits comment on the Agency’s preliminary determination in Section I. Issues (See Provisions of the Standards—Exposure Assessment). The proposed standard provides two options for periodic exposure assessment; (1) a fixed schedule option, and (2) a performance option. The performance option provides employers flexibility in the methods used to determine employee exposures, but requires employers to accurately characterize employee exposures. The proposed approach is explained in the Summary and Explanation for paragraph (d) Exposure Assessment. OSHA solicits comments on the proposed exposure assessment provision in Section I. Issues (See Provisions of the Standards—Exposure Assessment). Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 56434 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response (General Industry) Some SERs were also concerned about the wording of the exposure assessment provision of the draft proposed standard. These SERs felt that the wording could be taken to mean that an employer needed to perform initial assessments annually. The Panel recommended that OSHA clarify this issue. (General Industry) While some SERs currently provide both protective clothing and hygiene facilities, others provide neither. Those SERs that do not currently provide either felt that these provisions were both highly expensive and unnecessary. Some SERs stated that these provisions were pointless because silica is not a take-home hazard or a dermal hazard. Others suggested that such provisions only be required when the PEL is exceeded. The Panel recommended that OSHA carefully consider the need for these provisions, and solicit comment on the need for these provisions, and how they might be limited. (General Industry) The SER comments included several suggestions regarding the nature and wording of the health screening requirements. (See, e.g., OSHA, 2003, pp. 25–28.). The Panel recommended that OSHA consider revising the standard in light of these comments, as appropriate. (General Industry) The Panel recommended that OSHA explicitly examine and report on the availability of specialists called for by these provisions, and re-examine the costs and feasibility of such requirements based on their findings with respect to availability, as needed. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (General Industry) Though the provision for hazard communication simply repeats such provisions already in existence, some SERs urged OSHA to use this opportunity to change the requirement so that warning labels would only be required of substances that were more than 1% (rather than the current 0.1%) by weight of silica. The Panel recommended that OSHA consider this suggestion and solicit comment on it. (General Industry) The Panel recommended that OSHA carefully review the recordkeeping requirements with respect to both their utility and burden. (Construction) The Panel recommended that OSHA continue to evaluate the appropriateness of and consider modifications to scope Option 2 that can more readily serve to limit the scope of the standard. (Construction) Many SERs found the requirements for a competent person hard to understand. Many SERs took the competent person requirement as requiring a person with a high level of skills, such as the ability to conduct monitoring. Other SERs said this requirement would require training a high percentage of their employees as competent persons because they typically had many very small crews at many sites. In general, the SERs thought this requirement as written would be difficult to comply with and costly. The Panel recommended that OSHA seek ways to clarify OSHA’s intent with respect to this requirement and more clearly delineate the responsibilities of competent persons. (Construction) Many SERs did not understand that Table 1 was offered as an alternative to exposure assessment and demonstration that the PEL is being met. Some SERs, however, understood the approach and felt that it had merit. These SERs raised several issues concerning the use of Table 1, including:. • The Table should be expanded to include all construction activities covered by the standard, or the scope of the standard should be reduced to only those activities covered by Table 1; • The control measures endorsed in Table 1 need to be better established, as necessary; and • Table 1 should require less use of, and possibly no use of, respirators. VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 PO 00000 Frm 00162 Fmt 4701 The requirement for initial exposure assessment is clarified in the Summary and Explanation of paragraph (d) Exposure Assessment. The term ‘‘initial’’ indicates that this is the first action required to assess exposure and is required only once. As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, OSHA has proposed a limited requirement for use of protective clothing or other means to remove silica dust from contaminated clothing. This requirement would apply only in regulated areas where there is the potential for work clothing to become grossly contaminated with silica dust. No requirement for hygiene facilities