Chronic Beryllium Disease Prevention Program

Federal RegisterJun 7, 2016

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DEPARTMENT OF ENERGY

10 CFR Part 850

[Docket No. AU-RM-11-CBDPP]

RIN 1992-AA39

Chronic Beryllium Disease Prevention Program

AGENCY:

Office of Environment, Health, Safety and Security, U.S. Department of Energy.

ACTION:

Notice of proposed rulemaking and public hearings.

SUMMARY:

The Department of Energy (DOE or the Department) is proposing to amend its current chronic beryllium disease prevention program regulation. The proposed amendments would improve and strengthen the current provisions and continue to be applicable to DOE Federal and contractor employees who are, were, or potentially were exposed to beryllium at DOE sites.

DATES:

The comment period for this proposed rule will end on September 6, 2016. Public hearings will be held on:

1. June 28-30, 2016, in Richland, WA, from 9 a.m. to 1 p.m. and 6 p.m. to 9 p.m.;

2. July 12-14, 2016, in Oak Ridge, TN, from 9 a.m. to 1 p.m. and 6 p.m. to 9 p.m.;

3. July 27-28, 2016, in Las Vegas, NV, from 9 a.m. to 1 p.m. and 5 p.m. to 8 p.m.; and

4. August 11, 2016, in Washington, DC, from 9 a.m. to 4 p.m.

Requests to speak at any of the hearings should be made by June 24, 2016, for the Richland, WA hearing; July 8, 2016, for the Oak Ridge, TN hearing; July 25, 2016, for the Las Vegas, NV; and August 10, 2016, for the Washington, DC hearing. Each presentation is limited to 10 minutes.

ADDRESSES:

You may submit comments, identified by docket number AU-RM-11-CBDPP, and/or Regulation Identification Number (RIN) 1992-AA39 in one of four ways (please choose only one of the ways listed):

Federal e-Rulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Email: Rulemaking.850@hq.doe.gov.

Include docket number AU-RM-11-CBDPP and/or RIN 1992-AA39 in the subject line of the email. Please include the full body of your comments in the text of the message or as an attachment. If you have additional information such as studies or journal articles and cannot attach them to your electronic submission, please send them on a CD or USB flash drive to the address below. The additional material must clearly identify your electronic comments by name, date, subject, and docket number AU-RM-11-CBDPP.

Mail:

Address written comments to Jacqueline D. Rogers, U.S. Department of Energy, Office of Environment, Health, Safety and Security, Mailstop AU-11, Docket Number AU-RM-11-CBDPP, 1000 Independence Ave. SW., Washington, DC 20585 (due to potential delays in DOE's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt). If possible, please submit all items on a CD or USB flash drive, in which case it is not necessary to include printed copies.

Hand Delivery/Courier:

Jacqueline D. Rogers, U.S. Department of Energy, Office of Environment, Health, Safety and Security, 1000 Independence Ave. SW., Washington, DC 20585. Telephone 202-586-4714. If possible, please submit all items on a CD or USB flash drive, in which case it is not necessary to include printed copies.

For detailed instructions on submitting comments and additional information on the rulemaking process, see Section VI of this document (Public Participation).

Docket:

The docket, which includes

Federal Register

notices, public meeting attendee lists and transcripts, comments, and other supporting documents/materials, is available for review at

http://www.regulations.gov.

All documents in the docket are listed in the

regulations.gov

index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available. A link to the docket Web page can be found at:

http://www.energy.gov/ehss/chronic-beryllium-disease-prevention-10-cfr-850.

This Web page contains a link to the docket for this notice on the

regulations.gov

site. The

regulations.gov

Web page contains instructions on how to access all documents, including public comments, in the docket. See Section VI of this document for further information on how to submit comments through

www.regulations.gov.

The public hearings for this rulemaking will be held at the following addresses:

1. Richland, WA: Hammer Federal Training Facility, State Department Room, 2890 Horn Rapids Road, Richland, WA 99354;

2. Oak Ridge, TN: The Pollard Technology Conference Center, 210 Badger Avenue, Oak Ridge, TN 37830;

3. Las Vegas, NV: North Las Vegas Facility, 2621 Losee Road, Building B-03, North Las Vegas, NV 89030-4129; and

4. Washington, DC: U.S. Department of Energy, Forrestal Building, Room 1E-245, 1000 Independence Avenue SW., Washington, DC 20585. Requests to speak at any of the hearings should be telephoned in to Meredith Harris, 301-903-6061. For more information concerning public participation in this rulemaking proceeding, see Section VI of this proposed rulemaking (Public Participation).

FOR FURTHER INFORMATION CONTACT:

Jacqueline D. Rogers, U.S. Department of Energy, Office of Environment, Health, Safety and Security, Mailstop AU-11, 1000 Independence Ave. SW., Washington, DC 20585, telephone: (202) 586-4714, or Email:

jackie.rogers@hq.doe.gov.

For information concerning the hearings, requests to speak at the hearings, submittal of written comments, or to obtain copies of materials referenced in this document, contact Jacqueline D. Rogers, 202-586-4714.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Chemical Identification and Use

B. Health Effects

C. Beryllium Exposure at DOE Facilities

D. Value of Early Detection

II. Legal Authority and Relationship to Other Programs

III. Issues on Which DOE Requests Information and Seeks Comment

A. Surface Action Level

B. Beryllium Restricted Areas

C. Medical Screening for Individuals Conditionally Hired for Beryllium Work

IV. Section-by-Section Analysis

A. Subpart A—General Provisions

B. Subpart B—Administrative Requirements

C. Subpart C—Specific Program Requirements

D. Appendix A—Beryllium Worker Chronic Beryllium Disease Prevention Program Consent Form (Mandatory)

E. Appendix B to Part 850— Beryllium-Associated Worker Chronic Beryllium Disease Prevention Program Consent Form (Mandatory)

V. Procedural Requirements

A. Review Under Executive Orders 12866 and 13563

B. Review Under the Regulatory Flexibility Act

C. Review Under the Paperwork Reduction Act

D. Review Under the National Environmental Policy Act

E. Review Under Executive Order 12988

F. Review Under Executive Order 13132

G. Review Under Executive Order 13175

H. Review Under the Unfunded Mandates Reform Act of 1995

I. Review Under Executive Order 13211

J. Review Under the Treasury and General Government Appropriations Act, 1999

K. Review Under the Treasury and General Government Appropriations Act, 2001

VI. Public Participation

A. Attendance at the Public Hearing

B. Conduct of the Public Hearing

C. Submission of Comments

I. Introduction

The U.S. Department of Energy (DOE) has a long history of beryllium use because of the element's broad application to many nuclear operations and processes. Beryllium metal and ceramics are used in nuclear weapons, as nuclear reactor moderators or reflectors, and as nuclear reactor fuel element cladding. At DOE, beryllium operations have historically included foundry (melting and molding), grinding, and machine tooling of parts.

The inhalation and exposure to the skin of beryllium particles may cause beryllium sensitization (BeS) and chronic beryllium disease (CBD). BeS is a condition in which a person's immune system becomes highly responsive (allergic) to the presence of beryllium in the body. CBD is a chronic, often debilitating, and sometimes fatal lung condition. There has long been scientific consensus that exposure to airborne beryllium is the only cause of CBD.'

The current worker protection permissible exposure limit (PEL) of 2 μg/m

, measured as an 8-hour, time-weighted average (TWA), was adopted by the U.S. Department of Labor's (DOL) Occupational Safety and Health Administration (OSHA) in 1971 and codified in 29 CFR 1910.1000, Tables Z-1 and Z-2, by reference to existing national consensus standards. One of DOE's predecessor agencies, the Atomic Energy Commission, had previously established the same limit of 2 μg/m

for application at its facilities in 1949, and that limit has remained in effect at DOE's facilities up to the present. In 1977, the National Institute for Occupational Safety and Health (NIOSH), which is part of the U.S. Department of Health and Human Services, classified beryllium as a potential occupational carcinogen. Between the 1970s and 1984, there was a significant reduction in the incidence rate of CBD in the workplace. Coupled with its long latency period, this led to the assumption that CBD was occurring only among workers who were exposed to high levels of beryllium decades earlier; however, DOE medical screening programs continue to discover cases of CBD among workers employed at DOE facilities. These facilities are expected to maintain worker exposures to beryllium at levels below the OSHA PEL, as well as operate with an action level of 0.2 µg/m

that triggers a number of controls and protective measures designed to protect workers when their exposures are at or above that level.

On December 3, 1998, DOE published a notice of proposed rulemaking (NOPR) to establish a Chronic Beryllium Disease Prevention Program (CBDPP) (63 FR 66940). After considering the comments received, DOE published its final rule establishing the CBDPP on December 8, 1999 (64 FR 68854). DOE now has more than 14 years of job, exposure, and health data, as well as experience implementing the rule. New research related to BeS and CBD has been published in the years since 1999. In addition, on December 23, 2010, DOE published a Request for Information (RFI) (75 FR 80734) to request information and comments on issues related to its current CBDPP. DOE is publishing this NOPR to propose an update to its CBDPP regulations in light of the information it has obtained since December 1999, when the Final Rule was first published. The proposed amendments would strengthen the current CBDPP under 10 CFR part 850, and the worker protection programs established under 10 CFR part 851,

Worker Safety and Health Program.

Consistent with the requirements established in both rules, this proposal would continue to establish a CBDPP designed to reduce the occurrence of CBD among DOE Federal and contractor workers and any other individuals who perform work at a DOE site. The proposed amendments to the CBDPP would continue to accomplish this disease reduction mission through proposed provisions that: (1) Reduce the number of current workers who are exposed to beryllium by clearly identifying and limiting worker access to areas and operations that contain or utilize beryllium; (2) Minimize the potential for, and levels of, worker exposure to beryllium by implementing engineering and work practice controls that prevent the release of beryllium into the workplace atmosphere and/or capture and contain airborne beryllium particles before worker inhalation; (3) Establish medical surveillance to monitor the health of exposed workers and ensure early detection of disease; (4) Establish continual monitoring of the effectiveness of the program in preventing CBD and implementing program enhancements as appropriate, and (5) Require the collection of data to improve the information available to better understand the cause of CBD. The principle proposed amendments would:

• Revise the definitions of beryllium, beryllium worker, and beryllium associated worker, and add new definitions for beryllium sensitization and chronic beryllium disease.

• Lower the action level to 0.05 µg/m

• Allow the use portable laboratories.

• Modify the release criteria of formerly beryllium-contaminated equipment or areas without labeling if they contain beryllium in inaccessible locations or embedded in hard-to-remove substances, provided certain levels are not exceeded.

• Allow releasing beryllium-contaminated equipment, items or areas with removable beryllium above 0.2 µg/100 cm

or that have beryllium in material on the surface at levels above the natural level in soil at the point of release.

• Ensure beryllium-associated workers are notified yearly of their right to participate in the medical surveillance program.

• Require mandatory medical and periodic evaluations for beryllium workers.

• Require medical evaluations for beryllium and beryllium-associated workers showing signs and symptoms of beryllium sensitization or chronic beryllium disease when the SOMD determines an evaluation is warranted.

• Require exit medical evaluations for beryllium workers and beryllium-associated workers who voluntarily participated in the medical surveillance program

• Add medical restriction requirements for workers.

• Require mandatory medical removal for workers based on the site occupational medicine director's written opinion.

• Ensure beryllium workers are informed and understand that medical testing is mandatory.

• Revise the training requirements for beryllium-associated workers.

• Revised the wording on beryllium warning signs.

• Require labels for equipment or items containing beryllium in inaccessible locations or embedded in hard-to-remove substances.

• Revised the consent forms for beryllium and beryllium-associated workers.

The proposed rule is estimated to cost from $13.6 million to $17.2 million (annualized first year costs plus annual costs in 2014 dollars, using a 7 percent discount rate and a 10 year period lifetime of investment). This includes first year costs of $41.4 million to $42.7 million, of which $7.8 million to $11.2 million are annually recurring costs. In addition, DOE expects its sites will experience cost-savings attributable to

minor changes and clarifications in the proposed amendments to 10 CFR part 850. As discussed in the Economic Assessment, however, DOE was not able to obtain quantitative estimates of these savings, but anticipates the savings would result from:

•

Reduced controls from currently regulated areas that will no longer be regulated under the proposed definition of beryllium.

•

Reduced surface sampling for areas that are below 0.05 µg/m3 (instead of the current requirement to conduct sampling wherever beryllium is present).

•

Reduced turnaround time for exposure monitoring results as a result of using a portable laboratory;

•

Relaxed requirements for transferring contaminated equipment to another area in which beryllium work is performed.

•

Reduced costs, avoided confusion, reduced liability, and avoided disputes with employees over DOE's legal liability due to clarifications in the medical removal surveillance and removal requirements.

•

Reduced medical evaluation costs due to allowing the SOMD to determine what exams and tests are needed for each worker.

•

Reduced training requirements for beryllium-associated workers (who currently have the same training requirements as beryllium workers).

DOE expects its sites, contractors and workers to experience the following benefits from the proposed amendment:

•

Reduced medical costs.

•

Reduced mortality.

•

Increased quality of life.

•

Increased medical surveillance for workers at risk.

•

Increased work-life for beryllium workers.

•

Reduced confusion and dispute over legal liability for DOE and DOE contractors.

•

Reduced restrictions and costs for the release and transfer of equipment or areas with potential beryllium contamination.

•

Reduced control of areas where contamination is a result of naturally high levels of beryllium in the soil or surrounding environment.

•

Reduced turnaround time for sample analysis due to the use of portable laboratories.

•

Reduced medical costs for periodic evaluations due to the Site Occupational Medicine Director's ability to judge that certain medical tests may be unnecessary for some workers.

A. Chemical Identification and Use

Beryllium (atomic number 4) is a silver-gray metallic element with a density of 1.85 g/cm

and a high stiffness. The second lightest of the metals, beryllium also has a high melting point (1,285 °C) and high heat absorption capacity.

Beryllium occurs naturally in the earth's surface in about 30 minerals found in rocks, coal and oil, soil, and volcanic dust. Smith et al. report that the concentration of beryllium in surface soils in the United States ranges from 0.09 to 3.4 parts per million (ppm), with a median of 1.2 ppm. Trace levels are present in food, water, and ambient air (ref. 1).

Beryllium for industrial use is extracted from beryl and bertrandite ores as beryllium hydroxide, which is the feedstock for production of beryllium oxide, beryllium metal, and beryllium alloys and composite materials (ref. 2). Naturally occurring beryllium containing silicates are mined, processed into feed material, and cut and polished for sale as gemstones. Aquamarine and emerald are examples of gemstone forms of beryl.

A listing of references is included as appendix A to this

SUPPLEMENTARY INFORMATION

section.

Beryllium was not widely used in industry until the 1940s and 1950s. Beryllium can be used as a pure metal, mixed with other metals to form alloys, processed to salts that dissolve in water, and processed to form oxides and ceramic materials. Beryllium is primarily used to stiffen copper into alloys as strong as steel, but which retain copper's corrosion resistance and electrical and thermal conductivity (ref. 2). Copper alloy strip, rod, and wire containing 0.15 to 2.0 percent beryllium is stamped or machined into complex shapes for electrical connectors, clips, springs and molds for plastics. Copper-beryllium alloys are cast and machined into non-sparking tooling, for applications where fire and explosion are a concern, and into bushings, for bearings in landing gear of commercial and military aircraft. Its corrosion resistance has led to its use as housing for undersea cables. High-strength, light weight beryllium-aluminum alloys and composites are used for structural components in aerospace and defense applications. Nickel-beryllium alloys have niche markets as electrical connectors, in jewelry, and in dental prosthetic. The thermal conductivity and transparency to microwaves of beryllium oxide ceramic has led to its use in electronics, microwave and communication equipment.

