[Federal Register Volume 63, Number 232 (Thursday, December 3, 1998)]
[Proposed Rules]
[Pages 66940-66975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30277]



[[Page 66939]]

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Part III





Department of Energy





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10 CFR Part 850



Chronic Beryllium Disease Prevention Program; Proposed Rule

  Federal Register / Vol. 63, No. 232 / Thursday, December 3, 1998 / 
Proposed Rules  

[[Page 66940]]


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DEPARTMENT OF ENERGY

10 CFR Part 850

[Docket No. EH-RM-98-BRYLM]
RIN 1901-AA75


Chronic Beryllium Disease Prevention Program

AGENCY: Office of Environment, Safety and Health, Department of Energy.

ACTION: Notice of proposed rulemaking and public hearings.

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SUMMARY: The Department of Energy (DOE or the Department) is proposing 
regulations to establish a chronic beryllium disease prevention program 
(CBDPP) to reduce the number of workers currently exposed to beryllium 
in the course of their employment with DOE or its contractors, minimize 
the levels of and potential for exposure to beryllium, and establish 
medical surveillance requirements to ensure early detection and 
treatment of disease. The proposed rule would be applicable to DOE 
Federal and contractor employees and subcontractors during the 
performance of beryllium work at DOE facilities. This action would 
codify the interim program requirements currently prescribed in DOE 
directives and protect the health and safety of workers.

DATES: The comment period for this proposed rule will end on March 9, 
1999. Public hearings will be held on: February 3, 1999, in Oak Ridge, 
TN, from 9:00 a.m. to 1:00 p.m. and 6:00 p.m. to 9:00 p.m.; February 9, 
1999, in Golden, CO (Denver), from 9:00 a.m. to 1:00 p.m. and 6:00 p.m. 
to 9:00 p.m.; and February 11, 1999, in Washington, DC, from 9:00 a.m. 
to 1:00 p.m.
    Requests to speak at any of the hearings should be phoned in to 
Andi Kasarsky, 202-586-3012, by February 1, 1999, for the Oak Ridge, 
TN, hearing; February 5, 1999, for the Golden, CO, hearing; and 
February 10, 1999, for the Washington, DC, hearing. Each presentation 
is limited to 10 minutes.

ADDRESSES: Written comments (ten copies) should be addressed to: 
Jacqueline D. Rogers, U.S. Department of Energy, Office of Environment, 
Safety and Health, EH-51, Docket Number EH-RM-98-BRYLM, 1000 
Independence Avenue, SW, Washington, D.C. 20585. Where possible, 
commenters should identify the specific section to which they are 
responding.
    Copies of the public hearing transcripts, written comments 
received, technical reference materials referred to in this notice, and 
any other docket material may be reviewed and copied at the DOE Freedom 
of Information Reading Room, Room 1E-190, 1000 Independence Avenue, SW, 
Washington, DC 20585 between the hours of 8:30 a.m. and 4:00 p.m., 
Monday through Friday, except Federal holidays. The docket file 
material for this rulemaking will be filed under ``EH-RM-98-BRYLM.'' In 
addition, related prerulemaking docket material is filed under 
``BERYLLIUM STANDARD.'' This material may also be reviewed and copied 
at the DOE Freedom of Information Reading Room at the address noted 
previously. The technical material from the BERYLLIUM STANDARD docket 
file may also be reviewed at the DOE Rocky Flats Freedom of Information 
Reading Room and the DOE Oak Ridge Public Reading Room.
    The public hearings for this rulemaking will be held at the 
following addresses:

Oak Ridge, TN: The American Museum of Science and Energy, 300 South 
Tulane Avenue, Auditorium, Oak Ridge, TN 37830
Golden, CO (Denver): National Renewable Energy Laboratory, Visitor 
Center, Auditorium, 15013 Denver West Parkway, Golden, CO 80401 (I-70, 
Exit 263, right at top of exit ramp if coming from Denver, left at stop 
sign, building on right)
Washington, DC: U.S. Department of Energy, Room 1E-245 (first floor, E 
corridor), 1000 Independence Avenue, SW, Washington, DC 20585

    For more information concerning public participation in this 
rulemaking proceeding, see Section VIII of this notice (Public Comment 
Procedures).

FOR FURTHER INFORMATION CONTACT: Jacqueline D. Rogers, U.S. Department 
of Energy, Office of Environment, Safety and Health, EH-51, 1000 
Independence Avenue SW, Washington, DC 20585, 301-903-5684 or Edward 
LeDuc, U.S. Department of Energy, Office of General Counsel for 
Environment, 1000 Independence Avenue SW, Washington, DC 20585, 202-
586-6947.
    For information concerning the public hearings, requests to speak 
at the hearings, submittal of written comments, or to obtain copies of 
materials referenced in this notice, contact: Andi Kasarsky, 202-586-
3012.

SUPPLEMENTARY INFORMATION:

I. Overview
II. Legal Authority and Relationship to Other Regulatory Programs
III. Chemical Identification and Use
IV. Health Effects
    A. Introduction
    B. Chronic Beryllium Disease
    C. Beryllium Exposures at DOE Operations
    D. Epidemiology
    E. Value of Early Detection
V. Request for Information
VI. Section-by-Section Analysis
    A. Subpart A--General Provisions
    B. Subpart B--Administrative Requirements
    C. Subpart C--Specific Program Requirements
VII. Procedural Requirements
    A. Review Under Executive Order 12866
    B. Review Under the Regulatory Flexibility Act
    C. Review Under the Paperwork Reduction Act
    D. Review Under the National Environmental Policy Act
    E. Review Under Executive Order 12612
    F. Review Under Executive Order 12988
    G. Review Under the Unfunded Mandates Reform Act of 1995
VIII. Public Comment Procedures
    A. Written Comments
    B. Public Hearings
Appendix--References

I. Overview

    The Department of Energy (DOE) has a long history of beryllium use 
because of the element's broad application to many nuclear operations 
and processes. Beryllium metal and ceramics are used in nuclear 
weapons, as nuclear reactor moderators or reflectors, and as nuclear 
reactor fuel element cladding. At DOE, beryllium operations have 
historically included foundry (melting and molding), grinding, and 
machine tooling of parts.
    Inhalation of beryllium dust or particles causes chronic beryllium 
disease (CBD) and beryllium sensitization. CBD is a chronic, often 
debilitating, and sometimes fatal lung condition. Beryllium 
sensitization is a condition in which a person's immune system becomes 
highly responsive (allergic) to the presence of beryllium in the body. 
There has long been scientific consensus that exposure to airborne 
beryllium is the only cause of CBD.
    As of June 1998, 110 workers have been diagnosed with CBD, and 
another 232 workers have become sensitized to beryllium from among the 
8,951 current and former DOE Federal and contractor workers who were 
screened for the disease. DOE anticipates an increase in the number of 
workers who may be exposed to beryllium as the Department moves forward 
with deactivating and decommissioning former nuclear weapons production 
facilities.
    The current worker protection permissible exposure limit (PEL) of 2 
g/m3, measured as an 8-hour, time-weighted average 
(TWA), was adopted by the Occupational Safety and Health Administration 
(OSHA) as codified in 29 CFR 1910.1000 Tables Z-1, Z-2 and Z-3 in 1971 
by reference to existing

[[Page 66941]]

national consensus standards. This limit of 2 g/m3 
was set by DOE and its predecessor agencies, the Energy Research and 
Development Administration (ERDA) and the Atomic Energy Commission 
(AEC), for application at their facilities in 1949. Between the 1970s 
and 1984, there was a significant reduction in the incidence rate of 
the disease. This, coupled with the long latency period for the 
disease, led to the assumption that CBD was occurring only among 
workers who had been exposed to high levels of beryllium decades 
earlier (e.g., in the 1940's). However, DOE medical surveillance 
programs are discovering cases of CBD among workers who were first 
exposed after 1970, when DOE facilities were expected to maintain 
worker exposure to beryllium at levels below the OSHA PEL.
    The number of confirmed cases of CBD, data suggesting the 
occurrence of CBD among workers with low-level exposures, and the 
expected future increase in the number of workers potentially exposed 
to beryllium all indicate a need for more aggressive workplace controls 
to minimize worker exposure to beryllium in the DOE complex. 
Accordingly, DOE has developed this notice of proposed rulemaking 
(NOPR) to establish a performance-based approach to protecting DOE 
Federal and contractor employees from the adverse health effects 
resulting from occupational exposure to beryllium and preventing cases 
of CBD resulting from DOE operations. DOE proposes to accomplish this 
goal through the implementation of a comprehensive chronic beryllium 
disease prevention program (CBDPP), which is designed to reduce the 
number of workers exposed, minimize the levels of beryllium exposure 
and the potential for beryllium exposure, and establish medical 
surveillance protocols to ensure early detection of disease. Because 
the occupational health community, including OSHA and the American 
Conference of Governmental Industrial Hygienists (ACGIH), does not at 
this time have sufficient exposure and health effects data to establish 
a new 8-hour TWA exposure limit for beryllium exposure, DOE is instead 
including in the proposed regulation a short-term exposure limit (STEL) 
of 10 g/m\3\ for small-scale, short-duration operations, an 8-
hour TWA action level of 0.5 g/m\3\ for triggering certain 
precautions and control measures, and an exposure reduction and 
minimization requirement that will encourage contractors to reduce 
potential exposures to the action level or below. This combined 
approach should provide a reasonably safe and achievable added layer of 
protection to beryllium workers in view of data, which suggest that CBD 
or beryllium sensitization has occurred at exposures of 2 g/
m\3\ or less, and in view of the related scientific uncertainty with 
respect to the adequacy of the existing PEL. In addition to these 
immediate efforts, DOE intends to adopt a revised OSHA PEL for 
beryllium if OSHA rulemaking efforts for beryllium conclude that a new 
PEL for beryllium is appropriate. DOE acknowledges that Great Britain, 
which also employs a 2 g/m\3\ 8-hour TWA PEL, has experienced 
a minimal number of CBD cases among its exposed work force. The 
Department recognizes that the difference between DOE's and Great 
Britain's experiences with the occurrence of CBD may be indicative of 
the use of more stringent work practice controls at Great Britain's 
facilities. DOE believes, however, that the fortified approach set 
forth in the proposed regulation will work towards eradicating CBD 
within the Department.
    DOE contractors are already required, under DOE Order 440.1A, 
Worker Protection Management for DOE Federal and Contractor Employees, 
to have general worker protection programs. DOE Order 440.1A contains a 
set of minimum general requirements that establish the framework for 
the worker protection program. The proposed rule would enhance and 
supplement these existing programs with hazard-specific provisions to 
manage and control beryllium exposure hazards.
    This proposed CBDPP rulemaking initiative has been preceded by 2 
years of information-gathering and data analysis by the Department. In 
1996, the Department surveyed its contractors to characterize the 
extent of beryllium usage, the types of tasks involving beryllium 
usage, the controls in place for each task, the estimated number of 
workers exposed during each task, and the estimated exposure levels 
associated with each task.
    In summary, this survey found that between 1994 and 1996, 10 of the 
15 DOE sites surveyed performed 64 different operations or processes 
that could expose workers to beryllium. The surveyed DOE sites 
estimated that between 518 and 530 workers in 58 different job 
categories were potentially exposed to beryllium in the performance of 
these 64 operations or processes. Where available, reported 8-hour TWA 
exposure data (personal breathing zone monitoring results) for these 
workers ranged from nondetectable to 25 g/m\3\. Most of these 
exposure levels were reported to be below the 2 g/m\3\ 8-hour 
TWA PEL. To control worker exposures in the affected processes or 
operations, the surveyed sites reported the use of various engineering 
and administrative controls, including ventilation hoods, glove boxes, 
wet machining methods, high-efficiency particulate air (HEPA) vacuums, 
regulated areas, action levels and administrative warning levels, and 
personal protective equipment. Copies of this survey are available for 
review and copying at the DOE headquarters, Rocky Flats, and Oak Ridge 
Public Reading Rooms (see the ADDRESSES section of this NOPR for 
addresses and details) as part of the prerulemaking docket filed under 
BERYLLIUM STANDARD.
    To supplement the data obtained from the 1996 survey, the 
Department published a Federal Register notice on December 30, 1996, 
requesting scientific data, information, and views relevant to a DOE 
beryllium health standard (61 FR 68725). The survey and Federal 
Register notice were followed by two Beryllium Public Forums, held in 
Albuquerque, New Mexico, and Oak Ridge, Tennessee, in January 1997. 
Responses to the Federal Register notice and the proceedings of the 
public forums are also available in the ``BERYLLIUM STANDARD'' docket 
file.
    Acting on the information compiled from these various sources, and 
in view of the time needed to promulgate a rule, former Secretary of 
Energy Pena directed the Office of Environment, Safety and Health to 
publish a new DOE policy to protect the workforce while the Department 
moved forward with its rulemaking process. DOE Notice 440.1, Interim 
Chronic Beryllium Disease Prevention Program, was signed by former 
Secretary Pena and issued on July 15, 1997. The Department decided to 
issue the interim Notice to direct immediate action for the protection 
of workers while the rulemaking efforts continued. This interim Notice 
established a CBDPP that enhanced and supplemented worker protection 
programs already required by DOE Order 440.1A with hazard-specific 
provisions that are designed to manage and control beryllium exposure 
hazards in the DOE workplace.
    Because of the complexity and significance of issues regarding the 
development of a DOE health standard for beryllium, former Secretary 
Pena also established the Beryllium Rule Advisory Committee (BRAC) in 
June 1997 to advise the Department on issues pertinent to the proposed 
rulemaking activity. The BRAC, which consisted of a diverse set of 
stakeholders and

[[Page 66942]]

recognized experts from DOE, other Federal agencies, industry, labor, 
medicine, and academia, generated a set of recommendations for 
consideration in the development of a CBDPP rule.\1\
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    \1\ BRAC recommendations were made by individual members and 
groups of members, not by majority vote. They were generated by the 
facilitated process used during the meetings and were not adopted by 
the committee as consensus opinions. For convenience of reference 
these recommendations are referred to as the ``BRAC 
recommendations.''
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    DOE used the BRAC recommendations and the lessons learned in the 
implementation of DOE Notice 440.1 to develop this NOPR. Consistent 
with the Department's worker protection philosophy and the BRAC 
recommendations, the objectives of this proposed rule are to: (1) 
Minimize the number of workers exposed to beryllium; (2) minimize the 
levels of beryllium exposure and the potential for beryllium exposure; 
(3) establish medical surveillance protocols to ensure early detection 
of CBD; and (4) assist affected workers who are dealing with beryllium 
health effects. In addition, the Department intends to collect and 
analyze as appropriate the resulting exposure and health data as part 
of its ongoing beryllium-related research efforts to ensure the 
protection of workers' health. DOE will consider the desirability of 
amendments to its regulations as additional information and feedback 
are collected.
    This proposed rule is not being promulgated as a nuclear safety 
requirement as defined in 10 CFR part 820, Procedural Rules for Nuclear 
Activities. Any radiological implications of the two radioisotopic 
forms of beryllium would be addressed under the provisions of 10 CFR 
part 835, Occupational Radiation Protection.

II. Legal Authority and Relationship to Other Regulatory Programs

    The Department of Energy has broad authority as provided by the 
Atomic Energy Act, 42 U.S.C. 2201(i)(3) and (p) to develop generally 
applicable policies covering all aspects of defense nuclear facilities, 
including protection of the health of workers. Under the Atomic Energy 
Act, DOE may impose requirements on its contractors either by 
regulation, or by administrative directive (orders and notices) that 
are made binding through incorporation into DOE contracts.
    DOE contractors currently are required by DOE Order 440.1A, Worker 
Protection Management for DOE Federal and Contractor Employees, to have 
general worker protection programs. Additionally, on July 15, 1997, 
former Secretary Pena issued DOE Notice 440.1, Interim Chronic 
Beryllium Disease Prevention Program, to supplement the general worker 
protection programs with provisions specifically aimed at the hazards 
of beryllium in the DOE work place. Implementation of the interim 
Notice depended upon negotiation with DOE contractors to include 
compliance with Notice 440.1 as a term of their contracts, or their 
agreement voluntarily to comply.
    As discussed in the Overview section of this preamble, former 
Secretary Pena established a Beryllium Rule Advisory Committee in June 
of 1997 to assist DOE to develop a rule to establish permanent Chronic 
Beryllium Disease Prevention Program provisions that would apply to all 
covered DOE contractors and employees. The Department's decision to use 
rulemaking to establish a CBDPP requirement is based on the need for 
consistency in the implementation of particular CBDPP requirements and 
a desire to give all potentially affected persons and institutions a 
meaningful opportunity to provide information and views on the proposed 
program. Without a DOE rule, DOE contractors would be obligated to 
bargain about such provisions with the organizations representing the 
contractors' employees for purposes of collective bargaining. That 
approach would likely produce inconsistent outcomes in areas such as 
worker exposure monitoring and medical surveillance. DOE believes a 
rule or regulation would result in more uniform implementation across 
the DOE complex and, thus, improve worker protection and the quality of 
information generated regarding the health effects of exposure to 
beryllium.
    DOE recognizes that it may be necessary in the future to amend its 
CBDPP regulations if other Federal agencies promulgate rules governing 
worker exposure to beryllium. Although DOE facilities currently are 
exempt from regulation by the Occupational Safety and Health 
Administration (OSHA), DOE routinely adopts OSHA health standards, as a 
matter of policy. DOE is aware that OSHA plans to initiate a rulemaking 
to examine, and possibly revise, their current health standard for 
beryllium. Additionally, DOE is working with the Congress on plans to 
eventually transfer responsibility for regulating health and safety at 
DOE facilities to another Federal agency (probably OSHA). In light of 
the uncertain timing of future actions by OSHA or another external 
regulator, and the present and potential risk to workers at DOE 
facilities from beryllium exposure, DOE has decided to proceed with 
this rulemaking now. However, considering OSHA's decision to examine 
the health standard for beryllium, DOE proposes (in proposed section 
850.22, Exposure Limits) to express the permissible exposure limit 
(PEL) as 2 ug/m\3\ calculated as an 8-hour TWA exposure, as measured in 
the worker's breathing zone, or any more stringent limit that OSHA may 
promulgate pursuant to section 4(b)(1) of the OSH Act. This language 
would permit DOE to continue its policy of requiring compliance with 
OSHA health standards without conducting notice and comment rulemaking 
to amend these regulations.

III. Chemical Identification and Use

    Beryllium (atomic number 4) is a silver-gray metal with a density 
of 1.85 g/cm3 and a high stiffness. Beryllium is found in 
the earth's surface in about 45 minerals. Bertrandite 
(Be4Si2O7[OH]2) is the 
major source of beryllium; other important beryllium-containing 
materials include beryl 
(3BeO.Al2O36.SiO2), chrysoberyl 
(BeAl2O4), and phenacite (BeSiO4). The 
alloying property of beryllium confers on metals specific properties of 
resistance to corrosion, vibration, and shock; beryllium can also 
improve alloy hardness and ductility. For example, the addition of only 
2 percent or less beryllium to copper forms an alloy with high strength 
and hardness. Few other copper alloys are capable of this type of 
strengthening.
    Because of their strength, formability, thermal and electrical 
conductivities, magnetic transparency, and corrosion resistance, 
beryllium alloys (especially beryllium-copper) are used extensively in 
industries such as automotive, electronics, aerospace, and defense. In 
electronics, for example, beryllia ceramics provide good electrical 
insulators with superior thermal conductivity to remove heat. 
Beryllium's low neutron absorption, high neutron scattering 
characteristics, and ability to multiply neutrons have led to its use 
in experimental nuclear reactors and nuclear weapons.

IV. Health Effects

A. Introduction

    Chronic beryllium disease (CBD) is a disease of the lungs. CBD is 
caused by the body's reaction to inhaled beryllium dust or fumes. The 
time in which an individual may develop CBD may vary from several 
months to many years after exposure to beryllium. The body's reaction 
to beryllium is often called ``sensitization.'' Sensitization means 
that beryllium specific lymphocyte

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proliferation testing has demonstrated that an individual is able to 
mount a cell mediated immune response to beryllium. Data suggest that 
even brief or small exposures can lead to CBD. Beryllium is also 
classified as a human carcinogen (cancer-causing agent) by the 
International Agency for Research on Cancer (IARC) and by the American 
Conference of Governmental Industrial Hygienists (ACGIH).
    Symptoms of CBD include one or more of the following: cough, 
difficulty breathing, fever, night sweats, fatigue, weight loss, or 
appetite loss. On physical examination, a doctor may find signs of CBD, 
such as changes in lung sounds, fever, and weight loss. A radiograph 
(X-ray) of the lungs may show many small scars. There may also be an 
abnormal breathing test, pulmonary function tests, and a blood test, 
the beryllium-induced lymphocyte proliferation test (Be-LPT). 
Examination of lung tissue under the microscope may show granulomas, 
which are signs of damage due to the body's reaction to beryllium. CBD 
may be confused with other lung diseases, especially sarcoidosis.
    Patients with CBD can be treated with medication and, in more 
serious cases, with oxygen. Patients who are sensitized to beryllium do 
not need medical treatment, but they must be checked regularly for 
signs or symptoms of CBD. CBD cannot be cured. Severe CBD may be very 
disabling.

B. Chronic Beryllium Disease

    Chronic beryllium disease is a granulomatous disease affecting 
primarily the lungs, although systemic involvement may also occur. 
Exposure occurs via inhalation of beryllium metal or insoluble 
beryllium salts. Beryllium is a hapten (a substance that provokes an 
immune response only when combined with another substance, generally a 
protein) that binds to peptides on mucosal surfaces. In susceptible 
individuals the beryllium-peptide complex initiates an immune response, 
which may progress ultimately to granuloma formation in the pulmonary 
interstitium. Data have suggested that CBD occurs at relatively low 
exposure levels and, in some cases, after relatively brief durations of 
exposure. The typical latency period is 5 to 10 years, but it varies 
from several months to 30 years or more.
    Frequently reported symptoms include dyspnea on exertion, cough, 
chest pain and, less frequently, arthralgias, fatigue, and weight loss. 
Physical examination may be normal or it may reveal rales, cyanosis, 
digital clubbing, or lymphadenopathy. In advanced cases, there may be 
manifestations of right-sided heart failure, including cor pulmonale.
    The peripheral blood beryllium-induced lymphocyte proliferation 
test (Be-LPT) is used to detect in vitro the immunologic response of 
human lymphocytes to beryllium. A positive Be-LPT indicates 
sensitization to beryllium-containing antigens. A diagnostic evaluation 
by means of bronchoscopy with bronchoalveolar lavage (BAL) and 
transbronchial biopsy is indicated. The presence of granulomata in the 
lung in a patient with a positive lung Be-LPT is diagnostic of CBD. In 
the absence of granulomata or other clinical evidence of CBD, 
individuals with positive Be-LPTs are classified as sensitized to 
beryllium.
    The rate of progression from sensitization to disease is unknown. 
Once sensitization has occurred, it is medically prudent to prevent 
additional exposure to beryllium. However, this measure has not been 
shown to prevent or delay the progression of sensitization to CBD.
    The clinical course of CBD is highly variable. Some individuals 
deteriorate rapidly; most experience long, gradual deteriorations. 
Treatment consists of oral corticosteroid therapy. Individuals with 
impaired respiratory gas exchange may require continuous oxygen 
administration.
    Individuals sensitized to beryllium are asymptomatic and not 
disabled. Individuals with CBD have clinical illness varying from mild 
to severe. In severe cases, the affected individuals may be permanently 
and totally disabled. Mortality directly attributable to CBD and its 
complications is estimated to be 30 percent (ref.1).\2\ The mortality 
estimate of 30% is based upon historical data reflecting both the 
higher levels of exposure that occurred in the workplace prior to 
regulation of workplace exposure in the late 1940s and a tracking of 
the medical history of subjects of CBD over several decades. DOE's more 
recent experience suggests a lower mortality rate of 3% for CBD cases.
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    \2\ A listing of references is included at the end of the 
preamble to this Notice of Proposed Rulemaking.
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C. Beryllium Exposures at DOE Operations

    Personal monitoring of occupational exposures to beryllium was not 
widely adopted at DOE sites until the 1980s. Prior to the 1980s many 
sites relied on area monitoring to assess occupational exposures to 
beryllium. However, these have been shown to significantly 
underestimate actual exposure levels. Since 1984, personal sampling 
data have provided more precise information on occupational exposure to 
beryllium at DOE sites.
    Available personal sampling data provides a clear indication of the 
low levels of beryllium exposure which can be achieved in both 
fabrication and machining operations and decommissioning and 
decontamination projects when effective control strategies are 
implemented. Most beryllium fabrication and machining operations at DOE 
to date have been at the Rocky Flats facility and at the Y-12 plant in 
Oak Ridge. Over time, engineering improvements and advanced control 
strategies have significantly reduced occupational beryllium exposure 
levels in these operations.
    Since 1980, and continuing through 1996, about 1600 personal 
samples have been collected at the Oak Ridge Y-12 Plant (Table 1). 
These samples were taken at several different Y-12 operations with a 
bias toward sampling those jobs where exposure potential was greatest 
or where previous monitoring results were high. Despite this bias, over 
two thirds of sample results were below the limit of detection of 0.1 
g/m3 (usually reported as ``none detected'').

            Table 1.--Oak Ridge Y-12 Plant Personal Sampling
------------------------------------------------------------------------
                                       1980-1989           1990-1996
------------------------------------------------------------------------
Number of samples...............  148...............  1448.
Arithmetic Mean.................  0.9 g/m3.  0.3 g/m3.
Percent of samples less than 2    94%...............  98%.
 g/m3.
------------------------------------------------------------------------

    These data are from beryllium operations that are associated with 
cases of chronic beryllium disease. The facilities where these 
operations take place have not been remodeled since the 1970s. 
Increased monitoring in the 1990s led to investigations of exceedences 
over the existing exposure limit and resulted in changes to work 
practices that contributed to the high readings. This focus on levels 
exceeding the limit also led to a significant reduction in average 
exposure levels.
    Personal sampling data from the Rocky Flats Building 444 Beryllium 
Machine Shop (Table 2) collected in 1984-85 and after extensive 
remodeling to the ventilation system in 1986 illustrate the impact and 
effectiveness of engineering modifications to control exposure.