is included in the proposed standard. OSHA solicits comment regarding appropriate requirements for use of protective clothing and hygiene facilities in Section I. Issues (See Provisions of the Standards—Regulated areas and access control). OSHA has considered these comments and revised the proposed standard where appropriate. The revisions are discussed in the Summary and Explanation of paragraph (n) Medical Surveillance. The provisions requiring B-readers and pulmonary specialists are discussed in the Summary and Explanation of paragraph (n) Medical Surveillance, and the numbers of available specialists are reported. OSHA solicits comment on this topic in Section I. Issues (See Provisions of the Standards—Medical surveillance). OSHA has preliminarily determined to rely on the provisions of the Hazard Communication Standard (HCS) in the proposed rule. The HCS requires labels for mixtures that contain more than 0.1% of a carcinogen. OSHA solicits comment on this topic in Section I. Issues (See Provisions of the Standards—Medical surveillance). The recordkeeping requirements are discussed in the Summary and Explanation for paragraph (j) Recordkeeping. OSHA solicits comment on these requirements in Section I. Issues (See Provisions of the Standards—Recordkeeping). OSHA has made the preliminary determination that scope Option 1 is most appropriate. OSHA solicits comment on this subject in Section I. Issues (See Provisions of the Standards—Scope). The standard requires a competent person only in limited circumstances when an employer selects the option to implement an ‘‘access control plan’’ in lieu of establishing a regulated area. Further clarification is provided in the Summary and Explanation of paragraph (e) Regulated Areas and Access Control. Sfmt 4702 E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 56435 TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued SBREFA Panel recommendation OSHA response The Panel recommended that OSHA carefully consider these suggestions, expand Table 1, and make other modifications, as appropriate The rationale for the operations and control measures to be included in Table 1 is provided in the Summary and Explanation for paragraph (f) Methods of Compliance. Table 1 includes some operations for which it is anticipated that even with the implementation of control measures, exposure levels will routinely exceed the proposed PEL, and thus reliance on the use of respiratory protection is appropriate. Table 1 has been modified to limit requirements for respirator use where operations are performed for less than 4 hours per day. OSHA solicits comment on the proposed requirements in Section I. Issues (See Provisions of the Standards—Methods of compliance). OSHA significantly expanded its economic impact and economic feasibility analyses in Chapter VI of the PEA. As part of the impact analysis, OSHA added data on normal year-to-year variations in prices and profit rates in affected industries to provide a context for evaluating potential price and profit impacts of the proposed rule. A section was also added to estimate the potential international trade impacts of the proposed rule. OSHA solicits comments in Chapter VI of the PEA on the issues of the economic impacts and the economic feasibility of the proposed rule. OSHA re-examined and updated its cost estimates for each type of respirator. Unit respirator costs included the cost of the respirator itself and the annualized cost of respirator use, to include accessories (e.g., filters), training, fit testing, and cleaning. All costs were updated to 2009 dollars. In addition, OSHA added a cost for employers to establish a respirator program. OSHA solicits comments on this issue in Chapter V of the PEA. To reflect the fact that an industrial hygienist could not typically take as many samples a day in a small establishment as in a large one, OSHA developed cost estimates for exposure monitoring as a function of the size of the establishment. OSHA’s cost estimates therefore now reflect the fact that smaller entities will tend to experience larger unit costs for exposure monitoring. To reflect possible problems of unpredictability of exposure in construction, Table 1 in the proposed standard has been designed to allow establishments in construction the option, for certain operations, to implement engineering controls, work practices, and respiratory protection without the need for exposure assessment. OSHA has carefully reviewed the basis for its exposure monitoring cost estimates and considered the concerns raised by the SERs. OSHA solicits comments on this issue in Chapter V of the PEA. OSHA has conducted a comprehensive review of the scientific evidence from toxicological and epidemiological studies on adverse health effects associated with occupational exposure to respirable crystalline silica. This review is summarized in Section V of this preamble, Health Effects Summary, and estimates of the risks of developing silica-related diseases are summarized in Section VI, Summary of the Preliminary Quantitative Risk Assessment. The significance of these risks is