[Federal Register Volume 63, Number 232 (Thursday, December 3, 1998)]
[Proposed Rules]
[Pages 66940-66975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30277]
[[Page 66939]]
_______________________________________________________________________
Part III
Department of Energy
_______________________________________________________________________
10 CFR Part 850
Chronic Beryllium Disease Prevention Program; Proposed Rule
Federal Register / Vol. 63, No. 232 / Thursday, December 3, 1998 /
Proposed Rules
[[Page 66940]]
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DEPARTMENT OF ENERGY
10 CFR Part 850
[Docket No. EH-RM-98-BRYLM]
RIN 1901-AA75
Chronic Beryllium Disease Prevention Program
AGENCY: Office of Environment, Safety and Health, 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
regulations to establish a chronic beryllium disease prevention program
(CBDPP) to reduce the number of workers currently exposed to beryllium
in the course of their employment with DOE or its contractors, minimize
the levels of and potential for exposure to beryllium, and establish
medical surveillance requirements to ensure early detection and
treatment of disease. The proposed rule would be applicable to DOE
Federal and contractor employees and subcontractors during the
performance of beryllium work at DOE facilities. This action would
codify the interim program requirements currently prescribed in DOE
directives and protect the health and safety of workers.
DATES: The comment period for this proposed rule will end on March 9,
1999. Public hearings will be held on: February 3, 1999, in Oak Ridge,
TN, from 9:00 a.m. to 1:00 p.m. and 6:00 p.m. to 9:00 p.m.; February 9,
1999, in Golden, CO (Denver), from 9:00 a.m. to 1:00 p.m. and 6:00 p.m.
to 9:00 p.m.; and February 11, 1999, in Washington, DC, from 9:00 a.m.
to 1:00 p.m.
Requests to speak at any of the hearings should be phoned in to
Andi Kasarsky, 202-586-3012, by February 1, 1999, for the Oak Ridge,
TN, hearing; February 5, 1999, for the Golden, CO, hearing; and
February 10, 1999, for the Washington, DC, hearing. Each presentation
is limited to 10 minutes.
ADDRESSES: Written comments (ten copies) should be addressed to:
Jacqueline D. Rogers, U.S. Department of Energy, Office of Environment,
Safety and Health, EH-51, Docket Number EH-RM-98-BRYLM, 1000
Independence Avenue, SW, Washington, D.C. 20585. Where possible,
commenters should identify the specific section to which they are
responding.
Copies of the public hearing transcripts, written comments
received, technical reference materials referred to in this notice, and
any other docket material may be reviewed and copied at the DOE Freedom
of Information Reading Room, Room 1E-190, 1000 Independence Avenue, SW,
Washington, DC 20585 between the hours of 8:30 a.m. and 4:00 p.m.,
Monday through Friday, except Federal holidays. The docket file
material for this rulemaking will be filed under ``EH-RM-98-BRYLM.'' In
addition, related prerulemaking docket material is filed under
``BERYLLIUM STANDARD.'' This material may also be reviewed and copied
at the DOE Freedom of Information Reading Room at the address noted
previously. The technical material from the BERYLLIUM STANDARD docket
file may also be reviewed at the DOE Rocky Flats Freedom of Information
Reading Room and the DOE Oak Ridge Public Reading Room.
The public hearings for this rulemaking will be held at the
following addresses:
Oak Ridge, TN: The American Museum of Science and Energy, 300 South
Tulane Avenue, Auditorium, Oak Ridge, TN 37830
Golden, CO (Denver): National Renewable Energy Laboratory, Visitor
Center, Auditorium, 15013 Denver West Parkway, Golden, CO 80401 (I-70,
Exit 263, right at top of exit ramp if coming from Denver, left at stop
sign, building on right)
Washington, DC: U.S. Department of Energy, Room 1E-245 (first floor, E
corridor), 1000 Independence Avenue, SW, Washington, DC 20585
For more information concerning public participation in this
rulemaking proceeding, see Section VIII of this notice (Public Comment
Procedures).
FOR FURTHER INFORMATION CONTACT: Jacqueline D. Rogers, U.S. Department
of Energy, Office of Environment, Safety and Health, EH-51, 1000
Independence Avenue SW, Washington, DC 20585, 301-903-5684 or Edward
LeDuc, U.S. Department of Energy, Office of General Counsel for
Environment, 1000 Independence Avenue SW, Washington, DC 20585, 202-
586-6947.
For information concerning the public hearings, requests to speak
at the hearings, submittal of written comments, or to obtain copies of
materials referenced in this notice, contact: Andi Kasarsky, 202-586-
3012.
SUPPLEMENTARY INFORMATION:
I. Overview
II. Legal Authority and Relationship to Other Regulatory Programs
III. Chemical Identification and Use
IV. Health Effects
A. Introduction
B. Chronic Beryllium Disease
C. Beryllium Exposures at DOE Operations
D. Epidemiology
E. Value of Early Detection
V. Request for Information
VI. Section-by-Section Analysis
A. Subpart A--General Provisions
B. Subpart B--Administrative Requirements
C. Subpart C--Specific Program Requirements
VII. Procedural Requirements
A. Review Under Executive Order 12866
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 12612
F. Review Under Executive Order 12988
G. Review Under the Unfunded Mandates Reform Act of 1995
VIII. Public Comment Procedures
A. Written Comments
B. Public Hearings
Appendix--References
I. Overview
The 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.
Inhalation of beryllium dust or particles causes chronic beryllium
disease (CBD) and beryllium sensitization. CBD is a chronic, often
debilitating, and sometimes fatal lung condition. Beryllium
sensitization is a condition in which a person's immune system becomes
highly responsive (allergic) to the presence of beryllium in the body.
There has long been scientific consensus that exposure to airborne
beryllium is the only cause of CBD.
As of June 1998, 110 workers have been diagnosed with CBD, and
another 232 workers have become sensitized to beryllium from among the
8,951 current and former DOE Federal and contractor workers who were
screened for the disease. DOE anticipates an increase in the number of
workers who may be exposed to beryllium as the Department moves forward
with deactivating and decommissioning former nuclear weapons production
facilities.
The current worker protection permissible exposure limit (PEL) of 2
g/m3, measured as an 8-hour, time-weighted average
(TWA), was adopted by the Occupational Safety and Health Administration
(OSHA) as codified in 29 CFR 1910.1000 Tables Z-1, Z-2 and Z-3 in 1971
by reference to existing
[[Page 66941]]
national consensus standards. This limit of 2 g/m3
was set by DOE and its predecessor agencies, the Energy Research and
Development Administration (ERDA) and the Atomic Energy Commission
(AEC), for application at their facilities in 1949. Between the 1970s
and 1984, there was a significant reduction in the incidence rate of
the disease. This, coupled with the long latency period for the
disease, led to the assumption that CBD was occurring only among
workers who had been exposed to high levels of beryllium decades
earlier (e.g., in the 1940's). However, DOE medical surveillance
programs are discovering cases of CBD among workers who were first
exposed after 1970, when DOE facilities were expected to maintain
worker exposure to beryllium at levels below the OSHA PEL.
The number of confirmed cases of CBD, data suggesting the
occurrence of CBD among workers with low-level exposures, and the
expected future increase in the number of workers potentially exposed
to beryllium all indicate a need for more aggressive workplace controls
to minimize worker exposure to beryllium in the DOE complex.
Accordingly, DOE has developed this notice of proposed rulemaking
(NOPR) to establish a performance-based approach to protecting DOE
Federal and contractor employees from the adverse health effects
resulting from occupational exposure to beryllium and preventing cases
of CBD resulting from DOE operations. DOE proposes to accomplish this
goal through the implementation of a comprehensive chronic beryllium
disease prevention program (CBDPP), which is designed to reduce the
number of workers exposed, minimize the levels of beryllium exposure
and the potential for beryllium exposure, and establish medical
surveillance protocols to ensure early detection of disease. Because
the occupational health community, including OSHA and the American
Conference of Governmental Industrial Hygienists (ACGIH), does not at
this time have sufficient exposure and health effects data to establish
a new 8-hour TWA exposure limit for beryllium exposure, DOE is instead
including in the proposed regulation a short-term exposure limit (STEL)
of 10 g/m\3\ for small-scale, short-duration operations, an 8-
hour TWA action level of 0.5 g/m\3\ for triggering certain
precautions and control measures, and an exposure reduction and
minimization requirement that will encourage contractors to reduce
potential exposures to the action level or below. This combined
approach should provide a reasonably safe and achievable added layer of
protection to beryllium workers in view of data, which suggest that CBD
or beryllium sensitization has occurred at exposures of 2 g/
m\3\ or less, and in view of the related scientific uncertainty with
respect to the adequacy of the existing PEL. In addition to these
immediate efforts, DOE intends to adopt a revised OSHA PEL for
beryllium if OSHA rulemaking efforts for beryllium conclude that a new
PEL for beryllium is appropriate. DOE acknowledges that Great Britain,
which also employs a 2 g/m\3\ 8-hour TWA PEL, has experienced
a minimal number of CBD cases among its exposed work force. The
Department recognizes that the difference between DOE's and Great
Britain's experiences with the occurrence of CBD may be indicative of
the use of more stringent work practice controls at Great Britain's
facilities. DOE believes, however, that the fortified approach set
forth in the proposed regulation will work towards eradicating CBD
within the Department.
DOE contractors are already required, under DOE Order 440.1A,
Worker Protection Management for DOE Federal and Contractor Employees,
to have general worker protection programs. DOE Order 440.1A contains a
set of minimum general requirements that establish the framework for
the worker protection program. The proposed rule would enhance and
supplement these existing programs with hazard-specific provisions to
manage and control beryllium exposure hazards.
This proposed CBDPP rulemaking initiative has been preceded by 2
years of information-gathering and data analysis by the Department. In
1996, the Department surveyed its contractors to characterize the
extent of beryllium usage, the types of tasks involving beryllium
usage, the controls in place for each task, the estimated number of
workers exposed during each task, and the estimated exposure levels
associated with each task.
In summary, this survey found that between 1994 and 1996, 10 of the
15 DOE sites surveyed performed 64 different operations or processes
that could expose workers to beryllium. The surveyed DOE sites
estimated that between 518 and 530 workers in 58 different job
categories were potentially exposed to beryllium in the performance of
these 64 operations or processes. Where available, reported 8-hour TWA
exposure data (personal breathing zone monitoring results) for these
workers ranged from nondetectable to 25 g/m\3\. Most of these
exposure levels were reported to be below the 2 g/m\3\ 8-hour
TWA PEL. To control worker exposures in the affected processes or
operations, the surveyed sites reported the use of various engineering
and administrative controls, including ventilation hoods, glove boxes,
wet machining methods, high-efficiency particulate air (HEPA) vacuums,
regulated areas, action levels and administrative warning levels, and
personal protective equipment. Copies of this survey are available for
review and copying at the DOE headquarters, Rocky Flats, and Oak Ridge
Public Reading Rooms (see the ADDRESSES section of this NOPR for
addresses and details) as part of the prerulemaking docket filed under
BERYLLIUM STANDARD.
To supplement the data obtained from the 1996 survey, the
Department published a Federal Register notice on December 30, 1996,
requesting scientific data, information, and views relevant to a DOE
beryllium health standard (61 FR 68725). The survey and Federal
Register notice were followed by two Beryllium Public Forums, held in
Albuquerque, New Mexico, and Oak Ridge, Tennessee, in January 1997.
Responses to the Federal Register notice and the proceedings of the
public forums are also available in the ``BERYLLIUM STANDARD'' docket
file.
Acting on the information compiled from these various sources, and
in view of the time needed to promulgate a rule, former Secretary of
Energy Pena directed the Office of Environment, Safety and Health to
publish a new DOE policy to protect the workforce while the Department
moved forward with its rulemaking process. DOE Notice 440.1, Interim
Chronic Beryllium Disease Prevention Program, was signed by former
Secretary Pena and issued on July 15, 1997. The Department decided to
issue the interim Notice to direct immediate action for the protection
of workers while the rulemaking efforts continued. This interim Notice
established a CBDPP that enhanced and supplemented worker protection
programs already required by DOE Order 440.1A with hazard-specific
provisions that are designed to manage and control beryllium exposure
hazards in the DOE workplace.
Because of the complexity and significance of issues regarding the
development of a DOE health standard for beryllium, former Secretary
Pena also established the Beryllium Rule Advisory Committee (BRAC) in
June 1997 to advise the Department on issues pertinent to the proposed
rulemaking activity. The BRAC, which consisted of a diverse set of
stakeholders and
[[Page 66942]]
recognized experts from DOE, other Federal agencies, industry, labor,
medicine, and academia, generated a set of recommendations for
consideration in the development of a CBDPP rule.\1\
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\1\ BRAC recommendations were made by individual members and
groups of members, not by majority vote. They were generated by the
facilitated process used during the meetings and were not adopted by
the committee as consensus opinions. For convenience of reference
these recommendations are referred to as the ``BRAC
recommendations.''
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DOE used the BRAC recommendations and the lessons learned in the
implementation of DOE Notice 440.1 to develop this NOPR. Consistent
with the Department's worker protection philosophy and the BRAC
recommendations, the objectives of this proposed rule are to: (1)
Minimize the number of workers exposed to beryllium; (2) minimize the
levels of beryllium exposure and the potential for beryllium exposure;
(3) establish medical surveillance protocols to ensure early detection
of CBD; and (4) assist affected workers who are dealing with beryllium
health effects. In addition, the Department intends to collect and
analyze as appropriate the resulting exposure and health data as part
of its ongoing beryllium-related research efforts to ensure the
protection of workers' health. DOE will consider the desirability of
amendments to its regulations as additional information and feedback
are collected.
This proposed rule is not being promulgated as a nuclear safety
requirement as defined in 10 CFR part 820, Procedural Rules for Nuclear
Activities. Any radiological implications of the two radioisotopic
forms of beryllium would be addressed under the provisions of 10 CFR
part 835, Occupational Radiation Protection.
II. Legal Authority and Relationship to Other Regulatory Programs
The Department of Energy has broad authority as provided by the
Atomic Energy Act, 42 U.S.C. 2201(i)(3) and (p) to develop generally
applicable policies covering all aspects of defense nuclear facilities,
including protection of the health of workers. Under the Atomic Energy
Act, DOE may impose requirements on its contractors either by
regulation, or by administrative directive (orders and notices) that
are made binding through incorporation into DOE contracts.
DOE contractors currently are required by DOE Order 440.1A, Worker
Protection Management for DOE Federal and Contractor Employees, to have
general worker protection programs. Additionally, on July 15, 1997,
former Secretary Pena issued DOE Notice 440.1, Interim Chronic
Beryllium Disease Prevention Program, to supplement the general worker
protection programs with provisions specifically aimed at the hazards
of beryllium in the DOE work place. Implementation of the interim
Notice depended upon negotiation with DOE contractors to include
compliance with Notice 440.1 as a term of their contracts, or their
agreement voluntarily to comply.
As discussed in the Overview section of this preamble, former
Secretary Pena established a Beryllium Rule Advisory Committee in June
of 1997 to assist DOE to develop a rule to establish permanent Chronic
Beryllium Disease Prevention Program provisions that would apply to all
covered DOE contractors and employees. The Department's decision to use
rulemaking to establish a CBDPP requirement is based on the need for
consistency in the implementation of particular CBDPP requirements and
a desire to give all potentially affected persons and institutions a
meaningful opportunity to provide information and views on the proposed
program. Without a DOE rule, DOE contractors would be obligated to
bargain about such provisions with the organizations representing the
contractors' employees for purposes of collective bargaining. That
approach would likely produce inconsistent outcomes in areas such as
worker exposure monitoring and medical surveillance. DOE believes a
rule or regulation would result in more uniform implementation across
the DOE complex and, thus, improve worker protection and the quality of
information generated regarding the health effects of exposure to
beryllium.
DOE recognizes that it may be necessary in the future to amend its
CBDPP regulations if other Federal agencies promulgate rules governing
worker exposure to beryllium. Although DOE facilities currently are
exempt from regulation by the Occupational Safety and Health
Administration (OSHA), DOE routinely adopts OSHA health standards, as a
matter of policy. DOE is aware that OSHA plans to initiate a rulemaking
to examine, and possibly revise, their current health standard for
beryllium. Additionally, DOE is working with the Congress on plans to
eventually transfer responsibility for regulating health and safety at
DOE facilities to another Federal agency (probably OSHA). In light of
the uncertain timing of future actions by OSHA or another external
regulator, and the present and potential risk to workers at DOE
facilities from beryllium exposure, DOE has decided to proceed with
this rulemaking now. However, considering OSHA's decision to examine
the health standard for beryllium, DOE proposes (in proposed section
850.22, Exposure Limits) to express the permissible exposure limit
(PEL) as 2 ug/m\3\ calculated as an 8-hour TWA exposure, as measured in
the worker's breathing zone, or any more stringent limit that OSHA may
promulgate pursuant to section 4(b)(1) of the OSH Act. This language
would permit DOE to continue its policy of requiring compliance with
OSHA health standards without conducting notice and comment rulemaking
to amend these regulations.
III. Chemical Identification and Use
Beryllium (atomic number 4) is a silver-gray metal with a density
of 1.85 g/cm3 and a high stiffness. Beryllium is found in
the earth's surface in about 45 minerals. Bertrandite
(Be4Si2O7[OH]2) is the
major source of beryllium; other important beryllium-containing
materials include beryl
(3BeO.Al2O36.SiO2), chrysoberyl
(BeAl2O4), and phenacite (BeSiO4). The
alloying property of beryllium confers on metals specific properties of
resistance to corrosion, vibration, and shock; beryllium can also
improve alloy hardness and ductility. For example, the addition of only
2 percent or less beryllium to copper forms an alloy with high strength
and hardness. Few other copper alloys are capable of this type of
strengthening.
Because of their strength, formability, thermal and electrical
conductivities, magnetic transparency, and corrosion resistance,
beryllium alloys (especially beryllium-copper) are used extensively in
industries such as automotive, electronics, aerospace, and defense. In
electronics, for example, beryllia ceramics provide good electrical
insulators with superior thermal conductivity to remove heat.
Beryllium's low neutron absorption, high neutron scattering
characteristics, and ability to multiply neutrons have led to its use
in experimental nuclear reactors and nuclear weapons.
IV. Health Effects
A. Introduction
Chronic beryllium disease (CBD) is a disease of the lungs. CBD is
caused by the body's reaction to inhaled beryllium dust or fumes. The
time in which an individual may develop CBD may vary from several
months to many years after exposure to beryllium. The body's reaction
to beryllium is often called ``sensitization.'' Sensitization means
that beryllium specific lymphocyte
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proliferation testing has demonstrated that an individual is able to
mount a cell mediated immune response to beryllium. Data suggest that
even brief or small exposures can lead to CBD. Beryllium is also
classified as a human carcinogen (cancer-causing agent) by the
International Agency for Research on Cancer (IARC) and by the American
Conference of Governmental Industrial Hygienists (ACGIH).
Symptoms of CBD include one or more of the following: cough,
difficulty breathing, fever, night sweats, fatigue, weight loss, or
appetite loss. On physical examination, a doctor may find signs of CBD,
such as changes in lung sounds, fever, and weight loss. A radiograph
(X-ray) of the lungs may show many small scars. There may also be an
abnormal breathing test, pulmonary function tests, and a blood test,
the beryllium-induced lymphocyte proliferation test (Be-LPT).
Examination of lung tissue under the microscope may show granulomas,
which are signs of damage due to the body's reaction to beryllium. CBD
may be confused with other lung diseases, especially sarcoidosis.
Patients with CBD can be treated with medication and, in more
serious cases, with oxygen. Patients who are sensitized to beryllium do
not need medical treatment, but they must be checked regularly for
signs or symptoms of CBD. CBD cannot be cured. Severe CBD may be very
disabling.
B. Chronic Beryllium Disease
Chronic beryllium disease is a granulomatous disease affecting
primarily the lungs, although systemic involvement may also occur.
Exposure occurs via inhalation of beryllium metal or insoluble
beryllium salts. Beryllium is a hapten (a substance that provokes an
immune response only when combined with another substance, generally a
protein) that binds to peptides on mucosal surfaces. In susceptible
individuals the beryllium-peptide complex initiates an immune response,
which may progress ultimately to granuloma formation in the pulmonary
interstitium. Data have suggested that CBD occurs at relatively low
exposure levels and, in some cases, after relatively brief durations of
exposure. The typical latency period is 5 to 10 years, but it varies
from several months to 30 years or more.
Frequently reported symptoms include dyspnea on exertion, cough,
chest pain and, less frequently, arthralgias, fatigue, and weight loss.
Physical examination may be normal or it may reveal rales, cyanosis,
digital clubbing, or lymphadenopathy. In advanced cases, there may be
manifestations of right-sided heart failure, including cor pulmonale.
The peripheral blood beryllium-induced lymphocyte proliferation
test (Be-LPT) is used to detect in vitro the immunologic response of
human lymphocytes to beryllium. A positive Be-LPT indicates
sensitization to beryllium-containing antigens. A diagnostic evaluation
by means of bronchoscopy with bronchoalveolar lavage (BAL) and
transbronchial biopsy is indicated. The presence of granulomata in the
lung in a patient with a positive lung Be-LPT is diagnostic of CBD. In
the absence of granulomata or other clinical evidence of CBD,
individuals with positive Be-LPTs are classified as sensitized to
beryllium.
The rate of progression from sensitization to disease is unknown.
Once sensitization has occurred, it is medically prudent to prevent
additional exposure to beryllium. However, this measure has not been
shown to prevent or delay the progression of sensitization to CBD.
The clinical course of CBD is highly variable. Some individuals
deteriorate rapidly; most experience long, gradual deteriorations.
Treatment consists of oral corticosteroid therapy. Individuals with
impaired respiratory gas exchange may require continuous oxygen
administration.
Individuals sensitized to beryllium are asymptomatic and not
disabled. Individuals with CBD have clinical illness varying from mild
to severe. In severe cases, the affected individuals may be permanently
and totally disabled. Mortality directly attributable to CBD and its
complications is estimated to be 30 percent (ref.1).\2\ The mortality
estimate of 30% is based upon historical data reflecting both the
higher levels of exposure that occurred in the workplace prior to
regulation of workplace exposure in the late 1940s and a tracking of
the medical history of subjects of CBD over several decades. DOE's more
recent experience suggests a lower mortality rate of 3% for CBD cases.
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\2\ A listing of references is included at the end of the
preamble to this Notice of Proposed Rulemaking.
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C. Beryllium Exposures at DOE Operations
Personal monitoring of occupational exposures to beryllium was not
widely adopted at DOE sites until the 1980s. Prior to the 1980s many
sites relied on area monitoring to assess occupational exposures to
beryllium. However, these have been shown to significantly
underestimate actual exposure levels. Since 1984, personal sampling
data have provided more precise information on occupational exposure to
beryllium at DOE sites.
Available personal sampling data provides a clear indication of the
low levels of beryllium exposure which can be achieved in both
fabrication and machining operations and decommissioning and
decontamination projects when effective control strategies are
implemented. Most beryllium fabrication and machining operations at DOE
to date have been at the Rocky Flats facility and at the Y-12 plant in
Oak Ridge. Over time, engineering improvements and advanced control
strategies have significantly reduced occupational beryllium exposure
levels in these operations.
Since 1980, and continuing through 1996, about 1600 personal
samples have been collected at the Oak Ridge Y-12 Plant (Table 1).
These samples were taken at several different Y-12 operations with a
bias toward sampling those jobs where exposure potential was greatest
or where previous monitoring results were high. Despite this bias, over
two thirds of sample results were below the limit of detection of 0.1
g/m3 (usually reported as ``none detected'').
Table 1.--Oak Ridge Y-12 Plant Personal Sampling
------------------------------------------------------------------------
1980-1989 1990-1996
------------------------------------------------------------------------
Number of samples............... 148............... 1448.
Arithmetic Mean................. 0.9 g/m3. 0.3 g/m3.
Percent of samples less than 2 94%............... 98%.
g/m3.
------------------------------------------------------------------------
These data are from beryllium operations that are associated with
cases of chronic beryllium disease. The facilities where these
operations take place have not been remodeled since the 1970s.
Increased monitoring in the 1990s led to investigations of exceedences
over the existing exposure limit and resulted in changes to work
practices that contributed to the high readings. This focus on levels
exceeding the limit also led to a significant reduction in average
exposure levels.
Personal sampling data from the Rocky Flats Building 444 Beryllium
Machine Shop (Table 2) collected in 1984-85 and after extensive
remodeling to the ventilation system in 1986 illustrate the impact and
effectiveness of engineering modifications to control exposure.
[[Page 66944]]
Table 2.--Rocky Flats Building 444 Beryllium Machine Shop Personal
Sampling Data
------------------------------------------------------------------------
1984-1985 1986
------------------------------------------------------------------------
Number of Samples............... 99................ 279.