Beryllium metal has been produced for various industrial uses, especially in the aerospace and defense industries. Both structural and instrument grade materials are manufactured, including windshield frames and other structures in high-speed aircraft and space vehicles, aircraft and space shuttles brakes, X-ray windows, neutron moderators or reflectors in nuclear reactors, and nuclear weapons components. Beryllium salts (

e.g.,

sulfate or fluoride) and beryllium hydroxide are intermediates in production processes and small quantities are sold for use as laboratory reagents. Copper-beryllium is a common substrate for gold plated electrical connectors and may be encountered during precious metal recovery. Other beryllium materials include soluble beryllium salts and oxides. Beryllium soluble salts such as beryllium fluoride, chloride and sulfate, are used in nuclear reactors, in glass manufacturer, and as catalysts for certain chemical reactions. Beryllium oxide is used to make ceramics for electronics, and other electrical equipment. Beneficial properties of beryllium oxide include hardness, strength, excellent heat conductivity, and good electrical insulation.

Beryllium is also found as a trace metal in materials such as aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive blasting grits such as coal slag and copper slag contain varying concentrations of beryllium, usually less than 0.1% by weight. The burning of bituminous and sub-bituminous coal for power generation causes the naturally occurring beryllium in coal to accumulate in the coal fly ash byproduct. Scrap and waste metal for smelting and refining may also contain beryllium (ref. 3).

Occupational exposure to beryllium can occur from inhalation of dusts, fumes, and mists. Beryllium dusts are created during operations where beryllium is cut, machined, crushed, ground, or otherwise mechanically sheared. Mists can also form during operations that use machining fluids. Beryllium fumes can form while welding with or on beryllium components, and from hot processes such as those found in metal foundries.

Occupational exposure to beryllium can also occur from skin, eye, and mucous membrane contact with beryllium particulates or solutions.

B. Health Effects

Beryllium exposure is associated with a wide range of health effects such as acute beryllium disease, immune system response and sensitization (BeS), CBD, lung cancer, and other possible systemic effects. The National Toxicology Program, the International Agency for Research on Cancer (IARC) and the American Conference for Governmental

Industrial Hygienists (ACGIH®) classify beryllium and beryllium compounds as human carcinogens (refs. 4, 5, 6). This section focuses, however, on BeS and CBD because they represent the critical effects for beryllium and beryllium-associated workers at DOE sites and are the focus of the CBDPP regulation and this amendment. As noted in the “Introduction” section of this NOPR “DOE now has more than 14 years of job, exposure, and health data, as well as experience implementing the rule. New research related to BeS and CBD has been published in the years since 1999.” This “Health Effects” section largely highlights these newer studies, particularly epidemiological and experimental studies that provide further insights about BeS and CBD—exposure, early disease detection, and disease progression.

1. Beryllium Sensitization (BeS)

BeS is an immune system response triggered by beryllium exposure (ref. 7). BeS can occur quickly or many years after exposure to beryllium, potentially progressing into disease (ref. 8). Only a subset of workers exposed to beryllium ever become sensitized. Reported prevalence of BeS ranges from less than 1% up to 19% (refs. 6, 7). BeS alone does not cause physical symptoms. However, individuals showing evidence of BeS may develop subclinical and clinical CBD, including disabling forms.

Sensitization to beryllium can result from both inhalation and skin exposure (refs. 5, 6, 7). The 2008 National Academy of Sciences review points to the hypothesis that “penetration of the skin by poorly soluble beryllium particles may be an immunologic route to sensitization, as can occur with skin contact and soluble beryllium salts” (ref. 7). The authors comment that some exposures may make beryllium more bioavailable to the skin (soluble metals and liquids) and others more bioavailable to the lung (respirable particles, mists and vapors). Tinkle, et al. observed that beryllium particles less than 1 micrometer in diameter, can penetrate intact human skin and reach dermal layers where sensitization can occur (ref. 9). Henneberger et al. found a contrast in chronic beryllium disease between long-term and short-term workers but not a contrast in BeS between these workers (ref. 10). The Henneberger study concludes that short-term workers may have developed beryllium sensitization from skin exposure. Day et al. published a review of the published literature, including epidemiologic, immunologic, genetic, and laboratory-based studies of

in vivo

and

in vitro

models concerning skin exposure to beryllium (ref. 11). The authors hypothesized “that skin exposure to beryllium may be sufficient to cause sensitization, while inhalation is necessary for progression to lung disease.” The ACGIH® and IARC have assigned a skin notation for beryllium and compounds, with the goal of preventing dermal exposure and possible sensitization by this route, possible absorption of beryllium through open cuts or wounds, and secondary inhalation of beryllium via the re-suspension of settled dust (refs. 5, 6).

As mentioned earlier, individuals sensitized to beryllium are asymptomatic and are not physically impaired. Once sensitization has occurred, it is medically prudent to prevent additional exposure to beryllium. Physicians generally recommend removing the sensitized individual from future beryllium exposure to reduce the risk of progression, based on experience with other immunologically mediated diseases and evidence that exposure is a risk factor for developing CBD. No published research studies are available, however, examining whether the general practice of recommending removal is a benefit. Moreover, the National Academy of Sciences points out that designing a study that would randomize workers to continue or avoid exposure “would likely be considered unethical because of the potential severity of CBD” (ref. 7).

The Beryllium-Induced Lymphocyte Proliferation Test (BeLPT) is used as a diagnostic tool, as well as for medical surveillance and screening for BeS. Currently, it is the most commonly available diagnostic tool for identifying BeS.

2. Chronic Beryllium Disease (CBD)

CBD is an immune-mediated, granulomatous lung disease caused by exposure to airborne beryllium particulate (ref. 8). Granulomas are abnormal tissues that form due to a proliferation of immune system cells known as lymphocytes. In the lung, accumulations of granulomas can interfere with gas exchange between the blood and the lungs. The immune response to beryllium in the lung includes inflammation, which, if it persists, forms scar tissue (fibrosis), resulting in permanent lung damage. This beryllium-induced proliferative and granulomatous response is specific to CBD. CBD pathology is similar to sarcoidosis, a more common disease. Sarcoidosis, however, usually resolves during its normal course, whereas clinically evident CBD generally does not resolve but may reach a steady state condition and may worsen over time.

Frequently reported symptoms of CBD include one or more of the following: dyspnea (shortness of breath) on exertion, cough, fever, night sweats, chest pain, and, less frequently, arthralgias (neuralgic pain in joints), fatigue, weight loss, and appetite loss. On physical examination, a physician may find signs of CBD, such as rales (changes in lung sounds), cyanosis (lack of oxygen), digital clubbing (thickening or widening of the ends of the fingers or toes), or lymphadenopathy (enlarged lymph nodes). A radiograph (X-ray) of the lungs may show many small scars. Patients may also have abnormal breathing and pulmonary function test results. Examination of the lung tissue under the microscope may show granulomas, which are signs of damage due to the body's reaction to beryllium. In advanced cases, there may be manifestations of right-sided heart failure, including cor pulmonale (enlarged right ventricle of the heart caused by blockage in the lungs).

Individuals with CBD may experience mild to severe forms of disease. In severe cases, the affected individuals may be permanently and totally disabled. Mortality of the sensitized individuals directly attributable to CBD and its complications is estimated to be 30% (ref. 12). This estimate is based upon historical data reflecting both the higher levels of exposure that occurred in the workplace prior to regulation of workplace exposure to beryllium in the late 1940s and a tracking of the medical history of subjects of CBD over several decades. DOE's recent experience with improved diagnoses and treatments may result in a lower mortality rate for CBD cases.

The BeLPT is used as a diagnostic tool for patients who present with possible CBD, as well as for medical surveillance and screening for BeS. For individuals with abnormal blood BeLPT screening results, a positive BeLPT conducted on cells washed from a segment of the lung of an individual can help confirm the presence of CBD. In the absence of granulomata or other clinical evidence of CBD, individuals with a positive BeLPT are classified as sensitized to beryllium.

Stange et al. provided estimates of the sensitivity and specificity of the BeLPT for BeS by evaluating paired results from different testing laboratories. The authors examined 20,275 BeLPT results from medical evaluations of 7,820 current and former DOE workers over a 10-year period. The program led to the diagnosis of 117 cases of CBD and the confirmation of 184 cases of BeS

without disease for a combined prevalence of 3.85% (301/7,820) (ref. 13). With borderline BeLPT results included, the sensitivity of the test was estimated to be 68.3% and the specificity was estimated to be 96.9%. In this same population, the percentage of beryllium sensitized individuals found to have CBD by clinical evaluation (positive predictive value) ranged from 71% for 24 sensitized beryllium machinists to 9% for 11 sensitized scientists, with an overall average of 35% for 235 subjects found sensitized by this study (ref. 14).

As noted above, BeS precedes the development of CBD, but the true risk and rate of disease progression is not known based on available study data (refs. 6, 7, 15). Data suggests that CBD can occur at relatively low exposure levels and, in some cases, after relatively brief durations of exposure (ref. 14). However, CBD can take months to years after initial beryllium exposure before signs and symptoms appear (ref. 15).

The clinical course—the latency period, rate of progression, and severity—of CBD is highly variable. A 2008 National Academy of Sciences review states “CBD has a clinical spectrum that can range from evidence of BeS and granulomas of the lung without clinically significant symptoms or deficits in lung function to end-stage lung disease” (ref. 7). Individuals who only have evidence of BeS and granulomas may or may not progress to a disabling form of CBD. Some individuals deteriorate rapidly; most experience long, gradual deterioration. Treatment generally consists of oral corticosteroid therapy. If lung damage is evident, CBD is treated with anti-inflammatory medications based on the course of treatment used for sarcoidosis to try to reduce granulomas, improve lung function, and minimize permanent damage from fibrosis. Individuals with impaired gas exchange may require continuous oxygen administration.

The observed variability in the clinical progression of CBD is possibly due to variation in exposure amount, route and type, and genetic and other host susceptibility factors. The factors that affect progression are not understood well enough to allow physicians to provide patients with specific advice on their likely prognosis. Currently, there is no medical therapy to prevent possible progression of BeS to CBD. Diagnostic evaluations are required to determine whether a BeS individual has progressed to CBD. Workers are counseled to seek medical attention if they develop new or worsening respiratory symptoms.

A number of studies suggest that the rate of progression from BeS to CBD may be related to the level of exposure and the form of beryllium (ref. 16). Newman et al. evaluated a group of patients with BeS but no CBD at two-year intervals (ref. 15). Of the 55 patients, 17 (31%) progressed to CBD within an average of 3.8 years. In this group, machinists had a higher risk of progression to CBD. The group of 55 patients was a subset of patients described in a subsequent publication by Mroz et al., which examined 171 beryllium exposed workers with CBD and 229 with BeS to look at risk factors for, and progression of, surveillance-identified CBD over a 20 year period (ref. 16). In addition to being machinists, those diagnosed with CBD, as opposed to BeS only, were more likely to have been exposed in the ceramics industry and less likely to have only bystander exposures, suggesting that the form and dose of beryllium may contribute to development of CBD. It was reported that 8.8% of all workers initially identified as having BeS only developed CBD over the course of the study. The study noted that physiologic changes can occur from within one month of first exposure to beyond 30 years from first exposure. However, the authors note that clinical follow-up was incomplete for this larger cohort.

Rosenman et al. studied 577 former workers from a beryllium processing plant whose first exposure, on average, began in the 1960s (ref. 17). This study involved testing subjects more than 20 years after their last exposure to beryllium. The authors identified 7.6% to have definite or probable CBD and another 7.0% with BeS at the time of the study. Those with BeS had a shorter duration of exposure to airborne beryllium, began work later, worked with beryllium longer ago, had lower measures of cumulative and peak exposure to airborne beryllium, and had lower non-soluble beryllium exposures than those with CBD, again suggesting that exposure variables may affect progression from BeS to CBD.

Two other studies have also reported that individuals with positive blood BeLPTs were less likely to have CBD at the time of their initial evaluation if they had jobs and worked in industries with low airborne beryllium exposures. Welch et al. report a total of 75,000 construction workers potentially available for screening, of which 4,458 were initially screened. Of those, 3,842 completed beryllium testing (BeLPT) (ref. 18). The authors reported that 53 (1.4%) of those tested had two or more abnormal BeLPT results. Of the 33 workers who were clinically evaluated, 5 (15%) were diagnosed with CBD. Arjomandi et al. reported similar results among current and former workers at Lawrence Livermore National Laboratory (LLNL) (ref. 19). Among the 1,875 participants tested, 59 (3.1%) were found with BeS. Of these, 50 accepted the offer of a clinical evaluation and 40 consented to bronchoscopy and bronchoalveolar lavage. Five of the 40 (12.5%) were diagnosed with CBD. The authors compared workroom air monitoring results from LLNL and the DOE Rocky Flats Plant and found the results from LLNL were much lower than those from the DOE Rocky Flats Plant. In addition, the incidence of CBD in workers identified as being sensitized was lower at LLNL (12.5%) than Rocky Flats where 38% of BeS cases were diagnosed with CBD. Therefore, there appears to be a correlation between the level of exposure to airborne beryllium and the incidence of disease.

Studies have shown that some people who are diagnosed with CBD have never been occupationally exposed to beryllium. For example, under the direction of Dr. Thomas Mancuso, 16 cases of CBD were diagnosed by X-ray examination among 20,000 residents living in Lorain, Ohio (ref. 20). Likewise, a 1949 report described 11 patients with CBD who lived near a beryllium extraction plant (ref. 21). Ten of the 11 lived within

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of a mile of the plant and exposure from the plant discharges into the air was the suggested cause of their CBD. Measurements of air concentrations of beryllium at various distances from the plant provided the basis for the Environmental Protection Agency's (EPA's) community permissible exposure limit (24-hour ambient air limit of 0.01 microgram of beryllium per cubic meter of air).

In addition, CBD has been reported among family members of beryllium workers who were presumably exposed to contaminated work clothing during the 1940s and 1950s (refs. 22, 23). The virtual disappearance of CBD caused by air pollution or household exposure has been attributed to more stringent control of air emissions and improved work practices, such as mandatory work clothing exchange. However, in 1989, a woman previously diagnosed with sarcoidosis was diagnosed with CBD. The woman had no occupational exposure to beryllium, but her husband was a beryllium production worker. This was the first new case of non-occupational CBD reported in 30 years (ref. 24).

C. Beryllium Exposure at DOE Facilities

The Department's medical screening programs discovered cases of CBD among workers who were first exposed after 1970, when DOE facilities were expected to maintain workers' exposure to beryllium below the OSHA PEL. As of September 30, 2014, the DOE Former Worker Medical Screening Program has provided BeLPTs to 64,645 former DOE and DOE contractor employees at least once. Of those, 823 (1.3%) had one abnormal BeLPT; 650 (1.0%) had two abnormal BeLPTs; and 223 (0.03%) had one abnormal and one+ borderline BeLPT result (one+ borderline BeLPT means the individual had more than one borderline BeLPT). Of the 64,645 former DOE and DOE contractor employees initially screened, 19,496 were rescreened. Of those rescreened, 139 (0.7%) had one abnormal BeLPT, 163 (0.8%) had two abnormal BeLPTs, and 71 (0.4%) had one abnormal and one+ borderline BeLPT.