examined in Section VII, Significance of Risk. The benefits associated with the proposed rule are summarized in Section VIII.G, Benefits and Net Benefits. Although OSHA’s preliminary analysis indicates that a variety of factors may affect the toxicologic potency of crystalline silica found in different work environments, OSHA has not identified information that would allow the Agency to calculate how these influences may affect disease risk to workers in any particular workplace setting. OSHA has carefully considered the Panel recommendations, and the Agency’s responses are listed in this table. In addition, specific issues raised in comments by individual SERs are addressed throughout the preamble. The Panel recommends that OSHA thoroughly review the economic impacts of compliance with a proposed silica standard and develop more detailed feasibility analyses where appropriate.. (Construction) The panel recommends that OSHA re-examine its cost estimates for respirators to make sure that the full cost of putting employees in respirators is considered. (Construction) Some SERs indicated that the unit costs were underestimated for monitoring, similar to the general industry issues raised previously. In addition, special issues for construction were raised (i.e., unpredictability of exposures), suggesting the rule would be costly, if not impossible to comply with. The Panel recommends that OSHA carefully review the basis for its estimated compliance costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 (General Industry) The Panel recommends that OSHA use the best scientific evidence and methods available to determine the significance of risks and magnitude of benefits for occupational exposure to silica. The Panel further recommends that OSHA evaluate existing state silicosis surveillance data to determine whether there are industry-specific differences in silicosis risks, and whether or how the draft standard should be revised to reflect such differences. The SERs, however, also had many specific issues concerning what OSHA should do if it chooses to go forward with a proposed rule. In order to reflect these specific issues, the Panel has made many recommendations concerning issues to be considered if the Agency goes forward with a rule. The Panel also recommends that OSHA take great care in reviewing and considering all comments made by the SERs. IX. OMB Review Under the Paperwork Reduction Act of 1995 A. Overview The proposed general industry/ maritime and construction standards VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 (‘‘the standards’’) for respirable crystalline silica contain collection of information (paperwork) requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of PO 00000 Frm 00163 Fmt 4701 Sfmt 4702 1995 (PRA–95), 44 U.S.C. 3501 et seq, and OMB’s regulations at 5 CFR part 1320. PRA–95 defines ‘‘collection of information’’ to mean, ‘‘the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties E:\FR\FM\12SEP2.SGM 12SEP2 56436 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules or the public, of facts or opinions by or for an agency, regardless of form or format’’ (44 U.S.C. 3502(3)(A)). Under PRA–95, a Federal agency cannot conduct or sponsor a collection of information unless OMB approves it, and the agency displays a currently valid OMB control number. B. Solicitation of Comments OSHA prepared and submitted an Information Collection Request (ICR) for the collection of information requirements identified in this NPRM to OMB for review in accordance with 44 U.S.C. 3507(d). The Agency solicits comments on the proposed new collection of information requirements and the estimated burden hours associated with these requirements, including comments on the following items: • Whether the proposed collection of information requirements are necessary for the proper performance of the Agency’s functions, including whether the information is useful; • The accuracy of OSHA’s estimate of the burden (time and cost) of the information collection requirements, including the validity of the methodology and assumptions used; • The quality, utility and clarity of the information collected; and • Ways to minimize the compliance burden on employers, for example, by using automated or other technological techniques for collecting and transmitting information. mstockstill on DSK4VPTVN1PROD with PROPOSALS2 C. Proposed Revisions to Information Collection Requirements As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the following paragraphs provide information about this ICR. 1. Title: Respirable Crystalline Silica Standards for General Industry/ Maritime (§ 1910.1053) and Construction (§ 1926.1053) 2. Description of the ICR: The proposed respirable crystalline silica standards contain collection of information requirements which are essential components of the occupational safety and health standards that will assist both employers and their employees in identifying exposures to crystalline silica, the medical effects of such exposures, and means to reduce or eliminate respirable crystalline silica overexposures. 