Arithmetic Mean................. 1.19 g/ 0.035 g/
m\3\. m\3\.
Percent of samples less than 2 84%............... 99.6%.
g/m\3\.
------------------------------------------------------------------------
The samples collected in 1984 were the first personal samples
collected in this shop following the discovery of a case of CBD that
year. Controls in that machine shop had previously been judged to be
adequate based on area monitoring. In addition to the extensive
remodeling of the ventilation system in the shop to minimize leakage
from hoods, operations performed outside of hoods were eliminated to
the extent possible. The decision to implement improved engineering
controls in this shop reduced average exposure levels by a factor
greater than 30 to levels approaching 1% of the limits established by
the existing PEL.
A final example, taken from personal sampling data collected during
decontamination of Rocky Flats buildings 865 and 867 in 1995-1996,
further demonstrates the low levels of beryllium exposure which can be
achieved through effective control planning (See Table 3). Each worker
was sampled during each work shift during this time period.
Table 3.--Decontamination of Rocky Flats Buildings 865 and 867 Personal
Sampling, 1995-1996
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of Samples......................... 7673.
Arithmetic Mean........................... 0.03 g/m\3\.
Percent of samples less than 2 g/ 99.8%.
m\3\.
------------------------------------------------------------------------
As can be seen from the foregoing examples, Rocky Flats machining
and D&D operations achieved an exceptional level of exposure control.
While the application of controls eliminates predictable sources of
exposure, there still can be large day-to-day variations in exposure.
The exposures that remain are likely to reflect accidents, equipment
failures, or poor work planning. Meeting exposure minimization goals
will require planning to limit the potential for such occurrences and
monitoring to detect those that do occur so they can be investigated
and prevented from reoccurring.
The personal monitoring results at Rocky Flats and Y-12 indicate
that most exposures are very low with a few exceptions. These
exceptions account for much of the total exposure that workers receive.
D. Epidemiology
The first evidence of the existence of chronic beryllium disease
(CBD) was reported in a 1946 paper by Hardy and Tabershaw (ref. 2). The
paper described ``delayed chemical pneumonitis'' among fluorescent lamp
workers exposed to beryllium compounds. The differential diagnosis
included tuberculosis and sarcoidosis, an immune disease of unknown
etiology.
There were also reports of CBD in individuals without known
occupational exposure to beryllium. Under the direction of Dr. Thomas
Mancuso, 16 cases of CBD were diagnosed (by X-ray examination) among
20,000 residents living near a beryllium production facility in Lorain,
Ohio (ref. 3). Likewise, a 1949 report described 11 patients with CBD
who lived near a beryllium extraction plant (ref. 4). Ten of these 11
lived within \3/4\ of a mile of the plant, and exposure from plant
discharges into the air was the suggested cause for 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
[g/m\3\]).
In addition, CBD has been reported among family members of
beryllium workers who were presumably exposed to contaminated work
clothing during the 1940's and 1950's (refs. 5, 6). The virtual
disappearance of CBD as a result of air pollution or household
exposures has been attributed to more stringent control of air
emissions and improved work practices, such as mandatory work clothing
exchange. This reduction in disease incidence is also attributed to
improvements in diagnostic testing (ref. 7). However, as recently as
1989, a woman previously diagnosed with sarcoidosis was diagnosed with
CBD. She had no occupational exposure, but her husband was a beryllium
production worker. This is the first new case of non-occupational CBD
reported in 30 years.
Sterner and Eisenbud suggested that CBD was a highly selective
immunologic response. Their conclusion was based on epidemiologic
evidence that (1) severe cases have occurred at low exposure; (2) the
level of beryllium contained in tissue did not correlate with the
extent of the disease; (3) there was a correlation between disease and
low atmospheric concentration, but not high concentrations; (4) the
onset of symptoms could occur years after the termination of exposure;
and (5) pulmonary lesions were not easily reproduced in animals (ref.
6).
A registry of production plant CBD cases was started at Columbia
University in 1947. A second registry of phosphor-lamp CBD cases was
started around the same time. In 1952, a Beryllium Case Registry was
established at the Massachusetts Institute of Technology (MIT) where
files from the other beryllium registries were consolidated. The
consolidated Beryllium Case Registry was moved to Massachusetts General
Hospital in the 1960's and ultimately relocated to the National
Institute for Occupational Safety and Health (NIOSH) in 1978. At that
time, the Beryllium Case Registry contained 622 cases of CBD, 224 cases
of acute beryllium disease, and 44 acute cases that developed into CBD.
Twenty-three cases were attributed to household exposures and 42 to air
pollution (ref. 5). The Beryllium Case Registry, which is now inactive,
was criticized as deficient in acquiring data on cases, identifying
populations at risk (denominator data), maintaining follow up of
questionable cases, and obtaining exposure data (ref. 8).
According to criteria utilized by the Beryllium Case Registry, the
diagnosis of CBD included at least four of the following six criteria
with one of the first two conditions required: (1) the establishment of
beryllium exposure based on occupational history or results of air
samples, (2) the presence of beryllium in lung tissue or thoracic lymph
tissue or in the urine, (3) evidence of lower respiratory tract disease
and a clinical course consistent with beryllium disease, (4)
pathological changes consistent with beryllium disease on examination
of lung tissue or thoracic lymph nodes, (5) radiologic evidence of
interstitial lung disease, and (6) decreased pulmonary function tests
(ref. 9).
The beryllium-induced lymphocyte proliferation test (Be-LPT) in
blood and bronchoalveolar lavage (BAL) fluid has allowed early
identification of the disease and is one of the criteria required for
diagnosis (refs. 10-12). Beryllium has been found to act as a specific
antigen, causing proliferation and accumulation of beryllium-specific
helper T lymphocytes (CD4) in the lung (ref. 13). Current data suggest
that the peripheral blood Be-LPT is a specific and sensitive method for
testing
[[Page 66945]]
beryllium sensitivity (ref. 10). The presence of granulomatous tissue
in the lung along with a positive BAL Be-LPT is considered definitive
evidence for diagnosis of CBD (ref. 11). Probable CBD is also diagnosed
based on signs and symptoms of CBD and a positive blood Be-LPT when
bronchoscopy is not indicated or is refused.
An article published by Cullen et al. in 1987 reported on cases of
CBD among precious-metal refinery workers (ref. 14). In 1993,
researchers at the National Jewish Medical and Research Center (NJMRC)
published two reports on epidemiologic studies that were designed to
determine the incidence of CBD among beryllium workers and the value of
the Be-LPT in detecting CBD (refs. 15, 16). One study was conducted at
DOE's Rocky Flats Environmental Technology Site (Rocky Flats). The
three epidemiologic studies showed that CBD incidence among exposed
workers was the same as had been reported among workers exposed in the
1940's, when the disease was first recognized. These were the first
studies of exposed workers since the adoption of the current
Occupational Safety and Health Administration (OSHA) 8-hour, time-
weighted average (TWA) permissible exposure limit (PEL) of 2
g/m\3\. The exposure limit was originally derived by analogy
to other toxic metals (ref. 17). A decline in the number of reports of
CBD led to the assumption that the 2 g/m\3\ limit had been
effective in preventing CBD (ref. 5). It is now clear that these
standards have not eliminated the incidence of disease.
In 1991, following the NJMRC study, the DOE Office of Environment,
Safety and Health initiated a beryllium worker health surveillance
program at Rocky Flats to provide medical screening to current and
former beryllium workers who had not participated in the earlier NJMRC
study. In addition, the Office of Environment, Safety and Health
initiated a study at the Oak Ridge Y-12 Plant (Y-12) in 1991 to learn
if the NJMRC findings on CBD incidence and the effectiveness of the Be-
LPT could be replicated. Results to date confirm NJMRC findings that
CBD incidence rates are high and that the Be-LPT is an effective
screening test for CBD as shown in Table 4.
Table 4.--Results of Medical Screening of Beryllium-Exposed Workers at 3
DOE Sites Through December 1997
------------------------------------------------------------------------
Rocky Flats Y-12 Mound
------------------------------------------------------------------------
Individuals Examined................. 6257 1949 632
Abnormal Be-LPT, Number (percent).... 221 (3.5) 77 (4) \1\1
Completed Diagnostic Exams........... 186 33 0
CBD\2\ Number (percent).............. 79\3\ (1.3) 25\4\ (1.3) 0
------------------------------------------------------------------------
\1\ The one Mound employee who was found to be consistently positive
declined to go on for diagnostic testing. Four others had one positive
blood test result and were awaiting retesting.
\2\ Includes 44 cases confirmed through biopsy and testing of lavage
cells and 35 presumptive cases in which the pulmonologist diagnosed
CBD but biopsy and/or lavage could not be completed.
\3\ Includes 56 cases found through the surveillance program since 1991,
17 through the 1987-1991 NJMRC study, and 6 between 1984 and 1987 for
a total of 79 CBD cases. Six of the 79 cases had consistently normal
Be-LPT results and were identified through lung disease symptoms or
abnormal chest X-rays.
\4\ Includes 17 cases found in the surveillance program since 1993, 2
found in 1991 among beryllium workers who had been diagnosed with
other lung diseases, and 6 cases found by the site clinic in 1993
among 146 currently exposed beryllium workers provided the Be-LPT.
In 1996, three studies reported on exposure to beryllium associated
with CBD and immunologic sensitization to beryllium (refs. 18-20). Two
of the studies reported on cases of CBD at Rocky Flats (refs. 18, 19).
The third reported on an epidemiology study of a private sector
beryllia ceramics fabrication plant that began operating in 1981 (ref.
20). Both Rocky Flats and the ceramics plant were extensively monitored
for compliance with the current OSHA 8-hour TWA exposure standard of 2
g/m\3\. The authors concluded that exposures among the highest
exposed groups in the plants were, on average, below the 2 g/
m\3\ limit. At both plants, cases of CBD and sensitization to beryllium
were found among administrative and other personnel, whose average
exposures were lower, as well as among the more highly exposed workers.
Stange and colleagues reported on the findings of a health
surveillance program at Rocky Flats that used the Be-LPT to screen for
CBD (ref. 18). Of 97 individuals who tested positive on the Be-LPT, 28
were found to have CBD. The article included an analysis of the work
histories of these 97 current and former workers. A qualitative
exposure estimate based on the work histories of individuals who
developed CBD concluded that exposures varied by more than an order of
magnitude. Extensive air monitoring data were available for one of the
highest exposed groups, machinists.
Barnard and colleagues completed an extensive analysis of the
monitoring data associated with machining operations at Rocky Flats
(ref. 19). Prior to 1984, air monitoring was accomplished with fixed
area monitors located near the machine tools that were thought to be
the primary sources of emissions into the work rooms. In 1984, personal
sampling was initiated, which was more representative of individual
exposure. The article reported a high degree of uncertainty in exposure
assessments prior to 1984 due to the lack of correlation between area
monitoring and personal monitoring. The authors concluded that
machinists, as a group, shared similar exposure potential, that average
exposures were less than but near the 2 g/m\3\ limit, and that
excursions above the limit were common.
Kreiss and colleagues studied CBD occurring in a beryllium oxide
ceramics manufacturing plant (ref. 20). They found that machinists had
the highest incidence rate of beryllium sensitization and the highest
exposure potential. The area monitoring conducted in this plant was
aimed at estimating exposures associated with job titles and was found
to correlate with personal sampling. The authors concluded that ``the
existing data suggests that the machining exposures resulting in the
14.3 odds ratio for beryllium sensitization were largely within those
permitted by current regulations.'' This article confirmed the findings
of a study of CBD in the neighborhood of a beryllium extraction plant,
which showed a correlation between ambient beryllium levels and
incidence of CBD (ref. 4). Further analyses of CBD incidence at Rocky
Flats, as yet unpublished, showed a similar higher risk for machinists
compared to that for other workers (See Table 5).
[[Page 66946]]
Table 5.--Incidence Rates of CBD at Rocky Flats
------------------------------------------------------------------------
Incidence
Job category \1\ Number CBD cases rate
tested (percent)
------------------------------------------------------------------------
Beryllium Machinist.............. 223 21 9.4
Administrative................... 1,903 23 1.2
Professional..................... 1,396 15 1.1
All Employees Tested............. 6,254 64 1.0
------------------------------------------------------------------------
\1\ Many employees held more than one job title.
Cases of CBD have occurred in machinists who worked in the Y-12
beryllia ceramic machine shop, where levels have been quite low. Only a
small percentage of samples have detected beryllium. Applying a
nonparametric tolerance limit test to 1980 and 1990 personal sampling
results from this shop shows, with 95 percent confidence, that 90
percent of exposures were lower than the detection limit (0.1
g/m\3\ in the 1980-1990 timeframe). Only one of several
hundred personal samples was over the 2 g/m\3\ limit.
Continuous area air monitors have operated in the shop throughout its
existence. One area sample indicated levels above 2 g/m\3\
when a machine tool was operated with a disconnected exhaust duct. No
other area measurement above 2 g/m\3\ were recorded, and the
median measurement was at the level of detection.
Several authors have highlighted the uncertainty that exists in the
exposure assessments (refs. 19-21). The chemical composition of the
beryllium materials used and the particle size distribution of the
aerosol created by the work operation affect the bioavailability of
beryllium, and neither is accounted for by current personal sampling
and analytical methods. It is not known what percentage of the
beryllium that is being measured in air is capable of reaching the
regions of the lung where the health effect occurs. In addition, area
monitoring used in the past does not correlate with the personal
monitoring that is thought to be more representative of exposure (refs.
19, 21).
Epidemiologic investigations to date have failed to show whether
the time course of exposure (dose rate) is biologically significant.
High day-to-day variation in exposure level and excursions above the 2
g/m\3\ limit have occurred in all groups studied. Excursions
make up a significant contribution to individuals' total doses,
confounding attempts to understand if dose rate is an important risk
factor. Beryllium oxide and metal in the lung dissolve slowly over a
period of months and years (ref. 22), producing the beryllium ion that
elicits an immune response (ref. 23). The persistent presence of the
beryllium ion in the lung makes CBD a chronic disease (ref. 24). Either
intermittent or chronic exposure to less soluble forms of beryllium can
create and maintain a lung burden that will not clear for many years,
if at all (ref. 25).
Certain individuals are more susceptible to CBD than others. It has
long been suspected that genetic predisposition plays an important role
in determining who will develop CBD. Recent advances in genetics and
immunology have made it possible for researchers to investigate the
basis for CBD and to identify a genetic component (ref. 26).
Differences in individual susceptibility have made it difficult to
understand the relationship between exposure and CBD. Early
epidemiologic studies detected similar disease rates among high- and
low-exposure occupational groups (Table 6). The NJMRC researchers
detected differences in disease rates among the workers they studied
(Table 7). The DOE surveillance findings supported this conclusion (See
Table 5). NJMRC researchers have found cases of CBD among those who had
been exposed for periods as short as 1 month and those who had
unrecognized or seemingly trivial exposure. However, they also found
evidence that disease incidence increased with increasing exposure and
concluded that exposure to beryllium should be minimized.
Table 6.--Chronic Beryllium Disease Rates
Estimated
Estimated level of
Exposed during the 1940's Estimated Cases incidence exposure
exposed per 100 g/
exposed m\3\
Residents Living Within 0.25 Mile of a Beryllium Extraction
Plant \1\................................................. 500 5 1.0 1
Fluorescent Lamp Manufacturing \1\
Massachusetts.......................................... 15,000 175 1.16 100
Ohio................................................... 8,000 32 0.4 100
Machine Shop \1\........................................... 225 11 4.9 500
Beryllium-Copper Foundry \1\............................... 1,000 13 1.3 500
Beryllium Extraction \1\
Lorain, Ohio........................................... 1,700 22 1.3 1000
Painesville, Ohio...................................... 200 0 0.0 1000
Reading, Pennsylvania.................................. 4,000 51 1.3 1000
----------------------------------------------------------------------------------------------------------------
Estimated
Incidence level of
Exposed from the 1970's to the 1980's Study Cases per 100 exposure
participants exposed g/
m\3\
----------------------------------------------------------------------------------------------------------------
Beryllia Ceramics Plant \2\............................... 505 9 1.8 NA
The DOE Rocky Flats Plant \3\............................. 895 15 1.7 1
[[Page 66947]]
Second Beryllia Ceramics Plant \4\........................ 709 8 1.1 0.5
----------------------------------------------------------------------------------------------------------------
\1\ Eisenbud and Lisson, ``Epidemiologic Aspects of Beryllium-Induced Non Malignant Lung Disease: A 30-Year
Update,'' JOM, Vol. 25, pp 196-202, 1983.
\2\ Kathleen Kreiss et al., ``Beryllium Disease Screening in the Ceramics Industry,'' JOM, Vol. 35, pp 267-274,
1993.
\3\ Kathleen Kreiss et al., ``Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,'' Am. Rev.
Res. Dis., Vol. 148, pp 985-991, 1993.
\4\ Kathleen Kreiss et al., ``Machining Risk of Beryllium Disease and Sensitization with Median Exposures Below
2 g/m\3\,'' Am. J. Ind. Med., Vol. 30, pp 16-25, 1996.
Table 7.--Beryllium Sensitization and Disease Rates at Rocky Flats
------------------------------------------------------------------------
Workers Sensitization
Beryllium process title Workers doing rate
sensitized process (percent)
------------------------------------------------------------------------
Cleaning Tools, Machines....... 7 255 2.7
Machining...................... 6 189 3.2
Inspection..................... 2 138 1.4
Metallurgical Sample
Preparation................... 3 115 2.6
Sawing......................... 5 06 4.7
Trepanning..................... 3 77 3.9
Band Sawing.................... 4 67 6.0
Decanning, Shearing............ 2 65 3.1
Precision Grinding............. 2 31 6.5
------------------------------------------------------------------------
Rate
All participants Number Participants (percent)
Sensitized...................... 18 895 2.0
Confirmed CBD Cases............. 15 895 1.7
------------------------------------------------------------------------
From Kathleen Kreiss et al. ``Epidemiology of Beryllium Sensitization
and Disease in Nuclear Workers,'' Am. Rev. Res. Dis., Vol. 148, pp 985-
991, 1993.
A recent publication by Eisenbud in January 1998, (ref. 27),
consolidated the previous epidemiologic studies that have questioned
the relevance of the current PEL after evaluating the effect of the
level of exposure on disease. In this article, Eisenbud concludes that
it ``appears'' the current 2 g/m\3\ standard is not protective
enough. Rather than recommend an alternative exposure limit, however,
Eisenbud points to the need for the development of an animal model to
aid in better understanding the etiology of CBD and suggests that
innovative measures may be needed to control the disease.
In summary, evidence suggests higher incidence of CBD among workers
with higher exposures (e.g., machinists), but, at lower exposure
levels, other factors may operate to confound a clear dose-response
relationship. These factors include: (1) The effect of peak exposures
(such that most of the exposure results from short-term episodes); (2)
inadequacy of area monitoring in reflecting actual exposure; (3)
chemical composition, etc., that may affect bioavailability; (4)
inadequate monitoring of beryllium composition/species associated with
exposures; and (5) the effect of genetic predisposition. As a result,
the existing literature does not point to a clear set of measures that
will reduce incidence.
E. Value of Early Detection
Researchers at the National Jewish Medical and Research Center
(NJMRC) compared the lung functions of patients with chronic beryllium
disease (CBD) who had been identified through abnormal chest X-rays or
clinical symptoms to those of patients whose CBD had been identified
through positive beryllium-induced lymphocyte proliferation tests (Be-
LPTs) (ref. 28). Twelve of 21 Be-LPT-identified patients had lung
abnormalities, including reduced exercise tolerance. Fourteen of 15
patients identified through chest X-rays or clinical symptoms had
abnormal lung function, and their abnormalities were more severe. The
authors concluded that the Be-LPT was useful because it permitted
detection of affected individuals earlier in the disease process.
Early identification also allows removal of patients with CBD from
jobs with beryllium exposure. There is no direct evidence that removal
from exposure improves the prognosis of patients with CBD, because
follow up studies have not been done. However, beryllium does clear
from the lung over time, and a reduced level of antigen in the lung
should reduce the severity of the inflammation and the amount of lung
damage.
The 79 cases of CBD diagnosed among Rocky Flats workers showed a
range of severity similar to that reported elsewhere. Thirty-nine
individuals had symptoms that required treatment ranging from inhaled
bronchodilators to corticosteroids to oxygen. Two individuals died of
CBD. Seventy-three of the 79 cases were identified among individuals
who had abnormal Be-LPT results but normal chest X-rays or pulmonary
function screening test results.
V. Request for Information
The Department is considering more stringent requirements in
various areas of the proposed NOPR. It is especially interested in
comments that are supported by evidence and rationale whenever
possible, regarding the following areas.
Industrial hygiene competencies: Proposed sections 850.21(b) and
850.24(a) would require that hazards assessments and exposure
monitoring, respectively be conducted by ``individuals with sufficient
knowledge in industrial hygiene.'' The Department
[[Page 66948]]
is considering using more prescriptive definitions for the
qualifications an individual must possess to perform the required
hazard assessments and exposure monitoring. One possible alternative
approach would be to use OSHA's ``competent person'' definition. OSHA
defines a competent person as:
* * * one who is capable of identifying existing and predictable
hazards in the surroundings or working conditions which are
unsanitary, hazardous, or dangerous to employees, and who has
authorization to take prompt corrective measures to eliminate them.
Another possible approach would be to require that hazards
assessments and exposure monitoring be performed by a ``certified
industrial hygienist'' as defined by the American Board of Industrial
Hygiene. DOE requests that interested parties submit comments regarding
the use of such prescriptive definitions and/or suggestions for
alternative approaches.
Permissible exposure limit: To address the uncertainties associated
with the existing PEL and the limitations of the existing scientific
data, DOE requests that interested parties submit any compelling,
scientific evidence that would assist the Department in establishing a
new permissible exposure limit that would be more protective of worker
health.
Percent exceedance: The Department is considering alternatives to
the action level as a basis for judging and interpreting exposure
monitoring results. Descriptions of three methods used to interpret
exposure level data are contained in the American Industrial Hygiene
Association, A Strategy for Occupational Exposure Assessment (ref. 29).
Of the three methods described, the percent exceedance approach appears
as the best alternative for achieving the policy goal of encouraging
periodic monitoring to understand the distribution of exposures and for
investigating the causes of high exposures to prevent their
reoccurrence. We are considering proposing that monitoring demonstrate
95% confidence that fewer than 5 percent of the 8-hour or 15 minute TWA
PEL levels exceed the exposure limit. The advantage of this method is
that periodic monitoring is needed to characterize the distribution of
exposure before compliance can be demonstrated, usually through an
upper tolerance limit test. In addition this method rewards day-to-day
management of exposure levels through investigation of the causes of an
exceedance and the implementation of corrective actions that will
prevent it from reoccurring. A weakness of this method is that it can
underestimate the degree of risk in a workplace where day-to-day, or
between worker variation, is very large. This weakness can be minimized
by assuring that long term mean levels are not high compared to the
PEL. DOE requests that interested parties provide information on: the
feasibility and implication of a percent exceedance approach to
defining an acceptable workplace; the percent exceedance that would
still provide the level of protection intended by the 8-hour or 15
minute TWA PEL; and whether mean testing should be specified as well.
Commentors should provide the rationale and associated costs for
approaches supported in their submittals, as well as input on
implementation strategies or issues.
Exposure monitoring: Given the uncertainty regarding the adequacy
of the PELs and whether any level of beryllium exposure should be
considered safe, DOE is considering establishing a requirement for
daily exposure monitoring of all beryllium workers to document and
characterize more completely a worker's exposure to beryllium, and to
better evaluate the adequacy of existing exposure levels or determine
appropriate levels for alternative exposure limits. At the very low
exposure levels that the Department is attempting to achieve, work
practices that would ordinarily be judged as presenting trivial
potential sources of exposure may be significant. The goal of an
exposure monitoring program should be routine sampling aimed at
characterizing the distribution of exposures due to typical work.
Monitoring results help identify both the cause of exposure above
limits and measures that can prevent recurrence. DOE requests that
interested parties provide information on the feasibility and
implications of this more restrictive monitoring requirement.
Commentors should also provide the rationale for the approaches
supported in their submittals.
Respiratory protection: DOE is considering requiring the use of
respiratory protection at the action level instead of the PEL due to
uncertainty about the protective value of the PEL. DOE requests that
interested parties submit comments regarding the impact of such a
change.
Protective clothing and equipment: DOE is requesting information
regarding the presence of soluble beryllium compounds within the DOE
complex and the appropriateness of the exclusion of such compounds from
the definition of beryllium in the proposed rule. In addition, DOE
requests comments with appropriate supporting rationale regarding the
need for the protective clothing provisions of proposed section
850.29(a)(2) given that soluble beryllium compounds apparently are not
present within the DOE complex.
