Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis

Supporting document for the Notice of Proposed Rulemaking for Occupational Exposure to Beryllium

    Occupational Safety and Health Administration U.S. Department of Labor

                                     2015
CHAPTER I: INTRODUCTION
      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 the proposed beryllium rule and evaluates regulatory alternatives to the proposed rule. When OSHA identifies a significant risk to workers, section 6(b)(5) of the Occupational Safety and Health Act (OSH Act) directs OSHA to review the best available evidence and select a standard that, to the extent feasible, ensures that employees will not suffer material impairment of health or functional capacity.  As OSHA drafts a beryllium standard to fulfill its statutory directive, the Agency must also comply with a number of procedural requirements.
      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, public health and safety effects, distributive impacts, and equity), unless a statute requires another regulatory approach. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules and of promoting flexibility.
OSHA has determined that this proposed rule governing occupational exposure to beryllium is an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. Accordingly, the Office of Regulatory Analysis within OSHA has prepared this preliminary economic analysis (PEA) for the proposed rule. In developing this PEA, OSHA has endeavored to meet the requirements of OMB's Circular A-4 (OMB, 2003), a guidance document for regulatory agencies preparing economic analyses under Executive Order 12866.
      This rule has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by Executive Order 12866.
      The purpose of this PEA is to:
   * Identify the establishments and industries potentially affected by the proposed rule;
   * Estimate current exposures and identify the technologically feasible methods of controlling these exposures;
   * Estimate the benefits resulting from employers coming into compliance with the rule in terms of the reduction in fatal cases of lung cancer; fatal cases of chronic beryllium disease (CBD), a non- malignant respiratory disease; and cases of CBD morbidity;
   * 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 rule for affected industries;
   * Evaluate the principal regulatory alternatives to the proposed rule that OSHA has considered; and
   * Estimate the impacts of the final rule on small entities as defined by the Small Business Administration (in accordance with the Regulatory Flexibility Act, as amended in 1996).
      This PEA includes all of the economic analyses OSHA is required to perform, including the findings of technological and economic feasibility and their supporting materials required by the OSH Act as interpreted by the courts (in Chapters III, IV, V, and VI);  those required by EO 12866 and EO13563 (primarily in Chapters III, V, and VII, though these depend on material in other chapters); and those required by the Regulatory Flexibility Act (in Chapters VI, VIII, and IX, though these depend, in part, on materials presented in other chapters).
      The rest of this chapter is devoted to a description of the need for a beryllium rule, a discussion of the major provisions of the proposed rule, and a list of the chapters to follow in this PEA. To develop this PEA, OSHA relied considerably on the support of OSHA's contractor, Eastern Research Group (ERG).  ERG's individual work products are referenced throughout this PEA.
REASONS WHY ACTION BY THE AGENCY IS BEING CONSIDERED
      When establishing the need for an occupational safety and health standard, OSHA must evaluate available data to determine whether or not workers will suffer a material impairment of their health or functional capacity as a result of being exposed to a particular safety or health hazard. Section 6(b)(5) of the Occupational Safety and Health Act (OSH Act) directs OSHA 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 dealt with by such standard for the period of his working life." 29 U.S.C. 655(b)(5).
      The Supreme Court, in reviewing previous OSHA standards, has also directed the Agency to make a determination that ". . . significant risks are present and can be eliminated or lessened by a change in practices" before promulgating any health or safety standard.  Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980).  While the Supreme Court did not specify what constituted a "significant risk" and considered that determination to be largely a policy decision for OSHA, the Court did offer guidance, stating that a reasonable person might well consider a 1 in 1000 risk of fatality to be significant.  Id. at 655.
      OSHA makes its material impairment and significant risk determinations by first evaluating available data to identify hazards to which employees are exposed in the workplace that are likely to induce material impairments of their health or functional capacity. The Agency looks at a broad array of scientific data and assesses the overall weight of evidence in making its significant risk determinations. In the next step, the Agency looks at the overall quality of the data to identify studies or other data that are useful in making quantitative estimates of the risk of those impairments of health among exposed employees over their working life (as mandated by the OSH Act). While many studies may add to the overall weight of evidence, often only select studies have suitable information for quantitatively assessing risk.
      The epidemiological literature on beryllium provides clear evidence that beryllium is a human lung carcinogen.  It includes multiple studies of U.S. beryllium workers (Sanderson et al., 2001; Ward et al., 1992; Wagoner et al., 1980; and Mancuso et al., 1979).  Most recently, a NIOSH cohort study found significantly increased lung cancer mortality among employees at seven beryllium processing facilities (Schubauer-Berigan et al., 2011).  Evidence supporting beryllium carcinogenicity comes from various animal studies as well as in vitro genotoxicity and other studies (EPA, 1998; ATSDR, 2002; Gordon and Bowser, 2003; NAS, 2008; Nickell-Brady et al., 1994; NTP, 1999 and 2005; IARC, 1993, 2009 and 2012).  The International Agency for Research on Cancer (IARC), National Toxicology Program (NTP), and American Conference of Governmental Industrial Hygienists (ACGIH) have all classified beryllium as a known human carcinogen (IARC, 2009).
      Exposure to beryllium also leads to a non-malignant respiratory disease, CBD.  CBD develops when the body's immune system reacts to the presence of beryllium in the lung, causing a progression of pathological changes including chronic inflammation and tissue scarring.  CBD can also impair other organs such as the liver, spleen, and kidneys and cause adverse health effects such as granulomas of the skin and lymph nodes and cor pulmanale (enlargement of the heart) (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and b).
      OSHA's risk assessment for cancer relied in part on the seven-facility study published by Schubauer-Berigan et al. (2011).  The cohort was exposed, on average, to lower levels of beryllium than those in most previous studies, had fewer short-term employees, and had sufficient follow-up time to observe lung cancer in the population.  OSHA also identified several studies that provided exposure information and screening results for beryllium sensitization (BeS) and/or CBD in cohorts of beryllium-exposed employees.  The Agency's preliminary risk assessment for CBD was based on studies conducted at a Tucson, AZ beryllium ceramics plant (Newman et al., 2001; Henneberger et al., 2001; Cummings et al., 2007); a Reading, PA alloy processing plant (Schuler et al., 2005; Thomas et al., 2009); a Cullman, AL beryllium machining plant (Kelleher et al., 2001; Madl et al., 2007); and an Elmore, OH metal, alloy, and oxide production plant (Kreiss et al., 1997; Bailey et al., 2010; Schuler et al., 2012), all of which demonstrate significant risk from exposure at the current PEL and below.  OSHA's quantitative estimates of risk at the current, proposed, and alternate PELs were based on the Cullman, AL machining cohort, because this was the only cohort for which OSHA could examine the effects of changes in airborne exposure independent of extensive respirator and PPE use among exposed employees.  Using data from a specific worker cohort to determine the risk to exposed employees has been upheld on judicial review in other standards regulating employee exposure to other toxic substances. It is also an accepted scientific approach used by other regulatory and non-regulatory entities in making decisions regarding public health.
      Based on a variety of relative risk models fit to the seven-plant cohort, NIOSH estimated that the excess lifetime lung cancer risk to employees exposed over a working life of 45 years at the current permissible exposure limit (PEL) of 2 μg/m[3] is between 33 and 200 deaths per 1,000 employees.  Reducing the PEL to the proposed PEL of 0.2 μg/m[3] is expected to achieve a substantial reduction of lung cancer risk, to a range estimated to be between 2.7 and 33 deaths from lung cancer per 1,000 employees.  A proportional hazards model fit to the Cullman, AL machinist data estimated a lifetime CBD risk between 96 and 313 per 1000 employees exposed for 45 years at the current PEL.  At the proposed PEL, the model estimate is between 8 and 30 per 1000 employees.
      Overall, OSHA estimates that the proposed rule would prevent 97 fatalities annually -- 93 from CBD, and 4 from lung cancer -- and an additional 50 cases of non-fatal CBD annually.  These estimates are based on exposures over a 45-year working life.
      Finally, it should be noted that the U.S. Congress has already recognized the dangers of beryllium exposure.  Congress passed the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) in 2000 to address occupational harm to workers from exposure to beryllium.  The EEOICPA provides compensation to Department of Energy (DOE) workers and workers employed by DOE contractors and vendors for beryllium-related health effects resulting from exposure on the job.  So far, the program, which the Department of Labor administers, has accepted over 2,200 individual cases of beryllium-related health effects and awarded over 1,600 workers more than $21 million in medical costs for cases that only involve beryllium-related health effects (information from U.S. Department of Labor, Office of Workers' Compensation Programs).  There are also more compensated cases involving multiple causes, which include beryllium-related health effects.  As is the case for most occupational illnesses, especially long-term, or chronic, illnesses, workers with beryllium-related health effects were very unlikely to qualify for workers' compensation benefits before EEOICPA.  Workers were neither protected from the risks of occupational beryllium exposure nor compensated for loss of income and health.
      Subsequently, DOE established its own beryllium regulation to protect its own workers as well as contract workers.  The DOE regulation is similar to OSHA's proposed standard in many respects (see 64 FR 68854, Dec. 8, 1999). Its action level of 0.2 μg/m[3] is the same as OSHA's proposed PEL.  Although DOE's program has reduced the frequency of beryllium-related health effects (the effectiveness of the DOE program is discussed in Chapter VII: Benefits of this PEA), some workers have still become sensitized to beryllium and developed CBD.  In recognition that its employees may not be fully protected, DOE has included in its regulations a requirement that covered employers must comply with any more stringent PEL established by OSHA in rulemaking (10 CFR 850.22).  Moreover, this DOE regulation does not eliminate the need for beryllium exposure regulation in the workplace; OSHA's proposed beryllium standard would only apply in workplaces not covered by the DOE beryllium rule.
SUMMARY OF THE PROPOSED STANDARD FOR BERYLLIUM
      OSHA has developed a comprehensive standard to protect employees from exposure to beryllium in general industry. The proposed standard contains a time-weighted average permissible exposure limit (PEL), short-term exposure limit (STEL), and other requirements, including: employee exposure assessment, beryllium work areas and regulated areas, methods of compliance, respiratory protection, personal protective clothing and equipment, hygiene areas and practices, housekeeping, medical surveillance, medical removal, communication of beryllium hazards to employees, and recordkeeping. The text below summarizes the requirements contained in the proposed standard.
 (a) Scope and application
      The proposed standard would apply to all workplaces where there is occupational exposure to beryllium within general industry, with two limitations.  It would not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), containing beryllium that the employer does not process.  And, it would not apply to materials containing less than 0.1% beryllium by weight.
(b) Definitions
      The definitions section explains important terms used in the proposed standard, such as "action level", "beryllium work area", "exposure", "regulated area," and others.
(c) Permissible Exposure Limit (PEL)
      OSHA's proposed time-weighted average (TWA) PEL and STEL are expressed in units of microgram(s) per cubic meter of air (μg/m[3]). The Agency is proposing a TWA PEL of 0.2 μg/m[3], calculated as an 8-hour time-weighted average, and is considering alternative TWA PELs of 0.5 μg/m[3] and 0.1 μg/m[3].  The proposed STEL is 2.0 μg/m[3], measured over a sampling period of 15 minutes and equal to ten times the proposed TWA PEL of 0.2 μg/m[3].  The Agency is considering alternative STELs equal to five times the proposed TWA PEL, or to five or ten times the alternative TWA PELs.
      Health risk data and analyses indicate that there is significant risk of CBD and lung cancer associated with exposure to 0.5 μg/m[3] beryllium over a working lifetime. Although OSHA is still evaluating the scientific evidence underlying these risk analyses, OSHA has made a preliminary decision not to consider an alternative PEL greater than 0.5 μg/m[3].
      In this proposed rule, OSHA is also setting an action level of 0.1 μg/m[3].  In the proposed standard, as in previous OSHA standards, the provisions for initial and periodic exposure monitoring are only triggered once the action level is reached or exceeded. Thus, employers may be able to considerably reduce the burden of complying with the proposed monitoring requirement by reducing employee exposures below the action level.
(d) Exposure Assessment
      This paragraph of the proposed standard has provisions for conducting an initial exposure assessment, for performing periodic and additional exposure monitoring, and for observing monitoring. Each employer is required to conduct an assessment of the work site to determine if employees are exposed to levels of beryllium at or above the action level, or above the TWA PEL or STEL. The purpose of this assessment is to determine not only whether or not engineering and work practice controls are required to meet the TWA PEL and STEL, but also whether certain provisions of the proposed standard -- such as medical surveillance, periodic monitoring, or respiratory protection -- would be needed.  Airborne exposures would be measured by personal breathing zone air samples.
   	In cases when the employer has conducted exposure monitoring in the past, when the current work operations, workplace conditions, and beryllium-containing material used still closely resemble those present when the previous exposure monitoring was conducted, and the employer has satisfied all other requirements within this section, the results of previous monitoring may be used to satisfy the initial monitoring provision.    In addition, in cases where the employer has objective data demonstrating that beryllium is not capable of being released in concentrations that meet or exceed the action level or exceed the STEL, the employer may rely upon such data to satisfy the initial exposure assessment requirements of this section.
      If the initial monitoring indicates that employee exposures are at or above the action level and at or below the TWA PEL, the employer must conduct periodic exposure monitoring at least annually.  The employer is not required to conduct periodic exposure monitoring for employees whose initial monitoring results show exposure levels below the action level or above the TWA PEL.
      Additional monitoring is required when there is a change in the production process, equipment, personnel, work practices, or control methods that may result in new or additional exposures to beryllium, or when the employer has any other reason to believe that new or additional exposure is occurring.
      The proposed standard requires employers to notify employees of the results of an exposure assessment within 15 days of completing an assessment.  This notification may be made individually in writing or by posting the results in a location that is accessible to all employees whose exposure is measured or represented by the exposure assessment. Where exposure levels are above the TWA PEL or STEL, the employer is required to describe in the written notification the corrective action being taken to lower the exposure levels below the TWA PEL and STEL.
      In addition, the proposed standard sets forth accuracy criteria for exposure monitoring methods used to conduct monitoring required by the standard. Employers are required to provide affected employees or their designated representatives with an opportunity to observe any monitoring of employees for exposure to beryllium. The employer is also required to provide appropriate personal protective equipment (PPE) at no cost to the observer(s) and to ensure that each observer uses the provided PPE and complies with all applicable OSHA requirements and the employer's workplace safety and health procedures.
 (e) Beryllium Work Areas and Regulated Areas
      To minimize any unnecessary employee exposures, the proposed standard requires employers to establish and maintain a beryllium work area wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium.  The proposed standard also requires employers to establish and maintain a regulated area wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL.
      The proposed standard requires employers to identify each beryllium work area through signs or other methods that adequately establish and inform employees of its boundaries.  Employers are required to identify regulated areas in accordance with paragraph (m)(2) of the proposed standard.  Employers must limit access to regulated areas to persons authorized or required to work in them, designated representatives of employees for the purpose of observing exposure monitoring, and persons authorized by law to be in a regulated area.  The employer must provide necessary respiratory protection and other PPE to each employee entering a regulated area and must ensure that the equipment is used in accordance with paragraphs (g) and (h) of the beryllium standard, respectively.
 (f) Methods of Compliance
      The proposed standard requires employers to establish, implement, and maintain a written exposure control plan for beryllium work areas, including: an inventory of operations and job titles that have beryllium exposure; an inventory of operations and job titles that have exposure at or above the action level, and those that may have exposure above the TWA PEL or STEL; an inventory of required engineering and work practice controls; procedures for minimizing cross-contamination and migration of beryllium out of beryllium work areas; procedures for keeping surfaces in beryllium work areas as free as practicable of beryllium; and procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.  Employers must update the exposure control plan when they have reason to believe there are new or additional beryllium exposures, such as a change in production processes, materials, equipment, personnel, work practices, or control methods, and when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows signs or symptoms of beryllium exposure.  A copy of the exposure control plan must be accessible to all employees who are, or can reasonably be expected to be, exposed to airborne beryllium.
