[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Proposed Rules]
[Pages 36704-36759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12547]



[[Page 36703]]

Vol. 81

Tuesday,

No. 109

June 7, 2016

Part III





Department of Energy





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10 CFR Part 850





Chronic Beryllium Disease Prevention Program; Proposed Rule

  Federal Register / Vol. 81 , No. 109 / Tuesday, June 7, 2016 / 
Proposed Rules  

[[Page 36704]]


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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.

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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):
    1. Federal e-Rulemaking Portal: http://www.regulations.gov. Follow 
the instructions for submitting comments.
    2. Email: [email protected]. 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.
    3. 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.
    4. 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: [email protected].
    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

[[Page 36705]]

    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 
[mu]g/m\3\, 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 [mu]g/m\3\ 
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 [micro]g/m\3\ 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 [micro]g/m\3\.
     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 [micro]g/100 cm\2\ 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

[[Page 36706]]

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 
[micro]g/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\3\ and a high stiffness. The second lightest of 
the metals, beryllium also has a high melting point (1,285 [deg]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).\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.
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    \1\ A listing of references is included as appendix A to this 
SUPPLEMENTARY INFORMATION section.
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    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

[[Page 36707]]

Industrial Hygienists (ACGIH[supreg]) 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[supreg] 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

[[Page 36708]]

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 
\3/4\ 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).

[[Page 36709]]

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....           21               0              0%            0           0%
Ames Laboratory..........................           34               2            5.9%            0           0%
Argonne National Laboratory..............          142               3            2.1%            0           0%
Brookhaven National Laboratory...........           25               1            4.0%            0           0%
DOE Oak Ridge Office.....................           93               1            1.1%            0           0%
East Tennessee Technology Plant..........          399               6            1.5%            4         1.0%
Fermi National Accelerator Laboratory....           20               0              0%            0           0%
Hanford Site.............................        7,480              91            1.2%           34         0.5%
Idaho National Laboratory................          355               3            0.8%            0           0%
Kansas City Plant........................        1,208              41            3.4%           14         1.2%
Knolls Atomic Power Laboratory...........           29               0              0%            0           0%
LATA Environmental Services of Kentucky,           112               2            1.8%            0           0%
 LLC (PAD LATAKY)........................
Lawrence Berkeley National Laboratory....           26               1            3.8%            0           0%
Lawrence Livermore National Laboratory           1,337              41            3.1%            3         0.2%
 (LLNL)..................................
LLNL-Clean Harbors Environmental Services           13               0              0%            0           0%
Los Alamos National Laboratory...........        2,474              21            0.8%            3         0.1%
National Strategic Protective Security              10               0              0%            0           0%
 Services................................
Nevada National Security Site............        1,028              23            2.2%            4         0.4%
Oak Ridge National Laboratory............          639              14            2.2%            0           0%
Pacific Northwest National Laboratory....          151               0              0%            0           0%
Pantex...................................        1,756              27            1.5%           15         0.9%
Sandia National Laboratory...............          604               1            0.2%            0           0%
Savannah River Site......................          713              15            2.1%            6         0.8%
Stanford Linear Accelerator Center.......           47               0              0%            1         2.1%
Y-12.....................................        2,691             114            4.2%           62         2.3%
Y-12 Navarro-Gem Joint Venture...........           18               0              0%            0           0%
Y-12 URS Corporation.....................           28               0              0%            0           0%
                                          ----------------------------------------------------------------------
    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

[[Page 36710]]

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:
    1. 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 [micro]g/100 cm\2\ 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 
[micro]g/100 cm\2\ surface action level. If an alternate level is 
suggested, provide the rationale and associated cost implications for 
choosing the alternate surface action level.
    2. 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 [micro]g/100 cm\2\, 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

[[Page 36711]]

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.
    3. 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 Sec.  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 Sec.  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:
    [cir] The job involves a beryllium activity at or above the action 
level, includes a medical qualification, and requires a medical 
evaluation;
    [cir] Any job offer would be conditional pending the outcome of the 
medical evaluation;
    [cir] 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
    [cir] 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:
    [cir] A detailed medical and work history with emphasis on exposure 
or potential exposure to beryllium;
    [cir] A respiratory symptoms questionnaire;
    [cir] A physical examination, with special emphasis on the 
respiratory system, skin, and eyes;
    [cir] 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;
    [cir] Spirometry consisting of forced vital capacity (FVC) and 
forced expiratory volume at one second (FEV1);
    [cir] Two peripheral blood BeLPTs; and
    [cir] Any other tests that would be deemed appropriate by the SOMD 
for evaluating beryllium-induced medical conditions.
    The Department is considering adding a new Sec.  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

[[Page 36712]]

section would require, with respect to a conditionally hired 
individual, that:
     The SOMD's written opinion to the employer would:
    [cir] Be delivered within 10 working days after the SOMD received 
the results of the medical evaluation performed pursuant to proposed 
Sec.  850.34(c)(5); and
    [cir] 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.
    4. 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 Sec.  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.
    5. 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 36713]]

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 Sec.  850.3.
    5. DOE is requesting comment on its proposal to lower the action 
level which triggers key worker protection measures, from 0.2 [micro]g/
m\3\ to 0.05 [micro]g/m\3\. See proposed Sec.  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 Sec.  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
----------------------------------------------------------------------------------------------------------------
                                                                Worker exposure or potential exposure levels (8-
                                                                                   Hour TWA)
                                                              --------------------------------------------------
                     Proposed provisions                                          >= Proposed
                                                                Be operation/     action level    >= PEL  (8-hr
                                                                 location \a\   (0.05 [micro]g/     TWA) (2.0
                                                                                     m\3\)        [micro]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Baseline Inventory (850.20)..................................               X   ...............  ...............
Hazard Assessment and Abatement (850.21).....................               X   ...............  ...............
Initial Exposure Monitoring (850.24).........................               X   ...............  ...............
Periodic Exposure Monitoring (850.24)........................  ...............               X   ...............
Exposure Reduction (850.25)..................................           X \b\                X   ...............
Beryllium Regulated Areas (850.26)...........................  ...............               X   ...............
Hygiene Facilities and Practices (850.27)....................  ...............               X   ...............
Respiratory Protection (850.28)..............................  ...............               X            X \c\
Protective Clothing and Equipment (850.29)...................           X \d\                X   ...............
Housekeeping (850.30)........................................           X \e\                X   ...............
Release and Transfer Criteria (850.31).......................           X \f\   ...............  ...............
Medical Surveillance (850.34)................................           X \g\                X   ...............
Medical Restriction (850.35).................................           X \h\                X   ...............
Training and counseling (850.38).............................           X \i\   ...............  ...............
Warning signs and labels (850.39)............................  ...............               X   ...............
----------------------------------------------------------------------------------------------------------------
\a\ Would apply to beryllium operations and other locations where there is a potential for beryllium
  contamination.
\b\ Employers would be required to establish a formal hazard prevention and abatement program.
\c\ Employers would be required to provide respirators that comply with 10 CFR part 851.
\d\ Employers would be required to provide protective clothing and equipment where surface contamination levels
  are above 3 [micro]g/100 cm\2\.
\e\ Housekeeping efforts would be required to maintain removable surface contamination at or below 3 [micro]g/
  100 cm\2\ during non-operational hours.
\f\ Would establish contamination criteria for equipment, items, or areas to be removed, released, or
  transferred from beryllium regulated areas.
\g\ Employers would be required to provide medical surveillance to beryllium and beryllium-associated workers.
\h\ Employers would be required to medically restrict certain workers from working in area at or above the
  action level.
\i\ 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.


[[Page 36714]]

    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 Sec.  850.1--Scope
    Proposed Sec.  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 Sec.  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 Sec.  850.2--Applicability
    Proposed Sec.  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 Sec.  
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 Sec.  
851.3 and in Sec.  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 Sec.  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 Sec.  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 Sec.  
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

[[Page 36715]]

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 Sec.  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 Sec.  850.3--Definitions
    Proposed Sec.  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 Sec.  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 Sec.  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[supreg]) (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

[[Page 36716]]

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[supreg] 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 Sec.  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

[[Page 36717]]

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 Sec.  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.

[[Page 36718]]

    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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 36719]]

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 Sec.  850.24 (Exposure monitoring).
    Proposed Sec.  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.
Sec.  850.4--Enforcement
    Proposed Sec.  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.
Sec.  850.5--Dispute Resolution
    Proposed Sec.  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 Sec.  708.13(a)(2). 
Proposed Sec.  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.
Sec.  850.6--Interpretations, Binding Interpretive Rulings and Requests 
for Information
    Proposed Sec.  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 Sec.  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 Sec.  850.10--Development and Approval of the CBDPP
    Proposed Sec.  850.10 would continue to establish the requirements 
for development and approval of the CBDPP. Proposed Sec.  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 Sec.  850.10(b). DOE would expect its employers 
to perform the beryllium inventory and hazard assessment as would be 
required by proposed Sec. Sec.  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 Sec.  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 Sec.  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 (Sec.  840.34), 
training and counseling (Sec.  840.38), and recordkeeping (Sec.  
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 Sec.  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 Sec.  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

[[Page 36720]]

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 Sec.  850.10(a)(4) would require multiple employers at a 
DOE site to share relevant assessment information gathered under 
proposed Sec.  850.41(a) of this proposed rule, to ensure the safety 
and health of their workers.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  850.10(b)(4) would amend Sec.  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 Sec.  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 Sec.  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 Sec.  850.11--General CBDPP Requirements
    Proposed Sec.  850.11 would continue to establish the general 
requirements of the CBDPP. Proposed Sec.  850.11(a) would continue to 
specify that the CBDPP would be expected to address the existing and 
planned beryllium activities. Also, proposed Sec.  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 Sec.  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 Sec.  
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 Sec.  850.22 of this 
part. Proposed Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  850.12--Implementation
    Proposed Sec.  850.12(a) would require employers to manage and 
control

[[Page 36721]]

beryllium activities consistent with the approved CBDPP. Proposed Sec.  
850.12(b) [currently Sec.  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 Sec.  850.12(c) [currently Sec.  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 Sec.  850.12(d), proposed Sec.  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 Sec.  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 Sec.  850.13--Compliance
    Proposed Sec.  850.13(a) would revise existing Sec.  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 Sec.  
850.13(b) would mandate that employers conduct beryllium activities in 
compliance with their approved CBDPP under this proposed rule.
    Proposed Sec.  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 Sec.  850.20--Beryllium Inventory
    Proposed Sec.  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 Sec.  850.20 include the 
requirement to maintain an up-to-date inventory. Proposed Sec.  
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 
Sec.  850.20(a)(3). However, subject to Sec.  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 Sec.  
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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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

[[Page 36722]]

the amount of reduced risk of beryllium disease that would be realized. 
Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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[supreg] threshold limit value (TLV[supreg]) of 
0.05 [mu]g/m\3\ (ref. 6) as its PEL, approximately two-thirds of the 
commenters rejected its adoption. Several commenters pointed out that 
TLVs[supreg] are not developed with technical or economic feasibility 
in mind and that TLVs[supreg], quoting from the ACGIH[supreg], ``are 
not developed for use as legal standards and ACGIH[supreg] does not 
advocate their use as such.'' Others suggested DOE adopt the 2010 
ACGIH[supreg] TLV[supreg] as its PEL because it is the most protective 
and conservative published level.
    Proposed Sec.  850.22(a) would continue to retain OSHA's 8-hour TWA 
PEL for airborne exposure to beryllium (2 [mu]g/m\3\), 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 [mu]g/m\3\ as an 8-hour 
TWA. In addition, Table Z-2 lists 5 [mu]g/m\3\ as an ``acceptable 
ceiling concentration'' and 25 [mu]g/m\3\ as an ``acceptable maximum 
peak above the acceptable ceiling concentration for an 8-hour shift'', 
where workers may be exposed above 5 [mu]g/m\3\ (but never above 25 
[mu]g/m\3\)'' for a maximum cumulative period of 30-minutes during an 
eight hour shift (ref. 35).
    The proposed requirement in Sec.  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 
Sec.  850.23) and to encourage and require regular medical monitoring 
of workers (proposed Sec.  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 
[micro]g/m\3\, 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 [micro]g/m\3\ would not provide any added protection for the 
worker given that the action level of 0.2 [micro]g/m\3\ would be 
exceeded in less than 15 minutes where exposure levels are at 10 
[micro]g/m\3\, 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 [micro]g/m\3\.
    DOE recognizes that OSHA has included a STEL of 2 [micro]g/m\3\ 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 [micro]g/m\3\ would be exceeded in less 
than 15 minutes where exposure levels are at 2 [micro]g/m\3\. 
Accordingly, the Department has elected to continue to not propose a 
STEL in this amendment.
Proposed Sec.  850.23--Action Level
    Proposed Sec.  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 [micro]g/m\3\ 
to 0.05 [micro]g/m\3\ (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 
[micro]g/m\3\ action level was chosen based on the Department's review 
of epidemiological studies and the ACGIH[supreg] TLV[supreg] (refs. 6-
28). Lowering the action level to 0.05 [micro]g/m\3\ 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

[[Page 36723]]

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 [mu]g/
m\3\ and 0.2 [mu]g/m\3\, but who are never exposed to levels above 0.2 
[mu]g/m\3\. Under an action level of 0.2 [mu]g/m\3\, these workers 
would not be provided the protective measures triggered by that action 
level. Under an action level of 0.05 [mu]g/m\3\, however, these workers 
would be provided the additional protective measures specified in 
proposed Sec.  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 Sec.  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 Sec.  850.24--Exposure Monitoring
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 36724]]

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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  850.24(a)(2)(ii)(D) would allow bulk 
sampling for heavy accumulations of materials on surfaces.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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

[[Page 36725]]

Programs, LLC (AIHA-LAP, LLC) or an equivalent organization. Currently, 
Sec.  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 Sec.  850.3.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  850.24(f) because its 
subject matter is proposed to be included in Sec.  850.24(e). Proposed 
Sec.  850.24(f) would amend the requirement in existing Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  850.25--Exposure Reduction
    Proposed Sec.  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 Sec.  850.26--Beryllium Regulated Areas
    Beryllium regulated areas typically are areas in which activities 
that involve beryllium are conducted. Proposed Sec.  850.26 would 
continue to establish beryllium regulated areas at DOE sites. 
Accordingly, proposed Sec.  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 Sec.  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 Sec.  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 Sec.  850.39 of this part.
    Proposed Sec.  850.26(b)(3) would continue to require employers to 
keep record of all individuals who enter beryllium regulated areas. The 
record

[[Page 36726]]

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 Sec.  850.27--Hygiene Facilities and Practices
    Proposed Sec.  850.27 would continue to provide requirements 
regarding hygiene facilities and practices of the CBDPP. Accordingly, 
proposed Sec.  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 Sec.  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 Sec.  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 Sec.  850.27(b)(2) would continue to require that the 
changing-rooms used to remove beryllium-contaminated clothing and 
protective equipment be maintained under negative pressure, or be 
located in a manner or area that prevents dispersion of beryllium 
contamination into clean areas. DOE believes that providing changing 
rooms for workers who work in beryllium-regulated areas is the most 
effective method for preventing workers from carrying beryllium 
contamination on their work clothes and bodies from beryllium regulated 
areas to other areas of the DOE site, and to their private automobiles 
and homes.
    Consistent with the goal of preventing the spread of contamination 
into adjacent work areas and into workers' homes and automobiles, 
proposed Sec.  850.27(c) continues to require employers to provide 
handwashing and shower facilities for workers in beryllium regulated 
areas. In addition to controlling the spread of contamination, 
showering also reduces the worker's period of exposure to beryllium by 
removing any beryllium that may have accumulated on the skin and hair. 
Requiring workers to change out of work clothes that are segregated 
from their street clothes, leave work clothing at the workplace (see 
Sec.  850.29), and shower before leaving the plant, significantly 
reduces the movement of beryllium from the workplace. These steps 
ensure that the duration of beryllium exposure does not extend beyond 
the work shift and, thus, protect workers and their families from off-
site exposures.
    Proposed Sec.  850.27(d) would continue to require employers to 
provide beryllium workers working in beryllium regulated areas with 
readily accessible lunchroom facilities. Employers must also ensure 
that workers in beryllium regulated areas do not enter the lunchroom 
wearing protective clothing unless the clothing is cleaned beforehand. 
Employers have discretion to choose the method for removing surface 
beryllium from the clothing, including HEPA vacuuming, so long as the 
method does not disperse the dust into the air.
    Proposed Sec.  850.27(e) would continue to require change rooms or 
areas, showers and handwashing facilities, and lunchroom facilities to 
comply with 29 CFR 1910.141, Sanitation.
Proposed Sec.  850.28--Respiratory Protection
    Proposed Sec.  850.28 would continue to establish the respiratory 
protection provisions of the CBDPP. However, proposed Sec.  850.28(a) 
would be revised for consistency with part 851 to require employers to 
establish a respiratory program in accordance with 10 CFR 851.23, 
Safety and Health Standards, and appendix A, section 6, Industrial 
Hygiene, for workers exposed, or potentially exposed to airborne 
concentrations of beryllium at or above the action level. The standards 
listed in 10 CFR 851.23 include 29 CFR 1910.134 ``Respiratory 
Protection'' and ANSI Z88.2 ``American National Standard for 
Respiratory Protection (1992). The requirements in appendix A, section 
6, Industrial Hygiene, cover the DOE Respirator Acceptance Program. 
Note that the requirements established in 10 CFR 851.23 are set forth 
as minimum requirements. DOE contractors may elect to implement 
alternative provisions (e.g., newer versions of consensus standards 
such as ANSI/ASSE Z88.2-2015) if they determine the alternative 
provisions are more appropriate and provide an equivalent or improved 
level of protection, and if the provisions are included in their CBDPP 
that has been approved by DOE.
Proposed Sec.  850.29--Protective Clothing and Equipment
    Proposed Sec.  850.29 would continue to establish the protective 
clothing and equipment provisions (other than respirator use) of the 
CBDPP. The objectives of this section would be to provide clothing and 
equipment that protects workers against the hazards of skin and eye 
contact with dispersible forms of beryllium and to prevent the spread 
of contamination outside work areas that could occur from the improper 
handling of beryllium-contaminated clothing and equipment. In addition, 
the requirement for handling protective clothing and equipment used for 
protecting workers from beryllium exposure in beryllium regulated areas 
would be clarified.
    The proposed rule would continue to require employers to provide 
protective clothing and equipment where skin or eye contact with 
dispersible forms of beryllium is possible. Proposed Sec.  850.29(a) 
would continue to require employers to provide protective clothing and 
equipment to beryllium workers where dispersible forms of beryllium may 
contact workers skin, enter openings in workers' skin or contact 
workers' eyes.
    An opening in workers' skin could include fissures, cuts, and 
abrasions. DOE recognizes that the potential for the development of 
contact dermatitis, chronic ulcerations, and conjunctivitis is mainly 
associated with contact with soluble forms of beryllium compounds that 
are not included in the definition of ``beryllium'' in this proposed 
rule because DOE believes that soluble forms of beryllium are not used 
at its beryllium sites. Insoluble beryllium, however, has also been 
shown to cause chronic ulcerations if introduced into or below the skin 
via cuts or abrasions (ref. 37). DOE believes that it is prudent 
practice to avoid skin or eye contact with a material that causes 
chronic ulcerations and, therefore, continues to include the protection 
of workers' skin and eyes from contact with insoluble

[[Page 36727]]

beryllium in proposed Sec.  850.29(a). The protective equipment 
required by this proposed section could include coveralls, overalls, 
jackets, footwear, headwear, face shields, goggles, gloves, and 
gauntlets, depending on the nature of operations and the related skin 
and eye exposure hazard.
    Proposed Sec.  850.29(a) would continue to require employers to 
provide protective clothing and equipment and ensure its appropriate 
use and maintenance by workers where dispersible forms of beryllium may 
contact workers' skin or eyes or may enter openings in which workers' 
skin, including where:
     Exposure monitoring has established that the airborne 
concentration of beryllium is at or above the action level [proposed 
Sec.  850.29(a)(1)];
     Surface contamination levels measured or presumed prior to 
initiating work are at or above the level prescribed in proposed Sec.  
850.30 of this part [proposed Sec.  850.29(a)(2)];
     Surface contamination level results obtained to confirm 
housekeeping efforts are above the level prescribed in proposed Sec.  
850.30 of this part [proposed Sec.  850.29(a)(3)]; and where;
     A worker requests the use of personal protective clothing 
and equipment for protection against airborne beryllium, regardless of 
the measured exposure level [proposed Sec.  850.29(a)(4)].
    Proposed Sec.  850.29(b) would continue to require employers to 
comply with 29 CFR 1910.132, Personal Protective Equipment General 
Requirements, when workers use personal protective clothing and 
equipment. This requirement to comply with 29 CFR 1910.132 is 
consistent with the general worker protection provisions of 10 CFR part 
851.
    Proposed Sec.  850.29(c) would continue to require employers to 
establish procedures for donning, doffing, handling, and storing 
protective clothing and equipment that prevent beryllium workers from 
exiting beryllium regulated areas with contamination on their bodies or 
personal clothing [proposed Sec.  850.29(c)(1)]. Proposed Sec.  
850.29(c)(2) would require these procedures include a requirement that 
workers exchange their personal clothing for full-body protective 
clothing and footwear (work shoes or booties) before beginning work in 
beryllium regulated areas. This change from personal clothes into 
protective work clothing must occur in a changing room that protects 
the worker's personal clothes and clean protective clothing from 
beryllium contamination. DOE believes the use of full-body protective 
clothing in lieu of personal clothes in beryllium regulated areas is 
necessary to prevent the spread of beryllium contamination into 
adjacent work areas and to preclude the possible transport of beryllium 
onto workers' private property.
    Proposed Sec.  850.29(d) would require employers to ensure that 
workers do not remove beryllium-contaminated protective clothing and 
equipment from beryllium regulated areas, except for workers authorized 
to launder, clean, maintain or dispose of the clothing and equipment.
    Proposed Sec.  850.29(e) would require employers to prohibit the 
removal of beryllium from protective clothing and equipment by blowing, 
shaking, or other means that might disperse beryllium particulates into 
the air. Although DOE generally believes that employers should have the 
flexibility to determine the most appropriate methods to clean 
contaminated clothes based on their own specific worksite conditions, 
DOE continues to include this well-recognized and accepted industrial 
hygiene control to prevent the dispersion of beryllium particles into 
the workplace atmosphere.
    Proposed Sec.  850.29(f) would continue to require employers to 
ensure that protective clothing and equipment is cleaned, laundered, 
repaired, or replaced as needed to maintain effectiveness. This section 
allows employers flexibility in determining the required frequency for 
laundering protective clothing based on specific work conditions and 
the potential for contamination.
    Proposed Sec.  850.29(f)(1) would continue to require employers to 
ensure that protective clothing and equipment removed for laundering, 
cleaning, maintenance, or disposal are placed in containers that 
prevent the dispersion of beryllium particulates and that these 
containers are labeled in accordance with proposed Sec.  850.39(b)(1). 
These warning labels would help ensure appropriate subsequent handling 
of materials contaminated with beryllium and may prevent inadvertent 
exposures that could result if laundry, maintenance, or disposal 
personnel are not aware of the contamination and the prescribed methods 
to prevent the release of airborne beryllium.
    Proposed Sec.  850.29(f)(2) would continue to require employers to 
ensure that organizations that launder or clean DOE beryllium-
contaminated clothing or equipment are informed that exposure to 
beryllium is harmful, and that clothing and equipment should be 
laundered or cleaned in a manner preventing the dispersion of 
beryllium. This section would require informing onsite cleaning and 
laundry services, as well as off-site cleaning and laundry vendors 
because employees performing the work may not know about the presence 
and hazards of beryllium on the clothing and equipment unless the 
employer informs them.
Proposed Sec.  850.30--Housekeeping
    Proposed Sec.  850.30 would continue to establish the housekeeping 
provisions of the CBDPP. Good housekeeping practices are necessary to 
prevent the accumulation of beryllium contamination on surfaces in 
operational areas where beryllium is used or handled. Such 
accumulations, if not controlled, may lead to the spread of beryllium 
contamination on surfaces and the re-suspension of beryllium particles 
into the air, both in the area where beryllium dust was originally 
generated and in other work areas. In addition, monitoring surface 
contamination levels is an indispensable tool for ensuring that 
beryllium emissions from operations are under control. The uncontrolled 
accumulation of beryllium-contamination on equipment in the workplace 
increases the potential for worker exposure to beryllium during the 
performance of equipment maintenance, handling, and disposal tasks. 
Accordingly, proposed Sec.  850.30(a) would continue to establish that 
the removable contamination housekeeping level on surfaces must not 
exceed 3 [micro]g/0;100 cm\2\ during non-operational periods to reduce 
the potential for beryllium to become re-suspended in the workplace or 
spread to non-controlled areas. Employers must conduct routine surface 
sampling to determine if operational work areas are compliant with the 
rule. Sampling should not be carried out during a normal work shift, 
but rather it should be undertaken after normal clean-up and during 
non-operational periods. As with the current Sec.  850.30(a), the 
sampling requirement would not include the interior of installed closed 
systems such as enclosures, glove boxes, chambers, or ventilation 
systems.
    The performance of housekeeping tasks can, in and of itself, lead 
to worker exposures to beryllium-contaminated dust. Therefore, this 
section would continue to seek to prevent the spread and re-suspension 
of dust during housekeeping activities.
    Proposed Sec.  850.30(b) would continue to require vacuuming using 
HEPA filters, wet methods, or other cleaning methods that avoid the 
dispersion of dust, and prohibits the use of