[[Page 66944]]



   Table 2.--Rocky Flats Building 444 Beryllium Machine Shop Personal
                              Sampling Data
------------------------------------------------------------------------
                                       1984-1985             1986
------------------------------------------------------------------------
Number of Samples...............  99................  279.
Arithmetic Mean.................  1.19 g/    0.035 g/
                                   m\3\.               m\3\.
Percent of samples less than 2    84%...............  99.6%.
 g/m\3\.
------------------------------------------------------------------------

    The samples collected in 1984 were the first personal samples 
collected in this shop following the discovery of a case of CBD that 
year. Controls in that machine shop had previously been judged to be 
adequate based on area monitoring. In addition to the extensive 
remodeling of the ventilation system in the shop to minimize leakage 
from hoods, operations performed outside of hoods were eliminated to 
the extent possible. The decision to implement improved engineering 
controls in this shop reduced average exposure levels by a factor 
greater than 30 to levels approaching 1% of the limits established by 
the existing PEL.
    A final example, taken from personal sampling data collected during 
decontamination of Rocky Flats buildings 865 and 867 in 1995-1996, 
further demonstrates the low levels of beryllium exposure which can be 
achieved through effective control planning (See Table 3). Each worker 
was sampled during each work shift during this time period.

 Table 3.--Decontamination of Rocky Flats Buildings 865 and 867 Personal
                           Sampling, 1995-1996
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Number of Samples.........................  7673.
Arithmetic Mean...........................  0.03 g/m\3\.
Percent of samples less than 2 g/  99.8%.
 m\3\.
------------------------------------------------------------------------

    As can be seen from the foregoing examples, Rocky Flats machining 
and D&D operations achieved an exceptional level of exposure control.
    While the application of controls eliminates predictable sources of 
exposure, there still can be large day-to-day variations in exposure. 
The exposures that remain are likely to reflect accidents, equipment 
failures, or poor work planning. Meeting exposure minimization goals 
will require planning to limit the potential for such occurrences and 
monitoring to detect those that do occur so they can be investigated 
and prevented from reoccurring.
    The personal monitoring results at Rocky Flats and Y-12 indicate 
that most exposures are very low with a few exceptions. These 
exceptions account for much of the total exposure that workers receive.

D. Epidemiology

    The first evidence of the existence of chronic beryllium disease 
(CBD) was reported in a 1946 paper by Hardy and Tabershaw (ref. 2). The 
paper described ``delayed chemical pneumonitis'' among fluorescent lamp 
workers exposed to beryllium compounds. The differential diagnosis 
included tuberculosis and sarcoidosis, an immune disease of unknown 
etiology.
    There were also reports of CBD in individuals without known 
occupational exposure to beryllium. Under the direction of Dr. Thomas 
Mancuso, 16 cases of CBD were diagnosed (by X-ray examination) among 
20,000 residents living near a beryllium production facility in Lorain, 
Ohio (ref. 3). Likewise, a 1949 report described 11 patients with CBD 
who lived near a beryllium extraction plant (ref. 4). Ten of these 11 
lived within \3/4\ of a mile of the plant, and exposure from plant 
discharges into the air was the suggested cause for their CBD. 
Measurements of air concentrations of beryllium at various distances 
from the plant provided the basis for the Environmental Protection 
Agency's (EPA's) community permissible exposure limit (24-hour ambient 
air limit of 0.01 microgram of beryllium per cubic meter of air 
[g/m\3\]).
    In addition, CBD has been reported among family members of 
beryllium workers who were presumably exposed to contaminated work 
clothing during the 1940's and 1950's (refs. 5, 6). The virtual 
disappearance of CBD as a result of air pollution or household 
exposures has been attributed to more stringent control of air 
emissions and improved work practices, such as mandatory work clothing 
exchange. This reduction in disease incidence is also attributed to 
improvements in diagnostic testing (ref. 7). However, as recently as 
1989, a woman previously diagnosed with sarcoidosis was diagnosed with 
CBD. She had no occupational exposure, but her husband was a beryllium 
production worker. This is the first new case of non-occupational CBD 
reported in 30 years.
    Sterner and Eisenbud suggested that CBD was a highly selective 
immunologic response. Their conclusion was based on epidemiologic 
evidence that (1) severe cases have occurred at low exposure; (2) the 
level of beryllium contained in tissue did not correlate with the 
extent of the disease; (3) there was a correlation between disease and 
low atmospheric concentration, but not high concentrations; (4) the 
onset of symptoms could occur years after the termination of exposure; 
and (5) pulmonary lesions were not easily reproduced in animals (ref. 
6).
    A registry of production plant CBD cases was started at Columbia 
University in 1947. A second registry of phosphor-lamp CBD cases was 
started around the same time. In 1952, a Beryllium Case Registry was 
established at the Massachusetts Institute of Technology (MIT) where 
files from the other beryllium registries were consolidated. The 
consolidated Beryllium Case Registry was moved to Massachusetts General 
Hospital in the 1960's and ultimately relocated to the National 
Institute for Occupational Safety and Health (NIOSH) in 1978. At that 
time, the Beryllium Case Registry contained 622 cases of CBD, 224 cases 
of acute beryllium disease, and 44 acute cases that developed into CBD. 
Twenty-three cases were attributed to household exposures and 42 to air 
pollution (ref. 5). The Beryllium Case Registry, which is now inactive, 
was criticized as deficient in acquiring data on cases, identifying 
populations at risk (denominator data), maintaining follow up of 
questionable cases, and obtaining exposure data (ref. 8).
    According to criteria utilized by the Beryllium Case Registry, the 
diagnosis of CBD included at least four of the following six criteria 
with one of the first two conditions required: (1) the establishment of 
beryllium exposure based on occupational history or results of air 
samples, (2) the presence of beryllium in lung tissue or thoracic lymph 
tissue or in the urine, (3) evidence of lower respiratory tract disease 
and a clinical course consistent with beryllium disease, (4) 
pathological changes consistent with beryllium disease on examination 
of lung tissue or thoracic lymph nodes, (5) radiologic evidence of 
interstitial lung disease, and (6) decreased pulmonary function tests 
(ref. 9).
    The beryllium-induced lymphocyte proliferation test (Be-LPT) in 
blood and bronchoalveolar lavage (BAL) fluid has allowed early 
identification of the disease and is one of the criteria required for 
diagnosis (refs. 10-12). Beryllium has been found to act as a specific 
antigen, causing proliferation and accumulation of beryllium-specific 
helper T lymphocytes (CD4) in the lung (ref. 13). Current data suggest 
that the peripheral blood Be-LPT is a specific and sensitive method for 
testing

[[Page 66945]]

beryllium sensitivity (ref. 10). The presence of granulomatous tissue 
in the lung along with a positive BAL Be-LPT is considered definitive 
evidence for diagnosis of CBD (ref. 11). Probable CBD is also diagnosed 
based on signs and symptoms of CBD and a positive blood Be-LPT when 
bronchoscopy is not indicated or is refused.
    An article published by Cullen et al. in 1987 reported on cases of 
CBD among precious-metal refinery workers (ref. 14). In 1993, 
researchers at the National Jewish Medical and Research Center (NJMRC) 
published two reports on epidemiologic studies that were designed to 
determine the incidence of CBD among beryllium workers and the value of 
the Be-LPT in detecting CBD (refs. 15, 16). One study was conducted at 
DOE's Rocky Flats Environmental Technology Site (Rocky Flats). The 
three epidemiologic studies showed that CBD incidence among exposed 
workers was the same as had been reported among workers exposed in the 
1940's, when the disease was first recognized. These were the first 
studies of exposed workers since the adoption of the current 
Occupational Safety and Health Administration (OSHA) 8-hour, time-
weighted average (TWA) permissible exposure limit (PEL) of 2 
g/m\3\. The exposure limit was originally derived by analogy 
to other toxic metals (ref. 17). A decline in the number of reports of 
CBD led to the assumption that the 2 g/m\3\ limit had been 
effective in preventing CBD (ref. 5). It is now clear that these 
standards have not eliminated the incidence of disease.
    In 1991, following the NJMRC study, the DOE Office of Environment, 
Safety and Health initiated a beryllium worker health surveillance 
program at Rocky Flats to provide medical screening to current and 
former beryllium workers who had not participated in the earlier NJMRC 
study. In addition, the Office of Environment, Safety and Health 
initiated a study at the Oak Ridge Y-12 Plant (Y-12) in 1991 to learn 
if the NJMRC findings on CBD incidence and the effectiveness of the Be-
LPT could be replicated. Results to date confirm NJMRC findings that 
CBD incidence rates are high and that the Be-LPT is an effective 
screening test for CBD as shown in Table 4.

Table 4.--Results of Medical Screening of Beryllium-Exposed Workers at 3
                     DOE Sites Through December 1997
------------------------------------------------------------------------
                                       Rocky Flats      Y-12      Mound
------------------------------------------------------------------------
Individuals Examined.................        6257         1949       632
Abnormal Be-LPT, Number (percent)....    221 (3.5)       77 (4)     \1\1
Completed Diagnostic Exams...........         186           33         0
CBD\2\ Number (percent)..............  79\3\ (1.3)  25\4\ (1.3)       0
------------------------------------------------------------------------
\1\ The one Mound employee who was found to be consistently positive
  declined to go on for diagnostic testing. Four others had one positive
  blood test result and were awaiting retesting.
\2\ Includes 44 cases confirmed through biopsy and testing of lavage
  cells and 35 presumptive cases in which the pulmonologist diagnosed
  CBD but biopsy and/or lavage could not be completed.
\3\ Includes 56 cases found through the surveillance program since 1991,
  17 through the 1987-1991 NJMRC study, and 6 between 1984 and 1987 for
  a total of 79 CBD cases. Six of the 79 cases had consistently normal
  Be-LPT results and were identified through lung disease symptoms or
  abnormal chest X-rays.
\4\ Includes 17 cases found in the surveillance program since 1993, 2
  found in 1991 among beryllium workers who had been diagnosed with
  other lung diseases, and 6 cases found by the site clinic in 1993
  among 146 currently exposed beryllium workers provided the Be-LPT.

    In 1996, three studies reported on exposure to beryllium associated 
with CBD and immunologic sensitization to beryllium (refs. 18-20). Two 
of the studies reported on cases of CBD at Rocky Flats (refs. 18, 19). 
The third reported on an epidemiology study of a private sector 
beryllia ceramics fabrication plant that began operating in 1981 (ref. 
20). Both Rocky Flats and the ceramics plant were extensively monitored 
for compliance with the current OSHA 8-hour TWA exposure standard of 2 
g/m\3\. The authors concluded that exposures among the highest 
exposed groups in the plants were, on average, below the 2 g/
m\3\ limit. At both plants, cases of CBD and sensitization to beryllium 
were found among administrative and other personnel, whose average 
exposures were lower, as well as among the more highly exposed workers.
    Stange and colleagues reported on the findings of a health 
surveillance program at Rocky Flats that used the Be-LPT to screen for 
CBD (ref. 18). Of 97 individuals who tested positive on the Be-LPT, 28 
were found to have CBD. The article included an analysis of the work 
histories of these 97 current and former workers. A qualitative 
exposure estimate based on the work histories of individuals who 
developed CBD concluded that exposures varied by more than an order of 
magnitude. Extensive air monitoring data were available for one of the 
highest exposed groups, machinists.
    Barnard and colleagues completed an extensive analysis of the 
monitoring data associated with machining operations at Rocky Flats 
(ref. 19). Prior to 1984, air monitoring was accomplished with fixed 
area monitors located near the machine tools that were thought to be 
the primary sources of emissions into the work rooms. In 1984, personal 
sampling was initiated, which was more representative of individual 
exposure. The article reported a high degree of uncertainty in exposure 
assessments prior to 1984 due to the lack of correlation between area 
monitoring and personal monitoring. The authors concluded that 
machinists, as a group, shared similar exposure potential, that average 
exposures were less than but near the 2 g/m\3\ limit, and that 
excursions above the limit were common.
    Kreiss and colleagues studied CBD occurring in a beryllium oxide 
ceramics manufacturing plant (ref. 20). They found that machinists had 
the highest incidence rate of beryllium sensitization and the highest 
exposure potential. The area monitoring conducted in this plant was 
aimed at estimating exposures associated with job titles and was found 
to correlate with personal sampling. The authors concluded that ``the 
existing data suggests that the machining exposures resulting in the 
14.3 odds ratio for beryllium sensitization were largely within those 
permitted by current regulations.'' This article confirmed the findings 
of a study of CBD in the neighborhood of a beryllium extraction plant, 
which showed a correlation between ambient beryllium levels and 
incidence of CBD (ref. 4). Further analyses of CBD incidence at Rocky 
Flats, as yet unpublished, showed a similar higher risk for machinists 
compared to that for other workers (See Table 5).

[[Page 66946]]



             Table 5.--Incidence Rates of CBD at Rocky Flats
------------------------------------------------------------------------
                                                              Incidence
         Job category \1\             Number     CBD cases       rate
                                      tested                  (percent)
------------------------------------------------------------------------
Beryllium Machinist..............          223           21          9.4
Administrative...................        1,903           23          1.2
Professional.....................        1,396           15          1.1
All Employees Tested.............        6,254           64         1.0
------------------------------------------------------------------------
\1\ Many employees held more than one job title.

    Cases of CBD have occurred in machinists who worked in the Y-12 
beryllia ceramic machine shop, where levels have been quite low. Only a 
small percentage of samples have detected beryllium. Applying a 
nonparametric tolerance limit test to 1980 and 1990 personal sampling 
results from this shop shows, with 95 percent confidence, that 90 
percent of exposures were lower than the detection limit (0.1 
g/m\3\ in the 1980-1990 timeframe). Only one of several 
hundred personal samples was over the 2 g/m\3\ limit. 
Continuous area air monitors have operated in the shop throughout its 
existence. One area sample indicated levels above 2 g/m\3\ 
when a machine tool was operated with a disconnected exhaust duct. No 
other area measurement above 2 g/m\3\ were recorded, and the 
median measurement was at the level of detection.
    Several authors have highlighted the uncertainty that exists in the 
exposure assessments (refs. 19-21). The chemical composition of the 
beryllium materials used and the particle size distribution of the 
aerosol created by the work operation affect the bioavailability of 
beryllium, and neither is accounted for by current personal sampling 
and analytical methods. It is not known what percentage of the 
beryllium that is being measured in air is capable of reaching the 
regions of the lung where the health effect occurs. In addition, area 
monitoring used in the past does not correlate with the personal 
monitoring that is thought to be more representative of exposure (refs. 
19, 21).
    Epidemiologic investigations to date have failed to show whether 
the time course of exposure (dose rate) is biologically significant. 
High day-to-day variation in exposure level and excursions above the 2 
g/m\3\ limit have occurred in all groups studied. Excursions 
make up a significant contribution to individuals' total doses, 
confounding attempts to understand if dose rate is an important risk 
factor. Beryllium oxide and metal in the lung dissolve slowly over a 
period of months and years (ref. 22), producing the beryllium ion that 
elicits an immune response (ref. 23). The persistent presence of the 
beryllium ion in the lung makes CBD a chronic disease (ref. 24). Either 
intermittent or chronic exposure to less soluble forms of beryllium can 
create and maintain a lung burden that will not clear for many years, 
if at all (ref. 25).
    Certain individuals are more susceptible to CBD than others. It has 
long been suspected that genetic predisposition plays an important role 
in determining who will develop CBD. Recent advances in genetics and 
immunology have made it possible for researchers to investigate the 
basis for CBD and to identify a genetic component (ref. 26).
    Differences in individual susceptibility have made it difficult to 
understand the relationship between exposure and CBD. Early 
epidemiologic studies detected similar disease rates among high- and 
low-exposure occupational groups (Table 6). The NJMRC researchers 
detected differences in disease rates among the workers they studied 
(Table 7). The DOE surveillance findings supported this conclusion (See 
Table 5). NJMRC researchers have found cases of CBD among those who had 
been exposed for periods as short as 1 month and those who had 
unrecognized or seemingly trivial exposure. However, they also found 
evidence that disease incidence increased with increasing exposure and 
concluded that exposure to beryllium should be minimized.

                                    Table 6.--Chronic Beryllium Disease Rates
 
                                                                                                      Estimated
                                                                                         Estimated     level of
                 Exposed during the 1940's                    Estimated       Cases      incidence     exposure
                                                               exposed                    per 100    g/
                                                                                          exposed        m\3\
Residents Living Within 0.25 Mile of a Beryllium Extraction
 Plant \1\.................................................          500          5             1.0            1
Fluorescent Lamp Manufacturing \1\
    Massachusetts..........................................       15,000        175            1.16          100
    Ohio...................................................        8,000         32             0.4          100
Machine Shop \1\...........................................          225         11             4.9          500
Beryllium-Copper Foundry \1\...............................        1,000         13             1.3          500
Beryllium Extraction \1\
    Lorain, Ohio...........................................        1,700         22             1.3         1000
    Painesville, Ohio......................................          200          0             0.0         1000
    Reading, Pennsylvania..................................        4,000         51             1.3         1000


----------------------------------------------------------------------------------------------------------------
                                                                                                      Estimated
                                                                                        Incidence     level of
           Exposed from the 1970's to the 1980's                Study        Cases       per 100      exposure
                                                            participants                 exposed     g/
                                                                                                        m\3\
----------------------------------------------------------------------------------------------------------------
Beryllia Ceramics Plant \2\...............................           505            9          1.8          NA
The DOE Rocky Flats Plant \3\.............................           895           15          1.7           1

[[Page 66947]]

 
Second Beryllia Ceramics Plant \4\........................           709            8          1.1           0.5 
----------------------------------------------------------------------------------------------------------------
\1\ Eisenbud and Lisson, ``Epidemiologic Aspects of Beryllium-Induced Non Malignant Lung Disease: A 30-Year
  Update,'' JOM, Vol. 25, pp 196-202, 1983.
\2\ Kathleen Kreiss et al., ``Beryllium Disease Screening in the Ceramics Industry,'' JOM, Vol. 35, pp 267-274,
  1993.
\3\ Kathleen Kreiss et al., ``Epidemiology of Beryllium Sensitization and Disease in Nuclear Workers,'' Am. Rev.
  Res. Dis., Vol. 148, pp 985-991, 1993.
\4\ Kathleen Kreiss et al., ``Machining Risk of Beryllium Disease and Sensitization with Median Exposures Below
  2 g/m\3\,'' Am. J. Ind. Med., Vol. 30, pp 16-25, 1996.


   Table 7.--Beryllium Sensitization and Disease Rates at Rocky Flats
------------------------------------------------------------------------
                                                Workers    Sensitization
    Beryllium process title        Workers       doing          rate
                                  sensitized    process      (percent)
------------------------------------------------------------------------
Cleaning Tools, Machines.......            7          255           2.7
Machining......................            6          189           3.2
Inspection.....................            2          138           1.4
Metallurgical Sample
 Preparation...................            3          115           2.6
Sawing.........................            5           06           4.7
Trepanning.....................            3           77           3.9
Band Sawing....................            4           67           6.0
Decanning, Shearing............            2           65           3.1
Precision Grinding.............            2           31           6.5
------------------------------------------------------------------------


 
                                                                 Rate
        All participants             Number    Participants   (percent)
Sensitized......................           18           895          2.0
Confirmed CBD Cases.............           15           895         1.7
------------------------------------------------------------------------
From Kathleen Kreiss et al. ``Epidemiology of Beryllium Sensitization
  and Disease in Nuclear Workers,'' Am. Rev. Res. Dis., Vol. 148, pp 985-
  991, 1993.

    A recent publication by Eisenbud in January 1998, (ref. 27), 
consolidated the previous epidemiologic studies that have questioned 
the relevance of the current PEL after evaluating the effect of the 
level of exposure on disease. In this article, Eisenbud concludes that 
it ``appears'' the current 2 g/m\3\ standard is not protective 
enough. Rather than recommend an alternative exposure limit, however, 
Eisenbud points to the need for the development of an animal model to 
aid in better understanding the etiology of CBD and suggests that 
innovative measures may be needed to control the disease.
    In summary, evidence suggests higher incidence of CBD among workers 
with higher exposures (e.g., machinists), but, at lower exposure 
levels, other factors may operate to confound a clear dose-response 
relationship. These factors include: (1) The effect of peak exposures 
(such that most of the exposure results from short-term episodes); (2) 
inadequacy of area monitoring in reflecting actual exposure; (3) 
chemical composition, etc., that may affect bioavailability; (4) 
inadequate monitoring of beryllium composition/species associated with 
exposures; and (5) the effect of genetic predisposition. As a result, 
the existing literature does not point to a clear set of measures that 
will reduce incidence.

E. Value of Early Detection

    Researchers at the National Jewish Medical and Research Center 
(NJMRC) compared the lung functions of patients with chronic beryllium 
disease (CBD) who had been identified through abnormal chest X-rays or 
clinical symptoms to those of patients whose CBD had been identified 
through positive beryllium-induced lymphocyte proliferation tests (Be-
LPTs) (ref. 28). Twelve of 21 Be-LPT-identified patients had lung 
abnormalities, including reduced exercise tolerance. Fourteen of 15 
patients identified through chest X-rays or clinical symptoms had 
abnormal lung function, and their abnormalities were more severe. The 
authors concluded that the Be-LPT was useful because it permitted 
detection of affected individuals earlier in the disease process.
    Early identification also allows removal of patients with CBD from 
jobs with beryllium exposure. There is no direct evidence that removal 
from exposure improves the prognosis of patients with CBD, because 
follow up studies have not been done. However, beryllium does clear 
from the lung over time, and a reduced level of antigen in the lung 
should reduce the severity of the inflammation and the amount of lung 
damage.
    The 79 cases of CBD diagnosed among Rocky Flats workers showed a 
range of severity similar to that reported elsewhere. Thirty-nine 
individuals had symptoms that required treatment ranging from inhaled 
bronchodilators to corticosteroids to oxygen. Two individuals died of 
CBD. Seventy-three of the 79 cases were identified among individuals 
who had abnormal Be-LPT results but normal chest X-rays or pulmonary 
function screening test results.

V. Request for Information

    The Department is considering more stringent requirements in 
various areas of the proposed NOPR. It is especially interested in 
comments that are supported by evidence and rationale whenever 
possible, regarding the following areas.
    Industrial hygiene competencies: Proposed sections 850.21(b) and 
850.24(a) would require that hazards assessments and exposure 
monitoring, respectively be conducted by ``individuals with sufficient 
knowledge in industrial hygiene.'' The Department

[[Page 66948]]

is considering using more prescriptive definitions for the 
qualifications an individual must possess to perform the required 
hazard assessments and exposure monitoring. One possible alternative 
approach would be to use OSHA's ``competent person'' definition. OSHA 
defines a competent person as:

    * * * one who is capable of identifying existing and predictable 
hazards in the surroundings or working conditions which are 
unsanitary, hazardous, or dangerous to employees, and who has 
authorization to take prompt corrective measures to eliminate them.

    Another possible approach would be to require that hazards 
assessments and exposure monitoring be performed by a ``certified 
industrial hygienist'' as defined by the American Board of Industrial 
Hygiene. DOE requests that interested parties submit comments regarding 
the use of such prescriptive definitions and/or suggestions for 
alternative approaches.
    Permissible exposure limit: To address the uncertainties associated 
with the existing PEL and the limitations of the existing scientific 
data, DOE requests that interested parties submit any compelling, 
scientific evidence that would assist the Department in establishing a 
new permissible exposure limit that would be more protective of worker 
health.
    Percent exceedance: The Department is considering alternatives to 
the action level as a basis for judging and interpreting exposure 
monitoring results. Descriptions of three methods used to interpret 
exposure level data are contained in the American Industrial Hygiene 
Association, A Strategy for Occupational Exposure Assessment (ref. 29). 
Of the three methods described, the percent exceedance approach appears 
as the best alternative for achieving the policy goal of encouraging 
periodic monitoring to understand the distribution of exposures and for 
investigating the causes of high exposures to prevent their 
reoccurrence. We are considering proposing that monitoring demonstrate 
95% confidence that fewer than 5 percent of the 8-hour or 15 minute TWA 
PEL levels exceed the exposure limit. The advantage of this method is 
that periodic monitoring is needed to characterize the distribution of 
exposure before compliance can be demonstrated, usually through an 
upper tolerance limit test. In addition this method rewards day-to-day 
management of exposure levels through investigation of the causes of an 
exceedance and the implementation of corrective actions that will 
prevent it from reoccurring. A weakness of this method is that it can 
underestimate the degree of risk in a workplace where day-to-day, or 
between worker variation, is very large. This weakness can be minimized 
by assuring that long term mean levels are not high compared to the 
PEL. DOE requests that interested parties provide information on: the 
feasibility and implication of a percent exceedance approach to 
defining an acceptable workplace; the percent exceedance that would 
still provide the level of protection intended by the 8-hour or 15 
minute TWA PEL; and whether mean testing should be specified as well. 
Commentors should provide the rationale and associated costs for 
approaches supported in their submittals, as well as input on 
implementation strategies or issues.
    Exposure monitoring: Given the uncertainty regarding the adequacy 
of the PELs and whether any level of beryllium exposure should be 
considered safe, DOE is considering establishing a requirement for 
daily exposure monitoring of all beryllium workers to document and 
characterize more completely a worker's exposure to beryllium, and to 
better evaluate the adequacy of existing exposure levels or determine 
appropriate levels for alternative exposure limits. At the very low 
exposure levels that the Department is attempting to achieve, work 
practices that would ordinarily be judged as presenting trivial 
potential sources of exposure may be significant. The goal of an 
exposure monitoring program should be routine sampling aimed at 
characterizing the distribution of exposures due to typical work. 
Monitoring results help identify both the cause of exposure above 
limits and measures that can prevent recurrence. DOE requests that 
interested parties provide information on the feasibility and 
implications of this more restrictive monitoring requirement. 
Commentors should also provide the rationale for the approaches 
supported in their submittals.
    Respiratory protection: DOE is considering requiring the use of 
respiratory protection at the action level instead of the PEL due to 
uncertainty about the protective value of the PEL. DOE requests that 
interested parties submit comments regarding the impact of such a 
change.
    Protective clothing and equipment: DOE is requesting information 
regarding the presence of soluble beryllium compounds within the DOE 
complex and the appropriateness of the exclusion of such compounds from 
the definition of beryllium in the proposed rule. In addition, DOE 
requests comments with appropriate supporting rationale regarding the 
need for the protective clothing provisions of proposed section 
850.29(a)(2) given that soluble beryllium compounds apparently are not 
present within the DOE complex.
    Surface contamination level: DOE requests that interested parties 
submit comments regarding the validity of the proposed 3 g/100 
cm2 surface contamination level. If an alternate level is 
suggested, the Department requests that the rationale and associated 
cost implications for choosing the alternate surface contamination 
level also be provided.
    Release level: DOE is aware of the need to set an acceptably free-
release surface contamination level for beryllium for unrestricted 
equipment release and transfer to uncontrolled areas and the public. 
DOE requests that interested parties submit comments regarding the 
setting of a beryllium free-release public contamination level. If a 
level is suggested, the Department requests that the rationale and 
associated cost implications for choosing the associated surface 
contamination level also be provided.
    Medical surveillance: DOE seeks comments on whether all workers 
with any potential exposure to beryllium, regardless of the level of 
exposure, should be provided the option to participate in a medical 
surveillance program to identify workers who may become sensitized to 
beryllium at exposures less than the action level or STEL.
    Anonymous testing: The Department realizes that some workers may 
elect not to participate in the medical surveillance program because 
they may believe that a diagnosis of CBD or beryllium sensitization 
could have a negative impact on future employment opportunities or on 
their health insurance. To address this concern and to encourage 
greater worker participation in the medical surveillance program, DOE 
is considering including a provision in the proposed rule that would 
allow for anonymous testing for CBD. Such a provision could include 
assigning an identification number (not traceable to the worker's name) 
to the worker's blood sample. The tested worker could use the 
identification number to call into the testing laboratory after a 
specified amount of time to retrieve the test results.
    DOE recognizes that such a system may encourage greater 
participation in the medical surveillance program, but it also has 
several drawbacks including the inability to correlate collected 
exposure data to health outcomes, and problems associated with the need 
for followup testing to confirm positive

[[Page 66949]]

results. DOE request that interested parties comment on appropriate 
methods for, and the feasibility and utility of provisions for 
anonymous testing for CBD.
    Outreach program: DOE is considering a requirement that contractors 
develop and implement an outreach education program for family members 
of beryllium workers. The outreach awareness program would address the 
hazards of exposure to beryllium and the purpose and content of the 
CBDPP. The objective of this requirement would be to increase awareness 
among the families of beryllium workers about the hazards associated 
with beryllium exposure and the actions being taken within the 
Department to address these hazards. DOE requests that interested 
parties comment on the feasibility, utility, and implications of such 
an outreach program.

