[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
1. Smith DB, Cannon WF, Woodrufff LG, Garrett RG, Klassen R,
Kilburn JE, Horton JD, King HD, Goldhaber MB, and Morrison JM.
``Major- and Trace-Element Concentrations in Soils from Two
Continental-Scale Transects of the United States and Canada.'' Open-
File Report 2005-1253, U.S. Geological Survey, 2005. Accessed on
March 25, 2015 at: http://pubs.usgs.gov/of/2005/1253/pdf/OFR1253.pdf.
2. Stonehouse AJ, Zenczak S. ``Properties, Production and
Applications.'' In: Beryllium Biomedical and Environmental Aspects.
Rossman MD, Preuss OP, and Powers MB, eds. Baltimore: Williams and
Wilkins, 1991.
3. Occupational Safety and health Administration. Occupational
Exposure to Beryllium and Beryllium Compounds, Proposed Rule. (80 FR
47565, August 7, 2015. Accessed on December 1, 2015 at: https://www.federalregister.gov/articles/2015/08/07/2015-17596/occupational-exposure-to-beryllium-and-beryllium-compounds.
4. National Toxicology Program. Thirteenth Report on
Carcinogens. ``Beryllium and Beryllium Compounds.'' 2014. Accessed
on 10/26/2015 at: http://ntp.niehs.nih.gov/ntp/roc/content/profiles/beryllium.pdf.
5. IARC Monographs on the Evaluations on of Carcinogenic Risk to
Humans. Beryllium and beryllium compounds. Accessed on 10/27/2015
at: http://monographs.iarc.fr/ENG/Classification/latest_classif.php.
6. ACGIH[supreg] Documentations of the Threshold Limit Values
and Biological Exposure Indices 7th Edition--2009 Supplement:
Beryllium and Compounds, American Conference of Governmental
Industrial Hygienists, Cincinnati, OH.
7. ``Managing Health Effects of Beryllium Exposure.'' Committee
on Beryllium Alloy Exposures, The National Academies Press, 2008.
8. Maier LA, Newman LS. ``Beryllium Disease.'' Environmental and
Occupational Medicine, 3rd edition. Rom WN, Ed. Lippincott-Raven,
New York, 1998.
9. Tinkle SS, Antonini JM, Rich BA, Roberts JR, Salman R, DePree
K, Adkins EJ. ``Skin as a route of exposure and sensitization in
chronic beryllium disease.'' Environmental Health Perspectives.
2003; 111:1202-1208.
10. Henneberger PK, Cumro D, Deubner, DD. ``Beryllium
Sensitization and Disease Among Long-term and Short-term Workers In
Beryllium Ceramics.'' International Archives of Occupational and
Environmental Health. 2001; 74(3):167-176.
11. Day GA, Stefaniak AB, Weston A, Tinkle SS. ``Beryllium
Exposure: Dermal and Immunological Considerations.'' International
Archives of Occupational and Environmental Health. 2006;
(79)(2):161:164.
12. Green DM, Newman LS. ``Agency for Toxic Substances and
Disease Registry (ASTDR) Case Studies in Environmental Medicine.
No.19, Beryllium Toxicity.'' U. S. Department of Health and Human
Services. 1992.
13. Stange AW, Furman FJ, Hilmas DE. ``The beryllium lymphocyte
proliferation test: Relevant issues in beryllium health
surveillance.'' American Journal of Industrial Medicine. 2004 Nov;
46(5):453-62.
14. Stange AW, Hilmas DE, Furman FJ, Gatliffe TR. ``Beryllium
sensitization and chronic beryllium disease at a former nuclear
weapons facility.'' Applied Occupational Environmental Hygiene. 2001
Mar;16(3):405-17.
15. Newman LS, Mroz MM, Balkissoon R, Maier LA. ``Beryllium
sensitization progresses to chronic beryllium disease: a
longitudinal study of disease risk.'' American Journal of
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
sensitization at a beryllium processing facility.'' Environmental
Health Perspectives. 2005 Oct; 113(10):1366-72. Erratum in:
Environmental Health Perspectives. 2006 Apr; 114(4):A214.
18. Welch L, Ringen K, Bingham E, Dement J, Takaro T, McGowan W,
Chen A, Quinn P. ``Screening for beryllium disease among
construction trade workers at Department of Energy nuclear sites.''
American Journal of Industrial Medicine. 2004 Sep; 46(3):207-18.
19. Arjomandi M, Seward J, Gotway MB, Nishimura S, Fulton GP,
Thundiyil J, King TE Jr, Harber P, Balmes JR. ``Low prevalence of
chronic beryllium disease among workers
[[Page 36747]]
at a nuclear weapons research and development facility.'' Journal of
Occupational and Environmental Medicine. 2010 Jun; 52(6):647-52.
20. Powers MB. ``History of Beryllium.'' In beryllium Biomedical
and Environmental Aspects. Rossman MD, Preuss OP, and Powers MB
editors. Baltimore: Williams and Wilkins, 1991.
21. Eisenbud M et al. ``Non-occupational Berylliosis.'' Journal
of Industrial Hygiene Toxicology. 1949; 31:282-294.
22. Eisenbud M, Lisson J. ``Epidemiologic Aspects of Beryllium-
Induced Nonmalignant Lung Disease: A 30-Year Update.'' Journal of
Occupational Medicine. 1983; 25:196-202.
23. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium
Intoxication.'' Archives of Industrial Hygiene and Occupational
Medicine. 1951; 4: 123-157.