[[Page 36728]]

compressed air or dry methods that may disperse beryllium particulates. 
The use of wet methods for reducing or minimizing the dispersal of dust 
during general housekeeping tasks is a common industrial hygiene 
practice. The purpose of using these methods is to reduce or eliminate 
the potential for re-suspension of beryllium dust into the air and 
breathing zone of the worker.
    Proposed Sec.  850.30(c) would require the use of HEPA filters in 
all vacuuming operations used to clean beryllium-contaminated surfaces, 
and further requires filter replacement, as needed, to maintain the 
capture efficiency of the vacuum system. HEPA filters must be used to 
prevent the spread of dust by effectively gathering the dust that is 
collected by vacuum systems. Employers should adhere to procedures for 
cleaning or replacing filters that ensure minimum employee exposure to 
beryllium dust.
    The movement of contaminated equipment from a regulated area to a 
non-regulated area may result in the spread of beryllium contamination 
to the non-regulated area. To prevent the potential spread of 
contamination from performing housekeeping activities, proposed Sec.  
850.30(d) would continue to require that cleaning equipment used in 
areas where surfaces are contaminated with beryllium be labeled, 
controlled, and not used for other non-hazardous materials. These 
procedures are similar to those required under OSHA's asbestos standard 
for equipment used during cleanup or removal of asbestos from 
buildings.
Proposed Sec.  850.31--Release and Transfer Criteria
    Proposed Sec.  850.31 would continue to establish beryllium 
contamination levels and other requirements that must be met before 
equipment and other items used in beryllium regulated areas may be 
released or transferred. However, DOE is proposing to amend the 
criteria for the release and transfer of beryllium-contaminated 
equipment and items, and add provisions for the release and transfer of 
``areas'' (i.e., real property, an area of a building, or a work area) 
at or above the specified level to this section. DOE's experience with 
managing beryllium-contaminated areas, as well as recent literature 
suggesting that surface contamination is a risk factor for BeS, 
motivated DOE to include release and transfer criteria for beryllium-
contaminated areas.
    This part, as issued in December 1999, included requirements to 
label decontaminated equipment and items and obtain a commitment from 
their recipients to implement safety controls to prevent exposure to 
beryllium. At that time, DOE's focus was on the typical machine shop 
equipment on which work with beryllium was reported to have caused 
cases of BeS and CBD. The machines in these shops contain many areas 
that were not accessible for decontamination and, therefore, considered 
potential sources of exposure to downstream users of the machines. 
DOE's wording in this part did not make allowances for equipment and 
items of simple construction that can be conclusively demonstrated to 
have all surfaces adequately decontaminated, or for equipment and items 
suspected but subsequently determined to not have been contaminated 
with beryllium, and that do not pose a risk to downstream users. Very 
few potentially interested parties were willing to accept equipment, 
items, or areas that were decontaminated, or found not to have been 
contaminated in the first place, that came with a warning label and 
required the commitment to implement controls.
    DOE's proposed amendments would allow for the release without 
restriction of equipment, items, and areas that are demonstrably 
decontaminated at or below specified levels or were suspected but 
subsequently shown not to have been contaminated. DOE expects that 
potential downstream users will be more willing to accept 
decontaminated equipment, items, and areas that do not include these 
unwarranted warnings.
    In this proposed section, the term ``items'' would be intended to 
cover tools, supplies, documents, etc., and any personal property in 
beryllium regulated areas that may not be encompassed by the term 
equipment. The terms ``equipment'' and ``items'' do not include real 
property or buildings. However, the term ``area'' would be intended to 
include real property, buildings or work areas.
    Proposed Sec.  850.31(a) would amend the requirements for releasing 
from beryllium regulated areas equipment, items, and areas contaminated 
at or below the levels specified in this subsection.
    Proposed Sec.  850.31(a)(1) would amend the existing regulation to 
require that, prior to the general release or transfer of equipment and 
items, or areas, employers ensure that for formerly beryllium-
contaminated equipment and items, or areas (except those that only 
contain beryllium in normally inaccessible locations or embedded in 
hard-to-remove substances), the removable contamination level of 
beryllium is at or below 0.2 [mu]g/100 cm\2\.
    Beryllium inventories of older sites that uncover records or other 
information indicating past beryllium activities are required by 
existing Sec.  850.20(b)(4) and would be required by proposed Sec.  
850.20(a)(3) to be surveyed to determine if legacy contamination is 
present. Such surveys would include sampling accumulated material on 
the surfaces of infrequently cleaned equipment and items, and in areas 
that may contain beryllium because of the trace quantities in soils and 
building materials (i.e., below 0.1% beryllium pursuant to the 
definition of beryllium in this proposed rule). For example, 
concentrations of beryllium range from 0.09 to 3.4 parts per million 
(ppm) in U.S. soils (ref. 18). Proposed Sec.  850.31(a)(2) recognizes 
that concentrations of beryllium in accumulated indoor material that is 
not greater than the concentration of beryllium in surrounding soil 
provides convincing evidence that the area is not contaminated. A 
variety of approaches may be used to compare beryllium concentrations 
in soil collected from a reference area to the concentration in settled 
dust in such reference area. The National Institute for Science and 
Technology Engineering Statistics Handbook provides methods used to 
demonstrate that the difference between two sets of samples is 
significant (ref. 38).
    In response to its RFI, DOE received several comments concerning 
whether the Department should establish both surface level and 
aggressive air sampling criteria (modeled after Environmental 
Protection Agency (EPA)'s aggressive air sampling criteria to clear an 
area after asbestos abatement) for releasing areas in a facility, or 
instead whether the Department should consider establishing only the 
aggressive air sampling criteria. Commenters' suggestions varied 
considerably in response to this question, with some recommending only 
surface sampling, some recommending only aggressive air sampling, and 
some recommending use of both for the area considered for release. Some 
commenters suggested that aggressive sampling in buildings that 
previously had known areas of beryllium use was not able to remove 
beryllium from structural beams, even though multiple fans were blowing 
large volumes of air. In addition, these commenters indicated that 
there is no need to assign a lower airborne level (i.e., lower than the 
action level) if the surface level is below 0.2 [mu]g/100 cm\2\. Others 
suggested use of aggressive air sampling as a means to release an area

[[Page 36729]]

where beryllium is suspected in hard to reach places, and that 
aggressive air sampling would be more representative than surface 
sampling for a worker's airborne exposure, which is the route of 
exposure of greater concern.
    DOE has considerable experience with repeat cycles of cleaning and 
verifying that decontaminated equipment, items, and areas have achieved 
either the 0.2 [mu]g/100 cm\2\ or 3 [mu]g/100 cm\2\ release criteria by 
wipe testing alone. DOE's experience includes decontaminating areas, 
even though there were no provisions regarding the release of such 
areas in the final rule, as issued in December 1999. The use of wipe 
testing to demonstrate completeness of decontamination often is very 
time consuming and costly, with diminishing reduction in health risk as 
the cycles are repeated, especially for surfaces that are many-faceted, 
rough, highly textured, or difficult to access (e.g., around many-
faceted and complex utility surfaces). DOE's objective in this part is 
to establish an effective method for assuring that decontaminated 
surfaces no longer present a beryllium health risk of concern.
    Proposed Sec.  850.31(a)(3) would establish that the airborne 
concentration of beryllium in an enclosure of the smallest practical 
size surrounding the equipment or item, or in an isolating enclosure of 
the area could not exceed 0.01[mu]g/m\3\. In such cases, DOE is not 
requiring, but believes its contractors would be able to demonstrate 
achieving this level by borrowing from EPA's 40 CFR part 763, subpart 
E, Asbestos-Containing Materials in Schools, approach to clearing an 
area after asbestos abatement. This approach involves enclosing the 
equipment or item, or creating an enclosure of the area, and 
demonstrating by aggressive air sampling that air levels in the 
enclosure do not exceed a specified level. Aggressive air sampling 
refers to the method of using leaf blower-equivalents and large fans to 
dislodge and keep suspended particles that were on a surface, and then 
sampling the air for the suspended particles. In proposed Sec.  
850.31(a)(3), DOE selected 0.01 [mu]g/m\3\ as the clearance level 
because it is the same as EPA's limit for beryllium emissions, as 
specified in ``National Emission Standards for Hazardous Air 
Pollutants,'' 40 CFR part 61. EPA's limit is a 30-day average in 
ambient air and is an around-the-clock exposure; therefore, applying 
that level to workers' hours of potential exposure provides a 
significant safety factor. Aggressive air sampling maximizes the amount 
of surface material entrained in the air and consequently, the amount 
of airborne material captured in the sample as well. Aggressive 
sampling, therefore, creates a ``worst-case'' contamination condition 
and a ``best-case'' for measuring the cleanliness of the equipment, 
item, or area.
    DOE included in this proposal the provision that the enclosure 
surrounding equipment or items must have as small a size as practical 
to prevent the use of unnecessarily large enclosures that would 
facilitate meeting the 0.01 [mu]g/m\3\ criteria simply by dilution. DOE 
believes clearance for release of equipment and items, and areas by 
aggressive air sampling would ensure that surfaces are not sufficiently 
contaminated to present a risk of BeS. This belief is based on the 
assumption that, under all realistic conditions, removable beryllium 
levels sufficient to present a risk of BeS would be entrained in the 
air and shown by the clearance air samples to exceed 0.01 [mu]g/m\3\. 
This approach would also more directly demonstrate that removable 
surface beryllium does not present an inhalation hazard, as opposed to 
making an assumption about a possible inhalation risk caused by the re-
suspension of surface contamination. Finally, this approach would allow 
for a potentially more cost-effective process than wipe testing for 
demonstrating completeness of decontamination for clearance of release 
of some types of surfaces.
    Proposed Sec.  850.31(b) would allow the release or transfer of 
equipment, items, or areas in which surface contamination is 
inaccessible or has been sealed with hard-to-remove substances (e.g., 
paint), and the requirements in paragraphs (a)(1) through (3) of this 
section are met. In this case, the employer would be required to ensure 
that the labeling requirements in 850.39(b)(2) are met as specified in 
proposed Sec.  850.31(b)(1). Proposed Sec.  850.31(b)(2) would require 
the employer to condition the release of equipment, item, or area based 
on the recipients' commitment to implement controls to ensure that 
exposure does not occur. Such a commitment should be based on the 
nature and possible use of the equipment or item, the nature of the 
beryllium contamination, and whether exposure to beryllium is 
foreseeable.
    Proposed Sec.  850.31(c) would be amended to allow for conditional 
release or transfer of equipment, items, or areas with levels that 
exceed 0.2 [mu]g/100 cm\2\. For equipment, items, or areas that have 
removable beryllium above 0.2 [mu]g/100 cm\2\, or that have beryllium 
in material on the surface at levels above the levels in soil at the 
point of release, the employer would be required to:
     Provide the recipient with a copy of this part [proposed 
Sec.  850.31(c)(1)];
     Condition the release of the equipment, item, or area on 
the recipient's commitment to control foreseeable beryllium exposures 
from the equipment, item, or area considering its future use [proposed 
Sec.  850.31(c)(2)];
     Label, or post signs on, as applicable, the equipment, 
item, or area in accordance with proposed Sec.  850.39(a) or (b)(1) of 
this part to warn recipients of potential beryllium hazards [proposed 
Sec.  850.31(c)(3)];
     Place equipment or items in sealed, impermeable bags or 
containers, or have a sealant applied to prevent the release of 
beryllium during handling and transporting [proposed Sec.  
850.31(c)(4)]; and
     Ensure that the beryllium that remains removable on the 
surfaces in areas that are being released do not exceed the 3 [mu]g/100 
cm\2\ surface contamination level [proposed Sec.  850.31(c)(5)].
Proposed Sec.  850.32--Waste Disposal
    Proposed Sec.  850.32 would continue to establish the waste 
disposal provisions of the CBDPP. Like many of the provisions of the 
rule (e.g., beryllium regulated areas, protective clothing and 
equipment, housekeeping), the waste disposal provisions are designed to 
minimize the spread of beryllium contamination on the site or beyond 
the site boundaries.
    Proposed Sec.  850.32(a)(1) would require employers to dispose of 
beryllium waste in sealed, impermeable bags, containers, or enclosures 
to prevent the release of beryllium during handling and transportation.
    Proposed Sec.  850.32(a)(2) would require employers to label the 
bags, containers, or enclosures for disposal in accordance with Sec.  
850.39(b)(1) of this part.
    DOE is proposing to delete existing Sec.  850.32(a), which is the 
requirement for employers to control the generation of beryllium-
containing waste, beryllium-contaminated equipment, and other items 
through the application of waste minimization principles, because waste 
minimization is outside the scope of this part and is addressed in the 
Department's environmental policy documents.
Proposed Sec.  850.33--Beryllium Emergencies
    Proposed Sec.  850.33 would continue to establish the beryllium-
related emergency provisions of the CBDPP. Such provisions continue to 
be particularly important in light of the possibility that a single 
high-level beryllium exposure may be the cause of

[[Page 36730]]

CBD among workers thought to have had no previous exposure or only 
incidental low-level exposure to beryllium. However, proposed Sec.  
850.33(a) would be revised for consistency with part 851 to require 
employers to establish provisions for beryllium-related emergencies in 
accordance with 10 CFR 851.23, Safety and Health Standards. The 
standards listed in 10 CFR 851.23 include 29 CFR 1910.120(l) for 
emergency response activities related to hazardous waste cleanup 
operations, and 29 CFR 1910.120(q) for emergency response activities 
related to all other operations.
Proposed Sec.  850.34--Medical Surveillance
    Proposed Sec.  850.34 would continue to establish the medical 
surveillance provisions for the CBDPP. Accordingly, proposed Sec.  
850.34(a) would continue to require employers to establish and 
implement a medical surveillance program for beryllium and beryllium-
associated workers. However, DOE proposes to make the surveillance 
program mandatory for beryllium workers and voluntary for beryllium-
associated workers.
    a. Public policy and legal issues related to mandatory medical 
evaluations, mandatory restrictions and mandatory removal. The 
Department proposes several changes in part 850 that make certain 
actions mandatory rather than voluntary. These include the following:
     Proposed Sec.  850.34(a) and (b)(1)(i) would require that 
medical evaluations be mandatory rather than voluntary for beryllium 
workers. In the final rule, as issued in 1999, Sec.  850.34(b) required 
employers to provide medical evaluations to beryllium-associated 
workers (which included beryllium workers); however, the final rule did 
not make participation in the medical surveillance program mandatory 
for those workers.
     Proposed Sec.  850.36(a)(3) would require the SOMD to 
recommend temporary removal of a beryllium worker pending the outcome 
of the medical evaluations conducted pursuant to Sec.  850.34(b), or 
pending the outcome of the multiple physician review process pursuant 
to Sec.  850.34(e) or the alternate physician review process pursuant 
to proposed Sec.  850.34(f), if the beryllium worker is showing signs 
or symptoms of BeS or CBD, and the SOMD believes that further exposure 
to beryllium may be harmful to the worker's health. Similarly, proposed 
Sec.  850.36(a)(4) requires the SOMD to recommend permanent removal of 
a beryllium worker if the SOMD makes a final medical determination that 
the worker should be permanently removed from exposure to beryllium at 
or above the action level, based on a diagnosis of BeS or CBD. The SOMD 
may not recommend medical restriction instead of medical removal if the 
SOMD determines that the beryllium worker should not work in an area 
where the airborne concentration of beryllium is at or above the action 
level, due to BeS or CBD. While both medical restriction and medical 
removal are means to ensure a worker is not exposed further to a work 
environment which would be harmful to the worker's health, medical 
removal under part 850 was conceived as a form of medical restriction 
specifically for those working with beryllium and provides additional 
protection and benefits to such workers. Medical restriction, however, 
is for workers with medical conditions (other than BeS or CBD) for 
which, exposure to beryllium would be contraindicated and, as indicated 
in 10 CFR 851, appendix A, section 8(h), is intended as a provision to 
facilitate a workers rehabilitation and return to work. Medical 
restrictions would be lifted by the SOMD when determined appropriate; 
medical removal, however, would be temporary pending final diagnosis, 
or permanent upon final diagnosis of BeS or CBD. The final rule, as 
issued in 1999, was silent on the issue of medical restriction. As a 
result, the Department has learned that there was some confusion about 
whether the SOMD could place beryllium workers on medical restriction 
instead of medical removal when the SOMD determined that the beryllium 
worker should not work in an area where the airborne concentration of 
beryllium is at or above the action level. The Department would clarify 
in the proposed rule that medical removal must be recommended if the 
SOMD determines that the beryllium worker with BeS or CBD should not 
work in an area where the airborne concentration of beryllium is at or 
above the action level.
     Proposed Sec.  850.36(c) would require an employer to 
remove a beryllium worker from a job that involves an activity where 
the airborne concentration of beryllium is at or above the action level 
within 15 working days after receiving the SOMD's written opinion 
pursuant to Sec.  850.36(b)(2) stating that it is medically appropriate 
to remove the worker. Section 850.35(a) of the final rule, as issued in 
1999, required the responsible employer to offer a beryllium-associated 
worker removal from exposure to beryllium if the SOMD determined in a 
written medical opinion that the worker should be removed from exposure 
to beryllium, but did not require the worker to be removed.
    The changes in the requirements above are based on the Department's 
commitment to the health and safety of its workers, and the 
understanding that early detection and removal from beryllium is 
important to prevent harm to workers at risk for developing CBD. These 
proposed changes are consistent with the Department's authorities under 
the AEA 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.
    b. Overview of the medical surveillance program. DOE continues to 
believe the medical surveillance program is important for: (1) 
Identifying workers at higher risk of adverse health effects from 
exposure to beryllium; (2) linking health outcomes to the beryllium 
tasks; and (3) making possible the early treatment of beryllium-induced 
medical conditions.
    The medical surveillance program is designed to ensure the prompt 
identification, and make possible the proper treatment and prevention 
of future exposures, of workers who become sensitized to beryllium or 
develop CBD. In addition to determining the incidence of CBD in the 
workforce, the medical surveillance program continues to fulfill a 
critical information development function, including identifying the 
risk factors associated with the development of CBD and beryllium 
sensitization. This proposed rule continues to require that medical 
surveillance be provided to the workers who are at the greatest risk 
from continued exposure. The determination that a worker should be 
included in the medical surveillance program should be made on the 
basis of the air monitoring results, the SOMD's recommendation, and any 
other relevant information the employer may possess, such as past 
medical or air monitoring records, workers' past job duties and work 
history, etc.
    Proposed Sec.  850.34(a)(1) would continue to require employers to 
designate an SOMD who will be responsible for administering the medical 
surveillance program.
    Proposed Sec.  850.34(a)(2) would require employers to ensure that 
medical evaluations and procedures are performed by, or under the 
supervision of, a licensed physician who is qualified to diagnose 
beryllium-induced medical conditions. Although a licensed physician is 
the appropriate person to

[[Page 36731]]

supervise and evaluate a medical evaluation, proposed Sec.  
850.34(a)(2) would continue to permit certain required elements of the 
evaluation to be performed by another appropriately qualified person 
under the supervision of the physician. The licensed physician is 
required to be qualified to diagnose beryllium-induced medical 
conditions. 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. DOE believes that this is necessary due to the unusual nature 
of CBD and the fact that not all physicians are familiar with the 
evaluation of patients exposed to beryllium in their workplace.
    Proposed Sec.  850.34(a)(3) would require employers to establish 
and maintain a list of all beryllium and beryllium-associated workers. 
The list should be based on the hazard assessments, exposure records, 
and any other information that will identify such workers.
    Proposed Sec.  850.34(a)(4)(i)-(vii) would require employers to 
provide the SOMD with the information needed to administer the medical 
surveillance program. This information includes the list of workers 
required by proposed Sec.  850.34(a)(3); hazard assessment and exposure 
monitoring data; the identity and nature of the activities that are 
covered in the CBDPP; a description of the workers' duties as they 
pertain to exposures to beryllium that are at or above the action 
level; records of the workers' beryllium exposures; a description of 
the personal and respiratory protective equipment used by the workers; 
and a copy of the final rule. DOE believes that this information is 
necessary to ensure that the SOMD can make informed decisions regarding 
the required content of the medical evaluation and the subsequent 
development of recommendations related to each beryllium and beryllium-
associated worker.
    Proposed Sec.  850.34(a)(5) would be added to clarify that 
employers are required to ensure that the SOMD and beryllium or 
beryllium-associated workers complete the consent form in appendix A or 
appendix B of this part, before performing any medical evaluations for 
beryllium or beryllium-associated workers.
    DOE has learned from implementing the rule as issued in December 
1999, there was confusion regarding how often the employer should offer 
participation in the medical surveillance program to beryllium-
associated workers, and when a worker would be eligible to participate 
in the program if he or she initially decline the offer. To clarify the 
confusion, DOE would propose to add Sec.  850.34(a)(6) to require 
employers to notify beryllium-associated workers yearly of their right 
to participate in the medical surveillance program. If the beryllium-
associated worker declines at that time, he or she may elect to 
participate at any time during the year, but the worker is required to 
notify the employer in writing of the intent to participate in the 
program.
    Proposed Sec.  850.34(b) would continue to require employers to 
provide, without cost to the worker, all of the medical evaluations and 
procedures required under this section. The proposed rule would add a 
requirement that the procedures be provided to workers without loss of 
pay. It is necessary that examinations and procedures be performed at a 
place convenient to the employee, and without loss of pay, which means 
the employee should not be required to use vacation or sick leave, in 
order to maximize the likelihood that beryllium and beryllium-
associated workers will participate in the medical evaluations. This 
proposed provision is consistent with OSHA's health standards [e.g., 
Asbestos, 29 CFR 1910.1001(l)(1)(ii)(A); Arsenic, 29 CFR 
1910.1018(n)(1)(ii); and Cadmium 29 CFR 1910.1027(l)(1)(iii)].
    c. Mandatory medical evaluations. The purposes of baseline medical 
evaluations are to: (1) Establish the current health status of the 
worker and determine whether it is appropriate to assign the worker to 
a job where the worker will be exposed to airborne concentrations of 
beryllium at or above the action level; (2) initially determine what 
level of medical surveillance the employer must provide to the workers; 
and (3) establish essential baseline data for the worker which is used 
to assess subsequent health changes attributable to beryllium exposure.
    DOE recognizes the potential negative consequences that medical 
evaluations for beryllium disease may have with respect to a worker's 
employability and insurability; work restrictions; and risk of 
complications from the medical evaluation. Nonetheless, it is DOE's 
considered determination that the early detection possible with medical 
evaluations is essential for removing workers at risk for CBD from 
further exposure to beryllium, thereby potentially reducing risk of 
symptomatic beryllium disease and the magnitude of symptoms that may 
occur--as well as for providing early opportunities for effective 
treatment. In 2008, researchers in France published results of a study 
of corticosteroid therapy in CBD cases and confirmed that the long-
standing standard of care for CBD--corticosteroid therapies--was 
beneficial in treating CBD (ref. 28). Corticosteroids were effective in 
suppressing granulomatous lesions in all cases and in stopping the 
evolution to pulmonary fibrosis in six of eight patients.
    Physicians who diagnose a worker with BeS or CBD generally 
recommend that their patients stop working with beryllium. The National 
Academy of Sciences recently published a study for the U.S. Air Force 
(ref. 7) that contains the following recommendations for physicians 
conducting diagnostic evaluations:

    Workers with CBD should discontinue work in areas that have 
beryllium exposure because of concern about worsening the disease. 
Although the effect of continuing exposure to beryllium at 
relatively low concentrations has not been clearly shown, the 
potential for CBD to become serious suggests that, given the current 
state of knowledge, it is prudent to avoid further beryllium 
exposure. Workers with CBD should continue to receive regular 
medical followup. Workers with CBD who discontinue work with 
beryllium should receive medical removal protection.