VI. Section-by-Section Analysis

Overview of the Proposed Rule

    The proposed rule would strengthen the Department's worker 
protection program established in DOE Order 440.1A, Worker Protection 
Management for DOE Federal and Contractor Employees (5483.1B, 5480.4, 
5480.8A, and 5480.10 for operations not covered contractually under 
440.1A), by supplementing the general worker protection program 
requirements of the order with hazard-specific provisions that are 
designed to manage and control beryllium exposure hazards in the DOE 
workplace. These hazard-specific provisions are derived largely from 
DOE Notice 440.1, ``Interim Chronic Beryllium Disease Prevention 
Program.''
    DOE Notice 440.1 was developed by the DOE Beryllium Rule 
Development Team and Executive Committee, both of which consisted of 
representatives of each of the affected DOE headquarters and field 
offices. The technical basis for the notice was based in part on public 
input provided to the DOE Office of Environment, Safety and Health (EH) 
by 43 commentors and organizations in response to a December 30, 1996, 
Federal Register notice requesting scientific data, information, and 
views relevant to a DOE beryllium standard (61 FR 68725). Much of this 
information was presented and discussed at public forums held in 
Albuquerque, NM, and Oak Ridge, TN, in January 1997. Records of these 
public forums, as well as copies of all related public input and the 
minutes and recommendations of the BRAC meetings, are available at the 
DOE Freedom of Information Reading Room in the prerulemaking docket 
file entitled ``BERYLLIUM STANDARD.'' See the preceding ADDRESSES 
section for details on how to review or obtain copies of this material.
    Consistent with DOE Notice 440.1 the proposed rule establishes a 
CBDPP that is designed to prevent the occurrence of chronic beryllium 
disease (CBD) among DOE Federal and contractor workers. The CBDPP will 
accomplish this disease-prevention mission through provisions that (1) 
reduce the number of current DOE Federal and contractor workers who are 
exposed to beryllium by clearly identifying and limiting worker access 
to areas and operations that contain or utilize beryllium; (2) minimize 
the potential for, and levels of, worker exposure to beryllium by 
implementing engineering and work practice controls that prevent the 
release of beryllium particles into the workplace atmosphere and/or 
capture and contain airborne beryllium particles before worker 
inhalation; (3) establish medical surveillance to monitor the health of 
exposed workers and ensure early detection and treatment of disease; 
and (4) continually monitor the effectiveness of the program in 
preventing CBD and implement program enhancements as appropriate.
    The provisions of the proposed rule are presented in three main 
subparts: A, B, and C. Subpart A of the proposed rule describes the 
purpose and applicability of the rule, defines terms that are critical 
to the rule's application and implementation, and establishes DOE and 
contractor responsibilities for executing the rule. Subpart B 
establishes administrative requirements to develop and maintain a CBDPP 
and to perform all beryllium-related activities according to the CBDPP. 
Subpart C establishes requirements that focus on protecting workers 
from the harmful health effects associated with exposure to airborne 
levels of beryllium. Some of the provisions of Subpart C would apply 
only when it is determined that the airborne concentrations of 
beryllium in a specific workplace or operation rise above a specified 
limit. Table 5 summarizes these provisions and indicates the levels of 
beryllium at which the provisions would be enacted. Subparts A, B, and 
C of the proposed rule are discussed in detail in the following 
sections.

 Table 5.--Levels at Which the Provisions of the CBDPP Would Be Enacted
------------------------------------------------------------------------
                                  Worker exposure or potential exposure
                                           levels (8-hour TWA)
                               -----------------------------------------
           Provision                           
                                     > 0      Action level   > PEL (8-hr
                                               or  > STEL   TWA or STEL)
------------------------------------------------------------------------
Baseline Beryllium Inventory
 (850.20).....................            X   ............  ............
Hazard Assessment (850.21)....            X   ............  ............
Initial Exposure Monitoring
 (850.24).....................            X   ............  ............
Periodic Exposure Monitoring
 (850.24).....................  ............            X   ............
Exposure Reduction and
 Minimization (850.25)........         X\1\          X\2\          X\3\
Regulated Areas (850.26)......  ............            X   ............
Change Rooms (850.27).........  ............            X   ............
Respiratory Protection
 (850.28).....................  ............  ............            X
Protective Clothing and
 Equipment (850.29)...........  ............            X   ............
Housekeeping (850.30).........         X\4\
Medical Surveillance (850.33).  ............            X   ............
Training (850.36).............         X\5\   ............  ............
Counseling (850.36)...........  ............         X\6\   ............
Warning Signs (850.37)........  ............            X   ............
Waste Disposal (850.31).......  Applies to beryllium waste and beryllium-
                                contaminated waste.
Beryllium Emergencies (850.32)  Applies to beryllium operations.

[[Page 66950]]

 
Warning Labels (850.37).......  Applies to beryllium and beryllium waste
                                and beryllium-contaminated material and
                                waste.
------------------------------------------------------------------------
\1\ If exposure levels are below the action level or STEL, contractors
  must establish exposure reduction and minimization goals to further
  reduce worker exposures where practicable.
\2\ Contractors must investigate opportunities for and, if feasible,
  implement controls for reducing exposures to below the action level or
  STEL.
\3\ Contractors must reduce exposures to or below the PEL or STEL.
\4\ Housekeeping efforts must maintain removable surface contamination
  at or below 3 g/100 cm\2\.
\5\ Hazard communication training is required for all workers who could
  be potentially exposed.
\6\ Counseling is required for beryllium workers diagnosed with CBD or
  beryllium sensitization.

A. Subpart A--General Provisions

    Proposed section 850.1 emphasizes that the proposed CBDPP would 
enhance, supplement, and be integrated into existing worker protection 
program requirements for DOE Federal and contractor employees. The 
Department has structured the proposed rule this way for two main 
reasons: (1) To take advantage of existing and effective comprehensive 
worker protection programs that have been implemented at DOE 
facilities, and (2) to minimize the burden on DOE contractors by 
clarifying that contractors need not establish redundant worker 
protection programs to comply with the proposed rule.
    Proposed section 850.2(a)(1) specifies that the proposed rule would 
apply to DOE Federal employees with responsibilities for operations or 
activities involving exposure or the potential for exposure to 
beryllium at DOE-owned or -leased facilities. The Department recognizes 
that its federal workers are not usually directly involved in 
production tasks or other activities in which they would be exposed to 
airborne beryllium. However, in performing management and oversight 
duties, DOE federal workers often must enter facilities where beryllium 
is handled. Federal workers are protected under the health and safety 
provisions of 29 CFR Part 1960, ``Basic Program Elements for Federal 
Employee Occupational Safety and Health Programs and Related Matters,'' 
as well as Executive Order (EO) 12196, ``Occupational Safety and Health 
Programs for Federal Employees.'' The Department's intent in proposed 
section 850.2(a)(1) is to supplement these general worker protection 
requirements with specific beryllium-related requirements in the 
limited instances where DOE federal workers may have the potential for 
beryllium exposure.
    Proposed section 850.2(a)(2) specifies that the proposed rule would 
also apply to DOE contractors with operations or activities involving 
exposure or the potential for exposure to beryllium. As clarified in 
the definition of DOE contractor (proposed section 850.3), the 
Department's intent is that the DOE contractors covered under this 
proposed rule would include any entity under contract to perform DOE 
activities at DOE-owned or -leased facilities, including contractors 
awarded contracts, integrating contractors, and subcontractors. This 
section further clarifies that the requirements of the CBDPP would 
apply only to contractors and subcontractors who work in areas or on 
DOE activities that involve the potential for worker exposure to 
beryllium. The Department's intent with this clarification is to focus 
DOE and contractor resources and efforts on areas and activities that 
present a real potential for worker exposure to beryllium and thus 
realize the most benefit from implementing the proposed CBDPP. DOE 
emphasizes this intent throughout the proposed rule by requiring that 
DOE contractors tailor their approach to implementing the CBDPP.
    The Department's intent with the applicability provisions of 
proposed section 850.2(a)(1) and (a)(2) is that the proposed rule would 
apply only to exposures and potential exposures to beryllium that occur 
in connection with facility operations. This recognizes the fact that 
beryllium occurs naturally in soils and that the focus of the CBDPP 
should not be on naturally occurring beryllium but rather on the 
occupational exposures resulting from DOE operations.
    Proposed section 850.2(b)(1) would exempt ``beryllium articles'' 
from the requirements of the proposed rule (see the discussion of the 
definition of ``beryllium article'' under proposed section 850.3). The 
Department recognizes that some beryllium-containing manufactured items 
may not pose beryllium hazards where they have been formed to specific 
shapes or designs and their subsequent uses or handling will not result 
in the release of beryllium. This exemption for beryllium articles is 
consistent with the approach taken by OSHA when defining hazardous 
materials subject to the Hazard Communication standard at 29 CFR 
1910.1200.
    Proposed section 850.2(b)(2) would establish that the rule does not 
apply to the DOE laboratory operations involving beryllium that are 
subject to the requirements of OSHA's Occupational Exposure to 
Hazardous Chemicals in Laboratories standard, 29 CFR 1910.1450, 
commonly called OSHA's laboratory standard. In establishing its 
laboratory standard, OSHA clarified its intent that 29 CFR 1910.1450 
supersede all other OSHA regulations for bench-top laboratory-scale 
activities, noting that the provisions of the standard were more 
relevant and suitable to the unique characteristics of laboratory 
activities. The Department agrees with OSHA's approach and believes 
that the provisions of OSHA's laboratory standard are adequate to 
protect workers from beryllium exposures in facilities that fall within 
the scope of the standard.
    Proposed section 850.3 would apply traditional industrial hygiene 
terminology to define key terms used throughout the proposed rule. In 
relying on such terminology and by using terms consistent with OSHA 
interpretations, DOE intends to signal the Department's increased 
emphasis on industrial hygiene compliance through the use of accepted 
occupational safety and health requirements and procedures. The 
following discussion defines and

[[Page 66951]]

explains each of the definitions in the proposed rule.
    Accepted applicant is any person who has accepted an offer of 
employment in beryllium work at a DOE facility but who has not yet 
begun performing beryllium work. DOE intends for DOE contractors to 
provide such individuals with baseline medical evaluations before 
allowing them to begin employment as beryllium workers to ensure that 
they can safely perform work in areas that may present the potential 
for exposure to beryllium.
    Action level means the level of airborne concentration of beryllium 
established pursuant to Subpart C, which, if exceeded, would require 
the implementation of certain provisions of the proposed rule. Using an 
action level to trigger certain provisions of the proposed rule is 
consistent with the approach applied in many of OSHA's substance-
specific standards. This approach ensures that appropriate workplace 
precautions are taken and that training and medical surveillance are 
provided in cases in which worker exposures to beryllium could approach 
the permissible exposure limit. Additional discussion on the 
application of the action level in this proposed rule is provided in 
the discussion on proposed section 850.23, Action Level, and in the 
discussions of the individual provisions of the proposed rule that 
would be triggered by exceeding the proposed action level.
    Authorized person means any person required by work duties to be in 
regulated areas. Authorized individuals are intended to be trained and 
experienced in the hazards of beryllium and in the means of protecting 
themselves and those around them against such hazards. Training 
requirements for all individuals working with beryllium are specified 
in proposed section 850.36 of the proposed rule. The concept of 
authorized persons is consistent with OSHA standards and with 
contractor practice in many facilities and is intended to ensure that 
the number of potentially exposed individuals is reduced to the lowest 
possible number and that workers who are granted access to regulated 
areas have the knowledge they need to protect themselves and other 
workers.
    Beryllium means elemental beryllium and any insoluble beryllium 
compound or alloy containing 0.1 percent beryllium or greater that may 
be released as an airborne particulate. The Department has chosen this 
definition of beryllium because it clearly reflects that the focus of 
the proposed rule is on exposure to airborne levels of beryllium. DOE 
notes in this definition that OSHA uses the criterion for a 
carcinogenic mixture as one that contains a carcinogenic component at a 
concentration of 0.1 percent (or 1,000 parts per million [ppm]) or 
greater, by weight or volume.
    Beryllium article means a manufactured item that is formed to a 
specific shape or design during manufacture and that has end-use 
functions that depend in whole or in part on the item's shape or design 
during use and that does not release beryllium or otherwise result in 
exposure to airborne concentrations of beryllium under normal-use 
conditions. The Department has included this definition of ``beryllium 
article'' to distinguish between forms of beryllium that could result 
in exposure and manufactured items containing beryllium that do not 
release beryllium or otherwise result in exposure to airborne 
concentrations of beryllium. This definition is consistent with the 
rationale employed by OSHA in formulating its definition of ``article'' 
in the Hazard Communication standard (29 CFR 1910.1200). The key 
concept is that an article does not have the potential to result in 
hazardous exposures; this definition of ``article'' also considers the 
item's intended use. For example, an item ceases to be an ``article'' 
when it is subjected to machining, cutting, or drilling. Similarly, if 
an item is manufactured for the purpose of being machined later, it is 
not considered an article.
    Beryllium emergency means any occurrence such as, but not limited 
to, equipment failure, container rupture, or failure of control 
equipment or operations, that unexpectedly releases a significant 
amount of beryllium. This definition is particularly important when 
determining appropriate emergency response procedures that fall within 
the scope of OSHA's Hazardous Waste Operations and Emergency Response 
standard, 29 CFR 1910.120. This definition is based on OSHA's 
interpretation of the term as applied in 29 CFR 1910.120 and is 
intended to refer to any untoward event, such as a major spill of 
powdered beryllium or an unexpected, massive upset that releases a 
significant amount of airborne beryllium into the workplace atmosphere. 
The use of the term ``beryllium emergency'' in this proposed rule 
applies to proposed section 850.32, Emergencies, which requires DOE 
contractors to develop emergency procedures and training to address 
emergency scenarios. Such procedures and training must focus on 
emergency events that can reasonably be foreseen by an employer, such 
as a spill or a rupture of a pipe or a container.
    Beryllium-induced lymphocyte proliferation test (Be-LPT) means an 
in vitro measure of the beryllium antigen-specific, cell-mediated 
immune response. This test measures the extent to which lymphocytes, a 
class of white blood cells, respond to the presence of beryllium by 
replicating in the laboratory. The Be-LPT is used by medical personnel 
to identify workers who have become sensitized to beryllium through 
their occupational exposure.
    Beryllium worker means a current worker who is exposed or 
potentially exposed to airborne concentrations of beryllium at or above 
the action level or above the STEL or who is currently receiving 
medical removal protection benefits. This individual is a DOE Federal 
or contractor worker, a worker of a subcontractor to a DOE contractor, 
or a visitor who performs work for or with DOE or uses DOE facilities. 
This definition, through the phrase ``current worker who is exposed or 
potentially exposed to airborne concentrations of beryllium,'' 
clarifies the Department's intent that the proposed rule would apply 
only to current workers who are part of the at-risk population. The 
definition further clarifies that current workers who have been removed 
from beryllium exposure as part of the medical removal plan would 
continue to be considered as beryllium workers under the proposed rule. 
Former DOE workers who were potentially exposed to beryllium do not 
fall within this definition or the proposed rule. These workers will be 
addressed under a separate DOE initiative that is under development.
    Breathing zone is the hemisphere forward of the shoulders, centered 
on the mouth and nose, with a radius of 6 to 9 inches. This definition 
applies specifically to proposed section 850.24, Exposure Monitoring, 
which would require DOE contractors to determine worker exposures to 
beryllium by monitoring for the presence of contaminants in the 
worker's personal breathing zone. This definition is consistent with 
sound and accepted industrial hygiene practice and ensures that samples 
collected for personal exposure monitoring represent the air inhaled by 
workers while performing their duties in affected work areas.
    DOE means the Department of Energy or Department.
    DOE beryllium activity means an activity performed for, or by, DOE 
that can expose workers to airborne concentrations of beryllium. 
Activities within the scope of this definition

[[Page 66952]]

include design, construction, operation, maintenance, and 
decommissioning. The definition further explains that, to the extent 
appropriate, a ``DOE activity'' may involve one DOE facility or 
operation, a combination of facilities and operations, or possibly an 
entire site. This definition is broad enough to include such activities 
as repair work performed by support-service subcontractors who visit 
the site infrequently.
    DOE contractor means any entity under contract (or its 
subcontractors) with DOE with responsibility for performing DOE 
activities at DOE-owned or -leased facilities. This does not apply to 
contractors or subcontractors who solely provide ``commercial items'' 
as defined under the Federal Acquisition Regulations (FAR). As 
explained in proposed section 850.10, subcontractors included in this 
definition who would be covered under the proposed rule would not 
necessarily be expected to produce their own written CBDPPs. However, 
these subcontractors should be included in the CBDPP that encompasses 
all beryllium-related activities at the site. See the discussion in 
proposed section 850.10 for further details on how the requirements of 
the proposed CBDPP would be extended to a subcontractor.
    DOE facility means any facility owned or leased by DOE.
    High-efficiency particulate air (HEPA) filter means a high-
efficiency filter capable of trapping and retaining at least 99.97 
percent of 0.3-micrometer monodisperse particles. Such filters are 
commonly used in heating and ventilating systems, respiratory 
protection equipment, local exhaust ventilation, and so on, to remove 
toxic or hazardous particulates like beryllium.
    Immune response refers to the series of cellular events by which 
the immune system reacts to challenge a specific antigen. Types of 
immune responses include acquired immunity and sensitization. The 
body's immune response to beryllium is indicated by the results of the 
Be-LPT.
    Medical removal protection benefits are employment rights 
established in proposed section 850.34 for beryllium workers who 
voluntarily accept temporary or permanent medical removal from 
regulated areas following medical evaluations that confirm beryllium 
sensitization or CBD. These provisions would ensure that contractors 
make reasonable efforts to find and offer alternate employment to 
beryllium workers who have suffered negative health effects due to 
exposure to beryllium. The definition of medical removal protection 
benefits and the requirements in proposed section 850.34 would ensure 
that such workers would suffer no reductions in wage rate, seniority, 
or other benefits for 2 years after medical removal. The 2-year period 
would allow the contractor to make a reasonable effort through job 
retraining and out-placement programs operated by many sites to locate 
alternate work placement for beryllium workers, either internally or 
with different employers.
    Regulated area means an area established and managed by the 
contractor to demarcate locations where the airborne concentration of 
beryllium exceeds, or can reasonably be expected to exceed, the action 
level (see the preceding definition of ``action level''). Employees 
working in regulated areas must be authorized to do so by the 
contractor and trained and equipped with protective clothing and 
equipment. The purpose of such areas is to limit beryllium exposure to 
as few employees as possible. This is a standard definition used 
throughout DOE, particularly with regard to radiation protection, and 
is consistent with OSHA's expanded health standards that address toxic 
particulates.
    Short-term exposure limit (STEL) means the level of airborne 
concentration established pursuant to Subpart C (calculated as a 15-
minute TWA, measured in the worker's breathing zone by personal 
monitoring), which should not be exceeded for any 15-minute period at 
any time during the workday. Additional discussion on the application 
of the STEL in this proposed rule is provided in the discussion on 
proposed section, 850.22, Exposure Limits.
    Site occupational medicine director (SOMD) means the physician 
responsible for the overall direction and operation of the site 
occupational medicine program. DOE's intent with this definition is to 
ensure that each site's occupational medicine program would be 
administered by a qualified medical professional.
    Surface contamination means the presence of beryllium on exposed 
work surfaces, which may cause skin irritation upon contact or which 
may present an airborne hazard when reentrained into the workplace air. 
This definition of ``surface contamination'' is also important in 
addressing the maintenance, decontamination, and cleaning of facilities 
and equipment for recycling or for release for other uses. The 
Department recognizes that airborne respirable beryllium particles 
differ from surface contamination, which is not respirable until it is 
disturbed. Therefore, the rule provides separate definitions of 
``beryllium'' and ``surface contamination.''
    Worker means a person who performs work for or on behalf of DOE, 
including a DOE employee, an independent contractor, a DOE contractor 
employee, or any other person who performs work at a DOE facility. As 
clarified in the definition of DOE contractor, a contractor employee 
can be an employee of a covered subcontractor.
    Worker exposure means the airborne concentration of beryllium in 
the breathing zone of the worker when the worker is not using 
respiratory protective equipment. This definition is consistent with 
accepted industrial hygiene practice and with OSHA's definition of the 
term ``employee exposure'' as applied in the OSHA expanded health 
standards.
    Proposed section 850.3(b) references the standard definitions 
contained in the Atomic Energy Act and related rules under 10 CFR part 
850 for other terms used throughout this proposed rule.
    Proposed section 850.4 would establish enforcement provisions for 
the proposed rule. Like other Departmental regulations that apply to 
DOE contractors, this provision would allow DOE to employ contractual 
mechanisms, such as contract termination or fee reduction, when 
contractors fail to comply with the provisions of this proposed rule. 
These mechanisms help the Department ensure that beryllium workers 
receive an appropriate level of protection while performing 
Departmental activities that involve exposure or the potential for 
exposure to beryllium.
    Proposed section 850.5 would provide the appropriate steps that the 
Department may take to enforce compliance with this proposed rule. The 
grievance-arbitration processes of collective bargaining agreements 
covering accepted applicants and beryllium workers employed by 
Department contractors would generally apply to disputes relating to 
implementation of this part. Therefore, proposed section 850.5 would 
provide that disputes arising under this part brought by beryllium 
workers and accepted applicants (or by labor organizations acting on 
their behalf) that are covered by grievance-arbitration processes 
should be resolved through such processes. This approach to dispute 
resolution would minimize the possibility of bypassing collective 
bargaining representatives or existing contractual grievance-
arbitration processes and minimize the possibility of conflicting 
outcomes that would exist with multiple avenues for enforcing 
compliance with the rule.

[[Page 66953]]

    However, where the individuals bringing such disputes are not 
covered by collective bargaining agreements or where such collectively 
bargained processes are not applicable, the proposed rule would provide 
that disputes brought by individuals may be resolved by the 
Department's Office of Hearings and Appeals (OHA). OHA is an 
established and impartial body that has experience in dealing with 
whistleblower, security, and other disputes brought by individual 
workers. The procedures in 10 CFR part 1003, Subpart C, shall apply to 
resolution of disputes by OHA.