3. Summary of the Collections of Information: VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 1910.1053(d) and 1926.1053(d)— Exposure Assessment Under paragraph (d)(6) of the proposed rule, employers covered by the general industry/maritime standard must notify each affected employee within 15 working days of completing an exposure assessment. In construction, employers must notify each affected employee not more than 5 working days after completing the exposure assessment. In these standards, the following provisions require exposure assessment monitoring: § 1910.1053(d)(1) and § 1926.1053(d)(1), General; § 1910.1053(d)(2) and § 1926.1053(d)(2), Initial Exposure Assessment; § 1910.1053(d)(3) and § 1926.1053(d)(3), Periodic Exposure Assessments; § 1910.1053 (d)(4) and § 1926.1053(d)(4), Additional Exposure Assessments; and § 1926.1053(d)(8)(ii), Specific Operations. Under § 1910.1053(d)(6)(i) and § 1926.1053(d)(6)(i), employers must either notify each affected employee in writing or post the monitoring results in an appropriate location accessible to all affected employees. In addition, paragraph (d)(6)(ii) of § 1910.1053 and § 1926.1053 require that whenever the employer exceeds the permissible exposure limit (PEL), the written notification must contain a description of the corrective action(s) the employer is taking to reduce employee exposures to or below the PEL. 1910.1053(e)(3) and 1926.1053(e)(3)— Written Access Control Plan The standard provides employers with the option to develop and implement a written access control plan in lieu of establishing regulated areas under paragraph (e)(3). Paragraph (e)(3)(ii) sets out the requirements for a written access control plan. The plan must contain provisions for a competent person to identify the presence and location of any areas where respirable crystalline silica exposures are, or can reasonably be expected to be, in excess of the PEL. It must describe how the employer will notify employees of the presence and location of areas where exposures are, or can reasonably be expected to be, in excess of the PEL, and how the employer will demarcate these areas from the rest of the workplace. For multi-employer workplaces, the plan must identify the methods the employers will use to inform other employers of the presence, and the location, of areas where respirable crystalline silica exposures may exceed the PEL, and any precautionary measures the employers need to take to PO 00000 Frm 00164 Fmt 4701 Sfmt 4702 protect employees. The written plan must contain provisions for restricting access to these areas to minimize the number of employees exposed, and the level of employee exposure. The plan also must describe procedures for providing each employee entering areas where respirable crystalline silica exposures may exceed the PEL, with an appropriate respirator in accordance with paragraph (g) of the proposed rule; the employer also must provide this information to the employee’s designated representative. Additionally, where there is the potential for employees’ work clothing to become grossly contaminated with finely divided material containing crystalline silica, the plan must include provisions for the employer to provide either appropriate protective clothing or other means to remove excessive silica dust from contaminated clothing, as well as provisions for the removal or cleaning of such clothing. The employer must review and evaluate the effectiveness of the written access control plan at least annually, and update it as necessary. The written access control plan must be available for examination and copying, upon request, to employees, their designated representatives, the Assistant Secretary, and the Director. 1910.1053(f)—Methods of Compliance Where the employer conducts abrasive blasting operations, paragraph (f)(2) in the general industry/maritime standard requires the employer to comply with the requirements of 29 CFR part 1915, subpart I (Personal Protective Equipment), as applicable. Subpart I contains several information collection requirements. Under subpart I, when conducting hazard assessments, the employer must: (1) Select the type of personal protective equipment (PPE) that will protect the affected employee from the hazards identified in the occupational hazard assessment; (2) communicate selection decisions to affected employees; (3) select PPE that properly fits each affected employee; and (4) verify that the required occupational hazard assessment has been performed. Additionally, subpart I requires employers to provide training and verification of training for each employee required to wear PPE. 1910.1053(g) and 1926.1053(g)— Respiratory Protection Paragraph (g) in the standards requires the employer to institute a respiratory protection program in accordance with 29 CFR 1910.134. The Respiratory Protection Standard’s information collection requirements E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 provide that employers must: develop a written respirator program; obtain and maintain employee medical evaluation records; provide the physician or other licensed health care professional (PLHCP) with information about the employee’s respirator and the conditions under which the employee will use the respirator; administer fit tests for employees who will use negative- or positive-pressure, tightfitting facepieces; and establish and retain written information regarding medical evaluations, fit testing, and the respirator program. 