    The prudent practice to have workers with BeS or CBD avoid 
additional exposure is based on the knowledge that, as is the case of 
other immune-system mediated diseases, continued exposure to the 
antigen may worsen the outcome. Observation that the rate of conversion 
from BeS to CBD appears to vary in a consistent manner with workers' 
exposures supports avoidance of additional exposure. Sensitized workers 
with low exposures appear to have relatively low rates of conversion, 
and sensitized workers with high exposures appear to have relatively 
high rates of conversion. A study published in 2004 of DOE construction 
workers thought to have intermittent and presumed low exposures, 
provides an example of a low rate of conversion. In this study, 15% of 
the workers with sensitization who underwent clinical evaluations were 
found to have CBD (ref. 18). Examples of medium rates of conversion of 
workers with presumed medium exposures are provided by the findings of 
two studies at DOE plants. First, a DOE plant that fabricated beryllium 
metal components reported that of 301 sensitized workers evaluated, 117 
(39%) had CBD (ref. 13). Second, a DOE plant that fabricated beryllium 
ceramic components reported

[[Page 36732]]

that 23 of 56 (41%) sensitized workers had CBD (ref. 39). Examples of 
high rates of conversion of workers with presumed high exposures are 
provided by a study of former workers at beryllium production plants in 
Pennsylvania in which 19 of 29 (66%) of sensitized workers were 
diagnosed as having CBD, and by a study of former workers at a Colorado 
ceramics fabrication plant in which 100% of seven sensitized workers 
were diagnosed with CBD (refs. 40, 41).
    The importance of early detection of beryllium sensitization in 
workers cannot be ignored in light of the fact that the existing 
studies provide support for the importance of early detection of 
beryllium sensitization. Proposed Sec.  850.34(b)(1)(i)(A) would 
require employers to make baseline medical evaluations mandatory rather 
than voluntary for beryllium workers. Proposed Sec.  850.34(b)(1)(i)(B) 
provides that baseline medical evaluations for beryllium-associated 
workers are voluntary. DOE believes that participation in the medical 
evaluation program should not be mandatory for beryllium-associated 
workers because these workers are not currently performing work in 
beryllium regulated areas. This approach would continue to ensure the 
early identification of those workers most at risk for health effects 
from exposure to beryllium, provide the greatest protection of worker 
health, and provide a more complete documentation of beryllium 
exposures.
    Proposed Sec.  850.34(b)(1)(ii)(A) through (G) is intended to 
ensure consistency among baseline medical evaluations in order to 
detect, at an early stage, any pathological changes that could lead to 
CBD or be aggravated by beryllium exposure. By detecting abnormalities 
early, workers may be medically removed to prevent further beryllium 
exposure. Therefore, each baseline medical evaluation would be required 
to include the following:
     A detailed medical and work history, particularly 
emphasizing exposures to levels of beryllium [proposed Sec.  
850.34(b)(1)(ii)(A)];
     A respiratory symptoms questionnaire [proposed Sec.  
850.34(b)(1)(ii)(B)];
     A physical examination with special emphasis on the 
respiratory system, skin and eyes [proposed Sec.  850.34(b)(1)(ii)(C)];
     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, unless there 
is an existing baseline chest radiograph that may be used to meet this 
requirement. The use of a digital radiographic image is new, and 
reflects the development of technology [proposed Sec.  
850.34(b)(1)(ii)(D)];
     Spirometry consisting of forced vital capacity (FVC) and 
forced expiratory volume (FEV1) at one second [proposed 
Sec.  850.34(b)(1)(ii)(E)];
     Two peripheral blood BeLPTs [proposed Sec.  
850.34(b)(1)(ii)(F)];
     Any other tests deemed appropriate by the SOMD for 
evaluating beryllium-induced medical conditions [proposed Sec.  
850.34(b)(1)(ii)(G)]. DOE believes it is important that the SOMD have 
such discretion because individuals may exhibit different responses to 
beryllium exposures.
    For purposes of the medical evaluations in this part (baseline, 
periodic and exit), two peripheral blood BeLPTs would be required. In 
the final rule, as issued in December 1999, only one BeLPT is required 
for the baseline and periodic evaluations. The reason for this change 
is that in the proposed rule, a diagnosis of BeS requires either: Two 
abnormal blood BeLPT results; or one abnormal and one borderline blood 
BeLPT; or one abnormal BeLPT of alveolar lung lavage cells. Employers 
are required to provide two peripheral blood BeLPTs to the worker in 
order to permit a proper diagnosis to be made by the SOMD. As set forth 
in the definition of BeLPT, a split sample BeLPT (where one blood draw 
is split and sent to two different testing facilities) would constitute 
two peripheral blood BeLPTs. If the SOMD determines that additional 
BeLPTs or other tests are required in order to diagnosis a worker, then 
the SOMD may order additional tests as part of the medical evaluation.
    d. Use of Beryllium-induced Lymphocyte Proliferation Test (BeLPT). 
DOE concludes there is a general consensus that medical surveillance 
that includes screening with the BeLPT on peripheral blood cells 
provides an opportunity for timely worker removal from exposure which 
may reduce the chances of progression of BeS to CBD, and from sub-
clinical CBD to significant lung damage and disability. In addition, 
positive BeLPT results lead to increased medical monitoring and 
therapy. This may also reduce an individual's chance of progressing to 
more severe disease.
    The peripheral blood BeLPT was included as a component of medical 
evaluations in this part of the final rule, as issued in December 1999. 
DOE is aware that concerns have been expressed over shortcomings of the 
peripheral blood BeLPT, but DOE continues to consider the test to be an 
effective tool for screening individuals for BeS (refs. 42, 43, 44).
    A published evaluation of the commonly used blood BeLPT method used 
for 12,194 current and former workers at 18 DOE sites found the test to 
have a positive predictive value that is comparable to other widely 
accepted medical tests and that it was, therefore, effective in the 
medical surveillance of beryllium-exposed workers (ref. 13). 
Epidemiology researchers commonly rely on peripheral blood BeLPT 
results in workforce medical surveillance data as an indicator of 
beryllium disease risk, as exemplified by Mroz, et al.: ``This 
longitudinal study demonstrated that workforce medical surveillance 
with the blood BeLPT identifies individuals at significant risk of 
disease progression and future impairment with sufficient time since 
first exposure'' (ref. 16). A National Academy of Sciences' study 
concluded, ``Despite some issues regarding the reproducibility, 
sensitivity, and specificity of the BeLPT, the committee judged it to 
be an adequate assay for use in a surveillance program'' (ref. 7). The 
authors note that BeS is ``a valuable indicator'' in a medical 
surveillance program in identifying high risk workers, though they 
acknowledge that quantitative predictions on the magnitude of the risk 
of disease progression are not possible based on available data. 
Further, the United Kingdom's Health and Safety Executive (HSE) 
recently published a review of the use of the BeLPT for screening or 
surveillance of beryllium workers (ref. 45). That review concludes:

    If the intent of health surveillance is to identify early 
beryllium sensitisation as a marker of those at risk of progressing 
to CBD (or as a minimum to characterise sensitisation in a group of 
exposed workers), then by definition the programme must include the 
BeLPT with an appropriate occupational health policy to deal with 
positive results, including educating the workforce about the 
implications of a positive test. The natural history of beryllium 
sensitisation is not fully understood, but in theory offers an early 
opportunity to identify early immune responses, to decrease exposure 
and hence intervene to improve prognosis.

    HSE ultimately concludes that BeLPT represents the currently most 
sensitive screening test available, samples are easy to obtain, and the 
test provides the potential to identify subclinical disease and allow 
exposures to be modified.
    DOE believes that the use of the peripheral blood BeLPT in medical 
evaluations is justified for its workforce, even for groups with low 
prevalence rates of beryllium disease. This belief is

[[Page 36733]]

based on DOE's experience in identifying and removing BeS workers from 
additional exposure and on the supportive findings of the literature 
referenced above in using BeLPT as an effective medical surveillance 
tool (refs. 7, 13, 16, 45).
    DOE welcomes improvements to the efficacy of the peripheral blood 
BeLPT. DOE has published a technical standard that can be used to 
reduce variation among laboratories in the procedures used in 
performing the test (ref. 46), and the Department expects that BeLPTs 
will be evaluated by laboratories that are certified by the College of 
American Pathologists. Furthermore, researchers continue to develop 
alternatives to the tritiated thymidine method currently used for 
counting proliferated lymphocytes (e.g., counting lymphocytes by flow 
cytometry), which may further improve the efficacy of the peripheral 
blood BeLPT (ref. 47).
    DOE has evaluated the consistency of imposing mandatory blood 
BeLPTs in the medical evaluations of DOE Federal and contractor workers 
with public policy established in Public Law 110-233, Genetic 
Information Nondiscrimination Act of 2008. The blood BeLPT is not a 
``genetic test'' for the purposes of that statute, as section 201(7)(B) 
of the statute states that ``the term `genetic test' does not mean an 
analysis of proteins or metabolites that does not detect genotypes, 
mutations, or chromosomal changes.''
    Proposed Sec.  850.34(b)(2), would continue to require employers to 
provide periodic medical evaluations. Employers would be required to 
provide periodic medical evaluations in order to detect, at an early 
stage, any pathological changes that could lead to CBD or be aggravated 
by beryllium exposure. By detecting abnormalities early, workers may be 
medically removed to prevent further beryllium exposure. Specifically, 
proposed Sec.  850.34(b)(2)(i) (A)-(B) would require employers to 
provide periodic medical evaluations annually to beryllium workers, and 
every three years to beryllium-associated workers who voluntarily 
participate in the program. Proposed Sec.  850.34(b)(2)(i)(C) would 
require employers to provide a medical evaluation to beryllium workers, 
or beryllium-associated workers who voluntarily participate in the 
program, and who exhibit signs and symptoms of BeS or CBD, if the SOMD 
determines that an evaluation is warranted. This change was made in 
recognition of the fact that a worker may show signs or symptoms of 
beryllium sensitization or CBD before he or she is due for a periodic 
review, and requires the employer to provide an evaluation if the SOMD 
determines that it is warranted.
    Proposed Sec.  850.34(b)(2)(ii) would continue to require employers 
to provide periodic medical evaluations to beryllium workers, and 
beryllium-associated workers who voluntarily participate in the 
program, which would include the following:
     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 unless 
there is a chest radiograph obtained in the previous five years that 
may be used to meet this requirement [proposed Sec.  
850.34(b)(2)(ii)(A)];
     Updates to the worker's medical and work history with 
emphasis on exposures to levels of beryllium [proposed Sec.  
850.34(b)(2)(ii)(B)];
     A respiratory symptom questionnaire [proposed Sec.  
850.34(b)(2)(ii)(C)];
     A physical examination, with special emphasis on the 
respiratory system, skin, and eyes [proposed Sec.  
850.34(b)(2)(ii)(D)];
     Two peripheral blood Be-LPTs [proposed Sec.  
850.34(b)(2)(ii)(E)]; and
     Any other test deemed appropriate by the SOMD for 
evaluating beryllium-induced medical conditions [proposed Sec.  
850.34(b)(2)(ii)(F)].
    Proposed Sec.  850.34(b)(3) would continue to require employers to 
provide medical evaluations for workers when a beryllium emergency 
occurs as defined in proposed Sec.  850.3 in this proposed rule. In 
these cases, medical evaluations would include the tests and 
examinations required as part of periodic medical evaluations provided 
pursuant to paragraph (b)(2)(ii) of this section.
    Proposed Sec.  850.34(b)(4) is being added to require employers to 
provide an exit medical evaluation to a beryllium worker, or offer an 
exit medical evaluation to a beryllium-associated worker who 
voluntarily participates in the medical surveillance program, if a 
baseline or periodic evaluation had not been performed within the 
previous six months at the time of separation from employment. The 
purpose of the exit medical evaluation is to determine and document the 
worker's health status at the time of separation. While 10 CFR part 
851, appendix A, section 8(g)(2)(v) provides for a health evaluation at 
the time of separation when determined necessary by the occupational 
medicine provider, DOE believes that obtaining information about a 
beryllium or beryllium-associated worker's health status at termination 
is important for contributing to the information available for 
performance feedback about the employer's CBDPP.
    Accordingly, proposed Sec.  850.34(b)(4)(i)(A) would require 
employers to provide an exit medical evaluation to beryllium workers 
upon separation from employment, and to beryllium-associated workers 
who voluntarily participate in the program at the time of separation 
[proposed Sec.  850.34(b)(4)(i)(B)] if a baseline or periodic 
evaluation has not been performed within the previous six months. The 
exit medical evaluation would include the following:
     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 unless 
there is a chest radiograph obtained in the previous five years that 
may be used to meet this requirement [proposed Sec.  
850.34(b)(4)(ii)(A)];
     Updates to the worker's medical and work history with 
emphasis on exposures to levels of beryllium [proposed Sec.  
850.34(b)(4)(ii)(B)];
     A respiratory symptom questionnaire [proposed Sec.  
850.34(b)(4)(ii)(C)];
     A physical examination, with special emphasis on the 
respiratory system, skin, and eyes [proposed Sec.  
850.34(b)(4)(ii)(D)];
     Two peripheral blood Be-LPTs [proposed Sec.  
850.34(b)(4)(ii)(E)]; and
     Any other test deemed appropriate by the SOMD for 
evaluating beryllium-induced medical conditions [proposed Sec.  
850.34(b)(4)(ii)(F)].
Proposed Sec.  850.34(c)--[Reserved]
    Note that following separation, these workers would be eligible for 
continued health monitoring under the Former Worker Medical Screening 
Program. Certain current or former workers who have contracted work-
related illnesses from work performed at DOE sites may be eligible to 
receive compensation through the Energy Employee Occupational Illness 
Compensation Program Act (EEOICPA).
    e. Reporting the results of the medical evaluations. Proposed Sec.  
850.34(d) [currently Sec.  850.34(e)], would be revised to clarify the 
requirements for the SOMD's reporting the results of the medical 
evaluations performed pursuant to paragraph (b) of this section. SOMDs 
are required to provide their written medical opinions to the worker 
within 15 working days after receiving the results of the evaluations 
performed

[[Page 36734]]

pursuant to paragraphs (b)(1) through (3) of this section.
    Specifically, proposed Sec.  850.34(d)(1)(i) would require the SOMD 
to provide a beryllium or beryllium-associated worker with:
     A written medical opinion containing the purpose and 
results of all medical test or procedures [proposed Sec.  
850.34(d)(1)(i)(A)];
     An explanation of any abnormal findings [proposed Sec.  
850.34(d)(1)(i)(B)];
     The basis for the SOMD's medical opinion [proposed Sec.  
850.34(d)(1)(i)(C)];
    Proposed Sec.  850.34(d)(1)(i)(D) would be added to require the 
SOMD to provide in this written medical opinion any determination of 
whether:
     In the case of a beryllium worker, temporary or permanent 
removal of the beryllium worker from beryllium exposure is warranted 
pursuant to Sec.  850.36 [proposed Sec.  850.34(d)(1)(i)(D)(1)];
     A medical restriction is appropriate for the worker 
pursuant to 10 CFR 851, appendix A, section 8(h) [proposed Sec.  
850.34(d)(1)(i)(D)(2)]; and
     The SOMD would also be required to give the worker an 
opportunity to ask and have answered, their questions regarding the 
information provided [proposed Sec.  850.34(d)(1)(i)(E)];
    Proposed Sec.  850.34(d)(1)(ii) would require the SOMD's written 
medical opinion to take into account the findings, determinations and 
recommendations of examining physicians who have examined the worker 
and provided written results of the examination to the SOMD, provided 
that the examining physician is qualified to diagnose beryllium-induced 
conditions. This proposed change responds to DOE's recognition, through 
its experience implementing this part, that many of those working at 
the DOE complex received regular medical evaluations from their private 
physician or through the DOL managed EEOICPA. While the SOMD must make 
the final decision regarding the worker's fitness for duty, and issues 
such as restriction and removal, the SOMD must take into account the 
findings, determinations and recommendations of qualified physicians 
who have examined the worker and provided their written recommendations 
to the SOMD.
    Proposed Sec.  850.34(d)(1)(iii) would be added to require the SOMD 
to obtain the workers signature on a dated copy of the written opinion 
and to include this information in the worker's medical record 
documenting that the employee received a copy of the opinion. If the 
worker declines to sign the statement, then the SOMD must make a record 
of that fact in the worker's medical record.
    Proposed Sec.  850.34(d)(1)(iv) would be added to clarify that 
within 15 working days after receiving the results from an exit 
evaluation performed pursuant to Sec.  850.34(b)(4) of this part, the 
SOMD is required to provide the worker with:
     A written medical opinion containing the purpose and 
results of all medical tests or procedures [proposed Sec.  
850.34(d)(1)(iv)(A)];
     An explanation of any abnormal findings [proposed Sec.  
850.34(d)(1)(iv)(B)];
     The basis for the SOMD's medical opinion [proposed Sec.  
850.34(d)(1)(iv)(C)]; and
     An opportunity to ask, and have answered, questions 
regarding the information provided [proposed Sec.  
850.34(d)(1)(iv)(D)].
    Proposed Sec.  850.34(d)(2)(i) would require the SOMD, within 5 
working days after delivering the written medical opinion pursuant to 
paragraph (d)(1)(i) of this section to the beryllium or beryllium-
associated worker, to provide to the employer a written medical opinion 
that includes the following:
     The diagnosis of the worker's condition relevant to 
occupational exposure to beryllium, and any other medical condition for 
which exposure to beryllium at or above the action level would be 
contraindicated [proposed Sec.  850.34(d)(2)(i)(A)].
    In this written medical opinion to the employer, the SOMD would be 
required to include a determination of whether:
     In the case of a beryllium worker, temporary or permanent 
removal of the worker from exposure to beryllium is warranted pursuant 
to Sec.  850.36 of this part [proposed Sec.  850.34(d)(2)(i)(B)(1)]. 
DOE is adding this requirement to clarify that the SOMD is the only 
individual who can medically determine when a worker is to be removed 
from exposures to beryllium; or
     A medical restriction pursuant to 10 CFR 851, appendix A, 
section 8(h) is appropriate for the worker [proposed Sec.  
850.34(d)(2)(i)(B)(2)].
    Proposed Sec.  850.34(d)(2)(i)(C) would continue to require the 
SOMD or examining physician to provide a statement that he or she has 
clearly explained to the worker the results of the medical evaluations, 
including all test results and any medical condition related to 
beryllium exposure that requires further evaluations or treatment.
    Proposed Sec.  850.34(d)(2)(ii) would be revised to conform with 
the requirements in 10 CFR part 851, appendix A, section 8(h)(1) and 
would require that the SOMD not include in the written medical opinion 
any specific records, determinations, or diagnoses that are not related 
to beryllium-induced medical conditions or to any other medical 
condition indicating the worker should not perform certain job tasks.
    Proposed Sec.  850.34(d)(2)(iii) would be added to clarify that 
within 5 working days after delivering the written medical opinion 
pursuant to paragraph (d)(1)(iv) of this section, for an exit 
evaluation performed pursuant to Sec.  850.34(b)(4) of this part, the 
SOMD would be required to provide the employer with the diagnosis of 
the worker's condition that is relevant to occupational exposure to 
beryllium, or indicates the worker should not perform certain job 
tasks.
    f. Multiple physician review process. Proposed Sec.  850.34(e) 
[currently Sec.  850.34(c)], would continue to require the 
establishment of a multiple physician review process for review of the 
initial findings, determinations, or recommendations from the medical 
evaluations. DOE adopted the multiple physician review mechanism as a 
means of providing workers with an opportunity to obtain independent 
review of the determinations of physicians selected by the employer. 
More importantly, use of this review mechanism should serve to engender 
worker trust and confidence in the employer-retained physician where 
merited. If workers distrust an employer's physician and the diagnoses 
of a second physician on several occasions proves there is no basis for 
distrust, then workers will be much more likely to trust the employer's 
physician in the future. If the choice of a second and third physician 
repeatedly results in medical determinations that greatly differ with 
that of the employer-retained physician, then the multiple physician 
review mechanism will have served the beneficial purposes of (1) 
correcting possibly inadequate medical determinations, and (2) exposing 
potential deficiencies in the employer's medical surveillance program. 
Therefore, DOE has identified the following benefits of providing a 
multiple physician review process: (1) It strengthens and broadens the 
basis for medical decisions that would be made in response to this rule 
when a beryllium or beryllium-associated worker questions the findings, 
recommendations, or determinations of an initial physician retained by 
the employer; (2) it increases workers' confidence in the soundness of 
medical findings, recommendations, and determinations that are made 
under this rule; and (3) it increases the workers' acceptance of, and 
participation in the medical surveillance program. These

[[Page 36735]]

independent reviews are likely to show that either a perceived low 
level of confidence in the physician retained by the employer is 
unwarranted, or the employer should improve the quality of the medical 
evaluations. In either case, the multiple physician review process will 
have served a beneficial purpose.
    Accordingly, proposed Sec.  850.34(e)(1) [current Sec.  
850.34(c)(1)] would continue to require employers to establish a 
multiple physician review process for beryllium and beryllium-
associated workers that allows for the review of the initial medical 
findings, determinations, or recommendations from any medical 
evaluation conducted in accordance with paragraphs (b)(1)-(3) of this 
section. Note that the rule as proposed would not require the employer 
to provide a multiple physician review process for exit evaluations 
which would be provided pursuant to proposed Sec.  850.34(b)(4).
    The Department recognizes the value to employers and workers alike 
of the process operating in an expeditious fashion, and thus has 
established explicit criteria for the beginning of the process. 
Therefore, proposed Sec.  850.34(e)(2) would clarify that the employer 
must notify a beryllium or beryllium-associated worker in writing 
within 15 working days after receiving the written medical opinion and 
determination regarding removal and/or work restriction pursuant to 
proposed paragraph (d)(2) of this section, of the worker's right to 
elect the multiple physician review process.
    Proposed Sec.  850.34(e)(3) [currently Sec.  850.34(c)(3)] would 
provide that the employer's participation in, and payment for the 
multiple physician review process or the alternative physician review 
process for a beryllium-associated worker would be conditioned on the 
worker's participation in the medical surveillance program pursuant to 
paragraph (b) of this section.
    Proposed Sec.  850.34(e)(4)(i) and (ii) would require the beryllium 
or beryllium-associated worker to notify the employer in writing within 
15 working days after receiving the employer's written notification 
pursuant to paragraph (e)(2) of this section, of the worker's intention 
to seek a second medical opinion on the results of any medical 
evaluation conducted pursuant to paragraphs (b)(1) through (3) of this 
section; and the beryllium or beryllium-associated worker identifying 
in writing to the SOMD within 20 working days after delivering the 
notice pursuant to paragraph (e)(4)(i) of this section, a physician who 
is qualified to diagnose beryllium-induced medical condition to:
     Review all findings, determinations, or recommendation of 
the initial physician [proposed Sec.  850.34(e)(4)(ii)(A)];
     Conduct such examinations, consultations, and laboratory 
tests as the second physician deems necessary to facilitate this review 
[proposed Sec.  850.34(e)(4)(ii)(B)]; and
     Provide the employer and the worker with a written medical 
opinion within 30 working days after completing the review pursuant to 
paragraphs (e)(4)(ii)(A) and (B) of this section [proposed Sec.  
850.34(e)(4)(ii)(C)].
    Proposed Sec.  850.34(e)(5) would clarify that if the findings, 
determinations, or recommendations of the two physicians differ 
substantively, then the employer and the worker would be required to 
assist the two physicians in resolving any disagreement. DOE expects 
that the two physicians will communicate with each other to resolve 
their differences, but the rule requires the employer and worker to 
encourage such a resolution. In most cases, this professional 
interaction should resolve any differences of opinion.
    If the first two physicians are unable to resolve expeditiously any 
significant differences of opinion with respect to a beryllium or 
beryllium-associated worker, then it would be necessary for a third 
qualified physician to resolve the dispute. It is important that this 
third physician be competent to resolve the dispute. Consequently, 
proposed Sec.  850.34(e)(6) [currently Sec.  850.34(c)(5)], would 
require the employer and the worker together, through their respective 
physicians, to designate a third physician. It is the responsibility of 
the employer and the worker to assure that a third physician is 
selected, but the selection is to be made by the two prior physicians. 
Since the third physician is chosen by the joint endorsement of the two 
prior physicians, the professional competence of the third physician 
will be assured. Proposed Sec.  850.34(e)(6) [currently Sec.  
850.34(c)(5)], would allow the third physician a full opportunity to:
     Review the findings, determinations, and recommendations 
of the two prior physicians [proposed Sec.  850.34(e)(6)(i)];
     Conduct such examinations, consultations, laboratory 
tests, and consultations with the other two physicians as the third 
physician deems necessary to resolve the disagreement among them 
[proposed Sec.  850.34(e)(6)(ii)]; and
     Provide the employer and the worker with a written medical 
opinion within 30 working days after completing the review pursuant to 
paragraph (e)(5)(i) and (ii) of this section [proposed Sec.  
850.34(e)(6)(iii)].
    Proposed Sec.  850.34(e)(7) [currently Sec.  850.34(c)(6)], would 
continue to require the SOMD to take action consistent with the 
findings, determinations, and recommendations of the third physician, 
unless the SOMD and the worker reach an agreement that is otherwise 
consistent with the recommendations of at least one of the other two 
physicians.
    The Department's experience in implementing the final rule 
provisions has shown there was some confusion among employers and 
workers about the multiple physician review process for a worker who 
has been laid off or whose contract ended during the multiple physician 
review process. To address these situations proposed Sec.  850.34(e)(8) 
would require the employer to complete the multiple physicians review 
process and treat the worker as though he is a current worker, even 
when a worker is laid off or his contract ends before the review 
process is complete, subject to the following conditions: (1) The 
worker must have elected the multiple physician review while he was in 
fact a current worker and in accordance with the conditions set forth 
in paragraph (e)(4) of this section; and (2) the worker must 
participate in good faith in the multiple physician review process. If 
a worker's job would have ended prior to the end of the multiple 
physician review process (e.g., if the worker was hired to do a 
particular job which has been completed), the proposed rule provides 
that the employer may place the worker on unpaid leave status until the 
review process is completed.
    Proposed Sec.  850.34(e)(9) would be added to clarify that the 
employer would not be required to provide the multiple physician review 
process in those cases where the worker had not elected the process in 
accordance with the conditions specified in paragraph (e)(4) of this 
section before the worker was laid off or contract ended. In these 
cases the workers may still be eligible for medical screening through 
DOE's FormerWorker Medical Screening Program.
    The employer would be required to pay for the expenses of the 
multiple physician review process when a beryllium-associated worker 
elects it in writing and in a timely manner. DOE does not expect the 
cost of this process to be burdensome to its contractor employers since 
DOE contractors typically receive reimbursement for the cost of 
complying with this process. If the employer establishes and