B. Subpart B--Administrative Requirements

    Subpart B of the proposed rule would establish general and 
administrative requirements to develop, implement, and maintain a CBDPP 
and to perform all beryllium-related activities according to the CBDPP.
    As owner or lessor of DOE-owned or -leased facilities, the 
Department has both a responsibility for overseeing the health and 
safety activities of its contractors and a partnership interest in 
achieving excellence in worker protection activities. Accordingly, 
proposed section 850.10(a)(1) would require DOE contractors who are 
responsible for DOE beryllium activities to prepare CBDPPs for their 
operations and submit the CBDPPs to the appropriate DOE Field 
Organization for approval. This section would establish a 90-day time 
frame from the effective date of the rule for contractor submission of 
the CBDPP to the appropriate DOE Field Organization. The Department is 
well aware of the burden of documentation that can be generated by new 
programs. However, most DOE contractors have already developed CBDPPs 
in response to the requirements of DOE Notice 440.1. The Department 
expects that the additional efforts that would be required to refine 
the existing CBDPPs to meet the requirements of the proposed rule would 
be minimal. The Department considers 90-days sufficient time for DOE 
contractors to examine their safety and health programs and make any 
changes necessitated by the rule.
    Proposed section 850.10(a)(2) would require that a single written 
CBDPP be submitted to encompass all beryllium-related activities at a 
site. Because the Department recognizes that one site may encompass 
multiple contractors and numerous work activities, however, this 
proposed section clarifies that the CBDPP for a given site may include 
specific sections for individual contractors, work tasks, and so on. 
DOE believes that this allowance for a segmented CBDPP structure would 
minimize the burden associated with the CBDPP update and approval 
requirements because it allows contractors to update and submit for 
approval only the affected sections of the CBDPP. When multiple 
contractors are involved, the DOE contractor designated by the DOE 
Field Organization shall take the lead in compiling the overall CBDPP 
document and coordinating the input from various subcontractors or work 
activities. This section further clarifies that in such cases where 
multiple contractors are involved, the designated contractor would have 
to review and approve the CBDPPs of other contractors engaged at the 
site before a consolidated CBDPP would be submitted to the head of the 
cognizant DOE Field Organization for final review and approval.
    Proposed section 850.10(b) would require heads of DOE Field 
Organizations to review and approve CBDPPs. DOE believes that DOE 
review and approval are necessary to ensure that each contractor's 
CBDPP is consistent with best industry practices for industrial 
hygiene, the Department's exposure reduction and minimization 
philosophy, and the objectives of the CBDPP. Through these proposed 
sections, DOE hopes to establish clear lines of authority for review 
and approval of contractors' CBDPPs.
    Proposed section 850.10(b)(1) would establish a 90-day period for 
DOE to review and either approve or reject the CBDPP. During its 
review, DOE could direct the contractor to modify the CBDPP, or it 
could modify the CBDPP itself. If DOE takes no action within 90 days, 
the initial CBDPP would be considered approved. The Department would 
establish this 90-day time frame to facilitate timely implementation of 
program elements by contractors and to ensure that DOE Field 
Organizations respond to contractors' submissions.
    Proposed section 850.10(b)(2) would require that the written CBDPPs 
be furnished upon request to the DOE Assistant Secretary for 
Environment, Safety and Health or his or her designee; DOE program 
offices; affected workers; and designated worker representatives. This 
proposed requirement would be in addition to the provisions of this 
section that would require contractors to submit the CBDPP, or portions 
(e.g., the medical surveillance section) of it, to cognizant DOE 
offices. The Department's intent with this requirement is to facilitate 
implementation and enforcement of the proposed rule. In addition, this 
proposed section would ensure that workers and their representatives 
could access information that is related to the protection of their 
health during the performance of DOE activities.
    Proposed section 850.10(c) would establish that updates to the 
written CBDPP be required under two circumstances: (1) Whenever a 
significant change or addition is made to the program and (2) whenever 
a contractor or subcontractor changes. DOE feels that such updates 
would be warranted to ensure that the CBDPP accurately reflects 
workplace conditions and appropriately addresses specific beryllium 
workplace exposure hazards.
    This proposed section would also require that DOE contractors 
review their written CBDPPs at least annually and revise these programs 
as necessary to reflect any significant changes. Only sections of the 
CBDPP that require changes would have to be resubmitted to the head of 
the DOE Field Organization for approval. The Department considers the 
annual review cycle to be appropriate and necessary to ensure that 
CBDPPs remain up-to-date and accurately reflect workplace conditions 
and required control procedures.
    Proposed section 850.10(d) was added to ensure that the CBDPP would 
be developed and implemented consistent with the requirements imposed 
by the National Labor Relations Act (NLRA) on employers in this 
context, and not to create obligations in excess of those that would be 
found in such circumstances under the NLRA.
    Proposed section 850.11(a) specifies that the CBDPP would be 
expected to address all existing and anticipated operational tasks that 
fall within its scope. In addition, the section would require all DOE 
contractors to develop and implement a CBDPP that is integrated into 
the Department's existing worker protection program. This proposed 
requirement would reflect the Department's desire to develop and 
implement one comprehensive, consistent, and integrated worker 
protection program that addresses all DOE workplace hazards. By 
including this provision, DOE notes the importance of controlling 
beryllium hazards within the framework of the worker protection program 
established under DOE Order 440.1A (or, where applicable, under 
predecessor orders like DOE Orders 5483.1A, 5480.4, 5480.8A, and 
5480.10) and related DOE health and safety initiatives. The existing 
industrial hygiene and occupational medicine programs, which were 
established in the comprehensive worker protection program and related 
initiatives, provide the basis needed to protect DOE federal

[[Page 66954]]

and contractor workers from health hazards like beryllium exposure. DOE 
believes that establishing a beryllium exposure control program outside 
the framework of this accepted program would create redundant and 
inconsistent requirements that would unnecessarily burden the regulated 
community and create an inefficient program.
    Unlike the DOE orders listed above, the regulatory requirements of 
this proposed rule would by operation of law apply to DOE contracts. 
Accordingly, the application and enforcement of this proposed rule 
would not be subject to the Work Smart Standards Program or other 
related processes. DOE believes that this mandatory application of the 
proposed CBDPP requirements to all DOE beryllium activities is 
appropriate given the hazardous nature of beryllium-related work.
    Proposed section 850.11(b) would require that contractors tailor 
the scope and content of their CBDPPs to the specific hazards 
associated with the DOE beryllium activities being performed. In 
addition, proposed section 850.11(b)(1) would require that these 
programs have to include formal plans outlining how DOE contractors 
would ensure that occupational exposures to beryllium are maintained at 
or below the PELs (8-hour TWA PEL of 2 g/m\3\ and 15-minute 
STEL of 10 g/m\3\).
    Proposed section 850.11(b)(2) further specifies that a contractor's 
CBDPP must, at a minimum, address each requirement in Subpart C of the 
rule. Consistent with the performance-based nature of the proposed 
rule, DOE's intent with this requirement is that DOE contractors 
include in their CBDPPs those provisions necessary to protect workers 
from exposure to beryllium during the performance of DOE beryllium 
activities at the contractors' respective sites. Proposed section 
850.11(b)(3) would clarify that the CBDPP provisions must focus on: (i) 
Minimizing the number of current workers exposed and potentially 
exposed to beryllium; (ii) minimizing the number of opportunities for 
workers to be exposed to beryllium; and (iii) setting challenging 
exposure reduction and minimization goals to facilitate the 
minimization of worker exposures. DOE believes that the establishment 
of exposure reduction and minimization goals is essential to the 
success of the CBDPP. With this catalyst to achieving further exposure 
reductions, DOE contractors would be encouraged to seek opportunities 
to provide enhanced worker protection, thereby assisting DOE in moving 
toward the ultimate goal of preventing CBD within the DOE complex.
    DOE is sensitive to concerns that exist within the DOE community 
regarding the need to approach the Department's exposure reduction and 
minimization objectives in a responsible and realistic manner. 
Accordingly, proposed section 850.11(b)(3)(iii) would establish a 
performance-based requirement that would allow contractors to establish 
their own exposure reduction and minimization goals tailored to their 
unique workplace needs and conditions. DOE's intention with this 
proposed requirement is that DOE contractors would establish reasonable 
but challenging goals based on sound industrial hygiene principles and 
the specific circumstances for each affected workplace and location. 
DOE believes that relevant circumstances must be considered in 
establishing these goals. Those circumstances would include the current 
level of worker exposures, the number of workers exposed, the existing 
controls that are in place, the technical feasibility and exposure 
reduction potential of possible additional controls, and the cost and 
operational impact of the controls.
    Proposed sections 850.12 (a) and (b) would require that DOE 
contractors manage and control beryllium exposures in all DOE beryllium 
activities in accordance with the approved CBDPP. This section would 
clarify that DOE and contractor personnel must follow applicable 
requirements of the rule and any resulting programs, plans, schedules, 
or processes, as well as requirements in other applicable Federal 
statutes and regulations.
    Proposed section 850.12(c) would clarify the Department's position 
that tasks involving potential beryllium exposure that would not be 
covered under the CBDPP could not be initiated until the CBDPP has been 
updated to include them and has been approved by the appropriate DOE 
Field Organization. DOE provides an exception of this requirement for 
urgent and unexpected situations. In such cases, the task could proceed 
with the approval of the DOE Field Organization prior to revision and 
approval of the CBDPP.
    Proposed section 850.12(d) would require that, depending on the 
circumstances of the work, other actions may be necessary to protect 
workers and that such actions are not to be limited by the provisions 
of the proposed rule. The Department recognizes that those individuals 
responsible for implementing CBDPP activities are accountable for using 
their professional judgment in protecting the health and safety of 
workers. Nothing in the proposed rule should be viewed as relieving 
these individuals of their professional responsibility to take whatever 
actions are warranted to protect the health and safety of the 
workforce.
    Proposed section 850.13(a) would mandate that DOE activities 
involving beryllium comply with their respective CBDPP that has been 
approved by the cognizant DOE Field Organization, as appropriate. 
Through this provision, DOE recognizes that even the best CBDPP will 
not adequately protect workers if it is not followed at the site. 
Proposed section 850.13(b) further proposes that once the final rule 
takes effect, DOE contractors would have 2 years to fully implement all 
aspects of the program (written plans, schedules, and other measures). 
The Department intends to reduce the resource impacts on contractors by 
permitting them to phase in costly controls over the 2-year period. 
However, the Department would expect portions of the program to be 
implemented as soon as practical during the 2-year period.
    Proposed section 850.13(c) would specify that the DOE contractor in 
charge of the activity involving a potential for beryllium exposure 
would be responsible for complying with the rule. When no contractor is 
responsible for the activity and Federal employees perform the 
activity, this section would require DOE to be responsible for 
compliance.

Subpart C--Specific Program Requirements

    Subpart C of the proposed rule would establish performance-based 
requirements for the CBDPP. These proposed requirements focus on 
preventing CBD by reducing the number of workers who could be exposed 
to beryllium, minimizing the potential level of beryllium in the 
workplace atmosphere, and continually monitoring worker health to 
ensure that workplace controls are sufficiently protective. The 
Department's intent is that implementation of the rule will increase 
understanding of the development and course of chronic beryllium 
disease. Throughout the Department's pre-rulemaking activities, 
including the public forums in Albuquerque, NM, and Oak Ridge, TN, and 
the BRAC meetings, many interested parties advised DOE to adopt various 
hazard-specific programs to address DOE beryllium hazards. For 
instance, several public forum participants suggested that DOE control 
beryllium hazards through an ``as low as reasonably achievable 
(ALARA)''

[[Page 66955]]

approach, similar to that the Department applies to control radiation 
hazards. These participants believed the ALARA approach was warranted 
due to the continued occurrence of CBD among the DOE workforce and 
questions regarding whether any level of beryllium exposure should be 
considered safe. Other public forum participants argued that OSHA's 
expanded health standard for asbestos would provide a better model 
because it applies accepted industrial hygiene practices to remediation 
activities similar to the remediation activities that may be 
encountered in DOE cleanup operations that involve beryllium. DOE 
acknowledges that both the ALARA approach and the OSHA Asbestos 
standard (as well as other OSHA expanded health standards) include 
provisions that could be applied effectively in controlling beryllium 
hazards in the DOE workplace. Accordingly, DOE combined the relevant 
components of the Asbestos standard (and other OSHA expanded health 
standards) and the ALARA approach in DOE Notice 440.1 and continues 
this approach in the proposed rule.
    Proposed section 850.20(a) would require that DOE contractors 
develop a baseline beryllium inventory to identify beryllium in DOE 
facilities and operations and to identify workers who are or may be 
potentially exposed to beryllium. Such baseline inventories would 
accomplish several functions that are critical to the success of the 
CBDPP, including: (1) The identification of locations and operations 
that should be physically isolated from other areas to prevent the 
spread of contamination, (2) the identification of areas in which 
worker access should be restricted to minimize the number of workers 
who could be exposed, (3) the identification of beryllium contamination 
in facilities scheduled for decontamination and decommissioning (D&D) 
operations to ensure the implementation of appropriate D&D control 
procedures, (4) the identification of beryllium contamination in 
facilities that are still used to determine the need for appropriate 
cleanup measures, and (5) the determination of which workers should be 
covered under the CBDPP.
    Proposed sections 850.20(b)(1) through (4) would supplement the 
generic inventory requirement originally established in DOE Order 
440.1A by requiring DOE contractors to conduct records reviews, 
employee interviews, and, if necessary, appropriate sampling procedures 
to determine and document the presence and locations of beryllium on 
DOE sites. These supplemental requirements are necessary because of the 
nature of past beryllium operations within the DOE complex, which were 
often conducted in open, uncontrolled work areas.
    Because the results of records reviews and employee interviews 
alone may not suffice to confirm the presence of beryllium 
contamination in a specific location, proposed section 850.20(b)(4) 
would require that DOE contractors conduct sampling procedures to 
assess beryllium workplace hazards. DOE contractors should design such 
sampling protocols according to the specific workplace conditions and 
the suspected types and locations of beryllium contamination. Sampling 
techniques could include collecting area and wipe samples and/or 
collecting personal breathing zone samples.
    Proposed section 850.20(c) would require contractors to ensure that 
the baseline beryllium inventory activities required under proposed 
section 850.20 are conducted by individuals with sufficient knowledge 
in industrial hygiene. The Department believes that this provision 
would be required to ensure that the inventory is accurate and complete 
and that the CBDPP provides protection to all affected workers. Because 
the identification of the possible presence of beryllium in a workplace 
does not, in and of itself, suffice to determine whether a hazard 
exists or whether various control measures must be employed, proposed 
section 850.21 would require DOE contractors to conduct a beryllium 
hazard assessment to characterize workplace beryllium exposure hazards. 
This requirement would allow each site to determine the appropriate 
risk-based approach for assessing beryllium-related hazards in its 
worksites where the baseline beryllium inventory has established that 
beryllium is present.
    The flexibility of proposed section 850.21 is particularly 
important because operations, conditions, and the potential for 
exposure may vary greatly from operation to operation and facility to 
facility. For instance, the hazard assessment required for a facility 
that houses current beryllium machining operations may be much more in-
depth than that required for an inactive storage facility that stored a 
used beryllium lathe temporarily. In both cases, proposed section 
850.21(a) would require a review of existing worksite conditions, 
exposure data, medical surveillance trends, and exposure potential of 
planned activities. In the beryllium machining operations example, 
however, this review would require an in-depth analysis of machining 
and other interrelated operations involving the performance of multiple 
tasks by multiple employees, each with varying exposure potentials. In 
this case, extensive medical surveillance and personal exposure 
monitoring data may already exist and may provide a sufficient basis 
for hazard assessment efforts. If the existing data do not suffice, 
however, the collection and analysis of additional personal breathing 
zone monitoring data for each task, operation, and work area may be 
necessary to accurately characterize potential beryllium exposure 
hazards.
    For the inactive storage area, a review of existing wipe sampling 
data, collected according to proposed section 850.20(b)(4), may suffice 
to ascertain that no beryllium exposure hazard exists in the facility. 
However, if wipe sampling data from the facility indicate that 
beryllium contamination exists in the storage facility, a more in-depth 
analysis could be required to determine the extent of contamination, 
the potential for the contamination to become airborne, and the need 
for facility cleanup and/or related exposure control measures.
    Proposed section 850.21(b) would require contractors to ensure that 
hazard assessments are conducted by individuals with sufficient 
knowledge in industrial hygiene. The Department believes that the 
establishment of such minimum personnel qualifications would be 
necessary to ensure the appropriate implementation of the provisions of 
the proposed rule and to ensure that the CBDPP provides protection to 
all affected workers. Proposed section 850.22(a) would retain the OSHA 
8-hour, TWA PEL for beryllium (2 (g/m\3\), as measured in the 
worker's breathing zone, or would adopt a lower 8-hour TWA PEL if such 
a PEL were established by OSHA through the rulemaking process. DOE is 
aware of viewpoints both for and against a lower DOE 8-hr TWA PEL for 
beryllium. Arguments in favor of lowering the PEL include the growing 
number of confirmed CBD cases (110 as of June 1998 among the 8,951 
current and former DOE federal and contractor workers who have 
undergone medical screening) and the apparent low-level, incidental 
beryllium exposures received by some of the afflicted workers. 
Arguments against lowering the PEL include a lack of compelling 
scientific evidence that the current exposure limit is not protective.
    There is scientific evidence (presented in the Health Effects 
discussion of this NOPR, Section IV) that suggests that the current 
exposure limit does not sufficiently protect worker health. However, 
existing scientific data does not currently

[[Page 66956]]

provide an adequate basis for determining an appropriate new DOE 
exposure limit. For this reason, DOE proposes to retain the existing 
OSHA 8-hr TWA PEL at this time and include in this proposed rule other 
provisions that are designed to minimize worker exposure in DOE 
facilities and to encourage continual monitoring of worker health to 
ensure an adequate level of protection. Chief among these provisions 
are the action level in proposed section 850.23, the exposure reduction 
and minimization requirements of proposed section 850.25, and the 
medical surveillance provisions of proposed section 850.33. Each is 
discussed below.
    OSHA has placed beryllium on its regulatory agenda but has 
indicated that it will take several years for a new OSHA standard on 
beryllium to be promulgated. Through proposed section 850.22(a), DOE 
has clarified its intent to adopt the new OSHA permissible exposure 
limit upon promulgation.
    Proposed section 850.22(b) would adopt the short-term exposure 
limit (STEL) established by the American Conference of Governmental 
Industrial Hygienists (ACGIH) of 10 g/m\3\, averaged over a 
15-minute sampling period. According to the ACGIH Threshold Limit Value 
(TLV) and Biological Exposure Indices booklet, a worker's 15-minute TWA 
exposure must not exceed the STEL at any time during the workday even 
if the worker's full shift exposure is within the 8-hour TWA PEL. 
Exposures above the PEL-TWA must not be longer than 15 minutes and must 
not occur more than four times per day. The ACHIH TLV and Biological 
Exposure Indices booklet further indicates that if such exposures occur 
more than once a day, there must be at least 60 minutes between 
successive exposures in this range.
    The ACGIH recently established this 10 g/m\3\ STEL for 
beryllium based on studies suggesting that acute beryllium disease did 
not appear in a group of workers exposed below 15 g/m\3\, and 
that CBD and lung cancer appear to be associated with exposure regimes 
in which short, high exposures occur. As noted in the ACGIH supporting 
rationale for the STEL, the 10 g/m\3\ STEL is in accord with 
the ACGIH's standard practice of recommending a generic excursion limit 
of 5 times the 8-hour TWA threshold limit value (TLV). The ACGIH 8-hr 
TWA TLV for beryllium is equal to OSHA's 8-hour TWA PEL of 2 
g/m\3\.
    DOE recognizes that the ACGIH 15-minute STEL is more protective 
than the OSHA acceptable maximum peak exposure for beryllium of 25 
g/m\3\ for a duration of 30 minutes. DOE also notes that the 
adoption of the ACGIH STEL in this proposed rule is consistent with 
current DOE policy and with minimum standards already in effect 
throughout the Department. As specified in DOE Order 440.1A and its 
predecessor Orders, DOE contractors must comply with both the OSHA 
standards and with the ACGIH TLVs. These Orders further clarify that 
where a conflict exists between the OSHA and ACGIH exposure limits, the 
more protective standard shall apply.
    DOE is aware of the continued occurrence of CBD among its workforce 
and intends to take every reasonable measure to minimize worker 
exposure to beryllium and to prevent the occurrence of CBD. One such 
measure is in proposed section 850.23, which would establish an 8-hour 
TWA action level of 0.5 g/m\3\, measured in the worker's 
breathing zone. Consistent with the worker protection practices 
employed in many of the OSHA expanded health standards, the action 
level would be used to trigger certain mandatory elements of the CBDPP: 
periodic exposure monitoring (proposed section 850.24(c)), regulated 
areas (proposed section 850.26), change rooms (proposed section 
850.27), protective clothing and equipment (proposed section 850.29), 
and medical surveillance (proposed section 850.33).
    In selecting the action level for the proposed rule, DOE 
considered: (1) OSHA's practice of establishing action levels; (2) the 
results of a 1996 survey of DOE facilities (presented in the draft DOE 
Beryllium Information Survey Report contained in the prerulemaking 
docket), which reported potential beryllium exposures and related 
control practices throughout the DOE complex; and (3) questions 
regarding the adequacy of the 8-hour TWA PEL. OSHA, in its expanded 
health standards, typically establishes action levels for hazardous and 
toxic substances at one-half the 8-hour TWA PEL. Applying this approach 
to beryllium would result in an 8-hour TWA action level of 1.0 
g/m\3\. According to the results of the 1996 DOE survey, 
however, two DOE facilities (Pantex and Rocky Flats) had already 
employed an action level of 0.5 g/m\3\. One facility (Lawrence 
Livermore National Laboratory) reported the use of an ``administrative 
warning range'' of 0.2 to 2.0 g/m\3\, which triggered a 
requirement for an investigation, and six DOE facilities employed an 
action level of 1.0 g/m\3\. Consistent with the Department's 
decision to implement aggressive exposure minimization efforts DOE 
proposes adopting the lower of the existing action levels currently 
used within the DOE complex in proposed section 850.23 rather than 
following typical OSHA practice. DOE believes that the successful 
implementation of this action level at two DOE facilities, and the 
implementation of an even lower ``administrative warning range'' at a 
third facility, provide sufficient evidence of the feasibility of 
implementing the 0.5 g/m\3\ action level across the DOE 
complex. DOE does not intend for this action level to discourage 
efforts to reduce exposures below 0.5 g/m\3\ in a regulated 
area. In fact, proposed section 850.25 would require contractors to 
establish and implement appropriate exposure reduction and minimization 
goals to further reduce worker exposures to beryllium.
    Proposed section 850.24 would establish CBDPP worker exposure 
monitoring requirements. Monitoring of breathing zone air space in 
areas where workers are potentially exposed is a well-recognized and 
widely accepted risk-management tool that is used to protect workers 
from exposure to airborne toxic substances. The proposed provisions in 
this section, which are also required under DOE Order 440.1A, are 
necessary to characterize worker exposures to a specific toxic 
substance and, based on these exposures, to determine the need for 
appropriate engineering or work-practice controls. In addition to this 
traditional compliance role, DOE proposes to expand the CBDPP's 
exposure monitoring element to provide continual feedback on the 
effectiveness of the program in preventing the occurrence of CBD. Such 
exposure monitoring results would help the Department to resolve 
uncertainties regarding the adequacy of the existing beryllium PEL and 
to refine the requirements of this rule as needed to protect worker 
health.
    Proposed section 850.24(a) would require that exposure monitoring 
be conducted by individuals with sufficient knowledge in industrial 
hygiene. The Department believes that the establishment of such minimum 
personnel qualifications is necessary to ensure the appropriate 
implementation of the provisions of the proposed rule and ensure that 
the CBDPP provides protection to all affected workers.
    Proposed section 850.24(b) would require that DOE contractors 
perform initial exposure monitoring for all workers who work in areas 
that may have airborne concentrations of beryllium as determined 
through the baseline beryllium inventory and hazard assessment. Such 
initial exposure

[[Page 66957]]

information is necessary to identify workers who must be enrolled in 
the medical surveillance program, determine the need for engineering 
and work practice controls, select appropriate personal protective 
clothing and respiratory protective equipment where needed, and 
identify the need to establish regulated areas. Because the proposed 
PELs include an 8-hour TWA PEL and a 15-minute STEL, proposed section 
850.24(b)(1) would require that worker exposure be measured by personal 
breathing zone samples that represent each worker's (i) full-shift 
exposure (for 8-hour TWA exposure measurements) or (ii) 15-minute 
exposure at operations where exposures may be above the STEL.
    DOE recognizes that many DOE contractors may have performed the 
required initial monitoring as part of their efforts to implement DOE 
Notice 440.1. DOE does not intend for DOE contractors to repeat these 
efforts. Accordingly, proposed section 850.24(b)(2) would allow 
contractors to use initial monitoring data collected within 12 months 
before the effective date of this rule to satisfy the rule's initial 
monitoring requirements.
    Proposed section 850.24(c) would require DOE contractors to conduct 
periodic exposure monitoring to detect any workers who have been 
exposed to beryllium at or above the action level or above the STEL. 
DOE believes that such periodic monitoring is necessary to ensure the 
continued protection of worker health. This requirement would provide 
contractors the flexibility to determine the monitoring frequency that 
is needed to characterize worker exposures accurately. DOE believes 
that such flexibility is warranted due to the wide range of beryllium-
related operations within the DOE complex. The Department recognizes 
that DOE contractors are best positioned to evaluate the potential 
variability of worker exposures in their operations and to tailor their 
periodic monitoring approaches as appropriate, based on existing 
exposure levels and the potential for these exposure levels to change. 
However, because slight process or procedural changes may go unnoticed 
over time and because equipment maintenance, aging, or deterioration 
can affect performance, DOE proposes in proposed section 850.24(c) a 
minimum exposure monitoring frequency requirement of 3 months 
(quarterly) for workers who are exposed to airborne concentrations of 
beryllium at or above the action level or above the STEL. DOE 
recognizes that the proposed minimum quarterly monitoring of workers 
exposed at or above the action level or above the STEL is more 
stringent than most OSHA expanded health standards. However, the 
Department feels this minimum monitoring frequency is necessary due to 
the uncertainties regarding the adequacy of the current PEL.
    To supplement this periodic monitoring requirement, proposed 
section 850.24(d) would also require that DOE contractors perform 
additional exposure monitoring when beryllium-related operations or 
procedures change. In the case of procedural or operational changes, 
this additional monitoring is needed to quantify how changes affect 
worker exposure to airborne beryllium, to ensure the continued 
effectiveness of existing engineering and work-practice controls, and 
to identify the need for additional control measures to minimize worker 
exposure to beryllium.
    To obtain accurate exposure monitoring results, proposed section 
850.24(e) would require that DOE contractors use monitoring and 
analytical methods that have an accuracy, at a confidence level of 95 
percent, of not less than plus or minus 25 percent for airborne 
concentrations of beryllium at exposure levels between the 8-hour TWA 
action level and the PEL. Proposed section 850.24(f) would further 
ensure the quality of monitoring results by requiring that all 
laboratory analyses of air sampling data be performed in a laboratory 
accredited for metals by the American Industrial Hygiene Association. 
These proposed accuracy and quality requirements would be consistent 
with similar requirements that appear in many of OSHA's expanded health 
standards for toxic substances. DOE believes that the quality and 
accuracy of exposure monitoring data are crucial to protecting workers 
from airborne toxic substances because monitoring results trigger the 
implementation of several critical elements of the worker protection 
program. Accordingly, effective implementation of the CBDPP and 
ultimately the health of affected beryllium workers would rest on the 
quality and accuracy of the collected exposure monitoring data.
    Proposed section 850.24(g)(1) would establish requirements to 
notify affected workers of monitoring results. This section would 
require DOE contractors to make this notification in writing within 10 
working days of receipt of the monitoring results. This section would 
also provide DOE contractors with two alternative methods of worker 
notification: (1) Provide written notification to each affected worker, 
or (2) post monitoring results in a location or locations readily 
accessible to affected workers. When the posting option is selected, 
DOE contractors would have to post the results in such a way as to 
protect the privacy of the affected workers.
    Proposed section 850.24(g)(2) also contains a provision for cases 
in which monitoring results indicate that worker exposure levels exceed 
the action level or STEL. In such cases, the DOE contractor would be 
required to notify the SOMD of the results within 10 working days of 
receipt of the results. DOE believes that the SOMD must be informed of 
such exposures in order to refine, as appropriate, the medical 
surveillance protocol for affected workers to ensure effective 
monitoring and early detection of beryllium-related health effects.
    Proposed section 850.25 would establish the exposure reduction and 
minimization provisions of the CBDPP that reflect the Department's goal 
of achieving aggressive reduction and minimization of worker exposures 
to airborne beryllium. DOE believes this is a prudent approach to 
worker protection in light of questions regarding the adequacy of the 
existing PEL and the relationship between beryllium worker exposure and 
disease.
    Proposed section 850.25(a) would establish the baseline requirement 
that DOE contractors ensure that no worker is exposed to airborne 
beryllium at levels above the exposure limits established in proposed 
section 850.22. The section would further clarify that DOE contractors 
must apply the hierarchy of industrial hygiene controls as established 
in DOE Order 440.1A to achieve this minimum exposure control 
requirement. This hierarchy dictates that DOE contractors must 
implement feasible engineering controls, followed by administrative 
controls, in their efforts to reduce exposure levels. If these 
engineering and administrative controls do not reduce beryllium levels 
to the exposure limits, DOE contractors must supplement these controls 
with personal protective clothing and equipment as appropriate to 
reduce exposure levels to within the exposure limits.
    Proposed section 850.25(b) would clarify the requirement to 
establish exposure reduction and minimization goals by requiring that 
DOE contractors include in their CBDPP, the rationale to support their 
exposure reduction and minimization goals. This section further 
requires that the CBDPP include a plan for meeting these goals as well 
as performance measures to be used to assess the contractor's status in 
achieving the goals. DOE considers this level of formality essential to 
the