1910.1053(h) and 1926.1053(h)— Medical Surveillance Paragraph (h)(2) in the standards requires employers to make available to covered employees an initial medical examination within 30 days after initial assignment unless the employee received a medical examination provided in accordance with the standard within the past three years. Proposed paragraphs (h)(2)(i)–(vi) specify that the baseline medical examination provided by the PLHCP must consist of the following information: 1. A medical and work history, with emphasis on: past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and symptoms of respiratory disease; history of tuberculosis; and smoking status and history; 2. A physical examination with special emphasis on the respiratory system; 3. A chest X-ray interpreted and classified according to the International Labour Organization International Classification of Radiographs of Pneumoconioses by a National Institute for Occupational Safety and Health (NIOSH)-certified ‘‘B’’ reader, or an equivalent diagnostic study; 4. A pulmonary function test administered by a spirometry technician with current certification from a NIOSHapproved spirometry course; 5. Testing for latent tuberculosis infection; and 6. Any other tests deemed appropriate by the PLHCP. Paragraph (h)(3) in the standards requires periodic medical examinations administered by a PLHCP, every three years or more frequently if recommended by the PLHCP, for covered employees, including medical and work history, physical examination emphasizing the respiratory system, chest X-rays or equivalent diagnostic VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 study, pulmonary function tests, and other tests deemed to be appropriate by the PLHCP. Paragraph (h)(4) in the standards requires the employer to provide the examining PLHCP with a copy of the standard. In addition, for each employee receiving a medical examination, the employer must provide the PLHCP with the following information: a description of the affected employee’s former, current, and anticipated duties as they relate to the employee’s occupational exposure to respirable crystalline silica; the employee’s former, current, and anticipated levels of occupational exposure to respirable crystalline silica; a description of any PPE used or to be used by the employee, including when and for how long the employee has used that equipment; and information from records of employment-related medical examinations previously provided to the affected employee and currently within the control of the employer. Paragraph (h)(5) in the standards requires the employer to obtain a written medical opinion from the PLHCP within 30 days of each medical examination performed on each employee. The employer must provide the employee with a copy the PLHCPs’ written medical opinion within two weeks of receipt. This written opinion must contain the following information: 1. A description of the employee’s health condition as it relates to exposure to respirable crystalline silica, including the PLHCP’s opinion as to whether the employee has any detected medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica; 2. Any recommended limitations upon the employee’s exposure to respirable crystalline silica or on the use of PPE such as respirators; 3. A statement that the employee should be examined by an American Board Certified Specialist in Pulmonary Disease (‘‘pulmonary specialist’’) pursuant to paragraph (h)(6) if the ‘‘B’’ reader classifies the chest X-ray as 1/0 or higher, or if referral to a pulmonary specialist is otherwise deemed appropriate by the PLHCP; and 4. A statement that the PLHCP explained to the employee the results of the medical examination, including findings of any medical conditions related to respirable crystalline silica exposure that require further evaluation or treatment, and any recommendations related to use of protective clothing or equipment. If the PLHCP’s written medical opinion indicates that a pulmonary specialist should examine an employee, PO 00000 Frm 00165 Fmt 4701 Sfmt 4702 56437 paragraph (h)(6) in the standards requires the employer to make available for the employee a medical examination by a pulmonary specialist within 30 days after receiving the PLHCP’s written medical opinion. The employer must provide the examining pulmonary specialist with information specified by paragraph (h)(4). The employer must obtain a written opinion from the pulmonary specialist within 30 days of the examination. The written opinion must be comparable to the written opinion obtained from the original PLHCP. The pulmonary specialist also must state in the written opinion that the specialist explained these findings to the employee. The employer also must provide a copy of the PLHCP’s written medical opinion to the examined employee within two weeks after receiving it. 1910.1053(i) and 1926.1053(i)— Communication of Respirable Crystalline Silica Hazards to Employees Paragraph (i)(1) of the standards requires compliance with the Hazard Communication Standard (29 CFR 1910.1200), and lists cancer, lung effects, immune system effects, and kidney effects as hazards that the employer must address in its hazard communication program. Additionally, employers must ensure that each employee has access to labels on containers of crystalline silica and safety data sheets. Under paragraph (i)(2)(ii), the employer must make a copy of this section readily available without cost to each affected employee. 