[[Page 36736]]

administers a medical surveillance program that engender worker 
confidence, workers should have little or no need to seek second 
medical opinions.
    The requirement for a multiple physician review is not intended to 
preclude employers from establishing and implementing alternate medical 
protocols. DOE would continue to include language in proposed Sec.  
850.34(f) [currently Sec.  850.34(d)] that establishes an alternate 
physician review process. Under this section, the employer, beryllium 
and beryllium-associated worker, or the worker's designated 
representative, would be allowed to agree on the use of any expeditious 
alternate physician determination process, instead of the multiple 
physician review process. The only condition is that the alternate 
process is reasonable, expeditious and adequately protects the worker's 
health. For example, a jointly agreed upon physician might be used in 
the first instance without recourse to other physicians. DOE would 
continue to encourage employers and workers to adopt medical 
determination procedures in which all parties have trust and 
confidence.
    Proposed Sec.  850.34(g)(1) would be revised to comply with the 
reporting requirements in 10 CFR part 851.23(a)(2). Proposed Sec.  
850.34(g)(2) and (3) would be added to comply with the reporting 
requirements for cases involving medical removal. Accordingly, proposed 
Sec.  850.34(g)(2) would require employers to record each case of 
medical removal on the applicable OSHA form when a worker is being 
medically removed in accordance with proposed Sec.  850.36 of this 
part. Proposed Sec.  850.34(g)(3) would require employers to enter each 
case of medical removal either as a case involving days away from work 
(if the worker does not work during the medical removal period) or as a 
case involving restricted work activity (if the worker continues to 
work but in an area where beryllium exposures are below the action 
level).
    DOE is proposing to delete Sec.  850.34(h) in the final rule. This 
section requires employers to establish routine and systematic analyses 
of medical, job and exposure data. The purpose of this requirement is 
to collect and analyze information so that the prevalence of disease 
can be accurately described and conclusions reached on causes or risk 
factors for disease. The Department intends to rely on the data 
collected from the Beryllium Registry for this purpose.
Proposed Sec.  850.35--Medical Restriction
    Proposed Sec.  850.35 would be added to establish the medical 
restriction provisions of the CBDPP. Part 850 is intended to address 
and prevent disease caused by exposure to beryllium at DOE sites. 
Medical removal benefits under the rule are not intended to apply in 
cases where beryllium is not the cause of the worker's illness. In the 
case where the worker is not suffering from beryllium disease or has 
not been sensitized to beryllium, but exposure to beryllium at or above 
the action level is contraindicated, medical restriction would ensure 
that workers with other medical conditions are not exposed to beryllium 
which could put them at a materially higher risk for developing serious 
medical problems. Other medical conditions include, but are not limited 
to, chronic obstructive pulmonary disease (COPD), sarcoidosis, asthma, 
emphysema, or any other medical condition with respect to which the 
SOMD may determine that exposure to beryllium at or above the action 
level is contraindicated.
    Proposed Sec.  850.35(a) would require medical restrictions to be 
conducted in accordance with 10 CFR part 851, appendix A, section 8(h). 
In such cases where medical restrictions appropriate, proposed Sec.  
850.35(b) would require employers to, within 15 working days after 
receiving the SOMD's written opinion pursuant to Sec.  850.34(d)(2) 
that it is medically appropriate to restrict a worker, restrict the 
worker from a job that involves a beryllium activity.
    The Department's experience in implementing the final rule 
provisions has shown there was some confusion among employers and 
workers about medical restriction and when to offer, or not offer, 
medical removal benefits. Therefore, DOE would add proposed Sec.  
850.35(c) to clarify that employers would only be required to provide 
the beryllium medical removal benefits specified in Sec.  850.36 of 
this proposed rule to beryllium workers who have been diagnosed with 
BeS or CBD, or pending the outcome of medical evaluations to determine 
whether the worker has BeS or CBD and the SOMD believes that further 
exposure to beryllium at or above the action level may be harmful to 
the health of the worker, or pending the alternate physician review or 
multiple physician review. Employers are not required to provide 
removal benefits to other types of workers with a medical restriction.
    Proposed Sec.  850.35(d) would be added for those situations when 
the SOMD determines that a beryllium worker should not work with 
beryllium at or above the action level due to BeS or CBD. In such 
cases, the SOMD would be required to recommend medical removal under 
Sec.  850.36 of this proposed rule, not medical restriction.
Proposed Sec.  850.36--Medical Removal and Benefits
    Proposed Sec.  850.36 [(currently Sec.  850.35] would continue to 
require employers to implement the medical removal (currently known as 
``medical removal protection'') and benefits (currently known as 
``medical removal protection benefits'') provisions of the CBDPP. DOE 
believes medical surveillance can only be effective in detecting and 
preventing disease if workers: (1) Seek medical attention when they 
feel ill; (2) refrain from efforts to conceal their true health status; 
and (3) fully cooperate with examining physicians to facilitate 
accurate medical diagnoses and effective treatment. This type of worker 
participation and cooperation will occur only where no major 
disincentives to meaningful worker participation exists. Without such 
participation, it would be much more difficult to adequately monitor 
workers' health and to identify workers who need temporary or permanent 
medical removal.
    Medical removal is a logical result of the medical surveillance 
program. Without medical removal, employees with BeS or CBD may remain 
undiagnosed and continue to be exposed to beryllium at or above the 
action level which would not be sufficiently protective of their 
health. Also, without medical removal benefits, workers with BeS or CBD 
could be terminated or transferred from higher-paying jobs where 
exposure to beryllium is at or above the action level to lower-paying 
jobs that do not include such exposure. This might be protective, but 
it would impair the workers' earning ability. In either case, the 
effectiveness and integrity of the medical surveillance program may be 
compromised.
    With medical removal, beryllium workers with BeS or CBD would be 
assured of being removed to jobs where the exposure to beryllium is 
below the action level, if such jobs are available and if removal is 
determined to be necessary to protect their health. With medical 
removal benefits, beryllium workers with BeS or CBD would be assured 
that, if the results require removal from their beryllium job, their 
normal earnings will be protected for a pre-determined period.
    Proposed Sec.  850.36(a)(1) would clarify that, subject to the 
terms set forth in this proposed section, employers would be required 
to remove beryllium workers

[[Page 36737]]

from jobs where the exposure to beryllium is at or above the action 
level. As set forth in this section, temporary or permanent removal is 
required when the SOMD has determined in a written medical opinion that 
it is appropriate to remove the beryllium worker from exposure to 
beryllium at or above the action level. This determination would be 
required to be based on a diagnosis that the worker has BeS or CBD, as 
defined in this proposed rule.
    The Department's experience in implementing the current rule 
provisions has shown there was some confusion about who has the 
authority to recommend temporary or permanent removal of a beryllium 
worker. Therefore, proposed Sec.  850.36(a)(2) would clarify that only 
the SOMD may recommend temporary or permanent removal of a beryllium 
worker from exposure to beryllium at or above the action level. DOE 
proposes revising the wording used in this section to clarify that the 
SOMD would make the final medical determination, even when a multiple 
physician review or alternative physician determination process is 
used. The SOMD, in making the final medical determination would be 
expected to take into account the findings, determinations and 
recommendations of other examining physicians who may have examined the 
worker, but the SOMD makes the final determination.
    Mandatory medical removal of beryllium workers. In response to its 
RFI, DOE received several comments concerning whether to continue to 
require a worker's consent for medical removal, or instead require 
mandatory medical removal. The majority of commenters recommended that 
DOE establish a mandatory medical removal practice; however, many of 
those commenters also recommended that DOE provide enhanced medical 
removal benefits. Some commenters suggested that mandatory removal 
should be implemented by DOE complex-wide. Some commenters suggested 
that DOE mandate that the employer offer a vocational training program 
to the affected worker to assist the employee in maintaining the 
financial compensation and benefits from his or her previous position, 
and that the length of time for medical removal benefits should be 
increased from two to five years. A minority of commenters believed 
that DOE should continue to leave medical removal up to the worker, 
pointing out that the National Academies suggests that the worker's 
consent be obtained. Some commenters indicated that DOE should retain 
voluntary medical removal only if DOE will accept the risk of future 
health issues from allowing a worker to resume activities after the 
SOMD has recommended medical removal.
    After consideration of all commenters' suggestions, DOE's 
experience in implementing the current rule provisions, and other 
available information, proposed Sec.  850.36(c)(1) would require 
mandatory medical removal for beryllium workers in jobs that include a 
beryllium activity in cases where an employee has a diagnosis of BeS or 
CBD. DOE proposes this amendment because removing workers from jobs 
that risk additional exposure will avoid increasing their body burden 
of beryllium, and potentially reduce the risk of symptomatic beryllium 
disease, or minimize the magnitude of symptoms that may occur.
    DOE recognizes that it is very difficult to establish policy that 
involves trade-offs between the unfettered pursuit of livelihood and 
other potential financial effects, such as insurability and the risk of 
debilitating disease; however, DOE believes that the medical removal 
benefits provisions in proposed Sec.  850.36(d) and the counseling 
provisions in proposed Sec.  850.38(b) of this part would be sufficient 
to assist workers in effectively preparing for, and responding to, 
possible medical removal. For these reasons, DOE believes that the 
proposed policy of mandatory removal is its optimal risk management 
strategy.
    Proposed Sec.  850.36(a)(3) [currently Sec.  850.35(a)(1)] would 
clarify the requirements for temporary or permanent removal of a 
beryllium worker from exposure to beryllium at or above the action 
level. Accordingly, proposed Sec.  850.36(a)(3) would require the SOMD 
to recommend to employers temporary removal of a beryllium worker:
     Pending the outcome of the medical evaluations conducted 
pursuant to Sec.  850.34(b) of this part, if the beryllium worker is 
showing signs or symptoms of BeS or CBD and the SOMD believes that 
further exposure to beryllium at or above the action level may be 
harmful to the worker's health [proposed Sec.  850.36(a)(3)(i)]; or
     Pending the outcome of the multiple physicians or 
alternative physician review process pursuant to proposed Sec.  
850.34(e) and (f) of this part, if the beryllium worker is showing 
signs or symptoms of BeS or CBD and the SOMD believes that further 
exposure to beryllium at or above an action level may be harmful to the 
worker's health [proposed Sec.  850.36(a)(3)(ii)].
    Proposed Sec.  850.36(a)(4) would require the SOMD to recommend 
permanent removal of a beryllium worker from exposure to beryllium at 
or above the action level only when he or she makes a final medical 
determination that the worker should be permanently removed. The SOMD's 
determination to permanently remove a worker would be required to be 
based on a diagnosis of BeS or CDB as defined in Sec.  850.3 of this 
proposed rule.
    Proposed Sec.  850.36(a)(5) would require, within 15 working days 
after a final medical determination has been made, the SOMD to provide 
the employer with a written notice to either return the temporarily 
removed beryllium worker to his or her previous job status, along with 
the steps needed to protect the workers' health including any work 
restrictions [proposed Sec.  850.36(a)(5)(i)]; or, to permanently 
remove the beryllium worker [proposed Sec.  850.36(a)(5)(ii)]. If a 
worker is temporarily removed and the final medical determination is 
made that the beryllium worker does not have a medical condition caused 
by beryllium, the temporary medical removal benefits specified in 
paragraph (d)(1) of this section would end, and the affected worker 
would be able to return to his or her normal duties, unless work 
restrictions would prevent the worker from doing so. If the SOMD makes 
a final medical determination that the worker is not sensitized to 
beryllium and does not have CBD, but further exposure to beryllium at 
or above the action level is medically contraindicated, the SOMD would 
be able to recommend a medical restriction for the worker.
    DOE has learned through its experience implementing this part, as 
issued in December 1999, that a lack of explicit expectations has 
resulted in different understandings of how the SOMD should recommend 
temporary or permanent removal of a worker. Accordingly, proposed Sec.  
850.36(a)(6) would be added to clarify that the SOMD is not required to 
recommend temporary removal first and then permanent removal. If it is 
clear based on the SOMD's medical evaluation that the worker should be 
permanently removed, based on a diagnosis of BeS or CBD, then the SOMD 
may recommend permanent removal.
    Proposed Sec.  850.36(b) [currently Sec.  850.35(a)(3)] would 
establish the counseling requirements for beryllium workers before they 
are placed on either temporary or permanent medical removal, as well as 
clarify the requirements for notifications to the employer. This 
proposed addition

[[Page 36738]]

would help beryllium workers understand and effectively manage the 
potential effects of medical removal.
    DOE has learned through its experience implementing this part, as 
issued in December 1999, that a lack of explicit expectations has 
resulted in different understandings of the individual worker's medical 
removal status. DOE, therefore, proposes adding requirements that will 
help workers understand their medical removal status. Accordingly, 
proposed Sec.  850.36(b)(1) would require that if the SOMD determines a 
beryllium worker should be temporarily or permanently removed, the SOMD 
would be required to perform the following when communicating the 
written medical opinion and determination to the worker pursuant to 
Sec.  850.34(d)(1):
     Advise the beryllium worker diagnosed with BeS or CBD or 
suspected of having BeS or CBD of the determination that medical 
removal is necessary to protect his or her health, and specify whether 
the SOMD is recommending temporary or permanent removal from work that 
involves exposure to beryllium at or above the action level [proposed 
Sec.  850.36(b)(1)(i)]; and
     Provide the beryllium worker with a copy of the rule, 
including its preamble, and information on the risks of continued 
exposure to beryllium at levels at or above the action level, as well 
as the benefits of removal [proposed Sec.  850.36(b)(1)(ii)].
    Proposed Sec.  850.36(b)(2) would be added to clarify the 
notifications the SOMD gives to the employers for removal of workers. 
The SOMD, in communicating the written medical opinion and 
determination to the employer, would be required to comply with Sec.  
850.34(e)(2) of this part. In the case of a final medical determination 
regarding permanent removal, the SOMD would be required to provide the 
employer with a written notice recommending that the employer either:
     If the worker has been on temporary removal, return the 
temporarily removed beryllium worker to his previous job status if the 
SOMD determines that removal is no longer warranted [proposed Sec.  
850.36(b)(2)(i)]; or
     Permanently remove the beryllium worker [proposed Sec.  
850.36(b)(2)(ii)]; or
     Medically restrict the worker pursuant to Sec.  850.35 of 
this part [proposed Sec.  850.36 (b)(2)(iii)].
    Proposed Sec.  850.36(c) would clarify the employer's 
responsibilities for removal of a worker. Proposed Sec.  850.36(c)(1) 
would require the employer, within 15 working days after receiving the 
SOMD's written opinion pursuant to paragraph (b)(2) of this section, 
stating that it is medically appropriate to remove a worker, to remove 
the beryllium worker from the job that involves a beryllium activity, 
regardless of whether at the time of removal a job is available into 
which the removed worker may be transferred.
    Proposed Sec.  850.36(c)(2) would require employers to formally 
notify beryllium workers in writing that they are in medical removal 
status when the employer receives the SOMD's determination that removal 
is warranted. Employers would be required to include a start date for 
medical removal in the written notification. This proposed addition 
should resolve difficulties that have occurred at DOE sites in 
determining when medical removal officially began.
    Proposed Sec.  850.36(c)(3) would establish that when a beryllium 
worker is medically removed, the employer must transfer the removed 
worker to a comparable job, if such a job is available, and provide 
removal benefits in accordance with paragraphs (d)(1) of this section, 
for temporary removal or (d)(2) of this section, for permanent removal.
    DOE is proposing to add Sec.  850.36(c)(4) to clarify that 
employers would not be able to return a worker who has been medically 
removed to his or her former job status unless the SOMD has determined 
in a written medical opinion that continued medical removal is no 
longer necessary to protect the worker's health.
    Proposed Sec.  850.36(d) [currently Sec.  850.35(b)] would continue 
to establish the medical removal benefits that must be provided to 
removed workers. DOE continues to believe that medical removal benefits 
are critical to minimize the disability associated with CBD. Removal 
from exposure and effective job-placement efforts, coupled with early 
diagnosis and treatment, will increase the likelihood that affected 
beryllium workers would continue as productive members of the DOE 
workforce.
    Proposed Sec.  850.36(d)(1)(i) would specify that when a beryllium 
worker has been temporarily removed from a job pursuant to paragraph 
(a)(2) of this section, employers would be required to, consistent with 
any applicable collective bargaining agreement:
     Transfer the worker to a comparable job [proposed Sec.  
850.36(d)(1)(i)(A)]; where beryllium exposures are below the action 
level [proposed Sec.  850.36(d)(1)(i)(A)(1)]; and for which the worker 
is qualified or can be trained for in 6 months or less [proposed Sec.  
850.36(d)(1)(i)(A)(2)];
     Maintain the worker's total normal earnings, and other 
employment rights, as they existed at the time of removal, on each 
occasion that the worker is temporarily removed. The purpose of this 
requirement is to ensure that a removed worker does not suffer 
immediate economic loss due to removal [proposed Sec.  
850.36(d)(1)(i)(B)]. Note, benefits received under the Energy Employees 
Occupational Illness Compensation Program (EEOICP) do not constitute 
wage replacement, and therefore would not offset the employee's medical 
removal benefits.
    DOE has learned with experience implementing this part, as issued 
in December 1999, that a lack of explicit expectations has resulted in 
different understandings of what happens when a job is not available 
for a beryllium worker. Therefore, proposed Sec.  850.36(d)(1)(ii) 
would be added to clarify the requirements for the employer. 
Specifically, if there is no such job for the beryllium worker, the 
employer would be required to provide the workers total normal 
earnings, seniority (to the extent allowed in an applicable bargaining 
agreement), and other employment rights, as if the worker were not 
removed. For temporary removal, the employer would be required to 
provide the beryllium worker's total normal earnings and other 
employment rights, until:
     A comparable job becomes available that meets the 
requirements of (d)(1)(i)(A), and the worker is placed in that job 
[proposed Sec.  850.36(d)(1)(ii)(A)];
     The SOMD determines that the beryllium worker is not 
sensitized to beryllium and does not have CBD and medical removal is 
ended [proposed Sec.  850.36(d)(1)(ii)(B)];
     The beryllium worker is permanently medically removed from 
the job [proposed Sec.  850.36(d)(1)(ii)(C)]; or
     The term of the removal period has expired [proposed Sec.  
850.36(d)(1)(ii)(D)].
    Proposed Sec.  850.36(d)(1)(iii) would be added to clarify that 
each period of temporary removal could not exceed one year and no term 
of temporary removal can immediately succeed a prior term of temporary 
removal to extend the term beyond one year.
    Proposed Sec.  850.36(d)(1)(iv) would be added to require that 
periods of temporary removal received by a worker not be considered 
part of any permanent removal period should the employer provide the 
beryllium worker with temporary and then permanent removal. This 
clarification supports DOE's intent to provide workers with sufficient 
time

[[Page 36739]]

to plan and implement changes in pursuing their livelihood as 
necessitated by permanent medical removal from jobs that involve 
beryllium activities at or above the action level.
    Proposed Sec.  850.36(d)(2) [currently Sec.  850.35(b)(1)] would 
continue to provide permanent medical removal benefits of the CBDPP. 
Accordingly, in proposed Sec.  850.36(d)(2)(i)(A) and (B), if a 
beryllium worker has been permanently removed from a job because of a 
beryllium-induced medical condition pursuant to paragraph (a)(4) of 
this section, the employer would be required to, consistent with any 
applicable collective bargaining agreement, transfer the worker to a 
comparable job [proposed Sec.  850.36(d)(2)(i)(A)], where beryllium 
exposures are below the action level [proposed Sec.  
850.36(d)(2)(i)(A)(I)], and for which the worker is qualified or can be 
trained within a period of up to one year [proposed Sec.  
850.36(d)(2)(i)(A)(II)].
    Proposed Sec.  850.36(d)(2)(i)(B) would clarify that if a beryllium 
worker could not be transferred to a comparable job that meets the 
requirements of (d)(2)(i)(A), the employer would be required to 
maintain the worker's total normal earnings and benefits at the time of 
removal, as if the worker were not permanently removed for up to two 
years. DOE continues to select 2 years as the maximum period during 
which the employer is required to pay medical removal benefits to a 
worker instead of the 18-month protection period established in OSHA's 
lead and cadmium standards. DOE established a different protection 
period for beryllium because of the toxicological differences between 
beryllium and the two metals covered in the OSHA standards. 
Specifically, the early stages of the health impairments associated 
with exposure to lead or cadmium will reverse in time with no 
additional exposure, but the health effects from BeS and CBD typically 
do not. The objective of OSHA's 18-month period is to provide workers 
with sufficient recovery time so they can return to their job. The 
objective of DOE's two-year period, however, is to allow workers 
permanently medically removed sufficient time to be retrained and 
placed in a different job. DOE believes that this period should be long 
enough to enable the majority of removed workers to be retrained and 
placed in another job or, for those workers who can be returned to 
their former job status, to be returned before their medical removal 
benefits expire. Proposed Sec.  850.36(d)(2)(i)(B) would also clarify 
that employers are not required to continue providing medical removal 
benefits after a worker has been permanently removed for up to two 
years. The removed worker who is transferred to a comparable job is not 
guaranteed removal benefits in the form of such job after the two-year 
removal period because permanent medical removal benefits consist of 
either the opportunity to transfer to a comparable job or to receive 
the earnings and benefits associated with a comparable job, if a 
comparable job is not available (e.g., due to layoffs, illness of the 
worker, etc.). After the two-year benefit period expires, employers are 
expected to treat removed workers who have been transferred to a 
comparable job in a neutral and nondiscriminatory fashion, in 
accordance with all applicable state and Federal labor laws.
    DOE does not intend for the beryllium medical removal benefit to 
function as a workers' compensation program. Workers' compensation and 
other work-related compensation for beryllium illness are provided by 
public or employer-funded compensation programs, including the Federal 
EEOICP administered by the DOL.
    Proposed Sec.  850.36(d)(3) [currently Sec.  850.35(b)(5)] would 
continue to establish additional conditions for both temporary and 
permanent removal benefits. Proposed Sec.  850.36(d)(3)(i) would 
clarify that employers providing medical removal benefits is not 
intended to expand upon, restrict or change any rights a worker has or 
would have had, absent medical removal, regarding a specific job 
classification or position under the terms of a collective bargaining 
agreement.
    Proposed Sec.  850.36(d)(3)(ii) [currently Sec.  850.35(b)(2)] 
would continue to establish that during a temporary or permanent 
removal period, employers are required to continue to provide a worker 
total normal earnings and benefits.
    DOE has learned from implementing this part, as issued in December 
1999, that not addressing medical removal benefits when there is a 
change in the worker's job status, caused confusion and different 
implementation among DOE sites. Therefore, proposed Sec.  
850.36(d)(3)(iii) would be added to clarify and require employers to 
continue providing workers medical removal benefits during the removal 
period designated by the SOMD regardless of changes in the workers' 
jobs (e.g., worker is laid off or the contract ends before the removal 
period ends) or whether workers can be transferred into comparable jobs 
because the workers are too sick to work, provided that:
     If the workers are on temporary removal, the employers are 
not required to continue the worker's benefits, as set forth in 
paragraph (d)(1) of this section, beyond one year [proposed Sec.  
850.36(d)(3)(iii)(A)];
     If the worker is on permanent removal, the employer is not 
required to continue the worker's benefits, as set forth in paragraph 
(d)(2) of this section, beyond two years [proposed Sec.  
850.36(d)(3)(iii)(B)].
    Proposed Sec.  850.36(d)(3)(iv) [currently Sec.  850.35(b)(3)] 
would continue to establish that if a removed worker files a claim for 
workers' compensation payments for a beryllium-related disability, the 
employer must continue to provide benefits pending disposition of the 
claim, but no longer than a period of two years. The employer must 
receive no credit for the workers' compensation payments received by 
the worker for treatment related expenses.
    Proposed Sec.  850.36(d)(3)(v) [currently Sec.  850.35(b)(4)] would 
continue to establish that the employer's obligation to provide medical 
removal benefits to a removed worker is reduced to the extent that the 
worker receives compensation for earnings lost during the period of 
removal from a publicly- or employer-funded compensation program, or 
from employment with another employer made possible by virtue of the 
worker's removal. This provision is necessary to ensure that medical 
removal benefits do not result in a ``windfall'' to the worker who 
collects other compensation, including a salary from another job, while 
the worker is on medical removal from beryllium exposure.
    Proposed Sec.  850.36(d)(3)(vi) would be added to inform worker 
that they may also apply for compensation through EEOICP for any 
additional benefits beyond those provided in this proposed section.
    DOE is proposing to delete current Sec.  850.35(a)(4). DOE has 
learned through its experience implementing this part, as issued in 
December 1999, that it would not be a prudent practice to return a 
beryllium worker who has been permanently removed to a job in which the 
worker will be exposed to beryllium at or above the action level.
Proposed Sec.  850.37--Medical Consent
    Proposed Sec.  850.37 [currently Sec.  850.36], would continue to 
establish the medical consent provisions of the CBDPP. This section is 
necessary to ensure that beryllium and beryllium-associated workers 
receive adequate information to make an informed decision about the 
medical surveillance program. Accordingly, proposed

[[Page 36740]]

Sec.  850.37(a) would require that in order to provide each beryllium 
and beryllium-associated worker with the information necessary for the 
workers to make informed decisions about consenting to the medical 
evaluation established in proposed Sec.  850.34 of this part, the 
employer must ensure that the SOMD has the worker sign and date the 
consent form in appendix A(for beryllium workers) or appendix B (for 
beryllium-associated workers) before performing any medical evaluation. 
The dated signature of the worker serves to document the worker 
consented to being tested. DOE would expect employers to make 
reasonable efforts to help workers understand the material.
    Proposed Sec.  850.37(b) would require employers to inform 
beryllium workers that testing is mandatory to transfer into or remain 
in a job involving exposure to beryllium at or above the action level, 
and that a beryllium worker who decides not to consent to the medical 
evaluations that would be required in Sec.  850.34 will be removed from 
a beryllium activity and will not receive medical removal benefits.
Proposed Sec.  850.38--Training and Counseling
    Proposed Sec.  850.38 [currently Sec.  850.37], would continue to 
establish the worker training and counseling requirements regarding 
exposure to beryllium, and the potential health effects associated with 
such exposure. This worker training is necessary because appropriate 
implementation of the required workplace procedures of the CBDPP 
ultimately rests upon the front-line workers who will be performing 
work on, with, or near beryllium or beryllium-contaminated materials. 
These workers cannot be expected to comply with the required CBDPP 
procedures if they are not aware of such procedures.
    DOE expects employers would conduct training in a manner that is 
easy to understand. Training material should be appropriate in content 
and vocabulary for the education level and language background of 
affected workers. The goal of the training would be to ensure all 
workers, regardless of cultural or educational background, have the 
knowledge necessary to reduce and minimize their exposure to beryllium.
    DOE's experience in implementing the training requirements of this 
part, as issued in December 1999, demonstrates that greater 
differentiation of training requirements for different types of workers 
is needed. Therefore, proposed Sec.  850.38 would continue to maintain 
the training requirements of the CBDPP but would clarify the training 
needs of beryllium workers and add training for these workers on the 
benefits of medical evaluations and the content of this part.
    Proposed Sec.  850.38(a)(1) [currently Sec.  850.37(a)(1))] would 
continue to require employers to develop and implement a training 
program for beryllium workers, beryllium-associated workers, and all 
other workers who work at a site where beryllium activities are 
conducted and ensure their participation in the program.
    Proposed Sec.  850.38(a)(2) would establish the training 
requirements for beryllium workers. Specifically, employers would be 
required to provide beryllium workers training on the following:
     The contents of the CBDPP [proposed Sec.  
850.38(a)(2)(i)];
     The potential health risks to family members and others 
who may come in to contact with beryllium if beryllium controls are not 
followed [proposed Sec.  850.38(a)(2)(ii)]. This section relies on the 
workers to relay the relevant beryllium hazard information to their 
families. DOE encourages employers to provide beryllium workers with 
information about beryllium risks that is also readily understandable 
to family members.
     Benefits of medical evaluations for diagnosing BeS and CBD 
[proposed Sec.  850.38(a)(2)(iii)]; and
     The contents of the final rule [proposed Sec.  
850.38(a)(2)(iv)].
    Proposed Sec.  850.38(a)(3) would establish the training 
requirements for beryllium-associated workers and other workers 
identified in paragraph (a)(1) of this section. The training for these 
individuals would continue to require general awareness about beryllium 
hazards and controls training for other workers at a site where 
beryllium activities are conducted. This training should also address 
the benefits of medical evaluations for early diagnosis of BeS or CBD.
    Proposed Sec.  850.38(a)(4) would continue to require employers to 
provide training to workers prior to or at the time of initial 
assignment, and at least every two years thereafter, to ensure that 
workers are appropriately prepared to deal with the hazards and risks 
of working with beryllium. The initial training requirement of this 
paragraph is important to ensure workers have the information they need 
to protect themselves before they are subject to actual or potential 
exposure hazards. Periodic training is necessary to reinforce and 
update initial training; especially with regard to the protective 
actions workers must take at their current jobs to reduce their 
potential for exposure to beryllium. DOE has established two years as 
the minimum frequency requirement.
    Proposed Sec.  850.38(a)(5) would require employers to provide 
retraining when they have reason to believe that a beryllium worker 
lacks the proficiency, knowledge, or understanding needed to work 
safely with beryllium. The retaining would include, at a minimum, the 
following situations:
     To address any new beryllium hazards resulting from a 
change to the beryllium inventory, activities, or controls about which 
the worker was not previously trained [proposed Sec.  850.38(a)(5)(i)]; 
or
     When a worker's performance involving beryllium activities 
indicates that the worker has not retained the requisite proficiency 
[proposed Sec.  850.38(a)(5)(ii)].
    Proposed Sec.  850.38(b) [currently Sec.  850.37(f)], would 
continue require employers to develop and implement a workers 
counseling program to assist workers diagnosed by the SOMD with BeS or 
CBD. The purpose of the counseling program is to communicate 
information to workers that may help them make important health- and 
work-related decisions and perform administrative activities, such as 
filing workers' compensation claims. Accordingly, proposed Sec.  
850.38(b)(1) would require employers to develop and implement a 
counseling program to assist beryllium and beryllium-associated workers 
who are diagnosed by the SOMD with BeS or CBD.
    Proposed Sec.  850.38(b)(2) would require the counseling program 
for beryllium workers to include communicating with the worker 
concerning:
     The medical surveillance program provisions and procedures 
[proposed Sec.  850.38(b)(2)(i)];
     Medical treatment options [proposed Sec.  
850.38(b)(2)(ii)];
     Medical, psychological, and career counseling [proposed 
Sec.  850.38(b)(2)(iii)];
     Medical removal benefits [proposed Sec.  
850.38(b)(2)(iv)];
     Administrative procedures and worker rights under EEOICPA 
and applicable workers' compensation laws and regulations [proposed 
Sec.  850.38(b)(2)(v)]; and
     The risk of continued exposure to beryllium at or above 
the action level and practices to limit exposure [proposed Sec.  
850.38(b)(2)(vi)].
    Proposed Sec.  850.38(b)(3) would clarify the counseling 
requirements for beryllium-associated workers. For beryllium-associated 
workers, employers would be required to communicate information to 
workers concerning the following topics:

[[Page 36741]]

     The medical surveillance program provisions and procedures 
[proposed Sec.  850.38(b)(3)(i)];
     Medical treatment options [proposed Sec.  
850.38(b)(3)(ii)];
     Medical, psychological, and career counseling [proposed 
Sec.  850.38(b)(3)(iii)]; and
     Application procedures under EEOICPA and applicable 
workers' compensation laws and regulations [proposed Sec.  
850.38(b)(3)(iv)].
    In this section, DOE would include the qualifying language 
``application procedures and workers rights' and ``under . . . 
applicable workers compensation laws and regulations'' to make clear 
that DOE still does not intend to establish any new workers' 
compensation obligations. DOE understands that employers may develop 
such counseling programs in consultation with labor organizations 
representing workers, and that employer may wish to advise the workers 
to consult their own attorneys on these matters.
Proposed Sec.  850.39--Warning Signs and Labels
    Proposed Sec.  850.39 [currently Sec.  850.38], would continue to 
require employers to post warning signs and labels to ensure that the 
presence of, and dangers associated with beryllium and beryllium-
contaminated items or areas are communicated to workers.
    DOE received several comments in response to its RFI concerning 
whether DOE should require warning labels for the transfer--to either 
another DOE entity or an entity to whom this rule does not apply--of 
items with surface areas that are free of removable beryllium but that 
might contain surface contamination that is inaccessible or has been 
sealed with hard-to-remove substances (e.g., paint). Most of the 
commenters suggested that DOE should require warning labels when 
individuals could be exposed during the handling of an item (e.g., 
servicing a seldom-accessed part, opening a waste container), or to 
warn the uninformed so as to prevent unplanned beryllium exposures. DOE 
pointed out that the further removed a worker is from direct DOE 
employment (e.g., some DOE facility general contractors hire 
subcontractors, who in turn hire their own subcontractors, and so on), 
the more likely it is that verbal instructions and warnings will be 
insufficient. Other commenters suggested that DOE's labeling 
requirement should allow flexibility to convey the beryllium exposure 
hazard without unduly alarming downstream individuals and without 
preventing potential downstream users from accepting items because of 
unfounded health concerns.
    DOE, in considering suggestions of the RFI commenters and other 
available information, has proposed minor changes to the wording of 
this section, as issued in December 1999. Proposed Sec.  850.39(a) 
would continue to require the posting of warning signs demarcating 
beryllium regulated areas and these signs bear the following warning:

BERYLLIUM REGULATED AREA
DANGER
CANCER AND LUNG DISEASE HAZARD
AUTHORIZED PERSONNEL ONLY

    The purpose of these warning signs is to minimize the number of 
individuals entering a beryllium regulated area by warning workers 
prior to entry. The signs alert workers that they must have the 
appropriate authorization from their supervisor to enter the beryllium 
regulated area. This is especially important when regulated areas are 
established on a temporary basis, such as during cleanup operations. In 
such cases, workers who typically work in or travel through the area 
may not be aware of the new potential for beryllium exposures and thus, 
may not be appropriately equipped for or aware of the need to protect 
themselves from potential exposures. Warning signs also serve as a 
constant reminder to those who work in beryllium regulated areas that 
the potential for exposure to beryllium exists in the area and that 
appropriate controls must be used.
    Proposed Sec.  850.39(b) would continue to require employers use 
warning labels to ensure that individuals who come in contact with 
containers of beryllium, or other beryllium-contaminated items are 
aware of their content and the need to implement special handling 
precautions. Accordingly, this proposed section would add a provision 
requiring employers affix warning labels to all bags, containers, 
equipment, or items that have surface levels of beryllium that exceed 
0.2 [micro]g/100 cm\2\, or that will be released and have beryllium 
material on the surface at levels above the level in soil at the point 
of release. Because the effectiveness of the warning label is greatly 
dependent upon the visibility, accuracy, and understandability of the 
content of the labels, proposed Sec.  850.39(b)(1) would specify that 
labels bear the following information:

DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD

    Proposed Sec.  850.39(b)(2) would add a new provision that would 
require employers to affix warning labels to equipment or items that 
contain sources of beryllium in typically inaccessible locations or 
embedded in hard-to-remove substances. This label is for less hazardous 
situations in which the beryllium is normally inaccessible but could be 
released with effort (e.g., by disassembling machine tools that were 
used for processing beryllium, or by removing paint that encapsulates 
beryllium particulates). This proposed section would require that 
labels bear the following information:

CAUTION
CONTAINS BERYLLIUM IN INACCESSIBLE LOCATIONS OR EMBEDDED IN HARD-TO-
REMOVE SUBSTANCES
DO NOT RELEASE AIRBORNE BERYLLIUM DUST
CANCER AND LUNG DISEASE HAZARD
Proposed Sec.  850.40--Recordkeeping and Use of Information
    Proposed Sec.  850.40 [currently Sec.  850.39] would continue to 
require employers to establish and effectively manage records that 
relate to the CBDPP and to periodically submit to the Office of 
Environment, Health, Safety and Security a registry of beryllium and 
beryllium-associated workers. Proposed Sec.  850.40 would also clarify 
recordkeeping requirements that are not clearly defined in the current 
rule, and the use of such information by both DOE contractor and 
Federal employers. Proposed Sec.  850.40(a) would require contractor 
employers to:
     Establish and maintain records in accordance with 10 CFR 
part 851, Worker Safety and Health Program, for records generated by 
their CBDPP, and include records of beryllium medical evaluations and 
training [proposed Sec.  850.40(a)(1)]. This would revise the current 
requirement for consistency with 10 CFR 851.26, Recordkeeping and 
reporting.
     Maintain employees' medical records in accordance with DOE 
System of Records DOE-33, Personnel Medical Records [proposed Sec.  
850.40(a)(2)]. This requirement would be added to clarify the system of 
records with which employers are required to comply.
     Maintain all records required by this part in current and 
accessible electronic systems [proposed Sec.  850.40(a)(3)]. This 
requirement, currently in Sec.  850.39(f), is necessary to facilitate 
timely, efficient, and cost-effective transfer and analysis of CBDPP-
related data. DOE continues to use the phrase ``current and 
accessible'' in this section because DOE's experience indicates that 
the ability to use information held in electronic records is severely 
hampered if the

[[Page 36742]]

electronic systems are out-of-date or the records are difficult to 
retrieve.
     Convey all record series required by this rule to the 
appropriate Head of DOE Field Element, or his or her designee, if this 
part ceases to be applicable (e.g., if the employer ceases to be a DOE 
contractor) [proposed Sec.  850.40(a)(4)]. This requirement would be 
added to ensure that DOE has access to and ownership of such records 
generated during contract performance for its contractors performing 
beryllium activities at DOE sites and clarifies management, retention 
and disposal of records after contract termination.
    Proposed Sec.  850.40(b) would continue to require Federal 
employers to:
     Establish and maintain complete and accurate records 
generated by the CBDPP submitted by DOE offices, including all 
beryllium inventory information, hazard assessments, exposure 
measurements of Federal employees, exposure control, medical 
evaluations, and training for operations or activities implemented by 
DOE offices [proposed Sec.  850.40(b)(1)].
     Maintain Federal employees' medical records in accordance 
with the Office of Personnel Management's OPM/GOVT-10, Employee Medical 
File System Records for Federal Employees [proposed Sec.  
850.40(b)(2)]. This requirement would be added to clarify the system of 
records for Federal employees.
     Maintain all records required by this part in current and 
accessible electronic systems. This requirement is necessary to 
facilitate timely, efficient, and cost-effective transfer and analysis 
of CBDPP-related data [proposed Sec.  850.40(b)(3); currently Sec.  
850.39(f)].
    Proposed Sec.  850.40(c) would continue to require Heads of DOE 
Field Elements and CSOs to designate all record series required by this 
rule as agency records and ensure that these records are retained for a 
minimum of 75 years. This practice is consistent with DOE's policy on 
retaining medical records. This requirement would continue to ensure 
that required CBDPP records that relate to workplace conditions will be 
available to correlate with the beryllium and beryllium-associated 
workers' medical records. DOE expects that Heads of DOE Field Elements 
will direct their DOE contracting officers to stipulate DOE ownership 
of these documents in those contracts.
    Proposed Sec.  850.40(d)(1) would require both contractor and 
Federal employers to ensure the confidentiality of all personally 
identifiable information in work-related records generated in response 
to this rule by making sure that:
     All records that are transmitted to other parties are 
transmitted consistent with the Privacy Act, the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), and their 
implementing regulations [proposed Sec.  850.40(d)(1)(i)]. DOE 
recognizes that employers must take these precautions to prevent the 
violation of privacy laws because personal information could be 
obtained from transmitted records, or inferred from information other 
than personal identifiers in the records, unless these precautions are 
taken.
     Individual medical information generated by the CBDPP is 
[proposed Sec.  850.40(d)(1)(ii)]:
     Either included as part of the worker's site medical 
records and maintained by the SOMD, or is maintained by another 
physician designated by the employer [proposed Sec.  
850.40(d)(1)(ii)(A)];
     Required to be maintained as confidential medical records 
separately from non-medical records [proposed Sec.  
850.40(d)(1)(ii)(B)]; and
     Used or disclosed in conformance with any applicable 
requirement of the American with Disabilities Act of 1990, HIPAA, and 
any other applicable law or regulation[proposed Sec.  
850.40(d)(1)(ii)(C)].
    Proposed Sec.  850.40(d)(2) would continue to require employers to 
maintain all records generated as required by this rule, in current and 
accessible electronic systems, which include the ability to readily 
retrieve data in a format that maintains confidentiality. This 
requirement is necessary to facilitate timely, efficient, and cost-
effective transfer and analysis of CBD-related data.
    Proposed Sec.  850.40(d)(3) would require employers to transmit all 
records generated by this rule to the Office of Environment, Health, 
Safety and Security, upon request.
    Proposed Sec.  850.40(d)(4) would continue to require employers to 
semi-annually transmit to the Office of Environment, Health, Safety and 
Security an electronic registry of beryllium and beryllium-associated 
workers that protects confidentiality, and the registry must include, a 
unique identifier for each individual, date of birth, gender, site job 
history, medical screening test results, exposure measurements, surface 
contamination levels, and results of referrals for specialized medical 
evaluations. The format of the information transmitted should currently 
comply with DOE Technical Standard 1187-2007 (DOE-STD-1187-2007), 
Beryllium-Associated Worker Registry Data Collection and Management 
Guidance, June 2007. Using this format would ensure consistency among 
DOE sites with respect to Beryllium Registry submittals. DOE expects 
employers to submit only the information that is already available. DOE 
does not propose requiring the employer to generate information solely 
for the purpose of submitting that information to the Beryllium 
Registry. DOE also believes that using the Beryllium Registry's format 
would implement DOE's Office of Inspector General's recommendation for 
CBDPPs in DOE/IG-0726, Implementation of the Department of Energy's 
Beryllium-Associated Worker Registry, April 2006, that Departmental 
program offices and sites adopt DOE-STD-1187-2007 in their individual 
CBDPPs.
Proposed Sec.  850.41--Performance Feedback.
    Proposed Sec.  850.41 [currently Sec.  850.40] would continue to 
establish the performance feedback provisions for the CBDPP. 
Accordingly, proposed Sec.  850.41(a) [currently Sec.  850.40(a)] would 
be revised for consistency among the sites and would require employers 
to conduct semi-annual assessments of the following:
     Monitoring results [proposed Sec.  850.41(a)(1)];
     Hazard assessments [proposed Sec.  850.41(a)(2)];
     Medical surveillance [proposed Sec.  850.41(a)(3)]; and
     Exposure reduction efforts [proposed Sec.  850.41(a)(4)].
    DOE believes that the assessment of this data is important for the 
continuous improvement of the program.
    Proposed Sec.  850.41(b), would be added to require the assessments 
to identify any:
     Individuals at risk for beryllium-induced medical 
conditions and the working conditions that may be contributing to that 
risk [proposed Sec.  850.41(b)(1)]; and
     Need for additional exposure controls [proposed Sec.  
850.41(b)(2)].
    To ensure that workers have the information necessary to safely 
perform their assigned tasks, proposed Sec.  850.41(c) [currently Sec.  
850.40(b)], would require employers to notify and make the assessment 
available to the appropriate Head of DOE Field Element, line managers, 
work planners, worker protection staff, medical staff, workers, and 
labor organizations representing beryllium workers performing beryllium 
activities. DOE believes that the requirement would improve 
communication among employers, managers, and others to more effectively

[[Page 36743]]

evaluate and monitor program effectiveness.

D. Appendix A to Part 850-- Beryllium Worker Chronic Beryllium Disease 
Prevention Program Consent Form (Mandatory) [Currently Appendix A to 
Part 850--Chronic Beryllium Disease Prevention Program Informed Consent 
Form]

    Proposed appendix A would revise the Chronic Beryllium Disease 
Prevention Program Informed Consent Form in the current rule by adding 
text to reflect the proposed amendments to Sec. Sec.  850.34 and 850.37 
requiring mandatory medical evaluations for beryllium workers. As 
stated earlier, 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 beryllium workers and 
beryllium associated workers.

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

    Proposed Appendix B would be added to reflect the proposed 
amendments to Sec. Sec.  850.34 and 850.37 as they relate to the 
voluntary medical evaluations for beryllium-associated workers.

V. Procedural Requirements

A. Review Under Executive Orders 12866 and 13563

    This regulatory action has been determined to be a significant 
regulatory action under Executive Order 12866, ``Regulatory Planning 
and Review,'' 58 FR 51735 (October 4, 1993). Accordingly, this action 
was subject to review under the Executive Order by the Office of 
Information and Regulatory Affairs (OIRA). The assessment of the 
potential costs and benefits of the rule required by section 6(a)(3) of 
the Executive Order has been made a part of the rulemaking file and is 
available for public review as provided in the ADDRESSES section of 
this NOPR.
    Before conducting the assessment, DOE profiled the 22 sites and 
activities affected by the proposed CBDPP rule and estimated the number 
of workers affected by the proposed rule. DOE estimated that 20,444 
workers may have been or be exposed or potentially exposed in the DOE 
complex. Based on exposure monitoring data submitted since 2002 to the 
Beryllium-Associated Worker Registry (BAWR), DOE estimated that 1,261 
of these workers are potentially exposed at or above the proposed 
action level (0.05 [micro]g/m\3\) or the permissible exposure limit 
prescribed in the CBDPP rule.
    DOE estimated the compliance costs of the proposed amendments to 
the CBDPP rule for its 22 beryllium sites. 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 un-annualized first year costs of $41.4 million to $42.7 
million, of which $7.8 million to $11.2 million are annually recurring 
costs. Most costs are related to establishing additional regulated 
areas, which are estimated to average $37.1 million in initial costs, 
or 84 to 87 percent of total initial costs. In addition, DOE expects 
its sites will experience cost-savings attributable to linguistic 
changes and clarifications in the proposed amendments to 10 CFR part 
850.
    DOE assessed potential benefits and cost-savings of the proposed 
amendments to the CBDPP for DOE, DOE contractors, and workers. DOE 
assessed the following benefits of the proposed CBDPP rule if it is 
adopted as a final rule: (1) Reduced medical costs; (2) reduced 
mortality; (3) increased quality of life; (4) increased medical 
surveillance for workers at risk; (5) increased work-life for beryllium 
workers; (6) reduced confusion and dispute over the legal liability of 
DOE and DOE contractors; (7) reduced restrictions and costs for the 
release and transfer of equipment or areas with potential beryllium 
contamination; (8) reduced control of areas where measured beryllium is 
a result of naturally high levels of beryllium in the soil or 
surrounding environment; (9) reduced turnaround time for sample 
analysis due to the use of portable laboratories; and (10) 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.
    DOE also assessed the potential economic impact of the proposed 
rule on the provision of public goods that contain beryllium and the 
impact on the market for beryllium. DOE assessed each of these 
potential impacts and determined neither will impose a significant 
economic impact. DOE determined that the potential reduction in the 
provision of beryllium-containing public goods will be minimal and, 
consequently, the reduction in demand for beryllium will be small.
    DOE has also reviewed this regulation pursuant to Executive Order 
13563, issued on January 18, 2011 (76 FR 3281, Jan. 21, 2011). 
Executive Order 13563 is supplemental to and explicitly reaffirms the 
principles, structures, and definitions governing regulatory review 
established in Executive Order 12866. To the extent permitted by law, 
agencies are required by Executive Order 13563 to: (1) Propose or adopt 
a regulation only upon a reasoned determination that its benefits 
justify its costs (recognizing that some benefits and costs are 
difficult to quantify); (2) tailor regulations to impose the least 
burden on society, consistent with obtaining regulatory objectives, 
taking into account, among other things, and to the extent practicable, 
the costs of cumulative regulations; (3) select, in choosing among 
alternative regulatory approaches, those approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity); 
(4) to the extent feasible, specify performance objectives, rather than 
specifying the behavior or manner of compliance that regulated entities 
must adopt; and (5) identify and assess available alternatives to 
direct regulation, including providing economic incentives to encourage 
the desired behavior, such as user fees or marketable permits, or 
providing information upon which choices can be made by the public.
    DOE emphasizes as well that Executive Order 13563 requires agencies 
to use the best available techniques to quantify anticipated present 
and future benefits and costs as accurately as possible. In its 
guidance, the Office of Information and Regulatory Affairs has 
emphasized that such techniques may include identifying changing future 
compliance costs that might result from technological innovation or 
anticipated behavioral changes. DOE believes that this NOPR is 
consistent with these principles, including the requirement that, to 
the extent permitted by law, agencies adopt a regulation only upon a 
reasoned determination that its benefits justify its costs and, in 
choosing among alternative regulatory approaches, those approaches 
maximize net benefits.

[[Page 36744]]

B. Review Under the Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) 
requires that an agency prepare an initial regulatory flexibility 
analysis for any regulation for which a general notice of proposed 
rulemaking is required, unless the agency certifies that the rule, if 
promulgated, will not have a significant economic impact on a 
substantial number of small entities (5 U.S.C. 605(b)).
    This proposed rule would update DOE's regulations on CBDPP. This 
proposed rule applies only to activities conducted by DOE or by DOE's 
contractors. The contractors who manage and operate DOE facilities 
would be principally responsible for implementing the rule 
requirements. DOE considered whether these contractors are ``small 
businesses'' as the term is defined in the Regulatory Flexibility Act 
(5 U.S.C. 601(3)). The Regulatory Flexibility Act's definition 
incorporates the definition of small business concerns in the Small 
Business Act, which the Small Business Administration (SBA) has 
developed through size standards in 13 CFR part 121. DOE expects that 
any potential economic impact of this proposed rule on small businesses 
would be minimal because work performed at DOE sites is under contracts 
with DOE or the prime contractor at the site. DOE contractors are 
usually reimbursed through their contracts for the costs of complying 
with CBDPP requirements. Therefore, most would not be adversely 
impacted by the requirements in this proposed rule. For these reasons, 
DOE certifies that this proposed rule, if promulgated, would not have a 
significant economic impact on a substantial number of small entities, 
and therefore, no regulatory flexibility analysis has been prepared.

C. Review Under the Paperwork Reduction Act

    The information collection provisions of this proposed rule are not 
substantially different from those contained in DOE contracts with DOE 
prime contractors covered by the current CBDPP rule, and were 
previously approved by the Office of Management and Budget (OMB) and 
assigned OMB Control No. 1910-5112. That approval covered submission to 
develop and submit an initial CBDPP to DOE for approval; periodically 
revise the CBDPP; conduct a baseline inventory of beryllium at the 
site; notify workers of exposure monitoring results; develop and 
maintain a registry of beryllium workers; require workers to sign 
consent forms for beryllium work and medical surveillance; establish 
and maintain records related to the beryllium inventory and hazard 
assessment, exposure monitoring, workplace controls and medical 
surveillance; and establish a performance feedback process for 
continually evaluating and improving the CBDPP. Accordingly, no 
additional OMB clearance is required by the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.) and the procedures implementing that Act, 
5 CFR 1320.1 et seq.

D. Review Under the National Environmental Policy Act

    DOE has determined that this proposed rule is covered under the 
Categorical Exclusion found in DOE's National Environmental Policy Act 
regulations at paragraph A.5 of appendix A to subpart D, 10 CFR part 
1021, which applies to a rulemaking that amends an existing rule or 
regulation that does not change the environmental effect of the rule or 
regulation being amended.

E. Review Under Executive Order 12988

    Section 3 of Executive Order 12988, ``Civil Justice Reform,'' 61 FR 
4729 (February 7, 1996), instructs each agency to adhere to certain 
requirements in promulgating new regulations. Executive agencies are 
required by section 3(a) to adhere to the following general 
requirements: (1) Eliminate drafting errors and ambiguity; (2) write 
regulations to minimize litigation; and (3) provide a clear legal 
standard for affected conduct rather than a general standard and 
promote simplification and burden reduction. With regard to the review 
required by section 3(a), section 3(b) of Executive Order 12988 
specifically requires that Executive agencies make every reasonable 
effort to ensure that the regulation: (1) Clearly specifies the 
preemptive effect, if any; (2) clearly specifies any effect on existing 
Federal law or regulation; (3) provides a clear legal standard for 
affected conduct while promoting simplification and burden reduction; 
(4) specifies the retroactive effect, if any; (5) adequately defines 
key terms; and (6) addresses other important issues affecting clarity 
and general draftsmanship under any guidelines issued by the Attorney 
General. Section 3(c) of Executive Order 12988 requires Executive 
agencies to review regulations in light of applicable standards in 
section 3(a) and section 3(b) to determine whether they are met or it 
is unreasonable to meet one or more of them. DOE has completed the 
required review and determined that, to the extent permitted by law, 
this proposed rule meets the relevant standards of Executive Order 
12988.

F. Review Under Executive Order 13132

    Executive Order 13132, ``Federalism'' (64 FR 43255, August 4, 
1999), imposes certain requirements on agencies formulating and 
implementing policies or regulations that preempt State law or that 
have federalism implications. Agencies are required to examine the 
constitutional and statutory authority supporting any action that would 
limit the policymaking discretion of the States and carefully assess 
the necessity for such actions. DOE has examined this proposed rule and 
has determined that it would not preempt State law and would not have a 
substantial direct effect on the States, the relationship between the 
national government and the States, or the distribution of power and 
responsibilities among the various levels of government. No further 
action is required by Executive Order 13132.

G. Review Under Executive Order 13175

    Under Executive Order 13175 (65 FR 67249, November 6, 2000) on 
``Consultation and Coordination with Indian Tribal Governments,'' DOE 
may not issue a discretionary rule that has ``tribal'' implications and 
imposes substantial direct compliance costs on Indian tribal 
governments. DOE has determined that the proposed rule would not have 
such effects and concluded that Executive Order 13175 does not apply to 
this proposed rule.

H. Review Under the Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires each Federal agency to prepare a written assessment of 
the effects of any Federal mandate in a proposed or final agency 
regulation that may result in the expenditure by states, tribal, or 
local governments, on the aggregate, or by the private sector, of $100 
million in any one year. The Act also requires a Federal agency to 
develop an effective process to permit timely input by elected 
officials of state, tribal, or local governments on a proposed 
``significant intergovernmental mandate,'' and requires an agency plan 
for giving notice and opportunity to provide timely input to 
potentially affected small governments before establishing any 
requirements that might significantly or uniquely affect small 
governments. DOE has determined that the proposed rule published does 
not contain any Federal mandates affecting small governments, so these 
requirements do not apply.

