[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Rules and Regulations]
[Pages 68854-68914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31181]
[[Page 68853]]
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Part III
Department of Energy
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10 CFR Part 850
Chronic Beryllium Disease Prevention Program; Final Rule
Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 /
Rules and Regulations
[[Page 68854]]
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: Final rule.
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SUMMARY: The Department of Energy (DOE) is today publishing a final
rule to establish a chronic beryllium disease prevention program
(CBDPP) to reduce the number of workers currently exposed to beryllium
in the course of their work at DOE facilities managed by DOE or its
contractors, minimize the levels of, and potential for, exposure to
beryllium, and establish medical surveillance requirements to ensure
early detection of the disease. This program improves and codifies
provisions of a temporary CBDPP established by DOE directive in 1997.
EFFECTIVE DATE: This rule is effective January 7, 2000.
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.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Background
B. Chemical Identification and Use
C. Health Effects
1. Chronic Beryllium Disease
2. Beryllium Exposures at DOE Operations
3. Epidemiology
4. Value of Early Detection
II. Legal Authority and Relationship to Other Programs
III. Overview of the Final Rule
IV. Section-by-Section Discussion of Comments and Rule Provisions
A. Subpart A--General Provisions
B. Subpart B--Administrative Requirements
C. Subpart C--Specific Program Requirements
List of Commenters
V. 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 13132
F. Review Under Executive Order 12988
G. Review Under the Unfunded Mandates Reform Act of 1995
H. Review Under Small Business Regulatory Enforcement Fairness
Act of 1996
Appendix A to the Preamble--References
Appendix B to the Preamble--Questions and Answers Concerning the
Beryllium Induced Lymphocyte Proliferation Test (Be-LPT), Medical
Records, and the Department of Energy (DOE) Beryllium Registry
I. Introduction
This final rule implements a chronic beryllium disease prevention
program (CBDPP) for the Department of Energy (DOE or the Department).
This program will reduce the number of workers currently exposed to
beryllium at DOE facilities managed by DOE or its contractors, minimize
the levels of, and potential for, exposure to beryllium, establish
medical surveillance requirements to ensure early detection of disease,
and improve the state of information regarding chronic beryllium
disease and beryllium sensitization.
On December 3, 1998, DOE published a Notice of Proposed Rulemaking
(NOPR) for public comment in the Federal Register (63 FR 66940)
proposing regulations for a chronic beryllium disease prevention
program. The public comment period for the NOPR ended on March 9, 1999.
DOE received 36 comment letters. In addition, public hearings were held
on February 3, 1999, in Oak Ridge, Tennessee; February 9, 1999, in
Golden, Colorado; and February 11, 1999, in Washington, DC. Comment
letters were received from private individuals, DOE contractors, other
federal agencies, trade associations, academia, public health and
medical professionals, and attorneys.
On June 3, 1999, DOE published a notice of limited reopening of the
comment period (64 FR 29811) to solicit public comments on options that
DOE was considering for the criteria to be used for the release or
transfer of equipment and other items previously used in DOE beryllium
operations, either to other DOE facilities or to the public. In
response to this reopening of the comment period, DOE received 15
additional comments.
DOE has carefully considered the comments and data from interested
parties, as well as reference works, journal articles, and other
information relevant to the subject of the rulemaking.
A. Background
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 melting,
casting, grinding, and machine tooling of parts.
Inhalation of beryllium dust or particles can cause chronic
beryllium disease (CBD) or 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 September 1999, among the 11,266 current and former DOE
federal and contractor workers who were screened for the disease, 130
workers had been diagnosed with CBD, and another 277 workers had become
sensitized to beryllium. DOE anticipates an increase in the number of
workers who may be exposed to beryllium as DOE 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) in 1971 and codified in 29 CFR 1910.1000, Tables Z-1, Z-2 and Z-
3 by reference to existing national consensus standards. DOE's
predecessor agency, the Atomic Energy Commission (AEC), had previously
established the same limit of 2 g/m3 for
application at its facilities in 1949, and that limit has remained in
effect at DOE's facilities up to the present. In 1977, the National
Institute for Occupational Safety and Health (NIOSH), a federal agency,
recommended to OSHA an exposure limit of 0.5 g/m3
for beryllium. NIOSH, at the same time, classified beryllium as a
potential occupational carcinogen.
Between the 1970s and 1984, there appeared to be a significant
reduction in the incidence rate of CBD. 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 1940s). However, the number of
confirmed cases of CBD, more recent 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
(during decontamination and decommissioning activities) all indicate a
need for more
[[Page 68855]]
aggressive workplace controls to minimize worker exposure to beryllium
in the DOE complex.
In December 1998, the American Conference of Governmental
Industrial Hygienists (ACGIH) published a Notice of Intended Change for
its beryllium exposure limit. ACGIH is a professional organization that
develops and publishes consensus occupational health standards. In the
Notice, ACGIH proposed an 8-hour TWA of 0.2 g/m3 to
help minimize the occurrence of CBD and sensitization. DOE's NOPR did
not address ACGIH's proposed change because publication of the NOPR
preceded ACGIH's announcement.
DOE has reviewed current technical information and is of the
opinion that it is difficult to determine the exposure level that is
necessary to eliminate the risk of contracting CBD. Until OSHA
completes its rulemaking, DOE has decided to implement an aggressive,
two-pronged exposure reduction and minimization program that is
expected to further protect DOE federal and contractor workers from the
hazards associated with exposure to beryllium. While DOE acknowledges
that this rule may not eliminate the risk of contracting CBD, DOE
believes that this rule will significantly decrease the number of
workers exposed and the level of exposure to beryllium, and therefore,
is expected to decrease disease. First, DOE is establishing an 8-hour
TWA action level of 0.2 g/m3 that triggers certain
workplace precautions and control measures. Second, DOE is requiring
its contractors and any covered DOE employers to establish in their
CBDPPs exposure reduction and minimization measures designed to reduce
potential exposure to levels below the action level. This program will
enhance and supplement existing worker protection programs established
under DOE Order 440.1A, Worker Protection Management for DOE Federal
and Contractor Employees.
This rulemaking initiative was preceded by several years of
information gathering and data analysis. In 1996, DOE 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. 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. These
estimates were updated in 1999 through a cost survey conducted by the
Office of Environment, Safety and Health (1999 Environment, Safety and
Health Cost Survey). In this survey, 14 DOE sites indicated that they
would be affected by the proposed rule. These sites reported that 1,634
workers in more than 100 different job categories would be potentially
exposed to beryllium and 1,236 of these workers (75.6 percent) would be
potentially exposed at the proposed action level or PEL.
The 1996 survey also provided information on exposure levels
experienced by workers at the surveyed sites. Although the exposure
data were not comprehensive, the reported 8-hour TWA exposure data
(personal breathing zone monitoring results) for these workers ranged
from nondetectable to 25 g/m3. Most of these
exposure levels were reported to be below the 2 g/
m3 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. The
survey showed that beryllium exposure controls varied considerably
among the DOE facilities.
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 new
DOE beryllium health standard (61 FR 68725). This was followed by two
Beryllium Public Forums, one held in Albuquerque, New Mexico, and one
held in Oak Ridge, Tennessee, in January 1997.
Acting on the information compiled from these various sources, and
in view of the time needed to promulgate a rule, then-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 Secretary
Pena and issued on July 15, 1997. This interim Notice established a
CBDPP that enhanced and supplemented worker protection programs under
DOE Order 440.1A.
Because of the complexity and significance of issues regarding the
development of a DOE beryllium worker protection rule, Secretary Pena
also established the Beryllium Rule Advisory Committee (BRAC) in June
1997 to advise DOE on issues pertinent to the proposed rulemaking. The
BRAC, which consisted of a diverse set of stakeholders and recognized
experts from DOE, other federal agencies, industry, labor, medicine,
and academia, explored issues and generated recommendations for
consideration in the development of a CBDPP rule.\1\
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\1\ Individual members and groups of members made BRAC
recommendations. The recommendations 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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B. Chemical Identification and Use
Beryllium (atomic number 4) is a silver-gray, metallic element with
a density of 1.85 g/cm3 and a high stiffness. The second
lightest of the metals, beryllium also has a high melting point
(1285 deg. C) and heat absorption capacity; a pound of beryllium will
absorb as much heat as 5 pounds of copper.
Beryllium occurs naturally in the earth's surface in about 30
minerals found in rocks, coal and oil, soil, and volcanic dust.
Beryllium used in industry begins as a silicate (BeSiO3) in
beryl and bertrandite ores. In very pure crystalline form, beryl takes
the form of gems, such as blue-green aquamarine and green emeralds.
Bertrandite is mined in Utah. The United States is the world's leading
producer, processor, and consumer of beryllium products.
Beryllium, discovered in 1798, was not widely used in industry
until the 1940s and 1950s. Beryllium can be used as a pure metal, mixed
with other metals to form alloys, processed to salts that dissolve in
water, and processed to form oxides and ceramic materials.
Beryllium metal has been produced for various industrial uses,
especially in the aerospace and defense industries. Both structural and
instrument grade materials are manufactured, including windshield
frames and other structures in high-speed aircraft and space vehicles,
aircraft and space shuttle brakes, satellite mirrors and space
telescopes, inertial guidance systems and gyroscopes, neutron
moderators or reflectors in nuclear reactors, X-ray windows, and
nuclear weapons components.
In alloys, beryllium confers on metal specific properties of
resistance to corrosion, wear, and fatigue; high electrical and thermal
conductivity;
[[Page 68856]]
strength; and hardness. Beryllium-copper (BeCu) alloys usually contain
about 2 percent beryllium, but vary greatly in composition to meet
different industrial and consumer needs. Beryllium is also added to
aluminum, nickel, zinc, and zirconium for some applications. Beryllium
alloys are used for springs, switches, relays, and connectors in
automobiles, computers, radar and telecommunications equipment, and
other instruments; high-strength non-sparking tools; molds or casts to
make metal, glass, and plastic items; sports equipment such as golf
clubs and bicycle frames; and dental bridges and related applications.
Other beryllium materials include soluble salts and oxides.
Beryllium soluble salts, such as beryllium fluoride, chloride, and
sulfate, are used in nuclear reactors, in glass manufacture, and as
catalysts for certain chemical reactions. Beryllium Oxide (BeO) is used
to make ceramics for electronics, and other electrical equipment.
Beneficial properties of BeO include hardness, strength, excellent heat
conductivity, and good electrical insulation.
C. Health Effects
DOE received a number of comments (Exs. 2, 5, 14, 19, 20, 22, 23,
24, 26, 29, 30) \2\ regarding the ``Health Effects'' section of the
NOPR. DOE has carefully considered these comments and has revised the
following health effects discussion as appropriate.
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\2\ A list of commenters is included as an appendix to the
Section-by-Section Discussion of Comments and Rule Provisions in
this Supplementary Information section.
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1. Chronic Beryllium Disease
Chronic beryllium disease (CBD) is a granulomatous lung disease
that is caused by the body's immune system response (similar to an
allergic reaction) to inhaled dust or fumes containing beryllium metal,
alloys, beryllium compounds or mixtures, or insoluble beryllium salts.
The body's immune system response to beryllium is often called
beryllium sensitization. Beryllium sensitization precedes the
development of CBD. Sensitization can occur quickly or many years after
exposure to beryllium, progressing into disease at a rate of
approximately 10 percent a year (ref. 1) \3\.
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\3\ A listing of references is included as an appendix to this
Supplementary Information section.
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It is hypothesized that 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 can occur
at relatively low exposure levels and, in some cases, after relatively
brief durations of exposure. The International Agency for Research on
Cancer (IARC) and ACGIH classify beryllium as a human carcinogen.
Frequently reported symptoms include one or more of the following:
dyspnea (shortness of breath) on exertion, cough, fever, night sweats,
and chest pain and, less frequently, arthralgias (neuralgic pain in
joints), fatigue, weight loss, or appetite loss. On physical
examination, a doctor may find signs of CBD results, such as rales
(changes in lung sounds), cyanosis (lack of oxygen), digital clubbing,
or lymphadenopathy (enlarged lymph nodes). A radiograph (X-ray) of the
lungs may show many small scars. Patients may also have an abnormal
breathing test, pulmonary function test, and a blood test, the
peripheral blood beryllium-induced lymphocyte proliferation test (Be-
LPT). Examination of the 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. In advanced cases, there may be manifestations of right-
sided heart failure, including cor pulmonale (enlarged right ventricle
of the heart caused by blockage in the lungs).
The Be-LPT is highly specific for beryllium sensitivity and has a
high predictive value for beryllium disease. It is the most definitive
means of ruling out beryllium disease as the cause of non-specific lung
and other symptoms. Therefore, this measurement of sensitization to
beryllium identifies at-risk individuals, as well as individuals whose
lung problems are not beryllium related (ref. 1). For individuals whose
Be-LPT screening results exceed a certain threshold, an additional Be-
LPT is conducted on cells washed from a segment of the lung. The
presence of granulomata in the lung of an individual with a positive
lung Be-LPT confirms the presence of CBD. In the absence of granulomata
or other clinical evidence of CBD, individuals with a positive Be-LPT
are classified as sensitized to beryllium.
The clinical course of CBD is highly variable. Some individuals
deteriorate rapidly; most experience long, gradual deterioration.
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
physically impaired. Once sensitization has occurred, it is medically
prudent to prevent additional exposure to beryllium. Individuals with
CBD have a clinical illness varying from mild to severe. In severe
cases, the affected individuals may be permanently and totally
disabled. Mortality of the sensitized individuals directly attributable
to CBD and its complications is estimated to be 30 percent (ref. 2).
This estimate is based upon historical data reflecting both the higher
levels of exposure that occurred in the workplace prior to regulation
of workplace exposure in the late 1940s and a tracking of the medical
history of subjects of CBD over several decades. DOE's more recent
experience with improved diagnoses and treatments may result in a lower
mortality rate for CBD cases.
2. Beryllium Exposures at DOE Operations
DOE's medical surveillance programs are discovering cases of CBD
among workers who were first exposed after 1970, when DOE facilities
were expected to maintain workers exposure to beryllium below the OSHA
PEL. As of June 1999, 119 workers (88 at the Rocky Flats facility in
Golden Colorado, 29 at the Y-12 Plant in Oak Ridge, Tennessee, and two
at the Hanford facility in Richland, Washington) have been diagnosed
with CBD, and another 258 workers (197 at the Rocky Flats facility, 59
at the Y-12 Plant, one at the Hanford facility, and one at the Mound
facility in Miamisburg, Ohio) have been diagnosed as sensitized to
beryllium from among approximately 10,000 current and former DOE
federal and contractor workers who were screened for the disease.
A worker's exposure is measured by personal monitoring, which is
accomplished by sampling the air within the breathing zone of the
worker. 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, results from area monitoring 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
[[Page 68857]]
levels of beryllium exposure that 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 have occurred to
date at the Rocky Flats facility, and at the Y-12 Plant. 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 were collected at the Oak Ridge Y-12 Plant (Table 1). These
samples were taken at several different Y-12 operations associated with
CBD, 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 for the sampling and
analytical method used at Y-12.
Table 1.--Oak Ridge Y-12 Plant Personal Sampling for Beryllium Exposure
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1980 to 1989 1990 to 1996
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Number of Samples.................. 148............................................ 1448
Estimated Arithmetic Mean Level of 0.9 g/m3.............................. 0.3 g/m3
Exposure \1\.
Percent of Samples Less Than 2 94%............................................ 98%
g/m3,2.
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\1\ The arithmetic mean was estimated from the samples using linear regression.
\2\ Samples were analyzed using flame spectroscopy with a detection limit of about 0.1 g/m3.
These Y-12 data are from beryllium operations where cases of CBD
have been found. The facilities where these operations take place have
not been remodeled since the 1970s. Thus the differences between
sampling results measured before and after 1990 are attributed to
changing work practices. For example, increased monitoring in the 1990s
identified a greater number of exposures over the existing exposure
limit. The investigations of these exposures resulted in changes to
work practices that had contributed to the high exposures. This focus
on operations with elevated exposure levels 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 then again in 1986
after extensive remodeling to the ventilation system illustrates the
impact and effectiveness of engineering modifications to control
exposure.
Table 2.--Rocky Flats Building 444 Beryllium Machine Shop Personal Sampling Data (Beryllium Exposure)
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1984 to 1985 1986
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Number of Samples.................... 99.............................................. 279
Estimated Arithmetic Mean Level of 1.19 g/m3,1............................ 0.035 g/m\3\
Exposure\1\.
Percent of Samples Less Than 2 g/m3,2.
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\1\ The arithmetic mean was estimated from the samples using linear regression.
\2\ Samples were analyzed using graphite furnace atomic absorption (AA) or Inductively Coupled Plasma (ICP)
spectroscopy with a detection limit of about 0.01 g/m\3\.
The samples collected in 1984 and 1985 were the first personal
samples collected in this shop following the discovery of a case of CBD
in 1984. 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 ventilation hoods, operations performed outside of hoods were
eliminated to the extent possible. The improved engineering controls in
this shop reduced average exposure levels by a factor greater than 30,
to levels approaching 1% of the existing PEL.
A final example, taken from personal sampling data collected during
the decontamination of Rocky Flats Buildings 865 and 867 in 1995-1996,
further demonstrates the low levels of beryllium exposure which can be
achieved through the implementation of effective controls (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 to 1996
Number of Samples....................... 7,673
Arithmetic Mean Level of Exposure....... 0.03 g/m3
Percent of Samples Less Than 2 g/m3.
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As can be seen from the foregoing examples, machining and D&D
operations at Y-12 and Rocky Flats 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 future occurrences can be prevented.
3. Epidemiology
Epidemiology is the field of public health that examines
relationships between disease in people, and exposures or events that
are related to that disease. Occupational epidemiology is the study of
the effects of workplace exposures on the frequency and distribution of
diseases and injuries.
Hardy and Tabershaw (ref. 3) reported the first evidence of the
existence of CBD in a 1946 paper. The paper described ``delayed
chemical pneumonitis'' among fluorescent lamp workers exposed to
beryllium compounds. The differential diagnosis included sarcoidosis
(an immune disease of unknown etiology) and tuberculosis.
There also are reports of CBD in individuals without known
occupational exposure to beryllium. Under the direction of Dr. Thomas
Mancuso, 16 cases of CBD were
[[Page 68858]]
diagnosed by X-ray examination among 20,000 residents living near a
beryllium production facility in Lorain, Ohio (ref. 4). Likewise, a
1949 report described 11 patients with CBD who lived near a beryllium
extraction plant (ref. 5). 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 of their CBD. Measurements of air concentrations of
beryllium at various distances from the plant provided the basis for
the Environmental Protection Agency's (EPA's) community permissible
exposure limit (24-hour ambient air limit of 0.01 microgram of
beryllium per cubic meter of air [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 1940s and 1950s (refs. 6, 7). The virtual
disappearance of CBD caused by 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. 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 (ref. 8).
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.
7).
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 1960s, and ultimately was 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. 6). 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. 9).
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 upon examination
of lung tissue or thoracic lymph nodes, (5) radiologic evidence of
interstitial lung disease, and (6) decreased pulmonary function tests
(ref. 10).
The beryllium-induced lymphocyte proliferation test (Be-LPT) in
blood and bronchoalveolar lavage (BAL) fluid have allowed earlier
identification of the disease. The BAL Be-LPT now is one of the
criteria required for diagnosis (refs. 11-13). 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. 14). Current data suggest that the peripheral blood Be-LPT is a
specific and sensitive method for testing beryllium sensitivity (ref.
11). The presence of granulomatous tissue in the lung along with a
positive BAL Be-LPT is considered definitive evidence for diagnosis of
CBD (ref. 12). When a worker has clear signs and symptoms of
interstitial lung disease and a positive Be-LPT, CBD may be presumed
only if performing a bronchoscopy on the worker is deemed to be too
risky given the health status of that of that worker.
An article published by Cullen et al. in 1987 reported on an
epidemiology study of CBD among precious-metal refinery workers (ref.
15). In 1993, researchers at the National Jewish Medical and Research
Center (NJMRC) published two reports on epidemiology studies that were
designed to determine the incidence of CBD among beryllium workers and
the value of the Be-LPT in detecting CBD (refs. 16, 17). One of these
two studies was conducted at DOE's Rocky Flats Environmental Technology
Site (Rocky Flats). These three epidemiology studies showed that CBD
incidence among exposed workers was the same as had been reported among
workers exposed in the 1940s, when the disease was first recognized.
This exposure limit was originally derived by analogy to other toxic
metals (ref. 18). A decline in the number of reports of CBD in the
1970s and up to 1984 led to the assumption that the 2 g/m\3\
limit had been effective in preventing CBD (ref. 6). DOE recognizes
that the 1980s-1990s studies used more effective screening and
diagnostic methods than the earlier studies. Nevertheless, these 1980s-
1990s studies provide strong evidence that adherence to the OSHA
standard has not prevented new cases of disease.
In 1991, responding to NJMRC findings, DOE's 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 NJMRC studies.
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 Three DOE Sites Through December 1997
----------------------------------------------------------------------------------------------------------------
Rocky Flats Y-12 Mound
----------------------------------------------------------------------------------------------------------------
Individuals Examined............ 6,257....................... 1,949...................... 632
Abnormal Be-LPT Number (percent) 221 (3.5%).................. 77 (4%).................... 1 \1\
Completed Diagnostic Exams...... 186......................... 33......................... 0
[[Page 68859]]
CBD Number (percent) \2\........ 79 (1.3%) \3\............... 25 (1.3%) \4\.............. 0
----------------------------------------------------------------------------------------------------------------
\1\ The one Mound employee who was found to be consistently positive declined 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 cases through the 1987-1991 NJMRC
study, and 6 cases 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 cases 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 who were provided the Be-LPT.
In 1996, three studies reported on exposure to beryllium associated
with CBD and immunologic sensitization to beryllium (refs. 19-21). Two
of the studies reported on cases of CBD at Rocky Flats (refs. 19, 20).
The third reported on an epidemiology study of a private sector
beryllium ceramics fabrication plant that began operating in 1981 (ref.
21). 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 not only among the highest exposed workers, but also among
the lowest exposed workers, including administrative and other
personnel who did not work directly with beryllium.
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. 19). 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 one order of
magnitude. Extensive air monitoring data were available for machinists,
which were one of the highest exposed groups.
Barnard and colleagues completed an extensive analysis of the
monitoring data associated with machining operations at Rocky Flats
(ref. 20). 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/m3 limit,
and that excursions above the limit were common.
Kreiss and colleagues studied CBD occurring in a beryllium oxide
ceramic manufacturing plant (ref. 21). 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, ``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. 5). 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).
Table 5.--Incidence Rates of CBD at Rocky Flats
------------------------------------------------------------------------
Incidence
Job category Number tested CBD cases rate
(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
------------------------------------------------------------------------
Cases of CBD have occurred in machinists who worked in the Y-12
beryllium ceramic machine shop, where levels have been quite low. Only
a small percentage of samples there have detected beryllium. Continuous
area air monitors have operated in the shop throughout its existence.
One area sample indicated levels above 2 g/m3 when
a machine tool was operated with an exhaust duct that was disconnected.
No other area measurements above 2 g/m3 were
recorded, and the median measurement was at the level of detection.
Kreiss (ref. 22) describes the relative hazards in sectors of the
beryllium industry, and risk factors for CBD and sensitization related
to work processes in a beryllium manufacturing plant that produced pure
metal, oxide, alloys, and ceramics. Employees in the pebble plant
(producing beryllium metal) had the highest prevalence of CBD (6.4%)
compared with other workers (1.3%). The pebble plant was not associated
with the highest gravimetric industrial hygiene measurements,
indicating that total beryllium was probably not a good indicator for
hazard surveillance. The
[[Page 68860]]
report indicates that particle size or other characteristics may be
more important contributors to risk than the total mass of breathing
zone particles, that daily-weighted averages are poor estimates of
personal exposure, and that methods of exposure assessment may poorly
reflect actual exposures from accidents.
Several authors have highlighted the uncertainty that exists in the
exposure assessments (refs. 20, 21, 23). 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 measurable
airborne beryllium is capable of reaching the regions of the lung where
health effects occur. 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. 20, 23).
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/m3 limit have occurred in all groups studied for
which exposure data is available. 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. 24), producing the beryllium ion that elicits an immune response
(ref. 25). The persistent presence of the beryllium ion in the lung
makes CBD a chronic disease (ref. 26). Both intermittent high and
continual low exposures to insoluble forms of beryllium can create and
maintain a lung burden that will not clear for many years, if at all
(ref. 27).
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. 28).
Differences in individual susceptibility have made it difficult to
understand the relationship between exposure and CBD. Early
epidemiology 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 one month and those who had
unrecognized or seemingly trivial exposure. However, the NJMRC 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 1940s Estimated Cases incidence exposure
exposed per 100 g/m
exposed \3\
----------------------------------------------------------------------------------------------------------------
Residents Living Within 0.25 Mile of a Beryllium 500 5 1.0 1
Extraction Plant \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 1,000
Painesville, Ohio..................................... 200 0 0.0 1,000
Reading, Pennsylvania................................. 4,000 51 1.3 1,000
----------------------------------------------------------------------------------------------------------------
Estimated
Incidence level of
Exposed from the 1970s to the 1980s 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
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/m3,'' Am. J. Ind. Med., Vol. 30, pp 16-25, 1996.
Table 7.--Beryllium Sensitization and Disease Rates at Rocky Flats \1\
------------------------------------------------------------------------
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 3 115 2.6
Preparation.................