1910.1053(j) and 1926.1053(j)— Recordkeeping Paragraph (j)(1)(i) of the standards requires that employers maintain an accurate record of all employee exposure measurement results as prescribed in paragraph (d) of these standards. The record must include the following information: the date of measurement for each sample taken; the operation monitored; sampling and analytical methods used; number, duration, and results of samples taken; identity of the laboratory that performed the analysis; type of PPE, such as respirators, worn by the employees monitored; and the name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were monitored. The employer must maintain, and make available, employee exposure records in accordance with 29 CFR 1910.1020. Paragraph (j)(2)(i) requires the employer to maintain an accurate record of all objective data relied on to comply E:\FR\FM\12SEP2.SGM 12SEP2 56438 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 with the proposed requirements of this section. The record must include the following information: the crystalline silica-containing material in question; the source of the objective data; the testing protocol and results of testing; and a description of the process, operation, or activity, and how the data support the assessment; and other data relevant to the process, operation, activity, material, or employee exposures. The employer must maintain, and make available, the objective data records in accordance with 29 CFR 1910.1020. Paragraph (j)(3)(i) requires the employer to establish and maintain an accurate record for each employee covered by medical surveillance under paragraph (h). The record must include the following information: the employee’s name and social security number; a copy of the PLHCP’s and pulmonary specialist’s written opinions; and a copy of the information provided to the PLHCP and pulmonary specialist as required by paragraph (h)(4) of the proposed rule. The employer must maintain, and make available, the medical surveillance records in accordance with 29 CFR 1910.1020. 4. Number of respondents: Employers in general industry, maritime, or construction that have employees working in jobs affected by respirable crystalline silica exposure (543,041 businesses). 5. Frequency of responses: Frequency of response varies depending on the specific collection of information. 6. Number of responses: 4,242,296. 7. Average time per response: Varies from 5 minutes (.08 hour) for the employer to provide a copy of the written physician’s opinion to the employee, to 8 hours to establish a new respiratory protection program in large establishments. 8. Estimated total burden hours: 2,585,164. 9. Estimated costs (capital-operation and maintenance): $273,504,281. D. Submitting Comments Members of the public who wish to comment on the paperwork requirements in this proposal must send their written comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, OSHA (RIN–1218 –AB70), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202–395–6929/Fax: 202–395–6881 (these are not toll-free numbers), email: OIRA_submission@ omb.eop.gov. The Agency encourages commenters also to submit their comments on these paperwork VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 requirements to the rulemaking docket (Docket Number OSHA–2010–0034), along with their comments on other parts of the proposed rule. For instructions on submitting these comments to the rulemaking docket, see the sections of this Federal Register notice titled DATES and ADDRESSES. Comments submitted in response to this notice are public records; therefore, OSHA cautions commenters about submitting personal information such as Social Security numbers and date of birth. E. Docket and Inquiries To access the docket to read or download comments and other materials related to this paperwork determination, including the complete Information Collection Request (ICR) (containing the Supporting Statement with attachments describing the paperwork determinations in detail) use the procedures described under the section of this notice titled ADDRESSES. You also may obtain an electronic copy of the complete ICR by visiting the Web page at http://www.reginfo.gov/public/ do/PRAMain, scroll under ‘‘Currently Under Review’’ to ‘‘Department of Labor (DOL)’’ to view all of the DOL’s ICRs, including those ICRs submitted for proposed rulemakings. To