      The proposed standard also requires that employers use one or more of the following engineering and work practice controls to minimize employee exposure in beryllium work areas: (1) material and/or process substitution; (2) ventilated partial or full enclosures; (3) local exhaust ventilation; or (4) process controls, such as wet methods and automation.  Employers who can establish that such controls are not feasible, or who can demonstrate that employees' exposures are below the action level, are exempt from this requirement.  If, after implementing one or more of these controls, exposures exceed the TWA PEL or STEL, the employer must implement additional or enhanced engineering and work practice controls to reduce exposures to or below the TWA PEL and STEL, unless the employer can demonstrate that such controls are not feasible. Wherever feasible engineering and work practice controls are not sufficient to reduce employee exposure to the PEL, the employer must use them to reduce employee exposure to the lowest level feasible and supplement them with respiratory protection.  The proposed standard prohibits employers from rotating employees to different jobs to achieve compliance with the PEL or STEL.
 (g) Respiratory Protection
      The proposed standard requires employers to provide at no cost, and to ensure that employees use, respiratory protection during: (1) periods necessary to install or implement feasible engineering and work practice controls where exposures exceed, or can reasonably be expected to exceed, the TWA PEL or STEL; (2) operations, including maintenance and repair activities and non-routine tasks, where meeting the PEL with engineering and work practice controls is not feasible and exposures exceed, or can reasonably be expected to exceed, the TWA PEL or STEL; (3) work operations for which an employer has implemented all feasible engineering and work practice controls and these controls do not reduce exposures to or below the TWA, PEL or STEL; and (4) emergencies.  The use of respiratory protection required by this standard must be in accordance with the Respiratory Protection Standard (29 CFR 1910.134).
(h)  Personal Protective Clothing and Equipment
      The proposed standard requires employers to provide at no cost, and ensure that employees use, appropriate personal protective clothing and equipment (PPE) in accordance with the written exposure control plan required under paragraph (f) of the standard and OSHA's Personal Protective Equipment standards (29 CFR Part 1910 Subpart I) where any of the following occurs: (1) where employee exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL; (2) where employees' clothing or skin may become visibly contaminated with beryllium, including during maintenance and repair activities or during non-routine tasks; or (3) where employees' skin can reasonably be expected to be exposed to soluble beryllium compounds.  Employers must ensure that employees remove all beryllium-contaminated PPE at the end of the work shift or at the completion of tasks involving beryllium, whichever comes first, or when PPE becomes visibly contaminated with beryllium.  Employers must ensure that PPE visibly contaminated with beryllium is removed as specified in the exposure control plan required by paragraph (f) of the standard and that employees store and keep required protective clothing separate from street clothing.  Employers must ensure that employees do not remove beryllium-contaminated PPE from the workplace, except for employees authorized to do so for laundering, cleaning, maintaining, or disposing of beryllium-contaminated PPE.  Employers must ensure that, when PPE is removed for these purposes, it is stored and transported in sealed bags or other closed containers that are impermeable and labeled in accordance with paragraph (m)(3) of this standard and the Hazard Communication standard (29 CFR 1910.1200).
      Employers must ensure that all reusable PPE required by this standard is cleaned, laundered, repaired, and replaced as needed to remain effective, and that beryllium is not removed from PPE by blowing, shaking, or other means that disperses beryllium into the air.  Employers must inform in writing persons or businesses who launder, clean, or repair PPE required by this standard of the potentially harmful effects of exposure to airborne beryllium and contact with soluble beryllium compounds, and that the PPE must be handled in accordance with this standard.
(i) Hygiene Areas and Practices
      The proposed standard requires employers to provide readily accessible washing facilities for employees who work in beryllium work areas to remove beryllium from the hands, face, and neck, and ensure that employees exposed to beryllium use these facilities when necessary.  In addition, employers must provide employees with a designated change room and washing facilities in accordance with this standard and the Sanitation standard (29 CFR 1910.141) where employees are required to remove their personal clothing.  Employers must provide showers that comply with the requirements of the Sanitation standard where two requirements are met:  (1) exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL, and (2) beryllium can reasonably be expected to contaminate employees' hair or body parts other than hands, face, and neck.  Where showers are required, employers must ensure that each employee shower at the end of the work shift or work activity if the employee reasonably could have been exposed above the TWA PEL or STEL and if beryllium could reasonably have contaminated the employee's hair or body parts other than hands, face, and neck.
      Whenever the employer allows employees to consume food or beverages in a beryllium work area, the employer shall ensure that surfaces in eating and drinking areas are as free as practicable of beryllium; that no employee in an eating and drinking area is exposed to airborne beryllium at or above the action level; and that eating and drinking facilities provided by the employer are in accordance with the Sanitation standard.  The employer must ensure that no employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in regulated areas, and that no employees enter an eating or drinking area with PPE unless surface beryllium has been removed from the PPE.
(j) Housekeeping
      The proposed standard requires employers to maintain all surfaces in beryllium work areas as free as practicable of accumulations of beryllium and in accordance with the exposure control plan required under paragraph (f) and the cleaning methods required in paragraph (j) of the standard.  Employers must ensure that all spills and emergency releases of beryllium are cleaned up promptly and in accordance with the exposure control plan and required cleaning methods.
      The cleaning methods required by paragraph (j) are as follows: (1) surfaces in beryllium work areas must be cleaned by HEPA-filter vacuuming or other methods that minimize the likelihood and level of beryllium exposure; (2) employers must not allow dry sweeping or brushing for cleaning surfaces in beryllium work areas unless HEPA-filtered vacuuming or other exposure-minimizing methods have been tried and were not effective; (3) employers must not allow the use of compressed air for cleaning beryllium-contaminated surfaces unless it is used with a ventilation system designed to capture the airborne particulates that result from using compressed air; (4) where dry sweeping, brushing, or compressed air is used to clean beryllium-contaminated surfaces, employers must provide and ensure employees' use of respiratory protection and PPE in accordance with this standard; and (5) the employer must ensure that cleaning equipment is handled and maintained so as to minimize the likelihood and level of employee exposure and the re-entrainment of airborne beryllium in the workplace.
	Employers must ensure that waste, debris, and materials visibly contaminated with beryllium and consigned for disposal are disposed of in sealed, impermeable enclosures, such as bags or containers.  These bags or containers must be labeled in accordance with paragraph (m)(3) of this standard.  Materials designated for recycling that are visibly contaminated with beryllium must be cleaned to remove visible particulate, or placed in sealed, impermeable enclosures labeled in accordance with paragraph (m)(3).
(k) Medical Surveillance
      The proposed standard requires employers to make medical surveillance available, at no cost to the employee and at a reasonable time and place, for those employees who (1) worked in regulated areas for more than 30 days in the previous 12 months; (2) show signs or symptoms of CBD; or (3) were exposed to beryllium during an emergency.  Employees meeting one or more of these conditions must be offered a medical examination and any other test deemed appropriate by the physician or licensed health care professional (PLHCP).  The medical examination must be offered to an eligible employee within 30 days after determining that the employee has worked in a regulated area for more than 30 days in the previous 12 months; or within 30 days of showing signs or symptoms of CBD or exposure in an emergency. The examinations must be offered annually thereafter, so long as the employee continues to meet the eligibility criteria; and at the termination of employment, unless the employee's last medical examination was provided within the previous 6 months.
      The medical examination must include a physical examination with emphasis on the respiratory tract; a physical examination for skin breaks and wounds; pulmonary function tests, including forced vital capacity and forced expiratory volume at one (1) second (FEV1); and a beryllium lymphocyte proliferation test (BeLPT) upon the first examination and within every 2 years from the first examination, ending if and when the employee is found to be sensitized.  If a more reliable and accurate test for beryllium sensitization is developed, that test may be used in lieu of the BeLPT.  The medical examination must also include an evaluation of the employee's medical and work history, with emphasis on past and present exposure, smoking history, and any history of respiratory system dysfunction.
      After an employer learns that an employee is sensitized to beryllium, the employee will consult with the employer's designated physician and, if desired, be provided evaluation for CBD at a CBD diagnostic center at no cost to the employee.
      In addition, employees who were exposed to airborne beryllium above 0.2 ug/m[3] for more than 30 days in a 12-month period for 5 years or more must be offered a low dose helical tomography (CT) scan biennially for the duration of their employment.  This obligation begins on the start-up date of the standard or on the 15[th] year after the employee's first exposure above 0.2 ug/m[3] for more than 30 days in a 12-month period, whichever is later.
      The employer is required to ensure that the PLHCP has a copy of the standard and all appendices, and must provide the following information, if known: (1) a description of the employee's former and current duties that relate to the employee's occupational exposure; (2) the employee's former and current levels of occupational exposure; (3) a description of any PPE used, including respirators, and when and for how long they were used; and (4) information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining a medical release from the employee.
      The employer is required to obtain a written medical opinion from the licensed physician within 30 days of the medical exam. The written opinion must explain: (1) whether the employee has any detected medical condition that would place the employee at increased risk of CBD from further exposure to beryllium; (2) any recommended limitations on the employee's exposure, including the use and limitations on use of respirators or other PPE; and (3) a statement that the PLHCP has explained to the employee the results of the medical examination, including any tests conducted, any medical conditions related to exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.  The employer must provide a copy of the licensed physician's written medical opinion to the employee within 2 weeks after receiving it, and must ensure that neither the licensed physician nor any other PLHCP reveals to the employer specific findings or diagnoses unrelated to exposure to airborne beryllium or contact with soluble beryllium compounds.
      Upon request by OSHA, employers must convey employees' beryllium sensitization test results to OSHA for evaluation and analysis.  Employers must remove employees' names, social security numbers, and other personally identifying information from the test results before conveying them to OSHA.
(l) Medical Removal
      If an employee works in a job with exposure at or above the action level and is diagnosed with CBD or confirmed positive for beryllium sensitization, the employee is eligible for medical removal.  The employee may choose to be removed from exposure at or above the action level, or to remain in a job with exposure at or above the action level and wear a respirator in accordance with the Respiratory Protection standard (29 CFR 1910.134).
      If the employee chooses medical removal, the employer must remove the employee to comparable work in an environment where exposure is below the action level, for which the employee is qualified or can be trained within 1 month.  The employee must accept comparable work if it is available.  If comparable work is not available, the employer must place the employee on paid leave for 6 months or until comparable work becomes available, whichever comes first. Whether the employee is removed to comparable work or placed on paid leave, the employer must maintain for 6 months the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.  The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal from a publicly or employer-funded compensation program, or receives income from another employer made possible by virtue of the employee's removal.
 (m) Communication of Hazards
      The proposed standard requires chemical manufacturers, importers, distributors, and employers to comply with all requirements of the HCS (29 CFR 1910.1200) for beryllium.  This is not a new requirement, as the HCS requires that hazardous chemicals such as beryllium be included in the employer's hazard communication program.
      Employers must ensure that each employee has access to labels on containers of beryllium and to safety data sheets, and is trained in accordance with the provisions of the HCS and paragraph (m) of the proposed standard.  In classifying the hazards of beryllium, the employer must address at least the following hazards: cancer; lung effects (CBD and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation.
      The employer must provide and display legible, readily visible warning signs at each approach to a regulated area so that each employee is able to read and understand the signs and take necessary protective steps before entering the area.  These warning signs must bear the legend specified in paragraph (m) of the proposed standard.  The employer must label each bag and container of clothing, equipment, and materials visibly contaminated with beryllium consistent with the HCS and must include the minimum information specified in paragraph (m).
      The employer must provide information and training in accordance with the HCS to each employee who is or can reasonably be expected to be exposed to airborne beryllium, by the time of the employee's initial assignment.  The employer must repeat the training required under this section annually for each employee and must ensure that each exposed employee can demonstrate knowledge of at least the following: health hazards associated with beryllium exposure, including signs and symptoms of CBD; the written exposure control plan; the purpose, proper selection, fitting, use, and limitations of PPE, including respirators; emergency procedures; measures employees can take to protect themselves from beryllium exposure, including personal hygiene practices; the medical surveillance and medical removal protection programs; the contents of the beryllium standard; and the employee's right of access to records under the Records Access standard (29 CFR 1910.1020).  When a workplace change results in new or increased employee exposure exceeding either the TWA PEL or the STEL, the employer must provide additional training to those employees affected by the change in exposure.  The employer must make a copy of this standard and its appendices readily available at no cost to employees and designated employee representatives.
(n) Recordkeeping
      The employer is responsible for maintaining a record of employee exposure measurements, objective data, and employee medical surveillance information. Exposure and medical records must be maintained in accordance with 29 CFR 1910.1020.
      For records of exposure measurements, the proposed standard requires that the records include the date when each sample was taken; the operation involving exposure to beryllium that was monitored; the sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of the samples; type of PPE, including respirators, used by the employee at the time of monitoring; and name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
      The employer must establish and maintain an accurate record of any historical data used to satisfy the initial monitoring requirements of this standard.  The record must demonstrate that the data comply with the requirements of paragraph (d) of the standard and must be maintained as required by the Records Access standard.
      Where an employer uses objective data to satisfy the monitoring requirements of the standard, the employer must establish and maintain a record of the objective data relied upon, including at least the following information: the data relied upon; the beryllium-containing material in question; the source of the objective data; a description of the operation exempted from initial monitoring and how the data support the exemption; and other information demonstrating that the data meet the requirements for objective data in paragraph (d) of this standard.
      The proposed standard requires employers to establish and maintain records of each employee covered by medical surveillance. The information maintained should include: name, social security number, and job classification of the employee; a copy of all licensed physicians' written opinions; and a copy of the information provided to the PLHCPs as required by the medical surveillance section of the standard.
      At the completion of any training required by this standard, the employer must prepare a record of the name, social security number, and job classification of each employee trained, the date the training was completed, and the topic of the training.  This record must be maintained for 3 years after the completion of training.
      Upon request, the employer shall make all records maintained as a requirement of this standard available for examination and copying to the Assistant Secretary of OSHA, the Director of NIOSH, each employee, and each employee's designated representative(s) in accordance with the Records Access standard (29 CFR 1910.1020).
(o) Dates
      Employers are required to comply with effective dates and start-up dates set forth in the proposed rule for certain provisions. The proposed effective date is 60 days after publication of the final standard in the Federal Register.  All obligations of the final standard would become enforceable 90 days after the effective date, except for (1) change rooms required by paragraph (i), which must be provided no later than 1 year after the effective date; and (2) engineering controls required by paragraph (f) of this standard, which must be implemented no later than 2 years after the effective date.
THE REST OF THIS PEA
      Following this Introduction, the PEA contains the following chapters:
   * 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 Feasibility Analysis and Regulatory Flexibility Determination
   * Chapter VII: Benefits and Net Benefits
   * Chapter VIII: Regulatory Alternatives
   * Chapter IX: Initial Regulatory Flexibility Analysis
References
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ATSDR  (Agency for Toxic Substance and Disease Registry). (2002) Toxicological Profile of Beryllium.  Sept, 2002.