Sawing....................... 5 6 4.7
Trepanning................... 3 77 3.9
Band Sawing.................. 4 67 6.0
[[Page 68861]]
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
------------------------------------------------------------------------
\1\ 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. 29)
consolidated the previous epidemiology 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/m3 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)
the inadequacy of area monitoring in reflecting actual exposure; (3)
the effect of chemical composition, size, and shape on the
bioavailability of the inhaled particles; (4) inadequate monitoring of
the chemical beryllium composition, size, and shape of inhaled
particles; and (5) the effect of genetic predisposition on developing
beryllium sensitization and CBD. As a result, the existing literature
does not point to a specific tolerance level for exposure to beryllium.
4. Value of Early Detection
Early detection of a disease is of value if it leads to earlier
treatment and a better prognosis for the individual being tested.
Screening for CBD with the Be-LPT can provide earlier detection than is
possible with other tests. In some cases this has led to treatment of
CBD to reduce lung damage that would not have been possible if the CBD
remained undiagnosed by other tests, such as chest X-ray. Researchers
at the NJMRC compared the lung functions of patients with CBD who had
been identified through abnormal chest X-rays or clinical symptoms to
those of patients whose CBD had been identified through positive Be-
LPTs (ref. 30). Twelve out 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.
DOE's experience is consistent with this conclusion. The 79 cases
of CBD diagnosed among Rocky Flats workers showed a range of severity.
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. Clinical evaluations
using computer aided tomography (CAT) scan, bronchoalveolar lavage-
BeLPT (BAL Be-LPT), transbronchial biopsy, and gas diffusion studies of
workers confirmed the presence of CBD in these workers.
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 (ref. 27). Additionally,
members of the work force who are consistently positive on the Be-LPT
are those most likely to eventually develop CBD. Treating physicians
generally recommend that these individuals receive more frequent and
more extensive pulmonary function testing so that the lung damage
associated with CBD can be minimized through early detection and
treatment. Sensitized and early CBD patients can be removed from jobs
with beryllium exposure.
Finally, beryllium sensitization found through screening with the
Be-LPT is the earliest indication that working conditions and work
practices are affecting the health of exposed workers. This allows for
an earlier opportunity to initiate corrective actions and possibly to
prevent cases of CBD. Early detection enhances the contribution of
medical surveillance to the management of the CBDPP.
II. Legal Authority and Relationship to Other Programs
Today's rule, which establishes minimum requirements for the
protection of beryllium-associated workers, is promulgated pursuant to
DOE's authority under section 161 of the Atomic Energy Act of 1954
(AEA) to prescribe such regulations as it deems necessary to govern any
activity authorized by the AEA, specifically including standards for
the protection of health and minimization of danger to life or property
(42 U.S.C. 2201(i)(3) and (p)). Additional authority for the rule,
insofar as it applies to DOE Federal employees, is found in section 19
of the Occupational Safety and Health Act of 1970 (29 U.S.C. 668) and
Executive Order 12196, ``Occupational Safety and Health Programs for
Federal Employees,'' (5 U.S.C. 7902 note), which require Federal
agencies to establish comprehensive occupational safety and health
programs for their employees.
DOE intends this final rule to be integrated with the existing
worker protection management program for DOE Federal and contractor
employees established by DOE Order 440.1A. The requirements in this
final rule will supersede any conflicting provisions of DOE Order
440.1A on the effective date of the rule. On that date the rule also
[[Page 68862]]
will supersede DOE Notice 440.1, ``Interim Chronic Beryllium Disease
Prevention Program,'' established by then-Secretary Pena on July 15,
1997.
Some comments on the NOPR raised questions about the effect of the
rule on collective bargaining and grievance-arbitration processes
established by collective bargaining agreements. One union urged (Ex.
22) DOE to clarify whether the terms of this rule are subject to
negotiation between a union and a contractor.
DOE has concluded that there is a compelling need for the CBDPP
requirements in this final rule in order for DOE to meet its obligation
under the AEA to protect the health of its employees and other workers
at DOE facilities. The regulatory requirements of this rule will by
operation of law apply to DOE contracts. Therefore, the application and
enforcement of this rule are not subject to the Work Smart Standards
Program or other related processes. DOE believes that this mandatory
application of the CBDPP requirements to all DOE beryllium activities
is appropriate given the hazardous nature of beryllium-related work.
While the minimum requirements in the rule are non-negotiable and
may not be waived, the rule does not preclude all collective bargaining
on matters related to beryllium exposure protections. Some rule
provisions, such as the requirement for a beryllium exposure reduction
and minimization provision in an employer's CBDPP, are performance-
based and allow for negotiation between the employer and employee
representatives. Other rule requirements, however, are stated in
specific terms that do not permit any change. For example, section
850.24(e) of the rule specifies the accuracy that must be achieved by
exposure monitoring of workers: not less than plus or minus 25 percent,
with a confidence level of 95 percent, for airborne concentrations of
beryllium at the action level. DOE's objectives of controlling worker
exposure to airborne beryllium and obtaining better exposure data would
be defeated if accuracy of monitoring were a subject of collective
bargaining. Although today's rule may incidentally affect collective
bargaining, it is neutral with respect to the balance of bargaining
power of organized labor and management. The rule applies to all DOE
contractors whether or not they are involved in collective bargaining.
This final rule is not being promulgated as a nuclear safety
requirement under 10 CFR Part 820, Procedural Rules for Nuclear
Activities, because beryllium generally is not a nuclear material. Any
radiological implications of the two radioisotopic forms of beryllium
would be addressed under the provisions of 10 CFR part 835,
Occupational Radiation Protection.
III. Overview of the Final Rule
The final rule strengthens the worker protection program
established under DOE Order 440.1A, Worker Protection Management for
DOE Federal and Contractor Employees (or DOE Orders 5483.1B, 5480.4,
5480.8A, and 5480.10 for operations not covered by DOE Order 440.1A),
by supplementing the general worker protection program requirements
with provisions that are specifically 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,'' but a number of provisions have
been modified as a result of DOE's consideration of comments received
in the rulemaking.
Consistent with DOE Notice 440.1, this final rule establishes a
CBDPP that is designed to reduce the occurrence of CBD among DOE
federal and contractor workers and any other individuals who perform
work at DOE facilities. The CBDPP will accomplish this disease-
reduction mission through provisions that: (1) Reduce the number of
current workers who are exposed to beryllium by clearly identifying and
limiting worker access to areas and operations that contain or utilize
beryllium; (2) minimize the potential for, and levels of, worker
exposure to beryllium by implementing engineering and work practice
controls that prevent the release of beryllium into the workplace
atmosphere and/or capture and contain airborne beryllium particles
before worker inhalation; (3) establish medical surveillance to monitor
the health of exposed workers and ensure early detection that makes
possible early treatment of disease; and (4) establish continual
monitoring of the effectiveness of the program in preventing CBD and
implementing program enhancements as appropriate. Another key purpose
of the rule is the collection of consistent data, which will improve
the information available to better understand the cause of CBD.
DOE has made numerous changes in the final rule after considering
the public comments on the proposed rule. The principal changes are as
follows:
The final rule requires responsible employers to assign a
qualified individual, such as a Certified Industrial Hygienist, to
manage and supervise beryllium inventories, hazard assessments, and
exposure monitoring.
The final rule establishes the airborne beryllium
concentration action level, which in this rule triggers key worker
protection measures, at 0.2 g/m\3\, instead of 0.5
g/m\3\ as proposed. The STEL has been deleted, because the
proposed STEL would not provide any added protection for workers given
that the new action level of 0.2 g/m\3\ would be exceeded in
less than 15 minutes where exposure levels are at 10g/m\3\.
The final rule provides that responsible employers must
require workers to use respirators in areas where the beryllium
exposure level is at or above the action level, rather than at or above
the PEL as proposed in the NOPR, and must provide a respirator to any
worker exposed to beryllium who requests one, regardless of the
concentration of airborne beryllium.
The final rule includes criteria and requirements to
govern the release of beryllium-contaminated equipment and other items
at DOE sites for use by other DOE facilities or the public.
The final rule requires responsible employers to offer
medical surveillance to any ``beryllium-associated worker,'' defined to
include any current worker who is exposed through beryllium work or who
had past exposure or potential exposure to beryllium at a DOE facility.
The final rule contains medical removal protection and
multiple physician review provisions that are modeled on provisions of
three of OSHA's expanded health standards.
The provisions of the rule are presented in three subparts. Subpart
A 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 provisions requiring responsible
employers to develop and maintain a CBDPP and to perform all beryllium-
related activities according to the CBDPP. Subpart C establishes
requirements for the content and implementation of the CBDPP. Some of
the provisions of Subpart C apply only when it is determined that the
airborne concentration of beryllium in a specific workplace or
operation rises above a specified limit. Table 8 summarizes these
provisions and indicates the levels of beryllium at which the
provisions apply.
[[Page 68863]]
Table 8.--Levels at Which the Provisions of the CBDPP Apply
----------------------------------------------------------------------------------------------------------------
Worker exposure or potential exposure levels (8-
Hour TWA)
------------------------------------------------
PEL
Provision Be Action (8-hr TWA)
operations/ level (0.2 g/m \3\) m>g/m \3\)
\1\
----------------------------------------------------------------------------------------------------------------
Baseline 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 \2\ X\3\ X\4\
Regulated Areas (850.26)....................................... ............ X ..............
Hygiene Facilities and Practices (850.27)...................... ............ X ..............
Respiratory Protection (850.28)................................ X \5\ X ..............
Protective Clothing and Equipment (850.29)..................... X \6\ X ..............
Housekeeping (850.30).......................................... X \7\ ................. ..............
Release Criteria (850.31)...................................... X \8\,\9\ ................. ..............
Medical Surveillance (850.34).................................. X \10\ ................. ..............
Training and Counseling (850.37)............................... X\11\ ................. ..............
Warning Signs (850.38)......................................... ............ X ..............
----------------------------------------------------------------------------------------------------------------
\1\ Applies to beryllium operations and other locations where there is a potential for beryllium contamination.
\2\ Responsible employers must implement actions for reducing and minimizing exposures, if practicable.
\3\ Responsible employers must establish a formal exposure reduction and minimization program, if practicable.
\4\ Responsible employers must reduce exposures to or below the PEL.
\5\ Responsible employers must provide respirators when requested by the worker.
\6\ Responsible employers must provide protective clothing and equipment where surface contamination levels are
above 3 g/100 cm2.
\7\ Housekeeping efforts must maintain removable surface contamination at or below 3 g/100 cm2 during
non-operational hours.
\8\ Removable contamination on equipment surfaces must not exceed 0.2 g/100 cm2 when released to the
public or for non-beryllium use.
\9\ Removable contamination on equipment surfaces must not exceed 3 g/100 cm2 when released to other
beryllium handling facilities.
\10\ Responsible employers must provide medical surveillance for all beryllium-associated workers.
\11\ Training is required for all workers who could be potentially exposed. Counseling is required for beryllium-
associated workers diagnosed with CBD or beryllium sensitization.
IV. Section-by-Section Discussion of Comments and Rule Provisions
This section of the Supplementary Information responds to
significant comments on specific proposed rule provisions. It also
contains explanatory material for some final rule provisions in order
to provide interpretive guidance to DOE offices and DOE contractors
that must comply with this rule. All substantive changes from the
notice of proposed rulemaking (NOPR) are explained in this section.
However, some non-substantive changes, such as the renumbering of
paragraphs and changes to clarify the meaning of rule provisions, are
not discussed.
DOE has determined that the requirements set forth in this final
rule are those which, based on currently available data, are necessary
to provide protection to workers who may be exposed to beryllium.
A. Subpart A--General Provisions
Section 850.1--Scope
The CBDPP required by this rule will enhance, supplement, and be
integrated into existing worker protection program requirements for DOE
Federal and contractor employees. DOE has structured the 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 protect workers from hazards of exposure to
airborne beryllium.
Section 850.2--Applicability
As in the proposed rule, section 850.2 specifies that this rule
applies to DOE offices and DOE contractors with responsibility for
operations or activities that involve present or past exposure, or the
potential for exposure, to beryllium at DOE facilities. It also applies
to any current DOE employee, DOE contractor employee, or any other
current worker at a DOE facility who is or was exposed or potentially
exposed to beryllium at a DOE facility, regardless of which
organization currently employs the worker.
Except at the few DOE-operated facilities, DOE federal workers are
not usually directly involved in production tasks or other activities
in which they would be exposed to airborne beryllium. However, in
performing management and oversight duties, DOE federal workers may
enter facilities where beryllium is handled. Federal agencies are
required to ensure the protection of federal workers under the health
and safety provisions of 29 CFR Part 1960, ``Basic Program Elements for
Federal Employee Occupational Safety and Health Programs and Related
Matters,'' as well as Executive Order (EO) 12196, ``Occupational Safety
and Health Programs for Federal Employees.'' DOE's intent in 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.
Section 850.2(a)(2) specifies that the rule also applies to DOE
contractors with operations or activities involving exposure or the
potential for exposure to beryllium. As clarified in the definition of
``DOE contractor'' (section 850.3), DOE's intent is that the
contractors covered under this rule include any entity under contract
to perform DOE activities at DOE-owned or -leased facilities, including
contractors awarded management and operating contracts, integrating
contractors, and subcontractors. This section further clarifies that
the requirements of the CBDPP apply only to contractors and
subcontractors who work in areas or on DOE activities that involve the
potential for worker exposure to beryllium.
The provisions of this rule do not apply to former DOE workers; to
activities at DOE facilities that do not involve exposure or potential
exposure to beryllium; or to activities not
[[Page 68864]]
conducted at a DOE facility, such as the off-site laundering of
beryllium-contaminated protective clothing from a DOE site.
Section 850.2(b) exempts ``beryllium articles'' from the rule (see
the definition of ``beryllium article'' under section 850.3). DOE
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 airborne beryllium. This exemption for beryllium articles is
consistent with the approach taken by OSHA in regulating hazardous
materials under the Hazard Communication standard at 29 CFR 1910.1200.
Section 850.2(c) establishes 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. Three commenters (Exs. 30, 31, 32) opposed this
exemption, stating that lesser protection would be afforded to
laboratory workers than to those workers covered by the rule. One
commenter (Ex. 30) suggested that laboratory exposures are difficult to
predict and that a lack of sampling resulting from the perception that
little hazard is present in laboratory settings may lead to incomplete
exposure characterizations.
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. DOE 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.
DOE notes the laboratory exemption only applies in instances where
relatively small quantities of beryllium are used in a non-production
activity. In addition, OSHA's Laboratory standard has specific
provisions to ensure that protective laboratory practices are followed.
Many of the provisions in OSHA's Laboratory standard are the same as,
or similar to, those in this final rule. For instance, OSHA's
Laboratory standard establishes provisions for identifying the presence
of hazardous chemicals (baseline inventory), establishing a chemical
hygiene plan (hazard assessment), performing periodic monitoring at the
action level, implementing exposure reduction measures at the PEL,
training employees on related hazards, and providing employees the
opportunity for medical consultation and examination. In part because
each of these aspects of the beryllium rule is already included in the
OSHA Laboratory standard, DOE has retained the laboratory operations
exemption in section 850.2(b)(2).
Section 850.3--Definitions
Commenters on the proposed rule's ``Definitions'' section typically
requested clarification or modification of the proposed definitions.
New terms. In response to public comment, the following additional
terms have been defined in section 850.3: ``beryllium-associated
worker,'' ``Head of DOE Field Element,'' ``removable contamination,''
``responsible employer,'' and ``unique identifier.'' A discussion of
each term is included in the alphabetical listing of definitions
provided below.
Terms and definitions deleted. In response to public comment, the
following definitions in the NOPR are deleted in the final rule:
``accepted applicant,'' ``short term exposure limit (STEL),'' and
``surface contamination.'' The deletions are explained in the section-
by-section discussion of the rule provisions in which the terms were
previously used.
Section 850.3 defines key terms using traditional industrial
hygiene terminology and terminology used by OSHA in its regulations.
The use of such terminology is consistent with DOE's increased emphasis
on industrial hygiene compliance through the use of accepted
occupational safety and health requirements and procedures. The
following discussion explains the definitions in the rule. Although
some of these terms are commonly used, DOE believes that these
definitions will help ensure that their meaning as used in the context
of the rule is clear.
Action level means the level of airborne concentration of beryllium
established pursuant to Subpart C, which, if met or exceeded, requires
the implementation of certain specified provisions of the rule. Using
an action level to trigger certain provisions of the rule is consistent
with the approach applied in many of OSHA's substance-specific
standards. The word ``exceeded'' was amended to read ``met or
exceeded'' in the final rule to clarify DOE's intent that worker
protection provisions must be implemented in cases where worker
exposure levels are measured at, as well as above, the action level.
Authorized person means any person required by work duties to be in
regulated areas. The concept of authorized person is consistent with
OSHA standards and with contractor practice in many DOE facilities, and
is intended to ensure that the population of potentially exposed
individuals is reduced to the lowest possible number and that workers
who are granted access to regulated areas have the knowledge they need
to protect themselves and other workers. Under this rule, authorized
individuals are to be trained in the hazards of beryllium and in the
means of protecting themselves and those around them against such
hazards. Training requirements for individuals working with beryllium
are specified in section 850.37 of the rule. DOE did not receive any
comments on this definition, which remains unchanged in the final rule.
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. This definition of beryllium
reflects the focus of this rule on worker exposure to airborne
beryllium. One commenter (Ex. 26) questioned whether exposure to
naturally occurring beryllium compounds in excess of 0.1 percent was
covered by the DOE program. However, as correctly noted by the same
commenter, sections 850.2(a)(1) and (2) provide that the rule only
applies to exposures and potential exposures to beryllium that occur in
connection with facility operations. Another commenter (Ex. 10)
suggested that 0.1 percent beryllium was too inclusive, and suggested
that a level of 0.5 percent be used instead. DOE notes, however, that
the concentration specified in the definition is consistent with the
criterion that OSHA uses for a carcinogenic mixture, i.e., 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.
Therefore, DOE has not changed the definition in the final rule.
Beryllium activity means an activity performed for, or by, DOE at a
DOE facility that can expose workers to airborne concentrations of
beryllium. Activities within the scope of this definition may involve
design, construction, operation, maintenance, and decommissioning. The
definition further explains that a ``beryllium activity'' may involve
one DOE facility or operation, or a combination of facilities and
operations. This definition
[[Page 68865]]
is broad enough to include activities such as repair work performed by
support-service subcontractors who visit the site infrequently. DOE did
not receive comments on this proposed definition. However, DOE modified
the language to clarify that maintenance operations are within the
scope of the term.
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 the item's shape or design, and that
does not release beryllium or otherwise result in exposure to airborne
concentrations of beryllium under normal use conditions. DOE has
included this definition of ``beryllium article'' to distinguish
between forms of beryllium that may result in exposure to airborne
beryllium and manufactured items containing beryllium that do not
release beryllium or otherwise result in exposure to airborne
concentrations of beryllium. All of the persons (Exs. 9, 26, 30, 31)
commenting on this definition agreed that exempting beryllium articles
from the program is a logical approach. Two of these commenters (Exs.
9, 26) stated that an item destined for machining should be considered
a beryllium article up to the time of that machining. In response to
these comments DOE notes that the beryllium article definition is
consistent with the approach 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, if used as intended,
does not have the potential to result in hazardous exposures. However,
an item ceases to be an ``article'' when it is subjected to machining,
cutting, drilling, or similar action other than its intended end use.
Similarly, if an item is manufactured for the purpose of being machined
later, it is not considered an article. Another commenter (Ex. 31)
suggested that examples of activities that could release beryllium,
such as burning, grinding and chipping, be included in a parenthetical
listing in the definition. DOE recognizes that there are many
activities that could lead to a release, and is concerned that
providing examples could be interpreted to exclude other activities. To
avoid such confusion, DOE believes that examples should not be included
in the definition, but rather should be included in a companion
implementation guide for the rule.
Beryllium-associated worker means a current worker who is or was
exposed or potentially exposed to airborne concentrations of beryllium
at a DOE facility. This individual may be a DOE Federal or contractor
worker, an employee of a subcontractor to a DOE contractor, or a
visitor who, pursuant to a DOE-approved arrangement, performs work at a
DOE facility. This definition clarifies DOE's intent that the rule
applies only to current workers. The definition further clarifies that
current workers who have been removed from beryllium exposure as part
of the medical removal plan are beryllium-associated workers under the
rule, but they are not ``beryllium workers'' (see definition of
``beryllium worker'').
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 ``emergency'' as applied in 29 CFR 1910.120
and refers to any untoward event, such as a major spill of powdered
beryllium or an unexpected upset that releases a significant amount of
beryllium into the workplace atmosphere. Two commenters (Exs. 24, 31)
expressed concern that the term ``significant release'' was open to too
much interpretation and needed further clarification. Emergency
situations, by their very nature, are difficult to anticipate and
describe. DOE believes that the examples listed provide a general
indication as to what constitutes a significant release. The use of the
term ``beryllium emergency'' is used in section 850.33, which requires
DOE contractors to develop emergency procedures and training to address
emergency scenarios.
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. Medical personnel use the Be-LPT to
identify workers who have become sensitized to beryllium through their
occupational exposure. DOE did not receive any comments on this
proposed definition, which remains unchanged in the final rule.
Beryllium worker means a current worker who is regularly employed
in a DOE beryllium activity. Section 850.3 of the NOPR defined
``beryllium worker'' as ``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 proposed definition
included DOE Federal or contractor workers, workers employed by a
subcontractor to a DOE contractor and visitors performing work at DOE
facilities. Consistent with other provisions of the proposed rule, DOE
intended this definition to apply only to current workers. DOE
specifically stated in the NOPR that former workers would not be
included in the proposed ``beryllium worker'' definition, but instead
would be addressed under a separate initiative.
DOE received eight comments on the definition of ``beryllium
worker'' in the proposed rule. Five commenters (Exs. 2, 14, 16, 17, 28)
stated that the term beryllium worker was too limiting. These
commenters argued that the proposed definition of beryllium worker
should not be limited to those workers exposed to levels of beryllium
at or above the action level, but rather should include all workers
with the potential for beryllium exposure. Three commenters (Exs. 2,
14, 28) supported this position by noting that current scientific
evidence does not suggest a ``safe'' level of beryllium exposure, and
that CBD has been identified in individuals thought to have only low or
incidental exposure to beryllium. DOE shares this concern, and has
omitted the reference to the action level from the definition of
``beryllium worker'' in the final rule. DOE has revised the definition
in the final rule to apply to each ``current worker who is regularly
employed in a DOE beryllium activity.''
These same five commenters (Exs. 2, 14, 16, 17, 28) also argued
that medical surveillance should be offered to all individuals with
beryllium exposure and that the beryllium worker definition, therefore,
should be expanded to include reassigned and former workers with prior
beryllium exposure. These commenters were concerned that restricting
medical surveillance to ``beryllium-workers,'' as defined in section
850.3 of the proposed rule, would exclude workers with incidental
beryllium exposure who also may be at risk of contracting CBD.
Two commenters (Exs. 2, 28) questioned the need for separate
medical surveillance programs for former and current beryllium workers.
These two commenters raised the issues of increased cost, lack of
continuity, and the added confusion to participants associated with
maintaining separate surveillance programs.
[[Page 68866]]
In response to these comments, DOE added the term ``beryllium-
associated worker,'' which is more inclusive than the term ``beryllium
worker.'' (See definition of ``beryllium-associated worker.'') The term
``beryllium-associated worker'' is used in provisions of the rule where
DOE has determined that coverage should not be limited to workers
regularly employed in DOE beryllium activities. Use of the term
``beryllium-associated worker'' clarifies DOE's intent that current
employees with past beryllium exposures or potential exposures, as well
as current individuals who are exposed to airborne beryllium at DOE
facilities, be included under the following rule provisions: 850.5
(dispute resolution), 850.10 (development and approval of the CBDPP),
850.33 (medical surveillance), 850.34 (medical removal), 850.35
(medical consent), 850.36 (training and counseling) and 850.39
(beryllium registry).
DOE, however, has not expanded the definition to include former
workers. DOE previously established the Former Beryllium Workers
Medical Surveillance Program and offers medical examinations to former
(retired and separated) workers who are at risk for developing CBD due
to their work at DOE. The elements of the Former Beryllium Workers
Medical Surveillance Program are: (1) identification of beryllium
workers who have retired or separated from employment; (2) notifying
workers of their eligibility to participate in the program, and general
announcements to provide former workers an opportunity to self-identify
as a former beryllium worker; (3) informed consent on the risks and
benefits of participating in the program; (4) screening for CBD using
the Be-LPT, a standardized questionnaire on respiratory symptoms, and a
chest radiograph if indicated by responses to the questionnaire; (5) an
offer of diagnostic medical examinations to individuals found to have
either a positive Be-LPT or signs or symptoms of CBD; (6) periodic
medical monitoring; (7) funds for medical care that is not covered by
insurance; and (8) epidemiologic surveillance to identify high risk
operations where additional primary preventative actions are needed.
One commenter (Ex. 23) took issue with the phrase ``potentially
exposed'' in the proposed definition of ``beryllium worker,'' arguing
that it is too vague and could allow too much room for individual
interpretation. DOE believes that limiting the definition to workers
with actual personal exposure monitoring results at or above a
specified airborne level would unnecessarily limit responsible
employers' options for meeting the exposure monitoring requirements of
this rule. For instance, if the phrase ``potentially exposed'' were
removed from the definition, the use of representative sampling would
no longer be an acceptable option for meeting the exposure monitoring
requirements in the rule. Employers would be required to determine
actual exposures for all workers to determine whether the workers are
beryllium-associated workers. DOE believes that such an inflexible
requirement would be burdensome and inconsistent with sound industrial
hygiene practices and the provisions of section 850.21 of the rule,
which requires qualified industrial hygienists to apply their
professional knowledge and experience in the performance of beryllium
hazard assessments. Accordingly, the final rule (in the definitions of
``beryllium-associated worker'' and ``beryllium activity'') requires
responsible employers to consider potential exposures in identifying
beryllium workers.