[[Page 66958]]

establishment and implementation of meaningful goals, and to the use of 
these goals in achieving the exposure reduction and minimization 
objectives of the CBDPP. In addition, DOE believes that appropriate 
documentation of the supporting rationale for these goals is necessary 
to address concerns among the DOE community regarding overzealous DOE 
enforcement of the exposure reduction and minimization requirements of 
this proposed rule and to avoid second-guessing of contractor CBDPP 
efforts.
    Proposed sections 850.25(b)(1) and (2) would establish the 
Department's minimum expectations for the implementation of exposure 
reduction and minimization efforts. DOE does not intend for these 
minimum requirements to stifle contractor innovation but intends for 
them to serve as a starting point in efforts to implement an effective 
exposure reduction and minimization program. Specifically, proposed 
section 850.25(b)(1) would require DOE contractors to include in their 
CBDPP strategies for the use of the action level to trigger actions to 
reduce or minimize worker exposures and the potential for exposures. 
Proposed section 850.25(b)(2) would clarify that CBDPP strategies shall 
also include use of the conventional hierarchy of industrial hygiene 
controls as a means of achieving exposure reduction and minimization 
goals. The intent of these provisions is to encourage contractors to 
(1) investigate opportunities for exposure reductions when worker 
exposures reach or could reach the action level (or at lower levels of 
exposure if appropriate) and (2) implement control measures that are 
feasible and consistent with sound industrial hygiene principles, the 
objectives of the CBDPP, and the contractor's own internal exposure 
reduction and minimization goals.
    Proposed section 850.26 would establish the regulated area 
provisions of the CBDPP. These regulated areas, managed by the 
contractors, would help minimize the number of workers exposed to 
airborne beryllium by preventing or minimizing the spread of beryllium 
to clean work areas. Because most if not all DOE contractors that would 
be affected by this proposed rule have already implemented varying 
provisions to control access to areas and operations with a potential 
for worker exposures to beryllium (as reported in the draft 1996 DOE 
Beryllium Information Survey Report), DOE believes that the majority of 
the provisions of this proposed section would pose minimal additional 
burden on DOE contractors.
    Proposed section 850.26(a) would require that DOE contractors 
establish regulated areas where airborne concentrations of beryllium 
are in excess of the action level or STEL. DOE selected the action 
level in lieu of the 8-hour PEL as the trigger for this proposed 
requirement in keeping with the Department's aggressive beryllium 
exposure reduction and minimization philosophy. The STEL is included as 
a trigger for this requirement to address workplace areas where full-
shift exposure levels may be below the action level but operations or 
activities result in exposures above the STEL.
    Proposed section 850.26(b) of the proposed section would require 
that DOE contractors adequately identify regulated areas so that 
workers are aware of the presence and boundaries of such areas. This 
requirement would allow contractors the flexibility to determine the 
most appropriate means of identifying each regulated area based on 
specific worksite conditions.
    Proposed section 850.26(c) would require that DOE contractors limit 
access to regulated areas to authorized persons only. The contractor 
would determine which workers should have the authority to enter the 
work area and how the entry of unauthorized individuals will be 
prevented. DOE's intention is that only individuals who are essential 
to the performance of work in the regulated area would be granted entry 
authority. DOE contractors would have to evaluate the affected 
operation and determine which personnel (including managers, 
supervisors, and workers) are necessary for the performance of the work 
and thus must have entry authority. Methods for preventing unauthorized 
persons from entering a regulated area may range from, at a minimum, 
posting a sign indicating that only authorized persons may enter (as 
would be required by proposed section 850.37) to the use of locked 
access doors and other security measures on the basis of worksite 
conditions. DOE believes that contractors are best equipped to 
determine whether any access control methods are needed in addition to 
those already specified in proposed section 850.37.
    Proposed section 850.26(d) would require that DOE contractors keep 
a record of all persons who enter regulated areas. The record must 
include the name of the person who entered, the date of entry, the time 
in and time out, and the work performed. The function of these records 
within the framework of the CBDPP is clarified in proposed section 
850.38, Recordkeeping. Specifically, DOE believes that these records 
are necessary to monitor the effectiveness of each contractor's 
regulated area efforts and to provide valuable information regarding 
each worker's history of potential exposures. This historical 
information would assist the contractor's occupational medicine staff 
in establishing appropriate medical surveillance protocols and would 
aid in the Department's efforts to establish links between working 
conditions and potential health outcomes.
    Proposed section 850.27 would establish change room provisions for 
workers in regulated areas. These hygiene provisions are common in 
OSHA's expanded health standards, specifically in those standards 
designed to protect workers from exposures to hazardous particulates. 
Proposed section 850.27(a)(1) would require that change rooms used to 
remove beryllium-contaminated clothing and protective equipment be 
maintained under negative pressure or, located in a manner or area that 
prevents dispersion of beryllium contamination into clean areas. 
Proposed 850.27(a)(2) would require that separate facilities be 
provided for workers to change into and store personal clothing and 
clean protective clothing and equipment. DOE believes that such 
provisions are necessary to prevent cross-contamination between work 
and personal clothing and the subsequent spread of beryllium into clean 
areas of the facility and into workers' private automobiles and homes. 
These provisions would also address the need to prevent contamination 
of clean protective clothing and equipment, ensuring that protective 
clothing and equipment actually protect workers rather than contribute 
to their exposures.
    Consistent with the goal of preventing the spread of contamination 
into adjacent work areas and into affected workers' homes, proposed 
section 850.27(b) would require that DOE contractors provide hand-
washing and shower facilities for workers assigned to regulated areas. 
DOE recognizes that the installation of such facilities may take time 
in some cases. Accordingly, proposed section 850.13(b) would allow 
contractors 2 years to achieve full compliance with the requirements of 
the rule.
    Proposed section 850.28 would establish the respiratory protection 
provisions of the CBDPP. Specifically, proposed section 850.28(a) would 
require that DOE contractors comply with the OSHA Respiratory 
Protection standard (29 CFR 1910.134). Proposed section 850.28(b) would 
require that

[[Page 66959]]

DOE contractors provide appropriate respiratory protective equipment 
for all workers exposed to airborne concentrations of beryllium above 
the PELs established in proposed section 850.22 and ensure that the 
workers use protective equipment. Proposed section 850.28(c) would 
require that DOE contractors select and use only National Institute for 
Occupational Safety and Health (NIOSH)-approved or DOE-accepted 
respiratory protective equipment as required by DOE Order 440.1A.
    None of the provisions of this proposed section are new. For 
instance, DOE contractors have historically been subject to the OSHA 
standards, including 29 CFR 1910.134, through the provisions of DOE 
Order 440.1A and its predecessor orders, which incorporate the OSHA 
standards. DOE Order 440.1A require DOE contractors to provide, and DOE 
workers to use, appropriate respiratory protective equipment necessary 
to protect workers from exposures to hazardous substances, including 
airborne beryllium, at levels above established OSHA PELs. In addition, 
the provisions of 29 CFR 1910.134 include a requirement that employers 
select only NIOSH-approved respirators. In recognition of the unique 
nature of certain DOE operations, DOE Order 440.1A expanded this NIOSH-
approval restriction to allow for the use of DOE-accepted respiratory 
protection when NIOSH-approved respiratory protection did not exist for 
a specific DOE task.
    Proposed section 850.29 would establish the protective clothing and 
equipment provisions of the CBDPP. Proposed section 850.29(a) would 
require that DOE contractors provide workers who are potentially 
exposed to beryllium at or above the action level or above the STEL 
with protective clothing and equipment and ensure that the protective 
clothing and equipment are maintained and used as appropriate. Proposed 
section 850.29(a)(1) would clarify that appropriate protective clothing 
for work in areas where beryllium contamination is present includes 
full-body protective clothing and footwear (work shoes or booties). 
This section further stipulates that workers must exchange their 
personal clothing for this protective clothing before beginning work in 
regulated areas. As would be required under proposed section 850.27(a), 
this change from personal clothes into protective work clothing must 
occur in a change room that protects the worker's personal clothes and 
clean protective clothing from beryllium contamination. DOE believes 
that the use of full-body protective clothing in lieu of personal 
clothes in regulated areas is necessary to prevent the spread of 
beryllium contamination into adjacent work areas and to preclude the 
possible transport of beryllium into affected workers' private 
property.
    Because direct contact with beryllium can cause contact dermatitis 
and possibly conjunctivitis, proposed section 850.29(a)(2) would 
require that DOE contractors provide workers with additional protective 
gear where skin or eye contact with powdered or liquid forms of 
beryllium is possible. This additional protective gear could include 
face shields, goggles, gloves, and gauntlets, depending on the nature 
of the operation and the related skin and eye exposure hazards 
involved. DOE recognizes that the potential for the development of 
contact dermatitis or conjunctivitis is mainly associated with contact 
with soluble forms of beryllium compounds. Nevertheless, DOE believes 
that the provisions of proposed section 850.29(a)(2) represent prudent 
industrial hygiene measures for work with all forms of beryllium, 
particularly in light of the fact that both soluble and insoluble forms 
of beryllium have been shown to cause chronic ulcerations if introduced 
into or below the skin via cuts or abrasions.
    As clarified in the definition of beryllium in proposed section 
850.3, soluble beryllium compounds would not be covered by the proposed 
rule. DOE omitted soluble beryllium compounds from the definition of 
beryllium based on information provided by the DOE field offices 
indicating that soluble beryllium compounds were not used within the 
DOE complex.
    The Department's objective is to prevent the spread of beryllium 
contamination, thereby reducing the number of workers exposed and the 
opportunities for potential exposures. In keeping with this objective, 
proposed sections 850.29(b) through (e) would establish provisions to 
control the handling, maintenance, cleaning, and disposal of beryllium-
contaminated protective clothing and equipment. Specifically, proposed 
section 850.29(b) would require DOE contractors to ensure that workers 
do not take contaminated clothing or equipment from the change room or 
worksite unless specifically authorized to do so for the purposes of 
cleaning, maintenance, or disposal. Where workers are authorized to 
remove contaminated clothing and equipment from the change-room or 
worksite, proposed sections 850.29(b)(1) and (b)(2) stipulate that such 
materials must be placed in sealed impermeable containers that bear 
warning labels to clearly identify the contents and appropriate 
handling precautions. Such warning labels would help ensure appropriate 
subsequent handling of beryllium-contaminated materials and in 
preventing inadvertent exposures that could result if laundry, 
maintenance, or disposal personnel are not aware of the presence of 
beryllium contamination.
    Proposed section 850.29(c) would require that DOE contractors 
clean, launder, repair, and replace protective clothing and equipment 
as needed to ensure its continued effectiveness in protecting workers. 
This section would allow contractors some flexibility in determining 
the required frequency for laundering protective clothing based on 
specific work conditions and the potential for contamination. Because 
DOE believes that certain minimal laundering frequencies must be 
maintained to ensure that the protective clothing does not contribute 
to worker exposures, the proposed paragraph stipulates a minimal 
laundering frequency of at least once a week.
    To reduce and minimize the potential for exposures to beryllium 
during laundering operations, proposed section 850.29(d) would require 
that DOE contractors launder contaminated clothing using methods that 
would prevent the release of airborne beryllium in excess of the action 
level or STEL. DOE would provide DOE contractors the flexibility to 
determine the most appropriate means to launder contaminated clothes 
based on their own specific worksite conditions. DOE has, however, 
included in this section one specific requirement designed to prevent 
the dispersion of beryllium particles into the workplace atmosphere: 
proposed section 850.29(e) would prohibit the use of blowing, shaking, 
or any other means of cleaning that could disperse beryllium particles 
into the air. This is a well-recognized and accepted industrial hygiene 
control employed to minimize exposures to airborne particulates.
    Proposed section 850.30 would establish the housekeeping provisions 
of the CBDPP. Good housekeeping practices are necessary in areas where 
beryllium is used or handled to prevent the accumulation of beryllium-
containing dusts on surfaces throughout the workplace. Such 
accumulations, if not controlled, may lead to reentrainment of 
beryllium particles into the atmosphere. This potential for beryllium 
accumulations to become reentrained into the atmosphere increases 
potential beryllium exposure hazards in locations where beryllium

[[Page 66960]]

dusts were originally generated and introduces the potential for such 
exposures in other work areas. In addition, the uninhibited 
accumulation of beryllium-containing dust on equipment in the workplace 
increases the potential for worker exposure to beryllium during the 
performance of equipment maintenance, handling, and disposal tasks. 
Accordingly, the housekeeping program focuses on the prevention of 
accumulation of beryllium-containing dust in the workplace. Because the 
performance of housekeeping tasks can, in and of itself, lead to worker 
exposures to beryllium-contaminated dust, the provisions of this 
housekeeping section also focus on preventing the reentrainment of dust 
during the performance of housekeeping activities.
    Proposed section 850.30(a) would require that DOE contractors 
conduct routine surface sampling to ensure the effectiveness of 
housekeeping efforts. Surface sampling has become an accepted method 
for providing qualitative information on chemical contamination of work 
surfaces. Unfortunately, surface sampling procedures have not reached 
the stage of development that would allow an industrial hygienist to 
predict a personal exposure or a potential airborne concentration of 
reentrained contaminants. Such sampling, however, can identify the 
presence of beryllium contamination and thus can provide an indication 
of the effectiveness of housekeeping efforts. Accordingly, this 
proposed requirement is intended only as a housekeeping performance 
measure and should not be interpreted as a proposed mechanism for 
measuring, predicting, or controlling airborne concentrations of 
beryllium. In addition, this proposed requirement would only apply to 
removable or loose surface contamination which could become reentrained 
into the workplace atmosphere.
    Affected sites throughout the Department have already established 
beryllium surface contamination levels to ensure the effectiveness of 
their housekeeping procedures. According to representatives from these 
sites, existing surface contamination limits employed throughout the 
DOE complex range from 1 to 5 g/100 cm\2\, with the majority 
of the sites using approximately 3 g/100 cm\2\ (e.g., Pantex, 
Lawrence Berkeley National Laboratory, Y-12, Rocky Flats). Accordingly, 
DOE has adopted the 3 g/100 cm\2\ level in the proposed rule.
    The use of diverse sampling methods (differences include type of 
sample media, type of solvent (if any) on the sample media, area 
sampled, etc.) may easily lead to the reporting of inconsistent or 
incorrect results. To reduce the variability in reported surface 
contamination across the DOE complex, DOE recommends the use of a 
single sampling method: NIOSH method 9100 (NIOSH Manual of Analytical 
Methods (NMAM), 4th Edition, August 15, 1994, Lead in Surface Wipe 
Samples). This method may have to be modified for surfaces smaller than 
100 cm\2\ using a procedure such as that described in Appendix D of 10 
CFR part 835.
    Proposed sections 850.30(b) and (c) would establish provisions for 
the use of housekeeping methods that will prevent or minimize the 
reentrainment of beryllium particulates into the workplace atmosphere. 
Specifically, proposed section 850.30(b) would require the use of wet 
methods or vacuuming for the cleaning of beryllium-contaminated floors 
and other surfaces, and prohibit the use of compressed-air or dry 
methods for such activities. Proposed 850.30(c) would require the use 
of HEPA filters in all vacuuming operations for contaminated or 
potentially contaminated surfaces and would further require filter 
replacement as needed to maintain the capture efficiency of the vacuum. 
The use of wet methods for reducing or minimizing the dispersal of dust 
during general housekeeping tasks such as sweeping is a common 
industrial hygiene practice, as is the use of HEPA filters, which 
prevent the spread of dust by effectively collecting the dust as it is 
vacuumed or brought into a hood.
    As discussed in earlier sections of this analysis, the movement of 
contaminated or potentially contaminated equipment from a regulated 
area to a nonregulated area may result in the spread of beryllium 
contamination. To prevent this potential spread of contamination in the 
performance of housekeeping activities that would be required under 
this rule, proposed section 850.30(d) would require that cleaning 
equipment used in areas where surfaces are contaminated or potentially 
contaminated with beryllium be labeled, controlled, and not used in 
other clean areas of the facility. These procedures are similar to 
those required under OSHA's Asbestos standard for any equipment used 
during cleanup or removal of asbestos from buildings.
    Proposed section 850.31 would establish the waste disposal 
provisions of the CBDPP. Like many of the regulated area, protective 
clothing and equipment, and housekeeping provisions of the proposed 
rule, the waste disposal provisions of this section focus on minimizing 
the spread of beryllium contamination throughout the facility. As 
mentioned throughout this NOPR, such contamination control measures are 
necessary to achieve the Department's objectives of reducing the number 
of workers exposed to beryllium and minimizing the opportunities for 
beryllium exposures.
    DOE believes that the most effective way to control the spread of 
contamination resulting from waste disposal activities is to first 
prevent or minimize the generation of beryllium waste. Accordingly, 
proposed section 850.31(a) would require that DOE contractors control 
the generation and disposal of beryllium waste through good 
housekeeping practices, the performance of appropriate hazard analyses 
for operations with the potential to generate waste, and the 
application of waste minimization principles. Good housekeeping 
practices aid in this effort by continually removing beryllium dust 
accumulations from work surfaces, thereby reducing the potential for, 
and significance of, contamination of workplace equipment. The 
performance of hazard analyses on operations with the potential to 
generate wastes can help DOE contractors identify potential sources of 
wastes and evaluate possible controls that could be implemented to 
prevent or reduce waste generation. Other waste minimization practices, 
such as minimizing the equipment and material that is exposed to 
beryllium contamination, will also assist in reducing the amount of 
material that must be disposed of as beryllium or beryllium-
contaminated waste, thus reducing the potential beryllium exposure 
hazards associated with waste disposal activities.
    Proposed section 850.31(b) would require that DOE contractors 
dispose of all waste, scrap, debris, bags, containers, small equipment, 
and clothing contaminated with beryllium in sealed impermeable bags or 
other closed impermeable containers that are labeled in accordance with 
section 850.37. DOE believes these waste disposal provisions are 
necessary to prevent the reentrainment of beryllium contamination into 
the workplace atmosphere. Warning labels are necessary to ensure that 
workers are aware that containers or bags contain beryllium 
contamination so that they can take appropriate precautions.
    Proposed section 850.32 would establish the beryllium-related 
emergency provisions of the CBDPP. Such provisions are particularly 
important in light of suggestions made by several participants in the 
public forums that a single, high-level beryllium exposure may have 
been the

[[Page 66961]]

cause of CBD occurring among several workers thought to have no 
exposure or only incidental, low-level exposures to beryllium.
    Proposed section 850.32(a) would require that DOE contractors 
develop and implement procedures to address potential beryllium 
emergency situations for each facility engaged in beryllium operations. 
The Department's intent is for DOE contractors to evaluate their 
respective beryllium-related operations to determine possible emergency 
scenarios. Then, based on these facility- and operation-specific 
scenarios, the contractors would fashion procedures to specifically 
address the types of emergencies that could be encountered at the 
facility. DOE believes that this tailored approach would provide 
workers the best opportunity to be prepared in the event of an 
emergency, enabling them to respond in an appropriate and safe manner 
and to remedy site conditions with minimal potential for additional 
exposures to themselves or other personnel in the facility.
    Proposed section 850.32(a)(1) would require that DOE contractors 
establish procedures to alert workers in the event of a beryllium 
emergency. By ensuring that workers are continually aware of how they 
are expected to respond in the event of an emergency and by ensuring 
that they receive prompt notification or warning when an emergency 
situation has developed, DOE contractors would enable workers to 
quickly implement the actions needed for protection while bringing an 
emergency situation under control.
    Proposed section 850.32(a)(2) would require DOE contractors to 
ensure that workers engaged in the cleanup of emergency spills of 
beryllium, or in handling other emergency situations involving 
beryllium contamination, are provided with and wear protective clothing 
and equipment as specified in this proposed rule. DOE believes that 
such protective equipment is necessary to adequately protect workers 
from exposures to beryllium. DOE feels that this protection is even 
more critical when responding to uncontrolled situations where airborne 
levels of beryllium may not be adequately characterized and may exceed 
the PEL.
    Because even the best emergency response procedures will be 
ineffective if personnel required to implement the procedures are not 
aware of them, DOE has included in proposed section 850.32(b) a 
requirement that contractors train affected workers on required 
emergency procedures.
    Proposed section 850.33 would establish the medical surveillance 
provisions of the CBDPP. Proposed sections 850.33(a) and (b) propose 
that DOE contractors and Field Organizations designate a SOMD to be 
responsible for administering the respective contractor and federal 
medical surveillance programs required by this rule. Proposed section 
850.33(c) would also require that the written medical surveillance 
program that is required for inclusion in the CBDPP be submitted and 
reviewed by the DOE Office of Environment, Safety and Health and 
approved by the head of the cognizant DOE Field Organization. DOE 
review and approval authority is necessary to ensure that contractor 
medical surveillance requirements are consistent with the intent of the 
CBDPP and that these programs are applied uniformly across the DOE 
complex.
    Proposed section 850.33(d) would require DOE contractors to 
establish and implement a medical surveillance program for all 
beryllium workers exposed at or above the action level or above the 
STEL. Under this program, DOE would offer medical evaluations to 
affected beryllium workers. Once an employee is enrolled in the 
program, he or she would remain enrolled for the duration of employment 
at that site. The program would have two purposes: (1) Ensure the 
prompt identification and proper treatment of workers who become 
sensitized to beryllium or develop CBD, and (2) evaluate and ensure the 
effectiveness of the CBDPP in preventing CBD by determining the 
incidence of CBD in the workforce and by identifying risk factors 
associated with the development of CBD and beryllium sensitization.
    Proposed section 850.33(e) would require that DOE contractors 
provide the SOMD with the information needed to administer the medical 
surveillance program. This information would include, but may not be 
limited to, the baseline beryllium inventory, hazard assessment, and 
exposure monitoring data, as well as information regarding the identity 
and nature of activities or operations on the site that are covered 
under the CBDPP, the related duties of beryllium workers, and the types 
of personal protective equipment employed in the performance of these 
duties.
    Proposed section 850.33(f) would require the SOMD to establish and 
maintain a list of beryllium workers in the medical surveillance 
program based on records and other information regarding the identity 
of beryllium workers. Current employees who are at risk for CBD because 
of past beryllium operations would not be included on this list or 
covered under this proposed rule. Rather, they would be identified and 
offered medical surveillance under a separate, directly funded program.
    The Department views medical surveillance as a primary tool for 
determining the extent of CBD risk in an employee population. The list 
developed under section 850.33(f)(1) would establish the population of 
beryllium workers who may be eligible for medical surveillance. The 
Department's expectation is that SOMDs will use inclusive criteria for 
identifying beryllium workers to be covered under medical surveillance. 
In addition, proposed section 850.33(f)(2) clarifies DOE's intention 
that SOMDs refine the list of beryllium workers based on subsequent 
analyses of medical surveillance results required under proposed 
section 850.33(k). For example, the results of Be-LPTs would be used to 
determine risk factors that appear to be associated with CBD. Based on 
the apparent risk factors, the SOMD would adjust the surveillance 
program to better identify workers at risk of developing CBD.
    Proposed section 850.33(g) would require the SOMD to provide the 
examining physician with (1) a copy of this rule, (2) a description of 
the workers' relevant duties as they pertain to beryllium exposure, (3) 
records of the workers' beryllium exposure, (4) a description of 
personal protective and respiratory protective equipment in current or 
anticipated use, and (5) any relevant information from previous medical 
examinations of the workers that is not otherwise available to the 
examining physician. The Department believes that this information is 
necessary to ensure that the physician can make informed decisions 
regarding the required content of the medical evaluation and the 
subsequent development of recommendations related to each beryllium 
worker's work.
    Proposed section 850.33(h)(1) would clarify that DOE contractors 
must provide required medical examinations and procedures to beryllium 
workers and accepted applicants at no cost to the workers and accepted 
applicants at a time and place convenient to them. In addition to 
minimizing the financial burden on affected workers, DOE believes that 
this provision will encourage DOE contractors to minimize the levels of 
beryllium exposures in the workplace and the number of workers exposed 
or potentially exposed to beryllium. DOE also believes that this 
provision will help ensure that workers obtain proper medical 
evaluations.
    Proposed section 850.33(h)(2) would specify that DOE contractors 
must provide baseline medical evaluations to