[[Page 36745]]

I. Review Under Executive Order 13211

    Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use,'' 66 FR 28355 
(May 22, 2001) requires Federal agencies to prepare and submit to the 
OMB a Statement of Energy Effects for any proposed significant energy 
action. A ``significant energy action'' is defined as any action by an 
agency that promulgated or is expected to lead to promulgation of a 
final rule, and that: (1) Is a significant regulatory action under 
Executive Order 12866, or any successor order; and (2) is likely to 
have a significant adverse effect on the supply, distribution, or use 
of energy, or (3) is designated by the Administrator of OIRA as a 
significant energy action. For any proposed significant energy action, 
the agency must give a detailed statement of any adverse effects on 
energy supply, distribution, or use should the proposal be implemented, 
and of reasonable alternatives to the action and their expected 
benefits on energy supply, distribution, and use. This regulatory 
action would not have a significant adverse effect on the supply, 
distribution, or use of energy and is therefore not a significant 
energy action. Accordingly, DOE has not prepared a Statement of Energy 
Effects.

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

    Section 654 of the Treasury and General Government Appropriations 
Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family 
Policymaking Assessment for any proposed rule that may affect family 
well being. The proposed rule would not have any impact on the autonomy 
or integrity of the family as an institution. Accordingly, DOE has 
concluded that it is not necessary to prepare a Family Policymaking 
Assessment.

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

    The Treasury and General Government Appropriations Act, 2001 (44 
U.S.C. 3516 note) provides for agencies to review most disseminations 
of information to the public under guidelines established by each 
agency pursuant to general guidelines issued by OMB.
    OMB's guidelines were published at 67 FR 8452 (February 22, 2002), 
and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). 
DOE has reviewed this proposed rule under the OMB and DOE guidelines 
and has concluded that it is consistent with applicable policies in 
those guidelines.

VI. Public Participation

A. Attendance at the Public Hearings

    Public hearings will be held at the times, dates, and places 
indicated in the DATES and ADDRESSES sections at the beginning of this 
NOPR. Any person who is interested in making an oral presentation 
should, by 4:30 p.m. on the date specified, make a phone request to the 
telephone number in the DATES section of this NOPR. The person should 
provide a daytime telephone number where he or she may be reached. A 
person requesting an opportunity to speak will be notified as to the 
approximate time he or she will be speaking. Each presentation is 
limited to 10 minutes. A person making an oral presentation should 
bring a copy of their statements to the hearing on a CD or USB flash 
drive and submit them at the registration desk. Foreign nationals 
visiting DOE Headquarters are subject to advance security screening 
procedures. Please note that foreign nationals visiting DOE 
Headquarters are subject to advance security screening procedures. Any 
foreign national wishing to participate in this public hearing should 
advise DOE as soon as possible by contacting Ms. Rogers to initiate the 
necessary procedures. Please also note that those wishing to bring 
laptops into the Forrestal Building will be required to obtain a 
property pass. Visitors should avoid bringing laptops, or allow an 
extra 45 minutes.

B. Conduct of the Public Hearings

    A DOE official will be designated to preside at each hearing, which 
will not be judicial or evidentiary. Only those conducting the hearing 
may ask questions. Any further procedural rules needed to conduct the 
hearing properly will be announced by the DOE presiding official. A 
court reporter will be present to record the proceedings and prepare a 
transcript. DOE reserves the right to select the people who will speak. 
In the event that requests exceed the time allowed, DOE also reserves 
the right to schedule speakers' presentations and to establish the 
procedures for conducting the hearing.
    A transcript of each hearing will be included in the docket, which 
can be viewed as described in the Docket section at the beginning of 
this notice. In addition, transcripts may be purchased from the 
transcribing reporter.
    If DOE must cancel the hearings, it will make every effort to give 
advance notice.

C. Submission of Comments

    DOE will accept comments, data and information regarding this 
proposed rule before or after the public hearings, but no later than 
the date provided in the DATES section at the beginning of this 
proposed rule. Interested individuals are invited to participate in 
this proceeding by submitting data, views, or arguments with respect to 
this proposed rule using any of the methods described in the ADDRESSES 
section at the beginning of this notice. To help the Department review 
the submitted comments, commenters are requested to reference the 
paragraph(s), e.g., Sec.  850.3(a), to which they refer where possible.
    1. Submitting comments via regulations.gov. The regulations.gov Web 
page will require you to provide your name and contact information. 
Your contact information will be viewable to DOE's Office of 
Environment, Health, Safety and Security staff only. Your contact 
information will not be publicly viewable except for your first and 
last names, organization name (if any), and submitter representative 
name (if any). If your comment is not processed properly because of 
technical difficulties, DOE will use this information to contact you. 
If DOE cannot read your comment due to technical difficulties and 
cannot contact you for clarification, DOE may not be able to consider 
your comment. However, your contact information will be publicly 
viewable if you include it in the comment itself or in any documents 
attached to your comment. Any information that you do not want to be 
publicly viewable should not be included in your comment, nor in any 
document attached to your comment. Otherwise, persons viewing comments 
will see only first and last names, organization names, correspondence 
containing comments, and any documents submitted with the comments.
    Do not submit to regulations.gov information for which disclosure 
is restricted by statute, such as trade secrets and commercial or 
financial information (hereinafter referred to as Confidential Business 
Information (CBI)). Comments submitted through regulations.gov cannot 
be claimed as CBI. Comments received through the Web site will waive 
any CBI claims for the information submitted. For information on 
submitting CBI, see the

[[Page 36746]]

Confidential Business Information section below.
    DOE processes submissions made through regulations.gov before 
posting. Normally, comments will be posted within a few days of being 
submitted. However, if large volumes of comments are being processed 
simultaneously, your comment may not be viewable for up to several 
weeks. Please keep the comment tracking number that regulations.gov 
provides after you have successfully uploaded your comment.
    2. Submitting comments via email, mail or hand delivery/courier. 
Comments and documents submitted via email, mail, or hand delivery/
courier, also will be posted to regulations.gov. If you do not want 
your personal contact information to be publicly viewable, do not 
include it in your comment or any accompanying documents. Instead, 
provide your contact information in a cover letter. Include your first 
and last names, email address, telephone number, and optional mailing 
address. The cover letter will not be publicly viewable as long as it 
does not include any comments.
    Include contact information each time you submit comments, data, 
documents, and other information to DOE. If you submit via mail or hand 
delivery/courier, please provide all items on a CD or USB flash drive, 
if feasible. It is not necessary to submit printed copies. No 
facsimiles (faxes) will be accepted.
    Comments, data, and other information submitted to DOE 
electronically should be provided in PDF (preferred), Microsoft Word or 
Excel, WordPerfect, or text (ASCII) file format. Provide documents that 
are not secured, that are written in English, and that are free of any 
defects or viruses. Documents should not contain special characters or 
any form of encryption and, if possible, they should carry the 
electronic signature of the author.
    3. Confidential Business Information. Pursuant to the provisions of 
10 CFR 1004.11, anyone submitting information or data he or she 
believes to be confidential and exempt by law from public disclosure 
should submit via email, postal mail two well-marked copies: One copy 
of the document marked ``CONFIDENTIAL BUSINESS INFORMATION'' including 
all the information believed to be confidential, and one copy of the 
document marked ``NO CONFIDENTIAL BUSINESS INFORMATION'' with the 
information believed to be confidential deleted. Submit these documents 
via email or CD, if feasible. DOE will make its own determination as to 
the confidentiality of the information and treat it accordingly. 
Factors of interest to DOE when evaluating requests to treat submitted 
information as confidential include: (1) A description of the items; 
(2) whether and why such items are customarily treated as confidential 
within the industry; (3) whether the information is generally known by 
or available from other sources; (4) whether the information has 
previously been made available to others without obligation concerning 
its confidentiality; (5) an explanation of the competitive injury to 
the submitting person which would result from public disclosure; (6) 
when such information might lose its confidential character due to the 
passage of time; and (7) why disclosure of the information would be 
contrary to the public interest.
    It is DOE's policy that all comments may be included in the public 
docket, without change and as received, including any personal 
information provided in the comments (except information deemed to be 
exempt from public disclosure).
    4. Campaign form letters. Please submit campaign form letters by 
the originating organization in batches of between 50 to 500 form 
letters per PDF or as one form letter with a list of supporters' names 
compiled into one or more PDFs. This reduces comment processing and 
posting time.

References

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    14. Stange AW, Hilmas DE, Furman FJ, Gatliffe TR. ``Beryllium 
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Mar;16(3):405-17.
    15. Newman LS, Mroz MM, Balkissoon R, Maier LA. ``Beryllium 
sensitization progresses to chronic beryllium disease: a 
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Respiratory and Critical Care Medicine. 2005;171:54-60
    16. Mroz MM, Maier LA, Strand M, Silviera L, Newman LS. 
``Beryllium lymphocyte proliferation test surveillance identifies 
clinically significant beryllium disease.'' American Journal of 
Industrial Medicine. 2009 Oct; 52(10):762-73.
    17. Rosenman K, Hertzberg V, Rice C, Reilly MJ, Aronchick J, 
Parker JE, Regovich J, Rossman M. ``Chronic beryllium disease and 
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Thundiyil J, King TE Jr, Harber P, Balmes JR. ``Low prevalence of 
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at a nuclear weapons research and development facility.'' Journal of 
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    23. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium 
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    25. McCanlies EC, Yucesoy B, Mnatsakanova A, Slaven JE, Andrew 
M, Frye BL, Schuler CR, Kreiss K, Weston A. ``Association between 
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    28. Marchand-Adam S, El Khatib A, Guillon F, Brauner MW, 
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Industrial Hygienists, Cincinnati, OH.
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Chemosphere, doi:10.1016/j.chemosphere.2010.12.088, 2011.
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``In Vitro Dissolution Characteristics of Beryllium Oxide and 
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19(3):333-342.
    32. Stefanik AB, Day GA, Hoover MD, Breysse PN, Scripsick R. 
``Differences in dissolution behavior in phagolysosomal stimulant 
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``Identification of an abnormal beryllium lymphocyte proliferation 
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Theoretical Medicine and Bioethics. 05 Dec 2008.
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``Flow Cytometric Test for Beryllium Sensitivity.'' Cytometry Part B 
Clinical Cytometry. 2004:60B:23-30.

List of Subjects in 10 CFR Part 850

    Beryllium, Hazardous substances, Lung diseases, Occupational safety 
and health, Reporting and recordkeeping requirements.

    Issued in Washington, DC, on May 16, 2016.
Ernest J. Moniz,
Secretary of Energy.

    For the reasons set forth in the preamble, the Department of Energy 
proposes to revise part 850 of chapter III of title 10 of the Code of 
Federal Regulations to read as follows:

PART 850--CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM

Subpart A--General Provisions
Sec.
850.1 Scope.
850.2 Applicability.
850.3 Definitions.
850.4 Enforcement.
850.5 Dispute resolution.
850.6 Interpretations, binding interpretive rulings and requests for 
information.
Subpart B--Administrative Requirements
850.10 Development and approval of the CBDPP.
850.11 General CBDPP requirements.
850.12 Implementation.
850.13 Compliance.
Subpart C--Specific Program Requirements
850.20 Beryllium inventory.
850.21 Hazard assessment and abatement.
850.22 Permissible exposure limit.
850.23 Action level.
850.24 Exposure monitoring.
850.25 Exposure reduction.
850.26 Beryllium regulated areas.
850.27 Hygiene facilities and practices.
850.28 Respiratory protection.
850.29 Protective clothing and equipment.
850.30 Housekeeping.
850.31 Release and transfer criteria.
850.32 Waste disposal.
850.33 Beryllium emergencies.
850.34 Medical surveillance.
850.35 Medical restriction.
850.36 Medical removal and benefits.
850.37 Medical consent.
850.38 Training and counseling.
850.39 Warning signs and labels.
850.40 Recordkeeping and use of information.
850.41 Performance feedback.

Appendix A to Part 850--Beryllium Worker Chronic Beryllium Disease 
Prevention Program Consent Form (Mandatory)

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

    Authority: 42 U.S.C. 2201(i)(3), (p); 42 U.S.C. 2282c; 29 U.S.C. 
668; 42 U.S.C. 7101 et seq., 50 U.S.C. 2401 et seq., E.O. 12196, as 
amended.

[[Page 36748]]

Subpart A--General Provisions


Sec.  850.1  Scope.

    This part provides for the establishment of a chronic beryllium 
disease prevention program (CBDPP) for DOE employees and DOE contractor 
employees, and supplements and is deemed an integral part of the worker 
safety and health program required under part 851 of this chapter for 
DOE contractor employees. If there is a conflict between the 
requirements of this part, and part 851, this part controls.


Sec.  850.2  Applicability.

    (a) This part applies to:
    (1) DOE contractors and DOE offices responsible for operations or 
activities that involve present or past exposure, or the potential for 
exposure, to airborne concentrations of beryllium at or above the 
action level at DOE sites;
    (2) Any current DOE contractor employee and DOE employee at a DOE 
site who was exposed or potentially exposed to airborne concentrations 
of beryllium at or above the action level at a DOE site; and
    (3) The Site Occupational Medical Directors (SOMD) responsible for 
providing the overall direction and operation of the employer's 
beryllium medical surveillance program.
    (b) This part does not apply to:
    (1) Activities involving beryllium articles; and
    (2) DOE laboratory operations that meet the definition of 
laboratory use of hazardous chemicals in 29 CFR 1910.1450, Occupational 
Exposure to Hazardous Chemicals in Laboratories.


Sec.  850.3  Definitions.

    (a) As used in this part:
    Action level means the airborne concentration of beryllium which, 
at or above, triggers the implementation of worker protection 
provisions as specified in Sec.  850.23 of this part are required.
    Authorized person means any person required by work duties to be in 
a regulated area.
    Beryllium means elemental beryllium, beryllium oxide, and any alloy 
containing 0.1% or greater of beryllium by weight that may be released 
as an airborne particulate.
    Beryllium activity means any activity taken for or by DOE at a DOE 
site that can expose workers to levels of airborne beryllium at or 
above the action level, including the disturbance of legacy beryllium-
containing dust.
    Beryllium article means 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 which does not release 
particulate beryllium at or above the action level under normal 
conditions of use.
    Beryllium-associated worker means a current worker, who was exposed 
or potentially exposed to airborne concentrations of beryllium at a DOE 
site, including a worker:
    (1) Whose work history shows that the worker may have been exposed 
to airborne concentrations of beryllium at a DOE site;
    (2) Who exhibits signs or symptoms of beryllium exposure; or
    (3) Who is receiving medical removal benefits under this part.
    Beryllium emergency means 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.
    Beryllium-Induced Lymphocyte Proliferation Test (BeLPT) is an in 
vitro measure of the beryllium antigen-specific, cell-mediated immune 
response to beryllium. In this part, 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.
    Beryllium-induced medical condition refers to CBD and BeS. Other 
diseases may resemble CBD, but are not attributable to beryllium.
    Beryllium Registry refers the DOE Beryllium-Associated Worker 
Registry.
    Beryllium regulated area means an area demarcated by the employer 
in which the airborne concentration of beryllium at or above, or can 
reasonably be expected to be at or above, the action level.
    Beryllium sensitization or sensitivity (BeS) means 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.
    Beryllium worker means a current worker who is exposed or 
potentially exposed to levels of airborne concentration of beryllium at 
or above the action level in the course of the worker's employment in a 
DOE beryllium activity.
    Breathing zone is a hemisphere forward of the shoulders, centered 
on the mouth and nose, with a radius of 6 to 9 inches.
    Chronic beryllium disease (CBD) means 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 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) means, 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 means any entity, including affiliated entities, such as 
a parent corporation, under contract with DOE, or a subcontractor at 
any tier that has responsibilities for performing beryllium work at a 
DOE site in furtherance of a DOE mission.
    DOE means the U.S. Department of Energy.
    DOE site means a DOE-owned or -leased area or location or other 
area or 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.
    Employer means:
    (1) For DOE contractors employees, the DOE contractor that is 
directly responsible for the safety and health of DOE contractor 
employees while performing a beryllium activity or other activity at a 
DOE site; or
    (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 a DOE office or 
contractor with respect to terms and conditions of employment of 
beryllium and beryllium-associated workers.
    Final medical determination means the final written medical 
determination of the SOMD as to whether the beryllium worker should be 
permanently removed because of BeS or CBD as those terms are defined in 
this part. If the worker is eligible and has elected the multiple 
physician review or alternate physician's review, the SOMD issues the 
final medical determination at the conclusion of such process. The

[[Page 36749]]

initial determination is also the final determination if the worker 
does not make a timely request for a multiple physician review or 
alternate physician review.
    Head of DOE Field Element means an individual who is the manager or 
head of the DOE operations office or field office.
    High-efficiency particulate air (HEPA) filter means a filter 
capable of trapping and retaining at least 99.97% of 0.3 micrometer 
mono-dispersed particles.
    Medical removal benefits means the employment benefits established 
by Sec.  850.36 of this part for beryllium workers who are temporarily 
or permanently medically removed from beryllium activities at or above 
the action level following a determination by the SOMD that removal is 
warranted.
    Medical restriction means the outcome of the process in which the 
SOMD recommends that the worker be restricted from a job that involves 
a beryllium activity when health evaluations indicate the worker is not 
suffering from CBD or has not been sensitized to beryllium, but the 
SOMD determines that exposure to beryllium at or above the action level 
is contraindicated due to other medical conditions of the worker. In 
addition, medical restrictions must be performed in accordance with 10 
CFR part 851, appendix A, section 8.
    Qualified Individual means 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) means the physician 
responsible for the overall direction and operation of the site 
occupational medicine program.
    Surface levels of beryllium means the amount of beryllium easily 
removed from surfaces by means such as casual contact, wiping, or 
brushing.
    Unique identifier means 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 means 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.
    (b) Terms undefined in this part that are defined in the Atomic 
Energy Act of 1954, as amended, or 10 CFR part 851, Worker Safety and 
Health Program, have the same meaning as under that Act and regulation, 
as applicable.


Sec.  850.4  Enforcement.

    DOE may take appropriate steps pursuant to part 851 of this chapter 
to enforce compliance by contractors with this part and any DOE-
approved contractor CBDPP.


Sec.  850.5  Dispute resolution.

    (a) Any worker who is adversely affected by an action taken, or a 
failure to act, under this part may petition the Office of Hearings and 
Appeals for relief in accordance with 10 CFR part 1003, subpart G, 
Office of Hearings and Appeals Procedural Regulations; Private 
Grievances and Redress, subject to paragraphs (b) and (c) of this 
section.
    (b) The Office of Hearings and Appeals may elect not to accept a 
petition from a worker unless the worker had requested that the 
employer correct the violation, and the employer refused or failed to 
take corrective action within a reasonable time.
    (c) If the dispute relates to a term or condition of employment 
that is covered by a grievance-arbitration provision in a collective 
bargaining agreement, the worker must exhaust all applicable grievance-
arbitration procedures before filing a petition for relief with the 
Office of Hearings and Appeals. A worker is deemed to have exhausted 
all applicable grievance-arbitration procedures if 150 days have passed 
since the filing of a grievance and a final decision has not been 
issued.


Sec.  850.6  Interpretations, binding interpretive rulings, and 
requests for information.

    Requests for legal interpretations, binding interpretive rulings, 
and requests for information regarding this part must be in accordance 
10 CFR 851.6, Petitions for generally applicable rulemaking, 851.7, 
Requests for a binding interpretative ruling, or 851.8, Informal 
requests for information, respectively.

Subpart B--Administrative Requirements


Sec.  850.10  Development and approval of the CBDPP.

    (a) Preparation and submittal of CBDPP to DOE. (1) Subject to the 
provisions of Sec.  851.13 of this part, each employer engaged in 
beryllium activities at a DOE site must submit a CBDPP for review and 
approval, as indicated in Sec.  850.10(b), no later than [date 90 days 
after effective date of final rule];
    (2) Each employer at a DOE site which is not engaged in beryllium 
activities but which employs beryllium-associated workers must submit a 
CBDPP with the provisions applicable to those workers (e.g., medical 
evaluations, training, recordkeeping) for review and approval as 
indicated in Sec.  850.10(b), no later than [date 90 days after 
effective date of final rule];
    (3) If the CBDPP has separate sections addressing the beryllium 
activities of multiple contractors at the site, the Head of DOE Field 
Element will designate a single contractor to review the sections 
prepared by the other contractors, so that a single consolidated CBDPP 
for the site is submitted to the Head of DOE Field Element for review 
and approval; and
    (4) Employers at a multiple contractor site must share relevant 
information generated by the assessment required by Sec.  850.41(a), to 
ensure the safety and health of their workers.
    (b) DOE review and approval. (1) The appropriate Head of DOE Field 
Element must review and provide written approval or rejection of the 
applicable contractor's CBDPP, or any updates to the CBDPP, within 90 
working days of receiving the document. The appropriate Head of DOE 
Field Element may direct the applicable contractor to modify the CBDPP 
or any updates to the CBDPP during their review.
    (2) The appropriate CSO must review and provide written approval or 
rejection of the CBDPP, or any updates to the CBDPP submitted by DOE 
offices within 90 working days of receiving the document. The 
appropriate CSO may direct the DOE office to modify the CBDPP or any 
updates to the CBDPP during their review.
    (3) The CBDPP and any updates are deemed approved 90 working days 
after submission to the Head of DOE Field Element or the CSO, if they 
are not specifically approved or rejected earlier.
    (4) Employers must furnish a copy of the approved CBDPP to the 
Office of Environment, Health, Safety and Security; DOE program 
offices; and affected workers or their designated representative upon 
request.
    (c) Updates. Employers must submit an update of the CBDPP for 
review and approval within 30 working days after a significant change 
or significant addition to the CBDPP is made or warranted, or a change 
in contractors occurs. The Head of DOE Field Element or appropriate 
CSO, as applicable, must review the CBDPP at least annually and,

[[Page 36750]]

if appropriate, require the employer to update the CBDPP.
    (d) Labor organizations. If an employer employs or supervises 
workers who are represented for collective bargaining purposes by a 
labor organization, the employer must:
    (1) Give the labor organization timely notice of the development 
and implementation of the CBDPP and any updates thereto; and
    (2) Upon timely request, bargain concerning implementation of this 
part, consistent with Federal labor laws and this part.


Sec.  850.11  General CBDPP requirements.

    (a) The CBDPP must specify existing and planned beryllium 
activities.
    (b) The scope and content of the CBDPP must be commensurate with 
the hazard of the activities performed. In all cases it must:
    (1) Include formal plans and measures for maintaining exposures to 
beryllium that are below the levels prescribed in Sec.  850.22;
    (2) Satisfy the requirements in subpart C, Specific Program 
Requirements, of this part; and
    (3) Contain provisions for minimizing the number of:
    (i) Workers exposed to airborne concentrations of beryllium at or 
above the action level; and
    (ii) Instances in which workers are exposed to airborne 
concentrations of beryllium at or above the action level.


Sec.  850.12  Implementation.

    (a) Employers must manage and control beryllium activities 
consistent with the approved CBDPP.
    (b) Activities that are outside the scope of the approved CBDPP 
involving unexpected exposure to airborne concentrations of beryllium 
at or above the action level may only be initiated upon written 
approval by the Head of DOE Field Element or appropriate CSO, as 
applicable.
    (c) No person employed by DOE or a DOE contractor may take or cause 
any action inconsistent with the requirements of 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.
    (d) Nothing in this part precludes an employer from taking any 
additional protective actions that it determines to be necessary to 
protect the safety and health of workers provided that the employer 
continues to comply with the requirements of this part.
    (e) Nothing in this part is intended to diminish the 
responsibilities of DOE officials under the Federal Employee 
Occupational Safety and Health Program (29 CFR part 1960) and related 
DOE directives.


Sec.  850.13  Compliance.

    (a) Employers may continue to conduct beryllium activities in 
compliance with their previously approved CBDPP until [date 1 year 
after the effective date of the final rule].
    (b) Employers must conduct activities under their approved CBDPP in 
compliance with this part as issued on [effective date of the final 
rule] by [1 year after the effective date of the final rule].
    (c) With respect to a particular beryllium activity, the contractor 
in charge of the activity is responsible for complying with this part. 
If no contractor is responsible for the beryllium activity, and Federal 
employees perform the activity, DOE must ensure implementation of, and 
compliance with, this part.

Subpart C--Specific Program Requirements


Sec.  850.20  Beryllium inventory.

    (a) The employer must identify and develop an inventory of 
beryllium activities and locations of potential beryllium 
contamination. In developing the inventory the employer must:
    (1) Review current and historical records;
    (2) Interview workers;
    (3) Conduct air, surface, and bulk sampling, as appropriate, to 
characterize the beryllium and its locations; and
    (4) Document the locations of beryllium at or above the action 
level at the site.
    (b) Inventory results obtained within 12 months prior to [effective 
date of the final rule] may be used to satisfy this requirement if a 
Qualified Individual determines that conditions represented by the 
results have not changed in a manner that warrants changes in the 
beryllium inventory. The employer must update the beryllium inventory 
at least annually and when significant changes occur to beryllium 
activities.
    (c) The employer must ensure that the beryllium inventory is 
conducted and managed by a Qualified Individual as defined in this 
rule.


Sec.  850.21  Hazard assessment and abatement.

    (a) Employers must conduct a beryllium hazard assessment if the 
inventory establishes the presence of airborne beryllium that is 
potentially at or above the action level.
    (b) The beryllium hazard assessment must be conducted in accordance 
with 10 CFR 851.21, Hazard Identification and Assessment.
    (c) Beryllium hazards must be abated in accordance with 10 CFR 
851.22, Hazard prevention and abatement.
    (d) Employers must ensure that paragraphs (a) through (c) of this 
section are managed by a Qualified Individual as defined in this part.


Sec.  850.22  Permissible exposure limit.