Another commenter (Ex.16) stated that the proposed definition of
``beryllium worker,'' as applied in determining a worker's eligibility
to participate in the medical surveillance program, could be too narrow
in some respects and too broad in others. This commenter favored
including current workers no longer working with beryllium and those
with exposures below the action level in the definition of ``beryllium
worker.'' This commenter recommended allowing the industrial hygiene
and medical staff to use a ``graded approach'' to determine which
workers received medical surveillance, based on the needs of the
individual and ``common sense judgement about cost and benefit.'' DOE
agrees that current workers no longer working with beryllium and those
with exposures below the action level should be eligible for medical
surveillance and, thus, has included such individuals in the final
rule's definition of ``beryllium-associated workers.'' DOE does not
agree, however, that determining whether a worker should receive
medical surveillance should be left to the discretion of the industrial
hygiene and medical staff. DOE believes that such discretionary
application of medical surveillance will result in an inconsistent
level of protection for workers across the DOE complex. Therefore,
section 850.34 of the final rule requires responsible employers to
develop and implement a medical surveillance program for all beryllium-
associated workers (see discussion of section 850.34).
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
is used principally in section 850.24, Exposure Monitoring, which
requires DOE contractors to determine worker exposures to beryllium by
monitoring for the presence of contaminants in the worker's personal
breathing zone. One commenter (Ex. 9) stated that this proposed
definition was imprecise. DOE disagrees and views this definition as
being consistent with sound and accepted industrial hygiene practice.
It will ensure that samples collected for personal exposure monitoring
represent the air inhaled by workers while performing their duties in
affected work areas. Therefore, DOE has not revised this definition in
the final rule.
DOE means the Department of Energy.
DOE contractor means any entity under contract with DOE, including
a subcontractor, with responsibility for performing DOE activities at
DOE-owned or -leased facilities. This term does not apply to a
contractor or subcontractor who provides only ``commercial items'' as
defined under the Federal Acquisition Regulations (FAR). Such
contractors would not be performing DOE beryllium activities. As
explained in the discussion of section 850.10, subcontractors who are
covered under the rule normally will not be designated to prepare the
written CBDPP for a site. However, these subcontractors will be
included in the CBDPP that encompasses all beryllium-related activities
at the site.
DOE facility means any facility operated by or for DOE, whether
owned or leased by DOE.
Head of DOE Field Element is the high-level DOE official in a DOE
field or operations office who has the responsibility for identifying
the contractors and subcontractors covered by this part and for
ensuring compliance with this part.
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, etc., to remove toxic
or hazardous particulates like beryllium.
Immune response refers to the series of cellular events by which
the immune system reacts to a specific antigen. Types of immune
responses include acquired immunity and sensitization.
[[Page 68867]]
The body's immune response to beryllium is sensitization and is
indicated by the results of the Be-LPT.
Medical removal protection benefits are employment rights
established in section 850.35 for beryllium-associated workers
temporarily or permanently subject to medical removal from working in
regulated areas following medical evaluations. These provisions give
contractors an incentive to make reasonable efforts to find and offer
alternate employment to workers who have suffered negative health
effects due to exposure to beryllium. The definition of medical removal
protection benefits and the requirements in section 850.35 ensure that
such workers would suffer no reductions in total earnings, seniority,
or other worker rights and benefits for two years after permanent
medical removal. The two-year period for medical removal protection
benefits after permanent removal will allow the contractor to make a
reasonable effort to find alternate employment for a removed worker or,
through job retraining and out-placement programs operated by many
sites, to locate alternate outside employment for the worker.
Regulated area means an area demarcated and managed by the
responsible employer where the airborne concentration of beryllium
exceeds, or can reasonably be expected to exceed, the action level (see
the definition of ``action level.''). Employees working in regulated
areas must be authorized to do so by the responsible employer, and must
be trained and equipped with protective clothing and equipment. The
purpose of such areas is to limit potential exposure to beryllium to as
few workers as possible. Regulated areas are commonly used throughout
DOE, particularly with regard to radiation protection, and their use is
consistent with OSHA's expanded health standards for toxic
particulates.
Removable contamination means beryllium contamination that can be
removed from surfaces by nondestructive means, such as casual contact,
wiping, brushing, or washing. This term was adopted from DOE's
Radiological Control Manual, April 1994. One commenter (Ex. 23) stated
that ``surface contamination'', a term defined in the proposed rule,
should refer to contamination that is removable, not simply beryllium
on surfaces. DOE agrees with this commenter that only removable surface
contamination can become airborne and inhaled by workers, and has
replaced the term ``surface contamination'' with ``removable
contamination.''
Responsible employer means the DOE contractor office that is
directly responsible for the safety and health of DOE contractor
employees while performing a beryllium activity or other activity at a
DOE facility; or for DOE employees, the DOE office that is directly
responsible for the safety and health of DOE Federal employees while
performing a beryllium activity or other activity at a DOE facility;
and any person acting directly or indirectly for such office with
respect to terms and conditions of employment of beryllium-associated
workers. This definition is added to clarify DOE's intent that
provisions of the final rule apply to both DOE Federal and contractor
workers at DOE facilities.
Site Occupational Medical Director (SOMD) means the physician
responsible for the overall direction and operation of the site
occupational medicine program. DOE intends, through this definition, to
ensure that a physician administers each DOE facility's occupational
medicine program.
Unique identifier means a number or alphanumeric code used to
identify each worker individually and distinctively while protecting
the worker's privacy. Unique identifiers are used in DOE's health
surveillance program to help identify the exposures each worker has
experienced in the course of his or her work in a DOE facility without
personally identifying the worker. The unique identifiers will allow
DOE to link worker's exposure and occupational health data.
Worker means a person who performs work at a DOE facility including
(but not limited to) a DOE employee, an independent contractor, or a
DOE contractor employee. As clarified in the definition of ``DOE
contractor,'' an employee of a covered subcontractor is a contractor
employee under this part.
Worker exposure means the airborne concentration of beryllium in
the breathing zone of the worker that would occur if the worker were
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.
Section 850.4-Enforcement
DOE proposed that enforcement of the CBDPP requirements in Part 850
would be through contractual remedies, including contract termination
or reduction in fee. Section 850.4 of the final rule adheres to this
approach. This section provides that DOE may take appropriate steps
under its contracts to ensure compliance with this rule, including (but
not limited to) contract termination or reduction in fee.
One union commented (Ex. 22) that the proposed enforcement
provision would be inadequate because DOE is not likely to terminate a
prime contractor's contract for failure to comply with health and
safety requirements, and because award fee reductions are only useful
if the contracting officer is aware of, and qualified to investigate,
noncompliance. The union requested that the rule be enforced under
DOE's nuclear safety requirement enforcement procedures in 10 CFR Part
820 or pursuant to section 3131 of the National Defense Authorization
Act for Fiscal Years 1992 and 1993 (42 U.S.C. 7274d). The union also
suggested that while awaiting a compliance officer, a worker should
have the right to shut down the job without loss of pay.
DOE has not adopted the commenter's recommendation to enforce this
rule under 10 CFR Part 820 or section 3131 of the National Defense
Authorization Act for Fiscal Years 1992 and 1993. Part 820,
``Procedural Rules For DOE Nuclear Activities,'' contains procedures
for enforcement of DOE nuclear safety requirements. Beryllium is not
normally considered a nuclear material, and, therefore, enforcement of
this rule would not fall within the scope of Part 820. DOE also cannot
enforce this rule under section 3131 of the National Defense
Authorization Act because that section's scope is limited, authorizing
only the imposition of civil penalties against a DOE contractor for
failing to train or certify to DOE the adequacy of employee training in
hazardous substance response or emergency response (42 U.S.C.
7274d(b)).
In DOE's view, the existing mechanisms and contractual remedies
available for enforcing DOE contractor worker protection programs are
adequate for enforcement of this rule. For instance, under DOE Order
440.1A, DOE and, to the extent incorporated into contracts, DOE
contractors are required to implement worker protection programs that
ensure compliance with applicable health and safety requirements. The
worker protection program must provide workers with certain rights,
including, among other things, the right to accompany DOE worker
protection personnel during workplace inspections on official time; the
right to express concerns related to worker protection; to decline to
perform an assigned task based on a reasonable belief that the task
poses an imminent risk of death or serious bodily harm
[[Page 68868]]
when there is insufficient time to obtain redress through normal
reporting and abatement procedures; the right to observe monitoring or
measuring of hazardous agents and have access to the results of
exposure monitoring; the right to be notified if monitoring results
indicate they were overexposed to hazardous materials; and the right to
receive results of inspections and accident investigations upon
request. These provisions of DOE Order 440.1A continue to apply under
the CBDPP.
Additionally, a contractor employee is protected from retaliation
for a refusal to work under certain circumstances, as specified in an
interim final rule that DOE promulgated on March 15, 1999, which
substantially revises 10 CFR part 708, DOE Contractor Employee
Protection Program (64 FR 12862 as amended at 64 FR 37396). An employee
of a contractor (or a subcontractor) may file a complaint under the
``whistleblower'' regulations if he or she is subject to retaliation
for refusing to participate in an activity based on a reasonable fear
of serious injury (10 CFR 708.5(c)).
Section 850.5-Dispute Resolution
In the NOPR, DOE proposed that disputes arising under this part
that are brought by beryllium workers be resolved through applicable
grievance-arbitration processes or, if such processes are not
available, through referral to the DOE's Office of Hearings and
Appeals.
A union commented (Ex. 22) that the proposal to relegate a worker
to the grievance and arbitration provision of the collective bargaining
agreement would be inadequate because it erroneously assumes that an
arbitrator would find a final rule to be part of the collective
bargaining agreement. The union stated that unless DOE required
employers to propose this rule, and unions accepted it as a contract
condition, an arbitrator would decline to enforce this rule. The same
commenter asked that DOE clarify in the final rule that an employee
representative may file grievances under a collective bargaining
agreement or seek other remedies under the labor laws to compel
contractor compliance or deter contractor retaliation for seeking
enforcement of the rule.
A DOE contractor (Ex. 23) expressed concern that proposed section
850.5 might interfere with existing dispute resolution processes, or
might violate Federal law by imposing an obligation on the employment
relationship between a DOE contractor and its employees who are subject
to the terms of a collective bargaining agreement.
In proposing section 850.5, DOE sought to avoid creating
opportunities for workers represented by labor organizations to
circumvent collective bargaining agreement procedures for resolving
disputes concerning terms and conditions of employment. Thus, DOE
proposed that workers use available grievance-arbitration procedures
for resolution of disputes related to the subject of this rule.
However, DOE agrees with the comment that an arbitrator deciding a
grievance under a collective bargaining agreement might not look beyond
the collective bargaining agreement in making a decision. Because this
rule establishes minimum requirements that are independent of
collective bargaining agreements, available grievance-arbitration
procedures may not in some cases be sufficient to ensure compliance
with the rule.
DOE, therefore, has modified the text of section 850.5 to permit
any adversely affected person to refer a dispute regarding compliance
with the rule to the Office of Hearings and Appeals for resolution, but
employees who are represented by a labor organization are required
first to exhaust any grievance-arbitration procedure that is available
for resolving disputes over terms and conditions of employment. This is
the approach DOE took in its interim final rule for the DOE Contractor
Employee Protection Program, 10 CFR part 708 (64 FR 12862, March 15,
1999). Consistent with section 708.13(a) of the Contractor Employee
Protection Program rule, DOE has revised section 850.5 in the final
rule to provide that a worker will be deemed to have exhausted all
applicable grievance-arbitration procedures if 150 days have passed
after the filing of a grievance and a final decision on it has not been
issued.
B. Subpart B--Administrative Requirements
Subpart B of the final rule establishes general and administrative
requirements to develop, implement, and maintain a CBDPP and to perform
all beryllium-related activities according to the CBDPP.
Section 850.10--Development and Approval of CBDPP
Section 850.10 establishes the procedures for the development and
approval of the CBDPP. Section 850.10(a)(1) requires a responsible
employer in charge of DOE beryllium activities to prepare a CBDPP for
its operations and submit the CBDPP to the appropriate Head of DOE
Field Element for approval. This section establishes a 90-day time
frame from the effective date of the rule for responsible employers'
submission of the CBDPP to the appropriate Head of DOE Field Element.
DOE is aware of the burden of documentation that can be generated by
new programs. However, most responsible employers have already
developed CBDPPs in response to DOE Notice 440.1. DOE expects the
additional effort required to refine the existing CBDPPs to meet the
requirements of the rule will be minimal.
Section 850.10(a)(2) requires that a single CBDPP be submitted to
encompass all beryllium-related activities at a site. Because DOE
recognizes that one site may encompass multiple contractors and
numerous work activities, this section clarifies that the CBDPP for a
given site may include specific sections for individual contractors,
work tasks, etc. DOE believes that this allowance for a segmented CBDPP
structure will minimize the burden associated with the CBDPP update and
approval requirements because it allows individual contractors to
update and submit for approval only the section of the CBDPP pertaining
to their specific activities. If multiple contractors are involved, the
DOE contractor designated by the Head of DOE Field Element must take
the lead in compiling the overall CBDPP and coordinating the input from
various other contractors, subcontractors or work activities. This
section further clarifies that in such cases the designated contractor
must review and approve the CBDPPs of other contractors engaged at the
site before a consolidated CBDPP can be submitted to the Head of DOE
Field Element for final review and approval.
One commenter (Ex. 31) stated that the rule did not clearly
designate an ``ultimate authority'' responsible for designating
physical areas covered by the rule. DOE notes that in sections 850.20
and 850.21, the responsible employer is assigned the responsibility of
developing a baseline beryllium inventory and, where appropriate,
conducting a beryllium hazard assessment. The actions effectively
determine which areas of the facility are covered by the rule. DOE
believes that the responsible employer is the most familiar with
activities and operations that occur on a given DOE site and, thus, is
best equipped to make this determination through the performance of the
baseline beryllium inventory and hazard assessment.
Section 850.10(b) requires Heads of DOE Field Elements to review
and approve CBDPPs. DOE believes that its review and approval is
necessary to
[[Page 68869]]
ensure that each contractor's CBDPP is consistent with the requirements
and objectives of this final rule. Through these sections, DOE hopes to
establish clear lines of authority for review and approval of
contractors' CBDPPs. One commenter (Ex. 23) was concerned that local
approval of the CBDPPs by DOE field offices could lead to uneven
enforcement and increased cost of compliance. DOE does not agree with
this assessment, and believes that the Head of DOE Field Element is not
only responsible for operations within his or her jurisdiction, but is
also familiar with the operations and any related special circumstances
or unique situations that may affect implementation or effectiveness of
the CBDPP. Thus, DOE believes the Head of DOE Field Element is the most
appropriate DOE approval authority for CBDPPs. DOE notes, however, that
mechanisms exist to provide independent oversight of DOE's field
organizations. Specifically, the Office of Oversight within the Office
of Environment, Safety and Health is charged with providing information
and analysis needed to ensure that DOE's top management officials,
Congress and the public have an accurate and comprehensive
understanding of the effectiveness, vulnerabilities, and trends of
DOE's environment, safety, health, nuclear safeguards, and security
policies and programs. DOE believes that this independent oversight
will help assure consistency among CBDPPs across the complex.
Section 850.10(b)(1) establishes a 90-day period for DOE to review
and either approve or reject the CBDPP. During its review, DOE may
direct the contractors to modify the CBDPP. If DOE takes no action
within 90 days, the initial CBDPP is considered approved. DOE
established this 90-day time frame to facilitate timely implementation
of program elements by responsible employers and to ensure that Heads
of DOE Field Elements respond to responsible employers' submissions.
One commenter (Ex.18) stated that labor organizations should
receive initial and updated CBDPPs. DOE notes that proposed section
850.10(b)(2) would require contractors to give interested DOE offices,
affected workers, and designated worker representatives a copy of the
CBDPP, upon request. This provision is retained in section 850.10(b)(2)
of the final rule. This section ensures that workers and their
representatives have access to information that is related to the
protection of their health during the performance of DOE activities.
Section 850.10(c) requires responsible employers to update the
written CBDPP in two circumstances: (1) whenever a significant change
or addition is made to the program, and (2) whenever a contractor or
subcontractor changes. DOE believes that such updates are warranted to
ensure that the CBDPP accurately reflects workplace conditions and
appropriately addresses specific workplace beryllium exposure hazards.
This section also requires that responsible employers review their
written CBDPPs at least annually and revise these programs as necessary
to reflect any significant changes. Only those sections of the CBDPP
that require a change will have to be resubmitted to the Head of DOE
Field Element for approval. DOE considers the annual review cycle to be
appropriate and necessary to ensure that CBDPPs remain up-to-date and
that they accurately reflect workplace conditions and required control
procedures.
Section 850.10(d) ensures that CBDPPs are developed and implemented
consistent with the requirements imposed by the National Labor
Relations Act (NLRA), 29 U.S.C. 141 et seq., on employers in this
context, and not to create obligations in excess of those that would be
found in such circumstances under the NLRA.
Section 850.11-General CBDPP Requirements
Section 850.11 establishes the general requirements of the CBDPP.
Section 850.11(a) specifies that the CBDPP must address all existing
and anticipated operational tasks that fall within its scope. In
addition, the section requires all responsible employers to develop and
implement a CBDPP that is integrated into DOE's existing worker
protection program. 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, if
applicable, under predecessor orders) and related DOE health and safety
initiatives. The existing industrial hygiene and occupational medicine
programs provide the basis for protecting DOE Federal 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 may create redundant and potentially
inconsistent requirements.
One commenter (Ex. 23) stated that the proposed requirement to
specify in the CBDPP existing and planned operational tasks within the
scope of the rule would not be feasible for decontamination and
decommissioning (D&D) closure sites. This commenter argued that, due to
the non-routine and unpredictable nature of D&D projects, identifying
D&D tasks in the CBDPP would result in unnecessary costs, project
delays, and administrative burdens because the CBDPP would have to be
constantly updated. DOE strongly disagrees, and believes that
identifying operational tasks within the scope of the CBDPP at D&D
closure sites is practical and necessary. The non-routine and
unpredictable nature of operations on D&D closure sites often makes
such operations more hazardous than routine production operations
involving beryllium. DOE believes that the appropriate way to protect
workers from this increased hazard potential is through the
implementation of the structured assessment, planning, and control
provisions of the CBDPP. Based on experience under the interim CBDPP
policy, DOE believes the CBDPP is feasible for D&D operations. DOE also
notes that OSHA's Hazardous Waste Operations and Emergency Response
standard, 29 CFR 1910.120, requires employers at hazardous waste
remediation sites, in addition to conducting ongoing task-specific
hazard analyses, to develop a site specific safety and health plan that
addresses existing and planned activities. Thus, DOE has retained this
requirement in the final rule.
Section 850.11(b) requires responsible employers to tailor the
scope and content of their CBDPPs to the specific hazards associated
with the DOE beryllium activities being performed. In addition, section
850.11(b)(1) requires that these programs include formal plans
outlining how responsible employers will ensure that occupational
exposures to beryllium are maintained at or below the PEL (8-hour TWA
PEL of 2 g/m3).
Section 850.11(b)(2) further specifies that the responsible
employer's CBDPP must, at a minimum, address each requirement in
Subpart C of the rule. Section 850.11(b)(3) clarifies 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; (iii)
minimizing the disability and lost time experienced by workers due to
CBD, beryllium sensitization, and associated medical care; and (iv)
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 and in moving toward the
[[Page 68870]]
ultimate goal of preventing CBD within the DOE complex.
DOE is sensitive to concerns that exist within its community
regarding the need to approach exposure reduction and minimization
objectives in a responsible and realistic manner. Accordingly, section
850.11(b)(3)(iv) establishes a performance-based requirement that will
allow responsible employers to establish their own exposure reduction
and minimization goals tailored to their unique workplace needs and
conditions, subject to DOE review and approval pursuant to section
850.10(b). DOE intends for responsible employers to establish
reasonable, but challenging, goals based on sound industrial hygiene
principles and the specific circumstances for each affected DOE
workplace and location. DOE expects responsible employers to consider,
in establishing these goals, 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.
Section 850.12-Implementation
Proposed in section 850.12 required responsible employers to manage
and control beryllium exposures in all DOE beryllium activities
consistent with the approved CBDPP, the rule, or any other program,
plan, schedule or other process established by this part, as well as
requirements in other applicable Federal statues and regulations. One
commenter (Ex. 16) believed that the preceding requirement should be
changed to state that DOE and contractor personnel follow the CBDPP
only. This commenter's concern was that including all applicable
programs, plans, etc., was too broad. DOE agrees and has deleted
including all applicable programs, plans, etc., from the final rule.
Section 850.12(c) clarifies DOE's position that tasks involving
potential beryllium exposure that are not covered under the CBDPP may
not be initiated until the CBDPP has been updated to include them and
the updated plan has been approved by the appropriate Head of DOE Field
Element. The rule provides an exception to this requirement for urgent
and unexpected situations. In such cases, the task could proceed with
the written approval from the Head of DOE Field Element prior to the
CBDPP being revised and approved. One commenter (Ex. 16) sought
clarification as to when a change in the CBDPP was required. This
commenter proposed that when new beryllium activities require
additional controls and/or procedures, a change in the CBDPP is
warranted. Also, when new activities are within the range of potential
exposures to beryllium as described in the existing CBDPP, the
commenter suggested that no revision should be necessary. DOE's
position is consistent with the views of this commenter. In general,
only those activities outside the scope of the existing CBDPP would
require a revision to the CBDPP.
Section 850.12(d) recognizes that, depending on the circumstances
of the work, responsible employers may have to take other actions to
protect their workers, and DOE does not intend to preclude such actions
by the provisions of the rule. DOE recognizes that individuals
responsible for implementing CBDPP activities must use their
professional judgment in protecting the health and safety of workers.
Nothing in the 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.
Section 850.13-Compliance
Section 850.13(a) requires responsible employers to conduct DOE
activities involving beryllium in compliance with their respective
CBDPP that has been approved by the Head of DOE Field Element. Through
this provision, DOE recognizes that even the best CBDPP will not
adequately protect workers if it is not followed at the site. Section
850.13(b) requires that once the rule takes effect, responsible
employers have 2 years to fully implement all aspects of the program
(written plans, schedules, and other measures). Although DOE seeks to
lessen the burden on responsible employers by permitting them to phase
in costly controls over the 2-year period, DOE expects employers to
implement portions of the program as soon as practical during the 2-
year period.
Section 850.13(c) provides that the responsible employer in charge
of an activity involving a potential for beryllium exposure is
responsible for complying with the rule. When no contractor is
responsible for the activity and Federal employees perform the
activity, this section requires DOE to be responsible for compliance.
Subpart C--Specific Program Requirements
Subpart C of this rule establishes performance-based requirements
for the CBDPP. These requirements are designed principally to prevent
CBD by reducing the number of workers 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. DOE expects implementation of the rule to
increase its understanding of the development and course of CBD, which
may lead DOE, at some future date, to propose modifications of this
rule.
Section 850.20--Baseline Beryllium Inventory
Section 850.20(a) requires responsible employers to develop a
baseline beryllium inventory. By developing the baseline inventory,
responsible employers will accomplish the following functions that are
critical to the success of the CBDPP: (1) Identification of locations
and operations that should be physically isolated from other areas to
prevent the spread of contamination, (2) identification of areas in
which worker access should be restricted to minimize the number of
workers who could be exposed, (3) identification of beryllium
contamination that must be controlled in facilities that are scheduled
for decontamination and decommissioning, (4) identification of
beryllium contamination in facilities that are being used for non-
beryllium activities, to determine the need for cleanup, and (5) the
determination of which workers should be covered under the CBDPP.
Section 850.20(b) supplements the generic inventory requirement
under DOE Order 440.1A by requiring responsible employers to review
current and historical records, interview workers, and sample as
necessary to document the characteristics and locations of beryllium at
DOE sites. These supplemental requirements are necessary because those
persons who are responsible for activities at DOE sites may not
recognize that activities under their supervision involve beryllium or
are conducted in areas where beryllium was used in the past. Workers
often know of past beryllium activities for which no records exist.
Sampling can identify beryllium contamination where the record reviews
and worker interviews are not conclusive. These supplemental
requirements are particularly necessary because past beryllium
operations at DOE facilities were often conducted in uncontrolled work
areas.
Section 850.20(b)(3) requires that responsible employers conduct
air, surface, and bulk sampling procedures to characterize the
beryllium. Characterizing the beryllium is
[[Page 68871]]
necessary to assess and control beryllium workplace hazards.
Responsible employers should conduct the sampling that is appropriate
for the specific workplace conditions and the suspected types and
locations of beryllium contamination. Sampling techniques could include
collecting area and wipe samples and collecting personal breathing zone
samples. (Sections 850.24(a), (b), and (e)-(g) address the personal
monitoring that may be a component of the baseline inventory.)
Section 850.20(c) requires responsible employers to ensure that
individuals conducting the baseline beryllium inventory activities have
sufficient qualifications in industrial hygiene. DOE believes that this
provision is necessary to ensure that the inventory is accurate and
complete. DOE requested in the NOPR that interested parties submit
comments on the need to provide further specification in the rule
regarding the minimum qualifications that an individual must possess to
perform certain components of the CBDPP, such as hazard assessments and
exposure monitoring. One alternative approach suggested was use of
OSHA's ``competent person'' definition to define competency of the
individual. Another alternative was to require that hazard assessments
and exposure monitoring be performed by a ``certified industrial
hygienist'' (CIH) as defined by the American Board of Industrial
Hygiene (ABIH).