The final rule, issued in 1999, established a Beryllium-Associated Worker Registry (the Beryllium Registry) to gather beryllium task, exposure, and health data for use in identifying trends that inform DOE in how best to continuously improve the Department's CBDPP. In 2002, employers began submitting data to the Beryllium Registry. As of December 2013, a total of 29,869 current beryllium and beryllium-associated workers are listed in the Beryllium Registry. Of those beryllium and beryllium-associated workers, 21,921 (71%) had been screened using BeLPT and 8,416 (28%) were not screened. Of the workers screened, 20,900 (97%) had normal results while 553 (3%) had abnormal results. Of the 553 workers with abnormal results, 407 (74%) had BeS and 146 (26%) had CBD.

Table 1 shows the BeS and CBD rates at DOE sites. Genetic factors have been reported to be a risk factor in determining who will progress from BeS to CBD (ref. 25). This makes a few percent of exposed individuals more sensitive to exposure to beryllium (ref. 26). DOE assumes that the proportion of workers with a genetic predisposition to contract BeS and CBD is essentially the same among the different sites and, therefore, differences in the prevalence of sensitization and disease among the sites are due to differences in exposure levels.

Table 1—Prevalence of Sensitization (BeS) and Chronic Beryllium Disease (CBD) by DOE Site Through 2013

Site

Employees with BeLPT

results

Sensitized employees (no CBD)

CBD Employees

Advance Mixed Waste Treatment Project

Ames Laboratory

5.9%

Argonne National Laboratory

142

2.1%

Brookhaven National Laboratory

4.0%

DOE Oak Ridge Office

1.1%

East Tennessee Technology Plant

399

1.5%

1.0%

Fermi National Accelerator Laboratory

Hanford Site

7,480

1.2%

0.5%

Idaho National Laboratory

355

0.8%

Kansas City Plant

1,208

3.4%

1.2%

Knolls Atomic Power Laboratory

LATA Environmental Services of Kentucky, LLC (PAD LATAKY)

112

1.8%

Lawrence Berkeley National Laboratory

3.8%

Lawrence Livermore National Laboratory (LLNL)

1,337

3.1%

0.2%

LLNL-Clean Harbors Environmental Services

Los Alamos National Laboratory

2,474

0.8%

0.1%

National Strategic Protective Security Services

Nevada National Security Site

1,028

2.2%

0.4%

Oak Ridge National Laboratory

639

2.2%

Pacific Northwest National Laboratory

151

Pantex

1,756

1.5%

0.9%

Sandia National Laboratory

604

0.2%

Savannah River Site

713

2.1%

0.8%

Stanford Linear Accelerator Center

2.1%

Y-12

2,691

114

4.2%

2.3%

Y-12 Navarro-Gem Joint Venture

Y-12 URS Corporation

Totals

21,453

407

1.9%

146

0.7%

Note:

“Sensitized” indicates the number of individuals found sensitized from two or more peripheral blood BeLPTs or from a bronchoalveolar lavage BeLPT, and does not include individuals who have been diagnosed as having CBD.

D. Value of Early Detection

Early detection of a disease is of value if it leads to reduced exposure, earlier treatment and a better prognosis for the tested individual. Screening for CBD with the BeLPT of peripheral blood can provide less invasive, earlier detection than is possible with other tests. In some cases, this has led to diagnosis and early treatment of CBD to reduce lung damage that may not have been possible if the CBD remained undiagnosed by other tests. In addition, there is increasing evidence that removal from exposure or reduction in exposure can lower the likelihood of progression from BeS to CBD and disability.

Pappas and Newman compared the lung functions of patients with CBD who had been identified through abnormal chest X-rays or clinical symptoms to those of patients with CBD who had been identified through positive BeLPTs of peripheral blood (ref. 27). Twelve of 21 BeLPT-positive patients were subsequently found to

have lung abnormalities, including reduced exercise tolerance. Fourteen of the 15 patients identified through chest X-rays or clinical symptoms had abnormal lung function, and their abnormalities were more severe than those identified through a positive BeLPT. The authors concluded that screening with the BeLPT of peripheral blood was useful because it permitted detection of CBD earlier in the disease process, when individuals are likely asymptomatic.

Early treatment of CBD may prevent progression of disease to permanent lung damage and disability. Although not providing definitive proof, studies have concluded that the long-standing standard of care for CBD has been shown to reduce the progression of disease in some patients. Marchand-Adams et al. (ref. 28), for example, concluded:

Corticosteroid treatment in patients suffering from serious chronic beryllium disease improved symptoms, pulmonary function tests and radiology by acting on inflammatory granulomas. The control of inflammatory granulomatosis limited the fibrotic evolution as long as doses were monitored under the control of clinical examination, serum angiotensin-converting enzyme and high resolution computed tomography scanning. However, corticosteroids seemed insufficient to stop this poor evolution for some patients.

Though a small study, the observed effectiveness of corticosteroids in suppressing the growth of granulomas and limiting progressive fibrosis in the majority of patients in the study suggests that proactive treatment may prevent the progression of disease to permanent lung damage and disability. BeS identified via BeLPT screening provides the earliest indication that working conditions and work practices are affecting the health of exposed workers. This allows for an earlier opportunity to initiate corrective actions and possibly to prevent cases of CBD.

II. Legal Authority and Relationship to Other Programs

This proposed rule continues to establish minimum requirements for the protection of beryllium and beryllium-associated workers, and is being promulgated pursuant to DOE's authority under section 161 of the Atomic Energy Act of 1954, as amended (AEA) to prescribe such regulations as it deems necessary to govern any activity authorized by the AEA, specifically including standards for the protection of health and minimization of danger to life or property (42 U.S.C. 2201(i)(3) and (p)). Also, section 3173(a) of the Bob Stump National Defense Authorization Act for 2003, Public Law 107-314, amended the AEA by adding section 234C, and required DOE to “promulgate regulations for industrial and construction health and safety at Department of Energy facilities that are operated by contractors covered by agreements of indemnification under section 170 d. of the Atomic Energy Act of 1954,” and authorized DOE to impose civil or contract penalties for violations of such regulations. Additional authority for the rule insofar as it applies to DOE Federal employees, is found in section 19 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 668) and Executive Order 12196,

Occupational Safety and Health Programs for Federal Employees

(5 U.S.C. 7902 note), which requires Federal agencies to establish comprehensive occupational safety and health programs for their employees. The Department recognizes that OSHA published a proposed rule,

Occupational Exposure to Beryllium and Beryllium Compounds

(80 FR 47565, August 7, 2015), that may differ from the CBDPP established in 10 CFR 850. The Department published its CBDPP in December 1999, after an extensive public review and comment period that included the DOE regulated community and its stakeholders. This notice proposes amendments to the CBDPP rule that would improve and strengthen the current provisions of the rule based on DOE's more than 14 years of experience implementing the rule. DOE believes the proposed amendment represents a balanced, well thought out approach reflecting the perspective of the DOE regulated community and its stakeholders. To avoid potential confusion between the CBDPP and OSHA's proposed beryllium rule, the Department has amended 10 CFR 851,

Worker Safety and Health Program

(80 FR 69564, November 10, 2015), to clarify its intent to only apply OSHA's 8-hour time weighted average permissible exposure limit (TWA PEL) for beryllium, and that DOE and DOE contractors are not subject to any other beryllium-specific OSHA requirements, including the ancillary provisions (

e.g.,

exposure assessment, personal protective clothing and equipment, medical surveillance, medical removal, training, and regulated areas or access control) OSHA has recently proposed to add to its health standard, if adopted by OSHA.

III. Issues on Which DOE Requests Information and Seeks Comment

A. Request for Information

The Department is considering additional requirements in other areas covered by the NOPR. It is especially interested in comments supported by technical evidence, rationale, and cost whenever possible, regarding the following areas:

Surface action level.

It appears that not all individuals who become sensitized progress to disease, but individuals with CBD are sensitized, which suggests that sensitization must occur before disease can occur. Preventing sensitization should, therefore, prevent disease.

DOE has found no studies that have determined a threshold of beryllium surface contamination that results in skin contact that, in turn, results in beryllium sensitization although a number of epidemiology studies and reviews of studies suggest that skin contact causes sensitization. DOE, therefore, is relying upon operational experience, rather than a demonstrated relationship between surface levels and health effects, in considering to propose a surface action level which would require employers to implement specified provisions of the rule.

DOE is considering adding in the final rule a surface action level of 1.5 µg/100 cm

as a preventive approach to control the beryllium health risk. This level is based on the assumption that surface contamination is a potential source of exposure through re-entrainment from energetic tasks. The Department requests that interested parties submit comments regarding the validity of a 1.5 µg/100 cm

surface action level. If an alternate level is suggested, provide the rationale and associated cost implications for choosing the alternate surface action level.

Beryllium restricted areas.

Currently, part 850 provides for “regulated areas”, which are areas demarcated by the employer in which the airborne concentration of beryllium is at or above, or can reasonably be expected to be at or above, the action level. However, part 850 contains no provision for demarcating areas designating specified

surface

levels of beryllium. The Department is considering requiring in the final rule the establishment of beryllium restricted areas where the surface levels of beryllium are at or above a surface action level of 1.5 µg/100 cm

, restricting access to authorized persons, and requiring employers to demarcate and control restricted areas from the rest of the workplace in a manner that alerts

workers to the boundaries of such areas. The Department requests that interested parties provide information on the feasibility and effect of requiring such restricted areas.

Medical screening for individuals conditionally hired for beryllium work.

When part 850 was issued in December 1999, DOE viewed the value of medical evaluations for beryllium-induced medical conditions in informing placement decisions to be limited by the fact that sensitization could not occur prior to initial exposure to beryllium. However, DOE has learned from experience that individuals working at DOE sites often have a history of employment at several sites. Their qualifications, such as having security clearances, radiation worker training, and hazardous waste site worker training, make them attractive candidates for positions around the entire DOE complex. As a result, newly hired beryllium workers may have previously been exposed to beryllium at a different DOE site and may have already developed BeS or CBD. It is also possible that newly hired beryllium workers were previously exposed to beryllium while working for other employers.

DOE believes the early detection, made possible with medical evaluations is essential for ensuring that individuals who have been adversely affected by beryllium are not placed in a job where they will be exposed to beryllium at or above the action level. In addition, given that under this NOPR, current beryllium workers with BeS and CBD will be subject to medical removal, and current beryllium workers with another medical condition for which exposure to beryllium at or above the action level would be contraindicated will be subject to medical restriction, the Department does not believe it is reasonable to place newly hired individuals with such conditions into jobs where the airborne concentration of beryllium is at or above the action level if they too would be subject to removal or restriction once hired. Under Section 161 of the AEA, the Department has broad authority to prescribe such regulations as it deems necessary to govern any activity authorized by the AEA, including standards for the protection of health and minimization of danger to life. Accordingly, DOE is considering including a requirement for mandatory medical screening of individuals conditionally hired for beryllium work to determine if such individuals have a medical condition for which exposure to beryllium at or above the action level is contraindicated. An “individual conditionally hired for beryllium work” would be an individual who has been offered a job as a beryllium worker (either a new hire or a current worker being transferred into a new job as a beryllium worker), but such offer would be subject to the outcome of a medical evaluation. DOE would require as part of these provisions that the employer inform applicants that any job offer would be conditional pending outcome of a medical evaluation, thus, candidates would have the option of not accepting the conditional offer.

In those cases where the medical screening indicates the individual conditionally hired for beryllium work has CBD, BeS, or another medical condition for which exposure to airborne concentrations of beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in an area where the airborne concentration of beryllium is at or above the action level, the employer would not be permitted to retain the individual as a beryllium worker. Such conditionally hired individuals would not be eligible for medical removal benefits under 10 CFR 850.36. Currently, under 10 CFR part 851, appendix A section 8(g)(2)(i), the occupational medical provider

may

require “[a]t the time of employment entrance or transfer to a job with new functions and hazards, a medical placement evaluation of the individual's general health and physical and psychological capacity to perform work” to “establish a baseline record of physical condition and assure fitness for duty.” Therefore, the Department is considering including in § 850.34(b)(1)(iii) a provision that would require employers to use the medical evaluation provided to conditionally hired individuals as the baseline medical evaluation for newly hired beryllium workers.

For consistency in the examinations provided to conditionally hired individuals, the Department is considering adding a provision requiring the identification of the elements of such examinations. In such cases, the Department is considering adding in § 850.34(c) the following:

• Employers would be required to provide individuals conditionally hired for beryllium work the required medical evaluations and procedures at no cost, and at a time and place that is reasonable and convenient for the conditionally hired individual.

• Employers would be required to inform applicants for jobs where exposure to airborne concentration of beryllium is at or above the action level, that:

○ The job involves a beryllium activity at or above the action level, includes a medical qualification, and requires a medical evaluation;

○ Any job offer would be conditional pending the outcome of the medical evaluation;

○ The employer would not be permitted to retain the individual as a beryllium worker if the Site Occupational Medical Director (SOMD) diagnosis indicates the individual has CBD, BeS, or another medical condition for which exposure to beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in a beryllium activity; and

○ Once conditionally hired, no work or training may be performed prior to the worker being cleared by the SOMD for beryllium work.

• Employers would be prohibited from asking or requiring a conditionally hired individual to have a medical evaluation performed before making the conditional job offer.

• Employers would be required to ensure both the SOMD and the conditionally hired individual complete the consent form included in an appendix, before any medical evaluations of the conditionally hired individual are performed.

• Medical evaluations for conditionally hired individuals would be required to include:

○ A detailed medical and work history with emphasis on exposure or potential exposure to beryllium;

○ A respiratory symptoms questionnaire;

○ A physical examination, with special emphasis on the respiratory system, skin, and eyes;

○ A chest radiograph (posterior-anterior, 14 x 17 inches) or a standard digital chest radiographic image, interpreted by a NIOSH B-reader of pneumoconiosis or a board-certified radiologist;

○ Spirometry consisting of forced vital capacity (FVC) and forced expiratory volume at one second (FEV

);

○ Two peripheral blood BeLPTs; and

○ Any other tests that would be deemed appropriate by the SOMD for evaluating beryllium-induced medical conditions.

The Department is considering adding a new § 850.34(d)(3), which would provide the requirements for the medical opinion and determination for individuals conditionally hired for beryllium work. This proposed new

section would require, with respect to a conditionally hired individual, that:

• The SOMD's written opinion to the employer would:

○ Be delivered within 10 working days after the SOMD received the results of the medical evaluation performed pursuant to proposed § 850.34(c)(5); and

○ Contain a determination of whether the conditionally hired individual is sensitized to beryllium, has CBD, or has another medical condition for which exposure to beryllium at or above the action level would be contraindicated.

• The employer would not be permitted to retain the conditionally hired individual as a beryllium worker, if the SOMD determines that the individual conditionally hired for beryllium work has CBD, BeS, or another medical condition for which exposure to beryllium at or above the action level would be contraindicated, and the employer determines that no reasonable accommodation is available to enable the conditionally hired individual to work in a beryllium activity.

The Department is considering including in part 850 an appendix with a new mandatory form for conditionally hired individuals to ensure they receive consistent information on the medical testing required prior to working in a beryllium area. This proposed new form would be similar to the proposed mandatory form in appendix A and entitled:

Conditionally Hired Individual Chronic Beryllium Disease Prevention Program Consent Form,

and include sections for consent, medical evaluation consent, and the physician's review of the medical evaluation results. DOE is aware that the term “informed consent” has a different meaning when used in other contexts (

e.g.,

human subject research). The Department, however, used this term in the original 10 CFR part 850 published in December 1999 to ensure beryllium associated workers were informed of the medical evaluation process before medical evaluations were performed. However, DOE is proposing to not use “informed consent” but would use the term “consent” and expand it to address consent for medical evaluations for conditionally hired individuals. See part A of the proposed mandatory form in appendix A.