Bailey DO, Thomas CA, Deubner DC, Kent MS, Kreiss K, Schuler CR.  (2010) Evaluation of a Preventative Program to Reduce Sensitization at a Beryllium Metal, Oxide, and Alloy Production Plant.  JOEM 52: 505-12.

Conradi C, Burri PH, Kapanet Y, and Robinson FR. (1971) Lung changes after beryllium inhalation: Ultrastructural and morphometric study. Arch Environ Health 23: 348-358.

Cummings KJ, Deubner DC, Day GA, Henneberger PK, Kitt MM, Kent MS, Kreiss K, Schuler CR.  (2007) Enhanced preventive programme at a beryllium oxide ceramics facility reduces beryllium sensitization among new workers.  Occup Environ Med: 64(2): 134-40.

EPA (Environmental Protection Agency)(CASRN 7440-41-7). (1998) Toxicological review of beryllium and compounds. U.S. Environmental Protection Agency, Washington DC.  Available at: http://www.epa.gov/iris/subst/0012.htm

Gordon T and Bowser D. (2003) Beryllium: genotoxicity and carcinogenicity.
      Mutat Res. Dec 10; 533(1-2):99-105.

Henneberger PK, Cumro D, Deubner DD, Kent MS, McCawley M, Kreiss K. (2001)  Beryllium Sensitization and Disease Among Long-Term and Short-Term Workers in a Beryllium Ceramics Plant.  Int Arch Occup Environ Health 74(3):167-76.

IARC (International Agency for Research on Cancer) (1993) Beryllium, cadmium, mercury and exposures in the glass manufacturing industry. Monogr Eval Carcinog Risk Hum 58:41-117.

IARC (International Agency for Research on Cancer) (2009) Special Report: Policy A review of human carcinogens -- Part C: metals, arsenic, dusts, and fibres. The Lancet/Oncology. Vol 10 May 2009.

IRAC (International Agency for Research on Cancer) (2012) Beryllium and Beryllium Compounds.  Available at: http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-7.pdf

Kelleher PC, Martyny JW, Mroz MM, Maier LA, Ruttenber AJ, Young DA, Newman LS. (2001)  Beryllium Particulate Exposure and Disease Relations in a Beryllium Machining Plant.  J Occup Environ Med. 43(3):238-49.

Kreiss K, Mroz MM, Zhen B, Wiedemann H, Barna B. (1997)  Risks of beryllium disease related to work processes at a metal, alloy, and oxide production plant.  Occup Environ Med. 54(8): 605-12.

Kriebel D, Sprince NL, Eisen EA, Greaves IA (1988a) Pulmonary function in beryllium workers: assessment of exposure. Br J Ind Med. 45(2): 83-92.

Kriebel D, Sprince NL, Eisen EA, Greaves IA, Feldman HA, Greene RE (1988b) Beryllium exposure and pulmonary function: a cross sectional study of beryllium workers. Br J Ind Med. 45(3): 167-73.

Madl AK, Unice K, Brown JL, Kolanz ME, Kent MS. (2007)  Exposure-Response Analysis For Beryllium Sensitization and Chronic Beryllium Disease Among Workers in a Beryllium Metal Machining Plant. J Occup Environ Hyg. 4(6):448-66.

Mancuso TF.  (1979) Occupational lung cancer among beryllium workers.  Dusts and Diseases, R. Lemen and JM Dement eds.  Park Forest South, Il: Pathotox Publishers. Pp 463-471.

National Academies of Science (NAS). (2008) Managing Health Effects of Beryllium Exposure Committee on Beryllium Alloy Exposures. National Research Council of the National Academies; The National Academies Press, Washington, DC.

Newman LS, Mroz MM, Balkissoon R, Maier LA. (2001)  Efficacy of Serial Medical Surveillance For Chronic Beryllium Disease in a Beryllium Machining Plant.  J Occup Environ Med. 43(3):231-7.

Nickell-Brady C, Hahn FF, Finch GL, and Belinsky SA. (1994) Analysis of K-ras, p53, and c-raf-1 mutations in beryllium-induced rat lung tumors. Carcinogenesis 15:257-262.

NTP (National Toxicology Program). 1999. Report on Carcinogens Background Document for Beryllium and Beryllium Compounds. Meeting of the NTP Board of Scientific Counselors. Report on Carcinogens Subcommittee. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC.

NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program [online]. Available at: http://ntp.niehs.nih.gov/ntp/roc/toc11.htm

OMB (U. S. Office of Management and Budget), 2003. Circular A-4, September 17.  Available at: http://www.whitehouse.gov/sites/default/files/omb/assets/regulatory_matters_pdf/a-4.pdf

Sanderson WT, Ward EM, Steenland K, Petersen MR. (2001) Lung Cancer Case Control Study of Beryllium Workers.  Am J Ind Med. 39(2):133-44.

Schubauer-Berigan MK, Deddens JA, Peterson MR. (2011)  Risk of lung cancer associated with quantitative beryllium exposure metrics within an occupational cohort.  Occup Environ Med 68(5): 354-60. Epub 2010 Nov 16.

Schuler CR, Kent MS, Deubner DC, Berakis MT, McCawley M, Henneberger PK, Rossman MD, Kreiss K. (2005)  Process-Related Risk of Beryllium Sensitization and Disease in a Copper-Beryllium Alloy Facility.  Am J Ind Med. 47(3):195-205.