    (a) Employers must ensure that no worker is exposed to an airborne 
concentration of beryllium greater than the 8-hour TWA PEL established 
in 29 CFR 1910.1000, as measured in the worker's breathing zone by 
personal monitoring, or a more stringent 8-hour TWA PEL that may be 
promulgated by the Occupational Safety and Health Administration (OSHA) 
as an expanded health standard for beryllium.
    (b) DOE must inform employers through a notice in the Federal 
Register of any applicable changes to the OSHA 8-hour TWA PEL described 
in paragraph (a) of this section.


Sec.  850.23  Action level.

    (a) Employers must include in their CBDPPs an action level that is 
no greater than 0.05 [mu]g/m\3\, calculated as an 8-hour time weighted 
average exposure, as measured in the worker's breathing zone by 
personal monitoring.
    (b) If the airborne level of beryllium is at or above the level 
specified in paragraph (a) of this section, employers must implement 
Sec. Sec.  850.24(c) (periodic exposure monitoring), 850.25 (exposure 
reduction), 850.26 (beryllium regulated areas), 850.27 (hygiene 
facilities and practices), 850.28 (respiratory protection), 850.29 
(protective clothing and equipment),850.30 (housekeeping), and 850.39 
(warning signs and labels).


Sec.  850.24  Exposure monitoring.

    (a) General. (1) The employer must ensure that exposure monitoring 
is managed by a Qualified Individual and conducted as specified in the 
approved CBDPP.
    (2) The employer must ensure that:
    (i) Air exposure levels are determined by conducting breathing zone 
sampling and reported as the 8-hour time-weighted average level to 
which a worker would be exposed if the worker were not using 
respiratory protective equipment.
    (ii) Surface levels of beryllium are determined by using:
    (A) Wet wipes; or
    (B) Dry wipes if wet wipes would have an undesirable effect on the 
surface being sampled or surrounding surfaces, or if it is not 
technically feasible because the texture of the

[[Page 36751]]

surface is not compatible with wet wiping methods; or
    (C) Vacuum surface sampling if wipes are not technically feasible 
because the texture of the surface is not compatible with wiping 
methods; or
    (D) Bulk sampling where accumulations of material on a surface 
exceed amounts that are conducive to wipe or vacuum sampling.
    (3) Surface sampling is not required for the interior of installed 
closed systems such as enclosures, glove boxes, chambers, or 
ventilation systems, or normally inaccessible surfaces such as under 
fixed cabinets or on the tops of overhead structural beams, unless 
these surfaces will become accessible or disturbed by planned work 
activity.
    (b) Initial exposure monitoring. (1) Employers, except as provided 
for in paragraphs (b)(2) and (3) of this section, must perform initial 
exposure monitoring when the inventory and hazard assessment show there 
is, or the potential for, airborne concentrations of beryllium at or 
above the action level.
    (2) Monitoring results obtained within 12 months prior to 
[effective date of the final rule] may be used to satisfy this 
requirement if a Qualified Individual determines that conditions 
represented by the results have not changed in a manner that would 
necessitate changes in beryllium controls.
    (3) Where the employer has relied upon objective data that 
demonstrate 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, then no initial monitoring 
is required.
    (c) Periodic exposure monitoring. (1) The employer must conduct 
periodic exposure monitoring of workers in locations where the airborne 
concentration of beryllium is at or above the action level. The 
monitoring must be conducted:
    (i) In a manner and at a frequency necessary to represent workers' 
exposures; and
    (ii) For the first year of operation, at least quarterly (every 
three months).
    (2) After the first year, and subject to paragraph (d) of this 
section, the employer may reduce or terminate monitoring if it 
demonstrates that the airborne concentration of beryllium is below the 
action level for 6 months, based 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, the employer must 
continue periodic monitoring on a quarterly basis.
    (d) Additional exposure monitoring. The employer must conduct 
additional monitoring whenever there has been a production, process, 
control, or other change that may result in an exposure to beryllium 
that is at or above the action level. This monitoring must continue on 
a quarterly basis until the employer can demonstrate that the airborne 
concentration of beryllium is below the action level.
    (e) Analysis quality assurance. (1) All samples collected to 
satisfy the monitoring requirements of this part must be analyzed in a 
laboratory that:
    (i) Is accredited for beryllium analysis by the American Industrial 
Hygiene Association's Laboratory Accreditation Programs, LLC (AIHA-LAP, 
LLC), or
    (ii) Is certified or accredited by a recognized laboratory quality 
assurance certifying or accrediting organization and demonstrates 
quality assurance for metal analysis, including beryllium, that is 
equivalent to AIHA-LAP, LLC accreditation for beryllium.
    (2) The employer may use:
    (i) Field or portable laboratories that are accredited by an AIHA-
LAP, LLC or in an equivalent quality assurance program that addresses 
field or portable laboratory analyses of beryllium samples; and
    (ii) Air exposure results below laboratory reporting limits.
    (f) Notification of monitoring results. (1) The employer must 
notify workers in the same work area of the exposure monitoring results 
within 10 working days after receipt of the results. Notifications of 
exposure monitoring results must be:
    (i) In written or electronic format and posted in locations or in 
electronic systems that are readily accessible to the workers, but in a 
manner that does not identify an individual worker; and
    (ii) For individuals that were sampled, the results must be 
provided in written or electronic format directly to the individual.
    (2) If the monitoring results indicate that exposures are at or 
above the action level, the employer's notification of exposure 
monitoring results must include:
    (i) A statement that exposures are at or above the specified level;
    (ii) A description of the controls being implemented to address 
those exposures.
    (3) If the monitoring results indicate that worker exposure is at 
or above the action level, the responsible employer must also notify 
the appropriate Head of DOE Field Element and the SOMD of these results 
within 10 working days after receipt of the results.


Sec.  850.25  Exposure reduction.

    The employer must establish a formal hazard prevention and 
abatement program in accordance with 10 CFR 851.22, Hazard Prevention 
and Abatement, to reduce exposures to below the action level.


Sec.  850.26  Beryllium regulated areas.

    (a) Employers must establish a beryllium regulated area in 
facilities wherever the level of airborne beryllium is at or above the 
action level;
    (b) Employers must:
    (1) Demarcate beryllium regulated areas from the rest of the 
workplace in a manner that adequately alerts workers to the boundaries 
of such areas;
    (2) Limit access to beryllium regulated areas to authorized 
persons; and
    (3) Keep records of all individuals who enter beryllium regulated 
areas that include the name, date, time in and time out, and work 
activity.


Sec.  850.27  Hygiene facilities and practices.

    (a) General. The employer must ensure that in beryllium regulated 
areas:
    (1) Food or beverage and tobacco products are not consumed or used;
    (2) Cosmetics are not applied, except in changing rooms or areas 
and shower facilities required under paragraphs (b) and (c) of this 
section; and
    (3) Workers are prevented from exiting areas that contain beryllium 
with contamination on their bodies or their personal clothing.
    (b) Change rooms or areas. The employer must:
    (1) Provide separate rooms or areas for beryllium workers to change 
into, and store, personal clothing and clean protective clothing and 
equipment; and
    (2) Ensure that changing rooms or areas being used to remove 
beryllium-contaminated clothing and protective equipment are kept under 
negative pressure or located so as to minimize dispersion of beryllium 
into clean areas.
    (c) Showers and hand washing facilities. The employer must:
    (1) Provide handwashing and shower facilities for beryllium workers 
who work in beryllium regulated areas; and
    (2) Ensure that beryllium workers who work in beryllium regulated 
areas shower at the end of their work shifts.
    (d) Lunchroom facilities. The employer must:
    (1) Provide lunchroom facilities that are readily accessible to 
beryllium workers and in which the airborne concentration of beryllium 
is not at or above the action level.
    (2) Ensure that beryllium workers do not enter lunchroom facilities 
with

[[Page 36752]]

protective clothing or equipment that has been used in a regulated area 
unless the surfaces have been cleaned by HEPA vacuuming or other method 
that removes beryllium without dispersing it.
    (e) The change rooms or areas shower and handwashing facilities, 
and lunchroom facilities must comply with 29 CFR 1910.141, Sanitation.


Sec.  850.28  Respiratory protection.

    (a) The employers must provide a respiratory protection in 
accordance with 10 CFR 851.23, Safety and Health Standards, and 10 CFR 
part 851, appendix A, section 6. Industrial Hygiene.
    (b) [Reserved]


Sec.  850.29  Protective clothing and equipment.

    (a) The employer must provide protective clothing and equipment to 
beryllium workers and ensure its appropriate use and maintenance by 
workers where dispersible forms of beryllium may contact workers' skin, 
enter openings in workers' skin, or contact workers' eyes including 
where:
    (1) Exposure monitoring has established that the airborne 
concentration of beryllium is at or above the action level;
    (2) Surface contamination levels measured or presumed prior to 
initiating work are at or above the level prescribed in Sec.  850.30;
    (3) Surface contamination levels results obtained to confirm 
housekeeping efforts are above the level prescribed in Sec.  850.30; 
and
    (4) Any worker requests the use of protective clothing and 
equipment for protection against airborne beryllium, regardless of the 
measured exposure level.
    (b) Employers must comply with 29 CFR 1910.132, Personal Protective 
Equipment General Requirements, when workers use personal protective 
clothing and equipment.
    (c) Employers must establish procedures for donning, doffing, 
handling, and storing protective clothing and equipment that:
    (1) Prevent beryllium workers from exiting beryllium regulated 
areas with contamination on their bodies or clothing; and
    (2) Include beryllium workers exchanging their personal clothing 
and footwear for protective clothing and footwear before entering 
beryllium regulated areas.
    (d) Employers must ensure that no worker removes beryllium-
contaminated protective clothing and equipment from beryllium regulated 
areas except for workers authorized to launder, clean, maintain, or 
dispose of the clothing and equipment.
    (e) Employers must prohibit the removal of beryllium from 
protective clothing and equipment by blowing, shaking, or other 
cleaning methods that may disperse beryllium into the air.
    (f) Employers must ensure that protective clothing and equipment is 
cleaned, laundered, repaired, or replaced as needed to maintain 
effectiveness. Employers must:
    (1) Ensure that beryllium-contaminated protective clothing and 
equipment when removed for laundering, cleaning, maintenance, or 
disposal is placed in containers that prevent the dispersion of 
beryllium particulate and that the container is labeled in accordance 
with Sec.  850.39(b)(1); and
    (2) Inform organizations that launder or clean DOE beryllium-
contaminated clothing or equipment that exposure to beryllium is 
harmful, and that clothing and equipment should be laundered or cleaned 
in a manner prescribed by the informing employer to prevent the 
dispersion of beryllium particulates.


Sec.  850.30  Housekeeping.

    (a) Where beryllium is present in operational areas of DOE 
facilities at or above the action level, the employer must conduct 
routine surface sampling to determine housekeeping conditions. Surfaces 
contaminated with beryllium dusts and waste must not exceed a removable 
contamination level of 3 [mu]g/100cm\2\ during non-operational periods. 
This sampling would not include the interior of installed closed 
systems such as enclosures, glove boxes, chambers, or ventilation 
systems.
    (b) When cleaning floors and surfaces of removable beryllium, the 
employer must use a wet method, HEPA vacuuming, or other cleaning 
methods that avoid the dispersion of dust, such as wiping with sticky 
cloths. Compressed air or dry methods that may disperse beryllium 
particulates must not be used for such cleaning.
    (c) The employer must use vacuum units that are equipped with HEPA 
filters, as defined in this part, to clean beryllium-contaminated 
surfaces, and change the filters as often as needed to maintain the 
effectiveness of the vacuum unit.
    (d) The employer must ensure that the cleaning equipment that is 
used to clean beryllium-contaminated surfaces is labeled in accordance 
with Sec.  850.39(b), controlled, and not used for non-hazardous 
materials.


Sec.  850.31  Release and transfer criteria.

    (a) Release and transfer. Except where the beryllium is in normally 
inaccessible locations or embedded in hard-to-remove substances, prior 
to the release or transfer of equipment, items, or areas to areas that 
are not beryllium regulated areas, the employer must ensure that for 
formerly beryllium-contaminated equipment, items or areas the removable 
contamination level does not exceed the following:
    (1) Surface level of beryllium is at or below 0.2 [mu]g/100 cm\2\; 
or
    (2) Concentration of beryllium in bulk material on the surface is 
lower than the concentration in soil at the point of release; or
    (3) Airborne levels of beryllium in an enclosure of the smallest 
practical size surrounding the equipment or item, or in an isolating 
enclosure of the area do not exceed 0.01 [mu]g/m\3\.
    (b) Release or transfer with inaccessible beryllium. For the 
release from a beryllium regulated area of equipment, items, or areas 
that contain sources of beryllium in normally inaccessible locations or 
embedded in hard-to-remove substances, the employer must comply with 
paragraphs (a)(1) through (3) of this section for accessible beryllium, 
and the employer must ensure that:
    (1) The equipment, item, or area is labeled in accordance with 
Sec.  850.39(b)(2); and
    (2) The release is conditioned on the recipient's commitment to 
implement controls that will prevent foreseeable beryllium exposure, 
considering the nature of the equipment or item or area and its future 
use.
    (c) Release or transfer with levels that exceed 0.2 [mu]g/100 
cm\2\. For equipment, items, or areas that have removable beryllium 
above 0.2 [mu]g/100 cm\2\; or that have beryllium in material on the 
surface at levels above the natural level in soil at the point of 
release, the employer must:
    (1) Provide the recipient with a copy of this part;
    (2) Condition the release on the recipient's commitment to control 
foreseeable beryllium exposures from the equipment, item, or area 
considering its future use;
    (3) Label the equipment, item, or area in accordance with Sec.  
850.39(a) or (b)(1), as applicable;
    (4) Place any such equipment or items in sealed, impermeable bags 
or containers, or have sealants applied that prevent the release of 
beryllium during handling and transportation; and
    (5) Ensure that the beryllium that remains removable on the 
surfaces of areas is below 3.0 [mu]g/100 cm\2\.

[[Page 36753]]

Sec.  850.32  Waste disposal.

    (a) When disposing of beryllium waste, the employer must:
    (1) Use sealed, impermeable bags, containers, or enclosures to 
prevent the release of beryllium dust during handling and 
transportation; and
    (2) Label the bags, containers and enclosures for disposal 
according to Sec.  850.39(b)(1).
    (b) [Reserved]


Sec.  850.33  Beryllium emergencies.

    (a) The employers must provide and ensure compliance with 
procedures for handling beryllium emergencies as they relate to 
decontamination and decommissioning operations and all other 
operations, that are in accordance with 10 CFR 851.23, Safety and 
Health Standards.
    (b) [Reserved]


Sec.  850.34  Medical surveillance.

    (a) General. Employers must establish and implement a medical 
surveillance program which is mandatory for beryllium workers and 
voluntary for the beryllium-associated workers. Employers must:
    (1) Designate a SOMD who is responsible for administering the 
medical surveillance program;
    (2) Ensure that the medical evaluations and procedures required by 
this section are performed by, or under the supervision of, a licensed 
physician who is qualified to diagnose beryllium-induced medical 
conditions;
    (3) Establish and maintain a list of all beryllium and beryllium-
associated workers; and
    (4) Provide the SOMD with the information needed to operate and 
administer the medical surveillance program, including:
    (i) The list of workers established pursuant to paragraph (a)(3) of 
this section;
    (ii) Hazard assessment and exposures monitoring data;
    (iii) The identity and nature of activities that are covered under 
the CBDPP;
    (iv) A description of the workers' duties as they pertain to 
exposures to levels of beryllium at or above the action level;
    (v) Records of the workers' beryllium exposures;
    (vi) A description of the personal and respiratory protective 
equipment used by the workers; and
    (vii) A copy of this part.
    (5) Ensure that the SOMD and beryllium or beryllium-associated 
workers complete the consent form in appendix A of this part for 
beryllium workers or appendix B of this part for beryllium-associated 
workers, before performing any medical evaluations for beryllium or 
beryllium-associated workers.
    (6) Notify beryllium-associated workers on an annual basis of their 
right to participate in the medical surveillance program. If the 
beryllium-associated worker declines at that time, he or she may elect 
to participate at any time during the year, but must notify the 
employer in writing of his or her intent to participate.
    (b) Medical evaluations and procedures. Employers must provide the 
medical evaluations and procedures required by this section at no cost 
to the worker, without loss of pay, and at a time and place that is 
reasonable and convenient for the worker.
    (1) Baseline medical evaluations. (i) Employers must provide 
baseline medical evaluations that are:
    (A) Mandatory for beryllium workers; and
    (B) Voluntary for beryllium-associated workers.
    (ii) Baseline medical evaluations must include:
    (A) A detailed medical and work history with emphasis on exposure 
or the potential for exposure to beryllium;
    (B) A respiratory symptoms questionnaire;
    (C) A physical examination, with special emphasis on the 
respiratory system, skin and eyes;
    (D) 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, unless there 
is an existing baseline chest radiograph that may be used to meet this 
requirement;
    (E) Spirometry consisting of forced vital capacity (FVC) and forced 
expiratory volume at 1 second (FEV1);
    (F) Two peripheral blood BeLPTs; and
    (G) Any other tests deemed appropriate by the SOMD for evaluating 
beryllium-induced medical conditions.
    (iii) [Reserved]
    (2) Periodic medical evaluations. (i) Employers must provide:
    (A) An annual medical evaluation to beryllium workers;
    (B) A medical evaluation every three years to beryllium-associated 
workers who voluntarily participate in the program; and
    (C) A medical evaluation to a beryllium worker or a beryllium-
associated worker who voluntarily participates in the program, and when 
the worker exhibits signs and symptoms of beryllium sensitization or 
chronic beryllium diseases if the SOMD determines that an evaluation is 
warranted.
    (ii) The periodic medical evaluation must include the following:
    (A) 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 unless there 
is a chest radiograph obtained in the previous five years that may be 
used to meet this requirement.
    (B) Updates to the worker's medical and work history with emphasis 
on exposures to levels of beryllium;
    (C) A respiratory symptoms questionnaire;
    (D) A physical examination, with special emphasis on the 
respiratory system, skin and eyes;
    (E) Two peripheral blood Be-LPTs; and
    (F) Any other tests deemed appropriate by the SOMD for evaluating 
beryllium-induced medical conditions.
    (3) Emergency evaluation. The employer must provide a medical 
evaluation as soon as possible to any worker who may have been exposed 
to beryllium because of a beryllium emergency, as defined in this part. 
The medical evaluation must include the tests and examinations listed 
in paragraph (b)(2)(ii) of this section.
    (4) Exit medical evaluation. (i) If a baseline or periodic 
evaluation has not been performed within the previous six months, 
employers must:
    (A) Provide an exit medical evaluation to beryllium workers at the 
time of the worker's separation from employment; and
    (B) Offer an exit medical evaluation to beryllium-associated 
workers who voluntarily participate in the medical surveillance program 
at the time of the worker's separation from employment.
    (ii) The exit medical evaluation must include:
    (A) 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 unless there 
is a chest radiograph obtained in the previous five years that may be 
used to meet this requirement.
    (B) Updates of the workers' medical and work history with emphasis 
on exposures to levels of beryllium;
    (C) A respiratory symptoms questionnaire;
    (D) A physical examination, with special emphasis on the 
respiratory system, skin and eyes;
    (E) Two peripheral blood Be-LPTs; and
    (F) Any other tests deemed appropriate by the SOMD for evaluating 
beryllium-induced medical conditions.

[[Page 36754]]

    (c) [Reserved]
    (d) Written medical opinions and determinations. The SOMD must 
provide a written, signed medical opinion and determination after 
receiving the results from the medical evaluations performed pursuant 
to paragraph (b) of this section.
    (1) Written medical opinion and determination for beryllium and 
beryllium-associated workers. (i) Within 15 working days after 
receiving the results from the evaluations performed pursuant to 
paragraph (b)(1) through (3) of this section, the SOMD must provide the 
beryllium or beryllium-associated worker with:
    (A) A written medical opinion containing the purpose and results of 
all medical tests or procedures;
    (B) An explanation of any abnormal findings;
    (C) The basis for the SOMD's medical opinion;
    (D) Any determination of whether:
    (1) In the case of a beryllium worker, temporary or permanent 
removal of the beryllium worker from beryllium exposure is warranted 
pursuant to Sec.  850.36; or
    (2) A medical restriction pursuant to 10 CFR part 851, appendix A, 
section 8(h) is appropriate for the worker.
    (E) An opportunity to ask, and have answered, questions regarding 
the information provided.
    (ii) The written medical opinion must take into account the 
findings, determinations and recommendations of physicians who have 
examined the worker and provided written results of such examination to 
the SOMD, provided the examining physician is qualified to diagnose 
beryllium-induced conditions.
    (iii) The SOMD must obtain the beryllium or beryllium-associated 
worker's dated signature on a copy of the written opinion and include 
it in the worker's medical record. If the worker declines to sign the 
statement, then the SOMD must make a record of that fact, the date on 
which the information was provided, and that the worker declined to 
sign the statement.
    (iv) Within 15 working days after receiving the results from an 
exit evaluation performed pursuant to Sec.  850.34(b)(4), the SOMD must 
provide the worker with:
    (A) A written medical opinion containing the purpose and results of 
all medical tests or procedures;
    (B) An explanation of any abnormal findings;
    (C) The basis for the SOMD's medical opinion; and
    (D) An opportunity to ask, and have answered, questions regarding 
the information provided.
    (2) Written medical opinion and determination for the employer. (i) 
Within 5 working days after delivering the written medical opinion 
pursuant to paragraph (d)(1)(i) of this section to the beryllium or 
beryllium-associated worker, the SOMD must provide the employer with a 
written medical opinion that includes:
    (A) The diagnosis of the worker with BeS or CBD, or any other 
medical condition for which exposure to beryllium at or above the 
action level would be contraindicated.
    (B) A determination of whether:
    (1) In the case of a beryllium worker, temporary or permanent 
removal of the worker from beryllium exposure is warranted pursuant to 
Sec.  850.36 of this part; or
    (2) A medical restriction pursuant to 10 CFR part 851, appendix A, 
section 8(h) is appropriate for the worker; and
    (C) A statement that the SOMD has clearly explained to the worker 
the results of the medical evaluations, including all test results and 
any medical condition related to beryllium exposure that requires 
further evaluations or treatment.
    (ii) The SOMD's written medical opinion to the employer must not 
reveal specific records, findings, and diagnoses that are not related 
to beryllium-induced conditions or other medical conditions indicating 
the worker should not perform certain job tasks.
    (iii) Within 5 working days after delivering the written medical 
opinion pursuant to paragraph (d)(1)(iv) of this section, for an exit 
evaluation performed pursuant to Sec.  850.34(b)(4) of this part, the 
SOMD must provide the employer with the diagnosis of the worker's 
condition or indicating the worker should not perform certain job 
tasks.
    (3) [Reserved]
    (e) Multiple physician review process. (1) The employer must 
establish a multiple physician review process for beryllium and 
beryllium-associated workers that allows for the review of initial 
medical findings, determinations, or recommendations from any medical 
evaluation conducted pursuant to paragraphs (b)(1) through (3) [i.e., 
baseline, periodic or emergency evaluation] of this section.
    (2) Within 15 working days after the employer receives the written 
medical determination pursuant to paragraph (d)(2) of this section, the 
employer must notify a beryllium or beryllium-associated worker in 
writing of the worker's right to elect the multiple physician review 
process or alternate physician review process pursuant to this section.
    (3) The employer's participation in, and payment for, the multiple 
physician review process for a beryllium-associated worker is 
conditioned on the worker's participation in the medical surveillance 
program pursuant to paragraph (b) of this section.
    (4) The beryllium or beryllium-associated worker must:
    (i) Notify the employer in writing within 15 working days after 
receiving the employer's written notification pursuant to paragraph 
(e)(2) of this section, of the worker's intention to seek a second 
opinion on the results of any medical evaluation conducted pursuant to 
paragraphs (b)(1) through (3) of this section;
    (ii) Identify in writing to the SOMD within 20 working days after 
delivering the notice pursuant to paragraph (e)(4)(i) of this section, 
a physician who is qualified to diagnose beryllium-induced medical 
conditions to:
    (A) Review all findings, determinations, or recommendations of the 
initial physician;
    (B) Conduct such examinations, consultations, and laboratory tests 
as the second physician deems necessary to facilitate this review; and
    (C) Provide the employer and the worker with a written medical 
opinion within 30 working days after completing the review pursuant to 
paragraphs (e)(4)(ii)(A) and (B).
    (5) If the findings, determinations, or recommendations of the two 
physicians differ significantly, then the employer and the beryllium or 
beryllium-associated worker must make efforts to encourage and assist 
the two physicians to resolve the disagreement.
    (6) If the two physicians are unable to resolve their disagreement, 
then the employer and the beryllium or beryllium-associated worker, 
through their respective physicians, must designate a third physician 
to:
    (i) Review any findings, determinations, or recommendations of the 
other two physicians;
    (ii) Conduct such examinations, consultations, laboratory tests, 
and consultations with the other two physicians as the third physician 
deems necessary to resolve the disagreement among them; and
    (iii) Provide the employer and the beryllium or beryllium-
associated worker with a written medical opinion within 30 working days 
after completing the review pursuant to paragraphs (e)(6)(i) and (ii) 
of this section.
    (7) The SOMD's written medical opinion must be consistent with the 
findings, determinations, and recommendations of the third physician, 
unless the SOMD and the

[[Page 36755]]

beryllium or beryllium-associated worker reach an agreement that is 
consistent with the determinations of at least one of the other two 
remaining physicians.
    (8) The employer must complete the multiple physician review 
process even in cases where the beryllium or beryllium-associated 
worker is laid off or his contract ends before the review process is 
complete, provided the worker:
    (i) Elected the multiple physician review while he or she was a 
current worker and in accordance with the conditions set forth in 
paragraph (e)(4) of this section; and
    (ii) Continues to participate in good faith in the multiple 
physician review process. If the worker's job is scheduled to end prior 
to the completion of the multiple physician review process, the 
employer may elect to place the worker on unpaid leave status until the 
review process is completed.
    (9) The employer is not required to provide the multiple physician 
review process if the worker had not elected the process in accordance 
with the conditions set forth in paragraph (e)(4) of this section, 
before he or she was laid off or contract ended. In this case, the 
worker may still be eligible for medical screening through DOE's Former 
Worker Medical Screening Program;
    (f) Alternate physician review. The employer and the beryllium or 
beryllium-associated worker, or the worker's designated representative, 
may agree on the use of an alternate form of physician opinion and 
recommendation in lieu of the multiple physician review process 
pursuant to paragraph (e) of this section, as long as the alternative 
is expeditious and adequately protects the worker.
    (g) Reporting. (1) When reporting cases of CBD, employers must 
comply with the reporting requirements in 10 CFR 851.23(a)(2).
    (2) When a worker is medically removed in accordance with Sec.  
850.36, employers must record the case on the applicable OSHA form.
    (3) Employers must enter each medical removal case on the 
applicable OSHA form as either a case involving days away from work if 
the worker does not work during the removal period, or a case involving 
restricted work activity, if the employee continues to work, but in an 
area where there is no exposure to beryllium.


