# Chronic Beryllium Disease Prevention Program

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-30277

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** December 3, 1998
- **Citation:** 63 FR 66940

## Text

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

[[Page 66943]]

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.
---------------------------------------------------------------------------

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

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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 appropri

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-30277. Public record. Not legal advice.