Schuler CR, Virji MA, Deubner DC, Stanton ML, Stefaniak AB, Day GA, Park JY, Kent MS, Sparks R, Kreiss K. (2012)  Sensitization and chronic beryllium disease at a primary manufacturing facility, part 3: exposure-response among short-term workers.  Scand J Work Environ Health. 38(3):270-81. Epub 2011 Aug 29.

Thomas CA, Bailey RL, Kent MS, Deubner DC, Kreiss K, Schuler CR. (2009) Efficacy of a Program to Prevent Beryllium Sensitization Among New Employees at a Copper-Beryllium Alloy Processing Facility.  Public Health Rep.124 Suppl 1:112-24.

Wagoner J, Infante P, Bayliss D. (1980) Beryllium: an etiologic agent in the induction of lung cancer, nonneoplastic respiratory disease and heart disease among industrially exposed workers. Environ Res 21:15-34.

Ward E, Okun A, Ruder A, Fingerhut M, Steenland K. (1992) A mortality study of workers at seven beryllium processing plants. Am J Ind Med 22:885-904
.

CHAPTER II:  ASSESSING THE NEED FOR REGULATION
Introduction
      The stated purpose of the OSH Act is to "assure so far as possible every working man and woman in the Nation safe and healthful work - ing conditions and to preserve our human resources" (29 U.S.C. 651(b)).  Section 2(b)(3) of the OSH Act specifically authorizes "the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce" (29 U.S.C. 651(b)(3)).  This congressional mandate provides the authority for OSHA's standard for respirable beryllium, which is designed to minimize workers' significant risk of adverse health effects associated with occupational exposure to this hazardous substance.
      Section 6(b)(5) of the OSH Act requires the Secretary of Labor, when promulgating health standards, to set the standard at the level "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)).  In its Benzene decision, the Supreme Court more precisely interpreted this language to mean that OSHA's health standards must reduce a "significant risk" of material health impairment, subject to other regulatory constraints such as economic and technological feasibility (Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 639-40 (1980) (Benzene)).
      The Agency has preliminarily determined that employees across a range of industries are exposed to levels of airborne beryllium that result in a significant risk that they will develop beryllium sensitization (BeS), chronic beryllium disease (CBD), lung cancer, and premature death.  Published studies and exposure data submitted in the record from industrial facilities involved in beryllium work show that occupational exposure to a variety of beryllium compounds at levels below the current PEL poses a significant risk to workers of developing CBD.  OSHA's preliminary risk assessment, presented in Section VI of the preamble, indicates that there is significant risk of beryllium sensitization and CBD from a 45-year (working life) exposure to beryllium at the current TWA PEL of 2 μg/m[3]. The risk assessment further indicates that there is significant risk of lung cancer to workers exposed to beryllium at the current TWA PEL of 2 μg/m[3].  This preliminary determination is based on risk models developed by NIOSH and discussed in the preamble at Section VI, Preliminary Beryllium Risk Assessment.  OSHA has preliminarily determined that compliance with the proposed PELs will substantially reduce those risks (see Section VI of the preamble, Preliminary Beryllium Risk Assessment).   A significant risk of these diseases in the workplace establishes the need for the Agency's remedy:  to increase worker protection from exposure to beryllium.
      As shown in Chapter VII of this PEA, the Agency estimates that the proposed beryllium standard would prevent 96 deaths and 50 non-fatal cases of CBD annually.
      In addition to meeting the statutory obligations of the OSH Act described above, OSHA must promulgate regulations in accordance with White House directives, including Executive Order 12866 (58 FR 51735, September 30, 1993)  and Executive Order 13563 (76 FR 3821, January 18, 2011).  These executive orders direct regulatory agencies to assess whether, from a legal or an economic view, a Federal regulation is needed.  For example, as Executive Order 12866 states:
      Section 1.  Statement of Regulatory Philosophy and Principles.
      (a) The Regulatory Philosophy.  Federal agencies should promulgate only such regulations as are required by law, are necessary to interpret the law, or are made necessary by compelling public need, such as material failures of private markets to protect or improve the health and safety of the public, the environment, or the well-being of the American people.
      As discussed in this chapter, OSHA believes there is a failure of private markets to protect the health of workers by exposing them to unnecessarily high levels of beryllium.  In making this statement, the Agency recognizes that many firms have responded to the risks posed by exposure to beryllium by implementing control programs for their workers.  For these firms and these workers, the economic incentives provided by private markets appear to be working effectively.  Nevertheless, the effectiveness of private markets in providing the optimal level of worker health and safety is not necessarily universal.
      The discussion below considers why private markets, as well as information dissemination programs, workers' compensation systems, and tort liability options, each may fail to protect workers from beryllium exposure, resulting in the need for a more protective OSHA beryllium rule.

Private Markets
      In the United States, the preferred mechanism for making economic decisions and taking economic actions is generally considered to be the private market.  Under suitable conditions, a market system is economically efficient in the following sense:  resources are allocated where they are most highly valued; the appropriate mix of goods and services, embodying the desired bundle of characteristics, is produced; and further improvements in the welfare of any member of society cannot be attained without making at least one other member worse off.
      Economic theory, supported by empirical data, states that in the job market  employers and workers bargain over the conditions of employment, including not only salary and other worker benefits, but also occupational risks to worker safety and health.  Employers compete among themselves to attract workers.  In order to induce workers to accept hazardous jobs, employers must offer a higher salary -- termed a "wage premium for risk" or "risk premium" for short -- to compensate for the additional job risk.  Because they must pay higher wages for more hazardous work, employers have an incentive to make the workplace safer by making safety-related investments in equipment and training or by using more costly but safer work practices.  According to economic theory, the operation of the private job market will provide the optimal level of occupational risk when each employer's additional cost for job safety just equals the avoided payout in risk premiums to workers.
      However, for the job market to function in a way that leads to optimal levels of occupational risk, three conditions must be satisfied.  First, workers, as well as employers, must have perfect information -- that is, they must be fully informed about their workplace options, including job hazards, or be able to costlessly acquire such information.  Second, participants in the job market must directly bear all of the costs and obtain all of the benefits of their actions.  In other words, none of the direct impacts of job market transactions can be externalized to outside parties.  Third, the relevant job market must be perfectly competitive, which means it must contain such a large number of employers and such a large number of workers that no individual economic agent is able to influence the risk-adjusted wage.
      In addition, the working of the job market, even if not subject to market imperfections, may sometimes lead to socially sub-optimal outcomes when important social values transcend the market. In such cases, government intervention might be justified to address a compelling public need (OMB, 2003, page 4).     .
      The discussion below examines (1) imperfect information, (2) externalities, (3) imperfect competition, and (4) compelling social need in the job market in more detail, with particular emphasis on worker exposure to beryllium, as appropriate.
      (1)    Imperfect Information
      As described below, imperfect information about job hazards is present at several levels that reinforce each other:  employers frequently lack knowledge about workplace hazards and how to reduce them; workers are often unaware of the workplace health and safety risks to which they are exposed; and workers typically have difficulty in understanding the risk information they are able to obtain.  Imperfect information at these various levels has likely impeded the efficient operation of the job market as far as workplace risk is concerned.  The reason is that workers unaware of job hazards do not seek, or receive, full compensation for the risks they bear, and, as a result, employers have less incentive to invest in safer working conditions than they would in the presence of full information.
Lack of Employer Information

      In the absence of regulation, employers may lack economic incentives to optimally identify the health risks that their workers face.  Furthermore, employers may have some incentive to withhold the information they do possess about job hazards from their workers, whose response would be to demand higher wages to compensate for the risk.  Similarly, employers who develop cost-effective methods of reducing workplace risk have little incentive to share information with their competitors about such methods (unless they are patentable).  As a result, without regulation, many employers are unlikely to make themselves aware of the magnitude of beryllium-related health risks in the workplace or of the availability of effective ways of ameliorating or eliminating these risks.
Lack of Worker Information
      Even without information from their employers, workers might reasonably be cognizant, at least at some simple qualitative level, of many occupational safety hazards.  Many safety hazards are obvious to the eye, such as holes in floors, ice and snow covered work surfaces, and work near electrical power lines.  Likewise, workers can expect that activities involving explosive materials or working at heights are inherently dangerous.  Furthermore, workers can develop some, admittedly limited, knowledge of safety hazards in their workplace from their own and their coworkers' on-the-job accident and injury experience.
      The same is less likely for occupational health hazards.  Whereas the relationship between a workplace accident and the resultant injury is both immediate and visible, the connection between exposure to an occupational health hazard and the resultant disease may not be.  Most diseases have multiple potential causes and may be the result of synergistic effects, thus creating difficulties in ascertaining whether a worker's disease is job-related rather than an "ordinary disease of life" resulting from genetic, physiological, lifestyle, or non-occupational environmental factors.
      In the case of beryllium, causation is less of an issue since BeS and CBD are uniquely associated with occupational beryllium exposure.  However, the symptoms of CBD are similar to other types of respiratory disease, and CBD has been misdiagnosed as sarcoidosis in the absence of specialized testing.  In addition, lung cancer -- although this particular disease represents only a minor share of beryllium-related health conditions -- does have multiple potential causes.
      In addition to causation issues, occupational health hazards frequently have a long latency period, sometimes 20 years or more between exposure and the manifestation of disease or other adverse effects.  Consequently, workers usually cannot logically or intuitively draw a connection between workplace exposure to a health hazard and a chronic disease or adverse health condition, as would be the case for an acute injury resulting from a safety hazard.  For example, should workers attribute their signs and symptoms of CBD (e.g., shortness of breath, persistent cough, reduced pulmonary function) to workplace exposure to beryllium, genetic predisposition (e.g., asthma), or non-occupational exposures? Furthermore, by the time that signs and symptoms of occupational health problems arise, it is often too late for workers to make use of that information.  Lung cancer does not surface until many years after the exposures that contributed to causing it, and preventive action can no longer be taken.  By the time that CBD is advanced enough to cause shortness of breath or a cough, the damage to the lungs cannot be reversed, and can progress in the absence of further exposure (see the preamble for OSHA's beryllium proposal at Section V, Health Effects).  However, the BeLPT can be used to detect the first stage towards the development of CBD, potentially allowing workers to avoid further exposure before irreversible damage to the lungs occurs.  In this sense, the medical surveillance requirements of the proposed standard make useful and timely information available to workers about their risk of adverse health effects from beryllium exposure.
      Even the preceding characterization fails to capture the extent to which imperfect information impairs the idealized job market's decision calculus, as workers supposedly weigh increased workplace safety or health hazards against wage increases.  One reason is that the risk information available to the worker is typically crude and imprecise.  For example, workers might reasonably be aware, at least over time, that their workplace exposure to beryllium creates some chance of becoming sensitized to beryllium or developing CBD.  However, they could hardly be expected to keep abreast of the scientific literature on hazardous exposures in their workplace, such as epidemiological studies showing that there is a CBD prevalence of eight percent among machinists with an average beryllium exposure level between 0.2 and 0.5 μg/m[3], and that the prevalence of CBD is typically less than one percent among workers whose exposures are kept below 0.1 μg/m[3] (see the preamble at Section VI, Significance of Risk). Even more to the point, workers would have no way of ascertaining their average beryllium exposure without exposure monitoring, and the current beryllium standard does not require employers to conduct exposure monitoring.
 	A second, related reason is that workers are unlikely to know the workplace risks associated with their particular employer, or with one employer versus another, even if the types of work assignments are the same or similar.  Again, absent exposure monitoring, how do workers know their level of beryllium exposure at a particular workplace?  More specifically, on tasks involving beryllium exposure, how do workers know whether their employers or potential employers have implemented adequate engineering controls, or provided respirators (or protective clothing and other personal protective equipment) that have adequate protection factors, have been properly fit-tested, and are properly maintained?  In fact, even the assumption that employers currently are using any engineering controls and supplying any personal protective equipment may not be correct in the absence of regulation.
Inability to Process Risk Information
      Equally problematic as the ability of workers to obtain workplace risk information is their ability to understand the information they manage to obtain.  Both experimental studies and observed market behavior suggest that individuals have considerable difficulty rationally processing information about low-probability, high-consequence events such as occupational injuries, illnesses, and fatalities.  For example, most individuals are unable to comprehend or rationally act on risk information when it is presented, as risk analysis often is, in mathematical terms -- a 1/1,000 versus a 1/10,000 versus a 1/100,000 annual risk of death from occupational causes.
      In order to cope with uncertain situations, individuals have developed various rules of thumb--termed "heuristics" (Tversky and Kahneman, 1974)--to aid in their decision-making.  In many circumstances, these heuristics work quickly and effectively, which is their purpose.  However, sometimes they introduce unintentional cognitive biases that can lead to illogical, inconsistent, or otherwise poor decision-making.  Examples of these apparently almost universal human biases include framing effects; biases due to representativeness, availability, and anchoring heuristics; and the interrelated effects of prior endowment, status quo bias, and loss aversion.
      Of course, in the abstract, many of the problems that workers face in obtaining and  processing occupational risk can lead workers to overestimate as well as underestimate the risk.  Just on that basis, these information problems may not necessarily be enough to provide a rationale for regulating a lower standard.  However, in the case of beryllium exposure, CBD may be sufficiently unfamiliar and unobvious and the amount of beryllium involved so minute that many workers may be completely unaware of the risk, and therefore will underestimate it.  In addition, for markets to optimally address this risk, employees need to be aware of the changes in risk brought about by an employer's actions.  Even if employees are aware of a risk, the employer may have limited economic motivation to install controls unless the employees are able to accurately assess the effects of those controls on their occupational risks.  Furthermore, there is substantial evidence that most individuals are unrealistically optimistic, even in high-stakes, high-risk situations and even if they are aware of the statistical risks (Thaler and Sunstein, 2009, pp. 31-33).  Although the Agency lacks specific evidence in the area of occupational safety and health, this suggests that some workers underestimate their own risk of work-related injury, disease, or fatality and, therefore, fail to demand adequate compensation for bearing those risks.  Finally, the difficulty that workers have in distinguishing marginal differences in risk in alternative worksites (even, and particularly, within an industry) create a disincentive for employers to incur the costs of reducing workplace risk.
      (2)    Externalities
      Externalities arise when an economic transaction generates direct positive or negative spillover effects on parties not involved in the transaction.  The resulting spillover, which amounts to a divergence between private and social costs, undermines the efficient allocation of resources in the market because the market is imparting inaccurate cost and price signals to economic agents.  Applied to the job market, when costs are externalized, they are not reflected in the decisions that employers and workers make -- leading to allocative distortions in that market.
      Negative externalities exist in the job market because many of the costs of occupational injury and illness are borne by parties other than individual employers or workers.  The major source of these externalities, for chronic occupational diseases, has to do with occupational illness costs that workers' compensation does not cover.  Workers and their employers often bear only a portion of these residual costs.  Outside of workers' compensation, workers incapacitated by an occupational injury or illness and their families often receive health care, rehabilitation, retraining, direct income maintenance, or life insurance benefits, most of which are paid for by society through Social Security and other social insurance and social welfare programs.  Furthermore, substantial portions of the medical care system in the United States are
      heavily subsidized by the government so that part of the medical cost of treating injured or ill workers is paid for by the rest of society (Nichols and Zeckhauser, 1977, pp. 44-45).  To the extent that employers and workers do not bear the full costs of occupational injury and illness, they will ignore these externalized costs in their job-market negotiations.  The result may be an inefficiently high level of occupational risk.  It should be noted, however, that OSHA expects that the effect of these externalities on the market-determined level of occupational risk would be relatively minor in comparison to the other types of market failure described here.