DOE received 14 comments in response to this request. Two of the 14
commenters (Exs. 4, 16) agreed with DOE's approach in proposed sections
850.20(c), 850.21(b) and 850.24(a). A commenter (Ex. 16) noted that if
more prescriptive definitions are used to define personnel
qualifications, the definitions should be appropriate to the required
task. For instance, CIHs should conduct hazard assessments, while
individuals possessing a lower level of knowledge should conduct
exposure monitoring. Another commenter (Ex. 4) favored the use of
OSHA's ``competent person'' definition over requirements for a CIH if
DOE elected to use one of these more prescriptive definitions.
Two commenters (Ex. 20, 29) stated that the industrial hygiene
competency requirements in proposed sections 850.20(c), 850.21(b) and
850.24(a) were too subjective and recommended instead, the use of
OSHA's ``competent person'' definition. A commenter (Ex. 20) further
noted that OSHA's Asbestos Standard, 29 CFR 1926.1101(b), included
definitions for ``competent person,'' ``industrial hygienist,'' and
``certified industrial hygienist'' and outlined specific training
courses that a competent person must complete. Two other commenters
(Exs. 3, 31) favored the use of OSHA's ``competent person'' definition
in lieu of the industrial hygiene competencies, but took exception to
the last phrase of the definition: ``and who has the authorization to
take prompt corrective measures to eliminate [hazards].'' The
commenters were concerned that limiting the performance of assessments
and monitoring to individuals with the authority to take prompt
corrective actions would exclude other qualified individuals, such as
third-party industrial hygienists.
Nine of the 14 commenters recommended that a CIH participate at
some level in the performance of beryllium inventories, hazard
assessments, and exposure monitoring. One commenter (Ex. 30) stated
that monitoring and assessments must be performed by a CIH, while the
other commenters (Exs. 3, 11, 13, 16, 19, 26, 28, 31) suggested that
qualified and trained persons working under the direct supervision of a
CIH could conduct these tasks, and that limiting the actual performance
of monitoring and assessments to CIHs would be too restrictive and
unnecessary. Although these commenters did not believe that a CIH is
needed to actually perform monitoring and assessments, many did believe
that minimum qualifications for those individuals performing these
tasks must be specified in the final rule. For instance, one commenter
(Ex. 11) recommended that DOE require that these individuals possess
sufficient industrial hygiene experience in addition to knowledge.
Another commenter (Ex. 13) suggested that a CIH, Industrial Hygienist
in Training (IHIT) as defined by the ABIH, or person with
``demonstrably equivalent qualifications'' perform assessments and
monitoring. Another commenter (Ex. 23) suggested that the industrial
hygienist definitions in DOE's ``Functional Area Qualification
Standard,'' or as defined by AIHA, be used to prescribe the
qualifications required to perform monitoring and assessments.
DOE agrees with the overwhelming majority of commenters who favored
a more prescriptive definition. DOE believes that a more prescriptive
definition will ensure proficiency and consistency in the conduct of
assessments and monitoring as well as in the overall implementation of
the CBDPP. Accordingly, DOE has provided language in sections
850.20(c), 850.21(b) and 850.24(a)(1) of the final rule for the use of
qualified individuals such as a CIH to manage and supervise beryllium
inventories, hazard assessments, and exposure monitoring, and the use
of individuals with sufficient industrial hygiene knowledge and
experience to actually perform these tasks. DOE believes this will
provide the level of consistency required to ensure that hazards are
properly identified and workers are appropriately protected without
being overly prescriptive. In this regard, DOE agrees with the
commenters who stated that the level of expertise needed to perform
beryllium inventories, hazard assessment, and exposure monitoring does
not require a CIH, and that such a requirement would cause an
unnecessary resource strain on both DOE and its contractors.
Five persons commented on other provisions of the proposed baseline
inventory section. Three of the commenters (Exs. 9, 21, 28) suggested
that DOE provide in the final rule greater specificity than DOE
proposed for baseline inventory requirements. DOE agrees with these
commenters and in the final rule has modified the requirement for
reviewing records to cover both current and historical records. The
final rule also modifies the requirement for conducting sampling to
specify air, surface, and bulk sampling. DOE believes that these
changes clarify DOE's intent, express good industrial hygiene practice,
and continue to allow the responsible employer appropriate flexibility
in conducting the baseline inventory. One commenter (Ex. 9) suggested
that DOE also specify in the final rule that baseline inventories
include the locations where beryllium activities are planned. DOE
considers locations where beryllium activities are planned to be
locations of potential beryllium contamination and exposure that must
be included in the baseline inventory under paragraph (a), and,
therefore, no change is needed.
One commenter (Ex. 18) recommended that the final rule mandate the
disclosure of health and safety documents related to past beryllium
emissions and exposures. DOE has not included such a provision in the
final rule because the Freedom of Information Act (5 U.S.C. 552)
already provides for the release of federal government records, except
for specified types of records that contain sensitive information, such
as classified information relating to national defense or foreign
policy, information in personnel and medical files, and trade secrets
or other confidential business information. Requests to DOE for release
of information related to past beryllium use and exposures may be
submitted to the appropriate DOE field office. Such requests should
follow DOE's
[[Page 68872]]
procedures for Freedom of Information Act requests in 10 CFR Part 1004.
Also see the discussion of public access to beryllium records in the
preamble discussion of section 850.39 (Recordkeeping and use of
information).
The same commenter (Ex. 18) recommended that the final rule provide
for independent review of the responsible employer's implementation of
the CBDPP. DOE does not think that such a provision is necessary,
because existing mechanisms already provide independent oversight of
DOE's contractors and include independent oversight of DOE's field
organizations. The DOE Office of Environment, Safety and Health's
Office of Oversight is charged with providing information and analysis
needed to ensure that DOE's top management officials, Congress, and the
public have an accurate and comprehensive understanding of the
effectiveness, vulnerabilities, and trends of DOE's environment,
safety, health, nuclear safeguards, and security policies and programs.
In addition, any interested individual or organization may conduct a
review of a responsible employer's compliance with this rule based on
information obtained from DOE.
One commenter (Ex. 14) recommended that the final rule provide
funding for the baseline inventory, and contended that responsible
employers will not conduct the baseline inventories unless the funding
required for this task is explicitly established by the final rule. DOE
does not require its contractors to perform unfunded tasks, but funding
of DOE programs is appropriately handled through the federal
government's budget process and not through the regulatory process. DOE
expects that its program offices will request the funds needed to meet
the obligations and objectives of their programs and activities,
including compliance with the CBDPP.
Section 850.21--Hazard Assessment
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,
section 850.21 of the final rule requires responsible employers to
conduct a beryllium hazard assessment to characterize workplace
beryllium exposure hazards. This requirement allows each site the
flexibility to determine the appropriate risk-based approach for
assessing beryllium-related hazards in its worksites where the baseline
inventory has established that beryllium is present. As noted by one
commenter (Ex. 25), flexibility in conducting hazard assessments is
particularly important because operations, conditions, and the
potential for exposure may vary greatly from operation to operation and
facility to facility.
Section 850.21(a) requires the responsible employer to conduct an
analysis of existing worksite conditions, exposure data, medical
surveillance trends, and the exposure potential of planned activities.
In addition, section 850.21(a) specifies that the responsible employer
must prioritize potential exposure activities so that the activities
with the greatest risks of exposure are evaluated first. DOE believes
that prioritizing activities is a logical first step in initiating a
hazard assessment. Targeting high-risk beryllium operations is an
effective way to reduce potential beryllium exposures throughout DOE
facilities.
Section 850.21(b) requires responsible employers to ensure that
hazard assessments are managed by qualified individuals (e.g., a CIH),
and that the individuals assigned to conduct hazard assessments have
sufficient knowledge and experience to perform such activities
properly. DOE requested in the NOPR that interested persons submit
comments on the need to further specify in the rule the minimum
qualifications that an individual must possess to perform certain key
components of the CBDPP, such as hazard assessments. DOE received 14
comments in response to this request. As noted in the preamble
discussion of section 850.20(c), 10 of the commenters either suggested
or supported establishing an additional specification that hazard
assessments be performed under the supervision of a CIH. DOE generally
agrees with these commenters about the need for a qualified individual
to manage hazard assessments and certain other tasks required by the
rule. But DOE will not require that person to be in all cases a CIH.
Thus, DOE provides in section 850.21(b)(1) that a qualified individual,
such as a CIH, must manage hazard assessments performed for the CBDPP.
By use of this language, DOE leaves open the possibility that a
responsible employer, in a particular case, may determine that someone
who is not a CIH possesses the requisite qualifications to manage the
hazard assessments.
In addition to the comments on the CIH issue, DOE received only
minor comments on section 850.21. One commenter (Ex. 21) suggested that
the exposure potential of planned activities should be rank ordered to
better focus each site's resources and efforts. DOE agrees with this
commenter, and in the final rule has modified the requirement for
hazard assessments to require the prioritization of beryllium
activities, beginning with those activities that present the greatest
risks of exposure. Another commenter (Ex. 30) was concerned about the
use of existing data, such as exposure monitoring results, in the
hazard assessment. While this commenter believed that using existing
data is appropriate, the commenter warned against the potential for
errors when relating existing data to current operations. In
particular, this commenter suggested that existing data relating to
exposure monitoring is often not well documented or is of poor quality,
thus making it difficult to determine whether the sampling is
representative of current beryllium operations. DOE agrees that
existing data can be a valuable tool if collected and documented
properly, and in many cases use of such data will expedite the hazard
assessment process. At the same time, DOE also shares this commenter's
concerns regarding the accuracy and applicability of existing data and
has retained in section 850.21(b) the requirement for the hazard
assessment to be managed by a qualified individual, such as a CIH.
DOE's intent is that this requirement will help ensure that the data
considered in the hazard assessment accurately reflects current site
conditions and hazards.
Another commenter (Ex. 24) favored the triggering of a hazard
assessment at detectable airborne beryllium levels from personal air
samples. DOE agrees that if such data is available, it must be
considered in the hazard assessment. As another commenter (Ex. 28)
pointed out, however, a hazard assessment should not be limited to the
inhalation risks posed by beryllium but must also include the presence
and characteristics of beryllium contamination in a facility.
Accordingly, the final rule requires the responsible employer to
perform a hazard assessment whenever the baseline inventory establishes
the presence of beryllium in an area.
Still another commenter (Ex. 11) requested that DOE include a non-
mandatory appendix to the rule to provide guidance on how to perform a
hazard assessment. This commenter was concerned that inexperienced
industrial hygienists may be called upon to perform a hazard
assessment, and suggested that additional guidance would be needed to
assure accuracy and consistency. DOE believes this concern is addressed
in section 850.21(b), which requires that hazard assessments be managed
by qualified individuals, such as CIHs, and performed by individuals
[[Page 68873]]
with sufficient knowledge and experience to perform such tasks.
Accordingly, DOE has not included the requested appendix to provide
guidance on how to perform a hazard assessment as a part of this
rulemaking.
Section 850.22--Permissible Exposure Limit
In the NOPR preamble, DOE reviewed the scientific evidence
suggesting that the current OSHA 8-hour TWA PEL does not sufficiently
protect worker health. However, DOE also stated that, in its view, it
is difficult to determine from this scientific evidence the exposure
level necessary to eliminate the risk of contracting CBD. For this
reason, DOE retained the existing OSHA 8-hr TWA PEL in proposed section
850.22, and proposed other provisions to minimize worker exposure to
airborne beryllium in DOE facilities. In addition, DOE included in
proposed section 850.22 language providing that DOE would adopt a more
stringent 8-hour TWA PEL if OSHA promulgated one through the rulemaking
process. Finally, DOE requested in the NOPR that interested persons
submit any compelling scientific evidence that would assist DOE in
establishing a new, more protective exposure limit for DOE facilities.
Fifteen persons commented on the 8-hour TWA permissible exposure
limit requirements in the proposed rule. Of these 15 commenters, four
supported DOE's proposal to retain the OSHA 8-hour TWA PEL (Exs. 4, 19,
26, 29). One of these four (Ex. 29) took issue with DOE's conclusion
that the existing OSHA PEL was not protective. This commenter pointed
to the inaccuracies associated with the use of area monitoring data in
referenced studies and the fact that most of the referenced studies
acknowledged that infrequent exposures above the PEL had occurred
within the study group. As a result, this commenter felt that the OSHA
PEL should be retained as the exposure limit in DOE work places.
Two commenters cited DOE's policy established in DOE Order 440.1 to
adopt the more protective of either OSHA's PEL or ACGIH's threshold
limit value (TLV) and recommended that DOE adopt the ACGIH's proposed
8-hour TWA TLV of 0.2 g/m3 as the new DOE exposure
limit (Exs. 28, 30). One commenter (Ex. 28) also supported adopting the
proposed ACGIH TLV as an 8-hour TWA action level, which DOE has done in
the final rule. (See section 850.23 in this Section-by-Section
Discussion for further discussion of the action level.) Another
commenter opposed adopting the proposed ACGIH limit and took issue with
the policy in DOE Order 440.1A, stating that any new DOE limit should
be subject to the rulemaking process (Ex. 16).
Five other persons suggested that DOE adopt one of a variety of
lower exposure limits ranging from the limit of detection to the NIOSH
Recommended Exposure Limit (REL), which is a ceiling limit of 0.5
g/m3. These commenters cited the occurrence of CBD
among workers exposed to beryllium at levels below the 8-hour TWA PEL,
and some of these commenters argued that studies presented in the
Health Effects discussion of the NOPR provided a sufficient basis for
the establishment of a new exposure limit. For example, one commenter
(Ex. 35) cited two studies that evaluated the occurrence of CBD among
the general population around a beryllium plant in Lorain, Ohio (refs.
5 and 6). Relying on these studies, this commenter suggested that the
U.S. Environmental Protection Agency's ambient air criterion for
beryllium of 0.01 g/m3 could be used as a basis for
a new 8-hour TWA exposure limit. Two other commenters (Exs. 14, 24)
cited the two Lorain, Ohio community studies, the occurrence of CBD
among workers with beryllium exposures ``well below the PEL,'' a study
published in 1997 (ref. 31) which suggests that beryllium sensitization
occurs at airborne beryllium exposure levels as low as 0.01 g/
m3, and the DOE policy to provide a workplace free of
recognized hazards (DOE Order 440.1A) to support their position that
workers should not be exposed to any detectable level of beryllium. The
remaining two commenters that offered suggestions for an alternative
exposure limit agreed with DOE's conclusion that the OSHA 8-hour TWA
PEL was not sufficiently protective and recommended adopting limits
established by other occupational health groups. One commenter (Ex. 18)
suggested that DOE adopt NIOSH's REL as a DOE exposure limit while the
other (Ex. 22) suggested that DOE apply a safety factor of 4 to the
ACGIH 8-hour TLV and use 0.05 g/m3 as the new DOE
limit.
Two other commenters (Ex. 20, 32) agreed with DOE's conclusion that
the OSHA 8-hour TWA PEL is not sufficiently protective and recommended
that DOE establish a new exposure limit. These commenters, however, did
not offer suggestions for alternative new exposure limits. Another
commenter did not directly address DOE's proposal to retain the OSHA
PEL, but instead recommended that DOE should consider the possible
effects of particle size on the occurrence of CBD.
DOE has carefully considered each of these comments and available
scientific data, and continues to believe that its original conclusion,
as outlined in the proposed rule, remains valid. Specifically, DOE
believes that existing scientific data indicates that there are
reasonable grounds to conclude that the OSHA 8-hour TWA PEL for
beryllium may not be sufficiently protective of worker health, a
conclusion supported by 12 of the 15 commenters that addressed this
section of the proposed rule. DOE is particularly influenced by the
published studies (refs. 16-17, 21) indicating that workers exposed
below the current PEL are contracting beryllium disease and exhibiting
Be-LPT sensitivity. A recent article by Eisenbud (ref. 29) also
concludes that it ``appears'' the current PEL is not protective enough.
However, DOE also believes, based on available scientific data,
that it is difficult to determine the exposure level necessary to
eliminate the risk of contracting CBD and, therefore, that the best
approach to providing improved worker protection is through the
establishment of a conservative 8-hour TWA action level, coupled with
aggressive exposure reduction and minimization efforts, and the
collection of medical surveillance data to better understand the cause
of CBD. Accordingly, DOE has retained the OSHA 8-hour TWA PEL in
section 850.22 of the final rule and has retained the action level
concept of the proposed rule, although at a lower level (see section
850.23 discussion). Section 850.22 has been revised to simply reference
29 CFR 1910.1000, instead of specifying the current numerical limit.
DOE intends this provision to result in the automatic incorporation of
a more stringent PEL that OSHA may subsequently promulgate. This does
not represent a substantive change to the provision as proposed.
In this rule, however, DOE has decided not to follow the policy
under the more general worker protection program established by DOE
Order 440.1A of adopting the more protective of either the OSHA PEL or
the ACGIH TLV. The incorporation of any new ACGIH TLV in this rule
would require that DOE conduct a rulemaking on the specific exposure
level and present the scientific basis for public comment. As stated
previously in this Supplementary Information section, DOE believes,
based on the existing scientific evidence, that such a rulemaking is
premature. By contrast, DOE may incorporate an OSHA PEL in this rule
because the OSHA PEL is promulgated following notice and comment
[[Page 68874]]
rulemaking, and the rules of the Office of the Federal Register permit
a reference to another part of the Code of Federal Regulations.
DOE proposed, in section 850.22(a) of the NOPR, to adopt the STEL
established by the ACGIH of 10 g/m3, averaged over
a 15-minute sampling period. In the final rule the STEL has been
deleted, because the proposed STEL would not provide any added
protection for the worker given that the new action level of 0.2
g/m3 would be exceeded in less than 15 minutes
where exposure levels are at 10g/m3. DOE did not
seek to establish a lower STEL because, as in the case of a lower PEL,
available scientific data do not provide a sufficient basis for the
establishment of a new STEL.
Section 850.23--Action Level
DOE proposed in the NOPR to establish an 8-hour TWA action level of
0.5 g/m3. In selecting the proposed action level,
DOE considered a number of factors. DOE considered OSHA's substance-
specific health standards, which typically establish action levels for
hazardous and toxic substances at one-half the 8-hour TWA PEL. Applying
this approach to beryllium would have resulted in a proposed 8-hour TWA
action level of 1.0 g/m3. OSHA's action levels are
premised on the safety of its PELs, and are set to provide an
additional margin of safety. As explained in the preceding discussion,
however, there is a body of evidence suggesting that the OSHA PEL for
beryllium does not adequately protect worker health. Therefore, DOE
decided that a lower action level is appropriate for DOE facilities.
According to the results of the 1996 DOE survey of DOE facilities which
reported potential beryllium exposures, two DOE facilities (Pantex and
Rocky Flats) had already employed an action level of 0.5 g/
m3. Another facility (Lawrence Livermore National
Laboratory) reported the use of an ``administrative warning range'' of
0.2 to 2.0 g/m3, which triggered a requirement for
an investigation, and six DOE facilities employed an action level of
1.0 g/m3. In light of this experience, DOE proposed
adopting an action level at the lower end of existing DOE complex
action levels (0.5 g/m3), rather than follow the
typical OSHA practice, in order to implement aggressive yet achievable
exposure minimization.
The majority of comments received on the proposed rule agreed with
the DOE's approach of using an action level that is lower than the
typical OSHA action level, but called for an even lower level than DOE
had proposed. The most commonly recommended level was 0.2 g/
m3, which is the same level as the ACGIH proposed TLV. Most
commenters believed that this level would prevent additional cases of
beryllium sensitization and disease. DOE believes that there is
reasonable technical basis for selecting 0.2 g/m3
as an action level, based on the following scientific analyses.
The U.S. Environmental Protection Agency's (EPA) Integrated Risk
Information System includes a Reference Concentration of 0.02
g/m3 for beryllium, which is ``an estimate (with
uncertainty spanning perhaps an order of magnitude) of a continuous
inhalation exposure to the human population (including sensitive
subgroups) that is likely to be without an appreciable risk of
noncancer effects during a lifetime'' (ref. 33). This concentration is
based on epidemiology studies. This continuous 24-hour per day, level
translates into an 8-hour TWA level of 0.84 g/m3.
Merrill Eisenbud conducted a study of CBD based on air sampling,
atmospheric dispersion modeling, and analysis of a beryllium production
plant's past operations. Eisenbud concluded that the lowest beryllium
concentration at the 3/4-mile boundary, beyond which no community cases
of chronic beryllium disease were found, was 0.025 g/
m3 during the 7-year period the plant operated at full
capacity (ref. 29). This 24-hour per day level translates into an 8-
hour TWA level of 0.84 g/m3, which essentially is
the same level that the EPA found to be without appreciable risk of
causing noncancer effects (i.e., CBD).
The ACGIH, a professional organization that publishes occupational
health consensus standards, has proposed to change its 8-hour TWA TLV
from 2 g/m3 to 0.2 g/m3, based
on its review of recent beryllium epidemiology studies (ref. 32).
The DOE recognizes that the EPA (0.84 g/m3),
Eisenbud (0.84 g/m3), and ACGIH (0.2 g/
m3) levels are normally used as exposure limits rather than
action levels. However, based on limitations of the studies done to
date, the difficulties in determining a safe threshold level for
occupational exposure to beryllium, and DOE's decision to implement
aggressive exposure reduction and minimization efforts, DOE has decided
that the most prudent course is to lower the action level to 0.2
g/m3 rather than set a new exposure limit. The
available science suggests that this level would be protective; is one-
quarter of the EPA and Eisenbud levels and the same as the ACGIH
proposed level. This is the lowest action or trigger level reported by
any DOE facility under the interim CBDPP, and a lower level has not
been demonstrated as being practicable. Lowering the action level to
0.2 g/m3 will result in greater protection for the
affected DOE work force by triggering additional monitoring,
surveillance, respiratory protection, and other protective measures.
Benefits of lowering the action level. As specified in this rule,
the action level triggers the use of a number of controls and
protective measures designed to protect employees from exposures to
beryllium, including:
Periodic exposure monitoring (10 CFR 850.24 (c));
Exposure reduction and minimization measure (10 CFR
850.25); \4\
---------------------------------------------------------------------------
\4\ The rule does not require that exposure reduction and
minimization efforts (e.g., engineering controls and work practices)
be triggered by the action level. DOE expects, however, that
affected sites will specify that some engineering controls and work
practices be triggered by the action level in their CBDPP plans.
---------------------------------------------------------------------------
Regulated areas (10 CFR 850.26);
Hygiene facilities and practices (10 CFR 850.27);
Respiratory protection (10 CFR 850.28); and
Protective clothing and equipment (10 CFR 850.29).
Thus, DOE sites where exposure levels exceed the action level would
be required to implement these controls to provide further protection
to workers exposed above the action level. This additional protection
will reduce the exposure levels experienced by these workers,
consequently reducing their risk of developing beryllium-related
disease and other health effects. Setting the action level at 0.2
g/m3, as opposed to 0.5 g/m3,
does not alter the set of controls that are triggered,\5\ but does
alter the timing of these additional controls. The additional
protective measures triggered by the action level will be put into
effect earlier. For example, consider an activity where airborne
concentrations of beryllium start very low (below 0.2 g/
m3), but rise over time (e.g., over a course of days or
weeks) in the workplace. Assume also that airborne concentrations will
eventually exceed 0.5 g/m3. If the responsible
employer recognizes the potential for exposures to exceed the action
level in this activity, this rule (as well as prudent industrial
hygiene practice) would require the responsible employer to conduct
exposure
[[Page 68875]]
monitoring to determine if and when the action level is exceeded. In
this situation, once the 0.2 g/m3 threshold is
crossed, the responsible employer would be required to implement the
controls specified above, and workers would benefit from the additional
protection provided by those controls. Under an action level of 0.5
g/m3, protective measures would not be implemented
until the airborne concentrations exceeded 0.5 g/
m3. Thus, during the time that exposures are between 0.2
g/m3 and 0.5 g/m3, workers
would not be afforded the additional protection of the triggered
controls. Thus, the first incremental benefit of setting the action
level lower is the reduction in risk afforded by the controls triggered
during the time that exposures are between 0.2 g/m3
and 0.5 g/m3 (See Table 9).
---------------------------------------------------------------------------
\5\ DOE did alter the set of controls that are triggered by the
action level between the proposed and the final rule. This, however,
was not done as a result of setting a lower action level, but was in
response to comments on the proposed rule.
---------------------------------------------------------------------------
The second benefit from setting the action level lower is to expand
the number of workers afforded the additional controls (See Table 10).
DOE believes there are a number of workers exposed to airborne
concentrations of beryllium between 0.2 g/m3 and
0.5 g/m3, but who are never exposed above 0.5
g/m3. DOE estimates that between 342 and 460
workers may be exposed at these levels.\6\ Under an action level of 0.5
g/m3, these workers would not be afforded the
protection of controls triggered by the action level. Under an action
level of 0.2 g/m3, however, these workers are
afforded the additional controls. These additional controls will reduce
the exposures faced by these workers, leading to a reduction in their
risk of developing beryllium-related disease and other health effects.
Thus, the second benefit of using the lower action level is a reduction
in risk among workers exposed to airborne concentrations between 0.2
g/m3 and 0.5 g/m3.
---------------------------------------------------------------------------
\6\ The lower bound estimate (342) is the difference between the
number of workers exposed above the 0.5 g/m3
action level estimated in the Economic Analysis (EA) for the
proposed rule (894 workers) and the number of workers exposed above
the 0.2 g/m3 action level estimated in the EA
for the final rule (1,236 workers). The estimates contained in the
two versions of the EA are not, however, completely comparable. In
developing the EA for the final rule, DOE obtained new data from the
sites on the number of workers exposed above 0.2 g/
m3. For some sites, the reported number of workers
exposed above 0.2 g/m3 was less than DOE's
previous estimate of the number exposed above 0.5 g/
m3. To correct for this inconsistency, DOE used the
minimum of the two estimates for each site as an estimate of the
number exposed above 0.5 g/m3. This resulted in
an estimated 776 workers exposed above 0.5 g/m3.