Surface contamination level: DOE requests that interested parties
submit comments regarding the validity of the proposed 3 g/100
cm2 surface contamination level. If an alternate level is
suggested, the Department requests that the rationale and associated
cost implications for choosing the alternate surface contamination
level also be provided.
Release level: DOE is aware of the need to set an acceptably free-
release surface contamination level for beryllium for unrestricted
equipment release and transfer to uncontrolled areas and the public.
DOE requests that interested parties submit comments regarding the
setting of a beryllium free-release public contamination level. If a
level is suggested, the Department requests that the rationale and
associated cost implications for choosing the associated surface
contamination level also be provided.
Medical surveillance: DOE seeks comments on whether all workers
with any potential exposure to beryllium, regardless of the level of
exposure, should be provided the option to participate in a medical
surveillance program to identify workers who may become sensitized to
beryllium at exposures less than the action level or STEL.
Anonymous testing: The Department realizes that some workers may
elect not to participate in the medical surveillance program because
they may believe that a diagnosis of CBD or beryllium sensitization
could have a negative impact on future employment opportunities or on
their health insurance. To address this concern and to encourage
greater worker participation in the medical surveillance program, DOE
is considering including a provision in the proposed rule that would
allow for anonymous testing for CBD. Such a provision could include
assigning an identification number (not traceable to the worker's name)
to the worker's blood sample. The tested worker could use the
identification number to call into the testing laboratory after a
specified amount of time to retrieve the test results.
DOE recognizes that such a system may encourage greater
participation in the medical surveillance program, but it also has
several drawbacks including the inability to correlate collected
exposure data to health outcomes, and problems associated with the need
for followup testing to confirm positive
[[Page 66949]]
results. DOE request that interested parties comment on appropriate
methods for, and the feasibility and utility of provisions for
anonymous testing for CBD.
Outreach program: DOE is considering a requirement that contractors
develop and implement an outreach education program for family members
of beryllium workers. The outreach awareness program would address the
hazards of exposure to beryllium and the purpose and content of the
CBDPP. The objective of this requirement would be to increase awareness
among the families of beryllium workers about the hazards associated
with beryllium exposure and the actions being taken within the
Department to address these hazards. DOE requests that interested
parties comment on the feasibility, utility, and implications of such
an outreach program.
VI. Section-by-Section Analysis
Overview of the Proposed Rule
The proposed rule would strengthen the Department's worker
protection program established in DOE Order 440.1A, Worker Protection
Management for DOE Federal and Contractor Employees (5483.1B, 5480.4,
5480.8A, and 5480.10 for operations not covered contractually under
440.1A), by supplementing the general worker protection program
requirements of the order with hazard-specific provisions that are
designed to manage and control beryllium exposure hazards in the DOE
workplace. These hazard-specific provisions are derived largely from
DOE Notice 440.1, ``Interim Chronic Beryllium Disease Prevention
Program.''
DOE Notice 440.1 was developed by the DOE Beryllium Rule
Development Team and Executive Committee, both of which consisted of
representatives of each of the affected DOE headquarters and field
offices. The technical basis for the notice was based in part on public
input provided to the DOE Office of Environment, Safety and Health (EH)
by 43 commentors and organizations in response to a December 30, 1996,
Federal Register notice requesting scientific data, information, and
views relevant to a DOE beryllium standard (61 FR 68725). Much of this
information was presented and discussed at public forums held in
Albuquerque, NM, and Oak Ridge, TN, in January 1997. Records of these
public forums, as well as copies of all related public input and the
minutes and recommendations of the BRAC meetings, are available at the
DOE Freedom of Information Reading Room in the prerulemaking docket
file entitled ``BERYLLIUM STANDARD.'' See the preceding ADDRESSES
section for details on how to review or obtain copies of this material.
Consistent with DOE Notice 440.1 the proposed rule establishes a
CBDPP that is designed to prevent the occurrence of chronic beryllium
disease (CBD) among DOE Federal and contractor workers. The CBDPP will
accomplish this disease-prevention mission through provisions that (1)
reduce the number of current DOE Federal and contractor 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 particles 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 and treatment of disease;
and (4) continually monitor the effectiveness of the program in
preventing CBD and implement program enhancements as appropriate.
The provisions of the proposed rule are presented in three main
subparts: A, B, and C. Subpart A of the proposed rule describes the
purpose and applicability of the rule, defines terms that are critical
to the rule's application and implementation, and establishes DOE and
contractor responsibilities for executing the rule. Subpart B
establishes administrative requirements to develop and maintain a CBDPP
and to perform all beryllium-related activities according to the CBDPP.
Subpart C establishes requirements that focus on protecting workers
from the harmful health effects associated with exposure to airborne
levels of beryllium. Some of the provisions of Subpart C would apply
only when it is determined that the airborne concentrations of
beryllium in a specific workplace or operation rise above a specified
limit. Table 5 summarizes these provisions and indicates the levels of
beryllium at which the provisions would be enacted. Subparts A, B, and
C of the proposed rule are discussed in detail in the following
sections.
Table 5.--Levels at Which the Provisions of the CBDPP Would Be Enacted
------------------------------------------------------------------------
Worker exposure or potential exposure
levels (8-hour TWA)
-----------------------------------------
Provision
> 0 Action level > PEL (8-hr
or > STEL TWA or STEL)
------------------------------------------------------------------------
Baseline Beryllium Inventory
(850.20)..................... X ............ ............
Hazard Assessment (850.21).... X ............ ............
Initial Exposure Monitoring
(850.24)..................... X ............ ............
Periodic Exposure Monitoring
(850.24)..................... ............ X ............
Exposure Reduction and
Minimization (850.25)........ X\1\ X\2\ X\3\
Regulated Areas (850.26)...... ............ X ............
Change Rooms (850.27)......... ............ X ............
Respiratory Protection
(850.28)..................... ............ ............ X
Protective Clothing and
Equipment (850.29)........... ............ X ............
Housekeeping (850.30)......... X\4\
Medical Surveillance (850.33). ............ X ............
Training (850.36)............. X\5\ ............ ............
Counseling (850.36)........... ............ X\6\ ............
Warning Signs (850.37)........ ............ X ............
Waste Disposal (850.31)....... Applies to beryllium waste and beryllium-
contaminated waste.
Beryllium Emergencies (850.32) Applies to beryllium operations.
[[Page 66950]]
Warning Labels (850.37)....... Applies to beryllium and beryllium waste
and beryllium-contaminated material and
waste.
------------------------------------------------------------------------
\1\ If exposure levels are below the action level or STEL, contractors
must establish exposure reduction and minimization goals to further
reduce worker exposures where practicable.
\2\ Contractors must investigate opportunities for and, if feasible,
implement controls for reducing exposures to below the action level or
STEL.
\3\ Contractors must reduce exposures to or below the PEL or STEL.
\4\ Housekeeping efforts must maintain removable surface contamination
at or below 3 g/100 cm\2\.
\5\ Hazard communication training is required for all workers who could
be potentially exposed.
\6\ Counseling is required for beryllium workers diagnosed with CBD or
beryllium sensitization.
A. Subpart A--General Provisions
Proposed section 850.1 emphasizes that the proposed CBDPP would
enhance, supplement, and be integrated into existing worker protection
program requirements for DOE Federal and contractor employees. The
Department has structured the proposed rule this way for two main
reasons: (1) To take advantage of existing and effective comprehensive
worker protection programs that have been implemented at DOE
facilities, and (2) 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 section 850.2(a)(1) specifies that the proposed rule would
apply to DOE Federal employees with responsibilities for operations or
activities involving exposure or the potential for exposure to
beryllium at DOE-owned or -leased facilities. The Department recognizes
that its 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 often must enter facilities where beryllium
is handled. Federal workers are protected 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 (EO) 12196, ``Occupational Safety and Health
Programs for Federal Employees.'' The Department's intent in proposed
section 850.2(a)(1) 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.
Proposed section 850.2(a)(2) specifies that the proposed rule would
also apply to DOE contractors with operations or activities involving
exposure or the potential for exposure to beryllium. As clarified in
the definition of DOE contractor (proposed section 850.3), the
Department's intent is that the DOE contractors covered under this
proposed rule would include any entity under contract to perform DOE
activities at DOE-owned or -leased facilities, including contractors
awarded contracts, integrating contractors, and subcontractors. This
section further clarifies that the requirements of the CBDPP would
apply only to contractors and subcontractors who work in areas or on
DOE activities that involve the potential for worker exposure to
beryllium. The Department's intent with this clarification is to focus
DOE and contractor resources and efforts on areas and activities that
present a real potential for worker exposure to beryllium and thus
realize the most benefit from implementing the proposed CBDPP. DOE
emphasizes this intent throughout the proposed rule by requiring that
DOE contractors tailor their approach to implementing the CBDPP.
The Department's intent with the applicability provisions of
proposed section 850.2(a)(1) and (a)(2) is that the proposed rule would
apply only to exposures and potential exposures to beryllium that occur
in connection with facility operations. This recognizes the fact that
beryllium occurs naturally in soils and that the focus of the CBDPP
should not be on naturally occurring beryllium but rather on the
occupational exposures resulting from DOE operations.
Proposed section 850.2(b)(1) would exempt ``beryllium articles''
from the requirements of the proposed rule (see the discussion of the
definition of ``beryllium article'' under proposed section 850.3). The
Department recognizes that some beryllium-containing manufactured items
may not pose beryllium hazards where they have been formed to specific
shapes or designs and their subsequent uses or handling will not result
in the release of beryllium. This exemption for beryllium articles is
consistent with the approach taken by OSHA when defining hazardous
materials subject to the Hazard Communication standard at 29 CFR
1910.1200.
Proposed section 850.2(b)(2) would establish that the rule does not
apply to the DOE laboratory operations involving beryllium that are
subject to the requirements of OSHA's Occupational Exposure to
Hazardous Chemicals in Laboratories standard, 29 CFR 1910.1450,
commonly called OSHA's laboratory standard. In establishing its
laboratory standard, OSHA clarified its intent that 29 CFR 1910.1450
supersede all other OSHA regulations for bench-top laboratory-scale
activities, noting that the provisions of the standard were more
relevant and suitable to the unique characteristics of laboratory
activities. The Department agrees with OSHA's approach and believes
that the provisions of OSHA's laboratory standard are adequate to
protect workers from beryllium exposures in facilities that fall within
the scope of the standard.
Proposed section 850.3 would apply traditional industrial hygiene
terminology to define key terms used throughout the proposed rule. In
relying on such terminology and by using terms consistent with OSHA
interpretations, DOE intends to signal the Department's increased
emphasis on industrial hygiene compliance through the use of accepted
occupational safety and health requirements and procedures. The
following discussion defines and
[[Page 66951]]
explains each of the definitions in the proposed rule.
Accepted applicant is any person who has accepted an offer of
employment in beryllium work at a DOE facility but who has not yet
begun performing beryllium work. DOE intends for DOE contractors to
provide such individuals with baseline medical evaluations before
allowing them to begin employment as beryllium workers to ensure that
they can safely perform work in areas that may present the potential
for exposure to beryllium.
Action level means the level of airborne concentration of beryllium
established pursuant to Subpart C, which, if exceeded, would require
the implementation of certain provisions of the proposed rule. Using an
action level to trigger certain provisions of the proposed rule is
consistent with the approach applied in many of OSHA's substance-
specific standards. This approach ensures that appropriate workplace
precautions are taken and that training and medical surveillance are
provided in cases in which worker exposures to beryllium could approach
the permissible exposure limit. Additional discussion on the
application of the action level in this proposed rule is provided in
the discussion on proposed section 850.23, Action Level, and in the
discussions of the individual provisions of the proposed rule that
would be triggered by exceeding the proposed action level.
Authorized person means any person required by work duties to be in
regulated areas. Authorized individuals are intended to be trained and
experienced in the hazards of beryllium and in the means of protecting
themselves and those around them against such hazards. Training
requirements for all individuals working with beryllium are specified
in proposed section 850.36 of the proposed rule. The concept of
authorized persons is consistent with OSHA standards and with
contractor practice in many facilities and is intended to ensure that
the number of potentially exposed individuals is reduced to the lowest
possible number and that workers who are granted access to regulated
areas have the knowledge they need to protect themselves and other
workers.
Beryllium means elemental beryllium and any insoluble beryllium
compound or alloy containing 0.1 percent beryllium or greater that may
be released as an airborne particulate. The Department has chosen this
definition of beryllium because it clearly reflects that the focus of
the proposed rule is on exposure to airborne levels of beryllium. DOE
notes in this definition that OSHA uses the criterion for a
carcinogenic mixture as one that contains a carcinogenic component at a
concentration of 0.1 percent (or 1,000 parts per million [ppm]) or
greater, by weight or volume.
Beryllium article means a manufactured item that is formed to a
specific shape or design during manufacture and that has end-use
functions that depend in whole or in part on the item's shape or design
during use and that does not release beryllium or otherwise result in
exposure to airborne concentrations of beryllium under normal-use
conditions. The Department has included this definition of ``beryllium
article'' to distinguish between forms of beryllium that could result
in exposure and manufactured items containing beryllium that do not
release beryllium or otherwise result in exposure to airborne
concentrations of beryllium. This definition is consistent with the
rationale employed by OSHA in formulating its definition of ``article''
in the Hazard Communication standard (29 CFR 1910.1200). The key
concept is that an article does not have the potential to result in
hazardous exposures; this definition of ``article'' also considers the
item's intended use. For example, an item ceases to be an ``article''
when it is subjected to machining, cutting, or drilling. Similarly, if
an item is manufactured for the purpose of being machined later, it is
not considered an article.
Beryllium emergency means any occurrence such as, but not limited
to, equipment failure, container rupture, or failure of control
equipment or operations, that unexpectedly releases a significant
amount of beryllium. 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 is based on OSHA's
interpretation of the term as applied in 29 CFR 1910.120 and is
intended to refer to any untoward event, such as a major spill of
powdered beryllium or an unexpected, massive upset that releases a
significant amount of airborne beryllium into the workplace atmosphere.
The use of the term ``beryllium emergency'' in this proposed rule
applies to proposed section 850.32, Emergencies, which requires DOE
contractors to develop emergency procedures and training to address
emergency scenarios. Such procedures and training must focus on
emergency events that can reasonably be foreseen by an employer, such
as a spill or a rupture of a pipe or a container.
Beryllium-induced lymphocyte proliferation test (Be-LPT) means an
in vitro measure of the beryllium antigen-specific, cell-mediated
immune response. This test measures the extent to which lymphocytes, a
class of white blood cells, respond to the presence of beryllium by
replicating in the laboratory. The Be-LPT is used by medical personnel
to identify workers who have become sensitized to beryllium through
their occupational exposure.
Beryllium worker means a current worker who is exposed or
potentially exposed to airborne concentrations of beryllium at or above
the action level or above the STEL or who is currently receiving
medical removal protection benefits. This individual is a DOE Federal
or contractor worker, a worker of a subcontractor to a DOE contractor,
or a visitor who performs work for or with DOE or uses DOE facilities.
This definition, through the phrase ``current worker who is exposed or
potentially exposed to airborne concentrations of beryllium,''
clarifies the Department's intent that the proposed rule would apply
only to current workers who are part of the at-risk population. The
definition further clarifies that current workers who have been removed
from beryllium exposure as part of the medical removal plan would
continue to be considered as beryllium workers under the proposed rule.
Former DOE workers who were potentially exposed to beryllium do not
fall within this definition or the proposed rule. These workers will be
addressed under a separate DOE initiative that is under development.
Breathing zone is 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 section 850.24, Exposure Monitoring,
which would require DOE contractors to determine worker 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 practice and ensures that samples
collected for personal exposure monitoring represent the air inhaled by
workers while performing their duties in affected work areas.
DOE means the Department of Energy or Department.
DOE beryllium activity means an activity performed for, or by, DOE
that can expose workers to airborne concentrations of beryllium.
Activities within the scope of this definition
[[Page 66952]]
include design, construction, operation, maintenance, and
decommissioning. The definition further explains that, to the extent
appropriate, a ``DOE activity'' may involve one DOE facility or
operation, a combination of facilities and operations, or possibly an
entire site. This definition is broad enough to include such activities
as repair work performed by support-service subcontractors who visit
the site infrequently.
DOE contractor means any entity under contract (or its
subcontractors) with DOE with responsibility for performing DOE
activities at DOE-owned or -leased facilities. This does not apply to
contractors or subcontractors who solely provide ``commercial items''
as defined under the Federal Acquisition Regulations (FAR). As
explained in proposed section 850.10, subcontractors included in this
definition who would be covered under the proposed rule would not
necessarily be expected to produce their own written CBDPPs. However,
these subcontractors should be included in the CBDPP that encompasses
all beryllium-related activities at the site. See the discussion in
proposed section 850.10 for further details on how the requirements of
the proposed CBDPP would be extended to a subcontractor.
DOE facility means any facility owned or leased by DOE.
High-efficiency particulate air (HEPA) filter means a high-
efficiency filter capable of trapping and retaining at least 99.97
percent of 0.3-micrometer monodisperse particles. Such filters are
commonly used in heating and ventilating systems, respiratory
protection equipment, local exhaust ventilation, and so on, to remove
toxic or hazardous particulates like beryllium.
Immune response refers to the series of cellular events by which
the immune system reacts to challenge a specific antigen. Types of
immune responses include acquired immunity and sensitization. The
body's immune response to beryllium is indicated by the results of the
Be-LPT.
Medical removal protection benefits are employment rights
established in proposed section 850.34 for beryllium workers who
voluntarily accept temporary or permanent medical removal from
regulated areas following medical evaluations that confirm beryllium
sensitization or CBD. These provisions would ensure that contractors
make reasonable efforts to find and offer alternate employment to
beryllium workers who have suffered negative health effects due to
exposure to beryllium. The definition of medical removal protection
benefits and the requirements in proposed section 850.34 would ensure
that such workers would suffer no reductions in wage rate, seniority,
or other benefits for 2 years after medical removal. The 2-year period
would allow the contractor to make a reasonable effort through job
retraining and out-placement programs operated by many sites to locate
alternate work placement for beryllium workers, either internally or
with different employers.
Regulated area means an area established and managed by the
contractor to demarcate locations where the airborne concentration of
beryllium exceeds, or can reasonably be expected to exceed, the action
level (see the preceding definition of ``action level''). Employees
working in regulated areas must be authorized to do so by the
contractor and trained and equipped with protective clothing and
equipment. The purpose of such areas is to limit beryllium exposure to
as few employees as possible. This is a standard definition used
throughout DOE, particularly with regard to radiation protection, and
is consistent with OSHA's expanded health standards that address toxic
particulates.
Short-term exposure limit (STEL) means the level of airborne
concentration established pursuant to Subpart C (calculated as a 15-
minute TWA, measured in the worker's breathing zone by personal
monitoring), which should not be exceeded for any 15-minute period at
any time during the workday. Additional discussion on the application
of the STEL in this proposed rule is provided in the discussion on
proposed section, 850.22, Exposure Limits.
Site occupational medicine director (SOMD) means the physician
responsible for the overall direction and operation of the site
occupational medicine program. DOE's intent with this definition is to
ensure that each site's occupational medicine program would be
administered by a qualified medical professional.
Surface contamination means the presence of beryllium on exposed
work surfaces, which may cause skin irritation upon contact or which
may present an airborne hazard when reentrained into the workplace air.
This definition of ``surface contamination'' is also important in
addressing the maintenance, decontamination, and cleaning of facilities
and equipment for recycling or for release for other uses. The
Department recognizes that airborne respirable beryllium particles
differ from surface contamination, which is not respirable until it is
disturbed. Therefore, the rule provides separate definitions of
``beryllium'' and ``surface contamination.''
Worker means a person who performs work for or on behalf of DOE,
including a DOE employee, an independent contractor, a DOE contractor
employee, or any other person who performs work at a DOE facility. As
clarified in the definition of DOE contractor, a contractor employee
can be an employee of a covered subcontractor.
Worker exposure means the airborne concentration of beryllium in
the breathing zone of the worker when the worker is not using
respiratory protective equipment. This definition is consistent with
accepted industrial hygiene practice and with OSHA's definition of the
term ``employee exposure'' as applied in the OSHA expanded health
standards.
Proposed section 850.3(b) references the standard definitions
contained in the Atomic Energy Act and related rules under 10 CFR part
850 for other terms used throughout this proposed rule.
Proposed section 850.4 would establish enforcement provisions for
the proposed rule. Like other Departmental regulations that apply to
DOE contractors, this provision would allow DOE to employ contractual
mechanisms, such as contract termination or fee reduction, when
contractors fail to comply with the provisions of this proposed rule.
These mechanisms help the Department ensure that beryllium workers
receive an appropriate level of protection while performing
Departmental activities that involve exposure or the potential for
exposure to beryllium.
Proposed section 850.5 would provide the appropriate steps that the
Department may take to enforce compliance with this proposed rule. The
grievance-arbitration processes of collective bargaining agreements
covering accepted applicants and beryllium workers employed by
Department contractors would generally apply to disputes relating to
implementation of this part. Therefore, proposed section 850.5 would
provide that disputes arising under this part brought by beryllium
workers and accepted applicants (or by labor organizations acting on
their behalf) that are covered by grievance-arbitration processes
should be resolved through such processes. This approach to dispute
resolution would minimize the possibility of bypassing collective
bargaining representatives or existing contractual grievance-
arbitration processes and minimize the possibility of conflicting
outcomes that would exist with multiple avenues for enforcing
compliance with the rule.
[[Page 66953]]
However, where the individuals bringing such disputes are not
covered by collective bargaining agreements or where such collectively
bargained processes are not applicable, the proposed rule would provide
that disputes brought by individuals may be resolved by the
Department's Office of Hearings and Appeals (OHA). OHA is an
established and impartial body that has experience in dealing with
whistleblower, security, and other disputes brought by individual
workers. The procedures in 10 CFR part 1003, Subpart C, shall apply to
resolution of disputes by OHA.
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.
As owner or lessor of DOE-owned or -leased facilities, the
Department has both a responsibility for overseeing the health and
safety activities of its contractors and a partnership interest in
achieving excellence in worker protection activities. Accordingly,
proposed section 850.10(a)(1) would require DOE contractors who are
responsible for DOE beryllium activities to prepare CBDPPs for their
operations and submit the CBDPPs to the appropriate DOE Field
Organization for approval. This section would establish a 90-day time
frame from the effective date of the rule for contractor submission of
the CBDPP to the appropriate DOE Field Organization. The Department is
well aware of the burden of documentation that can be generated by new
programs. However, most DOE contractors have already developed CBDPPs
in response to the requirements of DOE Notice 440.1. The Department
expects that the additional efforts that would be required to refine
the existing CBDPPs to meet the requirements of the proposed rule would
be minimal. The Department considers 90-days sufficient time for DOE
contractors to examine their safety and health programs and make any
changes necessitated by the rule.
Proposed section 850.10(a)(2) would require that a single written
CBDPP be submitted to encompass all beryllium-related activities at a
site. Because the Department recognizes that one site may encompass
multiple contractors and numerous work activities, however, this
proposed section clarifies that the CBDPP for a given site may include
specific sections for individual contractors, work tasks, and so on.
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 contractors to update and submit for
approval only the affected sections of the CBDPP. When multiple
contractors are involved, the DOE contractor designated by the DOE
Field Organization shall take the lead in compiling the overall CBDPP
document and coordinating the input from various subcontractors or work
activities. This section further clarifies that in such cases where
multiple contractors are involved, the designated contractor would have
to review and approve the CBDPPs of other contractors engaged at the
site before a consolidated CBDPP would be submitted to the head of the
cognizant DOE Field Organization for final review and approval.
Proposed section 850.10(b) would require heads of DOE Field
Organizations to review and approve CBDPPs. DOE believes that DOE
review and approval are necessary to ensure that each contractor's
CBDPP is consistent with best industry practices for industrial
hygiene, the Department's exposure reduction and minimization
philosophy, and the objectives of the CBDPP. Through these proposed
sections, DOE hopes to establish clear lines of authority for review
and approval of contractors' CBDPPs.
Proposed section 850.10(b)(1) would establish a 90-day period for
DOE to review and either approve or reject the CBDPP. During its
review, DOE could direct the contractor to modify the CBDPP, or it
could modify the CBDPP itself. If DOE takes no action within 90 days,
the initial CBDPP would be considered approved. The Department would
establish this 90-day time frame to facilitate timely implementation of
program elements by contractors and to ensure that DOE Field
Organizations respond to contractors' submissions.
Proposed section 850.10(b)(2) would require that the written CBDPPs
be furnished upon request to the DOE Assistant Secretary for
Environment, Safety and Health or his or her designee; DOE program
offices; affected workers; and designated worker representatives. This
proposed requirement would be in addition to the provisions of this
section that would require contractors to submit the CBDPP, or portions
(e.g., the medical surveillance section) of it, to cognizant DOE
offices. The Department's intent with this requirement is to facilitate
implementation and enforcement of the proposed rule. In addition, this
proposed section would ensure that workers and their representatives
could access information that is related to the protection of their
health during the performance of DOE activities.