The Department is requesting that interested parties provide their comments supported by technical evidence, rationale, and cost information whenever possible, on the feasibility and the effect of mandatory medical qualification for conditionally hired individuals for beryllium work. Alternatively, the Department is considering allowing conditionally hired individuals and current beryllium workers who are sensitized to beryllium but who do not have CBD to work in a beryllium job after signing an acknowledgment stating the worker has been informed of the risks of continued exposure to beryllium and has voluntarily elected to work in a beryllium job. The Department is also requesting that interested parties provide their comments supported by technical evidence, rationale, and cost information whenever possible, on the feasibility and the effect of allowing workers who are sensitized to beryllium to work in a beryllium job.

Mandatory medical evaluations and removals.

DOE is proposing both mandatory medical evaluations and mandatory medical removal provisions under this proposed amendment based on its commitment to the health and safety of its workers and the understanding that early detection and removal from beryllium exposure is important to prevent harm to workers at risk for developing CBD. Based on these considerations, DOE believes that these provisions are responsible and prudent measures in protecting the health of DOE and contractor workers. DOE recognizes that its proposed lower action level may result in an increased number of activities or work areas that pose the potential for airborne concentrations of beryllium at or above the action level with a corresponding increased number of beryllium workers subject to mandatory medical evaluations and the potential for mandatory medical removals. DOE believes, however, that the additional protections (triggered by the action level) available to workers at a lower action level would result in reduced worker exposures and fewer workers developing BeS or CBD. Since medical removal would be triggered by a BeS or CBD diagnosis, this would result in fewer workers being subject to medical removal.

DOE received several comments concerning whether to continue to require a worker's consent for medical removal, or instead require mandatory medical removal in response to its RFI. The majority of commenters recommended that DOE establish a mandatory medical removal practice (see discussions on proposed § 850.34(c) in the section-by-section analysis). In this NOPR, the Department requests that interested parties provide information on proposing the use of mandatory medical evaluations and medical removal for its beryllium workers, including evidence of their effectiveness, feasibility and appropriateness relative to voluntary approaches.

Site Occupational Medicine Director's written medical opinion.

DOE is aware of the increased concerns about protection of confidential medical information that have arisen since December 1999, when the current Final Rule was published. DOE is also aware that employers are not necessarily covered entities under the Health Insurance Portability and Accountability Act Privacy Rules, and that the American College of Occupational and Environmental Medicine has stated that “Physicians should disclose their professional opinion to both the employer and the employee when the employee has undergone a medical assessment for fitness to perform a specific job. However, the physician should not provide the employer with specific medical details or diagnoses unless the employee has given his or her permission.” In light of this, DOE requests comment on the proposed requirement for Site Occupational Medicine Directors (SOMDs) to provide employers with a written medical opinion that includes any diagnosis of the worker's condition related to exposure to beryllium (

i.e.,

BeS, CBD or any other medical condition for which exposure to beryllium at or above the action level would be contraindicated). See proposed § 850.34, Medical Surveillance.

B. Issues on Which DOE Seeks Comment

Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:

1. DOE requests comment on the proposed the definitions of beryllium and beryllium-associated workers. See proposed § 850.3.

2. DOE is requesting comments on the proposed definition of beryllium. DOE believes that soluble forms of beryllium are not used at its beryllium sites, and is proposing to exclude soluble forms of beryllium from the definition of beryllium. See proposed § 850.3.

3. DOE requests information on the different forms of beryllium (

i.e.,

soluble and insoluble) and the health effects associated with each form. See the definition of “beryllium” in proposed § 850.3. DOE is requesting comments on and evidence to support the following statement: DOE has learned by experience that common conditions and practices at DOE facilities—such as accumulations of wind-blown dust, abrasive blasting of brick surfaces with coal slag, and drilling into and

demolishing concrete structures—can result in breathing zone and surface levels at or above the proposed action level and release criteria, but with forms of beryllium that are not believed to cause BeS or CBD or with activities with work practices in place that mitigate the risks. See discussion on the definition of “beryllium” in proposed § 850.3.

5. DOE is requesting comment on its proposal to lower the action level which triggers key worker protection measures, from 0.2 µg/m

to 0.05 µg/m

. See proposed § 850.23.

6. DOE summarized various studies to address the major adverse health effects associated with exposure to beryllium. Are there additional studies or other data DOE should consider in evaluating the health effects of beryllium exposure? What is known or not known about factors influencing disease progression (including continued exposure and varying forms of beryllium) and the reported limitations and challenges in interpreting available study data (

e.g.,

small study sizes, limited exposure data, variability in susceptibility). See Health Effects and References sections of the preamble.

7. DOE recognizes that the potential for developing contact dermatitis, chronic ulcerations, and conjunctivitis is mainly associated with contact with soluble forms of beryllium compounds. DOE believes that soluble forms of beryllium are not used at its beryllium sites. Is DOE correct in this assumption? If soluble forms of beryllium are used, please indicate so and provide the operations where they are in use. See proposed § 850.29.

8. DOE estimated the compliance costs of the proposed rule by using data from the 1999 Economic Analysis (EA), Beryllium Registry, and an Economic Assessment Questionnaire (EAQ). The EAQ is a questionnaire administered by DOE to its sites potentially affected by the proposed rule in order to solicit the per-site cost of compliance with each provision of the proposed rule. DOE is requesting interested parties to provide comments on the per-site cost data used to prepare the EA for this proposed rule, and to provide alternate estimates where available. See Economic Assessment, section 3.

IV. Section-by-Section Analysis

Overview of the Proposed Rule

The provisions of the proposed rule are presented in three main subparts: A, B, and C. Subpart A of the proposed rule would describe the scope and applicability of the proposed rule, defines terms that are critical to the proposed rule's application and implementation, provides its proposed enforcement and dispute resolution provision. Subpart B would establish administrative requirements to develop and maintain a CBDPP and to perform all beryllium-related activities according to the CBDPP. Subpart C would establish requirements for the content and implementation of the CBDPP by focusing on protecting workers from being exposed to airborne beryllium, preventing BeS and CBD and providing benefits for workers with BeS or CBD who are or were removed from work assignments where the exposure to airborne beryllium is or was at or above the action level. Some of the proposed provisions of Subpart C apply only when it is determined that the airborne concentration of beryllium in a specific workplace or operation rises above the specified limit. Table 2 summarizes these provisions and indicates the levels of beryllium at which the provisions would apply.

Table 2—Levels at Which the Proposed Provisions of the CBDPP Would Apply

Proposed provisions

Worker exposure or potential exposure levels

(8-Hour TWA)

Be operation/location

≥ Proposed action level

(0.05 µg/m

)

≥ PEL

(8-hr TWA)

(2.0 µg/m

)

Baseline Inventory (850.20)

Hazard Assessment and Abatement (850.21)

Initial Exposure Monitoring (850.24)

Periodic Exposure Monitoring (850.24)

Exposure Reduction (850.25)

Beryllium Regulated Areas (850.26)

Hygiene Facilities and Practices (850.27)

Respiratory Protection (850.28)

Protective Clothing and Equipment (850.29)

Housekeeping (850.30)

Release and Transfer Criteria (850.31)

Medical Surveillance (850.34)

Medical Restriction (850.35)

Training and counseling (850.38)

Warning signs and labels (850.39)

Would apply to beryllium operations and other locations where there is a potential for beryllium contamination.

Employers would be required to establish a formal hazard prevention and abatement program.

Employers would be required to provide respirators that comply with 10 CFR part 851.

Employers would be required to provide protective clothing and equipment where surface contamination levels are above 3 µg/100 cm

Housekeeping efforts would be required to maintain removable surface contamination at or below 3 µg/100 cm

during non-operational hours.

Would establish contamination criteria for equipment, items, or areas to be removed, released, or transferred from beryllium regulated areas.

Employers would be required to provide medical surveillance to beryllium and beryllium-associated workers.

Employers would be required to medically restrict certain workers from working in area at or above the action level.

Training would be required for all workers who could be potentially exposed. Counseling would be required for beryllium and beryllium-associated workers diagnosed with BeS or CBD.

This section-by-section analysis describes the proposed changes in subparts A, B, C and the appendixes that the Department is proposing to make to the current CBDPP regulation (10 CFR part 850) that was published in December 1999.

A. Subpart A—General Provisions

Proposed § 850.1—Scope

Proposed § 850.1 would continue to establish the CBDPP for DOE employees and DOE contractor employees and clarifies that the CBDPP would also supplement and be an integral part of the worker safety and health program requirements under 10 CFR part 851 for DOE contractor employees. The Department would continue to structure the proposed rule this way to take advantage of existing and effective comprehensive worker protection programs at DOE facilities, and to minimize the burden on DOE contractors by clarifying that contractors need not establish redundant worker protection programs to comply with the proposed rule. Proposed § 850.1 also clarifies that if there is a conflict between the requirements of this part, and part 851, this part controls.

The Department recognizes that, except at the few DOE-operated sites, DOE Federal workers are not usually directly involved in production tasks or other activities in which they would be exposed to airborne beryllium; however, in performing management and oversight duties, DOE Federal workers sometimes must enter areas where beryllium is handled. The health and safety provisions of 29 CFR part 1960,

Basic Program Elements for Federal Employee Occupational Safety and Health Programs and Related Matters,

as well as Executive Order 12196,

Occupational Safety and Health Programs for Federal Employees,

protect Federal workers. DOE's intent is to supplement these general worker protection requirements with specific beryllium-related requirements in the limited instances where DOE Federal workers may have the potential for beryllium exposure at or above the action level.

Proposed § 850.2—Applicability

Proposed § 850.2(a)(1) and (2) continue to specify that the rule would apply to DOE Federal offices and DOE contractors with responsibility for operations or activities that involve present or past exposure to beryllium at DOE sites. It would also continue to apply to any current DOE employee, DOE contractor employee, or any other current worker at a DOE site who is or was exposed or potentially exposed to beryllium at a DOE site, regardless of which organization currently employs the worker.

Except at a few DOE-operated sites, DOE Federal workers are not usually directly involved in production tasks or other activities in which they would be exposed to airborne beryllium. However, in performing management and oversight duties, DOE Federal workers may enter sites where beryllium is handled. Federal agencies are required to ensure the protection of Federal workers under the health and safety provisions of 29 CFR part 1960,

Basic Program Elements for Federal Employee Occupational Safety and Health Programs and Related Matters,

as well as Executive Order 12196,

Occupational Safety and Health Programs for Federal Employees.

DOE's intent in proposed § 850.2(a)(1) and (2) would be to continue to supplement those general worker protection requirements with specific beryllium-related requirements in the limited instances where DOE Federal workers may have the potential for beryllium exposure.

In the current rule the term “DOE facility” is used instead of DOE sites. DOE is proposing to delete the term “DOE facility” and use in its place “DOE sites” to be consistent with the term used in 10 CFR part 851. A DOE site would continue to mean a DOE-owned or -leased area or location controlled by DOE where activities and operations are performed at one or more facilities or locations by a contractor in furtherance of a DOE mission. This definition is provided in 10 CFR 851 and includes all sites where DOE exercises regulatory control under the AEA, even if DOE does not own or lease the site. Changing the terminology in this proposed amendment does not affect the number of potentially regulated facilities. The Department will still have 22 beryllium sites.

As proposed in the definition of “contractor,” found in § 851.3 and in § 850.3 of the proposed rule, DOE's intent is that contractors covered under this rule include any entity, including affiliated entities, such as a parent corporation, under contract with DOE, and any subcontractor at any tier, that has responsibility for performing beryllium work at a DOE site in furtherance of a DOE mission. The requirements of the CBDPP would apply only to contractors and subcontractors who work in areas or on activities in which there is a potential for beryllium exposure at or above the action level.

As with the current rule, the proposed rule would not apply to former DOE Federal and contractor workers. When workers terminate their employment at a DOE site, they are eligible to have health monitoring through the Former Worker Medical Screening Program. The Former Worker Medical Screening Program was established following the issuance of the Fiscal Year (FY) 1993 National Defense Authorization Act (Pub. L. 102-484), which called for DOE to assist workers with determining whether they had health issues related to their prior work with DOE. Workers eligible for this program include all former DOE Federal, contractor, and subcontractor employees from all DOE sites. In FY 2005, DOE initiated a separate beryllium sensitization screening effort for employees who worked for now defunct DOE beryllium vendors, and who were employed with these companies while the vendor or company was under contract with DOE. These individuals typically have no other access to the beryllium sensitization screening, because their employers are no longer in business. Additional information on the Former Worker Medical Screening Program may be found on the Department's Web site located at:

http://energy.gov/hss/information-center/worker/former-worker-medical-screening-program.

The provisions of this rule would not apply to activities not conducted at a DOE site, such as the off-site laundering of beryllium-contaminated clothing from a DOE site.

DOE is proposing to add § 850.2(a)(3) to clarify that the Site Occupational Medicine Director (SOMD) would be responsible for providing the overall direction and operation of the employer's beryllium medical surveillance program.

Proposed § 850.2(b)(1) and (2) would continue to exempt activities involving beryllium articles and specify the rule would not apply to DOE laboratories that meet the definition of laboratory scale use of hazardous chemicals in OSHA's

Occupational Exposure to Hazardous Chemical in Laboratories

standard, 29 CFR 1910.1450. In § 1910.1450(b) of that standard, OSHA defines a laboratory as a workplace where relatively small qualities of hazardous chemicals are used on a nonproduction basis. Laboratory scale is defined as work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person. Workplaces whose function is to produce commercial quantities of materials are excluded. Also, the term laboratory scale of hazardous chemical is defined as the handling of such

chemicals where all of the following conditions are met: (1) Chemical manipulations are carried out on a laboratory scale; (2) multiple chemical procedures or chemicals are used; (3) the procedures involved are not part of a production process, nor in any way simulate a production process; and (4) protective laboratory practices and equipment are available and in common use to minimize the potential for employee exposure to hazardous chemicals.

The Department continues to believe OSHA's regulation is adequate to protect workers from beryllium exposures in facilities that meet the definition of laboratory use of hazardous chemicals. The requirements set forth in OSHA's regulation are made applicable to DOE contractors performing work on a DOE site in § 851.23(a)(3).

The exemption of laboratory use of hazardous chemicals would continue to apply only in instances where relatively small quantities of beryllium are used in a non-production activity. In addition, OSHA's laboratory standard has specific provisions to ensure protective laboratory practices are followed. Many of the provisions in OSHA's laboratory standard are the same as, or similar to, those in this proposed rule. For instance, OSHA's laboratory standard establishes provisions for identifying the presence of hazardous chemicals (baseline inventory), establishing a chemical hygiene plan (hazard assessment), performing periodic monitoring at the action level, implementing exposure reduction measures at the PEL, training employees on related hazards, and providing employees with the opportunity for medical consultation and examination. In part because each of these aspects of the proposed beryllium rule is already included in the OSHA laboratory standard, DOE is retaining the laboratory operations exemption.

Proposed § 850.3—Definitions

Proposed § 850.3(a) would continue to apply traditional industrial hygiene terminology to define key terms used throughout the proposed rule. The following discussion explains the definitions in the proposed rule.