The difference between this new estimate and the estimated number
exposed above 0.2 g/m3 (1,236 workers) provides
the upper bound estimate (460 workers).
---------------------------------------------------------------------------
Quantitative estimates of the reduction in risk and the consequent
reduction in the incidence of beryllium-related disease and other
health effects are not possible due to a lack of necessary information.
As discussed in this preamble and the Economic Analysis (Chapter 1,
Section 1.1), no quantitative dose-response relationship has been
defined for beryllium. Without this information, DOE is unable to
provide a quantitative estimate of the benefit of using a lower action
level. Nevertheless, DOE believes that the use of 0.2 g/
m3 action level as opposed to the 0.5 g/
m3 is justified based on the benefits discussed above and
the number of comments that suggested that an action level lower than
0.5 g/m3 is necessary.
Other issues. This revision to the final rule does not accommodate
the comments (Exs. 12, 18, 32) that urged DOE to lower its action level
to any detectable level of beryllium. DOE believes it would not be
practicable to use any detectable level of beryllium as its action
level because beryllium is ubiquitous; it can be detected virtually
anywhere if a sufficiently large air sample is taken. Furthermore,
according to the EPA's Integrated Risk Information System, discussed
above, the United States population is being exposed to detectable
background levels of beryllium without an appreciable risk of
contracting CBD in their lifetime. Therefore, that level is not
supported by the available science.
Table 9.--Comparative Cost Analysis for Different Action Levels
----------------------------------------------------------------------------------------------------------------
Annualized 0.5 g/m3 action 0.1 g/m3 Action
cost for level level
0.2 g/m3 Difference Difference
Category/requirement action from 0.2 from 0.2
level Annualized g/ Annualized g/
(final cost m3 action cost m3 action
rule) level level
----------------------------------------------------------------------------------------------------------------
Requirements Triggered By The Action Level in
the Final Rule:
Periodic exposure monitoring............... $1,962,620 $1,104,421 ($858,199) $3,574,937 $1,612,317
Notify workers monitoring results.......... 66,932 40,411 (26,521) 82,104 15,171
Exposure reduction and minimization........ 2,707,636 2 2,707,636 0 3,579,513 871,877
Regulated areas............................ 0 0 0 8,496 8,496
Change rooms and showers................... 249,730 249,730 0 272,337 22,607
Respiratory protection..................... 9,085 9,085 0 342,495 333,410
Protective clothing........................ 0 0 0 382,528 382,528
Disposal of protective clothing............ 0 0 0 42,738 42,738
----------------------------------------------------------------
Subtotal................................. 4,996,004 4,111,284 (884,720) 8,285,149 3,289,144
Other Requirements............................. 26,555,397 26,555,397 0 26,555,397 0
================================================================
Total for all requirements 1............. 31,551,401 30,666,680 (884,720) 34,840,545 3,289,144
----------------------------------------------------------------------------------------------------------------
Note: Column totals may contain some rounding error.
1 For this row, the annualized cost represents the annualized cost of the proposed rule for the specified action
level.
2 The costs for exposure reduction and minimization may be lower with a 0.5 g/m3 action level since
fewer requirements would be triggered under the higher action level. The information provided to DOE by the
sites, however, did not contain enough information to make an estimate of the reduction in the costs for this
category.
[[Page 68876]]
Table 10.--Estimated Number of Workers by Exposure Level
----------------------------------------------------------------------------------------------------------------
Estimated Percent of all
Beryllium exposure levels (g/m\3\) number of affected
workers \1\ workers
----------------------------------------------------------------------------------------------------------------
0.0 to 0.1.................................................................... 0 0
0.1 to 0.2.................................................................... 398 24.4
0.2 to 0.5.................................................................... 342 to 460 20.9 to 28.2
Above 0.5..................................................................... 776 to 894 47.5 to 54.7
---------------------------------
Total................................................................... 1,634 100
Total Above 0.1......................................................... 1,634 100
Total Above 0.2......................................................... 1,236 75.6
----------------------------------------------------------------------------------------------------------------
\1\ The Economic Analysis (EA) for the final rule estimates that 1,236 workers are exposed above the action
limit of 0.2 g/m\3\ and that a total of 1,634 workers are currently exposed to beryllium. Thus, 398
workers must be exposed below 0.2 g/m\3\ (398 = 1,634-1,236). Given that measurements of exposure
levels below 0.1 g/m\3\ begin to near the detection limits, DOE assumes that all workers exposed
below 0.2 g/m\3\ would be in the 0.1 to 0.2 group. Next, DOE estimated the upper bound of the above
0.5 group by taking the estimated number of workers exposed above 0.5 g/m\3\ from the EA for the
proposed rule (i.e., 894 workers). The difference between this number and 1,236 (the number exposed above 0.2
g/m\3\) provided the lower bound of the 0.2 to 0.5 group (342 = 1,236+894). To provide the lower
bound of the above 0.5 group (776 workers), DOE corrected for an inconsistency between the EA for the proposed
rule and the EA for the final rule. In developing the EA for the final rule, DOE obtained new data from the
sites on the number of workers exposed above 0.2 g/m\3\. For some sites, the reported number of
workers exposed above 0.2 g/m\3\ was less than DOE's previous estimate of the number exposed above
0.5 g/m\3\ (in the EA for the proposed rule). To correct for this inconsistency, DOE used the minimum
of the two estimates (i.e., the estimated number of workers exposed above 0.2 g/m\3\ in the EA for
the final rule and the estimated number of workers exposed above 0.5 g/m\3\ in the EA for the
proposed rule) for each site as an estimate of the number exposed above 0.5 g/m\3\. This resulted in
an estimated 776 workers exposed above 0.5 g/m\3\ which DOE uses as the lower bound for that group.
The difference between this number and the estimated number exposed above 0.2 g/m\3\ (1,236 workers)
provides the upper bound estimate for the 0.2 to 0.5 group (460 = 1,236-776).
Note: Column total may contain some rounding error.
Section 850.24--Exposure Monitoring
Section 850.24 establishes CBDPP worker exposure monitoring
requirements. The exposure monitoring provisions in this section are
necessary to determine the extent of exposure at the worksite; prevent
worker overexposure; identify the sources of exposure to beryllium;
collect exposure data so that the responsible employer can select the
proper control methods to be used; evaluate the effectiveness of
selected controls; and provide continual feedback on the effectiveness
of the program in controlling exposures. These requirements are more
specific than the provisions of exposure monitoring in DOE Order
440.1A.
Exposure monitoring is important not only to determine the level of
beryllium to which workers are exposed and the frequency at which
workers should be monitored, but also to determine whether other
protective provisions of the rule need to be implemented. The
employer's obligation to provide respiratory protection under section
850.28, for example, is triggered by monitoring results showing that a
worker is exposed at or above the action level. Exposure monitoring
results also may help DOE 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.
Because of the importance of adequately characterizing and
monitoring worker exposures to beryllium, DOE included a specific
request in the NOPR asking interested persons for views or information
on the need for daily exposure monitoring of all beryllium workers. DOE
was considering whether daily exposure monitoring was needed 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.
Of the ten commenters who responded to this request for information,
three favored a daily monitoring requirement while seven were opposed.
The commenters who favored daily monitoring for all workers (Exs.
18, 25, 30) argued that daily monitoring of each worker would more
accurately document and characterize beryllium exposures. One commenter
(Ex. 16) suggested that initial daily monitoring could be replaced with
periodic monitoring after sufficient data was obtained. Another (Ex.
30) noted that daily exposure monitoring might be the only accurate way
to determine exposures during changing workplace conditions. This
commenter suggested that daily monitoring is important in identifying
specific work activities that contribute to the worker exposures.
The majority of commenters responding to this request (Exs. 3, 4,
16, 17, 26, 28, 29) objected to daily monitoring of all workers to
determine beryllium exposures. These commenters stated that daily
monitoring would generate large amounts of data, at great cost, while
producing little or no added benefit. Some of these commenters (Exs. 3,
26, 28, 29) favored representative sampling of the workplace, using
statistical analysis to determine the number of samples required. These
commenters asserted that the principal benefits of a statistically-
based monitoring strategy would be the reduction in the number of
samples needed and resources used.
After considering all of the comments, DOE agrees that daily
monitoring would be unnecessarily burdensome for responsible employers,
and that a statistically-based approach will ensure the adequate
characterization of worker exposures. This position is reflected in
section 850.24(b), as discussed below.
Section 850.24(a) requires that exposure monitoring be managed by a
qualified individual such as a CIH, and conducted by individuals with
sufficient industrial hygiene knowledge and experience. DOE requested
in the NOPR that interested persons submit comments on the need to
further specify the minimum qualifications that an individual must
possess to perform certain key functions under the CBDPP, including
exposure monitoring. Most of the commenters suggested or supported
adding a requirement that exposure monitoring be performed under the
supervision of a CIH. DOE agrees that a CIH is often best qualified to
manage exposure monitoring activities, and provides in section
850.24(a)(1) that exposure monitoring performed for the CBDPP be
managed by a qualified individual, such as a CIH. However, in keeping
with the performance-based philosophy underlying this rule, DOE
[[Page 68877]]
does not preclude a responsible employer from determining, in a
particular situation, that a person other than a CIH possesses the
requisite knowledge to perform this function. Most of the commenters
were of the view that individuals conducting the monitoring, under the
management of a qualified individual, need sufficient knowledge and
experience but not necessarily the same level of qualification as a
CIH.
Section 850.24(b) requires the responsible employer to perform
initial exposure monitoring for all persons who work in areas that may
have airborne concentrations of beryllium, as determined through the
baseline beryllium inventory and hazard assessment. The responsible
employer must employ a statistically-based monitoring strategy to
obtain the number of samples needed to characterize worker exposures.
The initial exposure information is necessary to determine the need for
engineering and work practice controls, to select appropriate personal
protective clothing and respiratory protective equipment where needed,
and to identify the need to establish regulated areas. One commenter
(Ex. 28) recommended that sampling should be conducted to determine
particle size and chemical characterization of the potential exposure,
and another commenter (Ex. 30) recommended use of particle size-
selective personal monitoring. DOE has decided to leave details of this
nature to the qualified individual who manages exposure monitoring
under the CBDPP, rather than attempt to prescribe them in regulations.
This type of issue also may be addressed in future DOE guidance on
implementing the CBDPP.
Section 850.24(b)(1) requires the responsible employer to determine
the beryllium exposure of workers by collecting personal breathing zone
samples that reflect worker's exposure to airborne concentrations of
beryllium over an eight-hour period. As specified in the definition of
``worker exposure'' in section 850.3, this is a measurement of the
exposure that would occur if the worker were not using respiratory
protective equipment. Section 850.3 also includes a definition of
``breathing zone,'' which means ``a hemisphere forward of the
shoulders, centered on the mouth and nose, with a radius of 6 to 9
inches.'' Thus, a breathing zone sample is taken as close as practical
to the nose and mouth of the worker. For a full description of
breathing zone samples, see OSHA's Instruction CPL 2-2.20B, CH-1, Nov.
13, 1990.
DOE recognizes that many of its responsible employers may have
performed initial monitoring as part of their efforts to implement DOE
Notice 440.1. DOE does not intend to require employers to repeat these
efforts if they are adequate under the rule. Accordingly, section
850.24(b)(2) allows employers to use initial monitoring data collected
within 12 months before the effective date of this rule to satisfy the
rule's initial monitoring requirements. One commenter (Ex. 31)
cautioned DOE that any sampling performed prior to the issuance of the
final beryllium rule should only be accepted by DOE if the work
conditions during the sampling period are the same as current
conditions. DOE agrees with this commenter, and notes that several
provisions of the final rule require responsible employers to ensure
that sampling results reflect current workplace conditions.
Specifically, section 850.24(b) requires that the responsible employer
obtain a sufficient number of sample results to adequately characterize
exposures, and section 850.24(d) requires that the responsible employer
perform additional monitoring if operations, maintenance, or procedures
change, or if the responsible employer has any reason to suspect a
change has occurred which may result in new or additional exposures.
Further, DOE believes that the requirement that exposure monitoring be
managed by a qualified individual will help assure that exposure
monitoring results accurately characterize worker exposures.
Section 850.24(c) requires the responsible employer to conduct
periodic exposure monitoring of workers who work in areas where
airborne concentrations of beryllium are at or above the action level.
Periodic monitoring provides the responsible employer with assurance
that workers are not experiencing higher exposures that may require the
use of additional controls. In addition, periodic monitoring reminds
workers and responsible employers of the continued need to protect
against the hazards associated with exposure to beryllium. The
collection of exposure monitoring data also enables the SOMD to be
informed of the existence and extent of potential sources of beryllium
exposure.
Some commenters argued that the periodic monitoring requirements in
the rule should be more conservative than proposed in the NOPR. For
instance, one commenter (Ex. 13) recommended that the requirement for
periodic monitoring be implemented if employee exposures exceed 10% of
the PEL while another commenter (Ex. 18) suggested that periodic
monitoring be required for all workers regardless of previously
measured exposures. DOE has addressed the first commenter's concerns by
establishing the action level in the final rule at no greater than 0.2
g/m\3\ (ten percent of the PEL). DOE does not believe that
periodic monitoring should be mandated for all workers regardless of
exposure level, as suggested by the other commenter, but rather that
the responsible employer should determine the frequency of periodic
monitoring where levels are below the action level. However, DOE does
encourage sites to establish lower action levels to trigger components
of their CBDPP, as part of their exposure reduction and minimization
efforts required under section 850.25.
A third commenter (Ex. 14), addressing the periodic monitoring
requirements of proposed section 850.24(c), stated that periodic
monitoring on a continuous basis is the only way to determine worker
exposures. While DOE acknowledges that certain operations may warrant
continuous monitoring due to the dynamic nature of day-to-day
operations, DOE believes that an inflexible, one-size-fits all
monitoring policy is inappropriate due to the wide range of beryllium-
related operations within the DOE complex. Accordingly, DOE provides
responsible employers the flexibility to determine the monitoring
frequency that is needed to sufficiently characterize worker exposures.
DOE believes that responsible employers are best positioned to evaluate
the potential variability of worker exposures in their operations and
to tailor their periodic monitoring approaches as appropriate.
Nevertheless, because slight process or procedural changes may go
unnoticed over time and because equipment maintenance, aging, or
deterioration can affect performance, DOE, in section 850.24(c), is
requiring a minimum exposure monitoring frequency of every 3 months
(quarterly) for workers who are exposed to airborne concentrations of
beryllium at or above the action level.
DOE recognizes that the minimum quarterly monitoring of workers
exposed at or above the action level is more frequent than is required
in most OSHA expanded health standards. However, DOE considers this
minimum monitoring frequency to be necessary due to the uncertainties
regarding the adequacy of the current PEL. To supplement this periodic
monitoring requirement, section 850.24(d) requires that responsible
employers perform additional exposure monitoring when beryllium-related
operations or
[[Page 68878]]
procedures change, or they have any reason to suspect a change, which
may cause new or additional exposures to workers. This additional
monitoring is needed to protect workers from elevated exposures
resulting from changed circumstances, 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, section 850.24(e)
requires that responsible employers use monitoring and analytical
methods that have accuracy, at a confidence level of 95 percent, of not
less than plus or minus 25 percent for airborne concentrations of
beryllium at the action level. The main reason DOE is requiring this
degree of accuracy for exposure monitoring results is to ensure that
exposure monitoring results are sufficiently accurate at the exposure
level that is relevant for the CBDPP. Accuracy of measurements is
critical, since certain central requirements of the rule (e.g.,
engineering controls, exposure reduction and minimization, respirator
use, and regulated areas) are triggered by measured worker exposures
that meet or exceed the action level. In addition, the medical removal
provision requires that a removed worker not be placed in a job where
exposure levels are at or above the action level.
Section 850.24(f) further ensures 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 AIHA, or a
laboratory that demonstrates quality assurance for metals that is
equivalent to AIHA accreditation. Equivalency to AIHA's accreditation
means that a laboratory can demonstrate that their testing protocols
meet the accreditation standards of AIHA. These accuracy and quality
requirements are consistent with similar requirements that appear in
many of OSHA's expanded health standards for toxic substances. The only
commenter (Ex. 13) to address this issue agreed with DOE that the use
of an AIHA accredited laboratory will ensure the quality control,
consistency, and accuracy of beryllium sample analyses. DOE has added
to the final rule the language ``or a laboratory that demonstrates
quality assurance for metals analysis that is equivalent to AIHA
accreditation,'' to provide responsible employers more flexibility in
selecting a laboratory and to allow the use of an appropriate
laboratory currently being used by the employer.
Section 850.24(g)(1) requires responsible employers to notify
affected workers of monitoring results, in writing, within 10 working
days of receipt of the monitoring results. This section also provides
responsible employers with two alternative methods of worker
notification: (1) written notification to each affected worker, or (2)
posting of monitoring results in a location or locations readily
accessible to affected workers. Two commenters (Exs. 16, 23) expressed
concern about the use of personal identifiers in posted monitoring
results, citing worker privacy concerns.
One commenter (Ex. 26) objected strongly to DOE's proposal to
provide notice to workers in a manner that does not identify the
worker. This commenter argued that not only is there no right to
privacy implicated by posting of sampling results, but that anonymous
notification would not further personal accountability for work
practices. This commenter cited the Atomic Weapons Establishment's
(AWE) experience at its Cardiff (United Kingdom) facility to show the
beneficial effects of peer pressure on individual workers' adherence to
good work practice. DOE recognizes AWE's experience and the benefits of
peer pressure on workers' adherence to good work practices. However,
DOE is following the approach used in OSHA's substance-specific
standards that have posting requirements, which does not incorporate
the principle of applying peer pressure to establish good work practice
procedures. DOE, therefore, provides in the final rule that when the
posting option is selected, responsible employers must post the results
without disclosing the identity of the affected workers. This
protection of workers' privacy is consistent with OSHA's substance-
specific standards that have posting requirements.
Sections 850.24(g)(2) and (3) deal with cases in which monitoring
results indicate that the worker exposure level meets or exceeds the
action level. In such cases, the responsible employer is required by
paragraph (g)(2) to include in the notice to workers a description of
the corrective actions being taken to reduce worker exposure to below
the action level. Paragraph (g)(3) requires the responsible employer to
notify the SOMD of the results within 10 working days of receipt of the
monitoring 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.
Section 850.25--Exposure Reduction and Minimization
Section 850.25 establishes the exposure reduction and minimization
provisions of the CBDPP that reflect DOE's goal of achieving aggressive
reduction and minimization of worker exposures to airborne beryllium.
Section 850.25(a) establishes the baseline requirement that
responsible employers ensure that no worker is exposed to airborne
beryllium at levels above the exposure limit established in section
850.22.
Section 850.25(b)(1) requires the responsible employer to include
in the CBDPP a formal exposure reduction and minimization program to
reduce exposure levels that are at or above the action level to below
the action level, if practicable. Sections 850.25 (b)(1)(i)-(iv)
provide that the formal exposure reduction and minimization program
must include: (1) exposure reduction and minimization goals, (2) the
rationale to support the goals and a strategy for achieving them, (3)
the specific actions that the responsible employer plans to take to
achieve the goals, and (4) a means of tracking progress towards meeting
the goals or demonstrating that the goals have been met. Where levels
are below the action level, section 850.25(b)(2) requires responsible
employers to include in their CBDPP a description and rationale for the
steps they plan to take to reduce and minimize exposures, if such steps
are practicable. Such steps are applicable when exposures are measured
below the action level to provide additional worker protection. This
requirement assures responsible employer's commitment to address and
further reduce exposures, as practicable, below the action level and
implementing the steps included in their CBDPP.
Section 850.25(c) provides that responsible employers must apply
the hierarchy of industrial hygiene controls, as already required under
DOE Order 440.1A, to achieve exposure control. This hierarchy dictates
that responsible employers first must implement feasible engineering
controls, followed by administrative controls, in their efforts to
reduce and minimize exposures. Responsible employers can supplement
these controls with personal protective clothing and equipment to
reduce exposures where engineering and administrative controls are not
feasible.
In summary, section 850.25 establishes a graded approach to
reducing and minimizing beryllium exposures to levels as low as
[[Page 68879]]
practicable. This approach is familiar to the DOE community because it
is similar to DOE's ``as low as reasonably achievable'' approach to
radiation protection. DOE's requirement that the responsible employer
establish a formal program of setting and tracking reduction goals for
exposures above the action level will result in greater management
attention to potential high exposures. The requirement that the
responsible employer take steps to reduce and minimize exposures that
are below the action level commits DOE to continue reducing and
minimizing exposures, but without the same level of management
attention since these exposures are believed to represent a lower risk
to workers.
Six persons commented on the exposure reduction and minimization
requirements of the proposed rule. Two of the commenters (Exs. 18, 23)
recommended that the rule require responsible employers to initiate
reduction and minimization actions to maintain exposures below the
action level, rather than below the exposure limit. DOE would
essentially be setting a new DOE exposure limit if it followed this
recommendation. As previously explained, DOE believes that setting a
new exposure limit would be inappropriate because the scientific data
is not fully developed and does not yet provide an adequate basis for
determining an appropriate new limit. The discussion of section 850.22,
Permissible Exposure Limit, provides greater detail on the issue of
lowering the exposure limit.
Three of the commenters (Exs. 4, 18, 33) made recommendations that
relate to the appropriate trigger for requiring responsible employers
to initiate reduction and minimization actions where exposure levels
are below the action level. Two commenters (Exs. 18, 33) recommended
that the rule require responsible employers to initiate reduction and
minimization actions wherever beryllium is detected. One commenter (Ex.
4) interpreted Table 5 in the NOPR preamble to mean that DOE would
expect the responsible employer to undertake actions anywhere exposure
levels are greater than zero. DOE believes that using either the limit
of detection or greater than zero as the trigger is not practicable
because trace levels of beryllium are ubiquitous, and beryllium levels
in air can be measured everywhere if a large enough air sample is taken
to accumulate sufficient beryllium to exceed the lower detection limit
of the analytic method being used. DOE believes that final section
850.25(b)(2) best meets DOE's intention of establishing an effective
performance-based rule by requiring responsible employer actions, if
practicable, where exposure levels are below the action level.
Another commenter (Ex. 3) questioned the efficacy of enforcing a
rule that allows each site to establish individual exposure reduction
and minimization goals. DOE believes that this approach is adequately
enforceable based on its positive experience using contractual
mechanisms to enforce similar requirements in radiation protection
regulations.
Section 850.26--Regulated Areas
Section 850.26 establishes the regulated area provisions of the
CBDPP. Regulated areas are an effective means of minimizing the number
of workers exposed to airborne concentrations of beryllium because they
prevent or minimize the spread of beryllium to clean areas. This is
consistent with good industrial hygiene practice whenever exposure to a
toxic substance can cause serious health effects.
The final rule's requirements for regulated areas are essentially
the same as those proposed, with certain good hygiene practices being
added in response to a commenter's (Ex. 1) concern discussed below
under section 850.26(d).
Section 850.26(a) requires the responsible employer to establish
regulated areas where, based on breathing zone samples, the employer
determines that workers are exposed to airborne concentrations of
beryllium at or above the action level.
Three commenters addressed this provision, as proposed, and
suggested either alternate or supplemental criteria to trigger the
establishment of regulated areas. One commenter (Ex. 18) suggested that
the trigger level be lowered to require that regulated areas be
established wherever beryllium is detected. DOE believes that the final
rule's significantly lower action level provides a suitable mandatory
trigger for the establishment of regulated areas. In addition, DOE
believes that the CBDPP exposure reduction and minimization provisions
will result in the use of an even lower site-specific action level as
improved controls become feasible throughout the DOE complex.
The two other commenters (Ex. 3, 34) suggested that the proposed
provision for regulated areas be supplemented with a surface
contamination level limit that would trigger the establishment of
regulated areas. No reliable correlation has been established between
surface contamination level and airborne concentrations of beryllium.
DOE, therefore, believes that using a surface contamination level limit
as a trigger for the establishment of regulated areas would produce
minimal benefits to worker health and has not adopted this
recommendation.
One of the commenters (Ex. 3) suggested that if engineering or
process controls bring exposure levels to below the action level in a
regulated area, the area should remain a regulated area to ensure that
controls remain in place. DOE does not agree with this comment. While
the rule would not prevent responsible employers from implementing such
a practice, requiring that regulated area provisions remain in effect
after exposures have been reduced to acceptable levels would impose
additional financial burdens on employers with no corresponding
improvement in worker protection. In addition, DOE believes that such a
mandatory provision could undermine the incentives this rule creates
for employers to implement effective engineering or process controls.
If employers were required to maintain regulated areas regardless of
whether they had implemented effective engineering controls, employers
might have less motivation to implement the controls. This commenter's
concern is at least partly addressed by section 850.24(d), which
requires the performance of additional exposure monitoring if
operations or procedures change or if the employer suspects a change
that could affect exposure levels.
Section 850.26(b) of the rule requires responsible employers to
demarcate areas where worker exposures are at or above the action level
in a manner that alerts workers to the boundaries of such areas. Under
section 850.38 of this part, warning signs must be posted, stating that
only authorized personnel are allowed in the area. Due to the serious
nature of the adverse health effects associated with exposure to
beryllium, no one should be in a regulated area without proper personal
protection.