[[Page 66962]]

beryllium workers who qualify for medical surveillance. DOE believes 
that such baseline medical evaluations are necessary to ensure that 
beryllium workers can safely perform assigned duties in areas that may 
present the potential for exposure to beryllium. In addition, DOE 
believes that the proper evaluation and documentation of each worker's 
health status is essential for determining whether future health 
problems may be related to occupational exposure to beryllium.
    Proposed section 850.33(h)(3) would supplement the baseline medical 
evaluation requirement of proposed section 850.33(h)(2) by requiring 
that DOE contractors offer annual medical evaluations to beryllium 
workers who qualify for medical surveillance. Such annual evaluations 
shall be offered as long as the beryllium workers work in areas where 
beryllium is present at levels at or above the action level or above 
the STEL. DOE believes that such periodic medical evaluations would be 
critical to ensuring the early identification and treatment of 
beryllium sensitization and CBD. This proposed section further 
clarifies that in cases where beryllium workers no longer work in areas 
where beryllium is present at levels at or above the action level or 
above the STEL, the requirement for annual medical evaluations may be 
reduced to once every 3 years. DOE believes that this continued 
surveillance is warranted due to the extended latency period associated 
with the development of CBD.
    Both proposed sections 850.33(h)(2) and (h)(3) would also establish 
the minimum required content of the baseline and periodic medical 
evaluations, respectively. Among these minimum requirements for both 
types of evaluations is the need to conduct a Be-LPT. The Be-LPT is the 
only available laboratory test for determining individual immune 
response to beryllium in vitro. Its use in a surveillance program would 
permit detection of beryllium-related health effects at a preclinical 
stage. A positive Be-LPT would indicate the need for further evaluation 
to determine the presence of CBD. The use of the Be-LPT as an 
evaluation tool would not only allow the earliest opportunity for 
diagnosis and treatment of CBD, but would also assist in identifying 
unhealthy working conditions or operations and deficiencies in the 
CBDPP.
    In addition to the Be-LPT, some medical experts recommend that a 
chest radiograph (X-ray) and spirometry be obtained prior to exposure 
to beryllium to establish a baseline for possible comparison with 
future test results. Spirometry involves measuring the amount of air 
entering and leaving the lungs. Accordingly, proposed section 
850.33(h)(2) would further specify that baseline evaluations also 
include a chest radiograph (X-ray) and spirometry. However, because 
neither chest radiography nor spirometry has proven to be any more 
predictive in identifying the presence of CBD than symptom 
questionnaires, these additional tests would not be mandated as a part 
of the periodic evaluation required under proposed section 
850.33(h)(3). Instead, the need for these tests would be left to the 
discretion of the examining physician. DOE believes that the examining 
physician is in the best position to determine the need for such 
additional tests based on the unique circumstances associated with each 
worker's exposure scenarios and health status.
    Proposed section 850.33(h) would not establish a requirement for 
termination evaluations. DOE believes termination evaluations for 
beryllium workers who are reassigned to non-beryllium work would not be 
needed because periodic evaluations will continue for as long as the 
worker is employed by the DOE contractor. Termination evaluations for 
beryllium workers who resign or retire from employment with DOE 
contractors would also not be necessary because the Department intends 
to establish a separate, directly funded program that offers medical 
examinations to former employees at risk for developing CBD. DOE 
recognizes that many sites already have an internal requirement to 
provide termination medical evaluations to workers upon their 
separation from employment. Nothing in this proposed rule would 
preclude the SOMD from continuing this practice.
    Proposed section 850.33(h)(4) would require that DOE contractors 
ensure that all medical evaluations and procedures be performed by or 
under the supervision of a licensed physician who is familiar with the 
health effects of beryllium. Conducting a medical surveillance program 
for beryllium workers requires specialized medical knowledge and 
crucial clinical decision-making. DOE believes that a licensed 
physician with specialized knowledge of the health effects of beryllium 
is the most appropriate medical professional to provide medical 
evaluations. A physician is also needed to answer health-related 
questions and to discuss and interpret abnormal clinical findings with 
the affected worker.
    Proposed section 850.33(i) would establish requirements for 
referrals for additional diagnostic evaluation. Specifically, beryllium 
workers who have two or more positive Be-LPTs or other signs and 
symptoms of CBD, would be referred by the examining physician for 
diagnostic evaluation. Such an evaluation would be performed by a 
pulmonary medicine, occupational medicine, or other clinic with the 
specialized equipment and examination protocols required to 
definitively differentiate between CBD and other lung disease. DOE 
believes that this proposed referrals provision is warranted due to the 
unusual nature of CBD and the fact that not all physicians are familiar 
with the evaluation of beryllium-exposed patients.
    Proposed section 850.33(j) would establish requirements for 
physicians' written reports and recommendations. Proposed section 
850.33(j)(1) would ensure that employees and accepted applicants are 
informed of the results of their medical evaluations and tests within 
15 days of completion of the evaluations. In addition, proposed section 
850.33(j)(2) would specify that within this same 15 day time period, 
the DOE contractor obtain a copy of a limited version of the 
physician's report. This limited version must include any 
recommendations for restricting the employee from working with 
beryllium, or for wearing protective equipment.
    Proposed section 850.33(k) would establish the requirement for a 
routine and systematic analysis of medical, job, and exposure data. The 
purpose of this requirement is to establish a program that would follow 
the public health model for disease surveillance programs. Information 
would be collected and analyzed so that the prevalence of disease could 
be accurately described and conclusions could be reached on causes or 
risk factors for the disease. This data analysis would provide an 
effective performance measurement mechanism for use in correction and 
improvement of the CBDPP. Proposed section 850.33(k)(1) would require 
that the results of these analyses be used by the SOMD to determine 
which workers should be offered medical surveillance and the need for 
additional exposure controls. In addition, proposed section 
850.33(k)(2) would require that the SOMD provide copies of the data 
analyses to the contractor for performance feedback information.
    Proposed section 850.34 would establish medical removal 
requirements. Specifically, this section would require that upon 
recommendation of the SOMD, DOE contractors shall give workers with two 
positive Be-LPTs or a

[[Page 66963]]

diagnosis of CBD the option of: (1) placement in another position 
without occupational exposure to beryllium, or (2) continued employment 
in the current position with actual or potential exposure to beryllium.
    Proposed section 850.34(a) would require that, with the written 
consent of the worker, DOE contractors remove a beryllium worker from 
exposure to beryllium or postpone an accepted applicant's start of 
active duty as a beryllium worker if the SOMD recommends such actions 
due to confirmed CBD, two or more positive Be-LPTs results, or while 
other signs or symptoms are being evaluated for their relation to CBD. 
Proposed section 850.34(a)(1) would further require that DOE 
contractors provide the affected beryllium worker a follow-up medical 
examination to determine whether the worker may be returned to his or 
her beryllium work or whether the worker should be permanently removed 
from working in beryllium areas.
    Proposed section 850.34(a)(2) would provide affected beryllium 
workers and accepted applicants with the option to decline the medical 
removal or restriction by signing an informed consent waiver. DOE notes 
that prudent medical practice suggests that workers with two or more 
positive Be-LPTs or diagnosis of CBD should avoid additional exposure 
to beryllium however, since no medical evidence exists to suggest that 
removal from exposure will alter the course of disease, DOE believes 
that it is ultimately the affected worker's decision whether to remain 
in a job with potential or actual beryllium exposure.
    For beryllium workers or accepted applicants who choose to accept 
restriction from continued work with beryllium, proposed section 
850.34(a)(3) would require DOE contractors to make reasonable efforts 
to find and offer alternative employment. This section clarifies that 
the contractor is not required to displace an existing worker in order 
to create a vacancy, nor is the contractor required to promote the 
affected worker or accepted applicant or pay for job placement training 
costs in excess of $6,000.00. The contractor is also not required to 
provide training that takes longer than 6 months to complete.
    Proposed section 850.34(b) would establish the requirement for 
medical removal protection benefits for beryllium workers who choose to 
accept a physician's recommendation to be removed from working with 
beryllium. Specifically, proposed section 850.34(b) would establish a 
requirement to protect an employee's base pay, benefits, and seniority 
should that worker accept restriction from working with beryllium. The 
Department's intent with this provision is that DOE contractors would 
offer sensitized employees and employees with CBD placement in a job 
that does not involve exposure to beryllium and that provides base pay 
and benefits comparable to their current job. Under this provision, if 
no such job exists within the contractor's organization, DOE 
contractors may offer the affected workers out-placement assistance to 
find suitable alternative employment.
    Proposed section 850.34(b) would further clarify that DOE 
contractors would be required to protect the pay and benefits of 
affected workers for a two-year period. DOE believes that the 
establishment of a two-year period of protected pay and benefits is 
fair and would provide sufficient incentive for DOE contractors to put 
forth the level of job placement effort necessary to find suitable 
alternative employment that would be acceptable to the affected worker.
    One of the main goals of the medical surveillance program is to 
minimize the disability associated with CBD. The Department believes 
that the establishment of the medical removal protection benefits of 
proposed section 850.34(b) is critical to achieving this goal for two 
reasons: (1) removal from exposure and effective job-placement efforts 
coupled with early diagnosis and treatment would allow affected workers 
to continue as productive members of the workforce, and (2) providing 
beryllium workers with a reasonable level of assurance that a finding 
of sensitization or diagnosis of CBD would not lead to the loss of 
their employment would further encourage worker participation in the 
medical surveillance program.
    Proposed section 850.35 would establish the medical consent 
provisions of the proposed rule. Because DOE intends worker 
participation in medical surveillance to be voluntary, the provisions 
of this section would be necessary to ensure that beryllium workers 
receive the information they need to make an informed decision 
regarding their participation in the program.
    Proposed section 850.35(a) would require that DOE contractors 
provide beryllium workers with information on the benefits and risks of 
the medical tests and examinations offered as part of medical 
surveillance. This information must be provided at least one week prior 
to any examinations or tests. In addition to providing this 
information, the Department also believes that DOE contractors should 
take reasonable efforts to ensure that workers understand the material. 
Accordingly, proposed section 850.35(a) would further clarify that 
workers shall have the opportunity to ask questions and have their 
questions answered prior to the performance of a medical evaluation.
    Proposed section 850.35(b) would also require that DOE contractors 
provide beryllium workers and accepted applicants with a summary of the 
medical surveillance program, information explaining the purpose of the 
data, the type of data needed to be collected, how the data will be 
maintained, and the confidentiality of medical records will be 
protected. This information must also be provided at least one week 
prior to any examinations or tests.
    Proposed section 850.35(c) would require DOE contractors to use the 
informed consent form approved by the Assistant Secretary for 
Environment, Safety and Health (EH-1) to obtain the signed consent of a 
beryllium worker prior to performance of a medical examination. The 
signature of the beryllium worker is intended to document that he or 
she consented to being tested. The signature of the examining physician 
is intended to document the commitments made to the beryllium worker. 
An example of the consent form can be found in Appendix A to Part 850.
    Proposed section 850.35(d) would ensure that a beryllium worker or 
accepted applicant who develops a beryllium-related health effect, such 
as beryllium sensitization or CBD, would be given the information by 
the contractor that he or she needs to make an informed decision 
whether to accept medical removal. As clarified in this section, this 
information would include, at a minimum, information on opportunities 
for alternative placement with the contractor, out-placement benefits 
if no suitable positions exist within the contractor's organization, 
and any available long-term medical and disability insurance benefits 
for which the worker may qualify. The goal of this provision is to 
provide the worker with detailed information on the risks and benefits 
of accepting or rejecting medical removal to assist the worker in 
making the best possible decision.
    Proposed section 850.35(e) would clarify that the SOMD must first 
provide the affected worker or accepted applicant the opportunity to 
ask questions and have their questions answered prior to obtaining the 
workers agreement to medical removal or before

[[Page 66964]]

having the worker sign a medical removal waiver.
    Proposed section 850.36 would establish requirements for training 
and counseling regarding worker exposure to beryllium and the potential 
health effects associated with such exposure. DOE believes that such 
worker training is necessary because the appropriate implementation of 
the required workplace procedures of the CBDPP would ultimately rest 
upon the front-line workers who will actually be performing work on, 
with, or near beryllium or beryllium-contaminated materials. If these 
workers are not aware of the required procedures or if they do not 
fully appreciate the significance of these procedures, they cannot be 
expected to implement the procedures. For this reason, DOE believes 
that the ultimate success of the proposed CBDPP and the realization of 
the Department's goal to prevent future occurrences of CBD within the 
DOE complex depend to a great extent on the training and knowledge of 
the beryllium workers.
    Proposed section 850.36(a) would require contractors to develop and 
implement a worker training program for all workers who are exposed or 
potentially exposed to airborne concentrations of beryllium and ensure 
their participation in the program. DOE recognizes that OSHA's Hazard 
Communication standard (29 CFR 1910.1200) already requires that DOE 
contractors provide their workers with similar training regarding the 
risks associated with all hazardous materials in the workplace. DOE 
does not intend that contractors would implement two separate and 
redundant training and information programs to comply with this 
proposed rule and the Hazard Communication standard. Accordingly, 
proposed section 850.36(a)(1) would require that DOE contractors' CBDPP 
training and information programs comply with the Hazard Communication 
standard as well as address the contents of the CBDPP. Through this 
provision, DOE intends for its contractors to integrate their CBDPP 
training and information efforts into their existing Hazard 
Communication training program, thus minimizing the burden on 
contractors and providing for a consistent approach to worker training 
and the communication of workplace hazards.
    Proposed section 850.36(a)(2) would require that training be 
provided to workers prior to initial assignment and at least annually 
thereafter to ensure that workers are appropriately prepared to 
recognize the hazards and risks of working with beryllium. The initial 
training requirement of the paragraph is important to ensure that 
workers have the information they need to protect themselves before 
they are actually subject to exposure or potential exposure hazards. 
Annual training is necessary to reinforce initial training, especially 
with regard to the protective actions workers must take at their 
current jobs to reduce their potential for exposure to beryllium. DOE 
would establish this frequency as a minimum requirement, noting that 
changes in workplace operations, controls, or procedures, or the 
availability of new or updated information regarding the health risk 
associated with exposures to beryllium, may warrant the need for more 
frequent training.
    In addition, proposed section 850.36(a)(3) would require that the 
training include information regarding beryllium health risk, exposure 
reduction, safe handling of beryllium and medical surveillance. This 
proposed section does not limit the contractor from providing training 
in additional areas.
    All training must be conducted in a manner easy to understand so 
that workers can effectively translate CBDPP training into safe work 
practices. Training material should be appropriate in content and 
vocabulary to the education level, literacy, and language background of 
affected workers. Such targeted training would ensure that all workers, 
regardless of cultural or educational background, would have the 
requisite knowledge necessary to reduce and minimize their exposure to 
beryllium.
    To provide additional support to affected workers, proposed section 
850.36(b) would establish the requirement for the development and 
implementation of a worker counseling program that would assist 
beryllium-sensitized workers and workers diagnosed with CBD. The 
purpose of the counseling program would be to help communicate to 
workers the information that they will need to make important health- 
and work-related decisions and to facilitate the performance of 
required administrative activities, such as filing workers' 
compensation claims. Proposed section 850.36(b) would require the 
communication of information regarding the availability of: the medical 
surveillance program; medical treatment options; work practices aimed 
at limiting worker exposure to beryllium; the risk of continued 
exposure after sensitization; medical benefits; workers' compensation 
claims; and medical, psychological, and career counseling for workers 
with CBD or with positive results on Be-LPTs.
    Proposed section 850.37 would require DOE contractors to post 
warning signs and labels to ensure that the presence of and dangers 
associated with beryllium and beryllium-contaminated materials or areas 
are communicated to workers.
    Proposed section 850.37(a) would require the posting of warning 
signs at all entranceway locations where regulated areas have been 
established. This proposed section further requires that these signs 
bear the following warning:

DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY

    The purpose of these signs would be to minimize the number of 
persons in a regulated area by warning workers prior to entry. The 
signs would also alert workers to the fact that they must have the 
appropriate authorization from their supervisor to enter the regulated 
area. This is especially important when regulated areas are established 
on a temporary basis, such as during cleanup operations. In such cases, 
workers who typically work in or travel through the area may not be 
aware of the new potential for exposures to beryllium and thus may not 
be appropriately equipped for or aware of the need to protect 
themselves from potential exposures. Warning signs would also serve as 
a constant reminder to those who work in regulated areas that the 
potential for exposure to beryllium exists in the area and that 
appropriate controls must be used.
    Proposed sections 850.37(b)(1) and (2) would require that DOE 
contractors label all containers of beryllium, beryllium compounds, or 
beryllium-contaminated clothing, equipment, waste, scrap, or debris in 
accordance with OSHA's Hazard Communication standard (29 CFR 
1910.1200). Ensuring that the content and format of the warning labels 
are consistent with those of OSHA's Hazard Communication standard would 
provide DOE and its contractors with a consistent and comprehensive 
approach to alerting workers to beryllium's potential to cause serious 
disease. The use of such warning labels would also ensure that all 
those who come in contact with labeled containers are aware of the 
containers' contents and of the need to implement special handling 
precautions. Because the effectiveness of the warning labels in 
achieving these objectives is greatly dependent upon the visibility, 
accuracy, and understandability of the content of the

[[Page 66965]]

labels, proposed section 850.37(a)(2) would further specify that labels 
bear the following information:

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

    Proposed section 850.38 would address requirements for the 
establishment and maintenance of accurate records to demonstrate 
effective implementation of the program. Proposed section 850.38(a) 
would require the collection and maintenance of all beryllium inventory 
information, hazard assessments, exposure measurements, controls, and 
medical surveillance data. The Department feels that accurate and 
retrievable records are essential to the assessment of the adequacy of 
worker protection programs. Proposed section 850.38(b) would require 
that records required by this part be maintained in an electronic, 
easily retrievable format that can be easily transmitted to DOE 
headquarters when requested. This supplemental requirement would be 
necessary to facilitate timely, efficient, and cost-effective transfer 
and analysis of exposure monitoring and medical surveillance data.
    Although the Department does not at this time mandate any specific 
methods or types of records system in the proposed rule, DOE 
contractors are already required to keep records of beryllium inventory 
information (29 CFR 1910.1200, Hazard Communication) and hazard 
assessment, exposure measurement, and medical surveillance data (29 CFR 
1910.1020, Access to Employee Exposure and Medical Records). DOE 
contractors would be encouraged to take advantage of existing 
recordkeeping systems to minimize the implementation burden.
    Proposed section 850.38(c) would also require that DOE and 
contractors create links between data sets on working conditions and 
health outcomes to serve as a basis for understanding the beryllium 
health risk. This linkage of data will assist DOE and contractors in 
identifying unsafe work practices and defining the exposure-response 
relationship.
    The establishment and maintenance of useful, linked, and easily 
retrievable records would directly support and be an integral part of 
successful performance feedback, as described in proposed section 
850.40. Combining data facilitates analyses that might be impossible to 
perform in smaller populations. Combined analyses can identify 
associations between CBD prevalence and risk factors that might 
otherwise be missed, and can lead to the development of conclusions 
based on the predictive value of medical tests used earlier in the 
analysis process.
    Proposed section 850.38(d) specifically states that medical 
information generated by the CBDPP may only be maintained as a part of 
the site beryllium workers' medical records. This section further 
states that the medical information must be maintained separately from 
other personnel records and in conformity with the Americans with 
Disabilities Act, the Privacy Act and other applicable laws.
    Proposed section 850.39(a) would require that DOE contractors 
develop and maintain a separate electronic beryllium registry that 
includes all beryllium workers. This beryllium registry would serve as 
a repository for collecting and maintaining information on workers who 
are exposed to long term, low and moderate levels of beryllium. The 
results of beryllium sensitization testing and/or CBD status of exposed 
workers will be added to the registry as that information becomes 
available. As information accrues over time, the disease status of 
workers as it relates to past beryllium exposure would be determined. 
The goals of the registry would be to provide early guidance as to the 
effectiveness of exposure control mechanisms and intervention programs 
and assess the burden of health effects related to beryllium exposure. 
The beryllium registry would also facilitate the conduct of 
epidemiologic studies to better understand the development of the 
disease and better identify those at risk.
    Section 850.39(b) would specify the required content of the 
registry and establish that the registry and subsequent updates be 
forwarded electronically on a semi-annual basis to the Office of 
Environment, Safety and Health, Office of Epidemiologic Surveillance. 
For most sites, the electronic transfer of data would be similar to 
that used for the existing Epidemiologic Surveillance program. The 
Office of Epidemiologic Surveillance would be responsible for the 
administration and policy decisions related to the beryllium registry. 
This office would also provide technical support to the SOMD as 
required.
    The SOMD would provide demographic data, exposure data, and medical 
screening results. Personal identifying information would be required 
to link exposure data to an individual and to eliminate duplicate 
reports for each worker. This information would be collected pursuant 
to and contained within DOE Record System 88 ``Epidemiologic and Other 
Studies, Surveys, and Surveillance.''
    Proposed section 850.39(c) would require that information contained 
in the beryllium registry be disclosed only in a manner consistent with 
applicable legal requirements, such as the Privacy Act. Use of records 
under this act is governed by specific routine uses.
    DOE believes that the existence of a Department-wide registry of 
beryllium workers and CBD and sensitization cases would facilitate 
future research on improved diagnostic tests and treatments for the 
disease.
    Proposed section 850.40 would establish the performance feedback 
provisions of the CBDPP. Performance feedback mechanisms are essential 
to ensure that the effectiveness of the CBDPP is evaluated on a 
continual basis and that the necessary changes are made to ensure the 
protection of worker health. This section would mandate the use and 
analysis of the data collected through the reporting requirements in 
proposed section 850.38 to maintain and improve each element of the 
CBDPP.
    Proposed section 850.40(a) would require that DOE contractors 
conduct periodic analysis and assessment of monitoring results, hazards 
identified, medical surveillance results, attainment of exposure 
reduction and minimization goals, and occurrence reporting data. The 
Department believes that the analysis of these data would be important 
to the continuous improvement of the program. In addition, this 
information would provide insights to better understand and manage 
program implementation through the use of performance measures 
developed on a site-by-site basis.
    To ensure that all workers have the necessary information to safely 
perform their assigned tasks, proposed section 850.40(b) would require 
that results of performance assessments conducted in accordance with 
this part be provided to line managers, planners, worker protection 
staff, workers, medical staff, and others. This requirement would 
improve communication among employees, managers, and others to more 
effectively evaluate and monitor program implementation and 
effectiveness.

[[Page 66966]]

VII. Procedural Requirements

A. Review Under Executive Order 12866

    Today's regulatory action has been determined to be a significant 
regulatory action under Executive Order 12866, ``Regulatory Planning 
and Review,'' 58 FR 51735 (October 4, 1993). Accordingly, today's 
action was subject to review under the Executive Order by the Office of 
Information and Regulatory Affairs (OIRA). The assessment of the 
potential costs and benefits of the rule required by section 6(a)(3) of 
the Executive Order has been made a part of the rulemaking file and is 
available for public review as provided in the ADDRESSES section of the 
NOPR.

B. Review Under the Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, requires 
that an agency prepare an initial regulatory flexibility analysis for 
any rule for which a general notice of proposed rulemaking is required, 
unless the agency certifies that the rule, if promulgated, will not 
have a significant economic impact on a substantial number of small 
entities. 5 U.S.C. 605.
    DOE obtained information for 15 potentially affected sites to 
determine if the proposed rule, if promulgated, would have a 
significant economic impact on small entities. This information 
indicates that no small businesses currently would be affected by the 
proposed rule. A more detailed account of this information appears in 
the Economic Analysis prepared under the requirements of Executive 
Order 12866. Furthermore, DOE expects that any potential economic 
impact of this rule on small businesses would be minimal because 
businesses at DOE sites perform work under contracts to DOE or the 
prime contractor at the site. Increased funding may be available under 
this contractual arrangement to offset much of the impact that the rule 
would impose. In addition, many of the requirements of this part would 
apply to prime contractors and not subcontractors. Currently none of 
the prime contractors at affected DOE sites are small businesses.
    For the foregoing reasons, DOE certifies that today's proposed 
rule, if promulgated, would not have a significant economic impact on a 
substantial number of small entities. DOE invites public comment and 
information on this certification.

C. Review Under the Paperwork Reduction Act

    The proposed collections of information in this proposed rule have 
been submitted to the Office of Management and Budget (OMB) for review 
and approval under section 3507(d) of the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. An agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless the 
collection displays a valid control number assigned by OMB.
    This section describes the collections of information in the 
proposed rule and provides estimates of the annual burden on 
respondents. The burden estimates include the total time, effort, and 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for DOE. DOE invites public 
comment on: (1) Whether the proposed collections are necessary for the 
performance of DOE's functions, including whether the information will 
have practical utility; (2) the accuracy of DOE's estimates of the 
burden of the proposed collections of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collections of information 
on respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments should be addressed to the Department of Energy Desk 
Officer, Office of Information and Regulatory Affairs, OMB, 725 17th 
Street, NW, Washington, DC 20503. Persons submitting comments to OMB 
also are requested to send a copy to the contact person at the address 
given in the ADDRESSES section of this notice. Requests for a copy of 
the Department's Paperwork Reduction Act Submission to OMB should be 
directed to the contact person.
    Title: Reporting and recordkeeping requirements for the Chronic 
Beryllium Disease Prevention Program.
    Abstract: The proposed rule would require DOE contractors at sites 
where beryllium is present to: develop and submit an initial CBDPP to 
DOE for approval (Sec. 850.10); periodically revise the CBDPP 
(Sec. 850.10); conduct a baseline inventory of beryllium at the site 
(Sec. 850.20); notify workers of exposure monitoring results 
(Sec. 850.24); develop and maintain a registry of beryllium workers 
(Sec. 850.39); require workers to sign a consent form for beryllium 
work and medical surveillance (Sec. 850.35); establish and maintain 
records related to the beryllium inventory and hazard assessment, 
exposure monitoring, workplace controls and medical surveillance 
(Sec. 850.38); and establish a performance feedback process for 
continually evaluating and improving the CBDPP (Sec. 850.40). DOE has 
determined that these collections of information are necessary for 
implementation of an effective CBDPP.
    The burden of compliance with the collections of information in 
this rule will depend upon the nature of each requirement and the 
number and type of respondents. DOE estimates that DOE contractors at 
15 facilities would be required to develop and submit CBDPPs to DOE for 
approval and, thereafter, implement the CBDPPs including the 
collections of information. Approximately 1,057 workers at the 15 
facilities may be exposed to beryllium and, therefore, may be subject 
to certain of the information collection requirements.
    DOE estimates the total startup costs at $348,781. Initial CBDPPs 
were required from all of the affected facilities by DOE Notice 440.1. 
DOE estimates that 2,549 professional hours and 637 clerical hours were 
required to prepare and submit the initial CBDPPs, at a total cost of 
$112,220. DOE estimates that the baseline inventory of beryllium will 
require 5,026 professional hours and 2,417 clerical hours, for a total 
cost of $234,631. Development of the beryllium registry is expected to 
cost $1,930, which represents 168 hours of clerical time.
    DOE estimates the total recurring, annual paperwork burden at 
$318,860. This includes 3,498 professional hours ($142,047) and 15,375 
clerical hours ($176,812). Recordkeeping would impose the largest 
recurring monetary cost (an estimated 10,993 clerical hours). Other 
recurring paperwork burdens are attributable to submitting performance 
feedback reports, worker notification of exposure monitoring, obtaining 
signed medical consent forms from workers, maintenance of the beryllium 
registry, revising the CBDPP plan on an annual basis, obtaining written 
reports from physicians regarding the results of medical exams, and 
performing analyses of medical data.
    DOE estimates the total annualized cost of paperwork burdens for 
the Chronic Beryllium Disease Prevention Program would be $368,518.

D. Review Under the National Environmental Policy Act

    DOE is reviewing the promulgation of 10 CFR part 850 under the 
National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et 
seq.), the Council on Environmental Quality regulations for 
implementing NEPA, and DOE's NEPA implementing

[[Page 66967]]

procedures (10 CFR part 1021). DOE has prepared a draft Environmental 
Assessment (EA) (DOE/EA 1249) to support a decision on whether to issue 
a finding of no significant impact or to prepare an environmental 
impact statement for this proposed rule. Requests for copies of the 
draft EA and any comments on the EA should be submitted to the address 
indicated in the ADDRESSES section of this NOPR. Copies of the draft EA 
may also be downloaded from the ``Chronic Beryllium Disease Prevention 
Program'' home page on the Internet. The address is http://
tis.eh.doe.gov/be/ DOE will consider any comments on the draft EA and 
the proposed rule before completing the NEPA process.