Sec.  850.35  Medical restriction.

    (a) Medical restrictions must be conducted in accordance with 10 
CFR part 851, appendix A, section 8(h).
    (b) Within 15 working days after receiving the SOMD's written 
opinion pursuant to Sec.  850.34(d)(2), that it is medically 
appropriate to restrict a worker, an employer must restrict a worker 
from a job that involves a beryllium activity.
    (c) Employers must provide the medical removal benefits specified 
in Sec.  850.36 of this part only to beryllium workers who are 
diagnosed with BeS or CBD.
    (d) If the SOMD determines that a beryllium worker should not work 
with beryllium at or above the action level due to a diagnosis of BeS 
or CBD, the SOMD must recommend medical removal under Sec.  850.36, not 
medical restriction.


Sec.  850.36  Medical removal and benefits.

    (a) Medical removal. (1) The employer must medically remove a 
beryllium worker from exposure to beryllium at or above the action 
level, subject to the terms set forth in this section.
    (2) Recommendations for medical removal of a beryllium worker from 
exposure to beryllium at or above the action level may be temporary or 
permanent, and shall be made by the SOMD in accordance with this 
section.
    (3) The SOMD must recommend temporary removal of a beryllium worker 
from exposure to beryllium at or above the action level:
    (i) Pending the outcome of the medical evaluations conducted 
pursuant to Sec.  850.34(b), if the beryllium worker is showing signs 
or symptoms of BeS or CBD and the SOMD believes that further exposure 
to beryllium at or above the action level may be harmful to the 
worker's health; or
    (ii) Pending the outcome of the multiple physician review process 
pursuant to Sec.  850.34(e), or alternative physician review process 
pursuant to Sec.  850.34(f), if the beryllium worker is showing signs 
or symptoms of BeS or CBD and the SOMD believes that further exposure 
to beryllium at or above the action level may be harmful to the 
worker's health.
    (4) The SOMD must recommend permanent removal of a beryllium worker 
from exposure to beryllium at or above the action level if the SOMD 
makes a final medical determination that the worker should be 
permanently removed. The SOMD's determination to permanently remove a 
worker must be based on a diagnosis of BeS or CBD as defined in Sec.  
850.3 of this part.
    (5) Within 15 working days after a final medical determination has 
been made, the SOMD must provide the employer with a notice 
recommending that the employer either:
    (i) Return the temporarily removed beryllium worker to his previous 
job status, identifying any steps to be taken to protect the worker's 
health including any necessary work restriction pursuant to 10 CFR part 
851, appendix A, section 8(h); or
    (ii) Permanently remove the beryllium worker.
    (6) The SOMD is not required to recommend temporary removal before 
recommending permanent removal. The SOMD may recommend permanent 
removal based on a medical evaluation which results in a determination 
that the worker has BeS or CBD.
    (b) Counseling before temporary or permanent medical removal and 
notification to the employer--(1) Counseling. If the SOMD recommends 
that a beryllium worker should be temporarily or permanently removed, 
the SOMD must do the following when communicating the written medical 
opinion and determination to the worker pursuant to Sec.  850.34(d)(1).
    (i) Advise the beryllium worker diagnosed with or suspected of 
having BeS or CBD of the determination that medical removal is 
necessary to protect the worker's health, and specify that the SOMD is 
recommending either temporary or permanent removal from work that 
involves exposure to beryllium at or above the action level;
    (ii) Provide the beryllium worker with a copy of this part, and any 
other information on the risks of continued exposure to beryllium at or 
above the action level, and the benefits of removal.
    (2) Notification to the Employer. The SOMD, in communicating the 
written medical opinion and determination to the employer, must comply 
with Sec.  850.34(d)(2). In the case of a final medical determination 
regarding permanent removal, the SOMD must provide the employer with a 
written notice recommending that the employer either:
    (i) If the worker has been on temporary removal, return the 
temporarily removed beryllium worker to his previous job status if the 
SOMD determines that removal is no longer warranted; or
    (ii) Permanently remove the beryllium worker; or
    (iii) Medically restrict the worker pursuant to Sec.  850.35.
    (c) Employer responsibility to remove worker. (1) Within 15 working 
days after receiving the SOMD's written opinion pursuant to paragraph 
(b)(2) of this section stating that it is medically appropriate to 
remove the worker from jobs in areas that are at or above the action 
level or may potentially be at or above an action level, the employer

[[Page 36756]]

must remove a beryllium worker from such a job, regardless of whether, 
at the time of removal, a job is available into which the removed 
worker may be transferred.
    (2) Prior to, or at the time of the removal, the employer must 
provide the beryllium worker with a formal written notice of removal 
that includes the start date of the removal period;
    (3) When a beryllium worker is medically removed, the employer must 
transfer the removed worker to a comparable job, if such a job is 
available, and provide medical removal benefits in accordance with 
paragraphs (d)(1) of this section, for temporary removal or (d)(2) of 
this section, for permanent removal.
    (4) The employer may not return a beryllium worker who has been 
medically removed to his or her former job status unless the SOMD 
determines in a written medical opinion that continued medical removal 
is no longer necessary to protect the worker's health.
    (d) Medical removal benefits--(1) Temporary removal benefits. (i) 
When a beryllium worker has been temporarily removed from a job 
pursuant to paragraph (c) of this section, the employer must, 
consistent with any applicable collective bargaining agreement:
    (A) Transfer the worker to a comparable job:
    (1) Where beryllium exposures are below the action level; and
    (2) For which the worker is qualified or can be trained for in 6 
months or less.
    (B) Maintain the worker's total normal earnings, seniority, and 
other rights and benefits as if the worker had not been removed, on 
each occasion that the worker is temporarily removed.
    (ii) If there is no such job available for the beryllium worker 
meeting the requirements of (d)(1)(i)(A) of this section, the employer 
must continue to provide the worker's total normal earnings, and other 
benefits as if the worker had not been removed until:
    (A) A comparable job becomes available, and the worker is placed in 
that job;
    (B) The SOMD determines that the worker is not beryllium sensitized 
and does not have CBD and medical removal is ended;
    (C) The worker is permanently medically removed from the job; or
    (D) The term of the removal period has expired, as provided in 
(d)(1)(iii) of this section.
    (iii) Each term of temporary removal must not exceed one year, and 
no term of temporary removal can immediately succeed a prior term of 
temporary removal in order to extend the term beyond one year.
    (iv) Periods of temporary medical removal must not be included in 
the permanent medical removal benefits period.
    (2) Permanent medical removal benefits. (i) If a beryllium worker 
has been permanently removed from a job because of a beryllium-induced 
medical condition pursuant to paragraph (a)(4) of this section, the 
employer must consistent with any applicable collective bargaining 
agreement:
    (A) Transfer the beryllium worker to a comparable job:
    (1) Where beryllium exposures are below the action level, and
    (2) For which the worker is qualified or can be trained within one 
year.
    (B) If the beryllium worker cannot be transferred to a comparable 
job meeting the requirements of (d)(2)(ii)(A), maintain the beryllium 
worker's total normal earnings as if the worker had not been 
permanently removed for a period of up to two years.
    (3) Additional Conditions of Temporary or Permanent Removal 
Benefits. (i) For the purposes of this section, the requirement that an 
employer provide medical removal benefits is not intended to expand 
upon, restrict, or change any rights to a specific job classification 
or position under the terms of an applicable collective bargaining 
agreement.
    (ii) During a temporary or permanent removal period, the employer 
must continue to provide total normal earnings and benefits as if the 
worker were not removed for the removal period designated by the SOMD.
    (iii) Subject to paragraph (d)(3)(v) of this section, the employer 
must continue to provide the worker medical removal benefits throughout 
the term of the removal period, regardless of changes in the worker's 
job (e.g., worker is laid off, or the worker's contract ends before the 
removal period ends) or because the worker cannot be transferred into a 
comparable job because the worker is too sick to work, provided that:
    (A) If the worker is on temporary removal, the employer is not 
required to continue the worker benefits beyond the one-year period, as 
set forth in paragraph (d)(1) of this section.
    (B) If the worker is on permanent removal, the employer is not 
required to continue the worker benefits beyond the two-year period, as 
set forth in paragraph (d)(2) of this section.
    (iv) If a removed worker files a claim for workers' compensation 
payments for a beryllium-related disability, the employer must continue 
to provide benefits pending disposition of the claim, but no longer 
than a period of two years. The employer must receive no credit for the 
workers' compensation payments received by the worker for treatment-
related expenses.
    (v) The employer's obligation to provide medical removal benefits 
to a removed worker is reduced to the extent that the worker receives 
compensation for earnings lost during the period of removal from a 
publicly- or employer-funded compensation program, or from employment 
with another employer made possible by virtue of the worker's removal.
    (vi) The worker may also apply for compensation through the Energy 
Employee Occupational Illness Compensation Program, for any additional 
benefits beyond those provided in this section.


Sec.  850.37  Medical consent.

    (a) In order to provide each beryllium and beryllium-associated 
worker with the information necessary to make an informed decision 
about consenting to a medical evaluation established in Sec.  850.34, 
the employer must ensure that the SOMD has the worker sign and date the 
informed consent form in appendix A (for beryllium workers) or appendix 
B (for beryllium-associated workers) to this part.
    (b) Employers must ensure all beryllium workers understand that 
testing is mandatory to transfer into or remain in a job involving 
beryllium activities at or above the action level. A beryllium worker 
who decides not to consent to the testing, will be removed from the 
beryllium activity and will not receive any of the medical removal 
benefits.


Sec.  850.38  Training and counseling.

    (a) Training. (1) The employer must develop and implement a 
beryllium training program and ensure the participation of beryllium 
workers, beryllium-associated workers, and all other individuals who 
work at a site where beryllium activities are conducted.
    (2) Beryllium workers' training must include:
    (i) The contents of the CBDPP;
    (ii) Potential health risks to beryllium workers' family members 
and others who may come in contact with beryllium on beryllium workers, 
beryllium workers' clothing, or other personal items as the result of a 
failure of beryllium control;
    (iii) The benefits of medical evaluations for diagnosing BeS and 
CBD; and
    (iv) The contents of this part.

[[Page 36757]]

    (3) The training provided for beryllium-associated workers and 
other workers identified in paragraph (a)(1) of this section must 
consist of general awareness about beryllium hazards and controls and 
the benefits of medical evaluations for diagnosing BeS and CBD.
    (4) The training required by this section must be provided before 
or at the time of initial assignment and at least every two years 
thereafter.
    (5) Retraining must be provided when the employer has reason to 
believe that a beryllium worker lacks the proficiency, knowledge, or 
understanding needed to work safely with beryllium, including, at a 
minimum, the following situations:
    (i) To address any new beryllium hazards resulting from a change to 
the beryllium inventory, activities, or controls about which the worker 
was not previously trained; or
    (ii) When a worker's performance involving beryllium activities 
indicates the worker has not retained the requisite proficiency.
    (b) Counseling. (1) The employer must develop and implement a 
counseling program to assist beryllium and beryllium-associated workers 
who are diagnosed by the SOMD as being sensitized to beryllium or 
having CBD.
    (2) For beryllium workers, the counseling program must include 
communicating with the worker concerning:
    (i) The medical surveillance program provisions and procedures;
    (ii) Medical treatment options;
    (iii) Medical, psychological, and career counseling;
    (iv) Medical removal benefits;
    (v) Administrative procedures and workers' rights under EEOICPA and 
other applicable compensation laws and regulations; and
    (vi) The risk of continued exposure to levels of beryllium that are 
not at or above the action level and practices to limit exposures.
    (3) For beryllium-associated workers, the counseling program must 
include communicating with the worker concerning:
    (i) The medical surveillance program provisions and procedures;
    (ii) Medical treatment options;
    (iii) Medical, psychological, and career counseling; and
    (iv) Application procedures under the EEOICPA and other applicable 
compensation laws and regulations.


Sec.  850.39  Warning signs and labels.

    (a) Warning signs. The employer must post warning signs at each 
access point to a regulated area with the following information:

BERYLLIUM REGULATED AREA
DANGER
CANCER AND LUNG DISEASE HAZARD
AUTHORIZED PERSONNEL ONLY

    (b) Warning labels. The employer must affix warning labels to all 
bags, containers, equipment, or items that have beryllium material on 
the surface at levels that exceed 0.2 [micro]g/100 cm\2\ or that will 
be released and have beryllium material on the surface at levels above 
the level in soil at the point of release.
    (1) Warning labels must contain the following information:

DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD

    (2) The employer must affix warning labels to equipment or items 
that contain sources of beryllium in normally inaccessible locations or 
embedded in hard-to-remove substances. These warning labels must 
contain the following information:

CAUTION
CONTAINS BERYLLIUM IN INACCESSIBLE LOCATIONS OR EMBEDDED IN HARD-TO-
REMOVE SUBSTANCES
DO NOT RELEASE AIRBORNE BERYLLIUM DUST
CANCER AND LUNG DISEASE HAZARD

Sec.  850.40  Recordkeeping and use of information.

    (a) Contractor employers must:
    (1) Establish and maintain records in accordance with 10 CFR part 
851, Worker Safety and Health Program, for the records generated by 
their CBDPP and include records of beryllium medical surveillance and 
training;
    (2) Maintain employees' medical records in accordance with DOE 
Systems of Records DOE-33, Personnel Medical Record;
    (3) Maintain all records required by this part in current and 
accessible electronic systems; and
    (4) Convey all record series required under this part to the 
appropriate Head of DOE Field Element or designee, if this part ceases 
to be applicable to the contractor.
    (b) Federal employers must:
    (1) Establish and maintain complete and accurate records of 
information generated by the CBDPP submitted by DOE offices, including 
beryllium inventory information, hazard assessments, and Federal 
employee exposure measurements, exposure controls, medical evaluations 
and training for operations or activities implemented by the DOE 
office;
    (2) Maintain Federal employees' medical records in accordance with 
OPM/GOVT-10, Employee Medical File System Records for Federal 
Employees; and
    (3) Maintain all records required by this part in current and 
accessible electronic systems.
    (c) Heads of DOE Field Elements and Cognizant Secretarial Officers 
must designate all record series as required under this part as agency 
records and ensure retention for a minimum of 75 years.
    (d) Contractor and Federal employers must:
    (1) Ensure the confidentiality of all personally identifiable 
information in work-related records generated under this part by 
ensuring that:
    (i) All records that are transmitted to other parties are 
transmitted in compliance with the Privacy Act, the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), and their 
implementing regulations; and
    (ii) Individual medical information generated by the CBDPP is:
    (A) Either included as part of the worker's DOE site medical 
records and maintained by the SOMD or is maintained by another 
physician designated by the employer;
    (B) Maintained as confidential medical records separate from other 
records; and
    (C) Used or disclosed by the employer only in conformance with any 
applicable requirements imposed by the Americans with Disabilities Act 
of 1990 and any other applicable law and regulation.
    (2) Maintain all records generated as required by this rule, in 
current and accessible electronic systems, which include the ability to 
readily retrieve data in a format that maintains confidentiality.
    (3) Transmit all records generated as required by this rule to the 
Office of Environment, Health, Safety and Security upon request.
    (4) Semi-annually transmit to the Office of Environment, Health, 
Safety and Security an electronic registry of beryllium and beryllium-
associated workers that protects the confidentiality, and the registry 
must include, a unique identifier for each individual, date of birth, 
gender, site job history, medical screening test results, exposure 
measurements, surface contamination levels, and results of referrals 
for specialized medical evaluations. This information should comply 
with the format for the Beryllium Registry.


Sec.  850.41  Performance feedback.

    (a) The employer must conduct semi-annual analyses and assessments 
of:
    (1) Monitoring results;

[[Page 36758]]

    (2) Hazard assessments;
    (3) Medical surveillance; and
    (4) Exposure reduction efforts.
    (b) The assessments must identify any:
    (1) Individuals at risk for beryllium-induced medical conditions 
and working conditions that may be contributing to that risk; and
    (2) Need for additional exposure controls.
    (c) The employer must notify, and make the assessments available to 
the appropriate Head of DOE Field Element, line managers, work 
planners, worker protection staff, medical staff, workers, and labor 
organizations representing workers performing beryllium activities.

Appendix A to Part 850--Beryllium Worker Chronic Beryllium Disease 
Prevention Program Consent Form (Mandatory)

Part A: Consent

    Consistent with and subject to the provisions of 10 CFR part 
850, Chronic Beryllium Disease Prevention Program, I ____, 
understand the information the Site Occupational Medical Director 
(SOMD) explained and discussed with me about the Beryllium-Induced 
Lymphocyte Proliferation Test (BeLPT), on cells obtained from 
peripheral blood, and the other medical tests, as specified below. I 
have had the opportunity to ask and have answered any questions that 
I may have had concerning these tests and my questions have been 
adequately answered.
    I understand that the beryllium worker medical surveillance 
program is for jobs in which exposure to levels of beryllium may be 
at or above the action level. I understand that it is mandatory for 
me to participate in this medical surveillance program.
    I understand the tests are confidential, but not anonymous. If 
the results of any test suggest a health problem, I understand the 
examining physician will discuss the matter with me, whether or not 
the result is related to my work with beryllium. I understand my 
employer will be notified of my diagnosis only if I have beryllium 
sensitization (BeS), chronic beryllium disease (CBD), or another 
condition indicating that I should not perform certain job tasks. My 
employer will not receive the results or diagnoses of any health 
condition not related to beryllium exposure and my ability to 
perform my job tasks safely.
    For test or examination results pertaining to BeS or CBD, I 
understand I will have the right to seek a second medical opinion 
from a physician who is qualified to diagnose beryllium-induced 
medical conditions. My employer will condition its participation and 
payment for a second opinion on my informing my employer of my 
intent to seek a second opinion within 15 working days after 
receiving the employer's written notification of my right to elect 
the multiple physician review process or the alternate physician 
review process.
    I understand if the results of one or more of these tests 
suggest I have a health problem that is related to beryllium or for 
which exposure to beryllium is contraindicated, additional 
examinations may be recommended. If I am diagnosed with a condition 
(other than BeS or CBD) for which exposure to beryllium would be 
contraindicated, the SOMD may recommend that I be medically 
restricted from working jobs where exposure to beryllium is at or 
above the action level. If the tests reveal I have CBD or I am 
sensitized to beryllium, the SOMD will recommend that I be removed 
from working in beryllium jobs where exposure to beryllium may be at 
or above the action level and my employer will remove me from such 
jobs.
    I understand that if I am temporarily removed from a job where 
exposure to beryllium may be at or above the action level, I may be 
transferred to another job for which I am qualified (or for which I 
can be trained within six months), pending the outcome of the 
medical evaluations, where my beryllium exposures will in no case be 
at or above the action level, and I will continue to receive my 
total normal earnings, for up to one year from the date on each 
occasion that I am temporarily removed, regardless of whether I am 
transferred to another job.
    I understand that if I am permanently removed from a job where 
exposure to beryllium may be at or above the action level due to a 
diagnosis of BeS or CBD, I may be transferred to another job for 
which I am qualified (or for which I can be trained within one year) 
where my beryllium exposures will in no case be at or above the 
action level, and I will continue to receive my total normal 
earnings, for up to two years, regardless of whether I am 
transferred to another job.
    I understand that if I apply for another job or for insurance, 
there is a possibility that I may be required to release my medical 
records to a future employer or an insurance company.
    I understand my employer will maintain all medical information 
separate from my personnel files, treat them as confidential medical 
records, and use or disclose them only as provided by the Americans 
with Disabilities Act of 1990, the Privacy Act of 1974, the Health 
Insurance Portability and Accountability Act of 1996, or as required 
by a court order or under other law.
    I understand the results of my medical tests for health problems 
related to exposure to beryllium will be included in the Beryllium 
Registry maintained by DOE and that a unique identifier will be used 
to maintain the confidentiality of my medical information. Personal 
identifiers will not be included in any reports generated from the 
Beryllium Registry. I understand that the results of my test and 
examinations may be published in reports or presented at meetings, 
but I will not be identified.

-----------------------------------------------------------------------
Signature of Employee
-----------------------------------------------------------------------
Date

Part B: Medical Evaluation Consent

    I, ____, consent to the following medical evaluations:

/ /Physical examination concentrating on my respiratory system, skin 
and eyes
/ /Chest X-ray or a standard digital chest radiographic image
/ /Spirometry (a breathing test)
/ /Two BeLPTs on peripheral blood
/ /Other test(s). Specify:---------------------------------------------

-----------------------------------------------------------------------
Signature of Employee
-----------------------------------------------------------------------
Date

    I have explained and discussed any questions the employee asked 
concerning the medical surveillance program, BeLPT (on peripheral 
blood), physical examination, and other medical tests as well as the 
implications of those tests.

Examining Physician:
Printed Name:----------------------------------------------------------
Signature of Examining Physician:--------------------------------------
Date:------------------------------------------------------------------

Part C: Examining Physician Review of the Medical Evaluation Results

    I have explained and discussed with, ____, the results of the 
medical evaluations, including all test results and any medical 
condition related to beryllium exposure that should receive further 
evaluations or treatment.

Examining Physician:
Printed Name:----------------------------------------------------------
Signature of Examining Physician:--------------------------------------
Date:------------------------------------------------------------------

DOE Form No. 440.1X (Revised X, 20XX)

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

Part A: Consent

    Consistent with and subject to the provisions of 10 CFR part 
850, Chronic Beryllium Disease Prevention Program, I ____, 
understand the information the Site Occupational Medical Director 
(SOMD) explained and discussed with me about the Beryllium-Induced 
Lymphocyte Proliferation Test (BeLPT), on cells obtained from 
peripheral blood and the other medical tests, as specified below. I 
have had the opportunity to ask and have answered any questions that 
I may have had concerning these tests and my questions have been 
adequately answered.
    I understand this medical surveillance program is voluntary, and 
I can withdraw at any time + from all or any part of the program. I 
understand the tests are confidential, but not anonymous. If the 
results of any test suggest a health problem, I understand the 
examining physician will discuss the matter with me, whether or not 
the result is related to beryllium. I understand my employer will be 
notified of my diagnosis only if I have beryllium sensitization 
(BeS), chronic beryllium disease (CBD), or another condition 
indicating that I should not perform certain job tasks. My employer 
will not receive the results or diagnoses of any health condition 
not related to my ability to perform my job tasks safely.
    I understand I will have the right to seek a second medical 
opinion from a physician who is qualified to diagnose beryllium-
induced medical conditions. My employer

[[Page 36759]]

will condition its participation and payment for a second opinion on 
my informing my employer of my intent to seek a second opinion 
within 15 working days after receiving the employer's written 
notification of my right to elect the multiple physician review 
process or the alternate physician review process, and provided I 
continue to participate in the medical surveillance program.
    I understand that, if the results of one or more of these tests 
suggest I have a health problem related to beryllium, additional 
examinations may be recommended. If I am diagnosed with a condition 
for which exposure to beryllium would be contraindicated, the SOMD 
may recommend that I be medically restricted from working in jobs 
where exposure to airborne beryllium is at or above the action 
level.
    I understand that if I apply for another job or for insurance, 
there is a possibility that I may be required to release my medical 
records to a future employer or an insurance company.
    I understand my employer will maintain all medical information 
separate from my personnel files, treat them as confidential medical 
records, and use or disclose them only as provided by the Americans 
with Disabilities Act of 1990, the Privacy Act of 1974, the Health 
Insurance Portability and Accountability Act of 1996, or as required 
by a court order or under other law.
    I understand the results of my medical tests for health problems 
related to exposure to beryllium will be included in the Beryllium 
Registry maintained by DOE and that a unique identifier will be used 
to maintain the confidentiality of my medical information. Personal 
identifiers will not be included in any reports generated from the 
Beryllium Registry. I understand that the results of my test and 
examinations may be published in reports or presented at meetings, 
but I will not be identified.
    I, ____, consent to participating in the medical surveillance 
program.

Part B: Medical Evaluation Consent

    I, ____, consent to the following medical evaluations:

/ /Physical examination concentrating on my respiratory system, skin 
and eyes
/ /Chest X-ray or a standard digital chest radiographic image
/ /Spirometry (a breathing test)
/ /Two BeLPTs on peripheral blood
/ /Other test(s). Specify:---------------------------------------------
Signature of Employee--------------------------------------------------
Date-------------------------------------------------------------------
    I have explained and discussed any questions the employee asked 
concerning the medical surveillance program, BeLPT (on peripheral 
blood), physical examination, and other medical tests as well as the 
implications of those tests.

Examining Physician:
Printed Name:----------------------------------------------------------
Signature of Examining Physician:--------------------------------------
Date:------------------------------------------------------------------

Part C: Examining Physician Review of the Medical Evaluation Results

    I have explained and discussed with, ____, the results of the 
medical evaluations, including all test results and any medical 
condition related to beryllium exposure that should receive further 
evaluations or treatment.

Examining Physician:
Printed Name:----------------------------------------------------------
Signature of Examining Physician:--------------------------------------
Date:------------------------------------------------------------------

DOE Form No. 440.1X (Dated X, 20XX)

[FR Doc. 2016-12547 Filed 6-6-16; 8:45 am]
 BILLING CODE 6450-01-P