make inquiries, or to request other information, contact Mr. Todd Owen, Directorate of Standards and Guidance, OSHA, Room N–3609, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693–2222. OSHA notes that a federal agency cannot conduct or sponsor a collection of information unless it is approved by OMB under the PRA and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless the collection of information displays a currently valid OMB control number. Also, notwithstanding any other provision of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number. X. Federalism The Agency reviewed the proposed crystalline silica rule according to the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, Aug. 10, 1999), which requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States before taking actions that would restrict States’ policy options and take such actions PO 00000 Frm 00166 Fmt 4701 Sfmt 4702 only when clear constitutional authority exists and the problem is of national scope. The Executive Order allows Federal agencies to preempt State law only with the expressed consent of Congress; in such cases, Federal agencies must limit preemption of State law to the extent possible. Under Section 18 of the Occupational Safety and Health Act (the ‘‘Act’’’ or ‘‘OSH Act,’’ 29 U.S.C. 667), Congress expressly provides that States may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards; States that obtain Federal approval for such a plan are referred to as ‘‘State-Plan States.’’ (29 U.S.C. 667). Occupational safety and health standards developed by State-Plan States must be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. Subject to these requirements, State-Plan States are free to develop and enforce their own requirements for occupational safety and health standards. While OSHA drafted the proposed rule to protect employees in every State, Section 18(c)(2) of the OSHA Act permits State-Plan States to develop and enforce their own standards, provided the requirements in these standards are at least as safe and healthful as the requirements specified in the proposed rule if it is promulgated. In summary, the proposed rule complies with Executive Order 13132. In States without OSHA-approved State plans, Congress expressly provides for OSHA standards to preempt State occupational safety and health standards in areas addressed by the Federal standards; in these States, this rule limits State policy options in the same manner as every standard promulgated by the Agency. In States with OSHA-approved State plans, this rulemaking does not significantly limit State policy options. XI. State-Plan States When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, the 27 State and U.S. territories with their own OSHA-approved occupational safety and health plans (‘‘State-Plan States’’) must revise their standards to reflect the new standard or amendment. The State standard must be at least as effective as the Federal standard or amendment, and must be promulgated within six months of the publication date of the final Federal rule. 29 CFR 1953.5(a). The State may demonstrate that a standard change is not necessary E:\FR\FM\12SEP2.SGM 12SEP2 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS2 because, for example, the State standard is already the same as or at least as effective as the Federal standard change. In order to avoid delays in worker protection, the effective date of the State standard and any of its delayed provisions must be the date of State promulgation or the Federal effective date, whichever is later. The Assistant Secretary may permit a longer time period if the State makes a timely demonstration that good cause exists for extending the time limitation. 29 CFR 1953.5(a). Of the 27 States and territories with OSHA-approved State plans, 22 cover public and private-sector employees: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The five states and territories whose OSHA-approved State plans cover only public-sector employees are: Connecticut, Illinois, New Jersey, New York, and the Virgin Islands. This proposed crystalline silica rule applies to general industry, construction and maritime, and would impose additional or more stringent requirements. If adopted as proposed, all State Plan States would be required to revise their general industry and construction standards appropriately within six months of Federal promulgation. In addition, State plans that cover private sector maritime employment issues and/or have public employees working in the maritime industry covered by this standard would be required to adopt comparable provisions to their maritime employment standards within six months of publication of the final rule. XII. Unfunded Mandates Under Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1532, an agency must prepare a written ‘‘qualitative and quantitative assessment’’ of any regulation creating a mandate that ‘‘may result in the expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more’’ in any one year before issuing a notice of proposed rulemaking. OSHA’s proposal does not place a mandate on State or local governments, for purposes of the UMRA, because OSHA cannot enforce its regulations or standards on State or local governments. (See 29 U.S.C. 652(5).) Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State VerDate Mar<15>2010 19:12 Sep 11, 2013 Jkt 229001 standards must be equivalent to OSHA standards. The OSH Act also does not cover tribal governments in the performance of traditional governmental functions, though it does when tribal governments engage in commercial activity. However, the proposal would not require tribal governments to expend, in the aggregate, $100,000,000 or more in any one year for their commercial activities. Thus, although OSHA may include compliance costs for affected governmental entities in its analysis of the expected impacts associated with a proposal, the proposal does not trigger the requirements of UMRA based on its impact on State, local, or tribal governments. Based on the analysis presented in the Preliminary Economic Analysis (see Section VIII above), OSHA concludes that the proposal would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. The Preliminary Economic Analysis constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits required under Section 202(a) of the UMRA (2 U.S.C. 1532). XIII. Protecting Children From Environmental Health and Safety Risks Executive Order 13045 requires that Federal agencies submitting covered regulatory actions to OMB’s Office of Information and Regulatory Affairs (OIRA) for review pursuant to Executive Order 12866 must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. Executive Order 13045 defines ‘‘covered regulatory actions’’ as rules that may (1) be economically significant under Executive Order 12866 (i.e., a rulemaking that has an annual effect on the economy of $100 million or more, or would adversely effect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities), and (2) concern an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children. In this context, the term ‘‘environmental health risks and safety risks’’ means risks to health or safety that are attributable to products or substances that children are likely to come in contact with or ingest (e.g., through air, food, water, soil, product use). PO 00000 Frm 00167 Fmt 4701 Sfmt 4702 56439 The proposed respirable crystalline silica rule is economically significant under Executive Order 12866 (see Section VIII of this preamble). However, after reviewing the proposed respirable crystalline silica rule, OSHA has determined that the rule would not impose environmental health or safety risks to children as set forth in Executive Order 13045. The proposed rule would require employers to limit employee exposure to respirable crystalline silica and take other precautions to protect employees from adverse health effects associated with exposure to respirable crystalline silica. OSHA is not aware of any studies showing that exposure to respirable crystalline silica disproportionately affects children or that employees under 18 years of age who may be exposed to respirable crystalline silica are disproportionately affected by such exposure. Based on this preliminary determination, OSHA believes that the proposed respirable crystalline silica rule does not constitute a covered regulatory action as defined by Executive Order 13045. However, if such conditions exist, children who are exposed to respirable crystalline silica in the workplace would be better protected from exposure to respirable crystalline silica under the proposed rule than they are currently. XIV. Environmental Impacts OSHA has reviewed the silica proposal according to the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the regulations of the Council on Environmental Quality (40 CFR part 1500), and the Department of Labor’s NEPA procedures (29 CFR part 11). Based on that review, OSHA does not expect that the proposed rule, in and of itself, would create additional environmental issues. However, as noted in the SBREFA report (OSHA, 2003, p. 77), some Small Entity Representatives (SERs) raised the possibility that the use of wet methods to limit occupational (and environmental) exposures in some areas may violate EPA rules with respect to suspended solids in runoff unless provision is made for recycling or settling the suspended solids out of the water. The SBREFA Panel recommended that OSHA investigate this issue, add appropriate costs if necessary, and solicit comment on this issue. Some large construction projects may already require a permit to address storm water runoff, independent of any OSHA requirements to limit worker exposure to silica. These environmental E:\FR\FM\12SEP2.SGM 12SEP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 56440 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules requirements come from or reference the Clean Water Act of 1987. As applied to construction activities, EPA requirements generally pertain to projects of one acre or more and impose the use of Best Management Practices (BMPs) to minimize the pollution, via water runoff, of storm water collection systems and surface waters. In s