      (3)    Imperfect Competition
      In the idealized job market, the actions of large numbers of buyers and sellers of labor services establish the market-clearing, risk-compensated wage, so that individual employers and workers effectively take that wage as given.  In reality, however, the job market is not one market but many markets differentiated by location, occupation, and other factors; entrants in the labor market face search frictions because of limited information on employment options; and, furthermore, in wage negotiations with their own workers, employers are typically in an advantageous position relative to all other potential employers.  In these situations, discussed below, employers may have sufficient power to influence or to determine the wage their workers receive.  This may undermine the conditions necessary for perfect competition and can result in inadequate compensation for workers exposed to workplace hazards.
      Beyond the classic -- but relatively rare -- example of a town dominated by a single company, there is significant evidence that some employers throughout the economy are not wage-takers but, rather, face upward-sloping labor supply curves and enjoy some market power in setting wages and other conditions of employment.  An important source of this phenomenon is the cost of a job search and the employer's relative advantage, from size and economies of scale, in acquiring job market information.
      Another potentially noteworthy problem in the job market is that, contrary to the model of perfect competition, workers with jobs cannot costlessly quit and obtain a similar job at the same wage with another employer.  Workers leaving their current job may be confronted with the expense and time requirements of a job search, the expense associated with relocating to take advantage of better employment opportunities, the loss of firm-specific human capital, the cost and difficulty of upgrading job skills, and the risk of a prolonged period of unemployment.  In addition, employers derive market power from the fact that a portion of the compensation their workers receive is not transferable to other jobs.  Examples include job-specific training and associated compensation, seniority rights and associated benefits, investments in a pension plan, and most important, until recently, health insurance.  Even if competing employers provide health insurance, it may well be subject to exclusions for pre-existing conditions.
      Under the conditions described above, employers would not have to take the market-clearing wage as given, but could offer a lower wage than would be observed in a perfectly competitive market, including less than full compensation for workplace health and safety risks.  As a result, relative to the idealized competitive job market, employers would have less incentive to invest in workplace safety.
      (4)    Compelling Social Need
      Some individual actions are circumscribed by rights and duties or other social purpose that take precedence over market considerations, and these social purposes provide sufficient justification for regulation (OMB Circular A-4,  OMB 2003).  Market transactions in such circumstances may be legally forbidden or socially unacceptable on ethical grounds, even if there are willing parties to the transactions.  For example, in the United States, one's right to vote cannot be sold to another person, and the prison time a convicted criminal receives cannot be served by another person in exchange for a fee.  In the context of the job market, contracts of indentured servitude are not allowed.
      The preceding points suggest that, because of important rights and duties or other social purposes, government intervention may sometimes improve the workings of the unfettered job market.  In fact, the American people, through their elected representatives, have made a determination to override the operation of the unfettered job market, if necessary, by assuring in the OSH Act "so far as possible every working man and woman in the Nation safe and healthful working conditions . . . ." (29 U.S.C. 651(b)).  It is under this congressional mandate that OSHA has developed the proposed beryllium rule.
      OSHA welcomes comment and supporting evidence on the extent of these market failures and compelling public need in the job market, as well as their effects on worker health risks from exposure to beryllium.

non-market and quasi-market alternatives to regulation
      The discussion in this section considers whether non-market and quasi-market alternatives to the proposed rule would be capable of protecting workers from the hazards of beryllium exposure.  The alternatives under consideration are information dissemination programs, workers' compensation systems, and tort liability options.
Information Dissemination Programs
      An alternative to OSHA's proposed beryllium rule would be the dissemination of information, either voluntarily or through compliance with OSHA's hazard communication standard (HCS) (29 CFR 1910.1200), about the health risks associated with workplace exposure to beryllium.  Better informed workers could more accurately assess the occupational risks associated with different jobs, thereby facilitating, through labor market transactions, higher risk premiums for more hazardous work and inducing employers to make the workplace less hazardous.  The proposed rule recognizes the link between the dissemination of information and workplace risks by requiring that workers engaged in jobs involving exposure to beryllium be provided with information and training about beryllium-related illnesses and ways to prevent them.  There are several reasons, however, why reliance on information dissemination programs alone would not yield the level of worker protection achievable through the proposed beryllium rule.
      First, in the context of HCS, which requires employers to transmit information about the inherently hazardous properties of hazardous substances, the standard alone does not require that sufficient information be provided to identify risks in specific workplaces.  Beryllium-related risks, for instance, are highly specific to individual tasks and work environments.
   	Second, in the case of voluntary information dissemination programs, absent a regulation, there may be significant economic incentives, for all the reasons discussed in the private market incentives, for the employer not to gather relevant exposure data or distribute occupational risk information so that the workers would not demand higher wages to compensate for their newly identified occupational risks.
      Third, even if workers were better informed about workplace risks and hazards, all of the defects in the functioning of the private job market previously discussed -- the limited ability of workers to evaluate risk information, externalities, imperfect competition, and factors that transcend the market -- would still apply.  Because of the existence of these defects, better information alone would not ensure that the job market will yield wage premiums for risk in a manner that is consistent with an efficient allocation of resources.
      Thus, while improved access to information about beryllium-related hazards can provide for more rational decision-making in the private job market, OSHA preliminarily concludes that information dissemination programs may not, by themselves, produce an adequate level of worker protection.
Workers' Compensation Systems
      Another alternative to OSHA regulation is simply to use State workers' compensation programs to augment the workings of the private job market to limit occupational risks to worker safety and health.  After all, one of the objectives of the workers' compensation system is to shift the costs of occupational injury and disease from workers to employers in order to induce employers to improve working conditions.  Two other objectives are to provide fair and prompt compensation to workers for medical costs and lost wages resulting from workplace injury and disease and, through the risk-spreading features of the workers' compensation insurance pool, to prevent individual employers from suffering a catastrophic financial loss (Ashford, 2007, p. 1712).
      However, there are three reasons, discussed below, why the workers' compensation system has fallen short of the goal of shifting to employers the costs of workplace injury and disease -- including, in particular, the costs of worker exposure to beryllium.  As a result, OSHA preliminarily concludes that there may be inadequate worker protection in the absence of the proposed beryllium rule.
      (1) A Divergence between Workers' Compensation Premiums and Workplace Risk
      The first reason workers' compensation does not adequately shift the costs of work-related injuries and illnesses to employers is that the risk-spreading objective of workers' compensation conflicts with, and ultimately helps to undermine, the cost-internalization objective.  For the 99 percent of employers who rely on workers' compensation insurance, the payment of premiums represents their primary cost for occupational injuries and illnesses, such as beryllium-related illnesses.  However, the mechanism for determining an employer's workers' compensation insurance premium typically fails to reflect the actual occupational risk present in that employer's workplace.
      Approximately 85 percent of employers have their premiums set based on a "class rating," which is based on industry illness and injury history.  Employers in this class are typically the smallest firms and represent only about 15 percent of workers (Ashford, 2007, p. 1713).  Small firms are often ineligible for experience rating because of insufficient claims history or because of a high year-to-year variance in their claim rates.  These firms are granted rate reductions only if the experience of the entire class improves.  The remaining 14 percent of employers, larger firms representing approximately 70 percent of workers, have their premiums set on the basis of a combination of "class rating" and "experience rating," which adjusts the class rating to reflect a firm's individual claims experience.  A firm's experience rating is generally based on the history of workers' compensation payments to workers injured at that firm's workplace, not on the quality of the firm's overall worker protection program and safety and health record. Thus, for example, the existence of circumstances that may lead to catastrophic future losses are not included in an experience rating -- only actual past losses are.
      Insurance companies do have the right to refuse to provide workers' compensation insurance to an employer -- and frequently exercise that right based on their inspections and evaluations of a firm's health and safety practices.  However, almost all States have assigned risk pools that insist that any firm that cannot obtain workers' compensation policies from any insurer must be provided workers' compensation insurance at a State-mandated rate that reflects a combination of class and experience rating.
      Workers' compensation insurance does protect individual employers against a catastrophic financial loss due to work-related injury or illness claims.  As a result of risk spreading, however, employers' efforts to reduce the incidence of occupational injuries and illnesses are not fully reflected in reduced workers' compensation premiums. Conversely, employers who devote fewer resources to promoting worker safety and health may not incur commensurately higher workers' compensation costs.  This creates a type of moral hazard, in that the presence of risk spreading in workers' compensation insurance may induce employers to make fewer investments in equipment and training to reduce the risk of workplace injuries and illnesses.
      In short, the premiums most individual employers pay for workers' compensation insurance coverage do not reflect the actual cost burden those employers impose on the worker's compensation system. Consequently, employers considering measures to lower the incidence of workplace injuries and illnesses can expect to receive a less-than-commensurate reduction in workers' compensation premiums.
      (2) Failure to Provide Compensation for Most Occupational Diseases
      The second, and most important, reason that workers' compensation is not an adequate alternative, as a practical matter, is that State workers' compensation programs tend not to provide benefits for most work-related diseases -- including those resulting from beryllium exposure, such as CBD.  Several related factors account for this:
   * Most occupational diseases have multiple causes and are indistinguishable from ordinary diseases of life.  Therefore it is difficult for workers' compensation to trace the cause of these diseases to the workplace;
   * Many occupational diseases have long latency periods, which tends to obscure the actual cause of disease or the place of employment where exposure occurred;
   * Workers (as well as medical personnel) often do not realize that a disease is work-related and, therefore, fail to file a workers' compensation claim; and
   * Most States have filing restrictions.  For example, most states have statutes of limitations that are 10 years or less for filing workers' compensation claims.  This may preclude claims for illnesses involving long latency periods.  Also, many States have a minimum exposure time period before a disease can be attributed to an occupational cause.
With the exception of musculoskeletal disorders, workers' compensation actually covers only 5 percent of occupational diseases and 1.1 percent of occupational fatalities (Ashford, 2007, p. 1714).  Beryllium-related occupational diseases face a similar lack of workers' compensation coverage.
      (3) Limitations on Payouts
      The third reason that employers do not fully pay the costs of work-related injuries and disease under the workers' compensation system is that, even for those claims that are accepted into the system, states have imposed significant limitations on payouts.  Depending on the State, these limitations and restrictions include:
   * Caps on wage replacement based on the average wage in the State rather than the injured workers' actual wage;
   * Restrictions on medical care services that are compensated and the amount of that compensation;
   * No compensation for non-pecuniary losses, such as pain and suffering or impairment not directly related to earning power;
   * Either no, or limited, cost-of-living increases;
   * Restrictions on permanent, partial, and total disability benefits, either by specifying a maximum number of weeks for which benefits can be paid or by imposing an absolute ceiling on dollar payouts;
   * A low absolute ceiling on death benefits.
The last two restrictions may be the most important for occupational diseases with long-term health effects and possible fatal outcomes, such as those associated with worker exposure to beryllium.
      In summary, for all of the reasons discussed above, the workers' compensation system does not provide adequate incentives to employers to control occupational risks to worker safety and health.
Tort Liability Options
      Another alternative to OSHA regulation would be for workers to use the tort system to seek redress for work-related injuries and diseases, including beryllium-related ones.  A tort is a civil wrong (other than breach of contract), for which the courts provide a remedy in the form of an action for damages.  The application of the tort system to occupational injury and disease would allow workers to sue their employer, or other responsible parties (e.g., "third parties" such as suppliers of hazardous material or equipment used in the workplace) to recover damages.  In theory, the tort system could shift the liability for the direct costs of occupational injury and illness from the worker to the employer or to other responsible parties.  In turn, the employer or third parties would be induced to improve worker safety and health.
      With limited exceptions, however, the tort system has not been a viable alternative to occupational safety and health regulation because State statutes make workers' compensation the "exclusive remedy" for work-related injuries and illnesses.  Workers' compensation is essentially a type of no-fault insurance.  In return for employers' willingness to provide, through workers' compensation, timely wage-loss and medical coverage for workers' job-related injuries and diseases, regardless of fault, workers are barred from suing their employers for damages, except in cases of intentional harm or, in some States, gross negligence (Ashford and Caldart, 1996, p. 233).  Practically speaking, in most cases, workers' compensation is the exclusive legal remedy available to workers.
      In principle, workers may attempt to recover damages for work-related injuries and disease from third parties through the tort system.  However, the process is lengthy, adversarial, and expensive.  In addition, in tort cases involving chronic occupational disease, the likelihood of prevailing in court and ultimately obtaining compensation is small because:
      * In a tort action, the burden of proof is on the plaintiff (i.e., the worker) to demonstrate by "a preponderance of the evidence" that the defendant owed a duty to the plaintiff, that the defendant breached that duty, and that the breach caused the worker's injury or disease;
      * To establish third-party liability the worker must show that the third party's products or equipment or instructions were defective or negligently designed.  Liability is often in dispute and difficult to prove by a preponderance of the evidence;
      * In cases of chronic disease, it is typically even more difficult to prove that the third-party was causally responsible.  The worker must prove, based on a preponderance of the evidence, that not only was the disease the result of occupational exposure and not an ordinary disease of life or the result of non-occupational exposure, but also the causal exposure was due to the defendant's product at the plaintiff's particular worksite rather than exposure to some other third party's product or exposure at some other worksite.  For diseases with long-latency periods and workers with long work histories, it may be almost impossible to establish causation under this test based on a preponderance of the evidence;
      * For chronic diseases, the potentially lengthy latency period between worker exposure and manifestation of disease significantly lowers the probability that the responsible third party will still be in business when tort claims are ultimately filed and have sufficient assets to cover the claims, particularly if there are many of them; and
      * Workers may be deterred from filing tort actions because of the substantial costs involved -- including attorney fees, court costs, and the costs of obtaining evidence and securing witnesses -- and the lengthy period before a final decision is rendered.
      In sum, the use of the tort system as an alternative to regulation is severely limited because of the "exclusive remedy" provisions in workers' compensation statutes; because of the various legal and practical difficulties in seeking recovery from responsible third parties, particularly in cases of occupational disease such as CBD; and because of the substantial costs associated with a tort action.  The tort system, therefore, does not adequately serve to protect workers from exposure to hazards in the workplace.