Action level

would mean the airborne concentration of beryllium at which, or above which, the implementation of certain provisions of the proposed rule would be required. Using an action level to trigger certain provisions of the proposed rule ensures additional appropriate workplace precautions are taken and training and medical evaluations are provided, in situations where worker exposures could significantly increase the risk of workers developing CBD. Additional information on the application of the action level is presented in the discussion on proposed § 850.23,

Action level,

and in the discussions of other provisions that would continue to be triggered by airborne concentration of beryllium being at or above the proposed action level. Note that several provisions of the proposed rule would continue to apply independent of the action level. Specifically, the CBDPP requirement (10 CFR 850.10), the inventory requirement (10 CFR 850.20), the voluntary protective clothing and equipment requirement (10 CFR 850.29(a)(3)), the housekeeping requirements related to the cleaning of surfaces with removable beryllium (10 CFR 850.30(b) through (d)), the release or transfer requirements (10 CFR 850.31(c)), the waste disposal requirements (10 CFR 851.32), the beryllium emergencies requirement (10 CFR 850.33), the medical surveillance and restriction requirements as they relate to beryllium associated workers (10 CFR 850.34 and 850.35), the training and counseling requirements (10 CFR 850.38), the warning labels requirements (10 CFR 850.39(b)), and the recordkeeping and use of information requirements (10 CFR 850.40).

Authorized person

would continue to mean any person required by their work duties to be in a beryllium regulated area. Authorized individuals would be required to be trained and experienced in the hazards of beryllium, and the means of protecting themselves and those around them against such hazards. Proposed training requirements are specified in § 850.38 of this proposed rule. The concept of authorized person continues to be consistent with OSHA standards and with contractor practice at many DOE sites, and is intended to ensure that the population of potentially exposed individuals is reduced to the lowest possible number and that workers who are granted access to beryllium regulated areas have the knowledge they need to protect themselves and other workers.

Beryllium

would be revised to mean elemental beryllium, beryllium oxide, and alloys containing 0.1 percent or greater beryllium by weight that may be released as an airborne particulate. Though uncertainty exists, studies investigating the health effects of exposures to elemental beryllium, beryllium oxide, and beryllium alloy suggest no compelling evidence that BeS or CBD is caused by exposure to particulates that contain beryllium in forms other than elemental, oxide and alloys. An important consequence of this proposed change is to exclude mineral forms of beryllium from the definition of beryllium. The American Conference of Governmental Industrial Hygienists (ACGIH®) (ref. 29) reports, for example, that: “Beryllium occurs naturally as the silicate, bertrandite, and the aluminosilicate, beryl. Exposure to bertrandite and beryl dust occurs during ore crushing and grinding; however, the ores are not considered sources of beryllium sensitization.

”

While mineral forms of beryllium do not appear to be linked with BeS or CBD, these forms can be at or above the action level when samples are analyzed by currently available methodologies. This occurs because materials containing mineral forms of beryllium—such as clays, and concrete—are ubiquitous on many DOE sites, and the most common currently used analysis methods analyze all the beryllium in a sample without distinguishing the different forms of beryllium. DOE has learned by experience that common conditions and practices at DOE facilities—such as accumulations of wind-blown dust, abrasive blasting of brick surfaces with coal slag, and drilling into and demolishing concrete structures—frequently result in breathing zone levels at or above the proposed action level and release criteria, but with forms of beryllium that are not believed to cause BeS or CBD. Studies by Stefaniak

et al.

of dissolution rates of beryllium in various beryllium containing materials in airway and phagolysosomal fluids suggest that dissolution rates of beryllium metal and oxide in lungs are in a range that is relatively slow in lung airways fluid to prevent removal by dissolution and is sufficiently fast in phagolysosomal fluid to compete with removal by phagocytosis. The range of dissolution rates of beryllium-containing minerals (

e.g.,

beryl ore) are slow in phagolysosomal fluid, indicating the persistence of these particles until removed by mechanical clearance which may alter its capacity to influence development of CBD (ref. 30). DOE's proposal to eliminate beryllium-containing minerals from the definition of beryllium would greatly reduce the burden on its missions without diminishing worker safety and health protection.

The definition would continue to exclude soluble forms of beryllium, such as beryllium salts, from the definition of beryllium. High exposures to soluble beryllium compounds cause acute beryllium disease (

i.e.,

inflammation of the upper and lower respiratory tract), but this exposure

essentially has been eliminated by compliance with OSHA's PEL.

Cummings

et al.

reported in 2009 on two cases of production plant employees who in the 1980s were exposed to both highly and poorly soluble forms of beryllium and developed skin conditions, acute beryllium disease, and eventually CBD. The exposure monitoring results associated with these cases indicate levels were well above the OSHA PEL. Included in this article is the following statement: “More recently, insoluble beryllium metal and oxide have been shown to have dissolution lifetimes of hundreds of days to years in lung airway epithelial lung fluid and alveolar macrophage phagolysosomal fluid (ref. 31, 32). Autopsy studies have confirmed that beryllium particles are identifiable in granulomas formed in the lungs of individuals with CBD years after exposure ceased (Butnor et al. 2003; Sawyer

et al.

2005; Williams and Wallach 1989). Thus, Stefaniak

et al.

(2003, 2008) hypothesized that exposure aerosol physical properties, chemical properties, and physicochemical properties control development of beryllium lung burdens, and that the ongoing presence of a lung reservoir of beryllium may be necessary for the development of CBD” (ref. 33). Moreover, ACGIH® states, “Exposure to soluble beryllium salts (sulfate, ammonium carbonate, beryllium carbonate, and to a lesser extent, beryllium hydroxide) may occur during extraction of the metals from the ore (Deubner

et al.

, 2001). These salts are considered the main source of beryllium sensitization during beryllium extraction” (ref. 29).

DOE recognizes that inhalation and skin exposure to soluble beryllium compounds may create risk for BeS, however, DOE believes that soluble forms of beryllium are not used at its beryllium sites and, therefore, do not warrant regulation under this rule.

Distinguishing the forms of beryllium.

DOE believes it is feasible to distinguish the forms of beryllium specified in DOE's proposed definition of beryllium. The Department recognizes that the most common analytical techniques for determining the beryllium content of a sample begin with digesting all the beryllium into ions in solution. These techniques do not distinguish the form the beryllium was in before the digestion step. However, DOE believes Qualified Individuals (as defined in § 850.3 of this proposed rule) can make the determination that the beryllium at a DOE site is in a metal, oxide, or alloy form based on knowledge of the processes conducted at that site and matching the composition of certain constituents of air and surface samples with the composition of possible source materials. Another approach for distinguishing the form of beryllium is to demonstrate that the source of beryllium contamination is in infiltrated background soil. One technique that has been used successfully at DOE sites to determine if the beryllium in indoor settled particulates consists of beryllium that has infiltrated indoors, as a constituent of background soil, is to demonstrate that the concentration of beryllium in the accumulated indoor “dust” is not higher than the concentration in the outside background soil. Another technique is based on demonstrating that the ratio of atoms of beryllium to the atoms of a constituent of soil is the same in background soil and indoor dust. Other techniques may be available to determine whether beryllium is in an elemental, oxide, or alloy form. DOE believes the methods its sites use to determine the form of beryllium are technically defensible, which is important when the site determines that the source is a form of beryllium, such as background soil or coal fly ash, not included in the proposed definition of beryllium.

Beryllium activity

would mean an activity taken for or by DOE at a DOE site that can expose workers to airborne concentrations of beryllium at or above the action level, including any activity involving the disturbance of legacy beryllium-containing dust.

Beryllium article

would be revised to mean a “commercially available, off-the-shelf” item composed of beryllium that is formed to a specific shape or design during manufacture, has end-use functions that depend in whole or in part on its shape or design during end use, and does not release airborne beryllium at or above the action level under normal conditions of use. The proposed definition would revise the current definition from stating that it “does not release beryllium” to stating that it “does not release particulate beryllium at or above the action level under conditions of normal use.”

DOE is modifying this definition since some of its sites have found surface contamination associated with items that met the definition of “articles” but were part of the weapons systems. The identification of surface contamination on “articles” or manufactured products is not new. While the risk of airborne exposure is negligible, there have been Occurrence Reporting and Processing System reports and/or Lessons Learned, which highlight the need to reexamine the article definition and use around the DOE complex.

DOE recognizes the existence of weapon components that are categorized as articles, and they are exempt from the requirements of the beryllium program. Several weapons programs include operations involving beryllium-containing components classified as articles. The components are processed during weapon assembly, dismantlement, stockpile maintenance, and other operations. The operations involve routine handling, and may include light wiping of the components with a dry disposable wipe or a disposable wipe moistened with a solvent. These operations involving those alloy components do not result in measurable concentrations of airborne beryllium and are exempted from the requirements of this rule. However, the article exemption does not apply to these parts if they are processed in a more aggressive manner that might lead to the release of beryllium from the component.

Beryllium-associated worker

would be clarified to mean a current worker who was exposed or potentially exposed to airborne concentrations of beryllium at a DOE site. DOE is proposing to clarify the definition of beryllium-associated worker by removing the term “beryllium workers” (

i.e.,

workers who are currently exposed or potentially exposed to beryllium at or above the action level). DOE has learned from experience in implementing this part, as issued in 1999, that including “beryllium worker” in the definition caused confusion and different interpretations of the term by individuals responsible for implementing this provision.

The term “beryllium-associated worker” would continue to apply to current workers whose work history showed they may have been exposed to airborne concentrations of beryllium at a DOE site; or a worker who exhibits signs and symptoms of beryllium exposure. The definition clarifies that current workers who have been removed from beryllium exposure as part of the medical removal process and are receiving medical removal benefits are beryllium-associated workers under the proposed rule, but they are not “beryllium workers” (see definition of “beryllium worker”). Beryllium-associated workers may be DOE Federal or contractor workers, or employees of subcontractors to DOE contractors who perform work at DOE sites in furtherance of a DOE mission.

Beryllium emergency

would continue to mean any occurrence such as, but not limited to, equipment failure, container rupture, or failure of control equipment or operations that results in an

unexpected and significant release of beryllium at a DOE site. This definition is particularly important when determining appropriate emergency response procedures that fall within the scope of OSHA's

Hazardous Waste Operations and Emergency Response

standard, 29 CFR 1910.120. This definition continues to be based on OSHA's use of the term “emergency” as applied in 29 CFR 1910.120 and refers to any event, such as a major spill of powdered beryllium or an unexpected upset, that results in a significant release of beryllium into the workplace atmosphere.

Beryllium-Induced Lymphocyte Proliferation Test (BeLPT)

would remain unchanged from its current definition as an in vitro measure of the beryllium antigen-specific, cell-mediated immune response to beryllium. However, the Department is adding language to clarify that a split sample BeLPT (where one blood draw is split and sent to two different testing facilities) would constitute two tests for purposes of diagnosing BeS.

This test measures the extent to which lymphocytes, a class of white blood cells, respond to the presence of beryllium. Medical personnel use the blood Be-LPT to identify workers who have become sensitized to beryllium through their occupational exposure.

Beryllium-induced medical condition

would be added to provide a term in the rule that refers to CBD and BeS. Other diseases may resemble CBD, but are not attributable to beryllium. Medical tests, such as the lung lavage BeLPT, can help a physician decide if a person has CBD or another disease.

Beryllium Registry

would be added as a new term and refers to the DOE Beryllium-Associated Worker Registry, which is a collection of health and exposure information of individuals potentially at risk for CBD due to their work at DOE-owned or leased sites. The data from the Beryllium Registry is analyzed to better understand CBD and to identify those at risk. Reported data are cumulative through calendar year and are located at:

http://energy.gov/ehss/beryllium-associated-worker-registry.

The Beryllium Registry is also a risk management tool for sites to use in managing their CBDPP and other risk management operations. Sites are encouraged to use their Beryllium Registry data to evaluate beryllium exposure risks.

Beryllium regulated area currently known as “regulated area,”

would be clarified to mean an area established, demarcated, and managed by the employer where the airborne concentration of beryllium is at or above, or can reasonably be expected to be at or above, the action level. Employees working in beryllium regulated areas would be authorized by their employer to work in the area, and trained, and equipped with protective clothing and equipment. The purpose of such areas is to limit exposure to beryllium to as few workers as possible. The use of these “regulated areas” is consistent with OSHA's expanded health standards for toxic particulates.

Beryllium sensitization or sensitivity (BeS)

would be added as a new term to ensure consistency within the Department in how BeS is diagnosed. BeS would mean a condition diagnosed by the SOMD based on any of the following: (1) Two abnormal blood BeLPT results; (2) One abnormal and one borderline blood BeLPT; or (3) One abnormal BeLPT test of alveolar lung lavage cells. This definition would also make clear that it is the SOMD who makes the diagnosis of BeS.

The Department recognizes that OSHA has proposed slightly different criteria for BeS diagnosis in its proposed rule,

Occupational Exposure to Beryllium and Beryllium Compounds.

Specifically, OSHA proposed a BeS diagnosis based on two abnormal tests performed after two separate blood draws. DOE does not believe this slight difference in proposed approaches will create confusion because the Department would only be subject to the permissible exposure limit established in the current OSHA beryllium standard and any new OSHA beryllium standard when promulgated, and would not be subject to the ancillary provisions (

e.g.,

definitions, exposure assessment, personal protective clothing and equipment, medical surveillance, medical removal, training, and regulated areas or access control) of the new rule. Therefore, DOE workplaces will only be subject to the DOE provisions. The Department expects DOE and DOE contractors to continue to implement the provisions of 10 CFR part 850 at DOE sites.

Beryllium worker

would be revised to mean a current worker exposed or potentially exposed to airborne concentrations of beryllium that are at or above the action level in the course of the worker's employment in a DOE beryllium activity. Incorporation of the action level is necessary, as beryllium is ubiquitous in small amounts, and DOE's experience has been that “potentially exposed” has been misunderstood to refer to all workers on a site regardless of whether they were exposed to levels of beryllium of any consequence to their health.

This definition would also clarify potential confusion over what it means to be “regularly employed in a DOE beryllium activity” and to include those persons who are exposed to airborne concentrations of beryllium at or above the action level as part of their employment, such as supervisors or others who are authorized to enter beryllium regulated areas. The employer would be required under this proposed rule to provide the SOMD with a list of all beryllium workers, as well as beryllium-associated workers. Former workers would not be included in the definition of beryllium workers. The Department established the Former Worker Medical Screening Program and offers medical examinations to former (retired and separated) workers who are at risk for developing CBD due to their work at a DOE site.

Breathing zone

would continue to mean the hemisphere forward of the shoulders, centered on the mouth and nose, with a radius of 6 to 9 inches. This definition applies specifically to proposed § 850.24,

Exposure Monitoring,

which requires employers to determine the worker's exposures to beryllium by monitoring for the presence of contaminants in the worker's personal breathing zone. This definition is consistent with sound and accepted industrial hygiene practices, and ensures that samples collected for personal exposure monitoring represent the air inhaled by workers while performing their duties in their work areas.

Chronic beryllium disease (CBD)

would be added as a new term to ensure consistency within the Department in how CBD is diagnosed. CBD would mean a condition diagnosed by the SOMD based on the worker having the following: (1) BeS as defined in this section; and (2) a lung biopsy showing non-caseating granulomas or a lymphocytic process consistent with CBD, or radiographic (including computed tomographic (CT) scans) and pulmonary function testing results consistent with pulmonary granulomas.

Cognizant Secretarial Officer (CSO)

would be added as a new term by adopting the definition from 10 CFR part 851,

Worker Safety and Health Program.

The definition would clarify that the CSO would mean, with respect to a particular situation, the Assistant Secretary, Deputy Administrator, Program Office Director, or equivalent DOE official who has primary line management responsibility for a contractor, or any other official to whom the CSO delegates in writing a particular function under this part.