Proposed section 850.10(c) would establish that updates to the
written CBDPP be required under two circumstances: (1) Whenever a
significant change or addition is made to the program and (2) whenever
a contractor or subcontractor changes. DOE feels that such updates
would be warranted to ensure that the CBDPP accurately reflects
workplace conditions and appropriately addresses specific beryllium
workplace exposure hazards.
This proposed section would also require that DOE contractors
review their written CBDPPs at least annually and revise these programs
as necessary to reflect any significant changes. Only sections of the
CBDPP that require changes would have to be resubmitted to the head of
the DOE Field Organization for approval. The Department considers the
annual review cycle to be appropriate and necessary to ensure that
CBDPPs remain up-to-date and accurately reflect workplace conditions
and required control procedures.
Proposed section 850.10(d) was added to ensure that the CBDPP would
be developed and implemented consistent with the requirements imposed
by the National Labor Relations Act (NLRA) on employers in this
context, and not to create obligations in excess of those that would be
found in such circumstances under the NLRA.
Proposed section 850.11(a) specifies that the CBDPP would be
expected to address all existing and anticipated operational tasks that
fall within its scope. In addition, the section would require all DOE
contractors to develop and implement a CBDPP that is integrated into
the Department's existing worker protection program. This proposed
requirement would reflect the Department's desire to develop and
implement one comprehensive, consistent, and integrated worker
protection program that addresses all DOE workplace hazards. By
including this provision, DOE notes the importance of controlling
beryllium hazards within the framework of the worker protection program
established under DOE Order 440.1A (or, where applicable, under
predecessor orders like DOE Orders 5483.1A, 5480.4, 5480.8A, and
5480.10) and related DOE health and safety initiatives. The existing
industrial hygiene and occupational medicine programs, which were
established in the comprehensive worker protection program and related
initiatives, provide the basis needed to protect DOE federal
[[Page 66954]]
and contractor workers from health hazards like beryllium exposure. DOE
believes that establishing a beryllium exposure control program outside
the framework of this accepted program would create redundant and
inconsistent requirements that would unnecessarily burden the regulated
community and create an inefficient program.
Unlike the DOE orders listed above, the regulatory requirements of
this proposed rule would by operation of law apply to DOE contracts.
Accordingly, the application and enforcement of this proposed rule
would not be subject to the Work Smart Standards Program or other
related processes. DOE believes that this mandatory application of the
proposed CBDPP requirements to all DOE beryllium activities is
appropriate given the hazardous nature of beryllium-related work.
Proposed section 850.11(b) would require that contractors tailor
the scope and content of their CBDPPs to the specific hazards
associated with the DOE beryllium activities being performed. In
addition, proposed section 850.11(b)(1) would require that these
programs have to include formal plans outlining how DOE contractors
would ensure that occupational exposures to beryllium are maintained at
or below the PELs (8-hour TWA PEL of 2 g/m\3\ and 15-minute
STEL of 10 g/m\3\).
Proposed section 850.11(b)(2) further specifies that a contractor's
CBDPP must, at a minimum, address each requirement in Subpart C of the
rule. Consistent with the performance-based nature of the proposed
rule, DOE's intent with this requirement is that DOE contractors
include in their CBDPPs those provisions necessary to protect workers
from exposure to beryllium during the performance of DOE beryllium
activities at the contractors' respective sites. Proposed section
850.11(b)(3) would clarify that the CBDPP provisions must focus on: (i)
Minimizing the number of current workers exposed and potentially
exposed to beryllium; (ii) minimizing the number of opportunities for
workers to be exposed to beryllium; and (iii) setting challenging
exposure reduction and minimization goals to facilitate the
minimization of worker exposures. DOE believes that the establishment
of exposure reduction and minimization goals is essential to the
success of the CBDPP. With this catalyst to achieving further exposure
reductions, DOE contractors would be encouraged to seek opportunities
to provide enhanced worker protection, thereby assisting DOE in moving
toward the ultimate goal of preventing CBD within the DOE complex.
DOE is sensitive to concerns that exist within the DOE community
regarding the need to approach the Department's exposure reduction and
minimization objectives in a responsible and realistic manner.
Accordingly, proposed section 850.11(b)(3)(iii) would establish a
performance-based requirement that would allow contractors to establish
their own exposure reduction and minimization goals tailored to their
unique workplace needs and conditions. DOE's intention with this
proposed requirement is that DOE contractors would establish reasonable
but challenging goals based on sound industrial hygiene principles and
the specific circumstances for each affected workplace and location.
DOE believes that relevant circumstances must be considered in
establishing these goals. Those circumstances would include the current
level of worker exposures, the number of workers exposed, the existing
controls that are in place, the technical feasibility and exposure
reduction potential of possible additional controls, and the cost and
operational impact of the controls.
Proposed sections 850.12 (a) and (b) would require that DOE
contractors manage and control beryllium exposures in all DOE beryllium
activities in accordance with the approved CBDPP. This section would
clarify that DOE and contractor personnel must follow applicable
requirements of the rule and any resulting programs, plans, schedules,
or processes, as well as requirements in other applicable Federal
statutes and regulations.
Proposed section 850.12(c) would clarify the Department's position
that tasks involving potential beryllium exposure that would not be
covered under the CBDPP could not be initiated until the CBDPP has been
updated to include them and has been approved by the appropriate DOE
Field Organization. DOE provides an exception of this requirement for
urgent and unexpected situations. In such cases, the task could proceed
with the approval of the DOE Field Organization prior to revision and
approval of the CBDPP.
Proposed section 850.12(d) would require that, depending on the
circumstances of the work, other actions may be necessary to protect
workers and that such actions are not to be limited by the provisions
of the proposed rule. The Department recognizes that those individuals
responsible for implementing CBDPP activities are accountable for using
their professional judgment in protecting the health and safety of
workers. Nothing in the proposed rule should be viewed as relieving
these individuals of their professional responsibility to take whatever
actions are warranted to protect the health and safety of the
workforce.
Proposed section 850.13(a) would mandate that DOE activities
involving beryllium comply with their respective CBDPP that has been
approved by the cognizant DOE Field Organization, as appropriate.
Through this provision, DOE recognizes that even the best CBDPP will
not adequately protect workers if it is not followed at the site.
Proposed section 850.13(b) further proposes that once the final rule
takes effect, DOE contractors would have 2 years to fully implement all
aspects of the program (written plans, schedules, and other measures).
The Department intends to reduce the resource impacts on contractors by
permitting them to phase in costly controls over the 2-year period.
However, the Department would expect portions of the program to be
implemented as soon as practical during the 2-year period.
Proposed section 850.13(c) would specify that the DOE contractor in
charge of the activity involving a potential for beryllium exposure
would be responsible for complying with the rule. When no contractor is
responsible for the activity and Federal employees perform the
activity, this section would require DOE to be responsible for
compliance.
Subpart C--Specific Program Requirements
Subpart C of the proposed rule would establish performance-based
requirements for the CBDPP. These proposed requirements focus on
preventing CBD by reducing the number of workers who could be exposed
to beryllium, minimizing the potential level of beryllium in the
workplace atmosphere, and continually monitoring worker health to
ensure that workplace controls are sufficiently protective. The
Department's intent is that implementation of the rule will increase
understanding of the development and course of chronic beryllium
disease. Throughout the Department's pre-rulemaking activities,
including the public forums in Albuquerque, NM, and Oak Ridge, TN, and
the BRAC meetings, many interested parties advised DOE to adopt various
hazard-specific programs to address DOE beryllium hazards. For
instance, several public forum participants suggested that DOE control
beryllium hazards through an ``as low as reasonably achievable
(ALARA)''
[[Page 66955]]
approach, similar to that the Department applies to control radiation
hazards. These participants believed the ALARA approach was warranted
due to the continued occurrence of CBD among the DOE workforce and
questions regarding whether any level of beryllium exposure should be
considered safe. Other public forum participants argued that OSHA's
expanded health standard for asbestos would provide a better model
because it applies accepted industrial hygiene practices to remediation
activities similar to the remediation activities that may be
encountered in DOE cleanup operations that involve beryllium. DOE
acknowledges that both the ALARA approach and the OSHA Asbestos
standard (as well as other OSHA expanded health standards) include
provisions that could be applied effectively in controlling beryllium
hazards in the DOE workplace. Accordingly, DOE combined the relevant
components of the Asbestos standard (and other OSHA expanded health
standards) and the ALARA approach in DOE Notice 440.1 and continues
this approach in the proposed rule.
Proposed section 850.20(a) would require that DOE contractors
develop a baseline beryllium inventory to identify beryllium in DOE
facilities and operations and to identify workers who are or may be
potentially exposed to beryllium. Such baseline inventories would
accomplish several functions that are critical to the success of the
CBDPP, including: (1) The identification of locations and operations
that should be physically isolated from other areas to prevent the
spread of contamination, (2) the identification of areas in which
worker access should be restricted to minimize the number of workers
who could be exposed, (3) the identification of beryllium contamination
in facilities scheduled for decontamination and decommissioning (D&D)
operations to ensure the implementation of appropriate D&D control
procedures, (4) the identification of beryllium contamination in
facilities that are still used to determine the need for appropriate
cleanup measures, and (5) the determination of which workers should be
covered under the CBDPP.
Proposed sections 850.20(b)(1) through (4) would supplement the
generic inventory requirement originally established in DOE Order
440.1A by requiring DOE contractors to conduct records reviews,
employee interviews, and, if necessary, appropriate sampling procedures
to determine and document the presence and locations of beryllium on
DOE sites. These supplemental requirements are necessary because of the
nature of past beryllium operations within the DOE complex, which were
often conducted in open, uncontrolled work areas.
Because the results of records reviews and employee interviews
alone may not suffice to confirm the presence of beryllium
contamination in a specific location, proposed section 850.20(b)(4)
would require that DOE contractors conduct sampling procedures to
assess beryllium workplace hazards. DOE contractors should design such
sampling protocols according to the specific workplace conditions and
the suspected types and locations of beryllium contamination. Sampling
techniques could include collecting area and wipe samples and/or
collecting personal breathing zone samples.
Proposed section 850.20(c) would require contractors to ensure that
the baseline beryllium inventory activities required under proposed
section 850.20 are conducted by individuals with sufficient knowledge
in industrial hygiene. The Department believes that this provision
would be required to ensure that the inventory is accurate and complete
and that the CBDPP provides protection to all affected workers. 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 various control measures must be employed, proposed
section 850.21 would require DOE contractors to conduct a beryllium
hazard assessment to characterize workplace beryllium exposure hazards.
This requirement would allow each site to determine the appropriate
risk-based approach for assessing beryllium-related hazards in its
worksites where the baseline beryllium inventory has established that
beryllium is present.
The flexibility of proposed section 850.21 is particularly
important because operations, conditions, and the potential for
exposure may vary greatly from operation to operation and facility to
facility. For instance, the hazard assessment required for a facility
that houses current beryllium machining operations may be much more in-
depth than that required for an inactive storage facility that stored a
used beryllium lathe temporarily. In both cases, proposed section
850.21(a) would require a review of existing worksite conditions,
exposure data, medical surveillance trends, and exposure potential of
planned activities. In the beryllium machining operations example,
however, this review would require an in-depth analysis of machining
and other interrelated operations involving the performance of multiple
tasks by multiple employees, each with varying exposure potentials. In
this case, extensive medical surveillance and personal exposure
monitoring data may already exist and may provide a sufficient basis
for hazard assessment efforts. If the existing data do not suffice,
however, the collection and analysis of additional personal breathing
zone monitoring data for each task, operation, and work area may be
necessary to accurately characterize potential beryllium exposure
hazards.
For the inactive storage area, a review of existing wipe sampling
data, collected according to proposed section 850.20(b)(4), may suffice
to ascertain that no beryllium exposure hazard exists in the facility.
However, if wipe sampling data from the facility indicate that
beryllium contamination exists in the storage facility, a more in-depth
analysis could be required to determine the extent of contamination,
the potential for the contamination to become airborne, and the need
for facility cleanup and/or related exposure control measures.
Proposed section 850.21(b) would require contractors to ensure that
hazard assessments are conducted by individuals with sufficient
knowledge in industrial hygiene. The Department believes that the
establishment of such minimum personnel qualifications would be
necessary to ensure the appropriate implementation of the provisions of
the proposed rule and to ensure that the CBDPP provides protection to
all affected workers. Proposed section 850.22(a) would retain the OSHA
8-hour, TWA PEL for beryllium (2 (g/m\3\), as measured in the
worker's breathing zone, or would adopt a lower 8-hour TWA PEL if such
a PEL were established by OSHA through the rulemaking process. DOE is
aware of viewpoints both for and against a lower DOE 8-hr TWA PEL for
beryllium. Arguments in favor of lowering the PEL include the growing
number of confirmed CBD cases (110 as of June 1998 among the 8,951
current and former DOE federal and contractor workers who have
undergone medical screening) and the apparent low-level, incidental
beryllium exposures received by some of the afflicted workers.
Arguments against lowering the PEL include a lack of compelling
scientific evidence that the current exposure limit is not protective.
There is scientific evidence (presented in the Health Effects
discussion of this NOPR, Section IV) that suggests that the current
exposure limit does not sufficiently protect worker health. However,
existing scientific data does not currently
[[Page 66956]]
provide an adequate basis for determining an appropriate new DOE
exposure limit. For this reason, DOE proposes to retain the existing
OSHA 8-hr TWA PEL at this time and include in this proposed rule other
provisions that are designed to minimize worker exposure in DOE
facilities and to encourage continual monitoring of worker health to
ensure an adequate level of protection. Chief among these provisions
are the action level in proposed section 850.23, the exposure reduction
and minimization requirements of proposed section 850.25, and the
medical surveillance provisions of proposed section 850.33. Each is
discussed below.
OSHA has placed beryllium on its regulatory agenda but has
indicated that it will take several years for a new OSHA standard on
beryllium to be promulgated. Through proposed section 850.22(a), DOE
has clarified its intent to adopt the new OSHA permissible exposure
limit upon promulgation.
Proposed section 850.22(b) would adopt the short-term exposure
limit (STEL) established by the American Conference of Governmental
Industrial Hygienists (ACGIH) of 10 g/m\3\, averaged over a
15-minute sampling period. According to the ACGIH Threshold Limit Value
(TLV) and Biological Exposure Indices booklet, a worker's 15-minute TWA
exposure must not exceed the STEL at any time during the workday even
if the worker's full shift exposure is within the 8-hour TWA PEL.
Exposures above the PEL-TWA must not be longer than 15 minutes and must
not occur more than four times per day. The ACHIH TLV and Biological
Exposure Indices booklet further indicates that if such exposures occur
more than once a day, there must be at least 60 minutes between
successive exposures in this range.
The ACGIH recently established this 10 g/m\3\ STEL for
beryllium based on studies suggesting that acute beryllium disease did
not appear in a group of workers exposed below 15 g/m\3\, and
that CBD and lung cancer appear to be associated with exposure regimes
in which short, high exposures occur. As noted in the ACGIH supporting
rationale for the STEL, the 10 g/m\3\ STEL is in accord with
the ACGIH's standard practice of recommending a generic excursion limit
of 5 times the 8-hour TWA threshold limit value (TLV). The ACGIH 8-hr
TWA TLV for beryllium is equal to OSHA's 8-hour TWA PEL of 2
g/m\3\.
DOE recognizes that the ACGIH 15-minute STEL is more protective
than the OSHA acceptable maximum peak exposure for beryllium of 25
g/m\3\ for a duration of 30 minutes. DOE also notes that the
adoption of the ACGIH STEL in this proposed rule is consistent with
current DOE policy and with minimum standards already in effect
throughout the Department. As specified in DOE Order 440.1A and its
predecessor Orders, DOE contractors must comply with both the OSHA
standards and with the ACGIH TLVs. These Orders further clarify that
where a conflict exists between the OSHA and ACGIH exposure limits, the
more protective standard shall apply.
DOE is aware of the continued occurrence of CBD among its workforce
and intends to take every reasonable measure to minimize worker
exposure to beryllium and to prevent the occurrence of CBD. One such
measure is in proposed section 850.23, which would establish an 8-hour
TWA action level of 0.5 g/m\3\, measured in the worker's
breathing zone. Consistent with the worker protection practices
employed in many of the OSHA expanded health standards, the action
level would be used to trigger certain mandatory elements of the CBDPP:
periodic exposure monitoring (proposed section 850.24(c)), regulated
areas (proposed section 850.26), change rooms (proposed section
850.27), protective clothing and equipment (proposed section 850.29),
and medical surveillance (proposed section 850.33).
In selecting the action level for the proposed rule, DOE
considered: (1) OSHA's practice of establishing action levels; (2) the
results of a 1996 survey of DOE facilities (presented in the draft DOE
Beryllium Information Survey Report contained in the prerulemaking
docket), which reported potential beryllium exposures and related
control practices throughout the DOE complex; and (3) questions
regarding the adequacy of the 8-hour TWA PEL. OSHA, in its expanded
health standards, typically establishes action levels for hazardous and
toxic substances at one-half the 8-hour TWA PEL. Applying this approach
to beryllium would result in an 8-hour TWA action level of 1.0
g/m\3\. According to the results of the 1996 DOE survey,
however, two DOE facilities (Pantex and Rocky Flats) had already
employed an action level of 0.5 g/m\3\. One facility (Lawrence
Livermore National Laboratory) reported the use of an ``administrative
warning range'' of 0.2 to 2.0 g/m\3\, which triggered a
requirement for an investigation, and six DOE facilities employed an
action level of 1.0 g/m\3\. Consistent with the Department's
decision to implement aggressive exposure minimization efforts DOE
proposes adopting the lower of the existing action levels currently
used within the DOE complex in proposed section 850.23 rather than
following typical OSHA practice. DOE believes that the successful
implementation of this action level at two DOE facilities, and the
implementation of an even lower ``administrative warning range'' at a
third facility, provide sufficient evidence of the feasibility of
implementing the 0.5 g/m\3\ action level across the DOE
complex. DOE does not intend for this action level to discourage
efforts to reduce exposures below 0.5 g/m\3\ in a regulated
area. In fact, proposed section 850.25 would require contractors to
establish and implement appropriate exposure reduction and minimization
goals to further reduce worker exposures to beryllium.
Proposed section 850.24 would establish CBDPP worker exposure
monitoring requirements. Monitoring of breathing zone air space in
areas where workers are potentially exposed is a well-recognized and
widely accepted risk-management tool that is used to protect workers
from exposure to airborne toxic substances. The proposed provisions in
this section, which are also required under DOE Order 440.1A, are
necessary to characterize worker exposures to a specific toxic
substance and, based on these exposures, to determine the need for
appropriate engineering or work-practice controls. In addition to this
traditional compliance role, DOE proposes to expand the CBDPP's
exposure monitoring element to provide continual feedback on the
effectiveness of the program in preventing the occurrence of CBD. Such
exposure monitoring results would help the Department to resolve
uncertainties regarding the adequacy of the existing beryllium PEL and
to refine the requirements of this rule as needed to protect worker
health.
Proposed section 850.24(a) would require that exposure monitoring
be conducted by individuals with sufficient knowledge in industrial
hygiene. The Department believes that the establishment of such minimum
personnel qualifications is necessary to ensure the appropriate
implementation of the provisions of the proposed rule and ensure that
the CBDPP provides protection to all affected workers.
Proposed section 850.24(b) would require that DOE contractors
perform initial exposure monitoring for all workers who work in areas
that may have airborne concentrations of beryllium as determined
through the baseline beryllium inventory and hazard assessment. Such
initial exposure
[[Page 66957]]
information is necessary to identify workers who must be enrolled in
the medical surveillance program, determine the need for engineering
and work practice controls, select appropriate personal protective
clothing and respiratory protective equipment where needed, and
identify the need to establish regulated areas. Because the proposed
PELs include an 8-hour TWA PEL and a 15-minute STEL, proposed section
850.24(b)(1) would require that worker exposure be measured by personal
breathing zone samples that represent each worker's (i) full-shift
exposure (for 8-hour TWA exposure measurements) or (ii) 15-minute
exposure at operations where exposures may be above the STEL.
DOE recognizes that many DOE contractors may have performed the
required initial monitoring as part of their efforts to implement DOE
Notice 440.1. DOE does not intend for DOE contractors to repeat these
efforts. Accordingly, proposed section 850.24(b)(2) would allow
contractors to use initial monitoring data collected within 12 months
before the effective date of this rule to satisfy the rule's initial
monitoring requirements.
Proposed section 850.24(c) would require DOE contractors to conduct
periodic exposure monitoring to detect any workers who have been
exposed to beryllium at or above the action level or above the STEL.
DOE believes that such periodic monitoring is necessary to ensure the
continued protection of worker health. This requirement would provide
contractors the flexibility to determine the monitoring frequency that
is needed to characterize worker exposures accurately. DOE believes
that such flexibility is warranted due to the wide range of beryllium-
related operations within the DOE complex. The Department recognizes
that DOE contractors are best positioned to evaluate the potential
variability of worker exposures in their operations and to tailor their
periodic monitoring approaches as appropriate, based on existing
exposure levels and the potential for these exposure levels to change.
However, because slight process or procedural changes may go unnoticed
over time and because equipment maintenance, aging, or deterioration
can affect performance, DOE proposes in proposed section 850.24(c) a
minimum exposure monitoring frequency requirement of 3 months
(quarterly) for workers who are exposed to airborne concentrations of
beryllium at or above the action level or above the STEL. DOE
recognizes that the proposed minimum quarterly monitoring of workers
exposed at or above the action level or above the STEL is more
stringent than most OSHA expanded health standards. However, the
Department feels this minimum monitoring frequency is necessary due to
the uncertainties regarding the adequacy of the current PEL.
To supplement this periodic monitoring requirement, proposed
section 850.24(d) would also require that DOE contractors perform
additional exposure monitoring when beryllium-related operations or
procedures change. In the case of procedural or operational changes,
this additional monitoring is needed to quantify how changes affect
worker exposure to airborne beryllium, to ensure the continued
effectiveness of existing engineering and work-practice controls, and
to identify the need for additional control measures to minimize worker
exposure to beryllium.
To obtain accurate exposure monitoring results, proposed section
850.24(e) would require that DOE contractors use monitoring and
analytical methods that have an accuracy, at a confidence level of 95
percent, of not less than plus or minus 25 percent for airborne
concentrations of beryllium at exposure levels between the 8-hour TWA
action level and the PEL. Proposed section 850.24(f) would further
ensure the quality of monitoring results by requiring that all
laboratory analyses of air sampling data be performed in a laboratory
accredited for metals by the American Industrial Hygiene Association.
These proposed accuracy and quality requirements would be consistent
with similar requirements that appear in many of OSHA's expanded health
standards for toxic substances. DOE believes that the quality and
accuracy of exposure monitoring data are crucial to protecting workers
from airborne toxic substances because monitoring results trigger the
implementation of several critical elements of the worker protection
program. Accordingly, effective implementation of the CBDPP and
ultimately the health of affected beryllium workers would rest on the
quality and accuracy of the collected exposure monitoring data.
Proposed section 850.24(g)(1) would establish requirements to
notify affected workers of monitoring results. This section would
require DOE contractors to make this notification in writing within 10
working days of receipt of the monitoring results. This section would
also provide DOE contractors with two alternative methods of worker
notification: (1) Provide written notification to each affected worker,
or (2) post monitoring results in a location or locations readily
accessible to affected workers. When the posting option is selected,
DOE contractors would have to post the results in such a way as to
protect the privacy of the affected workers.
Proposed section 850.24(g)(2) also contains a provision for cases
in which monitoring results indicate that worker exposure levels exceed
the action level or STEL. In such cases, the DOE contractor would be
required to notify the SOMD of the results within 10 working days of
receipt of the results. DOE believes that the SOMD must 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 section 850.25 would establish the exposure reduction and
minimization provisions of the CBDPP that reflect the Department's goal
of achieving aggressive reduction and minimization of worker exposures
to airborne beryllium. DOE believes this is a prudent approach to
worker protection in light of questions regarding the adequacy of the
existing PEL and the relationship between beryllium worker exposure and
disease.
Proposed section 850.25(a) would establish the baseline requirement
that DOE contractors ensure that no worker is exposed to airborne
beryllium at levels above the exposure limits established in proposed
section 850.22. The section would further clarify that DOE contractors
must apply the hierarchy of industrial hygiene controls as established
in DOE Order 440.1A to achieve this minimum exposure control
requirement. This hierarchy dictates that DOE contractors must
implement feasible engineering controls, followed by administrative
controls, in their efforts to reduce exposure levels. If these
engineering and administrative controls do not reduce beryllium levels
to the exposure limits, DOE contractors must supplement these controls
with personal protective clothing and equipment as appropriate to
reduce exposure levels to within the exposure limits.