Section 850.26(c) requires responsible employers to limit access to
regulated areas to authorized persons only. DOE intends that only
individuals who are essential to the performance of work in the
regulated area will be authorized to enter regulated areas. Responsible
employers will 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 are authorized to
enter. Methods for preventing unauthorized persons from entering a
regulated area may include posting a sign indicating that only
authorized persons may enter, the use of locked access doors, and other
[[Page 68880]]
security measures as required by worksite conditions. DOE believes that
employers are best equipped to determine whether any access control
methods are needed in addition to warning signs specified in section
850.38.
Two commenters (Exs. 1, 31) suggested the incorporation of
additional personal hygiene controls, specifically recommending that
the rule prohibit smoking, eating, and drinking in regulated areas. DOE
agrees with these commenters and has included in section 850.27 a
prohibition on smoking, eating, and drinking in areas where beryllium
is above the action level (i.e., in regulated areas).
Section 850.26(d) requires responsible employers to 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 type of work performed. One commenter (Ex. 26) stated that
a log of worker activities is not needed unless DOE is conducting a
``prospective risk assessment.'' This commenter believed that a simple
log, only documenting who entered regulated areas, would be sufficient.
The intended function of these records is clarified in section 850.39,
Recordkeeping and Use of Information. DOE believes that recordkeeping
must be adequate to permit DOE to monitor the effectiveness of each
responsible employer's compliance activities and to provide information
regarding each worker's history of potential exposures. This
information will assist the responsible employer's occupational
medicine staff in establishing appropriate medical surveillance
protocols and will aid in DOE's efforts to establish links between
working conditions and potential health outcomes. DOE has retained the
proposed regulated area recordkeeping requirements in section 850.26(d)
of the final rule.
Section 850.27--Hygiene Facilities and Practices
Section 850.27 of the final rule retains the NOPR requirements for
responsible employers to provide change rooms or areas and hand washing
and shower facilities for beryllium workers. In addition to these
provisions, the final rule also requires responsible employers to
provide lunchroom facilities that are readily accessible to beryllium
workers, ensure that tables for eating are free of beryllium, that no
worker is exposed at any time at or above the action level, and
specifies that all of these facilities must comply with the
requirements of 29 CFR 1910.141. These hygiene provisions are common in
OSHA's expanded health standards designed to protect workers from
exposures to hazardous particulates.
Sections 850.27(a)(1) and (2) requires responsible employers to
assure that workers observe prohibitions on the availability and use of
cosmetics, tobacco and chewing products, and food and beverages in
areas where beryllium is above the action level. Section 850.27(a)(3)
requires responsible employers to prevent beryllium workers from
exiting areas that contain beryllium with contamination on their bodies
or their personal clothing. DOE believes that these provisions promote
sound work place hygiene practices that may protect workers from
exposure to other substances present in the workplace, as well as
beryllium. These provisions are commonly included in OSHA's substance-
specific health standards.
Section 850.27(b) requires responsible employers to provide clean
change rooms or areas for workers who work in regulated areas. In
addition, section 850.27(b)(1) requires 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 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.
Section 850.27(b)(2) requires that the change-rooms used to remove
beryllium-contaminated clothing and protective equipment be maintained
under negative pressure, or be located in a manner or area that
prevents dispersion of beryllium contamination into clean areas.
DOE received two comments on the hygiene facilities and practices
provisions of the NOPR. A commenter (Ex. 25) suggested that the
requirement to provide change rooms, hand washing facilities, and
showers be based on a hazard assessment. DOE believes that requiring
responsible employers to perform a separate hazard assessment to
determine the need for change rooms and showers is unnecessary and
overly burdensome to responsible employers. The requirement for change
rooms and showers is triggered by the requirement to establish
regulated areas. Regulated areas, in turn, are required wherever a
hazard assessment identifies the potential for worker exposures at or
above the action level. Thus, the requirement for change rooms and
showers is already indirectly triggered by the results of a hazard
assessment.
A commenter (Ex. 23) expressed concern that the impact and burden
of constructing new change rooms for D&D closure sites has not been
considered in the development of the change room provisions, and argued
that alternative methods of compliance should be considered for D&D
operations. In fact, DOE has addressed the economic impact of requiring
responsible employers to provide change rooms for workers in the
economic analysis prepared for the NOPR and made available for public
review. Based on that economic analysis, DOE is aware that the cost of
change rooms may be substantial for some DOE facilities. However, DOE
believes that providing change rooms and showers for workers who work
in regulated areas is the most effective method for preventing workers
from carrying beryllium contamination on their work clothes and bodies
from regulated areas to other areas of DOE facilities and to workers'
private automobiles and homes. DOE is unaware of any equally effective
alternative method for achieving this objective and, thus, has retained
the change room and shower provisions in the final rule. The economic
burden may be lessened by steps employers already have taken to comply
with existing hygiene facility requirements. For example, 29 CFR
1910.120(n)(7) of OSHA's Hazardous Waste Operations and Emergency
Response standard already requires employers to provide showers and
change rooms for workers on D&D operations of six months duration or
longer. DOE contractors at DOE sites are subject to this requirement
through their contracts, which require compliance with DOE Order 440.1A
or other analogous Orders or standards.
Consistent with the goal of preventing the spread of contamination
into adjacent work areas and into affected workers' homes, section
850.27(c)(1) requires responsible employers to provide shower and hand-
washing facilities for workers assigned to regulated areas. In addition
to controlling the spread of contamination, showering also reduces the
worker's period of exposure to beryllium by removing any beryllium that
may have accumulated on the skin and hair. Requiring workers to change
out of work clothes, which are segregated from their street clothes,
and to shower before leaving the plant, leaving work clothing
[[Page 68881]]
at the workplace, significantly reduces the movement of beryllium from
the workplace. These steps ensure that the duration of beryllium
exposure does not extend beyond the work shift and, thus, protect
workers and their families from off-site exposures. DOE recognizes that
the installation of such facilities may take time in some cases.
Accordingly, section 850.13(b) of the final rule allows responsible
employers two years to achieve full compliance with the requirements of
the rule.
Section 850.27(d) requires responsible employers to provide
beryllium workers working in regulated areas with readily accessible
lunchroom facilities in which tables for eating are free of beryllium
and no worker is exposed at any time to a concentration of beryllium at
or above the action level. DOE believes that it is imperative that
workers have a clean place to eat to reduce the likelihood of
additional exposure to loose beryllium dust through inhalation or
ingestion.
Responsible employers must also assure that workers in regulated
areas do not enter the lunchroom wearing protective clothing unless the
clothing is properly cleaned beforehand. Responsible employers are
given discretion to choose any method for removing surface beryllium
from the clothing that does not disperse the dust into the air. These
requirements are similar to the hygiene facilities and practices
provisions in a number of OSHA's health standards.
Section 850.28-Respiratory Protection
Section 850.28 establishes the respiratory protection requirements
for the CBDPP. Section 850.28(a) requires that responsible employers
comply with OSHA's Respiratory Protection standard (29 CFR 1910.134).
Section 850.28(b) requires that responsible employers provide
appropriate respiratory protective equipment for all workers exposed,
or potentially exposed based upon task analyses, to airborne
concentrations of beryllium at or above the action level. This section
also requires the responsible employer to ensure that workers use
respirators. Section 850.28(c) requires the responsible employer to
include in the respiratory protection program any beryllium-associated
worker who requests to use a respirator, regardless of exposure level.
Section 850.28(d) requires that responsible employers select and use
only National Institute for Occupational Safety and Health (NIOSH)-
approved respiratory protective equipment or, if none exist for a DOE
beryllium activity, DOE-accepted respiratory protective equipment.
Some of the requirements of section 850.28 are not new. For
instance, DOE contractors have historically been required to comply
with OSHA standards, including 29 CFR 1910.134, through contract
provisions requiring compliance with DOE Order 440.1A and its
predecessor orders. DOE also has followed OSHA standards in
implementing the Federal Employee Occupational Safety and Health
Program. DOE Order 440.1A requires employers to provide, and DOE
workers to use, appropriate respiratory protective equipment necessary
to protect workers from exposures to hazardous substances. In addition,
the provisions of 29 CFR 1910.134 include a requirement that employers
select only NIOSH-approved respirators. DOE Order 440.1A expands this
requirement to allow for the use of DOE-accepted respiratory protection
if NIOSH-approved respiratory protection does not exist for a specific
DOE task. The provisions of section 850.28 that are new in this final
rule are the requirements for the use of respiratory protection: (1) at
the action level (rather than at OSHA's PEL); (2) based on the analyses
of job activities (rather than only on measured levels); and (3) when
requested by beryllium-associated workers regardless of exposure level.
DOE does not expect that these new provisions will greatly increase the
number of workers who wear respirators at DOE sites. Under current
practice, DOE sites require use of respirators at their established
action level (ranging from 0.2 to 1.0 g/m\3\) rather than at
the PEL (see CBDPP Economic Analysis, Chapter 3, Section 3.2.8).
The NOPR (Section V, Request for Information) requested comments on
changing the trigger for requiring respiratory protection from the PEL
to the action level. Seven of the thirteen commenters on respiratory
protection (Exs. 16, 18, 23, 25, 26, 28, 30) recommended that the rule
be more protective of workers' health by requiring the use of
respiratory protection at the proposed action level. None of the
remaining four commenters on this issue (Exs. 3, 4, 20, 31) recommended
retaining the PEL as a trigger. The seven supporters of using the
action level as a trigger represent a wide variety of stakeholders.
These commenters' predominant reason for recommending the more
protective level as the trigger is the uncertainty about the protection
afforded by the current PEL. These commenters provided the following
additional reasons for lowering the respiratory protection trigger from
the PEL to the action level: (1) To provide a greater margin of safety
because of the imperfections in measuring exposure levels; (2) to
provide a greater margin of safety because of the imperfections in
understanding how to set exposure limits for materials, such as
beryllium, for which the cause of illness is the body's immune system
reaction; and (3) to establish an internally consistent CBDPP which
includes consistent triggers for its protective provisions and,
therefore, is rational and easy to communicate. DOE generally agrees
with these comments and has revised section 850.28 to require the use
of respirators when exposures are at or above the action level.
One commenter (Ex. 3) was concerned that using the action level as
a trigger for respiratory protection would render the action level a de
facto PEL, because OSHA uses the PEL as the trigger for respiratory
protection in OSHA substance-specific standards. Similarly, two
commenters (Exs. 4, 20) believed that using the action level as a
trigger for respiratory protection signifies that DOE believes that the
PEL is not adequately protective. Section I.C., Health Effects, of the
Supplementary Information section provides a detailed explanation of
the difficulties of determining a safe threshold level for occupational
exposure to beryllium, given the current state of knowledge of
occupational exposures and the etiology of beryllium disease. DOE's
strategy is to require a rigorous program to prevent chronic beryllium
disease by reducing and minimizing exposures, while studies continue
that may provide the data needed to establish a safe level of exposure
to airborne beryllium. The preamble discussions of sections 850.22 and
850.23 explain in greater detail DOE's rationale for continuing to
defer to OSHA's PEL, while establishing a more protective action level
for DOE.
One commenter (Ex. 26) recommended that the responsible employer
provide respiratory protection when warranted based upon an analysis of
the worker's job activities. DOE recognizes that many tasks involving
beryllium may result in high concentrations of airborne beryllium due
to a procedure error, a work error, or an equipment failure. An
analysis of the worker's job activities will determine whether
respiratory protection is necessary for such tasks. Therefore, DOE
added section 850.28(b)(2) requiring responsible employers to provide
respiratory protection for task involving such circumstances.
[[Page 68882]]
Two commenters (Exs. 26, 30) recommended that the responsible
employer provide respiratory protection when it is not otherwise
required if requested by a worker due to the uncertainty about what is
a safe level and uncertainties in monitoring and controlling a
substance like airborne beryllium. DOE agrees with these commenters and
has added section 850.28(c), which requires the responsible employer to
provide respiratory protection upon the request of the beryllium-
associated worker regardless of measured exposure levels.
One commenter (Ex. 3) recommended requiring respiratory protection
for exposures at or above the STEL. DOE agrees with the commenter that
the STEL would have been an appropriate trigger for respiratory
protection if the action level had remained at 0.5 g/m\3\.
However, a STEL of 10 g/m\3\ for 15 minutes, as proposed in
the NOPR, would provide no added protection for workers as a trigger
for respiratory protection in the final rule because its action level
of 0.2 g/m\3\ will be exceeded in less than 15 minutes where
exposure levels are at 10 g/m\3\. As explained in the
discussion of section 850.22, DOE has decided that it would not be
appropriate, given the current science, to establish a lower STEL in
this rule.
DOE has clarified its expectations on the use of DOE-accepted
respirators in response to one commenter (Ex. 31) who questioned the
use of DOE-accepted respirators rather than NIOSH-approved respirators.
This requirement as proposed in section 850.28(c) could have been
interpreted, as it was by this commenter, to mean that responsible
employers could choose between NIOSH-approved respirators and DOE-
accepted respirators. This was not DOE's intent. DOE's revision in
section 850.28(d)(2) clarifies that responsible employers may use the
DOE-accepted respirators only if NIOSH-approved respirators do not
exist for particular DOE tasks. This section also references DOE's
Respirator Acceptance Program to clarify that DOE only accepts for use
respirators that DOE deems acceptable based upon the results of a
formal testing and evaluation program.
One commenter (Ex. 31) recommended that the rule specify that all
respiratory protective equipment be furnished at no cost to the worker.
Section 850.28(a) requires that responsible employers comply with 29
CFR 1910.134, Respiratory Protection, which currently requires in
section 1910.134(c)(4), that employers provide respirators at no cost
to the employee. Accordingly, DOE will continue to rely upon OSHA's
requirements in lieu of making specific changes to the rule.
Section 850.29-Protective Clothing and Equipment
Section 850.29 establishes the protective clothing and equipment
provisions (other than respirator use) of the CBDPP. The objectives of
this section are to provide clothing and equipment that protects
workers against the hazards of skin and eye contact with dispersible
forms of beryllium and to prevent the spread of contamination outside
work areas that could occur from the improper handling of beryllium-
contaminated clothing and equipment.
DOE has clarified the proposed requirement for the responsible
employer to provide protective clothing and equipment where skin or eye
contact with beryllium is possible. Section 850.29(a) requires that
responsible employers provide protective clothing and equipment to
beryllium workers where dispersible forms of beryllium may contact
workers' skin, enter openings in workers' skin, or contact workers'
eyes.
The openings in workers' skin could include fissures, cuts, and
abrasions. DOE recognizes that the potential for the development of
contact dermatitis, chronic ulcerations, and conjunctivitis is mainly
associated with contact with soluble forms of beryllium compounds that
are not included in the definition of ``beryllium'' in this rule.
Insoluble beryllium, however, has also been shown to cause chronic
ulcerations if introduced into or below the skin via cuts or abrasions
(ref. 34). DOE believes that it is prudent industrial hygiene practice
to avoid skin or eye contact with a material that causes chronic
ulcerations and, therefore, has included protecting workers' skin and
eyes from contact with insoluble beryllium in section 850.29(a). The
protective equipment required by this section could include coveralls,
overalls, jackets, footwear, headwear, face shields, goggles, gloves,
and gauntlets, depending on the nature of the operation and the related
skin and eye exposure hazards involved.
In the NOPR, DOE requested 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 requested
comments regarding the need for the protective clothing and equipment
provisions of proposed section 850.29(a)(2), given a DOE survey that
had found that soluble beryllium compounds apparently were not present
within the DOE complex. One commenter (Ex. 4) recommended excluding
soluble beryllium from section 850.29 based on that survey result.
However, as a result of other public comments, DOE learned that that
survey result was incorrect because one DOE commenter (Ex. 16)
indicated that its facilities contain soluble beryllium. Moreover,
other commenters (Exs. 26, 30) pointed out that DOE facilities may
contain soluble beryllium in the future.
Nevertheless, DOE has not changed the definition of ``beryllium''
in the final rule to include soluble forms of beryllium, because the
principal focus of this rule is on preventing CBD, which is caused by
exposure to insoluble forms of beryllium. One commenter (Ex. 26)
correctly pointed out that the skin and eye effects that this section
is intended to prevent are different health effects than CBD. Although
another commenter (Ex. 25) questioned DOE's view that soluble beryllium
exposure to the lungs does not cause CBD, DOE finds no evidence in the
information on health effects presented in section I.C. that exposure
of the lungs to soluble forms of beryllium causes CBD. DOE expects
responsible employers to address soluble beryllium hazards in existing
worker protection programs under DOE Order 440.1 or analogous Orders or
standards cited in responsible employers' contracts with DOE.
Section 850.29(a)(1) requires responsible employers to provide
protective clothing and equipment to beryllium workers, at no cost,
where airborne beryllium levels are measured or presumed to be at or
above the action level, because elevated airborne levels are likely to
generate elevated surface levels which represent a skin and eye hazard.
DOE has included ``presumed to be'' in section 850.29(a)(1) in response
to a recommendation that one commenter (Ex. 26) made with respect to
respiratory protection that applies equally to protective clothing and
equipment. The commenter recommended that the responsible employer
provide respiratory protection when warranted based upon task analyses.
DOE recognizes that many tasks involve beryllium that could readily
become airborne in high concentrations due to a procedure error, a
worker error, or an equipment failure, but which will have no
measurable exposure level unless one or more of these problems occur.
DOE believes that an analysis of the worker's job activities would show
the need for protective clothing and equipment, and respiratory
protection to perform such activities.
[[Page 68883]]
Another commenter (Ex. 3) recommended that DOE add a surface
contamination level that would also trigger the requirement to provide
protective clothing and equipment. DOE agrees with this commenter
because elevated surface levels represent a skin and eye hazard, and,
accordingly, DOE has added paragraphs (a)(2) and (a)(3) to this
section. Section 850.29(a)(2) requires responsible employers to provide
protective clothing and equipment to beryllium workers where surface
contamination levels are measured to be, or prior to initiating work
are presumed to be, above the housekeeping level prescribed in section
850.30. Section 850.29(a)(3) requires responsible employers to provide
protective clothing and equipment to beryllium workers where surface
contamination level results obtained to confirm housekeeping efforts
are above the prescribed housekeeping level.
Section 850.29(a)(2) addresses the situation in which the
responsible employer is planning to conduct a task involving beryllium
and has time to measure or estimate surface levels before the task
begins. Section 850.29(a)(3) addresses the situation in which the
responsible employer learns from routine surface monitoring conducted
at the end of a shift that housekeeping efforts did not reduce surface
levels to below the surface contamination level specified in section
850.30. DOE recognizes that sampling to confirm the adequacy of
housekeeping efforts at the end of shifts, and the turnaround time of
as much as 24 hours for sample analysis, could result in workers not
using protective clothing and equipment for more than a day where
surface contamination levels exceed the prescribed surface
contamination level. However, DOE believes that these situations will
be rare, because routine post-shift cleaning should keep these surface
contamination levels from becoming excessive. Also, DOE believes that
responsible employers will be motivated to reduce turnaround times for
analyses in their efforts to reduce and minimize exposures. DOE
selected the term ``results'' in section 850.29(a)(3) to avoid creating
a situation in which the responsible employer would violate the rule
simply because the employer did not know that the housekeeping
criterion had been exceeded until surface monitoring results were
available.
Section 850.29(a)(4) requires the responsible employer to provide
protective clothing and equipment upon the request of the beryllium-
associated worker, regardless of measured exposure levels.
Section 850.29(b) incorporates into this rule 29 CFR 1910.132,
Personal Protective Equipment General Requirements. This OSHA standard
is responsive to a commenter's (Ex. 31) recommendation that the rule
should require the responsible employer to furnish the clothing and
equipment at no cost to the employee, and covers other well-established
practices, such as the topics to be included in protective clothing and
equipment training, and ensuring that protective clothing and equipment
fits properly. This requirement to comply with 29 CFR 1910.132 is
consistent with the general worker protection provisions of DOE Order
440.1A, and analogous Orders or standards cited in the responsible
employer's contract with DOE.
Section 850.29(c)(1) requires the responsible employer to establish
procedures for donning, doffing, handling, and storing protective
clothing and equipment that prevent beryllium workers from exiting
areas that contain beryllium with contamination on their bodies or
their personal clothing. DOE added this provision because one commenter
(Ex. 3) correctly pointed out that it was omitted in the proposed rule
and is needed to ensure that workers do not track contamination out of
areas that contain beryllium. The same commenter recommended that DOE
explicitly require HEPA vacuuming of contaminated protective clothing
and equipment as part of the required doffing procedure. This final
rule does not include a requirement to include HEPA vacuuming in
doffing procedure, because DOE believes that this would not allow the
employer sufficient flexibility in selecting cleaning procedures.
Section 850.29(c)(2) requires that the procedures for donning,
doffing, handling, and storing protective clothing and equipment
include a requirement that beryllium workers exchange their personal
clothing for full-body protective clothing and footwear (work shoes or
booties) before beginning work in regulated areas. 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 onto affected workers' private property. A recent study (ref.
35) has documented the transport from work areas of beryllium on
workers' hands and inside their personal vehicles.
One of DOE's objectives is to prevent the spread of beryllium
contamination, thereby reducing the number of persons exposed and the
opportunities for potential exposures. Thus, sections 850.29(d) through
(f) establish provisions to control the handling, maintenance,
cleaning, and disposal of beryllium-contaminated protective clothing
and equipment.
Section 850.29(d) requires the responsible employer to ensure that
workers do not remove beryllium-contaminated protective clothing and
equipment from areas that contain beryllium, except for authorized
activities such as cleaning and repairing the clothing and equipment.
DOE replaced ``site'' in the proposed rule with ``area that contains
beryllium'' in the final rule to clarify its intent to minimize
contamination of other areas at the site as well as outside the site.
Section 850.29(e) requires the responsible employer to prohibit the
removal of beryllium from protective clothing and equipment by blowing,
shaking, or other means that may disperse beryllium into the air.
Although DOE generally believes that responsible employers should have
the flexibility to determine the most appropriate means to clean
contaminated clothes based on their own specific worksite conditions,
DOE has included this well recognized and accepted industrial hygiene
control to prevent the dispersion of beryllium particles into the
workplace atmosphere.
Section 850.29(f), which was proposed as section 850.29(c),
requires responsible employers to clean, launder, repair, and replace
protective clothing and equipment as needed to ensure its continued
effectiveness in protecting workers. This section allows contractors
flexibility in determining the required frequency for laundering
protective clothing based on specific work conditions and the potential
for contamination.
Section 850.29(f)(1), which was proposed as section 850.29(b),
paragraphs (1)-(2), requires the responsible employer to ensure that
protective clothing and equipment removed for laundering, cleaning,
maintenance, or disposal, is placed in containers that prevent the
dispersion of beryllium dust, and that these containers are labeled in
accordance with section 850.38. These warning labels will help ensure
appropriate subsequent handling of beryllium-
[[Page 68884]]
contaminated materials and may prevent inadvertent exposures that could
result if laundry, maintenance, or disposal personnel are not aware of
the beryllium contamination and the precautions prescribed by the
responsible employer to prevent the release of airborne beryllium. In
section 850.29(f)(1) of the final rule, DOE has deleted the words
``impermeable'' and ``are designed'' which were in proposed section
850.29(b)(1) in response to a commenter's (Ex. 8) recommendation to
clarify DOE's intent. This change eliminates the possible implication
that DOE expects responsible employers to provide special containers
even if existing containers are capable of preventing the spread of
contamination.
Section 850.29(f)(2), which was proposed as section 850.29(d),
requires the responsible employer to ensure that organizations that
launder or clean DOE beryllium-contaminated protective clothing or
equipment are informed that exposure to beryllium is potentially
harmful, and that clothing and equipment should be laundered or cleaned
in the manner prescribed by the responsible employer to prevent the
release of airborne beryllium. DOE replaced ``any individual'' with
``organizations'' to clarify that DOE's objective for this section is
to ensure that any organization that launders beryllium contaminated
clothing is informed of the hazards of handling beryllium contaminated
items so that the organization can take steps to protect its workers.
The proposed wording ``any individual'' could have been interpreted as
establishing a direct relationship between the responsible employer
that generated the contaminated clothing and the employee of the
laundry or cleaning organization, which is not DOE's intent. Also, DOE
clarifies in section 850.29(f)(2) that this section requires informing
both on-site cleaning and laundry services, as well as off-site
cleaning and laundry vendors. On-site cleaning and laundry services are
covered by this rule, but may not know about the presence and hazards
of beryllium on the clothing and equipment unless the responsible
employer informs them.
DOE has deleted the words ``at or above the action level or above
the STEL,'' which in proposed section 850.29(a) qualified the
requirement to inform downstream launderers or cleaners of beryllium-
contaminated protective clothing and equipment. This change is
consistent with final section 850.25, which requires reduction and
minimization, if practicable, where exposure levels are below the
action level.
One commenter (Ex. 31) recommended including in the rule provisions
for preventing heat stress. DOE recognizes that requiring protective
clothing and equipment for dispersible forms of beryllium compounds at
the final rule's lower action level is likely to result in greater use
of protective clothing and equipment, including respirators, and
consequently greater potential for heat stress. DOE believes that the
health benefit from lowering the risk of CBD outweighs any increased
health risk caused by heat stress that results from the requirements of
this section. DOE has not included heat stress provisions in this rule
because it is a potential problem for many DOE activities that require
the use of protective clothing and equipment; and DOE expects heat
stress issues to be addressed in the responsible employer's existing
worker protection program.
Section 850.30--Housekeeping
Section 850.30 establishes the housekeeping provisions of the
CBDPP. Good housekeeping practices are necessary in operational areas
where beryllium is used or handled, to prevent the accumulation of
beryllium contamination on surfaces throughout the workplace. Such
accumulations, if not controlled, may lead to the spread of beryllium
contamination on surfaces and the re-suspension of beryllium particles
into the air, both in the area where beryllium dusts were originally
generated and in other work areas. In addition, the uncontrolled
accumulation of beryllium-contamination on equipment in the workplace
increases the potential for worker exposure to beryllium during the
performance of equipment maintenance, handling, and disposal tasks.