Summary
      As shown in the preamble to the proposed beryllium rule, OSHA has determined that some workers in certain industries are exposed to beryllium and face a significant risk of developing lung cancer, BeS, and CBD.  The private market -- augmented by information dissemination programs, workers' compensation systems, and tort liability options -- may be characterized by a level of risk for these workers that is higher than socially optimal; such an outcome could be due to a lack of information about health risks or (potentially) the presence of externalities or imperfect competition, and other factors discussed above.  Therefore, the Agency has preliminarily concluded that OSHA's existing beryllium exposure limits and the private market are unlikely to provide the level of protection afforded by an updated occupational beryllium standard that adheres to the statutory requirements of the OSH Act.

References

Ashenfelter, O. C., H. Farber, and M. R. Ransom, 2010.  "Labor Market Monopsony," 28(2) Journal of Labor Economics, pp. 203-210.

Ashford, N.A., 2007.  "Workers' Compensation" (pp. 1712-1719), in Environmental and Occupational Medicine (Fourth Edition), Rom, W. N. (editor).  Lippincott-Raven: Philadelphia.

Ashford, N.A., C. Ayers, and R.F. Stone, 1985.  "Using Regulation to Change the Market for Innovation," 9 Harvard Environmental Law Review 2, pp. 871-906.

Ashford, N.A., and C.C. Caldart, 1996.  Technology, Law, and the Working Environment (Revised Edition), Washington, DC: Island Press.

Boal, W.M., and M.R. Ransom, 1997.  "Monopsony in the Labor Market," XXXV (March 1997) Journal of Economic Literature, pp. 86-112.

Borjas, G. J., 2000.  Labor Economics (Second Edition),  Boston: Irwin McGraw-Hill.

Camerer, C., G. Loewenstein, and D. Prelec, 2005.  "Neuroeconomics:  How Neuroscience Can Inform Economics,"  Journal of Economic Literature XLIII(1), pp. 9-64.

Camerer, C., G. Loewenstein, and M. Rabin (eds), 2004.  Advances in Behavioral Economics,  Princeton:  Princeton University Press.

Kahneman, D., J. L. Knetsch, and R. H. Thaler, 1991.  "The Endowment Effect, Loss Aversion, and Status Quo Bias," Journal of Economic Perspectives 5(1), pp. 193-206.

Leigh, J.P., and H.H. Robbins, 2004.  "Occupational Disease and Workers' Compensation:  Coverage, Costs, and Consequences," 82 Milbank Quarterly 4, pp. 689-721.

Machina, M. J., 1987.  "Choice Under Uncertainty: Problems Solved and Unsolved,"  1 Journal of Economic Perspectives 1, pp. 121-154.

Nichols, A. L., and R. Zeckhauser, 1977.  "Government Comes to the Workplace:  An Assessment of OSHA,"   49 The Public Interest pp. 36-69.

OMB (Office of Management and Budget), 2003.  Circular A-4, September 17. Available at: http://www.whitehouse.gov/sites/default/files/omb/assets/regulatory_matters_pdf/a- - 4.pdf.

Thaler, R. H., and C. R. Sunstein, 2009.  Nudge,  New Haven: Yale University Press.

Tversky, A., and D. Kahneman, 1974.  "Judgment under Uncertainty: Heuristics and Biases," 185 Science pp. 1124-1131.

Weil, D., 2014.  The Fissured Workplace, Cambridge, Massachusetts: Harvard University Press.

      CHAPTER III:  PROFILE OF AFFECTED INDUSTRIES
	In this chapter, OSHA presents a profile of industries that use beryllium, beryllium oxide, and/or beryllium alloys.  For each industry sector identified, the Agency describes the uses of beryllium and estimates the number of establishments and employees that may be affected by this proposed rulemaking.  Employee exposure to beryllium can also occur as a result of certain processes such as welding that are found in many industries.  This analysis will use the umbrella term "application group" to refer either to an industrial sector or a cross-industry group with a common process. These groups are all mutually exclusive and are analyzed in separate sections below.
	Beryllium is rarely used by all establishments in any particular application group because its unique properties and relatively high cost typically result in only very specific and limited usage within a portion of a group.  The following sections briefly describe each application group and then explain how OSHA estimated the number of establishments working with beryllium and the number of employees exposed to beryllium.  Technological feasibility reports (summarized in Chapter IV of this PEA) for each beryllium-using application group provide a detailed presentation of processes and occupations with beryllium exposure, including available sampling exposure measurements and estimates of how many employees are affected in each specific occupation.
	The information in this chapter is based on reports prepared under task order by Eastern Research Group (ERG), an OSHA contractor; information collected during OSHA's Small Business Advocacy Review Panel (SBAR, 2008); and Agency research and analysis.
	OSHA has identified nine application groups that would be potentially affected by the proposed beryllium standard:
         1.  Beryllium Production
         2.  Beryllium Oxide Ceramics and Composites
         3.  Nonferrous Foundries
         4.  Secondary Smelting, Refining, and Alloying
         5.  Precision Turned Products
         6.  Copper Rolling, Drawing, and Extruding
         7.  Fabrication of Beryllium Alloy Products
         8.  Welding
         9.  Dental Laboratories

These application groups are broadly defined, and some include establishments in several North American Industrial Classification System (NAICS) codes.  For example, the Copper Rolling and Drawing, and Extruding application group is made up both of NAICS 331421 Copper Rolling, Drawing, and Extruding and NAICS 331422 Copper Wire Drawing.  While an application group may contain numerous NAICS six-digit industry codes, in most cases only a fraction of the establishments in any individual six-digit NAICS industry use beryllium and would be affected by the proposed rule.  For example, not all companies in the above application group work with copper that contains beryllium.
	One application group, welding, reflects industrial activities or processes that take place in various industry sectors.  All of the industries in which a given activity or process may result in worker exposure to beryllium are identified in the sections on the application group.  The section on each application group describes the production processes where occupational contact with beryllium can occur and contains estimates of the total number of firms, employees, affected establishments, and affected employees.
	Throughout this chapter, OSHA will be presenting formulas in the text, usually in parentheses, to help explain the derivation of estimates.  Because the values used in the formulas shown in the text are sometimes rounded, while the actual spreadsheet formulas used to create final costs are not, the calculation using the presented formula will sometimes differ slightly from the total presented in the text -- which is the actual total as shown in the tables.
      At the end of this chapter, OSHA discusses other industry sectors that have reportedly used beryllium in the past or for which there are anecdotal or informal reports of beryllium use.  The Agency was unable to verify beryllium use in these sectors that would be affected by the proposed standard (i.e., in general industry, where there is occupational exposure to beryllium or where materials are being processed that contain at least 0.1 percent beryllium by weight), and seeks further information in this rulemaking on these or other industries where there may be significant beryllium use and employee exposure.
AFFECTED APPLICATION GROUPS
1.  Beryllium Producers
      The Materion Corporation ("Materion," formerly Brush Wellman) plant in Elmore, Ohio, is currently the only facility in the United States that produces beryllium metal.  The beryllium manufacturing application group thus consists of a single plant.  Materion mines beryllium hydroxide at its Utah mining and extraction operation -- which is regulated by the Mine Safety and Health Administration (MSHA) rather than OSHA.  The beryllium hydroxide is converted into beryllium metal and beryllium oxide at the Elmore facility.  Because Materion integrates a number of different processes into a single plant, the activities at the Elmore plant overlap with some of the other application groups addressed in this industrial profile. For example, copper-beryllium alloy production and rolling and drawing operations are performed at this facility, and a large part of the operation is devoted to manufacturing a range of beryllium alloy products.  However, for purposes of this industrial profile, all workers at this facility are classified in this beryllium production application group. More information on specific job groups and their beryllium exposure at this facility is available in Chapter IV: Section 2 of this PEA.
      Beryllium production at the Elmore facility is classified in NAICS 331419: Primary Smelting and Refining of Nonferrous Metals.  ERG collected information about Materion's Elmore facility during site visits.  Materion also provided information to the Agency in several written comments to the docket (OSHA, H005C-2006-0870 Document ID #0080).
Estimates of the Number of Affected Employees
	In addition to the workers involved in beryllium, beryllium alloy, and beryllium oxide production, total employment at the Elmore facility includes administrative, research, and maintenance personnel.  In response to OSHA's 2002 Beryllium Request for Information, Materion reported beryllium exposure sampling results for 1999 based on an average employment of 616 workers (Materion, 2002).  Table III-1 shows the Materion staffing levels by work group at the Elmore plant in 1999.  These data from the company are the most recent figures available, and the Agency has based its estimates on these employment figures.