Proposed section 850.25(b) would clarify the requirement to
establish exposure reduction and minimization goals by requiring that
DOE contractors include in their CBDPP, the rationale to support their
exposure reduction and minimization goals. This section further
requires that the CBDPP include a plan for meeting these goals as well
as performance measures to be used to assess the contractor's status in
achieving the goals. DOE considers this level of formality essential to
the
[[Page 66958]]
establishment and implementation of meaningful goals, and to the use of
these goals in achieving the exposure reduction and minimization
objectives of the CBDPP. In addition, DOE believes that appropriate
documentation of the supporting rationale for these goals is necessary
to address concerns among the DOE community regarding overzealous DOE
enforcement of the exposure reduction and minimization requirements of
this proposed rule and to avoid second-guessing of contractor CBDPP
efforts.
Proposed sections 850.25(b)(1) and (2) would establish the
Department's minimum expectations for the implementation of exposure
reduction and minimization efforts. DOE does not intend for these
minimum requirements to stifle contractor innovation but intends for
them to serve as a starting point in efforts to implement an effective
exposure reduction and minimization program. Specifically, proposed
section 850.25(b)(1) would require DOE contractors to include in their
CBDPP strategies for the use of the action level to trigger actions to
reduce or minimize worker exposures and the potential for exposures.
Proposed section 850.25(b)(2) would clarify that CBDPP strategies shall
also include use of the conventional hierarchy of industrial hygiene
controls as a means of achieving exposure reduction and minimization
goals. The intent of these provisions is to encourage contractors to
(1) investigate opportunities for exposure reductions when worker
exposures reach or could reach the action level (or at lower levels of
exposure if appropriate) and (2) implement control measures that are
feasible and consistent with sound industrial hygiene principles, the
objectives of the CBDPP, and the contractor's own internal exposure
reduction and minimization goals.
Proposed section 850.26 would establish the regulated area
provisions of the CBDPP. These regulated areas, managed by the
contractors, would help minimize the number of workers exposed to
airborne beryllium by preventing or minimizing the spread of beryllium
to clean work areas. Because most if not all DOE contractors that would
be affected by this proposed rule have already implemented varying
provisions to control access to areas and operations with a potential
for worker exposures to beryllium (as reported in the draft 1996 DOE
Beryllium Information Survey Report), DOE believes that the majority of
the provisions of this proposed section would pose minimal additional
burden on DOE contractors.
Proposed section 850.26(a) would require that DOE contractors
establish regulated areas where airborne concentrations of beryllium
are in excess of the action level or STEL. DOE selected the action
level in lieu of the 8-hour PEL as the trigger for this proposed
requirement in keeping with the Department's aggressive beryllium
exposure reduction and minimization philosophy. The STEL is included as
a trigger for this requirement to address workplace areas where full-
shift exposure levels may be below the action level but operations or
activities result in exposures above the STEL.
Proposed section 850.26(b) of the proposed section would require
that DOE contractors adequately identify regulated areas so that
workers are aware of the presence and boundaries of such areas. This
requirement would allow contractors the flexibility to determine the
most appropriate means of identifying each regulated area based on
specific worksite conditions.
Proposed section 850.26(c) would require that DOE contractors limit
access to regulated areas to authorized persons only. The contractor
would determine which workers should have the authority to enter the
work area and how the entry of unauthorized individuals will be
prevented. DOE's intention is that only individuals who are essential
to the performance of work in the regulated area would be granted entry
authority. DOE contractors would have to evaluate the affected
operation and determine which personnel (including managers,
supervisors, and workers) are necessary for the performance of the work
and thus must have entry authority. Methods for preventing unauthorized
persons from entering a regulated area may range from, at a minimum,
posting a sign indicating that only authorized persons may enter (as
would be required by proposed section 850.37) to the use of locked
access doors and other security measures on the basis of worksite
conditions. DOE believes that contractors are best equipped to
determine whether any access control methods are needed in addition to
those already specified in proposed section 850.37.
Proposed section 850.26(d) would require that DOE contractors keep
a record of all persons who enter regulated areas. The record must
include the name of the person who entered, the date of entry, the time
in and time out, and the work performed. The function of these records
within the framework of the CBDPP is clarified in proposed section
850.38, Recordkeeping. Specifically, DOE believes that these records
are necessary to monitor the effectiveness of each contractor's
regulated area efforts and to provide valuable information regarding
each worker's history of potential exposures. This historical
information would assist the contractor's occupational medicine staff
in establishing appropriate medical surveillance protocols and would
aid in the Department's efforts to establish links between working
conditions and potential health outcomes.
Proposed section 850.27 would establish change room provisions for
workers in regulated areas. These hygiene provisions are common in
OSHA's expanded health standards, specifically in those standards
designed to protect workers from exposures to hazardous particulates.
Proposed section 850.27(a)(1) would require that change rooms used to
remove beryllium-contaminated clothing and protective equipment be
maintained under negative pressure or, located in a manner or area that
prevents dispersion of beryllium contamination into clean areas.
Proposed 850.27(a)(2) would require that separate facilities be
provided 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 facility and into workers' private automobiles and homes.
These provisions would 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 exposures.
Consistent with the goal of preventing the spread of contamination
into adjacent work areas and into affected workers' homes, proposed
section 850.27(b) would require that DOE contractors provide hand-
washing and shower facilities for workers assigned to regulated areas.
DOE recognizes that the installation of such facilities may take time
in some cases. Accordingly, proposed section 850.13(b) would allow
contractors 2 years to achieve full compliance with the requirements of
the rule.
Proposed section 850.28 would establish the respiratory protection
provisions of the CBDPP. Specifically, proposed section 850.28(a) would
require that DOE contractors comply with the OSHA Respiratory
Protection standard (29 CFR 1910.134). Proposed section 850.28(b) would
require that
[[Page 66959]]
DOE contractors provide appropriate respiratory protective equipment
for all workers exposed to airborne concentrations of beryllium above
the PELs established in proposed section 850.22 and ensure that the
workers use protective equipment. Proposed section 850.28(c) would
require that DOE contractors select and use only National Institute for
Occupational Safety and Health (NIOSH)-approved or DOE-accepted
respiratory protective equipment as required by DOE Order 440.1A.
None of the provisions of this proposed section are new. For
instance, DOE contractors have historically been subject to the OSHA
standards, including 29 CFR 1910.134, through the provisions of DOE
Order 440.1A and its predecessor orders, which incorporate the OSHA
standards. DOE Order 440.1A require DOE contractors to provide, and DOE
workers to use, appropriate respiratory protective equipment necessary
to protect workers from exposures to hazardous substances, including
airborne beryllium, at levels above established OSHA PELs. In addition,
the provisions of 29 CFR 1910.134 include a requirement that employers
select only NIOSH-approved respirators. In recognition of the unique
nature of certain DOE operations, DOE Order 440.1A expanded this NIOSH-
approval restriction to allow for the use of DOE-accepted respiratory
protection when NIOSH-approved respiratory protection did not exist for
a specific DOE task.
Proposed section 850.29 would establish the protective clothing and
equipment provisions of the CBDPP. Proposed section 850.29(a) would
require that DOE contractors provide workers who are potentially
exposed to beryllium at or above the action level or above the STEL
with protective clothing and equipment and ensure that the protective
clothing and equipment are maintained and used as appropriate. Proposed
section 850.29(a)(1) would clarify that appropriate protective clothing
for work in areas where beryllium contamination is present includes
full-body protective clothing and footwear (work shoes or booties).
This section further stipulates that workers must exchange their
personal clothing for this protective clothing before beginning work in
regulated areas. As would be required under proposed section 850.27(a),
this change from personal clothes into protective work clothing must
occur in a change room that protects the worker's personal clothes and
clean protective clothing from beryllium contamination. DOE believes
that the use of full-body protective clothing in lieu of personal
clothes in regulated areas is necessary to prevent the spread of
beryllium contamination into adjacent work areas and to preclude the
possible transport of beryllium into affected workers' private
property.
Because direct contact with beryllium can cause contact dermatitis
and possibly conjunctivitis, proposed section 850.29(a)(2) would
require that DOE contractors provide workers with additional protective
gear where skin or eye contact with powdered or liquid forms of
beryllium is possible. This additional protective gear could include
face shields, goggles, gloves, and gauntlets, depending on the nature
of the operation and the related skin and eye exposure hazards
involved. DOE recognizes that the potential for the development of
contact dermatitis or conjunctivitis is mainly associated with contact
with soluble forms of beryllium compounds. Nevertheless, DOE believes
that the provisions of proposed section 850.29(a)(2) represent prudent
industrial hygiene measures for work with all forms of beryllium,
particularly in light of the fact that both soluble and insoluble forms
of beryllium have been shown to cause chronic ulcerations if introduced
into or below the skin via cuts or abrasions.
As clarified in the definition of beryllium in proposed section
850.3, soluble beryllium compounds would not be covered by the proposed
rule. DOE omitted soluble beryllium compounds from the definition of
beryllium based on information provided by the DOE field offices
indicating that soluble beryllium compounds were not used within the
DOE complex.
The Department's objective is to prevent the spread of beryllium
contamination, thereby reducing the number of workers exposed and the
opportunities for potential exposures. In keeping with this objective,
proposed sections 850.29(b) through (e) would establish provisions to
control the handling, maintenance, cleaning, and disposal of beryllium-
contaminated protective clothing and equipment. Specifically, proposed
section 850.29(b) would require DOE contractors to ensure that workers
do not take contaminated clothing or equipment from the change room or
worksite unless specifically authorized to do so for the purposes of
cleaning, maintenance, or disposal. Where workers are authorized to
remove contaminated clothing and equipment from the change-room or
worksite, proposed sections 850.29(b)(1) and (b)(2) stipulate that such
materials must be placed in sealed impermeable containers that bear
warning labels to clearly identify the contents and appropriate
handling precautions. Such warning labels would help ensure appropriate
subsequent handling of beryllium-contaminated materials and in
preventing inadvertent exposures that could result if laundry,
maintenance, or disposal personnel are not aware of the presence of
beryllium contamination.
Proposed section 850.29(c) would require that DOE contractors
clean, launder, repair, and replace protective clothing and equipment
as needed to ensure its continued effectiveness in protecting workers.
This section would allow contractors some flexibility in determining
the required frequency for laundering protective clothing based on
specific work conditions and the potential for contamination. Because
DOE believes that certain minimal laundering frequencies must be
maintained to ensure that the protective clothing does not contribute
to worker exposures, the proposed paragraph stipulates a minimal
laundering frequency of at least once a week.
To reduce and minimize the potential for exposures to beryllium
during laundering operations, proposed section 850.29(d) would require
that DOE contractors launder contaminated clothing using methods that
would prevent the release of airborne beryllium in excess of the action
level or STEL. DOE would provide DOE contractors the flexibility to
determine the most appropriate means to launder contaminated clothes
based on their own specific worksite conditions. DOE has, however,
included in this section one specific requirement designed to prevent
the dispersion of beryllium particles into the workplace atmosphere:
proposed section 850.29(e) would prohibit the use of blowing, shaking,
or any other means of cleaning that could disperse beryllium particles
into the air. This is a well-recognized and accepted industrial hygiene
control employed to minimize exposures to airborne particulates.
Proposed section 850.30 would establish the housekeeping provisions
of the CBDPP. Good housekeeping practices are necessary in areas where
beryllium is used or handled to prevent the accumulation of beryllium-
containing dusts on surfaces throughout the workplace. Such
accumulations, if not controlled, may lead to reentrainment of
beryllium particles into the atmosphere. This potential for beryllium
accumulations to become reentrained into the atmosphere increases
potential beryllium exposure hazards in locations where beryllium
[[Page 66960]]
dusts were originally generated and introduces the potential for such
exposures in other work areas. In addition, the uninhibited
accumulation of beryllium-containing dust on equipment in the workplace
increases the potential for worker exposure to beryllium during the
performance of equipment maintenance, handling, and disposal tasks.
Accordingly, the housekeeping program focuses on the prevention of
accumulation of beryllium-containing dust in the workplace. Because the
performance of housekeeping tasks can, in and of itself, lead to worker
exposures to beryllium-contaminated dust, the provisions of this
housekeeping section also focus on preventing the reentrainment of dust
during the performance of housekeeping activities.
Proposed section 850.30(a) would require that DOE contractors
conduct routine surface sampling to ensure the effectiveness of
housekeeping efforts. Surface sampling has become an accepted method
for providing qualitative information on chemical contamination of work
surfaces. Unfortunately, surface sampling procedures have not reached
the stage of development that would allow an industrial hygienist to
predict a personal exposure or a potential airborne concentration of
reentrained contaminants. Such sampling, however, can identify the
presence of beryllium contamination and thus can provide an indication
of the effectiveness of housekeeping efforts. Accordingly, this
proposed requirement is intended only as a housekeeping performance
measure and should not be interpreted as a proposed mechanism for
measuring, predicting, or controlling airborne concentrations of
beryllium. In addition, this proposed requirement would only apply to
removable or loose surface contamination which could become reentrained
into the workplace atmosphere.
Affected sites throughout the Department have already established
beryllium surface contamination levels to ensure the effectiveness of
their housekeeping procedures. According to representatives from these
sites, existing surface contamination limits employed throughout the
DOE complex range from 1 to 5 g/100 cm\2\, with the majority
of the sites using approximately 3 g/100 cm\2\ (e.g., Pantex,
Lawrence Berkeley National Laboratory, Y-12, Rocky Flats). Accordingly,
DOE has adopted the 3 g/100 cm\2\ level in the proposed rule.
The use of diverse sampling methods (differences include type of
sample media, type of solvent (if any) on the sample media, area
sampled, etc.) may easily lead to the reporting of inconsistent or
incorrect results. To reduce the variability in reported surface
contamination across the DOE complex, DOE recommends the use of a
single sampling method: NIOSH method 9100 (NIOSH Manual of Analytical
Methods (NMAM), 4th Edition, August 15, 1994, Lead in Surface Wipe
Samples). This method may have to be modified for surfaces smaller than
100 cm\2\ using a procedure such as that described in Appendix D of 10
CFR part 835.
Proposed sections 850.30(b) and (c) would establish provisions for
the use of housekeeping methods that will prevent or minimize the
reentrainment of beryllium particulates into the workplace atmosphere.
Specifically, proposed section 850.30(b) would require the use of wet
methods or vacuuming for the cleaning of beryllium-contaminated floors
and other surfaces, and prohibit the use of compressed-air or dry
methods for such activities. Proposed 850.30(c) would require the use
of HEPA filters in all vacuuming operations for contaminated or
potentially contaminated surfaces and would further require filter
replacement as needed to maintain the capture efficiency of the vacuum.
The use of wet methods for reducing or minimizing the dispersal of dust
during general housekeeping tasks such as sweeping is a common
industrial hygiene practice, as is the use of HEPA filters, which
prevent the spread of dust by effectively collecting the dust as it is
vacuumed or brought into a hood.
As discussed in earlier sections of this analysis, the movement of
contaminated or potentially contaminated equipment from a regulated
area to a nonregulated area may result in the spread of beryllium
contamination. To prevent this potential spread of contamination in the
performance of housekeeping activities that would be required under
this rule, proposed section 850.30(d) would require that cleaning
equipment used in areas where surfaces are contaminated or potentially
contaminated with beryllium be labeled, controlled, and not used in
other clean areas of the facility. These procedures are similar to
those required under OSHA's Asbestos standard for any equipment used
during cleanup or removal of asbestos from buildings.
Proposed section 850.31 would establish the waste disposal
provisions of the CBDPP. Like many of the regulated area, protective
clothing and equipment, and housekeeping provisions of the proposed
rule, the waste disposal provisions of this section focus on minimizing
the spread of beryllium contamination throughout the facility. As
mentioned throughout this NOPR, such contamination control measures are
necessary to achieve the Department's objectives of reducing the number
of workers exposed to beryllium and minimizing the opportunities for
beryllium exposures.
DOE believes that the most effective way to control the spread of
contamination resulting from waste disposal activities is to first
prevent or minimize the generation of beryllium waste. Accordingly,
proposed section 850.31(a) would require that DOE contractors control
the generation and disposal of beryllium waste through good
housekeeping practices, the performance of appropriate hazard analyses
for operations with the potential to generate waste, and the
application of waste minimization principles. Good housekeeping
practices aid in this effort by continually removing beryllium dust
accumulations from work surfaces, thereby reducing the potential for,
and significance of, contamination of workplace equipment. The
performance of hazard analyses on operations with the potential to
generate wastes can help DOE contractors identify potential sources of
wastes and evaluate possible controls that could be implemented to
prevent or reduce waste generation. Other waste minimization practices,
such as minimizing the equipment and material that is exposed to
beryllium contamination, will also assist in reducing the amount of
material that must be disposed of as beryllium or beryllium-
contaminated waste, thus reducing the potential beryllium exposure
hazards associated with waste disposal activities.
Proposed section 850.31(b) would require that DOE contractors
dispose of all waste, scrap, debris, bags, containers, small equipment,
and clothing contaminated with beryllium in sealed impermeable bags or
other closed impermeable containers that are labeled in accordance with
section 850.37. DOE believes these waste disposal provisions are
necessary to prevent the reentrainment of beryllium contamination into
the workplace atmosphere. Warning labels are necessary to ensure that
workers are aware that containers or bags contain beryllium
contamination so that they can take appropriate precautions.
Proposed section 850.32 would establish the beryllium-related
emergency provisions of the CBDPP. Such provisions are particularly
important in light of suggestions made by several participants in the
public forums that a single, high-level beryllium exposure may have
been the
[[Page 66961]]
cause of CBD occurring among several workers thought to have no
exposure or only incidental, low-level exposures to beryllium.
Proposed section 850.32(a) would require that DOE contractors
develop and implement procedures to address potential beryllium
emergency situations for each facility engaged in beryllium operations.
The Department's intent is for DOE contractors to evaluate their
respective beryllium-related operations to determine possible emergency
scenarios. Then, based on these facility- and operation-specific
scenarios, the contractors would fashion procedures to specifically
address the types of emergencies that could be encountered at the
facility. DOE believes that this tailored approach would provide
workers the best opportunity to be prepared in the event of an
emergency, enabling them to respond in an appropriate and safe manner
and to remedy site conditions with minimal potential for additional
exposures to themselves or other personnel in the facility.
Proposed section 850.32(a)(1) would require that DOE contractors
establish procedures to alert workers in the event of a beryllium
emergency. By ensuring that workers are continually aware of how they
are expected to respond in the event of an emergency and by ensuring
that they receive prompt notification or warning when an emergency
situation has developed, DOE contractors would enable workers to
quickly implement the actions needed for protection while bringing an
emergency situation under control.
Proposed section 850.32(a)(2) would require DOE contractors to
ensure that workers engaged in the cleanup of emergency spills of
beryllium, or in handling other emergency situations involving
beryllium contamination, are provided with and wear protective clothing
and equipment as specified in this proposed rule. DOE believes that
such protective equipment is necessary to adequately protect workers
from exposures to beryllium. DOE feels that this protection is even
more critical when responding to uncontrolled situations where airborne
levels of beryllium may not be adequately characterized and may exceed
the PEL.
Because even the best emergency response procedures will be
ineffective if personnel required to implement the procedures are not
aware of them, DOE has included in proposed section 850.32(b) a
requirement that contractors train affected workers on required
emergency procedures.
Proposed section 850.33 would establish the medical surveillance
provisions of the CBDPP. Proposed sections 850.33(a) and (b) propose
that DOE contractors and Field Organizations designate a SOMD to be
responsible for administering the respective contractor and federal
medical surveillance programs required by this rule. Proposed section
850.33(c) would also require that the written medical surveillance
program that is required for inclusion in the CBDPP be submitted and
reviewed by the DOE Office of Environment, Safety and Health and
approved by the head of the cognizant DOE Field Organization. DOE
review and approval authority is necessary to ensure that contractor
medical surveillance requirements are consistent with the intent of the
CBDPP and that these programs are applied uniformly across the DOE
complex.
Proposed section 850.33(d) would require DOE contractors to
establish and implement a medical surveillance program for all
beryllium workers exposed at or above the action level or above the
STEL. Under this program, DOE would offer medical evaluations to
affected beryllium workers. Once an employee is enrolled in the
program, he or she would remain enrolled for the duration of employment
at that site. The program would have two purposes: (1) Ensure the
prompt identification and proper treatment of workers who become
sensitized to beryllium or develop CBD, and (2) evaluate and ensure the
effectiveness of the CBDPP in preventing CBD by determining the
incidence of CBD in the workforce and by identifying risk factors
associated with the development of CBD and beryllium sensitization.
Proposed section 850.33(e) would require that DOE contractors
provide the SOMD with the information needed to administer the medical
surveillance program. This information would include, but may not be
limited to, the baseline beryllium inventory, hazard assessment, and
exposure monitoring data, as well as information regarding the identity
and nature of activities or operations on the site that are covered
under the CBDPP, the related duties of beryllium workers, and the types
of personal protective equipment employed in the performance of these
duties.
Proposed section 850.33(f) would require the SOMD to establish and
maintain a list of beryllium workers in the medical surveillance
program based on records and other information regarding the identity
of beryllium workers. Current employees who are at risk for CBD because
of past beryllium operations would not be included on this list or
covered under this proposed rule. Rather, they would be identified and
offered medical surveillance under a separate, directly funded program.
The Department views medical surveillance as a primary tool for
determining the extent of CBD risk in an employee population. The list
developed under section 850.33(f)(1) would establish the population of
beryllium workers who may be eligible for medical surveillance. The
Department's expectation is that SOMDs will use inclusive criteria for
identifying beryllium workers to be covered under medical surveillance.
In addition, proposed section 850.33(f)(2) clarifies DOE's intention
that SOMDs refine the list of beryllium workers based on subsequent
analyses of medical surveillance results required under proposed
section 850.33(k). For example, the results of Be-LPTs would be used to
determine risk factors that appear to be associated with CBD. Based on
the apparent risk factors, the SOMD would adjust the surveillance
program to better identify workers at risk of developing CBD.
Proposed section 850.33(g) would require the SOMD to provide the
examining physician with (1) a copy of this rule, (2) a description of
the workers' relevant duties as they pertain to beryllium exposure, (3)
records of the workers' beryllium exposure, (4) a description of
personal protective and respiratory protective equipment in current or
anticipated use, and (5) any relevant information from previous medical
examinations of the workers that is not otherwise available to the
examining physician. The Department believes that this information is
necessary to ensure that the physician can make informed decisions
regarding the required content of the medical evaluation and the
subsequent development of recommendations related to each beryllium
worker's work.
Proposed section 850.33(h)(1) would clarify that DOE contractors
must provide required medical examinations and procedures to beryllium
workers and accepted applicants at no cost to the workers and accepted
applicants at a time and place convenient to them. In addition to
minimizing the financial burden on affected workers, DOE believes that
this provision will encourage DOE contractors to minimize the levels of
beryllium exposures in the workplace and the number of workers exposed
or potentially exposed to beryllium. DOE also believes that this
provision will help ensure that workers obtain proper medical
evaluations.
Proposed section 850.33(h)(2) would specify that DOE contractors
must provide baseline medical evaluations to
[[Page 66962]]
beryllium workers who qualify for medical surveillance. DOE believes
that such baseline medical evaluations are necessary to ensure that
beryllium workers can safely perform assigned duties in areas that may
present the potential for exposure to beryllium. In addition, DOE
believes that the proper evaluation and documentation of each worker's
health status is essential for determining whether future health
problems may be related to occupational exposure to beryllium.
Proposed section 850.33(h)(3) would supplement the baseline medical
evaluation requirement of proposed section 850.33(h)(2) by requiring
that DOE contractors offer annual medical evaluations to beryllium
workers who qualify for medical surveillance. Such annual evaluations
shall be offered as long as the beryllium workers work in areas where
beryllium is present at levels at or above the action level or above
the STEL. DOE believes that such periodic medical evaluations would be
critical to ensuring the early identification and treatment of
beryllium sensitization and CBD. This proposed section further
clarifies that in cases where beryllium workers no longer work in areas
where beryllium is present at levels at or above the action level or
above the STEL, the requirement for annual medical evaluations may be
reduced to once every 3 years. DOE believes that this continued
surveillance is warranted due to the extended latency period associated
with the development of CBD.
Both proposed sections 850.33(h)(2) and (h)(3) would also establish
the minimum required content of the baseline and periodic medical
evaluations, respectively. Among these minimum requirements for both
types of evaluations is the need to conduct a Be-LPT. The Be-LPT is the
only available laboratory test for determining individual immune
response to beryllium in vitro. Its use in a surveillance program would
permit detection of beryllium-related health effects at a preclinical
stage. A positive Be-LPT would indicate the need for further evaluation
to determine the presence of CBD. The use of the Be-LPT as an
evaluation tool would not only allow the earliest opportunity for
diagnosis and treatment of CBD, but would also assist in identifying
unhealthy working conditions or operations and deficiencies in the
CBDPP.