Contractor

would be revised from the current term “DOE contractor” by adopting the definition from 10 CFR part 851,

Worker Safety and Health Program,

but specifying that the definition applies to contractors performing beryllium work. This change would reflect DOE's intent that contractors covered under this rule includes any entity, including affiliated entities, such as parent corporation, under contract with DOE, and any subcontractor at any tier, that has responsibilities for performing beryllium work at a DOE site in furtherance of a DOE mission.

DOE

would continue to mean the United States Department of Energy, including the National Nuclear Security Administration.

DOE site

would be added as a new term by adopting the definition from 10 CFR part 851, and the current term “DOE facility”, would be deleted. The definition would clarify that a DOE site would mean a DOE-owned or -leased area or location or other location controlled by DOE where activities and operations are performed at one or more facilities or places by a contractor in furtherance of a DOE mission. This definition would include all locations where DOE exercises regulatory control under the Atomic Energy Act of 1954, as amended (AEA), even if DOE does not own or lease the site.

Employer

would replace the term “responsible employer” because DOE recognizes that “responsible” is self-evident in the context of this part. Therefore, an employer would be, (1) for DOE contractor employees, the DOE contractor that is directly responsible for the safety and health of employees while performing a beryllium activity or other activity at a DOE site; (2) for DOE employees, the DOE office that is directly responsible for the safety and health of DOE Federal employees while performing a beryllium activity or other activity at a DOE site; or (3) any person acting directly or indirectly for the contractor or DOE office with respect to terms and conditions of employment of beryllium workers and beryllium-associated workers.

Final medical determination

would be added to the definitions section and would mean the final written medical determination of the SOMD as to whether the beryllium worker should be permanently removed because of BeS or CBD. The final medical determination to permanently remove a worker must be made by the SOMD based on a diagnosis of BeS or CBD as defined in this section. If the worker is eligible, and has elected the multiple physician review or alternate physician's determination, the SOMD must issue the final medical determination at the conclusion of such process.

The current rule provides in § 850.35(a)(1)(i) that “final medical determination” is the “outcome of the multiple physician review process or the alternate medical determination process,” and thus temporary removal is only available pending this independent review. This proposed rule would be intended to permit the SOMD to determine that a worker should be put on temporary medical removal based on tests, recommendations, or any other symptoms that the SOMD deems medically sufficient, pending the SOMD's final medical determination as to whether the worker should be permanently removed. For example, if a SOMD evaluates a worker and believes the worker needs to undergo additional testing before a final determination can be made, the SOMD may determine that the worker should be temporarily removed pending the outcome of that testing. In instances where the worker does not request multiple physician review or alternate physician determination, the SOMD's initial determination may also be the final determination.

Head of DOE Field Element

would be revised by adopting the definition from 10 CFR part 851. This change would reflect DOE's intent that the Head of DOE Field Element is the individual who is the manager or head of the DOE operations office or field office.

High-efficiency particulate air (HEPA) filter

would continue to mean a filter capable of trapping and retaining at least 99.97% of 0.3 micrometer mono-dispersed particles.

Medical removal benefits

(currently medical removal protection benefits) is being revised to mean the employment benefits that would be established by § 850.36 of this proposed rule for beryllium workers temporarily or permanently removed from beryllium activities in which the workers can be exposed to airborne concentrations of beryllium at or above the action level following a recommendation by the SOMD. This proposed definition would clarify that only beryllium workers are eligible for medical removal benefits. Medical removal provisions give contractors an incentive to make reasonable efforts to find and offer alternate employment to beryllium workers who have suffered negative health effects due to exposure to beryllium. The proposed definition of medical removal benefits and the proposed requirements in proposed § 850.36 would ensure that permanently removed beryllium workers would suffer no reductions in total earnings, or other worker rights and benefits for up to two years after permanent medical removal, and up to one year for temporary removal. During this time the contractor would be required to make reasonable efforts to find alternate employment for a removed beryllium worker. Alternative employment may also be found through job retraining and out-placement programs operated by many sites during this two-year period. For workers who are removed, medical removal benefits would continue for the designated period, even where the employee has, during that period of removal, received a notice of and is subsequently laid-off.

Medical restriction

would be added and refer to the outcome of the process under § 850.35 in which the worker is not suffering from CBD or has not been sensitized to beryllium, but the SOMD determines that exposure to beryllium is nonetheless contraindicated due to other medical conditions of the worker and thus, the SOMD recommends that the worker be restricted from a job that involves an exposure to beryllium at or above the action level. For beryllium workers with BeS or CBD, this proposed rule would require medical removal—not medical restriction—if the SOMD determines that a beryllium worker should be removed from a beryllium job.

Qualified Individual

would be added and defined to mean an individual, designated by the employer, who possesses the knowledge, skills, and abilities needed to implement an industrial hygiene program (

i.e.,

an individual who is either a certified industrial hygienist or has a college degree in industrial hygiene or a related scientific, engineering, or technical degree); who has completed special studies and training in industrial hygiene; and who has at least five years of full-time employment in the professional practice of industrial hygiene.

Site Occupational Medical Director (SOMD)

would continue to mean the licensed physician responsible for the overall direction and operation of the site occupational medicine program. However, DOE believes the physician should be qualified to diagnose beryllium-induced medical conditions. Specifically, DOE expects the medical evaluations and procedures required to diagnose CBD will be performed or validated by a specialist in pulmonary medicine or occupational medicine, or by another physician familiar with the specialized equipment and examination protocols required to definitively

differentiate between CBD and other lung diseases.

Surface levels of beryllium

would replace the term “removable contamination,” and the definition would be revised by deleting the words “nondestructive” and “washing.” The word “nondestructive” gives the erroneous impression that actions to remove contamination can be very aggressive as long as the surface is not damaged. Washing is inconsistent with casual contact. The intent of the definition of “surface levels of beryllium” would be to describe the material that could be transferred to an individual by casual contact, such as brushing by the contaminated surface.

Unique identifier

would continue to mean the part of a paired set of labels used in records that contain confidential information that does not identify individuals except by using the matching label.

Worker

would be revised to mean an employee of DOE or a DOE contractor, or subcontractor, at any tier, who performs work in furtherance of a DOE mission at a DOE site.

Terms and definitions deleted and not explained above.

The definitions of “DOE facility,” “immune response,” “operational area,” and “worker exposure” would be deleted, as these terms are either not used in this proposed notice or are fully explained as established in § 850.24 (Exposure monitoring).

Proposed § 850.3(b) would be amended to provide that undefined terms shall have the same meanings as used in the AEA and 10 CFR part 851,

Worker Safety and Health Program.

§ 850.4—Enforcement

Proposed § 850.4 would continue to preserve the section as amended on February 9, 2006 (71 FR 6858, 6931). That amendment provides that DOE may take appropriate steps pursuant to 10 CFR part 851,

Worker Safety and Health Program,

to enforce compliance by contractors with this part, and any DOE-approved contractor's CBDPP. This provision would continue to allow DOE to employ contractual mechanisms such as a reduction in fees, or to assess a civil penalty when a contractor fails to comply with the provisions of the proposed rule.

§ 850.5—Dispute Resolution

Proposed § 850.5 would continue to establish that any adversely affected worker may refer a dispute regarding compliance with the rule to the Office of Hearings and Appeals (OHA) for resolution; however, employees who are represented by a labor organization are required first to exhaust any grievance-arbitration procedure that is available for resolving disputes over terms and conditions of employment. The rule would continue to provide that a worker will be deemed to have exhausted all applicable grievance-arbitration procedures if 150 days have passed after the filing of a grievance and a final decision on it has not been issued. This provision is consistent with 10 CFR part 708,

DOE Contractor Employee Protection Program,

at § 708.13(a)(2). Proposed § 850.5(b) would permit OHA to “elect not to accept a petition from a worker unless the worker had requested that the employer correct the violation,” rather than prohibit the petition from being accepted by OHA unless the worker had requested his employer correct the violation.

§ 850.6—Interpretations, Binding Interpretive Rulings and Requests for Information

Proposed § 850.6 would be added to establish and clarify that requests for legal interpretations under this proposed rule would be in accordance with 10 CFR 851.6,

Petitions for generally applicable rulemaking,

requests for binding interpretive rulings would be in accordance with § 851.7,

Requests for a binding interpretative ruling,

and informal requests for information would be made pursuant to 10 CFR 851.8,

Informal requests for information.

Informal requests for information and inquiries regarding technical requirements in this proposed rule would be directed to the Office of Environment, Health, Safety and Security (AU). The responses given by AU would be advisory only and would not be binding on DOE. In addition, to assist the DOE community in understanding the technical meaning or application of a specific requirement in this proposed rule, AU would continue to operate the DOE Response Line (1-800-292-8061) to provide information to DOE, DOE contractor and DOE subcontractor employees.

B. Subpart B—Administrative Requirements

Subpart B of the proposed rule would establish general and administrative requirements to develop, implement, and maintain a CBDPP and to perform all beryllium related activities according to the CBDPP.

Proposed § 850.10—Development and Approval of the CBDPP

Proposed § 850.10 would continue to establish the requirements for development and approval of the CBDPP. Proposed § 850.10(a)(1) would continue to require each employer engaged in beryllium activities at a DOE site to prepare and submit a CBDPP for review and approval as indicated in proposed § 850.10(b). DOE would expect its employers to perform the beryllium inventory and hazard assessment as would be required by proposed §§ 850.20 and 850.21 and then prepare and submit for approval a CBDPP that is warranted by the results of the beryllium inventory and hazard assessment.

Proposed § 850.10(a)(1) would also establish a 90 day timeframe from the effective date of the final rule for employers' submissions of the CBDPP. DOE is aware of the burden of documentation that can be generated by new programs. However, most employers have already developed CBDPPs in response to the current rule. DOE expects the additional effort required to refine the existing CBDPPs to meet the requirements of the proposed rule will be minimal.

Proposed § 850.10(a)(2) would require employers that employ beryllium-associated workers at a DOE site, but which are not engaged in beryllium activities, to submit a CBDPP with the provisions appropriate for its workers [

e.g.,

medical surveillance (§ 840.34), training and counseling (§ 840.38), and recordkeeping (§ 840.40)] for review and approval. This section clarifies that DOE does not expect employers to prepare and submit a CBDPP that includes all the provisions of this proposed rule if they do not employ beryllium workers. This proposed section would establish a 90-day timeframe from the effective date of the final rule for the employers' submission of a CBDPP to the appropriate Head of DOE Field Element. 10 CFR 851.26,

Recordkeeping and reporting,

requires documentation of all hazard inventory and hazard assessment results, so employers would be required to have records to support the conclusion that a CBDPP would not be required.

Proposed § 850.10(a)(3) would continue to require a single CBDPP be submitted to encompass all beryllium-related activities at a site, as currently provided in § 850.10(a)(2). Because DOE recognizes that one site may encompass multiple contractors and numerous work activities, this proposed sections would continue to clarify that the CBDPP for a given site may include specific sections for individual contractors or work tasks. DOE believes that this allowance for a segmented CBDPP structure would minimize the burden associated with the CBDPP update and approval requirements because it allows individual contractors

to update and submit for approval only the section of the CBDPP pertaining to their specific activities. If multiple contractors are involved, the DOE contractor designated by the Head of the DOE Field Element must take the lead in compiling the overall CBDPP and coordinating the input from various contractors, subcontractors, or work activities. This proposed section further clarifies that in such cases the designated contractor would be required to review the sections of the CBDPPs prepared by the other contractors engaged at the site before a consolidated CBDPP could be submitted to the Head of DOE Field Element for final review and approval.

Proposed § 850.10(a)(4) would require multiple employers at a DOE site to share relevant assessment information gathered under proposed § 850.41(a) of this proposed rule, to ensure the safety and health of their workers.

Proposed § 850.10(b)(1) would continue to require the Heads of DOE Field Elements to review and provide approval or rejection of the CBDPPs. However, the proposed section would amend the current rule by requiring that approvals or rejections of the CBDPP be provided in writing. DOE believes that its review and approval of CBDPPs is necessary to ensure that each contractor's CBDPP is consistent with the requirements and objectives of the rule. The Head of DOE Field Element is not only responsible for operations within his or her jurisdiction, but also is familiar with the operations and any related special circumstances or unique situations that may affect implementation or effectiveness of the CBDPP. Thus, DOE believes the Head of DOE Field Element is the most appropriate DOE approval authority for CBDPPs. This proposed section would establish a 90 working day period for DOE to review and either approve or reject the CBDPP or any updates to the CBDPP. During its review, DOE may direct the contractors to modify the CBDPP. DOE established this 90 working day period to facilitate timely implementation of program elements by employers and to ensure that Heads of DOE Field Elements respond to employers' submissions.

Proposed § 850.10(b)(2) would require the appropriate CSO to review and provide a written approval or rejection of the CBDPPs or any updates to the CBDPP for DOE Federal offices with beryllium workers or beryllium-associated workers. This proposed section would establish a 90 working day period for the CSO to review and either approve or reject the CBDPP. During its review, the CSO may direct the DOE Federal office to modify the CBDPP.

Proposed § 850.10(b)(3) clarifies that the CBDPP is would be deemed approved 90 working days after submission to the Head of DOE Field Element or the CSO if it has not been approved or rejected earlier.

Proposed § 850.10(b)(4) would amend § 850.10(b)(2) to require employers to give a copy of the approved CBDPP, upon request, to the Office of Environment, Health, Safety and Security, DOE program offices, affected workers, and their designated worker representatives. This section ensures that workers and their representatives have access to information related to the protection of their health.

Proposed § 850.10(c) would continue to require employers to update the written CBDPP for review and approval within 30 working days in two circumstances: (1) Whenever a significant change or addition to the CBDPP is made or warranted, and (2) whenever a contractor changes. DOE believes that such updates are appropriate to ensure that the CBDPP accurately reflects workplace conditions and addresses specific workplace beryllium exposure hazards. This section would also require the Head of DOE Field Elements, or appropriate CSO, if applicable, to review CBDPPs at least annually and, if appropriate, require the employers to update CBDPPs. DOE considers the annual review cycle to be appropriate and necessary to ensure that CBDPPs remain up-to-date and that they accurately reflect workplace conditions and required control procedures.

Proposed § 850.10(d) would continue to require employers to notify any associated labor organization of the development and implementation of the CBDPP plan and updates, and upon request, bargain with the labor organization on implementation of part 850 in a manner that is consistent with Federal labor laws and this part. This section continues to ensure that CBDPPs are developed and implemented consistently with the requirements imposed by the National Labor Relations Act (NLRA), 29 U.S.C. 151-169, and that they do not create obligations in excess of those that would be found in such circumstances under the NLRA.

Proposed § 850.11—General CBDPP Requirements

Proposed § 850.11 would continue to establish the general requirements of the CBDPP. Proposed § 850.11(a) would continue to specify that the CBDPP would be expected to address the existing and planned beryllium activities. Also, proposed § 850.11(b) continues to require employers to tailor the scope and content of the CBDPP to the specific hazards associated with the beryllium activities being performed, but would no longer require that the CBDPP augment or be integrated into existing Worker Safety and Health Programs. The existing provision is considered unnecessary because § 850.1,

Scope,

already provides that the CBDPP supplements, and is deemed an integral part of, the worker safety and health program under 10 CFR part 851, for DOE contractor employees. In addition, proposed § 850.11(b)(1) would require that the CBDPP include formal plans outlining how the employer would ensure that beryllium exposures are maintained below the level prescribed in proposed § 850.22 of this part. Proposed § 850.11(b)(2) would make clear that the plans must, at a minimum, satisfy each requirement in subpart C of the rule (

Specific Program Requirements

). Proposed § 850.11(b)(3) would clarify that the CBDPP provisions must contain provisions for minimizing the number of workers exposed to airborne levels of beryllium at or above the action level, and the instances in which workers are exposed to beryllium.