E. Review Under Executive Order 12612

    Executive Order 12612, 52 FR 41685 (October 30, 1987), requires 
that regulations, rules, legislation, any other policy actions be 
reviewed for any substantial, direct effects on states, on the 
relationship between the national government and the states, or in the 
distribution of power and responsibilities among various levels of 
government. If there are sufficient substantial, direct effects, then 
the Executive Order requires a federalism assessment to be used in all 
decisions involved in promulgating and implementing a policy action.
    This proposed rule, if promulgated as a final rule, would apply 
only to DOE facilities. It would not have a substantial direct effect 
on the institutional interests or traditional functions of the states.

F. Review Under Executive Order 12988

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

G. Review Under the Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each federal agency to prepare a written assessment of the 
effects of any federal mandate in a proposed or final agency rule that 
may result in the expenditure by State, local, and tribal governments, 
in the aggregate, or by the private sector, of $100 million in any one 
year. It also requires a federal agency to develop an effective process 
to permit timely input by elected officers of State, local, and tribal 
governments on a proposed ``significant intergovernmental mandate,'' 
requires an agency to develop a plan for giving notice and opportunity 
to timely input to potentially affected small governments before 
establishing any requirements that might significantly or uniquely 
affect small governments. The proposed rule published today does not 
contain any federal mandate. Thus, these requirements do not apply.

VIII. Public Comment Procedures

A. Written Comments

    Interested individuals are invited to participate in this 
proceeding by submitting data, views, or arguments with respect to this 
proposed rule. To help the Department review the submitted comments, 
commentors are requested to reference the paragraph(s) (e.g., 850.3[a]) 
to which they refer where possible.
    Ten copies of written comments should be submitted to the address 
indicated in the ADDRESSES section of this notice. Comments should be 
identified on the outside of the envelope and on the documents 
themselves with the designation ``Beryllium Rule, Docket No. EH-RM-98-
BRYLM.'' Should anyone wishing to provide written comments be unable to 
provide ten copies, alternative arrangements can be made in advance 
with the Department.
    All submitted comments will be available for public inspection as 
part of the administrative record on file for this rulemaking, which is 
in the DOE Freedom of Information Office Reading Room at the address 
indicated in the ADDRESSES section of this NOPR.
    Pursuant to the provisions of 10 CFR 1004.11, anyone submitting 
information or data he or she believes to be confidential and exempt by 
law from public disclosure should submit one complete copy of the 
document, as well as two copies, if possible, from which the 
information has been deleted. The Department will make its own 
determination as to the confidentiality of the information and treat it 
accordingly.

B. Public Hearings

    Public hearings will be held at the times, dates, and places 
indicated in the DATES and ADDRESSES sections of this NOPR. Any person 
who is interested in making an oral presentation should, by 4:30 p.m. 
on the date specified, make a phone request to the number in the DATES 
section of this NOPR. The person should provide a daytime phone number 
where he or she may be reached. Persons requesting an opportunity to 
speak will be notified as to the approximate time they will be 
speaking. Each presentation is limited to 10 minutes. Persons making 
oral presentations should bring ten copies of their statements to the 
hearing and submit them at the registration desk.
    DOE reserves the right to select the persons who will speak. In the 
event that requests exceed the time allowed, DOE also reserves the 
right to schedule speakers' presentations and to establish the 
procedures for conducting the hearing. A DOE official will be 
designated to preside at each hearing, which will not be judicial or 
evidentiary. Only those conducting the hearing may ask questions. Any 
further procedural rules needed to conduct the hearing properly will be 
announced by the DOE presiding official.
    A transcript of each hearing will be made available to the public. 
DOE will retain the record of the full hearing, including the 
transcript, and make it available for inspection in the DOE Freedom of 
Information Office, at the address provided in the ADDRESSES section of 
this NOPR. Transcripts may be purchased from the court reporter.
    If DOE must cancel the hearings, it will make every effort to give 
advance notice.

Appendix--References

    1. Green DM et al. ``Agency for Toxic Substances and Disease 
Registry (ASTDR)

[[Page 66968]]

Case Studies in Environmental Medicine, No. 19.'' U.S. Department of 
Health and Human Services. 1992.
    2. Hardy HL, Tabershaw IR. ``Delayed Chemical Pneumonitis 
Occurring in Workers Exposed to Beryllium Compounds.'' Journal of 
Industrial Hygiene Toxicology, Volume 28:197 (1946).
    3. Powers MB. ``History of Beryllium.'' In Beryllium Biomedical 
and Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, 
eds. Baltimore: Williams and Wilkins, 1991.
    4. Eisenbud M et al. ``Non-occupational Berylliosis.'' Journal 
of Industrial Hygiene Toxicology, Volume 31:282-294 (1949).
    5. Eisenbud M, Lisson J. ``Epidemiologic Aspects of Beryllium-
Induced Nonmalignant Lung Disease: A 30-Year Update.'' Journal of 
Occupational Medicine, Volume 25:196-202 (1983).
    6. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium 
Intoxication.'' Archives of Industrial Hygiene and Occupational 
Medicine, Volume 4:123-157 (1951).
    7. Newman LS, Kreiss K. ``Nonoccupational Beryllium Disease 
Masquerading as Sarcoidosis: Identification by Blood Lymphocyte 
Proliferative Response to Beryllium.'' American Review of 
Respiratory Disease, Volume 145:1212-1214 (1992).
    8. Tepper LB. ``Introduction.'' In: Beryllium Biomedical and 
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds. 
Baltimore: Williams and Wilkins, 1991.
    9. Sprince NL, Kazemi H. ``Beryllium Disease.'' In: 
Environmental and Occupational Medicine, 2nd ed. Room W, ed. Boston: 
Little, Brown, 1992.
    10. Newman LS et al. ``Pathologic and Immunologic Alterations in 
Early Stages of Beryllium Disease. Reexamination of Disease 
Definition and Natural History.'' American Review of Respiratory 
Disease, Volume 139:1479-11486, (1989).
    11. Kreiss K, Newman LS, Mroz MM, Campbell, PA. ``Screening 
Blood Test Identifies Subclinical Beryllium Disease.'' Journal of 
Occupational Medicine, Volume 31:603-608 (1989).
    12. Rossman MD, Kern JA, Elias JA et al. ``Proliferative 
Response of Bronchoalveolar Lymphocytes to Beryllium: A Test For 
Chronic Beryllium Disease.'' Annals of Internal Medicine, Volume 
108:687-693 (1988).
    13. Saltini C, Winestock K, Kirby M et al. ``Maintenance of 
Alveolitis in Patients with Chronic Beryllium Disease by Beryllium 
Specific Helper T-Cells.'' New England Journal of Medicine, Volume 
320:103-1109 (1989).
    14. Cullen MR et al. ``Chronic Beryllium Disease in a Metal 
Refinery. Clinical Epidemiologic and Immunologic Evidence for 
Continuing Risk from Exposure to Low Level Beryllium Fume.'' 
American Review of Respiratory Disease, Volume 135(1):201-208 
(1987).
    15. Kreiss K, Mroz MM, Zhen B et al. ``Epidemiology of Beryllium 
Sensitization and Disease in Nuclear Workers.'' American Review of 
Respiratory Disease, Volume 148:985-991 (1993).
    16. Kreiss K et al. ``Beryllium Disease Screening in the 
Ceramics Industry.'' Journal of Occupational Medicine, Volume 
35:267-274 (1993).
    17. Health Assessment Document for Beryllium [Publication No. 
EPA/600/8-84/026F] U.S. Environmental Protection Agency. (1987).
    18. Stange AW et al. ``Possible Health Risks from Low Level 
Exposure to Beryllium.'' Toxicology, Volume 111:213-224 (1996).
    19. Barnard AE, et al. ``Retrospective Beryllium Exposure 
Assessment at the Rocky Flats Environmental Technology Site.'' 
American Industrial Hygiene Association Journal, Volume 57:804-808 
(1996).
    20. Kreiss K et al. ``Machining Risk of Beryllium Disease and 
Sensitization with Median Exposures Below 2 g/m\3\,'' 
American Journal of Industrial Medicine, Volume 30:16-25 (1996).
    21. Cohen BS. ``Air Sampling.'' In: Beryllium Biomedical and 
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds. 
Baltimore: Williams and Wilkins, 1991.
    22. Finch GL. ``In Vitro Dissolution Characteristics of 
Beryllium Oxide and Beryllium Metal Aerosols.'' Journal of Aerosols 
Science, Volume 19:333-342 (1988).
    23. Newman LS. ``To Be2+ or Not to Be2+: 
Immunogenetics and Occupational Exposure.'' Science, Volume 262:197-
198 (8 October 1993).
    24. Haley PJ. ``Mechanisms of Granulomatous Lung Disease from 
Inhaled Beryllium: The Role of Antigenicity in Granuloma 
Formation.'' Toxicologic Pathology, Volume 19:514-525 (1991).
    25. Finch GL. ``Clearance, Translocation, and Excretion of 
Beryllium Following Inhalation of Beryllium Oxide by Beagle Dogs.'' 
Fundamentals of Applied Toxicology, Volume 15:231-241 (1990).
    26. Richeldi L et al. ``HLA-DPB1 Glutamate 69: A Genetic Marker 
of Beryllium Disease.'' Science, Volume 262:242-244 (8 October 
1993).
    27. Eisenbud M. ``The Standard for Control of Chronic Beryllium 
Disease.'' Applied Occupational Environmental Hygiene, Volume 
13(1):25-31 (January1998).
    28. Pappas GP et al. ``Early Pulmonary Physiologic Abnormalities 
in Beryllium Disease.'' American Review of Respiratory Disease, 
Volume 148:661-666 (1993).
    29. Hawkins NC, Norwood SK, and Rock JC, eds. A Strategy for 
Occupational Exposure Assessment. Virginia: American Industrial 
Hygiene Association (1991).

List of Subjects in 10 CFR Part 850

    Hazardous waste, Occupational safety and health, Reporting and 
recordkeeping requirements, Safety.

    Issued in Washington, DC on October 30, 1998.
Bill Richardson,
Secretary of Energy.
    For the reasons set forth in the preamble, Title 10, Chapter III of 
the Code of Federal Regulations is proposed to be amended by adding 
Part 850 to read as set forth below.

PART 850--CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM

Subpart A--General Provisions

Sec.
850.1  Scope.
850.2  Applicability.
850.3  Definitions.
850.4  Enforcement.
850.5  Dispute resolution.

Subpart B--Administrative Requirements

850.10  Development and approval of the CBDPP.
850.11  General CBDPP requirements.
850.12  Implementation.
850.13  Compliance.

Subpart C--Specific Program Requirements

850.20  Baseline beryllium inventory.
850.21  Hazard assessment.
850.22  Exposure limits.
850.23  Action level.
850.24  Exposure monitoring.
850.25  Exposure reduction and minimization.
850.26  Regulated areas.
850.27  Change rooms.
850.28  Respiratory protection.
850.29  Protective clothing and equipment.
850.30  Housekeeping.
850.31  Waste disposal.
850.32  Beryllium emergencies.
850.33  Medical surveillance.
850.34  Medical removal.
850.35  Medical consent.
850.36  Training and counseling.
850.37  Warning signs and labels.
850.38  Recordkeeping and use of information.
850.39  Beryllium registry.
850.40  Performance feedback.

    Appendix A to Part 850--Chronic Beryllium Disease Prevention 
Program Informed Consent Form
    Appendix B to Part 850--Questions and Answers Concerning the 
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical 
Records, and the DOE Beryllium Registry

    Authority: 42 U.S.C. 2201.

Subpart A--General Provisions


Sec. 850.1  Scope.

    This part establishes a chronic beryllium disease prevention 
program (CBDPP) that supplements and is integrated into existing worker 
protection programs that are established for Department of Energy (DOE) 
employees and DOE contractor employees.


Sec. 850.2  Applicability.

    (a) This part applies to:
    (1) DOE offices responsible for DOE beryllium activities and DOE 
employees exposed or potentially exposed to beryllium at DOE-owned or -
leased facilities; and
    (2) DOE contractors and contractor employees with operations or 
activities involving exposure or the potential for

[[Page 66969]]

exposure of employees to beryllium at DOE-owned or -leased facilities.
    (b) This part does not apply to:
    (1) Beryllium articles; and
    (2) DOE laboratory operations involving beryllium that are subject 
to the requirements of 29 CFR 1910.1450, Occupational Exposure to 
Hazardous Chemicals in Laboratories.


Sec. 850.3  Definitions.

    (a) As used in this part:
    Accepted applicant means a person who has accepted an offer of 
employment in beryllium work at a DOE facility but who has not begun 
performing beryllium work.
    Action level means the level of airborne concentration of beryllium 
established pursuant to Sec. 850.23 of this part that, if exceeded, 
requires the implementation of worker protection provisions specified 
in that section.
    Authorized person means any person required by work duties to be in 
a regulated area.
    Beryllium means elemental beryllium and any insoluble beryllium 
compound or alloy containing 0.1 percent beryllium or greater that may 
be released as an airborne particulate.
    Beryllium article means a manufactured item that is formed to a 
specific shape or design during manufacture that has end-use functions 
that depend in whole or in part on its shape or design during end use 
and that does not release beryllium or otherwise result in exposure to 
airborne concentrations of beryllium under normal conditions of use.
    Beryllium emergency means any occurrence such as, but not limited 
to, equipment failure, container rupture, or failure of control 
equipment or operations that results in an unexpected and significant 
release of beryllium at a DOE facility.
    Beryllium-induced lymphocyte proliferation test (Be-LPT) is an in 
vitro measure of the beryllium antigen-specific, cell-mediated immune 
response.
    Beryllium worker means a current worker who is exposed or 
potentially exposed to airborne concentrations of beryllium at or above 
the action level or above the STEL or who is currently receiving 
medical removal protection benefits.
    Breathing zone is defined as a hemisphere forward of the shoulders, 
centered on the mouth and nose, with a radius of 6 to 9 inches.
    DOE means the U.S. Department of Energy.
    DOE beryllium activity means an activity taken for, or by, DOE that 
can expose workers to beryllium, including but not limited to design, 
construction, operation, or decommissioning. The activity may involve 
one DOE facility or operation or a combination of facilities and 
operations.
    DOE contractor means any entity under contract (or its 
subcontractor) with DOE with responsibility to perform beryllium 
activities at DOE facilities.
    DOE facility means any facility operated by or for DOE.
    High-efficiency particulate air (HEPA) filter means a filter 
capable of trapping and retaining at least 99.97 percent of 0.3 
micrometer monodispersed particles.
    Immune response refers to the series of cellular events by which 
the immune system reacts to challenge by an antigen.
    Medical removal protection benefits are employment rights 
established by Sec. 850.34 of this part for beryllium workers who are 
removed temporarily from work in regulated areas or who voluntarily 
accept permanent medical removal from regulated areas following tests 
that confirm beryllium sensitivity or CBD.
    Regulated area means an area or physical location demarcated by the 
contractor in which the airborne concentration of beryllium exceeds, or 
can reasonably be expected to exceed, the action level or the STEL.
    Short term exposure limit (STEL) means the short term exposure 
limit established pursuant to Sec. 850.22(b) of this part.
    Site occupational medicine director (SOMD) means the physician 
responsible for the overall direction and operation of the site 
occupational medicine program.
    Surface contamination is the presence of beryllium on work 
surfaces, which may cause skin irritation by direct contact with 
damaged skin or which may present an airborne hazard when reentrained 
into the workplace air.
    Worker means a person who performs work for or on behalf of DOE, 
including a DOE employee, an independent contractor, a DOE contractor 
employee, or any other person who performs work at a DOE facility.
    Worker exposure means the exposure to airborne beryllium that would 
occur if the worker were not using respiratory protective equipment.
    Terms used in this part that are undefined but that are defined in 
the Atomic Energy Act shall have the same meaning as under the Atomic 
Energy Act.


Sec. 850.4  Enforcement.

    DOE may take appropriate steps under its contracts with DOE 
contractors to ensure compliance with this part, including contract 
termination or reduction in fee.


Sec. 850.5  Dispute resolution.

    Disputes arising under this part that are brought by beryllium 
workers and accepted applicants shall be resolved through applicable 
grievance-arbitration processes or, where such processes are not 
available, through referral to the Department's Office of Hearings and 
Appeals. The procedures in 10 CFR part 1003, subpart G, shall apply to 
resolution of disputes by the Office of Hearing and Appeals.

Subpart B--Administrative Requirements


Sec. 850.10  Development and approval of the CBDPP.

    (a) Preparation and Submission of Initial CBDPP to DOE. (1) DOE 
contractors responsible for DOE beryllium activities at DOE facilities 
shall ensure that a CBDPP is prepared for their respective facility and 
submitted to the appropriate DOE Field Organization before beginning 
beryllium activities, but no later than [90 days after the effective 
date of the final rule] of this part.
    (2) Where there are separate sections addressing the activities of 
particular contractors at the facility, the DOE contractor designated 
by the DOE Field Organization shall review and approve those sections 
so that a single consolidated CBDPP for the facility is submitted to 
the DOE Field Organization for review and approval.
    (b) DOE Review and Approval. Heads of DOE Field Organizations shall 
review and approve the CBDPPs.
    (1) The initial CBDPP and any updates shall be considered approved 
90 days after submission if not approved or rejected by DOE earlier.
    (2) DOE contractors shall furnish a copy of the approved CBDPP, 
upon request, to the DOE Assistant Secretary for Environment, Safety 
and Health or designee, DOE program offices, and affected workers or 
their designated representatives.
    (c) Update. DOE contractors shall submit an update of the CBDPP to 
the appropriate DOE Field Organization for review and approval whenever 
a significant change or significant addition to the CBDPP is made or a 
change in contractor or subcontractor occurs. CBDPPs shall be reviewed 
at least annually and updated as necessary.
    (d) Labor Organizations. If a DOE contractor employs beryllium 
workers who are represented for collective bargaining agreements by 
labor

[[Page 66970]]

organizations, the contractor must give those organizations timely 
notice of the development and implementation of the CBDPP and any 
updates thereto and must, upon timely request, bargain concerning 
implementation of this part, consistent with the National Labor 
Relations Act.


Sec. 850.11  General CBDPP requirements.

    (a) The CBDPP shall specify the existing and planned operational 
tasks that are within the scope of the CBDPP. The CBDPP shall augment 
and be integrated, to the extent feasible, into the existing worker 
protection programs that cover activities at the facility.
    (b) The detail, scope, and content of the CBDPP for DOE beryllium 
activities shall be commensurate with the hazard of the activities 
performed, but in all cases the CBDPP shall:
    (1) Include formal plans and measures for maintaining exposures to 
beryllium at or below the permissible exposure levels (PELs);
    (2) Satisfy each requirement in subpart C of this part;
    (3) Contain provisions for:
    (i) Minimizing the number of current workers exposed and 
potentially exposed to beryllium;
    (ii) Minimizing the number of opportunities for workers to be 
exposed to beryllium; and
    (iii) Setting specific exposure reduction and minimization goals 
that are appropriate for the DOE activities covered by the CBDPP to 
further reduce exposure below the exposure limits prescribed in section 
850.22.


Sec. 850.12  Implementation.

    (a) DOE contractors shall manage and control beryllium exposures in 
all DOE beryllium activities consistent with the approved CBDPP.
    (b) No DOE worker or DOE contractor worker shall take or cause any 
action inconsistent with the requirements of:
    (1) This part,
    (2) An approved CBDPP or any other program, plan, schedule, or 
other process established by this part,
    (3) Any other Federal statute or regulation concerning the exposure 
of workers to beryllium at DOE facilities.
    (c) No task involving potential beryllium exposure that is outside 
the scope of the existing CBDPP shall be initiated until an update of 
the CBDPP is approved by the DOE Field Organization, except in the 
event of an unexpected situation and, then, only upon approval of the 
DOE Field Organization.
    (d) Nothing in this part shall be construed as precluding a DOE 
contractor from taking any additional protective action that it 
determines to be necessary to protect the health and safety of workers.


Sec. 850.13  Compliance.

    (a) DOE contractors shall conduct activities in compliance with 
their respective CBDPP, as approved by the DOE Field Organization.
    (b) DOE contractors shall achieve compliance with all elements of 
their respective CBDPP no later than [2 years from the effective date 
of the final rule].
    (c) With respect to a particular DOE beryllium activity, the person 
in charge of the activity shall be responsible for complying with this 
part. If no contractor is responsible for a DOE beryllium activity, DOE 
shall ensure implementation of and compliance with this part.

Subpart C--Specific Program Requirements


Sec. 850.20  Baseline beryllium inventory.

    (a) DOE contractors shall develop a baseline inventory of beryllium 
operations and other locations of potential beryllium contamination, 
and identify the workers exposed or potentially exposed to beryllium at 
those locations.
    (b) In conducting the baseline inventory, DOE contractors shall:
    (1) Review employee records;
    (2) Interview employees;
    (3) Document the presence and locations of beryllium at the 
facility; and
    (4) Conduct sampling to identify the presence of beryllium.
    (c) DOE contractors shall ensure that the individuals assigned to 
this task have sufficient industrial hygiene knowledge to perform such 
activities properly.


Sec. 850.21  Hazard assessment.

    (a) If the baseline inventory establishes the presence of 
beryllium, DOE contractors shall conduct a beryllium hazard assessment 
that includes an analysis of existing conditions, exposure data, 
medical surveillance trends, and the exposure potential of planned 
activities.
    (b) DOE contractors shall ensure that the individuals assigned to 
this task have sufficient industrial hygiene knowledge to perform such 
activities properly.


Sec. 850.22  Exposure limits.

    (a) Eight-Hour Time-Weighted Average (TWA) Permissible Exposure 
Limit (PEL). DOE contractors shall not expose any worker to an airborne 
concentration of beryllium over 2 g/m\3\, calculated as an 8-
hour TWA exposure, as measured in the worker's breathing zone by 
personal monitoring, or a more stringent TWA PEL that may be 
promulgated by the Occupational Safety and Health Administration as a 
health standard.
    (b) Short-Term Exposure Limit (STEL). DOE contractors shall not 
expose any worker to an airborne concentration of beryllium over 10 
g/m\3\, averaged over a sampling period of 15 minutes, as 
measured in the worker's breathing zone by personal monitoring. 
Exposures above the PEL-TWA up to the STEL must not be longer than 15 
minutes and must not occur more than four times in a day. If such 
exposures occur more than once a day, there must be at least 60 minutes 
between successive exposures in this range.


Sec. 850.23  Action level.

    (a) DOE contractors shall include in their CBDPP an action level 
that, if met or exceeded, shall require the implementation of 
Secs. 850.24(c) (periodic monitoring), 850.26 (regulated areas), 850.27 
(change rooms), 850.29 (protective clothing and equipment), and 850.33 
(medical surveillance).
    (b) The provision enumerated in paragraph (a) of this section shall 
also be implemented if the STEL is exceeded.
    (c) The action level established under paragraph (a) of this 
section shall not exceed 0.5 g/m\3\, calculated as an 8-hour 
TWA exposure, as measured in the worker's breathing zone by personal 
monitoring.


Sec. 850.24  Exposure monitoring.

    (a) General. DOE contractors shall ensure that the individuals 
assigned to the monitoring tasks of this section have sufficient 
industrial hygiene knowledge to perform such activities properly.
    (b) Initial Monitoring. DOE contractors shall perform initial 
monitoring for all workers in areas that may have airborne 
concentrations of beryllium, as shown by the baseline inventory and 
hazard assessment.
    (1) DOE contractors shall determine each worker's exposure by 
conducting personal breathing zone sampling:
    (i) To determine the 8-hour TWA exposure level.
    (ii) To determine if exposure is above the STEL.
    (2) Exposure monitoring results obtained within the 12 months 
preceding the effective date of this part may be used to satisfy this 
requirement if the measurements were made as provided in paragraph 
(b)(1) of this section.
    (c) Periodic Exposure Monitoring. DOE contractors shall conduct 
periodic

[[Page 66971]]

monitoring of all workers who work in areas where airborne 
concentrations of beryllium are at or above the action level or above 
the STEL. The monitoring shall be conducted in a manner and at a 
frequency necessary to represent worker exposures as specified in their 
respective CBDPP, but in no case shall sampling be conducted at 
intervals greater than every 3 months (quarterly).
    (d) Additional Exposure Monitoring. DOE contractors shall perform 
additional monitoring if operations or procedures change.
    (e) Accuracy of Monitoring. DOE contractors shall use a monitoring 
method that has an accuracy (to a confidence level of 95 percent) of 
not less than plus or minus 25 percent or better for airborne 
concentrations of beryllium at the action level.
    (f) Analysis. DOE contractors shall have all samples collected to 
satisfy the monitoring requirements of this part analyzed in a 
laboratory accredited for metals by the American Industrial Hygiene 
Association.
    (g) Notification of Monitoring Results. (1) DOE contractors shall, 
within 10 working days after receipt of any monitoring results, notify 
the affected workers, and any labor organizations representing such 
workers, of monitoring results in writing. This notification shall be 
made personally to the affected workers or representatives, or in a 
posted form in location(s) that are readily accessible to affected 
workers, but in a manner that does not identify individual workers.
    (2) If the monitoring results indicate that worker exposure is at 
or above the action level or STEL, DOE contractors shall also notify 
the SOMD of these results within 10 working days after receipt.


Sec. 850.25  Exposure reduction and minimization.

    (a) DOE contractors shall ensure that no worker is exposed above 
the exposure limits prescribed in Sec. 850.22, using the conventional 
hierarchy of industrial hygiene controls (i.e., engineering and 
administrative controls, and personal protective equipment).
    (b) DOE contractors shall include in the CBDPP the rationale for 
reduction and minimization goals, strategies for achieving those goals, 
and the specific measures that will be used to assess the attainment of 
those goals. Strategies for achieving the exposure reduction and 
minimization goals shall include, but are not limited to:
    (1) Using the action level to initiate actions to reduce or 
minimize worker exposure, and the potential for exposure, to beryllium; 
and
    (2) Implementing work and contamination control strategies to 
reduce exposure to CBDPP goal levels using the conventional hierarchy 
of industrial hygiene controls.


Sec. 850.26  Regulated areas.