In addition to the Be-LPT, some medical experts recommend that a
chest radiograph (X-ray) and spirometry be obtained prior to exposure
to beryllium to establish a baseline for possible comparison with
future test results. Spirometry involves measuring the amount of air
entering and leaving the lungs. Accordingly, proposed section
850.33(h)(2) would further specify that baseline evaluations also
include a chest radiograph (X-ray) and spirometry. However, because
neither chest radiography nor spirometry has proven to be any more
predictive in identifying the presence of CBD than symptom
questionnaires, these additional tests would not be mandated as a part
of the periodic evaluation required under proposed section
850.33(h)(3). Instead, the need for these tests would be left to the
discretion of the examining physician. DOE believes that the examining
physician is in the best position to determine the need for such
additional tests based on the unique circumstances associated with each
worker's exposure scenarios and health status.
Proposed section 850.33(h) would not establish a requirement for
termination evaluations. DOE believes termination evaluations for
beryllium workers who are reassigned to non-beryllium work would not be
needed because periodic evaluations will continue for as long as the
worker is employed by the DOE contractor. Termination evaluations for
beryllium workers who resign or retire from employment with DOE
contractors would also not be necessary because the Department intends
to establish a separate, directly funded program that offers medical
examinations to former employees at risk for developing CBD. DOE
recognizes that many sites already have an internal requirement to
provide termination medical evaluations to workers upon their
separation from employment. Nothing in this proposed rule would
preclude the SOMD from continuing this practice.
Proposed section 850.33(h)(4) would require that DOE contractors
ensure that all medical evaluations and procedures be performed by or
under the supervision of a licensed physician who is familiar with the
health effects of beryllium. Conducting a medical surveillance program
for beryllium workers requires specialized medical knowledge and
crucial clinical decision-making. DOE believes that a licensed
physician with specialized knowledge of the health effects of beryllium
is the most appropriate medical professional to provide medical
evaluations. A physician is also needed to answer health-related
questions and to discuss and interpret abnormal clinical findings with
the affected worker.
Proposed section 850.33(i) would establish requirements for
referrals for additional diagnostic evaluation. Specifically, beryllium
workers who have two or more positive Be-LPTs or other signs and
symptoms of CBD, would be referred by the examining physician for
diagnostic evaluation. Such an evaluation would be performed by a
pulmonary medicine, occupational medicine, or other clinic with the
specialized equipment and examination protocols required to
definitively differentiate between CBD and other lung disease. DOE
believes that this proposed referrals provision is warranted due to the
unusual nature of CBD and the fact that not all physicians are familiar
with the evaluation of beryllium-exposed patients.
Proposed section 850.33(j) would establish requirements for
physicians' written reports and recommendations. Proposed section
850.33(j)(1) would ensure that employees and accepted applicants are
informed of the results of their medical evaluations and tests within
15 days of completion of the evaluations. In addition, proposed section
850.33(j)(2) would specify that within this same 15 day time period,
the DOE contractor obtain a copy of a limited version of the
physician's report. This limited version must include any
recommendations for restricting the employee from working with
beryllium, or for wearing protective equipment.
Proposed section 850.33(k) would establish the requirement for a
routine and systematic analysis of medical, job, and exposure data. The
purpose of this requirement is to establish a program that would follow
the public health model for disease surveillance programs. Information
would be collected and analyzed so that the prevalence of disease could
be accurately described and conclusions could be reached on causes or
risk factors for the disease. This data analysis would provide an
effective performance measurement mechanism for use in correction and
improvement of the CBDPP. Proposed section 850.33(k)(1) would require
that the results of these analyses be used by the SOMD to determine
which workers should be offered medical surveillance and the need for
additional exposure controls. In addition, proposed section
850.33(k)(2) would require that the SOMD provide copies of the data
analyses to the contractor for performance feedback information.
Proposed section 850.34 would establish medical removal
requirements. Specifically, this section would require that upon
recommendation of the SOMD, DOE contractors shall give workers with two
positive Be-LPTs or a
[[Page 66963]]
diagnosis of CBD the option of: (1) placement in another position
without occupational exposure to beryllium, or (2) continued employment
in the current position with actual or potential exposure to beryllium.
Proposed section 850.34(a) would require that, with the written
consent of the worker, DOE contractors remove a beryllium worker from
exposure to beryllium or postpone an accepted applicant's start of
active duty as a beryllium worker if the SOMD recommends such actions
due to confirmed CBD, two or more positive Be-LPTs results, or while
other signs or symptoms are being evaluated for their relation to CBD.
Proposed section 850.34(a)(1) would further require that DOE
contractors provide the affected beryllium worker a follow-up medical
examination to determine whether the worker may be returned to his or
her beryllium work or whether the worker should be permanently removed
from working in beryllium areas.
Proposed section 850.34(a)(2) would provide affected beryllium
workers and accepted applicants with the option to decline the medical
removal or restriction by signing an informed consent waiver. DOE notes
that prudent medical practice suggests that workers with two or more
positive Be-LPTs or diagnosis of CBD should avoid additional exposure
to beryllium however, since no medical evidence exists to suggest that
removal from exposure will alter the course of disease, DOE believes
that it is ultimately the affected worker's decision whether to remain
in a job with potential or actual beryllium exposure.
For beryllium workers or accepted applicants who choose to accept
restriction from continued work with beryllium, proposed section
850.34(a)(3) would require DOE contractors to make reasonable efforts
to find and offer alternative employment. This section clarifies that
the contractor is not required to displace an existing worker in order
to create a vacancy, nor is the contractor required to promote the
affected worker or accepted applicant or pay for job placement training
costs in excess of $6,000.00. The contractor is also not required to
provide training that takes longer than 6 months to complete.
Proposed section 850.34(b) would establish the requirement for
medical removal protection benefits for beryllium workers who choose to
accept a physician's recommendation to be removed from working with
beryllium. Specifically, proposed section 850.34(b) would establish a
requirement to protect an employee's base pay, benefits, and seniority
should that worker accept restriction from working with beryllium. The
Department's intent with this provision is that DOE contractors would
offer sensitized employees and employees with CBD placement in a job
that does not involve exposure to beryllium and that provides base pay
and benefits comparable to their current job. Under this provision, if
no such job exists within the contractor's organization, DOE
contractors may offer the affected workers out-placement assistance to
find suitable alternative employment.
Proposed section 850.34(b) would further clarify that DOE
contractors would be required to protect the pay and benefits of
affected workers for a two-year period. DOE believes that the
establishment of a two-year period of protected pay and benefits is
fair and would provide sufficient incentive for DOE contractors to put
forth the level of job placement effort necessary to find suitable
alternative employment that would be acceptable to the affected worker.
One of the main goals of the medical surveillance program is to
minimize the disability associated with CBD. The Department believes
that the establishment of the medical removal protection benefits of
proposed section 850.34(b) is critical to achieving this goal for two
reasons: (1) removal from exposure and effective job-placement efforts
coupled with early diagnosis and treatment would allow affected workers
to continue as productive members of the workforce, and (2) providing
beryllium workers with a reasonable level of assurance that a finding
of sensitization or diagnosis of CBD would not lead to the loss of
their employment would further encourage worker participation in the
medical surveillance program.
Proposed section 850.35 would establish the medical consent
provisions of the proposed rule. Because DOE intends worker
participation in medical surveillance to be voluntary, the provisions
of this section would be necessary to ensure that beryllium workers
receive the information they need to make an informed decision
regarding their participation in the program.
Proposed section 850.35(a) would require that DOE contractors
provide beryllium workers with information on the benefits and risks of
the medical tests and examinations offered as part of medical
surveillance. This information must be provided at least one week prior
to any examinations or tests. In addition to providing this
information, the Department also believes that DOE contractors should
take reasonable efforts to ensure that workers understand the material.
Accordingly, proposed section 850.35(a) would further clarify that
workers shall have the opportunity to ask questions and have their
questions answered prior to the performance of a medical evaluation.
Proposed section 850.35(b) would also require that DOE contractors
provide beryllium workers and accepted applicants with a summary of the
medical surveillance program, information explaining the purpose of the
data, the type of data needed to be collected, how the data will be
maintained, and the confidentiality of medical records will be
protected. This information must also be provided at least one week
prior to any examinations or tests.
Proposed section 850.35(c) would require DOE contractors to use the
informed consent form approved by the Assistant Secretary for
Environment, Safety and Health (EH-1) to obtain the signed consent of a
beryllium worker prior to performance of a medical examination. The
signature of the beryllium worker is intended to document that he or
she consented to being tested. The signature of the examining physician
is intended to document the commitments made to the beryllium worker.
An example of the consent form can be found in Appendix A to Part 850.
Proposed section 850.35(d) would ensure that a beryllium worker or
accepted applicant who develops a beryllium-related health effect, such
as beryllium sensitization or CBD, would be given the information by
the contractor that he or she needs to make an informed decision
whether to accept medical removal. As clarified in this section, this
information would include, at a minimum, information on opportunities
for alternative placement with the contractor, out-placement benefits
if no suitable positions exist within the contractor's organization,
and any available long-term medical and disability insurance benefits
for which the worker may qualify. The goal of this provision is to
provide the worker with detailed information on the risks and benefits
of accepting or rejecting medical removal to assist the worker in
making the best possible decision.
Proposed section 850.35(e) would clarify that the SOMD must first
provide the affected worker or accepted applicant the opportunity to
ask questions and have their questions answered prior to obtaining the
workers agreement to medical removal or before
[[Page 66964]]
having the worker sign a medical removal waiver.
Proposed section 850.36 would establish requirements for training
and counseling regarding worker exposure to beryllium and the potential
health effects associated with such exposure. DOE believes that such
worker training is necessary because the appropriate implementation of
the required workplace procedures of the CBDPP would ultimately rest
upon the front-line workers who will actually be performing work on,
with, or near beryllium or beryllium-contaminated materials. If these
workers are not aware of the required procedures or if they do not
fully appreciate the significance of these procedures, they cannot be
expected to implement the procedures. For this reason, DOE believes
that the ultimate success of the proposed CBDPP and the realization of
the Department's goal to prevent future occurrences of CBD within the
DOE complex depend to a great extent on the training and knowledge of
the beryllium workers.
Proposed section 850.36(a) would require contractors to develop and
implement a worker training program for all workers who are exposed or
potentially exposed to airborne concentrations of beryllium and ensure
their participation in the program. DOE recognizes that OSHA's Hazard
Communication standard (29 CFR 1910.1200) already requires that DOE
contractors provide their workers with similar training regarding the
risks associated with all hazardous materials in the workplace. DOE
does not intend that contractors would implement two separate and
redundant training and information programs to comply with this
proposed rule and the Hazard Communication standard. Accordingly,
proposed section 850.36(a)(1) would require that DOE contractors' CBDPP
training and information programs comply with the Hazard Communication
standard as well as address the contents of the CBDPP. Through this
provision, DOE intends for its contractors to integrate their CBDPP
training and information efforts into their existing Hazard
Communication training program, thus minimizing the burden on
contractors and providing for a consistent approach to worker training
and the communication of workplace hazards.
Proposed section 850.36(a)(2) would require that training be
provided to workers prior to initial assignment and at least annually
thereafter to ensure that workers are appropriately prepared to
recognize the hazards and risks of working with beryllium. The initial
training requirement of the paragraph is important to ensure that
workers have the information they need to protect themselves before
they are actually subject to exposure or potential exposure hazards.
Annual training is necessary to reinforce 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
would establish this frequency as a minimum requirement, noting that
changes in workplace operations, controls, or procedures, or the
availability of new or updated information regarding the health risk
associated with exposures to beryllium, may warrant the need for more
frequent training.
In addition, proposed section 850.36(a)(3) would require that the
training include information regarding beryllium health risk, exposure
reduction, safe handling of beryllium and medical surveillance. This
proposed section does not limit the contractor from providing training
in additional areas.
All training must be conducted in a manner easy to understand so
that workers can effectively translate CBDPP training into safe work
practices. Training material should be appropriate in content and
vocabulary to the education level, literacy, and language background of
affected workers. Such targeted training would ensure that all workers,
regardless of cultural or educational background, would have the
requisite knowledge necessary to reduce and minimize their exposure to
beryllium.
To provide additional support to affected workers, proposed section
850.36(b) would establish the requirement for the development and
implementation of a worker counseling program that would assist
beryllium-sensitized workers and workers diagnosed with CBD. The
purpose of the counseling program would be to help communicate to
workers the information that they will need to make important health-
and work-related decisions and to facilitate the performance of
required administrative activities, such as filing workers'
compensation claims. Proposed section 850.36(b) would require the
communication of information regarding the availability of: the medical
surveillance program; medical treatment options; work practices aimed
at limiting worker exposure to beryllium; the risk of continued
exposure after sensitization; medical benefits; workers' compensation
claims; and medical, psychological, and career counseling for workers
with CBD or with positive results on Be-LPTs.
Proposed section 850.37 would require DOE contractors to post
warning signs and labels to ensure that the presence of and dangers
associated with beryllium and beryllium-contaminated materials or areas
are communicated to workers.
Proposed section 850.37(a) would require the posting of warning
signs at all entranceway locations where regulated areas have been
established. This proposed section further requires that these signs
bear the following warning:
DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
The purpose of these signs would be to minimize the number of
persons in a regulated area by warning workers prior to entry. The
signs would also alert workers to the fact that they must have the
appropriate authorization from their supervisor to enter the 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 exposures to beryllium and thus may not
be appropriately equipped for or aware of the need to protect
themselves from potential exposures. Warning signs would also serve as
a constant reminder to those who work in regulated areas that the
potential for exposure to beryllium exists in the area and that
appropriate controls must be used.
Proposed sections 850.37(b)(1) and (2) would require that DOE
contractors label all containers of beryllium, beryllium compounds, or
beryllium-contaminated clothing, equipment, waste, scrap, or debris in
accordance with OSHA's Hazard Communication standard (29 CFR
1910.1200). Ensuring that the content and format of the warning labels
are consistent with those of OSHA's Hazard Communication standard would
provide DOE and its contractors with a consistent and comprehensive
approach to alerting workers to beryllium's potential to cause serious
disease. The use of such warning labels would also ensure that all
those who come in contact with labeled containers are aware of the
containers' contents and of the need to implement special handling
precautions. Because the effectiveness of the warning labels in
achieving these objectives is greatly dependent upon the visibility,
accuracy, and understandability of the content of the
[[Page 66965]]
labels, proposed section 850.37(a)(2) would further 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 section 850.38 would address requirements for the
establishment and maintenance of accurate records to demonstrate
effective implementation of the program. Proposed section 850.38(a)
would require the collection and maintenance of all beryllium inventory
information, hazard assessments, exposure measurements, controls, and
medical surveillance data. The Department feels that accurate and
retrievable records are essential to the assessment of the adequacy of
worker protection programs. Proposed section 850.38(b) would require
that records required by this part be maintained in an electronic,
easily retrievable format that can be easily transmitted to DOE
headquarters when requested. This supplemental requirement would be
necessary to facilitate timely, efficient, and cost-effective transfer
and analysis of exposure monitoring and medical surveillance data.
Although the Department does not at this time mandate any specific
methods or types of records system in the proposed rule, DOE
contractors are already required to keep records of beryllium inventory
information (29 CFR 1910.1200, Hazard Communication) and hazard
assessment, exposure measurement, and medical surveillance data (29 CFR
1910.1020, Access to Employee Exposure and Medical Records). DOE
contractors would be encouraged to take advantage of existing
recordkeeping systems to minimize the implementation burden.
Proposed section 850.38(c) would also require that DOE and
contractors create links between data sets on working conditions and
health outcomes to serve as a basis for understanding the beryllium
health risk. This linkage of data will assist DOE and contractors in
identifying unsafe work practices and defining the exposure-response
relationship.
The establishment and maintenance of useful, linked, and easily
retrievable records would directly support and be an integral part of
successful performance feedback, as described in proposed section
850.40. Combining data facilitates analyses that might be impossible to
perform in smaller populations. Combined analyses can identify
associations between CBD prevalence and risk factors that might
otherwise be missed, and can lead to the development of conclusions
based on the predictive value of medical tests used earlier in the
analysis process.
Proposed section 850.38(d) specifically states that medical
information generated by the CBDPP may only be maintained as a part of
the site beryllium workers' medical records. This section further
states that the medical information must be maintained separately from
other personnel records and in conformity with the Americans with
Disabilities Act, the Privacy Act and other applicable laws.
Proposed section 850.39(a) would require that DOE contractors
develop and maintain a separate electronic beryllium registry that
includes all beryllium workers. This beryllium registry would serve as
a repository for collecting and maintaining information on workers who
are exposed to long term, low and moderate levels of beryllium. The
results of beryllium sensitization testing and/or CBD status of exposed
workers will be added to the registry as that information becomes
available. As information accrues over time, the disease status of
workers as it relates to past beryllium exposure would be determined.
The goals of the registry would be to provide early guidance as to the
effectiveness of exposure control mechanisms and intervention programs
and assess the burden of health effects related to beryllium exposure.
The beryllium registry would also facilitate the conduct of
epidemiologic studies to better understand the development of the
disease and better identify those at risk.
Section 850.39(b) would specify the required content of the
registry and establish that the registry and subsequent updates be
forwarded electronically on a semi-annual basis to the Office of
Environment, Safety and Health, Office of Epidemiologic Surveillance.
For most sites, the electronic transfer of data would be similar to
that used for the existing Epidemiologic Surveillance program. The
Office of Epidemiologic Surveillance would be responsible for the
administration and policy decisions related to the beryllium registry.
This office would also provide technical support to the SOMD as
required.
The SOMD would provide demographic data, exposure data, and medical
screening results. Personal identifying information would be required
to link exposure data to an individual and to eliminate duplicate
reports for each worker. This information would be collected pursuant
to and contained within DOE Record System 88 ``Epidemiologic and Other
Studies, Surveys, and Surveillance.''
Proposed section 850.39(c) would require that information contained
in the beryllium registry be disclosed only in a manner consistent with
applicable legal requirements, such as the Privacy Act. Use of records
under this act is governed by specific routine uses.
DOE believes that the existence of a Department-wide registry of
beryllium workers and CBD and sensitization cases would facilitate
future research on improved diagnostic tests and treatments for the
disease.
Proposed section 850.40 would establish the performance feedback
provisions of the CBDPP. Performance feedback mechanisms are essential
to ensure that the effectiveness of the CBDPP is evaluated on a
continual basis and that the necessary changes are made to ensure the
protection of worker health. This section would mandate the use and
analysis of the data collected through the reporting requirements in
proposed section 850.38 to maintain and improve each element of the
CBDPP.
Proposed section 850.40(a) would require that DOE contractors
conduct periodic analysis and assessment of monitoring results, hazards
identified, medical surveillance results, attainment of exposure
reduction and minimization goals, and occurrence reporting data. The
Department believes that the analysis of these data would be important
to the continuous improvement of the program. In addition, this
information would provide insights to better understand and manage
program implementation through the use of performance measures
developed on a site-by-site basis.
To ensure that all workers have the necessary information to safely
perform their assigned tasks, proposed section 850.40(b) would require
that results of performance assessments conducted in accordance with
this part be provided to line managers, planners, worker protection
staff, workers, medical staff, and others. This requirement would
improve communication among employees, managers, and others to more
effectively evaluate and monitor program implementation and
effectiveness.
[[Page 66966]]
VII. Procedural Requirements
A. Review Under Executive Order 12866
Today's 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, today's
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 the
NOPR.
B. Review Under the Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, requires
that an agency prepare an initial regulatory flexibility analysis for
any rule 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.
DOE obtained information for 15 potentially affected sites to
determine if the proposed rule, if promulgated, would have a
significant economic impact on small entities. This information
indicates that no small businesses currently would be affected by the
proposed rule. A more detailed account of this information appears in
the Economic Analysis prepared under the requirements of Executive
Order 12866. Furthermore, DOE expects that any potential economic
impact of this rule on small businesses would be minimal because
businesses at DOE sites perform work under contracts to DOE or the
prime contractor at the site. Increased funding may be available under
this contractual arrangement to offset much of the impact that the rule
would impose. In addition, many of the requirements of this part would
apply to prime contractors and not subcontractors. Currently none of
the prime contractors at affected DOE sites are small businesses.
For the foregoing reasons, DOE certifies that today's proposed
rule, if promulgated, would not have a significant economic impact on a
substantial number of small entities. DOE invites public comment and
information on this certification.
C. Review Under the Paperwork Reduction Act
The proposed collections of information in this proposed rule have
been submitted to the Office of Management and Budget (OMB) for review
and approval under section 3507(d) of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless the
collection displays a valid control number assigned by OMB.
This section describes the collections of information in the
proposed rule and provides estimates of the annual burden on
respondents. The burden estimates include the total time, effort, and
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for DOE. DOE invites public
comment on: (1) Whether the proposed collections are necessary for the
performance of DOE's functions, including whether the information will
have practical utility; (2) the accuracy of DOE's estimates of the
burden of the proposed collections of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collections of information
on respondents, including the use of automated collection techniques or
other forms of information technology.
Comments should be addressed to the Department of Energy Desk
Officer, Office of Information and Regulatory Affairs, OMB, 725 17th
Street, NW, Washington, DC 20503. Persons submitting comments to OMB
also are requested to send a copy to the contact person at the address
given in the ADDRESSES section of this notice. Requests for a copy of
the Department's Paperwork Reduction Act Submission to OMB should be
directed to the contact person.
Title: Reporting and recordkeeping requirements for the Chronic
Beryllium Disease Prevention Program.
Abstract: The proposed rule would require DOE contractors at sites
where beryllium is present to: develop and submit an initial CBDPP to
DOE for approval (Sec. 850.10); periodically revise the CBDPP
(Sec. 850.10); conduct a baseline inventory of beryllium at the site
(Sec. 850.20); notify workers of exposure monitoring results
(Sec. 850.24); develop and maintain a registry of beryllium workers
(Sec. 850.39); require workers to sign a consent form for beryllium
work and medical surveillance (Sec. 850.35); establish and maintain
records related to the beryllium inventory and hazard assessment,
exposure monitoring, workplace controls and medical surveillance
(Sec. 850.38); and establish a performance feedback process for
continually evaluating and improving the CBDPP (Sec. 850.40). DOE has
determined that these collections of information are necessary for
implementation of an effective CBDPP.
The burden of compliance with the collections of information in
this rule will depend upon the nature of each requirement and the
number and type of respondents. DOE estimates that DOE contractors at
15 facilities would be required to develop and submit CBDPPs to DOE for
approval and, thereafter, implement the CBDPPs including the
collections of information. Approximately 1,057 workers at the 15
facilities may be exposed to beryllium and, therefore, may be subject
to certain of the information collection requirements.
DOE estimates the total startup costs at $348,781. Initial CBDPPs
were required from all of the affected facilities by DOE Notice 440.1.
DOE estimates that 2,549 professional hours and 637 clerical hours were
required to prepare and submit the initial CBDPPs, at a total cost of
$112,220. DOE estimates that the baseline inventory of beryllium will
require 5,026 professional hours and 2,417 clerical hours, for a total
cost of $234,631. Development of the beryllium registry is expected to
cost $1,930, which represents 168 hours of clerical time.
DOE estimates the total recurring, annual paperwork burden at
$318,860. This includes 3,498 professional hours ($142,047) and 15,375
clerical hours ($176,812). Recordkeeping would impose the largest
recurring monetary cost (an estimated 10,993 clerical hours). Other
recurring paperwork burdens are attributable to submitting performance
feedback reports, worker notification of exposure monitoring, obtaining
signed medical consent forms from workers, maintenance of the beryllium
registry, revising the CBDPP plan on an annual basis, obtaining written
reports from physicians regarding the results of medical exams, and
performing analyses of medical data.
DOE estimates the total annualized cost of paperwork burdens for
the Chronic Beryllium Disease Prevention Program would be $368,518.
D. Review Under the National Environmental Policy Act
DOE is reviewing the promulgation of 10 CFR part 850 under the
National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et
seq.), the Council on Environmental Quality regulations for
implementing NEPA, and DOE's NEPA implementing
[[Page 66967]]
procedures (10 CFR part 1021). DOE has prepared a draft Environmental
Assessment (EA) (DOE/EA 1249) to support a decision on whether to issue
a finding of no significant impact or to prepare an environmental
impact statement for this proposed rule. Requests for copies of the
draft EA and any comments on the EA should be submitted to the address
indicated in the ADDRESSES section of this NOPR. Copies of the draft EA
may also be downloaded from the ``Chronic Beryllium Disease Prevention
Program'' home page on the Internet. The address is http://
tis.eh.doe.gov/be/ DOE will consider any comments on the draft EA and
the proposed rule before completing the NEPA process.