2. Beryllium Oxide Ceramics and Composites
	Beryllium oxide (commonly called beryllia) is known for its high heat capacity and is an important component of certain sensitive electronic equipment.  Two facilities process beryllium oxide powder into ceramics and composites: Brush Ceramic Products in Tucson, Arizona (a subsidiary of Materion) and American Beryllia Inc. in Haskell, New Jersey. These two beryllium oxide ceramics producers also use fired oxide ceramics to manufacture finished products as well as to ship unfinished beryllium oxide ceramic products to a number of other manufacturers for further processing.
	ERG used data from the 2002 Economic Census and from the Occupational Employment Survey (OES) of the Bureau of Labor Statistics (BLS), in combination with information collected through discussions with fabricators and finishers of beryllium oxide products, distributors of beryllium oxide raw materials, professional society board members, ceramic engineers, industrial hygienists, and research scientists, to create the industry profile for this application group (more detail is available in Chapter IV: Section 4 of this PEA).
 Estimates of the Number of Affected Establishments
	The two beryllium oxide processors have been identified above.  Still needed are the downstream users with potentially affected employees. Most downstream users of beryllium that were contacted by ERG noted that they purchase at least some products from Brush Ceramic Products, whether or not they also purchase products from American Beryllia. Accordingly, OSHA assumes that Brush Ceramic Products' customers represent virtually all beryllium oxide customers.  Materion (Brush Ceramic Products) reported in 2001 that its beryllium oxide ceramics products were sold to 102 different customers (Kolanz, 2001).  By calculating the decrease in the overall number of establishments between the 2002 Economic Census and the 2010 County Business Patterns for each of the NAICS codes listed in Table III-2, and applying the same decreases to the relevant customer industries that received beryllium from Materion, OSHA estimates that 92 establishments are working with beryllium oxide today.  Below OSHA analyzes and allocates the 92 establishments among the various industries that have beryllium ceramic applications.
      NAICS 327113: Porcelain Electrical Supply Manufacturing
      The 2010 County Business Patterns reported a total of 106 establishments in NAICS 327113: Porcelain Electrical Supply Manufacturing.  That dataset does not include a further breakdown by industry sub-sectors, so OSHA has relied on earlier economic data to identify the specific sub-sector of ceramics establishments whose employees might be exposed to beryllium during the manufacturing process.  The 2002 Economic Census listed 18 firms in subsector 0351 of NAICS product code 327113 that manufacture ceramic materials that contain beryllium oxide, titanate, and other ceramic electrical products and components for electronic applications. OSHA is not aware of other subsectors of NAICS 327113 that involve beryllium.  Discussions with persons in the industry suggest that the actual number of firms currently is likely fewer than 18, and possibly as low as half this number (Pekrul, 2004), but absent additional data  OSHA is relying on the Census information and assuming that each of these firms uses beryllium in some part of the ceramic manufacture process, and that each of these firms has one establishment, to estimate that 18 establishments performed beryllium oxide operations in this industry in 2002.
      OSHA knows that the two primary producers in this subsector in 2002, Brush Ceramics and American Beryllia, remain active.  To estimate the decrease from 2002 to 2010 in the remaining 16 firms, OSHA assumes the same percentage decrease in subsector 0351 firms as in the overall number of firms.  The overall number of firms in NAICS 327113 decreased between the 2002 Economic Census and the 2010 County Business Patterns from 120 to 106.   OSHA therefore estimates that 16 establishments performed beryllium oxide operations in NAICS 327113 in 2010.  OSHA seeks comment on the number of domestic producers of beryllium oxide ceramics, including whether there are fewer than the 16 estimated establishments and whether there are additional data that would assist OSHA in identifying the number of affected establishments or firms for this industry.
      NAICS 334411: Electron Tube Manufacturing
A second group of downstream manufacturers produce traveling wave tubes included in NAICS 334411: Electron Tube Manufacturing.  The 2010 County Business Patterns did not provide disaggregated statistics regarding the number of establishments that manufacture traveling wave tubes, but did report an overall total of 79 firms in this NAICS industry (U.S. Bureau of the Census, 2010).  However, ERG's industry contacts indicated that a relatively small number of firms produce traveling wave tubes using beryllium.  Based on discussions with an industry expert, OSHA estimates that 25 companies used beryllium in producing electronic wave tubes in 2002, and OSHA assumes that each company operated one establishment. Based on the change in the number of establishments in NAICS 334411 from 2002 to 2010, OSHA estimates that, in 2010, 21 establishments used beryllium to produce electronic wave tubes. OSHA did not identify any other sources that provided profile information on this group of firms and invites comment on this issue.
       From OSHA's estimated total of 92 downstream users, this leaves 55 remaining users to be distributed among relevant industries.  Based on Materion's description of customers' use of beryllium oxide, OSHA believes that the remaining 55 customers use beryllium oxide ceramics in the production of four types of electrical and electronic products:  (1) wireless base stations (such as cell towers); (2) various electronics devices (including resistor cores, heat sinks for satellites, and automotive ignitions); (3) medical laser devices; and (4) lasers used in entertainment devices.
       Product manufacturers for these electronics products are classified in six different NAICS codes:
 	NAICS 334415: Electronic Resistor Manufacturing;
 	NAICS 334419: Other Electronic Component Manufacturing;
 	NAICS 336322: Other Motor Vehicle Electrical and Electronic Equipment
            Manufacturing;
       	NAICS 334220: Radio and Television Broadcasting and Wireless Communications
            Equipment Manufacturing;
 	NAICS 334510: Electromedical and Electrotherapeutic Apparatus Manufacturing; and
 	NAICS 334310: Audio and Video Equipment Manufacturing.
       OSHA has preliminarily concluded that the remaining 55 customers purchasing beryllium oxide from Materion will fall within these six industries.  ERG distributed these companies among these six NAICS codes based on Materion customer survey report descriptions and NAICS titles.  These estimates are shown in Table III-2.
       Estimates of the Number of Affected Employees
 	 The estimated number of affected employees is also presented in Table III-2 and, except for the two beryllium oxide ceramics producers, was derived from the average number of employees in an establishment in a particular NAICS code multiplied by the number of affected establishments estimated to be in this same NAICS code.   ERG's industry contacts verified that most beryllium-oxide handling operations at these manufacturing facilities are small and suggested that the fabrication facilities are among the smaller firms in Materion's customer population (and hence American Beryllia's as well).  Consequently, the Agency may be over-counting the number of employees by using the average number of employees per establishment to estimate the total.  Most establishments contacted by ERG employ between 5 and 20 production workers each.  One firm employs 50 to 60 production workers in total, but not all of them work on beryllium oxide projects (see Chapter IV: Section 4 of this PEA).  OSHA invites comment on these estimates.

3. Nonferrous Foundries
	Nonferrous foundries produce a variety of cast products using alloyed and unalloyed copper, aluminum, and other metals (see Chapter IV: Section 5 of this PEA).  These foundries may produce castings of copper-beryllium alloys or, to a lesser extent, aluminum-beryllium alloys, or both.  A limited amount of pure beryllium is cast for specialized aerospace applications; however, beryllium is usually alloyed with another metal.  To the extent that pure beryllium casting occurs, it happens as an occasional activity in aluminum foundries.
      Foundries that use beryllium alloys are classified as:
      NAICS 331525: Copper Foundries (Except Die-casting);
      NAICS 331521: Aluminum Die-casting Foundries;
      NAICS 331524: Aluminum Foundries (Except Die-casting); and
      NAICS 331522: Nonferrous (Except Aluminum) Die-casting Foundries.
      ERG used data from the 2002 Economic Census, 2010 OES, OSHA's Integrated Management Information System (IMIS) database, and discussions with industry contacts and trade groups in order to develop a profile of affected industries and estimate the number of employees for this application group (for more detail, see  Chapter IV: Section 5 of this PEA).  Table III-3 at the end of this section shows U.S. Census Bureau data describing the copper and aluminum foundry industries.
 Estimates of the Number of Affected Establishments
       NAICS 331525: Copper Foundries (Except Die casting)
U.S. Census Bureau data report the number of copper foundries with shipments of high-copper content alloys, which include copper-beryllium. The data show that, in 2002, 25 firms in NAICS 331525 product code 0416 produced high-copper sand castings, and 25 firms in NAICS 331525 product code 0541 produced investment castings out of high-copper alloys.  Fewer foundries produced high-copper mold castings (12 firms), high-copper centrifugal castings (13 firms), and other types of high-copper castings (10 firms).  Census data also show four firms in NAICS 331525 product code 06: Copper-base Alloy Bearings and Bushings, Nonmachined, which includes high-copper as well as other types of copper alloys.  These product code categories are not exclusive, however, and firms are probably counted in more than one group.  Hence, the number of foundries using high-copper alloys is very likely less than the total of 89, summed from these data, due to double-counting.  Also, in the 2002 Census, the number of establishments in NAICS 331525 was only one greater than the number of firms; thus, it is reasonable to make the simplifying assumption that each firm mentioned above owns one establishment.
Information from OSHA's IMIS indicated that beryllium was detected in 20 percent of the 110 copper foundries where air samples were taken during the period 1978 through 2008. An extrapolation of this percentage to the total population of copper foundries (208) classified in NAICS 331525 yields an estimate of 42 such foundries (0.2 x 208) that may work with copper-beryllium alloys.  Industry contacts suggest that the number of foundries casting beryllium alloys has declined in recent years.  Of seven foundries that ERG contacted that indicated they have used copper-beryllium, two have stopped using the material in recent years.
      While industry contacts could not provide quantitative estimates, ERG considered whether the number of foundries using beryllium according to the 2002 Economic Census was consistent with industry comments. Representatives of the American Foundry Society and the Non-Ferrous Founders' Society could not provide ERG with an estimate of the number of foundries casting beryllium alloy metals, but both stated that they believe the number is small.  The total population of foundries (according to the 2010 County Business Patterns) was 1,900.  In that context, ERG considered that a "small number" likely indicated fewer than 100.  Other industry sources, including a copper foundry, an aluminum foundry, a resistance welding electrode manufacturer, and a brass and copper rolling mill, also indicated that few foundries cast beryllium and beryllium alloys, although they could not provide quantitative estimates.  Although no industry sources provided quantitative estimates of the number of foundries using beryllium, ERG determined that the profile developed based on U.S. Census data was consistent with industry sources' comments.
      Considering the number of foundries suggested by information in the IMIS database (42) and the Census Bureau (89), given the likelihood of double counting by the Census Bureau, and the reported decline in copper-beryllium use in the foundry industry in the last decade, OSHA estimates that 45 establishments in the copper foundry industry sectors cast beryllium-containing alloys.
       NAICS 331521 and 331524: Aluminum Foundries (Die Casting and Other)
       ERG found no quantitative estimates of the number of foundries in the United States that cast aluminum-beryllium alloys. ERG's research indicated that use of these alloys is much less common than the use of copper-beryllium.  Furthermore, a representative of an aluminum foundry that uses aluminum-beryllium master alloys noted that use of beryllium alloys in aluminum foundries is decreasing (Barbetti, 2002).
       ERG estimated that there are 14 foundry companies that cast aluminum-beryllium alloys.  Of these foundries, OSHA estimates that at least 12 use aluminum-beryllium master alloys (Kosto, 2002).  The remaining two foundries cast both pure beryllium and beryllium composite or hybrid products.  For the purposes of this analysis, OSHA divided these 14 establishments between two application groups, assigning one-half of the total, or seven establishments, to each of the two aluminum foundry industries, NAICS 331521: Aluminum Die-Casting Foundries and NAICS 331524: Aluminum Foundries (Except Die-Casting).
       NAICS 331522: Nonferrous Die-casting Foundries (Except Aluminum)
       The U.S. Census Bureau (2002) reported that 38 firms in NAICS 331522: Nonferrous Die-casting Foundries produce copper or copper-base alloy die-castings, including bearings and bushings. ERG concluded that all of these establishments would use beryllium-copper alloy to some extent, because beryllium is commonly added to copper used to make bushings.  OSHA therefore preliminarily estimates that all of these firms work with copper-beryllium alloys (see Chapter IV: Section 5 of this PEA).
 Estimates of the Number of Affected Employees
 	Estimates of the number of employees in the nonferrous foundries are based on the average employment sizes for each of the respective industries discussed above (U.S. Census Bureau, 2004).  OSHA estimates that a total of 97 nonferrous foundry establishments, employing 3,601 workers, use beryllium.  Table III-3 summarizes the estimates of the numbers of affected foundries using beryllium alloys and the number of affected employees.