    (a) If airborne concentrations of beryllium in areas in DOE 
facilities are at or above the action level or above the STEL, DOE 
contractors shall establish regulated areas for those particular areas.
    (b) Regulated areas shall be demarcated from the rest of the 
workplace in a manner that adequately alerts workers to the boundaries 
of such areas.
    (c) DOE contractors shall limit access to regulated areas to 
authorized persons.
    (d) DOE contractors shall keep records of all individuals who enter 
regulated areas. These records shall include the name, date, time in 
and time out, and work activity.


Sec. 850.27  Change rooms.

    (a) DOE contractors shall provide change rooms for workers who work 
in regulated areas.
    (1) The change rooms that are used to remove beryllium-contaminated 
clothing and protective equipment shall be maintained under negative 
pressure or located so as to minimize dispersion of beryllium into 
clean areas; and
    (2) Separate facilities shall be provided for workers to change 
into, and store, personal clothing, and clean protective clothing and 
equipment.
    (b) DOE contractors shall provide handwashing and shower facilities 
for workers who work in regulated areas.


Sec. 850.28  Respiratory protection.

    (a) DOE contractors shall comply with the respiratory protection 
requirements of 29 CFR 1910.134, Respiratory Protection.
    (b) DOE contractors shall provide respirators to, and ensure that 
they are used by, all workers who are exposed to an airborne 
concentration of beryllium at or above the PEL.
    (c) DOE contractors shall select for use by beryllium workers 
respirators approved by the National Institute for Occupational Safety 
and Health (NIOSH) or those DOE has accepted for use for DOE employees.


Sec. 850.29  Protective clothing and equipment.

    (a) Where exposure monitoring has established airborne 
concentrations of beryllium at or above the action level or above the 
STEL, DOE contractors shall provide protective clothing and equipment 
to their beryllium workers and ensure its appropriate use and 
maintenance.
    (1) DOE contractors shall ensure that beryllium workers exchange 
their personal clothing for full-body protective clothing and footwear 
before they begin work in regulated areas.
    (2) DOE contractors shall provide beryllium workers with, and 
ensure the use of, additional protective equipment, such as face 
shields, goggles, gloves, and gauntlets, where skin or eye contact is 
possible from powdered or liquid forms of beryllium.
    (b) DOE contractors shall ensure that no worker takes beryllium-
contaminated protective clothing and equipment from the site, except 
for workers authorized to launder, clean, maintain, or dispose of the 
clothing and equipment.
    (1) DOE contractors shall ensure that contaminated protective 
clothing and equipment, when removed for laundering, cleaning, 
maintenance, or disposal, is stored in sealed, impermeable containers 
or other closed, impermeable containers that are designed to prevent 
the dispersion of beryllium dust.
    (2) DOE contractors shall ensure that the bags or containers of 
contaminated protective clothing and equipment that are to be removed 
from the change room areas or the site for laundering, cleaning, 
maintenance, or disposal shall bear labels according to section 850.37 
of this part.
    (c) DOE contractors shall ensure that protective clothing and 
equipment is cleaned, laundered, repaired, or replaced as needed to 
maintain effectiveness.
    (d) DOE contractors shall inform any individual who launders or 
cleans beryllium-contaminated protective clothing or equipment that 
exposure to beryllium is potentially harmful, and that clothing and 
equipment should be laundered or cleaned in a manner prescribed by the 
contractor to prevent the release of airborne beryllium at or above the 
action level or above the STEL.
    (e) DOE contractors shall prohibit the removal of beryllium from 
protective clothing and equipment by blowing, shaking, or other means 
that may disperse beryllium into the air.


Sec. 850.30  Housekeeping.

    (a) Where beryllium is present at DOE facilities, DOE contractors 
shall conduct routine surface sampling to determine housekeeping 
conditions. Surfaces contaminated with beryllium dusts and waste shall 
not exceed a removable surface contamination level of 3 g/100 
cm2.

[[Page 66972]]

    (b) Where beryllium is present at DOE facilities, DOE contractors 
shall clean beryllium-contaminated floors and surfaces using a wet 
method or vacuuming. Compressed-air or dry methods shall not be used 
for such cleaning.
    (c) DOE contractors shall equip the portable or mobile vacuum units 
that are used to clean beryllium-contaminated areas with HEPA filters, 
and change filters as often as necessary to maintain their capture 
efficiency.
    (d) DOE contractors shall ensure that the cleaning equipment that 
is used to clean beryllium-contaminated surfaces is labeled, 
controlled, and used in no other areas.


Sec. 850.31  Waste disposal.

    (a) DOE contractors shall control the generation and disposal of 
waste that contains beryllium through good housekeeping, hazard 
analysis, and the application of waste minimization principles.
    (b) Beryllium-contaminated waste, containers, small equipment, and 
clothing shall be disposed of in sealed, impermeable bags or 
containers. The bags and containers that are used to dispose of 
beryllium-contaminated waste or articles shall be labeled according to 
Sec. 850.37.


Sec. 850.32  Beryllium emergencies.

    (a) DOE contractors shall develop and implement procedures for 
handling beryllium emergencies at DOE facilities engaged in beryllium 
operations.
    (1) DOE contractors shall establish procedures to alert and protect 
workers in the event of an emergency.
    (2) DOE contractors shall ensure that workers who are engaged in 
cleanup related to a beryllium emergency are provided with, and wear, 
protective equipment and clothing.
    (b) DOE contractors shall provide beryllium emergency procedure 
training to workers who are assigned to handle beryllium emergencies.


Sec. 850.33  Medical surveillance.

    (a) General. DOE contractors shall designate a SOMD who shall be 
responsible for administering a medical surveillance program for 
contractor beryllium workers.
    (b) Heads of DOE Field Organizations shall designate a SOMD who 
shall be responsible for administering a medical surveillance program 
for federal employees who are beryllium workers.
    (c) The written medical surveillance program shall be reviewed by 
the Office of Environment, Safety and Health and approved by Heads of 
DOE Field Organizations.
    (d) DOE contractors shall establish and implement a medical 
surveillance program under the direction of the SOMD for all beryllium 
workers exposed at or above the action level or above the STEL.
    (e) DOE contractors shall provide the SOMD with the information 
needed to operate and administer the medical surveillance program, 
including the baseline inventory, hazard assessment and exposure 
monitoring data, identity and nature of activities or operations on the 
site that are covered under the CBDPP, related duties of beryllium 
workers, and type of personal protective equipment used.
    (f) The SOMD shall establish and maintain a list of beryllium 
workers that is based on records and other information regarding the 
identity of beryllium workers.
    (1) The list shall establish the population of beryllium workers 
who may be eligible for protective measures under this part.
    (2) The list shall be adjusted on the basis of periodic evaluations 
of beryllium workers performed under paragraph (h)(3) of this section.
    (g) Information provided to the examining physician. The SOMD shall 
provide the following information to the examining physician:
    (1) A copy of this rule;
    (2) A description of the beryllium worker's duties as they pertain 
to beryllium exposure;
    (3) Records of the beryllium worker's beryllium exposure;
    (4) A description of the personal protective and respiratory 
protective equipment in past, present, or anticipated use; and
    (5) Relevant information from the beryllium worker's previous 
medical examinations that is not otherwise available to the examining 
physician.
    (h) Medical evaluations. (1) DOE contractors shall provide medical 
examinations and procedures to beryllium workers and accepted 
applicants at no cost and at a time and place that is reasonable and 
convenient to them.
    (2) DOE contractors shall offer a baseline medical evaluation to 
beryllium workers who qualify for medical surveillance. This evaluation 
shall include:
    (i) A medical and work history;
    (ii) A physical examination with special emphasis on the 
respiratory system;
    (iii) A chest radiograph (posterior-anterior, 14  x  17 inches) 
interpreted by a National Institute for Occupational Safety and Health 
(NIOSH) B-reader or a board-certified radiologist (unless a baseline 
chest radiograph is already on file);
    (iv) Spirometry;
    (v) A Be-LPT; and
    (vi) Any other tests deemed appropriate by the examining physician 
for evaluating beryllium-related health effects.
    (3) Periodic evaluations. DOE contractors shall offer beryllium 
workers who qualify for medical surveillance under this section annual 
medical evaluations for as long as the beryllium worker performs 
beryllium work at a DOE site. DOE contractors shall offer beryllium 
workers who have been reassigned to non beryllium DOE work an 
evaluation every three years. Such periodic evaluations shall include:
    (i) A respiratory symptoms questionnaire;
    (ii) A physical examination;
    (iii) A Be-LPT; and
    (iv) Any other medical evaluations deemed appropriate by the 
examining physician for evaluating beryllium-related health effects.
    (4) The SOMD shall ensure that all medical evaluations and 
procedures that are required by this section are performed by, or under 
the supervision of, a licensed physician who is familiar with the 
health effects of beryllium.
    (i) Referrals. Beryllium workers who have two or more positive Be-
LPTs, or other signs and symptoms of CBD, shall be referred by the 
examining physician for further diagnostic evaluation.
    (j) Physician's written report and recommendation. (1) DOE 
contractors shall ensure that each beryllium worker or accepted 
applicant receives, within 15 calendar days after the completion of a 
medical evaluation performed under this section, a physician's written 
report containing the results of all medical tests or procedures, an 
explanation of any abnormal findings, and any recommendations that the 
worker be referred for additional testing for evidence of CBD.
    (2) DOE contractors shall, within 15 calendar days after the 
completion of a medical evaluation performed under this section, obtain 
a copy of the physician's written report, that is limited to the 
following information: any recommendations that the beryllium worker's 
exposure to beryllium be precluded or that the accepted applicant's 
start of beryllium work be postponed, either temporarily or 
permanently, and any recommendation on the use of respiratory or other 
protective equipment.
    (k) Data analysis. The SOMD shall routinely and systematically 
analyze medical, job, and exposure data with the

[[Page 66973]]

aim of identifying individuals or groups of individuals potentially at 
risk for CBD and working conditions that are unduly contributing to 
that risk.
    (1) Results of these analyses shall be used by the SOMD in 
determining which workers should be offered medical surveillance, and 
the need for additional exposure controls.
    (2) The SOMD shall provide copies of the data analyses to the DOE 
contractor for the performance feedback required in section 850.40.


Sec. 850.34  Medical removal.

    (a) Medical removal plan. With the express written consent of the 
beryllium worker or accepted applicant, as indicated on the consent 
form, DOE contractors shall remove a beryllium worker from exposure to 
beryllium, or postpone an accepted applicant's start of beryllium work, 
if the SOMD recommends that the beryllium worker or accepted applicant 
do so due to two or more positive Be-LPT results, confirmation of CBD, 
or the detection of other signs or symptoms that require evaluation for 
their relationship to CBD.
    (1) DOE contractors shall offer a beryllium worker removed from 
beryllium work a follow-up medical examination that the examining 
physician shall use to decide whether the beryllium worker may return 
to beryllium work.
    (2) Beryllium workers and accepted applicants with two or more 
positive Be-LPTs or confirmed CBD shall have the option at any time 
after testing, diagnosis, or the appearance of CBD-related symptoms to 
decline the medical removal or restriction and, after signing an 
informed consent waiver, resume working in a beryllium area.
    (3) DOE contractors shall make reasonable efforts to offer 
alternative employment to beryllium workers and accepted applicants who 
test positive on two or more Be-LPTs, or who are confirmed with CBD. 
The reasonable efforts to offer alternative employment required under 
this section shall not require the contractor: to displace any other 
worker in order to create a vacancy for the beryllium worker or 
accepted applicant; to promote the beryllium worker or accepted 
applicant; or to provide the beryllium worker or accepted applicant 
with training that costs in excess of $6,000.00, or requires longer 
than 6 months to complete.
    (b) Medical removal protection benefits. DOE contractors shall 
provide beryllium workers who are removed from beryllium work and 
placed in other jobs with the contractor employing them, protection 
against a reduction in base pay, seniority, or other benefits for a 
total period of two years after removal.


Sec. 850.35  Medical consent.

    (a) DOE contractors shall provide beryllium workers and accepted 
applicants with information on the benefits and risks of the medical 
tests and examinations available to them at least one week prior to any 
such examination or test. The examining physician shall provide 
beryllium workers and accepted applicants an opportunity to have their 
questions answered and shall obtain their signed consent before 
performing medical evaluations.
    (b) DOE contractors shall also provide beryllium workers and 
accepted applicants with a summary of the medical surveillance program, 
the type of data that will be collected, how the data will be collected 
and maintained, the purpose for which the data will be used, and how 
confidential data will be protected. This information shall be provided 
at least one week prior to the first medical examination or test, or at 
any time requested by the beryllium worker or accepted applicant.
    (c) DOE contractors shall use the form approved by the Assistant 
Secretary for Environment, Safety and Health to obtain the signed 
consent of a beryllium worker before performing a medical examination.
    (d) DOE contractors shall provide beryllium workers or accepted 
applicants information that will facilitate informed decisions on 
whether to accept medical removal offered by the SOMD. This information 
shall include information on opportunities for alternative placement 
within their organization, available out-placement benefits, and long-
term medical and disability insurance benefits for which they may 
qualify.
    (e) The SOMD shall provide a beryllium worker or an accepted 
applicant with an opportunity to have his or her questions answered 
before obtaining the worker's agreement to medical removal or a signed 
waiver of an offer of medical removal protection.


Sec. 850.36  Training and counseling.

    (a) DOE contractors shall develop and implement a beryllium 
training program for workers who may be exposed to beryllium, and 
ensure their participation.
    (1) The information and training provided shall be in accordance 
with 29 CFR 1910.1200, Hazard Communication.
    (2) Training shall be provided before or at the time of initial 
assignment and at least annually thereafter.
    (3) Training shall include, but not be limited to, beryllium health 
risk, exposure reduction, safe handling of beryllium, and medical 
surveillance.
    (b) DOE contractors shall develop and implement a beryllium worker 
counseling program to assist workers who are diagnosed by the SOMD to 
be sensitized to beryllium or to have CBD. This program shall include 
communicating with beryllium workers concerning the availability of: 
the medical surveillance program; medical treatment options; medical, 
psychological, and career counseling for workers with positive Be-LPT 
results or confirmed CBD; medical benefits; worker compensation claims; 
work practice procedures limiting worker exposure to beryllium; and the 
risk of continued exposure after sensitization.


Sec. 850.37  Warning signs and labels.

    (a) Warning signs. DOE contractors shall post warning signs at all 
entranceways to regulated areas with the following information:

DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY

    (b) Warning labels. (1) DOE contractors shall affix warning labels 
to all containers of beryllium, beryllium compounds, or beryllium-
contaminated clothing, equipment, waste, scrap, or debris.
    (2) Labels shall be in accordance with 29 CFR 1910.1200, Hazard 
Communication, and shall contain the following information:

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


Sec. 850.38  Recordkeeping and use of information.

    (a) DOE contractors shall establish and maintain accurate records 
of all beryllium inventory information, hazard assessments, exposure 
measurements, controls, and medical surveillance.
    (b) DOE contractors shall maintain all records required by this 
part in an electronic, easily retrievable form for transmittal to DOE 
Headquarters on request.
    (c) DOE contractors shall link data sets on working conditions and 
health outcomes to serve as a basis for understanding the beryllium 
health risk.
    (d) Medical information generated by the CBDPP shall be maintained 
by the contractor as part of the beryllium worker's site medical 
records. Such medical information shall be maintained separately from 
other

[[Page 66974]]

personnel records. This information must be kept confidential and used 
or disclosed by the contractor only in conformance with any applicable 
requirements imposed by the Americans with Disabilities Act, the 
Privacy Act of 1974, and any other requirements under applicable law.


Sec. 850.39  Beryllium registry.

    (a) DOE contractors shall establish and maintain a separate 
electronic beryllium registry that includes the name, social security 
number (SSN), date of birth, gender, site, job history, medical 
screening test results, and results of referrals for specialized 
medical evaluation. This data shall be submitted for all beryllium 
workers employed by them and all accepted applicants, subject to the 
requirements of Sec. 850.38.
    (b) DOE contractors shall transmit the beryllium registry 
information electronically to the Office of Environment, Safety and 
Health, Office of Epidemiologic Surveillance, semi-annually.
    (c) Information in the beryllium registry maintained by DOE under 
paragraph (a) of this section may be disclosed only in a manner 
consistent with the Privacy Act of 1974 and any other applicable legal 
requirements.


Sec. 850.40  Performance feedback.

    (a) DOE contractors shall conduct periodic analyses and assessments 
of monitoring efforts, hazards, medical surveillance, exposure 
reduction and minimization, and occurrence reporting data.
    (b) To ensure that information is available to maintain and improve 
all elements of the CBDPP continuously, results of periodic analyses 
and assessments shall be given to the line managers, planners, worker 
protection staff, workers, medical staff, and labor organizations 
representing beryllium workers who request such information.

Appendix A to Part 850--Chronic Beryllium Disease Prevention 
Program Informed Consent Form

    I have carefully read and understand the attached information 
about the Be-LPT and other medical tests. I have had the opportunity 
to ask any questions that I may have had concerning these tests.
    I understand that I am free to withdraw at any time from all or 
any part of the medical surveillance program. I understand that if 
the results of any test suggest a health problem, the examining 
physician will discuss the matter with me, whether or not the result 
is related to my work with beryllium.
    I understand that the results of my tests and examinations may 
be published in reports or presented at meetings, but that I will 
not be identified.
    I understand that the results of my medical tests for beryllium 
will be included in the Beryllium Registry maintained by DOE. The 
confidentiality of identified information maintained by DOE is 
protected under the Privacy Act of 1974. Personal identifiers will 
not be published in any reports generated from the DOE Beryllium 
Registry. All medical information relative to the tests performed on 
me retained by my employer will be maintained in segregated medical 
files separate from my personnel files, treated as confidential 
medical records, and used or disclosed only as provided by the 
Americans with Disability Act, the Privacy Act of 1974, or as 
required by a court order or DOE directive.
    I consent to having the following medical evaluations:

{time}  Physical examination concentrating on my lungs and breathing
{time}  Chest X-ray
{time}  Spirometry (a breathing test)
{time}  Blood test called the beryllium-induced lymphocyte 
proliferation test or Be-LPT
{time}  Other test(s). Specify:________

    I understand that, if the results of one or more of these tests 
indicate that I have a health problem that is related to beryllium, 
additional examinations will be recommended. If additional tests 
indicate I do have a beryllium sensitization or CBD, I may be 
advised to stop working with beryllium. Every effort will be made to 
offer me a job of equivalent grade and base pay for which I am 
qualified. I also may continue working in the job with beryllium 
exposure if I so choose. I understand that continuing to work with 
beryllium may increase the chance that I will develop chronic 
beryllium disease (CBD).

{time}  I decline to participate in any part of the medical 
surveillance program at this time. If I change my mind, I may 
participate in the program by contacting my supervisor.

Name of Participant:
SSN:
Signature of Participant:
Date:

    I have explained and discussed any questions that the above 
employee expressed concerning the Be-LPT, physical examination, and 
other medical testing as well as the implications of those tests.

Name of Examining Physician:
Signature of Examining Physician:
Date:

Appendix B to Part 850--Questions and Answers Concerning the 
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical 
Records, and the DOE Beryllium Registry

What is the Be-LPT blood test?

    In the Be-LPTs, disease-fighting blood cells that are normally 
found in the body, called lymphocytes, are examined in the 
laboratory and separated from your blood. Beryllium and other test 
agents are then added to small groups of these lymphocytes. If these 
lymphocytes react to beryllium in a specific way, the test results 
are ``positive.'' If they do not react with beryllium, the test is 
``negative.''
    Experts believe that the Be-LPT shows positive results in 
individuals who have become sensitive or allergic to beryllium. It 
is unclear what this sensitivity means. Studies have shown it to be 
an early sign of chronic beryllium disease (CBD) in many 
individuals. In others, sensitivity might simply mean that the 
person was exposed to beryllium and that his or her body has 
reacted. It might mean that an individual is more likely than others 
to get CBD. You are being offered the Be-LPT because doctors believe 
it is useful in detecting cases of CBD early or cases that might 
otherwise be missed or diagnosed as another type of lung problem. 
Once CBD is identified, doctors can determine the treatment that is 
needed to minimize the lung damage CBD causes.
    As in any other medical test, the Be-LPT sometimes fails or 
provides unclear results. The laboratory calls these results 
``uninterpretable.'' Even when the test appears successful, it may 
appear positive when it is not. This is called a ``false positive'' 
result. It is also possible that the test will show ``negative'' 
results when a person is actually ``sensitized'' to beryllium. This 
is a ``false negative'' result. If you have a ``uninterpretable'' 
blood Be-LPT result, you will be asked to provide another blood 
sample so the test can be repeated. If you have ``positive'' 
results, you will be offered further medical tests to confirm or 
rule out CBD. Remember, you may refuse further tests at this point 
or at any point during your medical evaluations.
    It is important for you to know that if the physical examination 
or the results from other tests you are receiving suggest that you 
have CBD, you may be offered further medical tests. These medical 
tests may be offered even if your Be-LPT is ``negative.''
    Some individuals with confirmed ``positive'' Be-LPTs but no 
other signs of CBD have developed the disease. The likelihood of 
this happening will only be known after large groups of potentially 
exposed individuals have had their blood tested, have had further 
medical tests, and are studied for many years.

What will happen if I decide to have the Be-LPT blood test?

    A small amount of your blood will be drawn from a vein in your 
arm and sent to a laboratory. There is little physical risk in 
drawing blood. Slight pain and bruising may occur in a few 
individuals. Rarely, the needle puncture will become infected. Other 
routine medical evaluation tests may be offered when you have the 
Be-LPTs including a physical examination, a chest X-ray, and 
breathing tests that help find signs of CBD, if they exist.
    Other diseases may resemble CBD. Different medical tests can 
help a physician decide if a person has CBD or another disease. If 
the examining physician suspects that you have CBD, he or she will 
recommend additional medical tests to help confirm a diagnosis. 
Separate information regarding these additional medical tests will 
be given to you if they are recommended. Your consent will be 
requested when the extra tests are given. You can always refuse

[[Page 66975]]

additional tests, if you so choose. All tests will be paid for by 
your employer.

When will I receive the results of my Be-LPT blood test?

    It could take 2 to 4 weeks for you to receive a letter informing 
you of your test results. The test itself usually takes 8 days to 
perform. The testing laboratory reports results to the physician who 
examined you and he or she will notify you.

Could a positive Be-LPT blood test affect my job assignment?

    Yes, but only if you elect to accept a change in your job 
assignment. If you have a positive Be-LPT or have been diagnosed 
with CBD, it may be advisable for you to stop working with 
beryllium. If you are working with beryllium at this time, every 
effort will be made to offer you another job that you are qualified 
to perform with your employer. This job will be of comparable 
responsibilities, base pay and benefits, and will not expose you to 
beryllium. If a comparable position cannot be found with your 
employer, you will be offered the choice of continuing to work for 
your employer with beryllium or assistance for a period of 2 years 
in finding employment with another employer, but in that case there 
can be no promise of continued base pay and benefits. If you become 
physically unable to continue working, you may be eligible for 
workers' compensation and other benefits.

Will I lose any pay or any other benefits by having the examination 
during normally scheduled working hours?

    No. Your examination will be scheduled during normal work hours. 
You will not be required to take leave to have the examination, nor 
will you lose pay or any other benefits.

What will happen to the records of the medical examination results?

    The results of your tests and examinations will be available to 
the physicians and nurses in this clinic, and possibly to scientists 
conducting health studies. The test results will be entered in your 
medical records, which will be kept in specially secured files under 
the supervision of physicians and nurses in the clinic, separate 
from other personnel records. Your test results will be medically 
confidential data and will not be released to anyone other than 
those listed in the following, unless you provide written 
permission. The following groups will have direct access to this 
information:
    1. Clinic staff members
    2. Medical specialists who will provide or arrange for 
additional medical treatment or tests, if necessary.
    3. U.S. Department of Energy Beryllium Registry staff.
    4. The Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health officials may require 
direct access to records that identify you by name for health 
studies.
    If information about you is used in reports or a published 
health study, your identity will be disguised. You will not be 
identified in any published report or presentation. The results of 
your Be-LPT and other screening tests will be made available to you 
and, upon your request, to your physician. The information also will 
become part of your medical record, which the clinic keeps.

What is the DOE beryllium registry?

    Your health and the health of all workers is a major concern to 
the Department. There is a need to learn more about chronic 
beryllium disease and what causes some individuals to react more 
strongly than others. A DOE beryllium registry has been established 
to collect and maintain information on workers who are exposed to 
long term, low and moderate levels of beryllium. This registry is a 
tool which will be used in health studies to better understand the 
nature of the disease. With it we can measure the burden of health 
effects related to beryllium exposure. The registry will also be 
used to evaluate the effectiveness of exposure control programs.
    In addition to information about your beryllium related 
exposures, the results of beryllium sensitization testing and/or CBD 
status collected by your employer will be added to the registry. 
Your employer must treat this information as confidential medical 
information and can only use or disclose of this information in 
conformance with the Privacy Act of 1974, the Americans with 
Disabilities Act, or any other applicable law. Personal identifying 
information (such as your name and social security number) is 
required to link exposure data to the results of the medical testing 
and to eliminate duplicate reports for each worker. At no time will 
your name or other personal identifying information be published in 
any report. The confidentiality of identified information in DOE 
records is protected under the Privacy Act of 1974.

What laws protect me if I consent to participating in the screening 
program?

    State medical and nursing licensing boards enforce codes of 
ethics that require doctors and nurses to keep medical information 
confidential. The Privacy Act prevents unauthorized access to your 
DOE records without your permission. The information in records kept 
by your employer must be handled in accordance with the Americans 
with Disabilities Act and the Privacy Act of 1974. The consent form 
you sign also provides additional protection.

Can my privacy and the confidentiality of my medical records be 
guaranteed?

    No. Access to or release of records could be required under 
court order, or DOE directive, but it is unlikely. If you apply for 
another job or for insurance, you may be requested to release the 
records to a future employer or an insurance company. If, for 
medical reasons, it is recommended that you transfer to an area 
where you will not contact beryllium, and you elect to do so, the 
personnel department and your supervisor will be notified. They will 
not be told the specific results of your tests but, because of the 
restrictions, they may assume that your Be-LPT results were 
positive.

Do I have to have the Be-LPT done?

    No. Your participation in the medical surveillance program is 
strictly voluntary. You may refuse any of the tests offered to you 
including the Be-LPT. If you change your mind, you are free to 
participate in the program at any time. Talking with your family, 
your doctor, or other people you trust may help you decide. The 
physicians in the clinic that provide the tests can also help answer 
any questions that you might have.

[FR Doc. 98-30277 Filed 12-2-98; 8:45 am]
BILLING CODE 6450-01-P