E. Review Under Executive Order 12612
Executive Order 12612, 52 FR 41685 (October 30, 1987), requires
that regulations, rules, legislation, any other policy actions be
reviewed for any substantial, direct effects on states, on the
relationship between the national government and the states, or in the
distribution of power and responsibilities among various levels of
government. If there are sufficient substantial, direct effects, then
the Executive Order requires a federalism assessment to be used in all
decisions involved in promulgating and implementing a policy action.
This proposed rule, if promulgated as a final rule, would apply
only to DOE facilities. It would not have a substantial direct effect
on the institutional interests or traditional functions of the states.
F. 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 final rule meets the relevant standards of Executive Order 12988.
G. Review Under the Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each federal agency to prepare a written assessment of the
effects of any federal mandate in a proposed or final agency rule that
may result in the expenditure by State, local, and tribal governments,
in the aggregate, or by the private sector, of $100 million in any one
year. It also requires a federal agency to develop an effective process
to permit timely input by elected officers of State, local, and tribal
governments on a proposed ``significant intergovernmental mandate,''
requires an agency to develop a plan for giving notice and opportunity
to timely input to potentially affected small governments before
establishing any requirements that might significantly or uniquely
affect small governments. The proposed rule published today does not
contain any federal mandate. Thus, these requirements do not apply.
VIII. Public Comment Procedures
A. Written Comments
Interested individuals are invited to participate in this
proceeding by submitting data, views, or arguments with respect to this
proposed rule. To help the Department review the submitted comments,
commentors are requested to reference the paragraph(s) (e.g., 850.3[a])
to which they refer where possible.
Ten copies of written comments should be submitted to the address
indicated in the ADDRESSES section of this notice. Comments should be
identified on the outside of the envelope and on the documents
themselves with the designation ``Beryllium Rule, Docket No. EH-RM-98-
BRYLM.'' Should anyone wishing to provide written comments be unable to
provide ten copies, alternative arrangements can be made in advance
with the Department.
All submitted comments will be available for public inspection as
part of the administrative record on file for this rulemaking, which is
in the DOE Freedom of Information Office Reading Room at the address
indicated in the ADDRESSES section of this NOPR.
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 one complete copy of the
document, as well as two copies, if possible, from which the
information has been deleted. The Department will make its own
determination as to the confidentiality of the information and treat it
accordingly.
B. Public Hearings
Public hearings will be held at the times, dates, and places
indicated in the DATES and ADDRESSES sections 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 number in the DATES
section of this NOPR. The person should provide a daytime phone number
where he or she may be reached. Persons requesting an opportunity to
speak will be notified as to the approximate time they will be
speaking. Each presentation is limited to 10 minutes. Persons making
oral presentations should bring ten copies of their statements to the
hearing and submit them at the registration desk.
DOE reserves the right to select the persons 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 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 transcript of each hearing will be made available to the public.
DOE will retain the record of the full hearing, including the
transcript, and make it available for inspection in the DOE Freedom of
Information Office, at the address provided in the ADDRESSES section of
this NOPR. Transcripts may be purchased from the court reporter.
If DOE must cancel the hearings, it will make every effort to give
advance notice.
Appendix--References
1. Green DM et al. ``Agency for Toxic Substances and Disease
Registry (ASTDR)
[[Page 66968]]
Case Studies in Environmental Medicine, No. 19.'' U.S. Department of
Health and Human Services. 1992.
2. Hardy HL, Tabershaw IR. ``Delayed Chemical Pneumonitis
Occurring in Workers Exposed to Beryllium Compounds.'' Journal of
Industrial Hygiene Toxicology, Volume 28:197 (1946).
3. Powers MB. ``History of Beryllium.'' In Beryllium Biomedical
and Environmental Aspects. Rossman MD, Preuss OP, and Powers MB,
eds. Baltimore: Williams and Wilkins, 1991.
4. Eisenbud M et al. ``Non-occupational Berylliosis.'' Journal
of Industrial Hygiene Toxicology, Volume 31:282-294 (1949).
5. Eisenbud M, Lisson J. ``Epidemiologic Aspects of Beryllium-
Induced Nonmalignant Lung Disease: A 30-Year Update.'' Journal of
Occupational Medicine, Volume 25:196-202 (1983).
6. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium
Intoxication.'' Archives of Industrial Hygiene and Occupational
Medicine, Volume 4:123-157 (1951).
7. Newman LS, Kreiss K. ``Nonoccupational Beryllium Disease
Masquerading as Sarcoidosis: Identification by Blood Lymphocyte
Proliferative Response to Beryllium.'' American Review of
Respiratory Disease, Volume 145:1212-1214 (1992).
8. Tepper LB. ``Introduction.'' In: Beryllium Biomedical and
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds.
Baltimore: Williams and Wilkins, 1991.
9. Sprince NL, Kazemi H. ``Beryllium Disease.'' In:
Environmental and Occupational Medicine, 2nd ed. Room W, ed. Boston:
Little, Brown, 1992.
10. Newman LS et al. ``Pathologic and Immunologic Alterations in
Early Stages of Beryllium Disease. Reexamination of Disease
Definition and Natural History.'' American Review of Respiratory
Disease, Volume 139:1479-11486, (1989).
11. Kreiss K, Newman LS, Mroz MM, Campbell, PA. ``Screening
Blood Test Identifies Subclinical Beryllium Disease.'' Journal of
Occupational Medicine, Volume 31:603-608 (1989).
12. Rossman MD, Kern JA, Elias JA et al. ``Proliferative
Response of Bronchoalveolar Lymphocytes to Beryllium: A Test For
Chronic Beryllium Disease.'' Annals of Internal Medicine, Volume
108:687-693 (1988).
13. Saltini C, Winestock K, Kirby M et al. ``Maintenance of
Alveolitis in Patients with Chronic Beryllium Disease by Beryllium
Specific Helper T-Cells.'' New England Journal of Medicine, Volume
320:103-1109 (1989).
14. Cullen MR et al. ``Chronic Beryllium Disease in a Metal
Refinery. Clinical Epidemiologic and Immunologic Evidence for
Continuing Risk from Exposure to Low Level Beryllium Fume.''
American Review of Respiratory Disease, Volume 135(1):201-208
(1987).
15. Kreiss K, Mroz MM, Zhen B et al. ``Epidemiology of Beryllium
Sensitization and Disease in Nuclear Workers.'' American Review of
Respiratory Disease, Volume 148:985-991 (1993).
16. Kreiss K et al. ``Beryllium Disease Screening in the
Ceramics Industry.'' Journal of Occupational Medicine, Volume
35:267-274 (1993).
17. Health Assessment Document for Beryllium [Publication No.
EPA/600/8-84/026F] U.S. Environmental Protection Agency. (1987).
18. Stange AW et al. ``Possible Health Risks from Low Level
Exposure to Beryllium.'' Toxicology, Volume 111:213-224 (1996).
19. Barnard AE, et al. ``Retrospective Beryllium Exposure
Assessment at the Rocky Flats Environmental Technology Site.''
American Industrial Hygiene Association Journal, Volume 57:804-808
(1996).
20. Kreiss K et al. ``Machining Risk of Beryllium Disease and
Sensitization with Median Exposures Below 2 g/m\3\,''
American Journal of Industrial Medicine, Volume 30:16-25 (1996).
21. Cohen BS. ``Air Sampling.'' In: Beryllium Biomedical and
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds.
Baltimore: Williams and Wilkins, 1991.
22. Finch GL. ``In Vitro Dissolution Characteristics of
Beryllium Oxide and Beryllium Metal Aerosols.'' Journal of Aerosols
Science, Volume 19:333-342 (1988).
23. Newman LS. ``To Be2+ or Not to Be2+:
Immunogenetics and Occupational Exposure.'' Science, Volume 262:197-
198 (8 October 1993).
24. Haley PJ. ``Mechanisms of Granulomatous Lung Disease from
Inhaled Beryllium: The Role of Antigenicity in Granuloma
Formation.'' Toxicologic Pathology, Volume 19:514-525 (1991).
25. Finch GL. ``Clearance, Translocation, and Excretion of
Beryllium Following Inhalation of Beryllium Oxide by Beagle Dogs.''
Fundamentals of Applied Toxicology, Volume 15:231-241 (1990).
26. Richeldi L et al. ``HLA-DPB1 Glutamate 69: A Genetic Marker
of Beryllium Disease.'' Science, Volume 262:242-244 (8 October
1993).
27. Eisenbud M. ``The Standard for Control of Chronic Beryllium
Disease.'' Applied Occupational Environmental Hygiene, Volume
13(1):25-31 (January1998).
28. Pappas GP et al. ``Early Pulmonary Physiologic Abnormalities
in Beryllium Disease.'' American Review of Respiratory Disease,
Volume 148:661-666 (1993).
29. Hawkins NC, Norwood SK, and Rock JC, eds. A Strategy for
Occupational Exposure Assessment. Virginia: American Industrial
Hygiene Association (1991).
List of Subjects in 10 CFR Part 850
Hazardous waste, Occupational safety and health, Reporting and
recordkeeping requirements, Safety.
Issued in Washington, DC on October 30, 1998.
Bill Richardson,
Secretary of Energy.
For the reasons set forth in the preamble, Title 10, Chapter III of
the Code of Federal Regulations is proposed to be amended by adding
Part 850 to read as set forth below.
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.
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 Baseline beryllium inventory.
850.21 Hazard assessment.
850.22 Exposure limits.
850.23 Action level.
850.24 Exposure monitoring.
850.25 Exposure reduction and minimization.
850.26 Regulated areas.
850.27 Change rooms.
850.28 Respiratory protection.
850.29 Protective clothing and equipment.
850.30 Housekeeping.
850.31 Waste disposal.
850.32 Beryllium emergencies.
850.33 Medical surveillance.
850.34 Medical removal.
850.35 Medical consent.
850.36 Training and counseling.
850.37 Warning signs and labels.
850.38 Recordkeeping and use of information.
850.39 Beryllium registry.
850.40 Performance feedback.
Appendix A to Part 850--Chronic Beryllium Disease Prevention
Program Informed Consent Form
Appendix B to Part 850--Questions and Answers Concerning the
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical
Records, and the DOE Beryllium Registry
Authority: 42 U.S.C. 2201.
Subpart A--General Provisions
Sec. 850.1 Scope.
This part establishes a chronic beryllium disease prevention
program (CBDPP) that supplements and is integrated into existing worker
protection programs that are established for Department of Energy (DOE)
employees and DOE contractor employees.
Sec. 850.2 Applicability.
(a) This part applies to:
(1) DOE offices responsible for DOE beryllium activities and DOE
employees exposed or potentially exposed to beryllium at DOE-owned or -
leased facilities; and
(2) DOE contractors and contractor employees with operations or
activities involving exposure or the potential for
[[Page 66969]]
exposure of employees to beryllium at DOE-owned or -leased facilities.
(b) This part does not apply to:
(1) Beryllium articles; and
(2) DOE laboratory operations involving beryllium that are subject
to the requirements of 29 CFR 1910.1450, Occupational Exposure to
Hazardous Chemicals in Laboratories.
Sec. 850.3 Definitions.
(a) As used in this part:
Accepted applicant means a person who has accepted an offer of
employment in beryllium work at a DOE facility but who has not begun
performing beryllium work.
Action level means the level of airborne concentration of beryllium
established pursuant to Sec. 850.23 of this part that, if exceeded,
requires the implementation of worker protection provisions specified
in that section.
Authorized person means any person required by work duties to be in
a regulated area.
Beryllium means elemental beryllium and any insoluble beryllium
compound or alloy containing 0.1 percent beryllium or greater that may
be released as an airborne particulate.
Beryllium article means a manufactured item that is formed to a
specific shape or design during manufacture that has end-use functions
that depend in whole or in part on its shape or design during end use
and that does not release beryllium or otherwise result in exposure to
airborne concentrations of beryllium under normal conditions of use.
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 facility.
Beryllium-induced lymphocyte proliferation test (Be-LPT) is an in
vitro measure of the beryllium antigen-specific, cell-mediated immune
response.
Beryllium worker means a current worker who is exposed or
potentially exposed to airborne concentrations of beryllium at or above
the action level or above the STEL or who is currently receiving
medical removal protection benefits.
Breathing zone is defined as a hemisphere forward of the shoulders,
centered on the mouth and nose, with a radius of 6 to 9 inches.
DOE means the U.S. Department of Energy.
DOE beryllium activity means an activity taken for, or by, DOE that
can expose workers to beryllium, including but not limited to design,
construction, operation, or decommissioning. The activity may involve
one DOE facility or operation or a combination of facilities and
operations.
DOE contractor means any entity under contract (or its
subcontractor) with DOE with responsibility to perform beryllium
activities at DOE facilities.
DOE facility means any facility operated by or for DOE.
High-efficiency particulate air (HEPA) filter means a filter
capable of trapping and retaining at least 99.97 percent of 0.3
micrometer monodispersed particles.
Immune response refers to the series of cellular events by which
the immune system reacts to challenge by an antigen.
Medical removal protection benefits are employment rights
established by Sec. 850.34 of this part for beryllium workers who are
removed temporarily from work in regulated areas or who voluntarily
accept permanent medical removal from regulated areas following tests
that confirm beryllium sensitivity or CBD.
Regulated area means an area or physical location demarcated by the
contractor in which the airborne concentration of beryllium exceeds, or
can reasonably be expected to exceed, the action level or the STEL.
Short term exposure limit (STEL) means the short term exposure
limit established pursuant to Sec. 850.22(b) of this part.
Site occupational medicine director (SOMD) means the physician
responsible for the overall direction and operation of the site
occupational medicine program.
Surface contamination is the presence of beryllium on work
surfaces, which may cause skin irritation by direct contact with
damaged skin or which may present an airborne hazard when reentrained
into the workplace air.
Worker means a person who performs work for or on behalf of DOE,
including a DOE employee, an independent contractor, a DOE contractor
employee, or any other person who performs work at a DOE facility.
Worker exposure means the exposure to airborne beryllium that would
occur if the worker were not using respiratory protective equipment.
Terms used in this part that are undefined but that are defined in
the Atomic Energy Act shall have the same meaning as under the Atomic
Energy Act.
Sec. 850.4 Enforcement.
DOE may take appropriate steps under its contracts with DOE
contractors to ensure compliance with this part, including contract
termination or reduction in fee.
Sec. 850.5 Dispute resolution.
Disputes arising under this part that are brought by beryllium
workers and accepted applicants shall be resolved through applicable
grievance-arbitration processes or, where such processes are not
available, through referral to the Department's Office of Hearings and
Appeals. The procedures in 10 CFR part 1003, subpart G, shall apply to
resolution of disputes by the Office of Hearing and Appeals.
Subpart B--Administrative Requirements
Sec. 850.10 Development and approval of the CBDPP.
(a) Preparation and Submission of Initial CBDPP to DOE. (1) DOE
contractors responsible for DOE beryllium activities at DOE facilities
shall ensure that a CBDPP is prepared for their respective facility and
submitted to the appropriate DOE Field Organization before beginning
beryllium activities, but no later than [90 days after the effective
date of the final rule] of this part.
(2) Where there are separate sections addressing the activities of
particular contractors at the facility, the DOE contractor designated
by the DOE Field Organization shall review and approve those sections
so that a single consolidated CBDPP for the facility is submitted to
the DOE Field Organization for review and approval.
(b) DOE Review and Approval. Heads of DOE Field Organizations shall
review and approve the CBDPPs.
(1) The initial CBDPP and any updates shall be considered approved
90 days after submission if not approved or rejected by DOE earlier.
(2) DOE contractors shall furnish a copy of the approved CBDPP,
upon request, to the DOE Assistant Secretary for Environment, Safety
and Health or designee, DOE program offices, and affected workers or
their designated representatives.
(c) Update. DOE contractors shall submit an update of the CBDPP to
the appropriate DOE Field Organization for review and approval whenever
a significant change or significant addition to the CBDPP is made or a
change in contractor or subcontractor occurs. CBDPPs shall be reviewed
at least annually and updated as necessary.
(d) Labor Organizations. If a DOE contractor employs beryllium
workers who are represented for collective bargaining agreements by
labor
[[Page 66970]]
organizations, the contractor must give those organizations timely
notice of the development and implementation of the CBDPP and any
updates thereto and must, upon timely request, bargain concerning
implementation of this part, consistent with the National Labor
Relations Act.
Sec. 850.11 General CBDPP requirements.
(a) The CBDPP shall specify the existing and planned operational
tasks that are within the scope of the CBDPP. The CBDPP shall augment
and be integrated, to the extent feasible, into the existing worker
protection programs that cover activities at the facility.
(b) The detail, scope, and content of the CBDPP for DOE beryllium
activities shall be commensurate with the hazard of the activities
performed, but in all cases the CBDPP shall:
(1) Include formal plans and measures for maintaining exposures to
beryllium at or below the permissible exposure levels (PELs);
(2) Satisfy each requirement in subpart C of this part;
(3) Contain provisions for:
(i) Minimizing the number of current workers exposed and
potentially exposed to beryllium;
(ii) Minimizing the number of opportunities for workers to be
exposed to beryllium; and
(iii) Setting specific exposure reduction and minimization goals
that are appropriate for the DOE activities covered by the CBDPP to
further reduce exposure below the exposure limits prescribed in section
850.22.
Sec. 850.12 Implementation.
(a) DOE contractors shall manage and control beryllium exposures in
all DOE beryllium activities consistent with the approved CBDPP.
(b) No DOE worker or DOE contractor worker shall take or cause any
action inconsistent with the requirements of:
(1) This part,
(2) An approved CBDPP or any other program, plan, schedule, or
other process established by this part,
(3) Any other Federal statute or regulation concerning the exposure
of workers to beryllium at DOE facilities.
(c) No task involving potential beryllium exposure that is outside
the scope of the existing CBDPP shall be initiated until an update of
the CBDPP is approved by the DOE Field Organization, except in the
event of an unexpected situation and, then, only upon approval of the
DOE Field Organization.
(d) Nothing in this part shall be construed as precluding a DOE
contractor from taking any additional protective action that it
determines to be necessary to protect the health and safety of workers.
Sec. 850.13 Compliance.
(a) DOE contractors shall conduct activities in compliance with
their respective CBDPP, as approved by the DOE Field Organization.
(b) DOE contractors shall achieve compliance with all elements of
their respective CBDPP no later than [2 years from the effective date
of the final rule].
(c) With respect to a particular DOE beryllium activity, the person
in charge of the activity shall be responsible for complying with this
part. If no contractor is responsible for a DOE beryllium activity, DOE
shall ensure implementation of and compliance with this part.
Subpart C--Specific Program Requirements
Sec. 850.20 Baseline beryllium inventory.
(a) DOE contractors shall develop a baseline inventory of beryllium
operations and other locations of potential beryllium contamination,
and identify the workers exposed or potentially exposed to beryllium at
those locations.
(b) In conducting the baseline inventory, DOE contractors shall:
(1) Review employee records;
(2) Interview employees;
(3) Document the presence and locations of beryllium at the
facility; and
(4) Conduct sampling to identify the presence of beryllium.
(c) DOE contractors shall ensure that the individuals assigned to
this task have sufficient industrial hygiene knowledge to perform such
activities properly.
Sec. 850.21 Hazard assessment.
(a) If the baseline inventory establishes the presence of
beryllium, DOE contractors shall conduct a beryllium hazard assessment
that includes an analysis of existing conditions, exposure data,
medical surveillance trends, and the exposure potential of planned
activities.
(b) DOE contractors shall ensure that the individuals assigned to
this task have sufficient industrial hygiene knowledge to perform such
activities properly.
Sec. 850.22 Exposure limits.
(a) Eight-Hour Time-Weighted Average (TWA) Permissible Exposure
Limit (PEL). DOE contractors shall not expose any worker to an airborne
concentration of beryllium over 2 g/m\3\, calculated as an 8-
hour TWA exposure, as measured in the worker's breathing zone by
personal monitoring, or a more stringent TWA PEL that may be
promulgated by the Occupational Safety and Health Administration as a
health standard.
(b) Short-Term Exposure Limit (STEL). DOE contractors shall not
expose any worker to an airborne concentration of beryllium over 10
g/m\3\, averaged over a sampling period of 15 minutes, as
measured in the worker's breathing zone by personal monitoring.
Exposures above the PEL-TWA up to the STEL must not be longer than 15
minutes and must not occur more than four times in a day. If such
exposures occur more than once a day, there must be at least 60 minutes
between successive exposures in this range.
Sec. 850.23 Action level.
(a) DOE contractors shall include in their CBDPP an action level
that, if met or exceeded, shall require the implementation of
Secs. 850.24(c) (periodic monitoring), 850.26 (regulated areas), 850.27
(change rooms), 850.29 (protective clothing and equipment), and 850.33
(medical surveillance).
(b) The provision enumerated in paragraph (a) of this section shall
also be implemented if the STEL is exceeded.
(c) The action level established under paragraph (a) of this
section shall not exceed 0.5 g/m\3\, calculated as an 8-hour
TWA exposure, as measured in the worker's breathing zone by personal
monitoring.
Sec. 850.24 Exposure monitoring.
(a) General. DOE contractors shall ensure that the individuals
assigned to the monitoring tasks of this section have sufficient
industrial hygiene knowledge to perform such activities properly.
(b) Initial Monitoring. DOE contractors shall perform initial
monitoring for all workers in areas that may have airborne
concentrations of beryllium, as shown by the baseline inventory and
hazard assessment.
(1) DOE contractors shall determine each worker's exposure by
conducting personal breathing zone sampling:
(i) To determine the 8-hour TWA exposure level.
(ii) To determine if exposure is above the STEL.
(2) Exposure monitoring results obtained within the 12 months
preceding the effective date of this part may be used to satisfy this
requirement if the measurements were made as provided in paragraph
(b)(1) of this section.
(c) Periodic Exposure Monitoring. DOE contractors shall conduct
periodic
[[Page 66971]]
monitoring of all workers who work in areas where airborne
concentrations of beryllium are at or above the action level or above
the STEL. The monitoring shall be conducted in a manner and at a
frequency necessary to represent worker exposures as specified in their
respective CBDPP, but in no case shall sampling be conducted at
intervals greater than every 3 months (quarterly).
(d) Additional Exposure Monitoring. DOE contractors shall perform
additional monitoring if operations or procedures change.
(e) Accuracy of Monitoring. DOE contractors shall use a monitoring
method that has an accuracy (to a confidence level of 95 percent) of
not less than plus or minus 25 percent or better for airborne
concentrations of beryllium at the action level.
(f) Analysis. DOE contractors shall have all samples collected to
satisfy the monitoring requirements of this part analyzed in a
laboratory accredited for metals by the American Industrial Hygiene
Association.
(g) Notification of Monitoring Results. (1) DOE contractors shall,
within 10 working days after receipt of any monitoring results, notify
the affected workers, and any labor organizations representing such
workers, of monitoring results in writing. This notification shall be
made personally to the affected workers or representatives, or in a
posted form in location(s) that are readily accessible to affected
workers, but in a manner that does not identify individual workers.
(2) If the monitoring results indicate that worker exposure is at
or above the action level or STEL, DOE contractors shall also notify
the SOMD of these results within 10 working days after receipt.
Sec. 850.25 Exposure reduction and minimization.
(a) DOE contractors shall ensure that no worker is exposed above
the exposure limits prescribed in Sec. 850.22, using the conventional
hierarchy of industrial hygiene controls (i.e., engineering and
administrative controls, and personal protective equipment).
(b) DOE contractors shall include in the CBDPP the rationale for
reduction and minimization goals, strategies for achieving those goals,
and the specific measures that will be used to assess the attainment of
those goals. Strategies for achieving the exposure reduction and
minimization goals shall include, but are not limited to:
(1) Using the action level to initiate actions to reduce or
minimize worker exposure, and the potential for exposure, to beryllium;
and
(2) Implementing work and contamination control strategies to
reduce exposure to CBDPP goal levels using the conventional hierarchy
of industrial hygiene controls.
Sec. 850.26 Regulated areas.
(a) If airborne concentrations of beryllium in areas in DOE
facilities are at or above the action level or above the STEL, DOE
contractors shall establish regulated areas for those particular areas.
(b) Regulated areas shall be demarcated from the rest of the
workplace in a manner that adequately alerts workers to the boundaries
of such areas.
(c) DOE contractors shall limit access to regulated areas to
authorized persons.
(d) DOE contractors shall keep records of all individuals who enter
regulated areas. These records shall include the name, date, time in
and time out, and work activity.
Sec. 850.27 Change rooms.
(a) DOE contractors shall provide change rooms for workers who work
in regulated areas.