DOE in section 850.30(a) has established that the removable
contamination housekeeping level on surfaces must not exceed 3
/100 cm2 during non-operational periods.
Establishing a surface removable contamination limit reduces the
potential for spread of beryllium contamination. Responsible employers
must perform measurements to determine if the operational work area is
in compliance with the rule. In addition, monitoring surface
contamination levels is an indispensable tool for ensuring that
beryllium emissions from operations are under control. The only
practical method of monitoring surface levels is to maintain the
surface contamination at an established housekeeping level so that
elevations above that level can readily be detected.
The performance of housekeeping tasks can, in and of itself, lead
to worker exposures to beryllium-contaminated dust. Therefore, the
housekeeping section also seeks to prevent the spread and re-suspension
of dust during housekeeping activities.
Two commenters (Exs. 26, 28) questioned the scientific basis for
establishing a 3 g/100 cm2 surface removable
contamination level. In addition, these two commenters stated that the
variability associated with wipe sampling makes surface sampling method
an unreliable method for sampling. DOE views wipe sampling as a useful
and accepted method for providing qualitative information on chemical
contamination of work surfaces, and agrees with the following statement
in the OSHA Technical Manual (Section II: Chapter 2, Sampling for
Surface Contamination): ``Wipe sampling is an important tool of work
site analysis for both identifying hazardous conditions, and in
evaluating the effectiveness of * * * housekeeping, and decontamination
programs.'' Accordingly, this requirement is intended only as a
housekeeping performance measure, and should not be viewed as a
mechanism for measuring, or predicting airborne concentrations of
beryllium. In addition, this requirement only applies to removable or
loose surface contamination, which could become re-suspended in the
workplace air or spread to non-controlled areas.
DOE does not intend the requirement for surface wipe sampling in
this rule to preclude the use of other surface sampling methods for
measuring beryllium contamination. DOE agrees with comments calling for
more research (Exs. 16, 28) and encourages the use, research, and
development of new technologies such as direct reading instruments,
which may provide better results than wipe sampling.
Section 850.30(a) requires that responsible employers conduct
routine surface sampling in operational areas, to ensure the
effectiveness of their housekeeping efforts. This sampling would not
include the interior of installed closed systems such as enclosures,
glove boxes, chambers, or ventilation systems. Sampling should not be
carried out during a normal work shift, but rather it should be
undertaken after normal clean-up and during non-operational periods.
Affected sites throughout DOE have already established, under the
interim CBDPP, allowable beryllium surface contamination levels to
ensure the
[[Page 68885]]
effectiveness of their housekeeping procedures. These levels range from
1 to greater than 5 g/100 cm2, with the majority of
the sites using approximately 3 g/100 cm2 or less
as the criterion for determining the cleanliness of their working
environment outside of regulated areas. Comments on the NOPR called for
setting levels ranging from less than 1 g/100 cm2
(Exs. 14, 18) to 5 g/100 cm2 (Ex. 24). Information
collected from the sites during the development of the interim
beryllium CBDPP indicated that the Pantex and Y-12 facilities currently
have an allowable surface concentration level of 25 g/100
cm2 for regulated areas. Los Alamos National Laboratory
(LANL) procedures call for re-evaluation of the operations with
additional cleaning of beryllium operations areas at levels greater
than 26 g/ft2 (2.8 g /100 cm2).
Lawrence Livermore National Laboratory (LLNL) indicated those areas
with surface concentrations greater than 3 g/100
cm2 are designated as regulated areas. Rocky Mountain
Remediation Services (a sub-contractor at Rocky Flats) indicated that a
surface contamination level greater than 25 g/ft (2.7
g/100 cm2) outside of regulated areas triggers
clean up actions at its site. The AWE facility at Cardiff (United
Kingdom) has utilized a surface action level of 10 g/
ft2 (1 g/100 cm2) outside of regulated
areas since 1990. Based on this range of data, DOE adopted the 3
g/100 cm2 housekeeping level in the proposed rule
and continues to believe it is a reasonable surface removable
contamination level that should not be exceeded.
One commenter (Ex. 3) recommended that the surface removable
contamination level be the same level as the criterion for releasing
contaminated equipment for other uses. Another commenter (Ex. 23)
objected to establishing a single surface limit for removable beryllium
contamination that would be both a housekeeping and release level,
recommending instead a tiered approach, with different levels for
normal or safe work conditions (and free release of equipment), for
beryllium work, and for special work conditions. For the reasons
discussed under section 850.31, Release Criteria, DOE has adopted
different levels for the release of equipment that depend on the
intended future use of the equipment.
One commenter (Ex. 24) expressed concern that certain beryllium
oxide weapons components could not meet the 3 g/100
cm2 level, and recommended that weapons components be exempt
from surface contamination limits. DOE has revised section 850.30 to
clarify that the surface removable contamination level is to be
measured post-shift, and that the purpose of the surface level is not
to have an absolute value of 3 g/100 cm2 at all
times during the machining or working with beryllium or beryllium
parts. DOE is aware that it may not be possible to maintain surface
levels of beryllium in an operational work area below the 3 g/
100 cm2 limit at all times. Again, the surface removable
contamination level is intended as a post-shift measure of the
effectiveness of routine housekeeping efforts.
DOE emphasizes that the housekeeping concerns addressed by section
850.30 apply to areas where workers may be exposed to beryllium, not to
closed-off rooms or buildings. To make this clear, DOE has added the
term ``operational areas'' in section 850.30(a). If routine surface
sampling during non-operational or post-shift periods shows that the
removable contamination level has been exceeded, clean-up measures must
be instituted.
DOE agrees with the comment (Ex. 28) that the meaning of the term
``removable'' contamination may not be clear. Therefore, DOE has added
a new definition of ``removable contamination'' and deleted the
definition of ``surface contamination'' in section 850.3. The
definition of ``removable contamination'' is taken from the U.S.
Department of Energy Radiological Control Manual (DOE/EH-0256T Revision
1, April 1994). Use of this language in this rule maintains a
consistent approach with DOE's radiological surface sampling program.
Two commenters suggested the use of wet wipes for surface sampling,
while another commenter (Ex. 24) indicated that there is no basis for
the application of a wet method. NIOSH, in its recent publication on
beryllium contamination inside worker vehicles, supports the use of a
wet wipe sampling method to collect beryllium samples in potentially
contaminated employee vehicles (ref. 35).
The use of diverse sampling methods (e.g., differences in type of
sample media, type of solvent (if any) on the sample media, area
sampled, etc.) may easily lead to the reporting of inconsistent
results. To reduce the variability in reported surface contamination
across the DOE complex, DOE recommends, but does not require, the use
of a single sampling method: NIOSH method 9100 (NIOSH Manual of
Analytical Methods, 4th Edition, August 15, 1994, Lead in Surface Wipe
Samples). This method may have to be modified for surfaces smaller than
100 cm2 using a procedure such as that described in Appendix
D of 10 CFR part 835. Sites using other methods, e.g., dry wipe
sampling, should transition to the NIOSH method in a cost-effective
manner. Current data is not clear on the relative efficiency of dry
verses wet sampling on the variety of surfaces found in the DOE.
Therefore, immediate adoption of the NIOSH method at sites across DOE
may be impractical and add no immediate value to worker health and
safety. In the long term, by recommending a single method (a wet
method) for conducting the surface sampling, DOE believes that the
variability associated with surface sampling will be reduced without
specifying a particular method in the rule.
One commenter (Ex. 3) suggested that the term ``routine'' in
section 850.30(a) should be more clearly defined, i.e., weekly or
monthly. Because DOE believes that this rule should be as performance-
based as possible, the frequency of ``routine'' monitoring procedures
under this section should be developed by the local health and safety
specialist (industrial hygienist) based on the specific circumstances
at the site.
Section 850.30(b) prohibits the use of compressed air or dry
methods and requires the use of vacuuming, wet or similar methods for
the cleaning of beryllium-contaminated floors and other surfaces. The
purpose of using these methods is to reduce or eliminate the potential
for re-suspension of beryllium dust into the air and breathing zone of
the worker.
One commenter (Ex. 23) requested flexibility in cleaning methods,
such as permitting the use of sticky tack cloths. DOE agrees with the
comment and in the final rule has allowed the use of other cleaning
methods, such as sticky tack cloths, that have the same end result as
wet vacuuming (i.e., a reduction of dust-producing cleaning methods).
These are appropriate methods for complying with the housekeeping
requirement of the rule.
Section 850.30(c) requires the use of HEPA filters in all vacuuming
operations used to clean contaminated or potentially contaminated
surfaces, and further requires filter replacement as needed, to
maintain the capture efficiency of the vacuum system. 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. HEPA filters must be used to prevent the spread of dust by
effectively collecting the dust that is collected by vacuum systems.
Responsible employers should have procedures for the cleaning or
replacement of filters that ensure
[[Page 68886]]
minimum employee exposure to beryllium dust on the filter.
As discussed in earlier sections of this analysis, the movement of
contaminated equipment from a regulated area to a nonregulated area may
result in the spread of beryllium contamination to the nonregulated
area. To prevent the potential spread of contamination from the
performance of housekeeping activities required by this rule, section
850.30(d) requires that cleaning equipment used in areas where surfaces
are contaminated or potentially contaminated with beryllium be labeled,
controlled, and not used for other, non-hazardous materials. These
procedures are similar to those required under OSHA's asbestos standard
for equipment used during cleanup or removal of asbestos from
buildings.
Section 850.31--Release Criteria
Section 850.31 establishes beryllium contamination levels and other
requirements that must be met before equipment and other items used in
beryllium work areas may be released or transferred to the general
public and non-beryllium areas of DOE facilities, or to facilities
engaged in work involving beryllium. DOE requested comments on the
setting of ``beryllium free-release'' public contamination levels in
the NOPR. After considering the comments received in response to this
broad request for views and information, DOE reopened the comment
period on June 3, 1999, to invite public comment on specific options
for release criteria that were being considered by DOE (64 FR 29811).
Section 850.31 reflects DOE's consideration of the substantial number
of comments received from organizations and individuals on this topic.
In the notice of reopening of the comment period, DOE suggested
that a reasonable contamination level for release of equipment and
other items to the public for non-beryllium uses would be 0.1
g/100cm2. This level was based on the housekeeping
and release levels believed to be in effect at various DOE facilities
and the AWE facility in the United Kingdom. DOE also stated that it was
inclined to adopt a contamination level of 3 g/100
cm2 for release of items for beryllium work in other
facilities. This level was based principally on the practice at the
Rocky Flats.
Ten organizations and individuals submitted comments that
recommended release level values. These values ranged from non-
detectable to 3 g/100 cm2 for public release and
non-detectable to 10 g/100 cm2 for release to
beryllium facilities.
One commenter (Ex. 47) stated that there should be a single
contamination level for both the housekeeping standard for beryllium
areas and for release of items for beryllium and non-beryllium uses.
Another commenter (Ex. 43) urged DOE to adopt a single criterion for
release to the public and DOE non-beryllium facilities and to
beryllium-handling facilities because it would be simpler to
administer. DOE does not agree with these comments, because the workers
in operational areas where beryllium is used have been trained in the
hazards of beryllium and the proper use of protective equipment that is
required to be worn in those areas. DOE does not believe that the
general population or DOE non-beryllium workers should be exposed to
the same level of a hazardous material as workers who have been trained
in the safe handling of that material. DOE, therefore, has included in
the rule separate requirements for the release of beryllium-
contaminated equipment and other items to facilities engaged in
beryllium work and for releases to the general public or DOE non-
beryllium facilities.
Section 850.31(a) requires the responsible employer to clean
beryllium-contaminated equipment and other items to a contamination
level that is as low as practicable, but not to exceed the removable
contamination levels specified in section 850.31(b), for release to the
general public or to non-beryllium areas of DOE facilities, and section
850.31(c), for release to facilities performing work with beryllium. In
addition, DOE has included in these sections other requirements that
are designed to protect workers and others from the hazards associated
with exposure to beryllium. DOE uses the words ``and other items''
after ``equipment'' in section 850.31(a) to cover tools, supplies,
documents, etc., and any personal property in beryllium-handling areas
that may not be encompassed by the term ``equipment.'' The phrase
``equipment and other items'' does not include real property or
buildings.
Release to the public and for use in DOE non-beryllium areas.
Section 850.31(b)(1) sets the removable contamination level for
equipment and other items to be released to the general public or for
use in DOE non-beryllium work areas at 0.2 g/100cm2
or the concentration level of beryllium in soil at the point of
release, whichever is higher. The equipment also must be labeled, in
accordance with section 850.38(b), to warn recipients of potential
beryllium hazards. The responsible employer must condition the release
of equipment and other items to the public based on the recipient's
commitment to implement controls to ensure that exposure does not
occur. Such a commitment should be based on the nature and possible
future uses of the equipment and other items, the nature of the
beryllium contamination, and whether exposure to beryllium is
foreseeable.
In the notice of reopening, DOE referenced a comment by the AWE
(Ex. 1) which reported that the housekeeping surface action level in
its Cardiff, Wales facility had been reduced to 1 g/ft\2\
(about 0.1 g/100 cm\2\) in 1990. DOE reasoned that, based on
the AWE experience and release limits included in DOE facilities'
interim CBDPPs, a public release limit as low as 0.1 g/100
cm\2\ would be achievable. Several commenters (Exs. 41, 43, 46, 47, 51)
argued that this level would be difficult and costly to achieve, and
that there is no technical basis for concluding that it would be more
beneficial than a higher level. AWE (Ex. 38) commented that it is not
using 0.1 g/100 cm\2\ as a release level; its current policy
is to dispose of contaminated items in a landfill site. The Pantex
Plant (Ex. 46) stated that its reported use of 0.1 g/100 cm\2\
as a release criterion was incorrect, possibly due to a typographical
error, and it recommended using 3 g/100 cm\2\ for the public
release limit. Rocky Flats (Ex. 47) pointed out significant differences
between the AWE Cardiff facility, which is a stable work environment,
and the Rocky Flats facility, which is engaged in decontamination and
decommissioning work. Two commenters (Exs. 43, 46) argued that a
surface removable contamination level of 0.1 g/100 cm\2\ could
easily be exceeded by background levels of beryllium.
Other commenters (Exs. 44, 45, 48, 49) took the position that any
detectable level of beryllium on the surface of an item should be
presumed to present a health risk and, therefore, that no item having a
detectable level of beryllium should be released to anyone for any
purpose. One commenter (Ex. 48) stated that the correlation between
surface beryllium levels and associated health hazards is unknown, and
the possibility exists for fixed or inaccessible beryllium to be
liberated when equipment is worked on or repaired. Another commenter
(Ex. 49) stated that DOE should take a cautious stance because of the
current lack of information regarding the nature of the exposure-
response relationship and the factors that underlie individual
sensitization towards beryllium. Two commenters (Exs. 49, 52)
recommended life-cycle
[[Page 68887]]
administrative controls for beryllium-contaminated equipment.
Section 850.31(b)(3) responds to the recommendation of comments
(Exs. 26, 38) calling for a risk assessment that considers the
downstream user's exposure potential, the history and type of
equipment, and the nature of the contamination, in order to decide
whether and how to release equipment and other items for non-beryllium
uses. As recognized by DOE in the reopening notice, surface or wipe
sampling is not an adequate means of characterizing potential exposure
risk. For example, a lathe or other piece of equipment released because
it is determined to be beryllium-free on the surface may contain
internal beryllium dust that could become airborne and present a health
hazard during future maintenance. On the other hand, other types of
equipment may contain internal beryllium that is combined with other
substances (e.g., grease) which would make it unlikely that the
beryllium would ever become airborne. The presence of this type of
suspended contamination, even at levels above the surface release
criterion, would not necessarily present a health hazard. Accordingly,
an assessment of potential risk of exposure should be undertaken before
the release of any equipment or other item to either the general public
or to DOE for non-beryllium uses. Based upon the assessment, the
decision should be made as to ultimate disposition of the equipment and
any conditions that should be placed on its future use.
After considering the comments, DOE is persuaded that it would be
costly, if not infeasible, to implement a contamination level of 0.1
g/100 cm\2\ or lower as the public release criterion. Section
850.31(a)(1) requires responsible employers to clean equipment and
other items to the lowest contamination level practicable and to ensure
that removable contamination on surfaces does not exceed 0.2
g/100 cm\2\ or the concentration level of beryllium in local
soil. This removable contamination criterion is based, in large
measure, on information provided in comments submitted by the
contractor that manages the Rocky Flats facility (Ex. 47). To comply
with the interim CBDPP established by DOE Notice 440.1, Rocky Flats
conducted an extensive site characterization (over 6000 samples) using
0.2 g/100 cm\2\ as the target contamination level. Rocky Flats
reported that they found the 0.2 g/100 cm\2\ to be an
achievable level and determined (using recently published re-suspension
factors) that any airborne beryllium generated from re-suspending
beryllium from surfaces, even with some beryllium surface levels above
0.2 g/100 cm\2\, would be expected to be well below the EPA's
National Emission Standards for Hazardous Air Pollutants (NESHAP) limit
of 0.01 g/m\3\ and therefore, at safe levels. EPA's NESHAP is
the national standard for community air that the population
continuously breathes.
DOE has addressed the concerns of commenters (Exs. 46, 50) that it
may not be possible to clean equipment and other items to below the
natural background of beryllium in local soil. It is highly unlikely
that this rule would apply to soil because soils generally contains
less than 0.1 percent beryllium and, therefore, is not considered
beryllium for the purposes of this rule. Nonetheless, DOE included in
section 850.31(b)(3) the words ``or the concentration level of
beryllium in local soil at the point of release'' to eliminate the
possibility that the rule would compel a responsible employer to clean
local soil off of equipment and other items before release.
DOE does not agree with the view of some commenters that, in the
absence of scientific evidence of a threshold or ``safe'' level of
exposure to beryllium, the surface contamination release level should
be at the limit of detection or zero. Although one commenter (Ex. 45,
45B) submitted information indicating that re-suspension of beryllium
in the air is possible on surfaces with less than 1.0 g/100
cm\2\ of beryllium, there currently is no scientific evidence that
surfaces cleaned to that level would result in airborne concentrations
of beryllium at levels that would be harmful to workers.
DOE has addressed the concern about the potential for exposure to
re-suspended beryllium by requiring a case-by-case assessment of risk
before equipment and other items are released for non-beryllium uses.
There is likely to be wide variation in these situations, and DOE is
not prepared at this time to prescribe uniform management controls.
However, this is an area for which DOE may develop guidance to assist
field elements, as experience is gained under this rule.
One commenter (Ex. 43) recommended establishing a general surface
release level of 1 g/100 cm\2\, plus labeling of items. The
commenter suggested the use of labels to shift responsibility for
controlling future exposures to the recipients of the equipment or
items. DOE does not believe that simply cleaning the outside of the
equipment and other items and providing warning to the new user is
adequate because some recipients, particularly recipients who have not
performed work using beryllium, may not fully understand the risks
associated with beryllium exposure.
Release for beryllium work. Section 850.31(c)(1) sets the
contamination level for equipment or other items released for use in
other facilities engaged in beryllium work at 3 g/100 cm\2\.
The equipment or item also must be labeled in accordance with section
850.38(b). Section 850.31(c)(3) requires the responsible employer to
ensure that a released item is enclosed or placed in sealed,
impermeable bags or containers to prevent exposure to beryllium during
handling and transportation to its destination. Enclosure of equipment
and other items to be released to other beryllium operations can be
accomplished by any practical means, such as wrapping in plastic.
Several commenters recommended that DOE establish a higher surface
contamination release level for equipment and other items to be
transferred to another facility for beryllium work than is allowed for
items released to the public or for use in DOE non-beryllium work (Exs.
38, 41, 42, 46, 51). Surface contamination levels recommended by the
commenters (see Table 9) for release of equipment and other items to be
used in beryllium areas range from 0 and non-detectable to 10
g/100 cm\2\. Rocky Flats (Ex. 47) previously established a
release level for equipment and other items to be transferred to other
DOE facilities for beryllium work at 2.5 g/100 cm\2\. Several
commenters (Exs. 41, 42, 51) and a number of the DOE sites reporting
release levels support the use of 3 g/100 cm\2\ or less as a
release level for equipment and other items that will be used for
beryllium work.
Based upon current surface sampling technology, DOE sees no
appreciable difference between 2.5 g/100 cm\2\ and 3
g/100 cm\2\ and, therefore, has adopted the 3 g 100
cm\2\ value for release of equipment and other items to other
facilities for beryllium work. Adoption of this value also maintains a
consistency with the housekeeping requirements for operational
beryllium areas, which will simplify implementation by DOE facilities.
Other issues. One commenter (Ex. 51) recommended that the rule
specify that an industrial hygienist should determine the number and
location of swipe samples. DOE views the determination of the number
and location of swipe samples to be part of the hazard assessment,
which must be managed by a qualified individual such as a CIH (see
discussion for section 850.21).
[[Page 68888]]
Two commenters (Exs. 49, 50) were concerned with dermal exposures
to beryllium. DOE agrees that there is a potential health hazard
associated with dermal exposure to beryllium, and has imposed
requirements under sections 850.29 and 850.37 to protect workers
handling beryllium. The hazards associated with dermal exposures also
are dealt with in the DOE facilities' health and safety programs under
DOE Order 440.1A or, analogous Orders or standards cited in responsible
employers' contract with DOE.
Section 850.32--Waste Disposal
Section 850.32 (proposed as section 850.31) establishes the waste
disposal provisions of the CBDPP. Like many of the provisions of the
rule (e.g., regulated areas, protective clothing and equipment, and
housekeeping), the waste disposal provisions are designed to minimize
the spread of beryllium contamination throughout the facility or beyond
the sites boundaries.
DOE believes that the most effective way to control the spread of
contamination resulting from waste disposal activities is to prevent or
minimize the generation of beryllium waste. Accordingly, section
850.32(a) of the final rule requires responsible employers to employ
waste minimization principles in conducting beryllium activities. Good
housekeeping practices, required by section 850.30, aid in this effort
by continually removing beryllium dust accumulations from work
surfaces, thereby reducing the level of contamination of workplace
equipment. The performance of hazard analyses on operations with the
potential to generate wastes, as required by section 850.21, can help
responsible employers 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.
Section 850.32(b) of the final rule requires responsible employers
to dispose of beryllium-containing waste, and beryllium-contaminated
equipment and other items that are disposed of as waste, in sealed
impermeable bags, containers, or enclosures that are labeled in
accordance with section 850.38. Enclosure can be any practical
mechanism for sealing, such as wrapping in plastic. DOE believes these
waste disposal provisions are necessary to prevent the re-suspension of
beryllium contamination into the workplace atmosphere. Warning labels
are necessary to ensure that workers are aware that bags, containers,
or enclosures contain beryllium so that they can take appropriate
precautions. Furthermore, responsible employers must comply with
applicable Federal, state, and local regulations governing the
management, transportation, and disposal of waste that contain
beryllium.
DOE received two comments regarding the waste disposal provisions
of the NOPR. One commenter (Ex. 31) applauded DOE for including waste
minimization principles as a control measure for reducing beryllium
exposures. This commenter suggested that DOE consider developing a non-
mandatory appendix to the rule or stand-alone guidance to illustrate
waste minimization principles and provide ideas for workers and
employers. DOE recognizes the utility of non-mandatory guidance in
assisting responsible employers in implementing certain mandatory
requirements of the CBDPP. DOE notes, however, that the U.S.
Environmental Protection Agency and other Federal agencies have already
developed a wide variety of guidance materials addressing waste
management, waste minimization, and pollution prevention principles and
practices. Not only are these guides readily available to the DOE
community, but many DOE sites have used these guides to develop their
own hazardous waste management plans. For this reason, DOE believes
that the development of an additional guidance document to address
waste minimization principles for the final CBDPP rule is not
necessary. DOE is developing an implementation guide for the CBDPP rule
that will provide general guidance for disposal of beryllium waste.
The other commenter (Ex. 18) suggested that the waste disposal
provisions should address the declassification of beryllium parts that
are classified for national security purposes at certain DOE sites.
This section of the final rule requires responsible employers to
control the generation of beryllium-containing waste, and beryllium-
contaminated equipment and other items that are disposed of as waste
and to dispose of this equipment and other items in a safe manner. DOE
does not intend for these provisions to alter or affect the
classification of beryllium-contaminated equipment and other items, nor
to supersede the applicable requirements for protection of such
equipment and items. Accordingly, beryllium-contaminated materials that
are classified must be handled in accordance with the governing
national security regulations, standards, and policies. Responsible
employers also must dispose of such materials in accordance with the
provisions of this rule.
Section 850.33--Beryllium Emergencies
Section 850.33 (proposed as section 850.32) establishes the
beryllium-related emergency provisions of the CBDPP. Such provisions
are particularly important in light of the possibility, suggested by
several commenters, that a single, high-level beryllium exposure may
have been the cause of CBD occurring among several workers thought to
have had no exposure or only incidental, low-level exposures to
beryllium.
Proposed section 850.32 would have established broad performance-
based provisions requiring responsible employers to develop procedures
for responding to and alerting workers to beryllium emergencies, to
ensure the availability and use of appropriate protective equipment
during related cleanup operations, and to provide emergency response
workers with appropriate training on proper response procedures.
Two commenters (Exs. 11, 31) responded to the proposed beryllium
emergencies section, and both requested that DOE provide additional
guidance regarding beryllium emergency procedures, training, and
personal protective equipment requirements. One commenter (Ex. 31)
suggested that this guidance was needed to ensure a consistent and
coordinated response to beryllium emergencies in cases in which workers
from different employers respond to the same event. Both commenters
suggested that DOE consider incorporating elements of the emergency
response provisions of OSHA's Hazardous Waste Operations and Emergency
Response standard (29 CFR 1910.120) in the CBDPP rule.