4. Secondary Smelting, Refining, and Alloying
	Secondary refining and smelting facilities produce metals from scrap and process waste.  Direct handling and processing of beryllium alloy scrap or processing of unalloyed nonferrous metals that contain trace amounts of beryllium can generate beryllium exposures.  As described in Chapter IV of this PEA, exposure data, containing industry and job descriptions, were obtained from OSHA's IMIS database, NIOSH Health Hazard Evaluations (HHEs) and an ERG site visit to a precious and base metals recovery facility (ERG, 2003).  Based on this information, the Agency has preliminarily judged that the primary potential exposure source for workers in these facilities is processing of beryllium-alloy scrap derived from electronics and computer parts and from metals recycled from defense, aerospace, and other similar applications.
      Establishments in secondary smelting, refining, and alloying fall under one of four NAICS industries:
      NAICS 331421: Copper Rolling, Drawing, and Extruding;
      NAICS 331314: Secondary Smelting and Alloying of Aluminum;
      NAICS 331423: Secondary Smelting, Refining, and Alloying of Copper; and
      NAICS 331492: Secondary Smelting, Refining, and Alloying of Nonferrous Metals.
Table III-4 at the end of this section presents data from the 2010 County Business Patterns describing affected secondary smelting, refining, and alloying industries.  ERG also used data from the 2002 Economic Census, 2010 OES, OSHA's IMIS database, interviews with industry contacts, and the Thomas Register in order to compile the industry profile for this application group. Chapter IV further describes how estimates of the number of affected establishments, a small subset of the entire NAICS population, are derived.
Estimates of the Number of Affected Establishments
      Three types of facilities in these industries use copper, aluminum, and other scrap to produce nonferrous metal products: smelters, refiners, and ingot makers.
      NAICS 331314, 331421 and 331423: Secondary Smelting, Aluminum and Copper
	Based on ERG's industry contacts, a review of the Thomas Register, and Internet searches, ERG identified only six establishments in NAICS 331314: Secondary Smelting and Alloying of Aluminum, that handle and/or produce aluminum-beryllium scrap alloys (Diroccho, 2002; KB, 2002; and Lefgren, 2002; also see  Chapter IV: Section 6 of this PEA).  One of these is the Materion facility in Elmore, Ohio, which has already been discussed in the earlier section on Beryllium Producers (NAICS 331419)  -- so Materion's facility is excluded from Table III-4.
	One of the remaining five companies produces rolled and extruded copper-beryllium products and is classified in Table III-4 as NAICS 331421: Copper Rolling, Drawing, and Extruding.  Three additional companies are classified in NAICS 331423: Secondary Smelting, Refining, and Alloying of Copper.  The remaining company -- of the six companies that currently produce copper-beryllium or aluminum-beryllium alloys -- specializes in aluminum alloys and is classified in NAICS 331314: Secondary Smelting and Alloying of Aluminum.
      NAICS 331492: Secondary Smelting, Refining, and Alloying of Nonferrous Metals (Except Copper and Aluminum)
      Establishments in NAICS 331492: Secondary Smelting, Refining, and Alloying of Nonferrous Metals (Except Copper and Aluminum) recover precious metals from copper scrap, which may contain beryllium, extracted from electronics equipment and other wastes.
      The 2007 Economic Census reports 29 firms in NAICS 331492 with sales greater than $100,000 that produce "secondary precious metals and precious metal alloys."  ERG did not find additional relevant information about firms with lower sales amounts or other information about the number of affected establishments.  Based on the possibility that there may be establishments with less than $100,000 in revenues that encounter beryllium and that some establishments with revenues greater than $100,000 may not process beryllium-containing materials, OSHA estimates that 30 establishments nationwide recover precious metals from electronic scrap and therefore could encounter copper-beryllium alloys.
      A review of beryllium exposure samples contained in the IMIS database, covering the period 1994 through 2002, shows that all but a few detectible samples in secondary metal recovery facilities came from establishments engaged in secondary copper smelting, copper refining and alloying, or precious metal recovery. While beryllium could be encountered in other types of secondary metal recovery, the Agency has preliminarily concluded that the 30 establishments shown in Table III-4 represent all of the establishments in this industry affected by the proposed beryllium standard. OSHA invites comment and further data on this estimate.
Estimates of the Number of Affected Employees
	Census-based industry statistics for NAICS 331423 and 331314 show an average of 32.9 and 39.7 employees per establishment, respectively (U.S. Census Bureau, 2010). Based on these averages, the Agency estimates that the total number of affected employees at the three establishments in NAICS 331423 that are estimated to be affected by this proposed rule is 99 employees (32.9  x 3) and that the total number of affected employees in NAICS 331314 is estimated to be 40 employees (39.7 x 1). Finally, there is only one establishment in NAICS 331421, and that establishment has 103 potentially affected employees.  Therefore, the estimated number of affected employees for NAICS 331421 is 103 workers. Table III-4 summarizes employment estimates for these establishments.

5. Precision Turned Products
	The precision turned product manufacturing application group includes companies that produce metal products by a combination of machining processes such as turning, milling, tapping, drilling, sawing, and grinding.  Beryllium-containing materials that might be used for these products include beryllium metal and beryllium alloyed with other metals including copper, nickel, aluminum, magnesium, gold, and zinc. Applications include the manufacture of military aircraft and space shuttle brake systems, structural parts for missiles and satellites, optical systems, and x-ray windows.
      Establishments in this application group are found in NAICS 332721: Precision Turned Product Manufacturing.  ERG used data from the 2010 County Business Patterns, 2010 OES, and discussions with industry contacts, including representatives of two of the largest machiners of pure beryllium and aluminum-beryllium alloys, in order to estimate the number of affected establishments and employees for this application group.
Estimates of the Number of Affected Establishments
      Table III-5 at the end of this section provides profile information for NAICS 332721: Precision Turned Product Manufacturing based on 2010 County Business Patterns data.  As shown, the industry includes an estimated 3,124 facilities and 78,749 employees.  More than half of the facilities are small, employing fewer than 20 employees.  Only 5 percent of the facilities employ 100 or more employees.
      The number of establishments that machine pure beryllium or aluminum-beryllium alloys is very small due to the limited demand for beryllium parts and the difficulties of working with beryllium metals.  Representatives of two of the largest machiners of pure beryllium and aluminum-beryllium alloys reported that 15 or fewer companies work with these materials in the United States, and of these companies no more than six work with pure beryllium.
      Copper-beryllium alloys, on the other hand, are easily machined and can be worked using conventional metalworking processes.  Nevertheless, according to industry sources, several factors limit the number of establishments working with copper-beryllium.  First, the market for machined copper-beryllium parts is small.  Second, due to a combination of health concerns and the high cost of copper-beryllium, manufacturers have increasingly preferred beryllium-free materials.  A number of industry contacts reported to ERG that their machine shops have stopped using copper-beryllium or are using it in small quantities and only occasionally. Sources, including an ERG contact at the National Machining and Tooling Association, reported that the number of machine shops working with copper-beryllium alloys represents a small percentage of the total number of machine shops.  Although OSHA included small entity representatives (SERs) from the precision machining industry in the Small Business Advocacy Review (SBAR) Panel process, no comments were provided on the number of affected machine shops.  Based on the information discussed above, OSHA estimates that 10 percent, or 312 of the 3,124 establishments in the precision turned products manufacturing industry, work with beryllium or its alloys. Based on discussions with industry contacts, OSHA estimates that about 18 (5.9 percent) of these 312 establishments might work with pure beryllium or high-beryllium alloys (see Chapter IV: Section 7 of this PEA) with the remaining 294 establishments working with low-beryllium alloys.  The Agency seeks comment and additional data regarding these estimates.

Estimates of the Number of Affected Employees
      OSHA assumes that the size distribution of beryllium-using establishments is the same as the size distribution of all industry establishments. Therefore, based on the 2010 County Business Patterns data identified earlier, OSHA estimates that the 312 establishments working with beryllium or beryllium alloys employ a total of 7,875 workers ((78,749 workers / 3,124 establishments) x 312 affected establishments). The 5.9 percent of these establishments using high-beryllium alloys yields an estimate of 465 (5.9% x 7,875) workers working with high-beryllium alloys, with the remaining 7,410 workers working with low-beryllium alloys.  These estimates are summarized in Table III-5.

6. Copper Rolling, Drawing, and Extruding
      Copper rolling, drawing, and extruding mills produce copper and copper-alloy rod, bar, sheet, strip, plate, piping, tube, and wire.  The metal-forming processes used to produce copper-beryllium (Cu-Be) products (which generally contain no more than 2 percent beryllium) are common to other metals and, depending on the product, may include rolling, extrusion, and hot or cold drawing.  These processes may be accompanied by annealing, pickling or metal cleaning, and slitting or cutting operations.  For those establishments making products out of copper alloys, copper-beryllium is only one of several copper alloys that may be used. Brass and bronze, for example, are common copper alloys that do not use beryllium.
      There are two NAICS industries in this application group:  NAICS 331421: Copper Rolling, Drawing, and Extruding, and NAICS 331422: Copper Wire Drawing. Table III-6 at the end of this section shows data from 2010 County Business Patterns for these two industries. ERG used data from the  2010 OES, County Business Patterns, information from the Copper Development Association, and interviews with contacts in industry and in trade associations in order to create the industrial profile for this application group (for more detail, see Chapter IV: Section 8 of this PEA).
Estimates of the Number of Affected Establishments
      A list of copper-beryllium product suppliers maintained by the Copper Development Association contains eight companies with 12 establishments that produce rolled, drawn, and extruded copper-beryllium products (CDA, 2002).  ERG identified three additional establishments engaged in re-drawing, re-rolling, or re-extruding copper-beryllium alloy. Based on this information, OSHA estimates that 15 establishments in this industry are currently engaged in the rolling, drawing, and extruding of copper-beryllium products.
      Information from Materion's customer database shows that 59 facilities in NAICS 331422: Copper Wire (Except Mechanical) Drawing use Be-Cu metal (see Chapter IV: Section 8 of this PEA).
Estimates of the Number of Affected Employees