(1) The change rooms that are used to remove beryllium-contaminated
clothing and protective equipment shall be maintained under negative
pressure or located so as to minimize dispersion of beryllium into
clean areas; and
(2) Separate facilities shall be provided for workers to change
into, and store, personal clothing, and clean protective clothing and
equipment.
(b) DOE contractors shall provide handwashing and shower facilities
for workers who work in regulated areas.
Sec. 850.28 Respiratory protection.
(a) DOE contractors shall comply with the respiratory protection
requirements of 29 CFR 1910.134, Respiratory Protection.
(b) DOE contractors shall provide respirators to, and ensure that
they are used by, all workers who are exposed to an airborne
concentration of beryllium at or above the PEL.
(c) DOE contractors shall select for use by beryllium workers
respirators approved by the National Institute for Occupational Safety
and Health (NIOSH) or those DOE has accepted for use for DOE employees.
Sec. 850.29 Protective clothing and equipment.
(a) Where exposure monitoring has established airborne
concentrations of beryllium at or above the action level or above the
STEL, DOE contractors shall provide protective clothing and equipment
to their beryllium workers and ensure its appropriate use and
maintenance.
(1) DOE contractors shall ensure that beryllium workers exchange
their personal clothing for full-body protective clothing and footwear
before they begin work in regulated areas.
(2) DOE contractors shall provide beryllium workers with, and
ensure the use of, additional protective equipment, such as face
shields, goggles, gloves, and gauntlets, where skin or eye contact is
possible from powdered or liquid forms of beryllium.
(b) DOE contractors shall ensure that no worker takes beryllium-
contaminated protective clothing and equipment from the site, except
for workers authorized to launder, clean, maintain, or dispose of the
clothing and equipment.
(1) DOE contractors shall ensure that contaminated protective
clothing and equipment, when removed for laundering, cleaning,
maintenance, or disposal, is stored in sealed, impermeable containers
or other closed, impermeable containers that are designed to prevent
the dispersion of beryllium dust.
(2) DOE contractors shall ensure that the bags or containers of
contaminated protective clothing and equipment that are to be removed
from the change room areas or the site for laundering, cleaning,
maintenance, or disposal shall bear labels according to section 850.37
of this part.
(c) DOE contractors shall ensure that protective clothing and
equipment is cleaned, laundered, repaired, or replaced as needed to
maintain effectiveness.
(d) DOE contractors shall inform any individual who launders or
cleans beryllium-contaminated protective clothing or equipment that
exposure to beryllium is potentially harmful, and that clothing and
equipment should be laundered or cleaned in a manner prescribed by the
contractor to prevent the release of airborne beryllium at or above the
action level or above the STEL.
(e) DOE contractors shall prohibit the removal of beryllium from
protective clothing and equipment by blowing, shaking, or other means
that may disperse beryllium into the air.
Sec. 850.30 Housekeeping.
(a) Where beryllium is present at DOE facilities, DOE contractors
shall conduct routine surface sampling to determine housekeeping
conditions. Surfaces contaminated with beryllium dusts and waste shall
not exceed a removable surface contamination level of 3 g/100
cm2.
[[Page 66972]]
(b) Where beryllium is present at DOE facilities, DOE contractors
shall clean beryllium-contaminated floors and surfaces using a wet
method or vacuuming. Compressed-air or dry methods shall not be used
for such cleaning.
(c) DOE contractors shall equip the portable or mobile vacuum units
that are used to clean beryllium-contaminated areas with HEPA filters,
and change filters as often as necessary to maintain their capture
efficiency.
(d) DOE contractors shall ensure that the cleaning equipment that
is used to clean beryllium-contaminated surfaces is labeled,
controlled, and used in no other areas.
Sec. 850.31 Waste disposal.
(a) DOE contractors shall control the generation and disposal of
waste that contains beryllium through good housekeeping, hazard
analysis, and the application of waste minimization principles.
(b) Beryllium-contaminated waste, containers, small equipment, and
clothing shall be disposed of in sealed, impermeable bags or
containers. The bags and containers that are used to dispose of
beryllium-contaminated waste or articles shall be labeled according to
Sec. 850.37.
Sec. 850.32 Beryllium emergencies.
(a) DOE contractors shall develop and implement procedures for
handling beryllium emergencies at DOE facilities engaged in beryllium
operations.
(1) DOE contractors shall establish procedures to alert and protect
workers in the event of an emergency.
(2) DOE contractors shall ensure that workers who are engaged in
cleanup related to a beryllium emergency are provided with, and wear,
protective equipment and clothing.
(b) DOE contractors shall provide beryllium emergency procedure
training to workers who are assigned to handle beryllium emergencies.
Sec. 850.33 Medical surveillance.
(a) General. DOE contractors shall designate a SOMD who shall be
responsible for administering a medical surveillance program for
contractor beryllium workers.
(b) Heads of DOE Field Organizations shall designate a SOMD who
shall be responsible for administering a medical surveillance program
for federal employees who are beryllium workers.
(c) The written medical surveillance program shall be reviewed by
the Office of Environment, Safety and Health and approved by Heads of
DOE Field Organizations.
(d) DOE contractors shall establish and implement a medical
surveillance program under the direction of the SOMD for all beryllium
workers exposed at or above the action level or above the STEL.
(e) DOE contractors shall provide the SOMD with the information
needed to operate and administer the medical surveillance program,
including the baseline inventory, hazard assessment and exposure
monitoring data, identity and nature of activities or operations on the
site that are covered under the CBDPP, related duties of beryllium
workers, and type of personal protective equipment used.
(f) The SOMD shall establish and maintain a list of beryllium
workers that is based on records and other information regarding the
identity of beryllium workers.
(1) The list shall establish the population of beryllium workers
who may be eligible for protective measures under this part.
(2) The list shall be adjusted on the basis of periodic evaluations
of beryllium workers performed under paragraph (h)(3) of this section.
(g) Information provided to the examining physician. The SOMD shall
provide the following information to the examining physician:
(1) A copy of this rule;
(2) A description of the beryllium worker's duties as they pertain
to beryllium exposure;
(3) Records of the beryllium worker's beryllium exposure;
(4) A description of the personal protective and respiratory
protective equipment in past, present, or anticipated use; and
(5) Relevant information from the beryllium worker's previous
medical examinations that is not otherwise available to the examining
physician.
(h) Medical evaluations. (1) DOE contractors shall provide medical
examinations and procedures to beryllium workers and accepted
applicants at no cost and at a time and place that is reasonable and
convenient to them.
(2) DOE contractors shall offer a baseline medical evaluation to
beryllium workers who qualify for medical surveillance. This evaluation
shall include:
(i) A medical and work history;
(ii) A physical examination with special emphasis on the
respiratory system;
(iii) A chest radiograph (posterior-anterior, 14 x 17 inches)
interpreted by a National Institute for Occupational Safety and Health
(NIOSH) B-reader or a board-certified radiologist (unless a baseline
chest radiograph is already on file);
(iv) Spirometry;
(v) A Be-LPT; and
(vi) Any other tests deemed appropriate by the examining physician
for evaluating beryllium-related health effects.
(3) Periodic evaluations. DOE contractors shall offer beryllium
workers who qualify for medical surveillance under this section annual
medical evaluations for as long as the beryllium worker performs
beryllium work at a DOE site. DOE contractors shall offer beryllium
workers who have been reassigned to non beryllium DOE work an
evaluation every three years. Such periodic evaluations shall include:
(i) A respiratory symptoms questionnaire;
(ii) A physical examination;
(iii) A Be-LPT; and
(iv) Any other medical evaluations deemed appropriate by the
examining physician for evaluating beryllium-related health effects.
(4) The SOMD shall ensure that all medical evaluations and
procedures that are required by this section are performed by, or under
the supervision of, a licensed physician who is familiar with the
health effects of beryllium.
(i) Referrals. Beryllium workers who have two or more positive Be-
LPTs, or other signs and symptoms of CBD, shall be referred by the
examining physician for further diagnostic evaluation.
(j) Physician's written report and recommendation. (1) DOE
contractors shall ensure that each beryllium worker or accepted
applicant receives, within 15 calendar days after the completion of a
medical evaluation performed under this section, a physician's written
report containing the results of all medical tests or procedures, an
explanation of any abnormal findings, and any recommendations that the
worker be referred for additional testing for evidence of CBD.
(2) DOE contractors shall, within 15 calendar days after the
completion of a medical evaluation performed under this section, obtain
a copy of the physician's written report, that is limited to the
following information: any recommendations that the beryllium worker's
exposure to beryllium be precluded or that the accepted applicant's
start of beryllium work be postponed, either temporarily or
permanently, and any recommendation on the use of respiratory or other
protective equipment.
(k) Data analysis. The SOMD shall routinely and systematically
analyze medical, job, and exposure data with the
[[Page 66973]]
aim of identifying individuals or groups of individuals potentially at
risk for CBD and working conditions that are unduly contributing to
that risk.
(1) Results of these analyses shall be used by the SOMD in
determining which workers should be offered medical surveillance, and
the need for additional exposure controls.
(2) The SOMD shall provide copies of the data analyses to the DOE
contractor for the performance feedback required in section 850.40.
Sec. 850.34 Medical removal.
(a) Medical removal plan. With the express written consent of the
beryllium worker or accepted applicant, as indicated on the consent
form, DOE contractors shall remove a beryllium worker from exposure to
beryllium, or postpone an accepted applicant's start of beryllium work,
if the SOMD recommends that the beryllium worker or accepted applicant
do so due to two or more positive Be-LPT results, confirmation of CBD,
or the detection of other signs or symptoms that require evaluation for
their relationship to CBD.
(1) DOE contractors shall offer a beryllium worker removed from
beryllium work a follow-up medical examination that the examining
physician shall use to decide whether the beryllium worker may return
to beryllium work.
(2) Beryllium workers and accepted applicants with two or more
positive Be-LPTs or confirmed CBD shall have the option at any time
after testing, diagnosis, or the appearance of CBD-related symptoms to
decline the medical removal or restriction and, after signing an
informed consent waiver, resume working in a beryllium area.
(3) DOE contractors shall make reasonable efforts to offer
alternative employment to beryllium workers and accepted applicants who
test positive on two or more Be-LPTs, or who are confirmed with CBD.
The reasonable efforts to offer alternative employment required under
this section shall not require the contractor: to displace any other
worker in order to create a vacancy for the beryllium worker or
accepted applicant; to promote the beryllium worker or accepted
applicant; or to provide the beryllium worker or accepted applicant
with training that costs in excess of $6,000.00, or requires longer
than 6 months to complete.
(b) Medical removal protection benefits. DOE contractors shall
provide beryllium workers who are removed from beryllium work and
placed in other jobs with the contractor employing them, protection
against a reduction in base pay, seniority, or other benefits for a
total period of two years after removal.
Sec. 850.35 Medical consent.
(a) DOE contractors shall provide beryllium workers and accepted
applicants with information on the benefits and risks of the medical
tests and examinations available to them at least one week prior to any
such examination or test. The examining physician shall provide
beryllium workers and accepted applicants an opportunity to have their
questions answered and shall obtain their signed consent before
performing medical evaluations.
(b) DOE contractors shall also provide beryllium workers and
accepted applicants with a summary of the medical surveillance program,
the type of data that will be collected, how the data will be collected
and maintained, the purpose for which the data will be used, and how
confidential data will be protected. This information shall be provided
at least one week prior to the first medical examination or test, or at
any time requested by the beryllium worker or accepted applicant.
(c) DOE contractors shall use the form approved by the Assistant
Secretary for Environment, Safety and Health to obtain the signed
consent of a beryllium worker before performing a medical examination.
(d) DOE contractors shall provide beryllium workers or accepted
applicants information that will facilitate informed decisions on
whether to accept medical removal offered by the SOMD. This information
shall include information on opportunities for alternative placement
within their organization, available out-placement benefits, and long-
term medical and disability insurance benefits for which they may
qualify.
(e) The SOMD shall provide a beryllium worker or an accepted
applicant with an opportunity to have his or her questions answered
before obtaining the worker's agreement to medical removal or a signed
waiver of an offer of medical removal protection.
Sec. 850.36 Training and counseling.
(a) DOE contractors shall develop and implement a beryllium
training program for workers who may be exposed to beryllium, and
ensure their participation.
(1) The information and training provided shall be in accordance
with 29 CFR 1910.1200, Hazard Communication.
(2) Training shall be provided before or at the time of initial
assignment and at least annually thereafter.
(3) Training shall include, but not be limited to, beryllium health
risk, exposure reduction, safe handling of beryllium, and medical
surveillance.
(b) DOE contractors shall develop and implement a beryllium worker
counseling program to assist workers who are diagnosed by the SOMD to
be sensitized to beryllium or to have CBD. This program shall include
communicating with beryllium workers concerning the availability of:
the medical surveillance program; medical treatment options; medical,
psychological, and career counseling for workers with positive Be-LPT
results or confirmed CBD; medical benefits; worker compensation claims;
work practice procedures limiting worker exposure to beryllium; and the
risk of continued exposure after sensitization.
Sec. 850.37 Warning signs and labels.
(a) Warning signs. DOE contractors shall post warning signs at all
entranceways to regulated areas with the following information:
DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
(b) Warning labels. (1) DOE contractors shall affix warning labels
to all containers of beryllium, beryllium compounds, or beryllium-
contaminated clothing, equipment, waste, scrap, or debris.
(2) Labels shall be in accordance with 29 CFR 1910.1200, Hazard
Communication, and shall contain the following information:
DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD
Sec. 850.38 Recordkeeping and use of information.
(a) DOE contractors shall establish and maintain accurate records
of all beryllium inventory information, hazard assessments, exposure
measurements, controls, and medical surveillance.
(b) DOE contractors shall maintain all records required by this
part in an electronic, easily retrievable form for transmittal to DOE
Headquarters on request.
(c) DOE contractors shall link data sets on working conditions and
health outcomes to serve as a basis for understanding the beryllium
health risk.
(d) Medical information generated by the CBDPP shall be maintained
by the contractor as part of the beryllium worker's site medical
records. Such medical information shall be maintained separately from
other
[[Page 66974]]
personnel records. This information must be kept confidential and used
or disclosed by the contractor only in conformance with any applicable
requirements imposed by the Americans with Disabilities Act, the
Privacy Act of 1974, and any other requirements under applicable law.
Sec. 850.39 Beryllium registry.
(a) DOE contractors shall establish and maintain a separate
electronic beryllium registry that includes the name, social security
number (SSN), date of birth, gender, site, job history, medical
screening test results, and results of referrals for specialized
medical evaluation. This data shall be submitted for all beryllium
workers employed by them and all accepted applicants, subject to the
requirements of Sec. 850.38.
(b) DOE contractors shall transmit the beryllium registry
information electronically to the Office of Environment, Safety and
Health, Office of Epidemiologic Surveillance, semi-annually.
(c) Information in the beryllium registry maintained by DOE under
paragraph (a) of this section may be disclosed only in a manner
consistent with the Privacy Act of 1974 and any other applicable legal
requirements.
Sec. 850.40 Performance feedback.
(a) DOE contractors shall conduct periodic analyses and assessments
of monitoring efforts, hazards, medical surveillance, exposure
reduction and minimization, and occurrence reporting data.
(b) To ensure that information is available to maintain and improve
all elements of the CBDPP continuously, results of periodic analyses
and assessments shall be given to the line managers, planners, worker
protection staff, workers, medical staff, and labor organizations
representing beryllium workers who request such information.
Appendix A to Part 850--Chronic Beryllium Disease Prevention
Program Informed Consent Form
I have carefully read and understand the attached information
about the Be-LPT and other medical tests. I have had the opportunity
to ask any questions that I may have had concerning these tests.
I understand that I am free to withdraw at any time from all or
any part of the medical surveillance program. I understand that if
the results of any test suggest a health problem, the examining
physician will discuss the matter with me, whether or not the result
is related to my work with beryllium.
I understand that the results of my tests and examinations may
be published in reports or presented at meetings, but that I will
not be identified.
I understand that the results of my medical tests for beryllium
will be included in the Beryllium Registry maintained by DOE. The
confidentiality of identified information maintained by DOE is
protected under the Privacy Act of 1974. Personal identifiers will
not be published in any reports generated from the DOE Beryllium
Registry. All medical information relative to the tests performed on
me retained by my employer will be maintained in segregated medical
files separate from my personnel files, treated as confidential
medical records, and used or disclosed only as provided by the
Americans with Disability Act, the Privacy Act of 1974, or as
required by a court order or DOE directive.
I consent to having the following medical evaluations:
{time} Physical examination concentrating on my lungs and breathing
{time} Chest X-ray
{time} Spirometry (a breathing test)
{time} Blood test called the beryllium-induced lymphocyte
proliferation test or Be-LPT
{time} Other test(s). Specify:________
I understand that, if the results of one or more of these tests
indicate that I have a health problem that is related to beryllium,
additional examinations will be recommended. If additional tests
indicate I do have a beryllium sensitization or CBD, I may be
advised to stop working with beryllium. Every effort will be made to
offer me a job of equivalent grade and base pay for which I am
qualified. I also may continue working in the job with beryllium
exposure if I so choose. I understand that continuing to work with
beryllium may increase the chance that I will develop chronic
beryllium disease (CBD).
{time} I decline to participate in any part of the medical
surveillance program at this time. If I change my mind, I may
participate in the program by contacting my supervisor.
Name of Participant:
SSN:
Signature of Participant:
Date:
I have explained and discussed any questions that the above
employee expressed concerning the Be-LPT, physical examination, and
other medical testing as well as the implications of those tests.
Name of Examining Physician:
Signature of Examining Physician:
Date:
Appendix B to Part 850--Questions and Answers Concerning the
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical
Records, and the DOE Beryllium Registry
What is the Be-LPT blood test?
In the Be-LPTs, disease-fighting blood cells that are normally
found in the body, called lymphocytes, are examined in the
laboratory and separated from your blood. Beryllium and other test
agents are then added to small groups of these lymphocytes. If these
lymphocytes react to beryllium in a specific way, the test results
are ``positive.'' If they do not react with beryllium, the test is
``negative.''
Experts believe that the Be-LPT shows positive results in
individuals who have become sensitive or allergic to beryllium. It
is unclear what this sensitivity means. Studies have shown it to be
an early sign of chronic beryllium disease (CBD) in many
individuals. In others, sensitivity might simply mean that the
person was exposed to beryllium and that his or her body has
reacted. It might mean that an individual is more likely than others
to get CBD. You are being offered the Be-LPT because doctors believe
it is useful in detecting cases of CBD early or cases that might
otherwise be missed or diagnosed as another type of lung problem.
Once CBD is identified, doctors can determine the treatment that is
needed to minimize the lung damage CBD causes.
As in any other medical test, the Be-LPT sometimes fails or
provides unclear results. The laboratory calls these results
``uninterpretable.'' Even when the test appears successful, it may
appear positive when it is not. This is called a ``false positive''
result. It is also possible that the test will show ``negative''
results when a person is actually ``sensitized'' to beryllium. This
is a ``false negative'' result. If you have a ``uninterpretable''
blood Be-LPT result, you will be asked to provide another blood
sample so the test can be repeated. If you have ``positive''
results, you will be offered further medical tests to confirm or
rule out CBD. Remember, you may refuse further tests at this point
or at any point during your medical evaluations.
It is important for you to know that if the physical examination
or the results from other tests you are receiving suggest that you
have CBD, you may be offered further medical tests. These medical
tests may be offered even if your Be-LPT is ``negative.''
Some individuals with confirmed ``positive'' Be-LPTs but no
other signs of CBD have developed the disease. The likelihood of
this happening will only be known after large groups of potentially
exposed individuals have had their blood tested, have had further
medical tests, and are studied for many years.
What will happen if I decide to have the Be-LPT blood test?
A small amount of your blood will be drawn from a vein in your
arm and sent to a laboratory. There is little physical risk in
drawing blood. Slight pain and bruising may occur in a few
individuals. Rarely, the needle puncture will become infected. Other
routine medical evaluation tests may be offered when you have the
Be-LPTs including a physical examination, a chest X-ray, and
breathing tests that help find signs of CBD, if they exist.
Other diseases may resemble CBD. Different medical tests can
help a physician decide if a person has CBD or another disease. If
the examining physician suspects that you have CBD, he or she will
recommend additional medical tests to help confirm a diagnosis.
Separate information regarding these additional medical tests will
be given to you if they are recommended. Your consent will be
requested when the extra tests are given. You can always refuse
[[Page 66975]]
additional tests, if you so choose. All tests will be paid for by
your employer.
When will I receive the results of my Be-LPT blood test?
It could take 2 to 4 weeks for you to receive a letter informing
you of your test results. The test itself usually takes 8 days to
perform. The testing laboratory reports results to the physician who
examined you and he or she will notify you.
Could a positive Be-LPT blood test affect my job assignment?
Yes, but only if you elect to accept a change in your job
assignment. If you have a positive Be-LPT or have been diagnosed
with CBD, it may be advisable for you to stop working with
beryllium. If you are working with beryllium at this time, every
effort will be made to offer you another job that you are qualified
to perform with your employer. This job will be of comparable
responsibilities, base pay and benefits, and will not expose you to
beryllium. If a comparable position cannot be found with your
employer, you will be offered the choice of continuing to work for
your employer with beryllium or assistance for a period of 2 years
in finding employment with another employer, but in that case there
can be no promise of continued base pay and benefits. If you become
physically unable to continue working, you may be eligible for
workers' compensation and other benefits.
Will I lose any pay or any other benefits by having the examination
during normally scheduled working hours?
No. Your examination will be scheduled during normal work hours.
You will not be required to take leave to have the examination, nor
will you lose pay or any other benefits.
What will happen to the records of the medical examination results?
The results of your tests and examinations will be available to
the physicians and nurses in this clinic, and possibly to scientists
conducting health studies. The test results will be entered in your
medical records, which will be kept in specially secured files under
the supervision of physicians and nurses in the clinic, separate
from other personnel records. Your test results will be medically
confidential data and will not be released to anyone other than
those listed in the following, unless you provide written
permission. The following groups will have direct access to this
information:
1. Clinic staff members
2. Medical specialists who will provide or arrange for
additional medical treatment or tests, if necessary.
3. U.S. Department of Energy Beryllium Registry staff.
4. The Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health officials may require
direct access to records that identify you by name for health
studies.
If information about you is used in reports or a published
health study, your identity will be disguised. You will not be
identified in any published report or presentation. The results of
your Be-LPT and other screening tests will be made available to you
and, upon your request, to your physician. The information also will
become part of your medical record, which the clinic keeps.
What is the DOE beryllium registry?
Your health and the health of all workers is a major concern to
the Department. There is a need to learn more about chronic
beryllium disease and what causes some individuals to react more
strongly than others. A DOE beryllium registry has been established
to collect and maintain information on workers who are exposed to
long term, low and moderate levels of beryllium. This registry is a
tool which will be used in health studies to better understand the
nature of the disease. With it we can measure the burden of health
effects related to beryllium exposure. The registry will also be
used to evaluate the effectiveness of exposure control programs.
In addition to information about your beryllium related
exposures, the results of beryllium sensitization testing and/or CBD
status collected by your employer will be added to the registry.
Your employer must treat this information as confidential medical
information and can only use or disclose of this information in
conformance with the Privacy Act of 1974, the Americans with
Disabilities Act, or any other applicable law. Personal identifying
information (such as your name and social security number) is
required to link exposure data to the results of the medical testing
and to eliminate duplicate reports for each worker. At no time will
your name or other personal identifying information be published in
any report. The confidentiality of identified information in DOE
records is protected under the Privacy Act of 1974.
What laws protect me if I consent to participating in the screening
program?
State medical and nursing licensing boards enforce codes of
ethics that require doctors and nurses to keep medical information
confidential. The Privacy Act prevents unauthorized access to your
DOE records without your permission. The information in records kept
by your employer must be handled in accordance with the Americans
with Disabilities Act and the Privacy Act of 1974. The consent form
you sign also provides additional protection.
Can my privacy and the confidentiality of my medical records be
guaranteed?
No. Access to or release of records could be required under
court order, or DOE directive, but it is unlikely. If you apply for
another job or for insurance, you may be requested to release the
records to a future employer or an insurance company. If, for
medical reasons, it is recommended that you transfer to an area
where you will not contact beryllium, and you elect to do so, the
personnel department and your supervisor will be notified. They will
not be told the specific results of your tests but, because of the
restrictions, they may assume that your Be-LPT results were
positive.
Do I have to have the Be-LPT done?
No. Your participation in the medical surveillance program is
strictly voluntary. You may refuse any of the tests offered to you
including the Be-LPT. If you change your mind, you are free to
participate in the program at any time. Talking with your family,
your doctor, or other people you trust may help you decide. The
physicians in the clinic that provide the tests can also help answer
any questions that you might have.
[FR Doc. 98-30277 Filed 12-2-98; 8:45 am]
BILLING CODE 6450-01-P