24. Newman LS, Kreiss K. ``Nonoccupational Beryllium Disease
Masquerading as Sarcoidosis: Identification by Blood Lymphocyte
Proliferation Response to Beryllium.'' American Review of
Respiratory Disease. 1992; 145: 1212-1214.
25. McCanlies EC, Yucesoy B, Mnatsakanova A, Slaven JE, Andrew
M, Frye BL, Schuler CR, Kreiss K, Weston A. ``Association between
IL-1A single nucleotide polymorphisms and chronic beryllium disease
and beryllium sensitization.'' American Journal of Occupational
Environmental Medicine. 2010 Jul; 52(7):680-4.
26. McCanlies EC, J.S. Ensey, C.R. Schuler, K. Kreiss, A.
Weston. ``The association between HLA-DPB1Glu69 and chronic
beryllium disease and beryllium sensitization.'' American Journal of
Industrial Medicine. 2004; 46:95-103.
27. Pappas GP, Newman LS. ``Early pulmonary physiologic
abnormalities in beryllium disease.'' American Review of Respiratory
Disease. 1993 Sep; 148(3):661-6.
28. Marchand-Adam S, El Khatib A, Guillon F, Brauner MW,
Lamberto C, Lepage V, Naccache JM, Valeyre D. ``Short- and long-term
response to corticosteroid therapy in chronic beryllium disease.''
European Respiratory Journal. 2008 Sep; 32(3):687-93.
29. ACGIH[supreg] Documentations of the Threshold Limit Values
and Biological Exposure Indices 7th Edition--2009 Supplement:
Beryllium and Compounds, American Conference of Governmental
Industrial Hygienists, Cincinnati, OH.
30. Stefaniak, AB et al. ``Dissolution of beryllium in
artificial lung alveolar macrophage phagolysosomal fluid.''
Chemosphere, doi:10.1016/j.chemosphere.2010.12.088, 2011.
31. Finch G, Mewhinney L, Eidson A, Hoover, M, Rothenberg, S.
``In Vitro Dissolution Characteristics of Beryllium Oxide and
Beryllium Metal Aerosols. Journal of Aerosol Science. 1988;
19(3):333-342.
32. Stefanik AB, Day GA, Hoover MD, Breysse PN, Scripsick R.
``Differences in dissolution behavior in phagolysosomal stimulant
fluid for single-constituent and multi-constituent materials
associated with beryllium sensitization and chronic beryllium
disease.'' Journal of Toxicology and Environmental Health, Part A.
2008; 71(22):1468-1481.
33. Cummings KJ, Stefaniak AB, Virji MA, Kreiss K. A
reconsideration of acute beryllium disease. Environmental Health
Perspective. 117(8):1250-6, 2009.
34. Occupational Safety and Health Administration. ``Preventing
adverse health effects from exposure to beryllium on the job.''
Hazard Information Bulletin, September 2, 1999.
35. 29 CFR 1910.1000(b), Table Z-2. Accessed on March 25, 2015
at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9993.
36. Dufay SK, Archuleta, M. ``Comparison of collection
efficiencies of sampling methods for removable beryllium surface
contamination.'' Journal of Environmental Monitor. 2006:8630-633.
37. Epstein WL. ``Cutaneous Effects of Beryllium.'' In:
Beryllium Biomedical and Environmental Aspects. Rossman MD, Preuss
OP, and Powers MB, eds. Baltimore: Williams and Wilkins, 1991.
38. NIST/SEMATECH e-Handbook of Statistical Methods. Accessed on
March 25, 2015 at http://www.itl.nist.gov/div898/handbook/prc/section3/prc3.htm.
39. Frome EL, Newman LS, Cragle DL, Colyer SP, Wambach PF.
``Identification of an abnormal beryllium lymphocyte proliferation
test.'' Toxicology. 2003 Feb 1;183(1-3):39-56. Erratum in:
Toxicology. 2003 Jun 10;188(2-3):335-6.
40. National Jewish Health. Chronic Beryllium Disease: Overview.
``How do you develop CBD?'' 2011. Accessed on 10/26/2015 at: http://www.nationaljewish.org/healthinfo/conditions/beryllium-disease/.
41. Kreiss K, Wasserman S, Mroz MM, Newman LS. ``Beryllium
disease screening in the ceramics industry. Blood lymphocyte test
performance and exposure-disease relations.'' Journal of
Occupational Medicine. 1993 Mar;35(3):267-74.
42. Borak J, Woolf SH, Fields CA. ``Use of Beryllium Lymphocyte
Proliferation Testing for Screening of Asymptomatic Individuals: An
Evidence-based Assessment.'' Journal of Occupational and
Environmental Medicine. 2006 September; 48:937-947.
43. Greene M, Smith SM. ``Consenting to uncertainty: challenges
for informed consent to disease screening--a case study.''
Theoretical Medicine and Bioethics. 05 Dec 2008.
44. Poulin M, Ricard S. ``The Blood Beryllium Lymphocyte
Proliferation Test (Belpt) from Theory to Practice.'' Qu[eacute]bec
National Public Health Institute. April 2004.
45. Darby A, Fishwick D. ``Beryllium: A review of the health
effects and the evidence for screening or surveillance in workers
exposed to beryllium.'' Research Report RR873, Health and Safety
Executive, HSE Books, 2011.
46. DOE-SPEC-1142-2001: Beryllium Lymphocyte Proliferation
Testing (BeLPT). Accessed on March 25,2015 at: http://www.energy.gov/ehss/downloads/doe-spec-1142-2001.
47. Milovanova TN, Popma SH, Cherian S, Moore JS, Rossman MD.
``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