DOE proposes to delete the requirement in the existing rule at § 850.11(b)(3)(iii) to minimize the disability and lost work time of workers due to beryllium-induced medical conditions and associated medical care, because DOE recognizes that this specific requirement has no practical effect and its intent is met by the other requirements in the CBDPP regulations.

DOE also proposes to delete the requirements in the existing rule at § 850.11(b)(3)(iv), which require the CBDPP to include specific exposure reduction and minimization goals to further reduce exposures below the PEL prescribed in proposed § 850.22,

Permissible exposure limit,

DOE is proposing this change because its experience in implementing this part indicates that the open-ended expression “further reduce exposures” is problematic to implement because beryllium is ubiquitous in small amounts. In addition, DOE believes the actions required when workers are exposed to airborne levels of beryllium at or above the proposed action level are protective and expects that few workers will develop CBD from future exposures.

Proposed § 850.12—Implementation

Proposed § 850.12(a) would require employers to manage and control

beryllium activities consistent with the approved CBDPP. Proposed § 850.12(b) [currently § 850.12(c)] would provide that tasks involving potential exposure to airborne levels of beryllium at or above the action level, that are not covered under the CBDPP may only proceed with the written approval from the Heads of DOE Field Elements, or appropriate CSO, as applicable.

Proposed § 850.12(c) [currently § 850.12(b)], would continue to establish that no person employed by DOE or a DOE contractor may take or cause any action that is inconsistent with the requirements specified in this part, an approved CBDPP, or any other applicable Federal statute or regulation concerning the exposure of workers to levels of beryllium at a DOE site. This section clarifies that DOE and contractor personnel would be required to follow applicable requirements of the rules as well as applicable requirements in other applicable Federal statutes and regulations concerning exposure of workers to beryllium.

As with the existing § 850.12(d), proposed § 850.12(d) would continue to recognize that, depending on the circumstance of the work, employers may choose to take additional actions to protect their workers. In implementing this part of the rule, the Department has learned that in certain instances, some sites took actions they felt were more protective of workers, but which in fact conflicted with the requirements of the rule. This provision makes it clear that while employers may take additional actions to protect their workers, employers would be required to first comply with the requirements of this part. DOE recognizes that individuals responsible for implementing CBDPP activities must use their professional judgment in protecting the safety and health of workers. Proposed § 850.12(e) would continue to provide that nothing in the rule is intended to diminish the responsibilities of DOE officials under 29 CFR part 1960 and related requirements for Federal workers.

Proposed § 850.13—Compliance

Proposed § 850.13(a) would revise existing § 850.13(a) to allow contractors or DOE offices, as applicable, who already have CBDPPs that have been approved by a Head of DOE Field Element, or appropriate CSO, as applicable, to continue to use them for one year after the effective date of the final rule. Thereafter, proposed § 850.13(b) would mandate that employers conduct beryllium activities in compliance with their approved CBDPP under this proposed rule.

Proposed § 850.13(c) would continue to require contractor employers responsible for a beryllium activity to be responsible for complying with the proposed rule. When no contractor is responsible for the beryllium activity and Federal employees perform the activity, this proposed section would require DOE to be responsible for compliance.

C. Subpart C—Specific Program Requirements

Subpart C of the proposed rule would continue to establish performance-based requirements for the CBDPP. These proposed requirements would focus on preventing CBD by requiring specified protective actions, reducing the number of workers exposed to beryllium, and continuous monitoring to ensure that workplace controls are sufficiently protective. DOE would expect implementation of the rule to continue to increase its understanding of the development, course and prevention of CBD.

Proposed § 850.20—Beryllium Inventory

Proposed § 850.20 would continue to require employers to take specific actions in order to develop a beryllium inventory, and would also provide that employers must update the inventory at least annually and when significant changes to beryllium activities occur.

DOE intended that the current version of § 850.20 include the requirement to maintain an up-to-date inventory. Proposed § 850.20(a)(1) through (4) would require employers to develop their beryllium inventory by reviewing current and historical records, interviewing workers, conducting air, surface and bulk sampling as appropriate to characterize the beryllium and its locations and documenting the locations of beryllium at or above the action level at a site. Characterizing the beryllium and identifying the locations of beryllium are necessary to assess and control beryllium workplace hazards. Employers should conduct the sampling that is appropriate for the specific workplace conditions and the suspected types and locations of beryllium contamination. Sampling techniques could include collecting area and wipe samples and collecting personal breathing zone samples.

By maintaining a beryllium inventory, employers will accomplish the following functions that are critical to the success of the CBDPP: (1) Identification of locations and operations that should be physically isolated from other areas to prevent the spread of contamination, (2) identification of areas in which worker access should be restricted to minimize the number of workers who could be exposed to beryllium at or above the action level, (3) identification of beryllium contamination that must be controlled in areas that are scheduled for decontamination and decommissioning, and (4) identification of beryllium contamination in areas that are being used for non-beryllium activities, to determine the need for cleanup.

Surface level data obtained with dry wipes before the effective date of the final rule will be acceptable for meeting the beryllium inventory requirements for conducting surface sampling in proposed § 850.20(a)(3). However, subject to § 850.20(b), employers that previously used dry wipe sampling would have to convert to wet wipe sampling for new surface exposure monitoring after the effective date of the final rule to comply with the requirements of proposed § 850.24(a)(2)(ii), unless the use of wet wipes would have an undesired effect on the surface being sampled or is not technically feasible.

DOE is proposing to delete from § 850.20(a) the requirement that employers identify workers that were exposed or potentially exposed to beryllium at the inventoried locations. DOE has found that identifying workers is more effectively accomplished by listing the identified locations, using surveys to ask workers about their activities in those locations, and looking at the work histories workers provide when undergoing medical evaluations. Also, proposed § 850.34(a)(3) and (4) would require employers to provide information related to workers' beryllium exposures, to facilitate the SOMD's determination of which workers should receive mandatory medical evaluations and which workers should be offered voluntary medical evaluations.

Proposed § 850.20(b) would permit employers to use inventory results obtained within 12 months prior to the effective date of the final rule to satisfy the requirements set forth in § 850.20(a) if a Qualified Individual determines that conditions represented by the results have not changed in a manner that would warrant changes in the beryllium inventory. While wet wipe data would replace the dry wipe beryllium data in inventories as surfaces are monitored as part of the employer's ongoing CBDPP activities, DOE believes that repeating surface measurements solely for updating the inventory as of the effective date of the final rule would not be cost-effective or justified based on

the amount of reduced risk of beryllium disease that would be realized. Proposed § 850.20(b) would also require employers to update their beryllium inventory at least annually and when significant changes occur to beryllium activities, which is consistent with the common practice at DOE sites.

Proposed § 850.20(c) would continue to require the employer to ensure that the beryllium inventory is managed by a Qualified Individual. DOE believes this provision is necessary to ensure that the inventory is accurate and complete.

Proposed § 850.21—Hazard Assessment and Abatement

Because the identification of the possible presence of beryllium in a workplace does not, in and of itself, suffice to determine whether a hazard exists or whether and, if so, what control measures must be employed, proposed § 850.21(a) would continue to require employers to conduct a beryllium hazard assessment if the inventory establishes the presence of beryllium. This section, as proposed, would limit the requirement to conduct hazard assessments to areas where the airborne concentration of beryllium is potentially at or above the action level. This requirement allows each site the flexibility to determine the appropriate risk-based approach for assessing beryllium-related hazards in its worksites. Flexibility is important because operations, conditions, and the potential for exposure may vary greatly from operation to operation and site to site.

Proposed § 850.21(b) would require employers to conduct the beryllium hazard assessment in accordance with the requirements in 10 CFR 851.21,

Hazard Identification and Assessment.

10 CFR 851.21 establishes the employer's duty to enact procedures for identifying the hazards and assessing the related risk in the workplace. This section lists the activities employers would perform as part of their hazard and risk assessment procedures (

e.g.,

conducting workplace monitoring, evaluating operations).

Proposed § 850.21(c) would be added to require employers to abate beryllium hazards in accordance with the requirements in 10 CFR 851.22,

Hazard Prevention and Abatement.

This section requires employers to develop and implement a process for preventing, prioritizing and abating beryllium hazards using the hierarchy of controls, starting with elimination (or substitution of the hazard, if appropriate and feasible) and ending with personal protective equipment.

Proposed § 850.21(d) would be added to provide that employers ensure paragraphs (a) through (c) of this section, are managed by a Qualified Individual as defined in this proposed rule.

Proposed § 850.22—Permissible Exposure Limit

DOE received several comments in response to its Request for Information (RFI) concerning the adoption of the OSHA PEL for beryllium. Approximately two-thirds of the commenters favored DOE no longer adopting the OSHA PEL and pointed out that even OSHA recognizes that the current OSHA PEL may not be adequate to prevent the occurrence of CBD (ref. 34).

In response to the Department's RFI concerning whether DOE should adopt the 2010 ACGIH® threshold limit value (TLV®) of 0.05 μg/m

(ref. 6) as its PEL, approximately two-thirds of the commenters rejected its adoption. Several commenters pointed out that TLVs® are not developed with technical or economic feasibility in mind and that TLVs®, quoting from the ACGIH®, “are not developed for use as legal standards and ACGIH® does not advocate their use as such.” Others suggested DOE adopt the 2010 ACGIH® TLV® as its PEL because it is the most protective and conservative published level.

Proposed § 850.22(a) would continue to retain OSHA's 8-hour TWA PEL for airborne exposure to beryllium (2 μg/m

), as measured in the worker's breathing zone by personal monitoring, but allows for the adoption of a stricter standard should OSHA establish one through its rulemaking process. As in the current rule, the PEL would supplement the action level by establishing an absolute 8-hour TWA level above which, no worker may be exposed. Engineering or work practice controls would be required to bring exposures to at or below the PEL.

OSHA has published the beryllium PELs in Tables Z-1 and Z-2 of 29 CFR 1910.1000. The values in Table Z-2 were American National Standards Institute (ANSI) standards that existed when OSHA was created and were adopted by OSHA. Tables Z-1 and Z-2 both list 2 μg/m

as an 8-hour TWA. In addition, Table Z-2 lists 5 μg/m

as an “acceptable ceiling concentration” and 25 μg/m

as an “acceptable maximum peak above the acceptable ceiling concentration for an 8-hour shift”, where workers may be exposed above 5 μg/m

(but never above 25 μg/m

)” for a maximum cumulative period of 30-minutes during an eight hour shift (ref. 35).

The proposed requirement in § 850.22(b) would provide that when OSHA promulgates a lower PEL, DOE would notify its contractors through a notice in the

Federal Register

While DOE is proposing to continue to adopt the OSHA PEL, the Department believes that provisions to minimize worker exposure to beryllium in DOE facilities by lowering the action level (proposed § 850.23) and to encourage and require regular medical monitoring of workers (proposed § 850.34) will ensure an adequate level of protection for workers engaged in beryllium activities.

DOE considered adopting a short term exposure limit (STEL) of 10 µg/m

, averaged over a 15-minute sampling period (the ACGIH STEL at the time) in its original rule in 1999, however, because the STEL of 10 µg/m

would not provide any added protection for the worker given that the action level of 0.2 µg/m

would be exceeded in less than 15 minutes where exposure levels are at 10 µg/m

, the Department elected not to establish a STEL. The ACGIH dropped its STEL in 2009 when it lowered its 8-hour TWA TLV to 0.05 µg/m

DOE recognizes that OSHA has included a STEL of 2 µg/m

in its proposed rule,

Occupational Exposure to Beryllium and Beryllium Compounds

(80 FR 47565, August 7, 2015), however, similar to the 1999 comparisons (between the DOE action level and ACGIH STEL), DOE's proposed action level of 0.05 µg/m

would be exceeded in less than 15 minutes where exposure levels are at 2 µg/m

. Accordingly, the Department has elected to continue to not propose a STEL in this amendment.

Proposed § 850.23—Action Level

Proposed § 850.23(a) would continue to require employers to include in their CBDPPs an 8 hour time weighted average action level for beryllium and would change the action level from 0.2 µg/m

to 0.05 µg/m

(8-hour TWA of 0.05 microgram of beryllium, per cubic meter of air), as measured in the worker's breathing zone by personal monitoring. Due to the number of workers who have been identified as being sensitized to beryllium or having CBD, the Department feels that it is prudent to lower the action level. The 0.05 µg/m

action level was chosen based on the Department's review of epidemiological studies and the ACGIH® TLV® (refs. 6-28). Lowering the action level to 0.05 µg/m

would result in greater protection for the affected work force because it would lower the trigger that requires the use of controls and protective measures designed to prevent worker exposure to

beryllium. DOE does not anticipate that the lower action level will require the use of new or different types of equipment; it will just require implementation of the controls at a lower level.

Benefits of lowering the action level.

As specified in this proposed rule, being at or above the action level triggers the requirements to use a number of controls and protective measures designed to protect employees from exposures to beryllium. Employers at DOE sites where exposure levels are at or above the action level would be required to implement these controls at DOE's proposed lower action level.

Lowering the action level would increase the number of workers afforded the protective measures. DOE believes there are still a number of workers exposed to concentrations of beryllium between 0.05 μg/m

and 0.2 μg/m

, but who are never exposed to levels above 0.2 μg/m

. Under an action level of 0.2 μg/m

, these workers would not be provided the protective measures triggered by that action level. Under an action level of 0.05 μg/m

, however, these workers would be provided the additional protective measures specified in proposed § 850.23(b). These additional protective measures would potentially reduce the exposures experienced by these workers, leading to a reduction in their risk of developing a beryllium-induced medical condition.

As stated earlier, several provisions of the proposed rule would continue to apply independent of the action level. Specifically, these are the CBDPP requirement (10 CFR 850.10), the inventory requirement (10 CFR 850.20), the voluntary protective clothing and equipment requirement (10 CFR 850.29(a)(3)), the housekeeping requirements related to the cleaning of surfaces with removable beryllium (10 CFR 850.30(b) through (d)), the release or transfer requirements (10 CFR 850.31(c)), the waste disposal requirements (10 CFR 851.32), the beryllium emergencies requirement (10 CFR 850.33), the medical surveillance and restriction requirements as they relate to beryllium associated workers (10 CFR 850.34 and 850.35), the training and counseling requirements (10 CFR 850.38), the warning labels requirements (10 CFR 850.39(b)), and the recordkeeping and use of information requirements (10 CFR 850.40).

Proposed § 850.23(b) would continue to require employers to implement a number of protective measures designed to protect workers from beryllium exposures when the levels are at or above the action level, including:

• Periodic exposure monitoring (10 CFR 850.24(c));

• Additional exposure monitoring (10 CFR 850.24(d));

• Exposure reduction (10 CFR 850.25);

• Beryllium regulated areas (10 CFR 850.26);

• Hygiene facilities and practices (10 CFR 850.27);

• Respiratory protection (10 CFR 850.28);

• Protective clothing and equipment (10 CFR 850.29);

• Housekeeping (10 CFR 850.30); and

• Warning signs and labels (10 CFR 850.39).

Thus, DOE sites where exposure levels are at or above the action level would be required to implement these protective measures to provide further protection to workers exposed at or above the action level. These additional protections would reduce the exposure levels experienced by these workers, potentially reducing their risk of developing a beryllium-induced medical condition.

Proposed § 850.24—Exposure Monitoring

Proposed § 850.24 would continue to establish the worker exposure monitoring requirements of the CBDPP. The exposure monitoring provisions in this section are necessary to determine the extent of exposure at the worksite; prevent worker overexposure; identify the sources of exposure to beryllium; collect exposure data so that the employer can select the proper control methods to be used; evaluate the effectiveness of selected protective measures; and provide continual feedback on the effectiveness of the program in controlling exposures.

Exposure monitoring is important not only to determine the level of beryllium to which workers are exposed and the frequency at which workers should be monitored, but also to determine whether other protective provisions of the rule need to be implemented. The employer's obligation to provide protective clothing and equipment, for example, is triggered by monitoring results showing that a worker is exposed to airborne concentrations of beryllium at or above the action level.

Proposed § 850.24(a)(1) would continue to require employers to ensure that exposure monitoring be managed by a qualified individual, and add the requirement for monitoring to be conducted in accordance with the approved CBDPP. Proposed § 850.24(a)(2) would require employers to determine the beryllium exposure of workers by collecting personal breathing zone samples that reflect a worker's exposure to airborne concentrations of total beryllium averaged over an 8-hour period. This is a measurement of the exposure that would occur if the worker was not using respiratory protection equipment. Breathing zone is defined in § 850.3(a) as “a hemisphere forward of the shoulders, centered on the mouth and nose, with a radius of 6 to 9 inches.” Thus, a breathing zone sample should be taken as close as practical to the nose and mouth of the worker and must be taken within a 6 to 9 inch radius.

Surface level monitoring.

DOE received several comments in response to its RFI concerning how current wipe sampling protocols aid exposure assessments and protect beryllium workers. The commenters' general view is that wipe sampling is effective at determining the presence of beryllium and can be used to define contaminated spaces, and that wipe sampling remains a valuable method to ensure that work areas are kept clean and equipment is properly released from controls. In addition, wipe samples aid in the identification of beryllium that could potentially become airborne and are therefore an important tool that should be used when assessing potential beryllium hazards. A few commenters suggested that measuring surface levels is not sufficiently exact and that surface levels do not correlate with health effects. Those commenters suggested that surface sampling should not be used to measure worker exposure or demonstrate regulatory compliance; that workers and the media have inappropriately focused attention on wipe sampling results as the indicator of what is “safe”; that DOE facilities have come under scrutiny for surface sampling results that do not accurately represent the potential for BeS or development of CBD; and that surface sampling is prohibitively expensive when used for the release of equipment.

DOE also received several comments in response to its RFI concerning how reliable and accurate current sampling and analytical methods are for beryllium wipe samples. Commenters pointed out that there is a high level of variability in measured surface loadings within and between individuals collecting wipe samples from the same surface. Studies have shown that a number of factors affect the reliability and accuracy of current wipe sampling methods, and recovery of material from surfaces is highly dependent on the skill, training, and work practices of the individual collecting the samples. Concerning analysis of wipe samples, however, commenters suggested that the

issues associated with the reliability and accuracy of analytical methods used for beryllium wipe samples are no different from those encountered in obtaining good results for airborne samples, and the current sampling and analytical protocols are reliable and accurate.

DOE has considered the commenters' suggestions, along with other available information, and proposes to amend this section by including requirements for monitoring the levels of beryllium on surfaces. Monitoring surface levels is necessary for implementing requirements applying to surfaces that have a potential for exceeding the release criteria established in proposed § 850.31.

DOE received several comments in response to its RFI concerning whether the Department should require the use of wet wipes for surface monitoring. Many of the commenters supported DOE requiring the use of wet wipes but also recommended allowing the use of dry wipes where necessary. These commenters also recommended that DOE specifically identify the standard wipe test method that employers must use. A few commenters recommended that DOE continue not to specify how surfaces are sampled for beryllium.

In the preamble to the final rule, DOE had encouraged the use of wet wipes rather than dry wipes for surface monitoring, but did not require this in the rule itself. DOE's experience with wipe testing since December 1999, when the final rule was issued, supported by the suggestions of commenters to its RFI, as well as published (ref. 36) and unpublished studies demonstrating that wet wipes recover more of the surface contamination than do dry wipes, leads to proposed § 850.24(a)(2)(ii)(A) and (B). The proposed section would require the use of wet wipes with certain exceptions. This will also allow DOE to achieve greater comparability of results across the DOE complex. DOE intends for wetting agents to be selected such that wipe test results would be representative of removable beryllium (

e.g.,

DOE would not expect employers to use aggressive solvents that would remove beryllium embedded in sticky cutting fluid on machine surfaces).

DOE recognizes that surface wipe sampling using wet wipes could have an undesirable effect on some potentially contaminated surfaces, or surfaces surrounding the target surface, and that it is not technically feasible on some textured surfaces. Proposed § 850.24(a)(2)(ii)(B) would allow dry surface wipe sampling for those situations. DOE recognizes that any type of wipe testing may not be technically feasible on highly textured surfaces and proposes in § 850.24(a)(2)(ii)(C) to allow vacuum sampling for those situations. DOE also recognizes that surface wipe testing does not recover a high proportion of heavy accumulations of materials on surfaces and is therefore not appropriate for measuring concentrations of beryllium on such surfaces. Proposed § 850.24(a)(2)(ii)(D) would allow bulk sampling for heavy accumulations of materials on surfaces.

Proposed § 850.24(a)(3) would not require surface monitoring in the interior of installed closed systems such as enclosures, glove boxes, chambers, ventilation systems, or normally inaccessible surfaces (

e.g.,

under fixed cabinets, on the tops of overhead structural beams), as beryllium in those locations normally is not accessible to workers. DOE expects that employers will consider the hazards posed by those sources of beryllium exposure in work planning or operating procedures that may involve disturbing the beryllium.

Proposed § 850.24(b)(1) would continue to require employers to perform initial exposure monitoring of workers who perform work in areas that may have airborne concentrations of beryllium, as shown by the inventory and hazard assessment that are at or above the action level, or have the potential to be at or above the action level. However, DOE is proposing to revise this section to make an exception for employers in paragraphs (b)(2) and (3) of this section. In implementing this part, as issued in December 1999, DOE has identified a great many stable situations at its sites in which beryllium has been effectively inventoried, controlled, and conditions have not changed for many years. DOE recognizes that many employers have performed initial exposure monitoring in areas that are accessible to workers and shown by the inventory and hazard assessment as part of their compliance with the current rule. DOE sees no value in repeating exposure monitoring if prior monitoring results are adequate under the proposed rule. Accordingly, proposed § 850.24(b)(2) would allow employers to use the monitoring results obtained within 12 months prior to the effective date of the final rule to satisfy this requirement when a qualified individual has determined that the conditions represented by the results have not changed in a manner that would necessitate changes in beryllium controls.

Proposed § 850.24(b)(3) would be added to clarify that no initial monitoring is required in cases where the employer has relied upon objective data that demonstrates that beryllium is not capable of being released in airborne concentrations at or above the action level under the expected conditions of processing, use, or handling.

Proposed § 850.24(c)(1)(i) would continue to require employers to conduct periodic exposure monitoring of workers in a manner and at a frequency necessary to represent workers' exposures in locations where the airborne concentration of beryllium is at or above the action level. Periodic monitoring provides employers with the assurance that workers are not experiencing higher exposures that might require the use of additional controls. In addition, periodic monitoring reminds workers and employers of the continued need to protect against the hazards associated with exposure to beryllium. Proposed § 850.24(c)(1)(ii) would require employers to conduct exposure monitoring at least quarterly for the first year of operation.

DOE is proposing to add § 850.24(c)(2) to allow employers, after the first year of conducting periodic monitoring, and subject to paragraph (d) of this section, to reduce or terminate monitoring if the employer can demonstrate for 6 months that the airborne concentration of beryllium is below the action level. Employers would be required to base their decision on an analysis of monitoring results and of any activities, controls, or other conditions that would affect beryllium levels. If the employer cannot demonstrate that the airborne concentration of beryllium is below the action level, then periodic monitoring must continue on a quarterly basis.

Proposed § 850.24(d) would require that employers conduct additional exposure monitoring whenever there has been a production, process, control or other change that may result in an exposure to beryllium at or above the action level. DOE is proposing this requirement to address a condition at several DOE sites in which beryllium controls usually keep exposure levels below the action level, but beryllium sources are still present, or could be present such as in waste streams exhumed from legacy sites—and could result in exposures if the controls fail. DOE would require periodic monitoring on a quarterly basis for those conditions so that monitoring results are available to verify the continued effectiveness of the controls.

Proposed § 850.24(e)(1) would be revised to require that samples that are collected be analyzed in a laboratory that is accredited for beryllium analysis by the American Industrial Hygiene Association's Laboratory Accreditation

Programs, LLC (AIHA-LAP, LLC) or an equivalent organization. Currently, § 850.24(f) requires samples to be analyzed in a laboratory accredited for metals by the AIHA-LAP, LLC or a laboratory that demonstrates quality assurance for metals analysis that is equivalent to AIHA-LAP, LLC accreditation. The proposed language is intended to correct the problem DOE has experienced in which laboratories, currently accredited by AIHA-LAP, LLC for metals, may not be aware that a significant amount of beryllium in samples (in the form of beryllium oxide) may not be recovered in the laboratories' sample preparation processes. DOE anticipates that AIHA-LAP, LLC, and perhaps other accrediting or certifying organizations, will have proficiency testing programs specifically for beryllium oxide and potentially other forms of beryllium-containing materials of interest which are present in field samples, to ensure that a high percentage of those forms of beryllium in the sample are recovered in the sample preparation step and are included in the analysis results. Such proficiency testing programs also would assist laboratories in using some of the strategies for distinguishing forms of beryllium as discussed in this preamble regarding proposed § 850.3.

Proposed § 850.24(e)(2) would require a number of additional changes dealing with the quality assurance of the sample analysis results. DOE proposes to delete the requirement that the method of sample monitoring and analysis has an accuracy of not less than plus or minus 25%, with a confidence level of 95%, because that data quality objective is superseded by requirements of the AIHA laboratory quality assurance program. Also, proposed § 850.24(e)(2)(i) would permit employers to use a field or portable laboratory that is accredited in an AIHA or equivalent quality assurance program, to support increasing the speed with which exposure results are delivered so that employers can more quickly identify and control beryllium hazards. DOE anticipates that this will also increase mission productivity.

Proposed § 850.24(e)(2)(ii) would allow employers to use results that are below laboratory reporting limits, which would enhance the usefulness of these results for determining if specified levels are exceeded.

DOE is proposing to delete existing § 850.24(f) because its subject matter is proposed to be included in § 850.24(e). Proposed § 850.24(f) would amend the requirement in existing § 850.24(g) for notification of results to clarify DOE's intent that the employer notify all the workers in the same work area of the monitoring results that represent those workers' exposures rather than only notifying the workers that were monitored. This clarification addresses DOE's observation that some DOE sites have interpreted the notification requirement to mean that workers are notified only of their individual airborne monitoring results. When this happens, it means that the group of unmonitored workers in the same work area failed to receive useful feedback regarding potential exposures and the need for various levels of exposure controls. Accordingly, proposed § 850.24(f)(1) would require employers to notify workers of their exposure monitoring results within 10 working days after receipt of the results. Proposed § 850.24(f)(1)(i) and (ii) would require employers to provide notification of exposure monitoring in written or electronic format and posted in locations or in electronic systems that are readily accessible to workers, but not in a manner that would identify an individual or workers. Employers would be required to give directly to individuals that were sampled their results in written or electronic format.

Proposed § 850.24(f)(2)(i) and (ii) would specify the form of notification required for monitoring results at or above the action level. Employers would be required to include in the notification a statement that exposures were at or above the specified action level, a descriptions of the controls being implemented to address those exposures. In addition, proposed § 850.24(f)(3) would continue to require employers to provide a notification to the SOMD, and a notification to the Head of DOE Field Element or their designee. DOE believes that the SOMD should be informed of such exposures in order to refine, as appropriate, the medical surveillance protocol for affected workers to ensure effective monitoring and early detection of beryllium-related health effects.

Proposed § 850.25—Exposure Reduction

Proposed § 850.25 would continue to establish the exposure reduction and minimization provisions of the CBDPP that reflect DOE's goal of achieving aggressive reduction and minimization of worker exposures to airborne beryllium. However, this section would be revised to require employers, where exposures and the action level, to establish a formal exposure reduction program in accordance with 10 CFR 851.22,

Hazard Prevention and Abatement,

to reduce exposure levels to below the action level.

DOE is proposing to delete the requirement to continue reducing and minimizing exposures that already are below the action level because DOE believes that the measures required at or above the proposed action level are protective. DOE would also delete the specific exposure reduction actions that are required of responsible employers in the current version of 10 CFR 850.25 because DOE expects employers to understand how to establish a formal exposure reduction program, and listing certain specific steps could constrain employers in unproductive ways.

Proposed § 850.26—Beryllium Regulated Areas

Beryllium regulated areas typically are areas in which activities that involve beryllium are conducted. Proposed § 850.26 would continue to establish beryllium regulated areas at DOE sites. Accordingly, proposed § 850.26(a) would continue to require employers to establish beryllium regulated areas in facilities at DOE sites where the airborne concentration of beryllium is at or above the action level.

Proposed § 850.26(b)(1) would require employers to demarcate beryllium regulated areas from the other workplace areas in a manner that alerts workers to the boundaries of such areas. This would allow employers the flexibility to determine the most appropriate means of identifying each beryllium regulated area based on specific worksite conditions.

Proposed § 850.26(b)(2) would continue to require employers to limit access to beryllium regulated areas to authorized persons only. DOE intends that only individuals who are essential to the performance of work in the beryllium regulated area will be authorized to enter beryllium regulated areas. Employers will have to evaluate the affected operation and determine which personnel (including managers, supervisor, and workers) are necessary for the performance of the work and authorized to enter. Methods for preventing unauthorized persons from entering a regulated area may include posting a sign indicating that only authorized persons may enter, using locked access doors, and employing other security measures, as required by worksite conditions. DOE believes that employers are best equipped to determine whether any access control methods are needed in addition to warning signs specified in proposed § 850.39 of this part.

Proposed § 850.26(b)(3) would continue to require employers to keep record of all individuals who enter beryllium regulated areas. The record

must include the name of the person who entered, the date of entry, the time in and time out, and the type of work performed. DOE believes that recordkeeping must be adequate to permit DOE to monitor the effectiveness of each employer's compliance activities and to provide information regarding each worker's history of potential exposures. This information will assist the employer's occupational medicine staff in establishing appropriate medical evaluations and will aid in DOE's efforts to establish links between working conditions and potential health outcomes.

Proposed § 850.27—Hygiene Facilities and Practices

Proposed § 850.27 would continue to provide requirements regarding hygiene facilities and practices of the CBDPP. Accordingly, proposed § 850.27(a)(1) and (2) would continue to require employers to ensure that beryllium workers observe prohibitions on the use of cosmetics and tobacco products, and consumption of food and beverages in beryllium regulated areas. Proposed § 850.27(a)(3) would require employers to prevent beryllium workers from exiting areas that contain beryllium with contamination on their bodies or their personal clothing. DOE believes these provisions would promote sound workplace hygiene practices that may protect workers from exposure to other substances present in the workplace as well as beryllium.

Proposed § 850.27(b)(1) would continue to require employers to provide a separate changing room or area for workers to change into and store personal clothing and clean protective clothing and equipment. DOE believes that such provisions are necessary to prevent cross-contamination between work and personal clothing and the subsequent spread of beryllium into clean areas of the site and workers' private automobiles and homes. These provisions also address the need to prevent contamination of clean protective clothing and equipment, ensuring that protective clothing and equipment actually protect workers rather than contribute to their exposure.

Proposed § 850.27(b)(2)

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