DOE agrees with the commenters, and notes that the beryllium
emergencies provisions of the NOPR were not intended to supersede the
applicable provisions of 29 CFR 1910.120. Accordingly, to avoid
confusion and duplicative efforts and to ensure consistent and
coordinated responses to beryllium emergencies at DOE facilities, DOE
has revised the beryllium emergencies section (renumbered section
850.33 in the final rule) to require responsible employers to comply
with 29 CFR 1910.120(l) for
[[Page 68889]]
emergency response activities related to hazardous waste cleanup
operations, and 29 CFR 1910.120(q) for emergency response activities
related to all other operations. Also, DOE will provide general
guidance on preparing for, and responding to, emergencies involving
beryllium in the DOE implementation guide for this rule.
Section 850.34--Medical Surveillance
Section 850.34 (proposed as section 850.33) establishes the medical
surveillance provisions of the CBDPP. These provisions are aimed at:
(1) Identifying workers at higher risk of adverse health effects from
exposure to beryllium; (2) preventing beryllium-induced disease by
linking health outcomes to beryllium tasks; and (3) making possible the
early treatment of beryllium-induced disease.
Several changes have been made to the medical surveillance
provisions as proposed. These changes include enlarging the scope of
the covered population to include former beryllium workers who are
still employed at DOE facilities in non-beryllium work; adding the term
``beryllium-associated worker,'' which includes all current workers who
have or had the potential for exposure to beryllium; adding a multiple
and alternate physician review process; deleting the requirement that
exposure be at or above the action level before initiating medical
surveillance; and deleting the requirement for Office of Environment,
Safety and Health review of the written medical surveillance program.
In addition, DOE has made editorial changes to clarify various
provisions.
The medical surveillance program is designed to ensure the prompt
identification, and makes possible the proper treatment, of workers who
become sensitized to beryllium or develop CBD. In addition to
determining the incidence of CBD in the workforce, the medical
surveillance program fulfills a critical information development
function, including identifying the risk factors associated with the
development of CBD and beryllium sensitization. This rule requires that
medical surveillance be given to workers who are at the greatest risk
from continued exposure. This determination should be made on the basis
of the air monitoring results, the SOMD's recommendation, and any other
relevant information the responsible employer may possess, such as past
medical or air monitoring records, workers' job tenure, etc.
DOE realizes that some workers may elect not to participate in the
medical surveillance program because they believe that a diagnosis of
CBD or beryllium sensitization could have a negative impact on future
employment opportunities or on their health insurance. In light of this
concern and DOE's desire to maximize worker participation in the
medical surveillance program, DOE in the NOPR requested interested
parties to comment on the feasibility and utility of including
anonymous testing as a provision in the final rule. In requesting
public comment, DOE noted two concerns it had regarding the use of
anonymous testing; specifically, concern about DOE's inability to
correlate collected exposure data to health outcomes for workers
choosing anonymous testing, and concern about the effect of anonymous
testing on DOE's ability to conduct follow-up tests to confirm positive
Be-LPT results.
Eight commenters (Exs. 4, 16, 17, 23, 26, 28, 30, 31) responded to
DOE's request for information regarding anonymous testing. Most
commenters stated that anonymous testing would not provide significant
additional benefits or protection for workers. In addition, all of the
commenters shared DOE's concerns regarding the resulting inability to
correlate collected exposure data to health outcomes, and the
difficulty of tracking employees for follow-up testing to confirm
positive results. The commenters believed that these two drawbacks
overshadow any potential increase in worker participation.
One commenter (Ex. 17) expressed concern that the use of anonymous
testing would limit the employer's ability to provide support to
workers receiving medical surveillance. This commenter noted that
ongoing support and reassurance is essential for those workers with
positive or inconclusive test results. Three commenters (Exs. 16, 23,
26) stated that medical surveillance should be used to determine
workplace exposures and evaluate the effectiveness of workplace
controls. These commenters believe that anonymous testing would hamper
this effort by preventing responsible employers from identifying
specific jobs or tasks that lead to beryllium-related health effects.
For reasons stated in the NOPR and expressed by all eight
commenters, DOE has decided against the use of anonymous testing.
However, DOE has taken steps in the final rule to protect the privacy
of beryllium-associated workers, e.g., by requiring the use of unique
identifiers (see discussion of section 850.39). DOE cannot responsibly
accomplish the tasks of ameliorating the effects of exposure to
beryllium and developing needed data on the cause and development of
CDB through anonymous testing. DOE also believes that offering
anonymous testing as a supplement to identified testing would
discourage workers from participating in identified testing.
Accordingly, provisions for anonymous testing are not included in the
final beryllium rule.
Section 850.34(a)(1) requires responsible employers to establish
and implement a medical surveillance program for beryllium-associated
workers. DOE adheres to its view that participation in the medical
surveillance program should not be mandatory for workers. The
responsible employer's obligation is to offer to provide the medical
tests and procedures as required. DOE expects that where worker
confidence in the medical program exists, refusal to participate will
be minimal.
The term ``beryllium-associated worker'' is used in the final rule
where DOE has determined that coverage of provisions should not be
limited to current workers regularly employed in DOE beryllium
activities. Use of the term ``beryllium-associated worker'' will
increase the population eligible to receive medical surveillance by
including current workers with past beryllium exposures or potential
for exposures.
Numerous commenters (Exs. 2, 3, 4, 14, 16, 17, 28, 30, 29, 31) made
recommendations regarding the level of employee exposure that should
trigger worker participation in the medical surveillance program. Two
of these commenters (Exs. 3, 4) objected to offering medical
surveillance to all workers potentially exposed to beryllium. However,
their reasons for not wanting to include all potentially exposed
workers differed. One commenter (Ex. 3) stated that placing all
potentially exposed employees in the medical surveillance program would
be inconsistent with the permissible exposure limit. The other
commenter (Ex. 4) was concerned with the costs associated with such a
strategy, and the potential for causing worker anxiety from false-
positive Be-LPT test results for workers with limited exposure
potential. While these commenters agreed that some level of worker
beryllium exposure should trigger the medical surveillance program,
neither provided recommendations for an appropriate trigger level.
One commenter (Ex. 16) suggested that DOE use a graded approach to
the medical surveillance program which would include current beryllium
workers and other workers with exposures or potential exposures at or
above the action level. DOE has
[[Page 68890]]
determined that a graded approach linked to exposure at or above the
action level would not ensure the necessary surveillance of all DOE and
contractor workers who may have had exposure to beryllium, whether
current or past.
Several commenters (Exs. 2, 14, 16, 17, 28, 29, 30, 31) favored the
inclusion of all potentially exposed workers in the medical
surveillance program regardless of the measured exposure level. These
commenters argued that medical surveillance should not be limited to
workers exposed to levels of beryllium at or above the action level,
but rather should include all workers with the potential for any
beryllium exposure. Three of these commenters stated that current
scientific evidence does not indicate a ``safe'' level of beryllium
exposure, and that CBD has been identified in individuals thought to
have only low or incidental exposure to beryllium. Their concern was
that restricting medical surveillance to ``beryllium workers,'' as
defined in proposed section 850.3, would exclude such workers, who in
their view are also at risk of contracting CBD. In addition, two of the
commenters (Exs. 28, 30) noted that allowing workers exposed at any
level to participate in the medical surveillance program would act as
an incentive for employers to minimize the number of individuals who
work in beryllium areas.
Similarly, three commenters (Exs. 28, 29, 31) argued that current
workers with past beryllium exposures should be offered the opportunity
to participate in the medical surveillance program. One commenter (Ex.
31) noted that, based on the proposed definition of ``beryllium
worker,'' medical surveillance would not be made available to current
workers with past beryllium exposure unless they were covered under the
medical removal provisions of proposed section 850.34. Another
commenter (Ex.15) suggested that all employees at DOE facilities, even
those with no exposure to beryllium, should be given the option of
participating in the medical surveillance program.
Several commenters (Exs. 2, 16, 28, 31, 19) raised the issue of
medical surveillance for former workers with past beryllium exposures
who no longer work at a DOE facility. The commenters stated that former
DOE workers should also be provided the opportunity to participate in
medical monitoring. They acknowledged DOE's proposed establishment of a
separate, directly funded program that offers medical examinations to
former workers at risk of developing CBD. However, two of the
commenters (Exs. 16, 31) argued that this program should be made
available to former workers at the same time as the program for current
workers. Another commenter argued that maintaining two separate
databases and programs was not practical.
DOE has revised the final rule to require responsible employers to
provide medical surveillance for all beryllium-associated workers. DOE
based this revision on the beryllium cases suggesting that low and even
incidental exposure to beryllium can lead to sensitization or beryllium
disease. This approach will ensure the early identification of workers
at risk of health effects from exposure to beryllium, provide the
greatest protection of worker health, and provide a more complete
documentation of beryllium exposures. Beryllium-associated workers
eligible for medical surveillance include any current worker who is
exposed or was exposed or potentially exposed to airborne
concentrations of beryllium at a DOE facility. Thus medical
surveillance will be available to a beryllium worker (as defined in
section 850.3), a current worker whose work history shows that the
worker may have been exposed to airborne concentrations of beryllium at
DOE facilities, a current worker who exhibits signs and symptoms of
beryllium exposure, and a worker who is receiving medical removal
protection benefits.
Section 850.34(a)(2) requires responsible employers to designate a
Site Occupational Medical Director (SOMD) who will be responsible for
administering the medical surveillance program. One commenter (Ex. 18)
stated that a panel comprised of individuals representing management,
labor, the public, and the local medical community should select the
SOMD. DOE has not adopted this recommendation because DOE believes that
the responsible employer must have ultimate responsibility for ensuring
compliance with this requirement.
A number of commenters (Exs. 12, 14, 20, 23) were concerned about
the quality of health care for workers with CBD and, more specifically,
whether or not workers would have a choice of physicians. One commenter
(Ex. 20) pointed out that OSHA no longer restricts the performance of
medical evaluations to licensed physicians because this requirement is
too prescriptive and fails to recognize the realities of today's health
care system. This commenter suggested adding a provision to include
other licensed health care professionals among those who may perform
medical evaluations.
DOE agrees with this commenter and has revised section 850.34(a)(3)
of the final rule to require responsible employers to ensure that all
medical evaluations and procedures are performed by or under the
supervision of a licensed physician who is familiar with the health
effects of beryllium. Although a licensed physician is the appropriate
person to supervise and evaluate a medical evaluation, certain required
elements of the evaluation may be performed by another, appropriately
qualified person under the supervision of the physician. The licensed
physician is required to be familiar with the health effects of
beryllium. DOE expects that the medical evaluations and procedures
required to diagnose CBD will be performed or validated by a specialist
in pulmonary medicine, occupational medicine, or other physician with
specialized equipment and examination protocols required to
definitively differentiate between CBD and other lung diseases. DOE
believes that this is necessary due to the unusual nature of CBD and
the fact that not all physicians are familiar with the evaluation of
beryllium-associated patients.
Three commenters (Exs. 15, 18, 22) expressed concern about certain
language in the NOPR preamble that they interpreted to mean that
workers would be limited to an evaluation performed by an employer's
physician. One commenter (Ex. 22) suggested that DOE adopt OSHA's Lead
Standard as a model for selecting physicians. DOE never intended to
limit an employee's choice of physicians. To clarify this point, DOE
has included in section 850.34, paragraphs (c) and (d), provisions for
a multiple physician and alternate physician review. These provisions
are explained in the discussion that follows.
DOE views medical surveillance as a primary tool for determining
the extent of CBD risk within the worker population. Therefore, section
850.34(a)(4) requires responsible employers to maintain and give to the
SOMD a list of beryllium-associated workers who may be eligible for
medical surveillance. The list must be based on hazard assessments,
exposure records, and any other information that will identify
beryllium-associated workers (section 850.34(a)(4)(i)). In addition,
section 850.34(a)(4)(ii) requires responsible employers to regularly
update the list based on the information from the periodic evaluations
performed pursuant to paragraph (b)(2) of this section.
One commenter (Ex. 16) questioned why DOE proposed to give the SOMD
the task of identifying working conditions that contribute to the risk
of CBD and determining the need for
[[Page 68891]]
additional exposure controls. This commenter believed that this task
should be performed by an industrial hygienist. Similarly, another
commenter (Ex. 23) stated that the SOMD should not be responsible for
performing data analysis to determine which workers should be included
in the medical surveillance program, or for maintaining the list of
beryllium workers at a site. The commenter argued that both of these
tasks are management functions that should be carried out by the
responsible employer based on technical guidance provided by the
industrial hygiene department and the SOMD. DOE agrees with both of
these commenters. The responsible employer, not the SOMD, should have
the function of identifying working conditions and evaluating the need
for workplace controls. Consequently, DOE has revised the final rule to
require that responsible employers identify beryllium-associated
workers. However, medical judgments that are requisite to management
decisions are the SOMD's responsibility.
Section 850.34(a)(5) requires the responsible employer to provide
the SOMD with the information needed to operate and administer the
medical surveillance program. This information includes, but is not
limited to, the baseline beryllium inventory, hazard assessment
results, 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.
Section 850.34(a)(6) requires the responsible employer to provide
the SOMD and the examining physician with (1) A copy of this rule and
its preamble; (2) a description of the workers' duties as they pertain
to beryllium exposure; (3) records of the workers' beryllium exposure;
and (4) a description of personal protective and respiratory protective
equipment in current or anticipated use. DOE 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-associated worker.
Several commenters (Ex. 8, 17, 18, 19) suggested including
provisions for providing beryllium education and training programs to
physicians and other health care providers in the rule. DOE has not
adopted this suggestion, because it would expand the scope of the rule.
Section 850.34(b) requires responsible employers to provide,
without cost to beryllium-associated workers, all medical evaluations
and procedures performed to comply with these regulations. This section
also requires that all evaluations and procedures be performed at a
time and place that are convenient for the worker. This provision is
consistent with similar provisions in OSHA's expanded health standards.
This section also requires responsible employers to provide the SOMD
with a list of beryllium-associated workers who may be eligible for
protective measures under the rule.
Section 850.34(b)(1) requires responsible employers to provide a
baseline medical evaluation to beryllium-associated workers. The
purpose of the baseline medical evaluation is to: (1) Establish the
current health status of the worker and determine whether it is
appropriate to assign the worker to jobs with beryllium exposure; (2)
initially determine what level of medical surveillance the responsible
employer must provide to the worker; and (3) establish essential
baseline data for the worker which is used to assess subsequent health
changes attributable to beryllium exposure.
DOE received a number of comments regarding baseline medical
evaluations and medical testing. One commenter (Ex. 25) requested
clarification as to the differences between pre-placement exams, as
specified in DOE Notice 440.1, ``Interim Chronic Beryllium Disease
Prevention Program,'' and the baseline exams specified in the NOPR. The
final rule will supersede DOE Notice 440.1, and the interim medical
surveillance program requirements will be replaced with those of the
final rule. The final rule does not refer to pre-placement exams.
Another commenter (Ex. 23) recommended that the meaning of spirometry
be clarified to ensure consistency. DOE agrees and has specified the
measurement of forced vital capacity (FVC) and forced expiratory volume
at 1 second (FEV 1) in section 850.34(b)(1)(v) of the final
rule.
A commenter (Ex. 19) questioned the value of baseline pulmonary
function tests and x-rays. This commenter suggested that baseline
studies cannot be used to determine which health changes are related to
work hazards and which are related to other activities or disease
processes. This commenter favored the approach of following patients
clinically and using Be-LPT and other studies, to augment clinical
impressions. Early identification of CBD, this commenter states, might
have no positive effect on the course of the disease.
DOE disagrees with this comment. Early identification and
intervention are important for identifying workers at higher risk of
exposure to beryllium, and for preventing and minimizing the effects of
beryllium-induced disease. DOE's position is supported by a commenter
(Ex. 29) who stated that while spirometry and X-rays may not be
predictive, X-rays have in some instances identified CBD cases in
individuals who had a normal Be-LPT. This commenter stated that these
cases are likely to be missed if spirometry and X-rays are not
required, and also recommended X-ray screening for Be-LPT negative
individuals with persistent chest problems. Another commenter (Ex. 19)
emphasized the benefits of good data collection to determine if early
removal of beryllium sensitized workers prevents the progression to
CBD.
One commenter (Ex. 33) suggested that, if available, recent chest
X-rays be utilized for the baseline medical evaluation to reduce X-ray
exposure. DOE agrees that if previous chest X-rays have been conducted,
for a baseline beryllium evaluation, additional X-rays should not be
used unless specified by a physician. However, to ensure that the chest
X-ray correlates with other diagnostic and historical information, only
those X-rays taken for the purpose of a baseline beryllium evaluation
or equivalent evaluation should be used to establish a baseline.
Section 850.34(b)(1)(vi) requires responsible employers to provide
a Be-LPT as part of the baseline evaluation. The Be-LPT is the only
available laboratory test for determining individual immune response to
beryllium in vitro. Its use in a surveillance program will permit
detection of beryllium-related health effects at a pre-clinical 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 provides an early opportunity for diagnosis and treatment of CBD.
Finally, section 850.34(b)(1)(vii) authorizes the examining
physician to make available to the worker any additional tests deemed
medically necessary. DOE believes that it is important that the
examining physician have such discretion because individuals may
exhibit different responses to beryllium. In this regard, one commenter
(Ex. 16) expressed concern regarding proposed section 850.33(i), which
provided that workers
[[Page 68892]]
would be referred for further diagnostic evaluation if there were two
or more positive Be-LPTs. The commenter interpreted this provision as a
mandatory requirement. DOE's intent is that workers have the
opportunity for additional testing if recommended by the examining
physician. A worker is not required by the rule to undergo additional
medical evaluation and treatment.
One commenter (Ex. 29) recommended clinical referral for additional
diagnostic tests after one positive Be-LPT, instead of two or more as
proposed by DOE. DOE believes that the examining physician is in the
best position to determine which additional tests, if any, would be
useful in evaluating the health of an individual worker. Therefore, DOE
has removed the requirement for follow-up testing based on two or more
positive Be-LPT tests, relying instead on the examining physician's
discretion under section 850.34(b)(1)(vii) to order follow-up tests
when appropriate.
Section 850.34(b)(2) requires responsible employers to provide
medical evaluations to beryllium workers annually, and to other
beryllium-associated workers every 3 years. Responsible employers must
provide the periodic medical evaluation elements described in section
850.34(b)(2)(i) to detect, at an early stage, any pathological changes
that could lead to CBD or be aggravated by beryllium exposure. By
detecting abnormalities early, workers may be medically removed to
prevent further beryllium exposure.
Section 850.34(b)(2)(ii) requires responsible employers to provide
to beryllium-associated workers a chest radiograph (X-ray) every 5
years. DOE includes this requirement for periodic X-rays because X-rays
have been shown to be effective in the early detection of beryllium-
related health effects (Ex. 29).
Following an emergency in which a worker, who is not already
participating in the beryllium medical surveillance program, is exposed
to an elevated amount of beryllium, the responsible employer is
required by section 850.34(b)(3) to provide a medical evaluation as
soon as possible.
A commenter (Ex. 23) suggested that a standard respiratory symptom
questionnaire, medical work history form, and physical examination form
be used at all DOE sites for consistency. DOE agrees that such
standardized forms may help ensure consistency across the DOE complex,
but is concerned that mandating the use of standardized forms may limit
the discretion of the SOMD in determining the appropriate medical
surveillance for each individual. Accordingly, DOE has decided to
include appropriate standardized forms as non-mandatory guidance in an
implementation guide to accompany the final rule. Another commenter
(Ex. 29) was concerned that the NOPR required a respiratory symptom
questionnaire for periodic medical evaluations, but not for the
baseline evaluation. DOE acknowledges this oversight and has included
the respiratory symptom questionnaire as part of both the periodic and
baseline medical evaluations in sections 850.34(b)(1)(ii) and
(b)(2)(I)(B) of the final rule.
Section 850.34(c) requires responsible employers to establish a
multiple physician review process for affected beryllium-associated
workers. DOE has identified three benefits of providing a multiple
physician review process: (1) to strengthen and broaden the bases for
medical decisions made pursuant to this rule when a beryllium-
associated worker questions the findings, recommendations, or
determinations of an initial physician retained by the responsible
employer; (2) to increase beryllium-associated workers' confidence in
the soundness of medical findings, recommendations and determinations
made under this rule; and (3) to increase beryllium-associated worker's
acceptance of, and participation, in the medical surveillance program.
Given the shortage of trained and experienced occupational
physicians, it is possible that some physicians performing examinations
or consultations under the beryllium rule will misdiagnose CBD.
However, rather than requiring multiple medical opinions in all cases,
which would be expensive and potentially wasteful, DOE is providing to
beryllium-associated workers an opportunity to obtain an independent
review of the findings, determinations or recommendations of the
physician selected by the responsible employer. Over time, this
independent review is likely to show either that a perceived low level
of confidence in the physician retained by the responsible employer is
unwarranted, or that the responsible employer should improve the
quality of the medical surveillance being provided. In either case, the
multiple physician review process will have served a beneficial
purpose.
In section 850.34(c)(1), a beryllium-associated worker may
designate a second physician to review any findings, determinations, or
recommendations of the physician chosen by the responsible employer,
and to conduct such examinations, consultations, and laboratory tests
as the second physician may deem necessary to facilitate this review.
The responsible employer's obligation to provide information to the
examining physician extends to other physicians involved in the
multiple physician review or alternate physician review process so that
all of the physicians involved will have an equal opportunity to assess
the beryllium-associated worker's health status.
Section 850.34(c)(2) requires that after an initial physician
conducts an examination or consultation, the responsible employer must
promptly notify the worker of his or her right to seek a second medical
opinion. This notification must be in writing.
Section 850.34(c)(3) requires that after the worker is notified of
this right, the responsible employer may condition its participation
in, and payment for, multiple physician review upon the worker, within
15 days after receipt of the notification or the initial physician's
written opinion, whichever is later, both (1) informing the responsible
employer that the worker intends to seek a second medical opinion, and
(2) initiating steps to make an appointment with a second physician.
The rule contains no limitation on a beryllium-associated worker's
choice of a second physician, except the requirement in section
850.34(a)(3) that the second physician must be a licensed physician who
is familiar with the health effects of beryllium.
If the second physician's findings, determinations, and
recommendations are the same as those of the initial physician, then
the multiple physician review process comes to an end. However, as
provided in section 850.34(c)(4), if the opinions of the two physicians
are in conflict, then the responsible employer and the beryllium-
associated worker must undertake to encourage the two physicians to
resolve any disagreement. DOE expects that the two physicians will
communicate with each other to resolve their differences, but the rule
requires the responsible employer and worker to encourage such a
resolution. In most cases, this professional interaction should resolve
any differences of opinion.
In cases where differences remain, these differences of opinion are
likely to be genuine and substantial. If the first two physicians are
unable to resolve expeditiously any differences of opinion with respect
to a beryllium-associated worker, then it is necessary for a third
qualified physician to resolve the dispute. It is critical that this
third
[[Page 68893]]
physician has the confidence of those concerned and is competent to
resolve the dispute. Consequently, section 850.34(c)(5) requires that
the responsible employer and the beryllium-associated worker together,
through their respective physicians, must designate the third
physician.
Under section 850.34(c)(5) the third physician will have a full
opportunity to review the findings, determinations, and recommendations
of the two prior physicians, and to conduct such examinations,
consultations and laboratory tests as the third physician deems
necessary. DOE's expects that the third physician will consult with the
other two physicians. The third physician should provide a written
medical opinion to the SOMD which will be used to resolve the
disagreement between the other two physicians. Section 850.34(c)(6)
requires the SOMD to act in a manner consistent with the findings,
determinations, and recommendations of the third physician, unless the
SOMD and the beryllium-associated worker reach an agreement that is
otherwise consistent with the recommendations of at least one of the
other two physicians.
Since the multiple physician review process will be a means by
which medical surveillance is provided to a beryllium-associated
worker, responsible employers must bear the expense of this process
when it is used. Based on OSHA's practice and experience with multiple
physician review in its health standards, DOE does not expect the costs
of this process to be burdensome to the responsible employers. If
responsible employers establish and administer medical surveillance
programs that engender worker confidence, workers should have little or
no need to seek second medical opinions.
The requirement for multiple physician review is not intended to
preclude responsible employers from establishing and implementing
alternate medical protocols. DOE has included language in section
850.34(d) to provide for alternate physician determination. Under that
section, the responsible employer and beryllium-associated worker, or
the worker's designated representative, may agree upon the use of any
expeditious alternate physician determination process, instead of the
multiple physician review process. The only condition is that the
alternate process be no less protective of the worker's health than the
multiple review process. For example, a jointly agreed upon physician
might be used in the first instance without recourse to other
physicians. DOE encourages responsible employers and workers to adopt
medical determination procedures in which all parties have trust and
confidence.
Section 850.34(e)(1) requires the SOMD to provide to responsible
employers, within two weeks after receipt of results, a written and
signed medical opinion after each medical evaluation of a beryllium-
associated worker. The purpose of requiring the SOMD to give the
responsible employer a written opinion is to inform the responsible
employer of the medical basis for determining the job placement of the
examined worker. This written medical opinion, as described in section
850.34(e)(i-iii), must contain any diagnosis of the worker's condition
related to occupational exposure to beryllium; any other detected
medical conditions relevant to further beryllium exposure; any
recommended restrictions on the worker's exposure to beryllium or on
the use of protective clothing or equipment; and a statement indicating
that the SOMD or the examining physician has provided to the worker the
results of the test, the medical evaluation, including all tests
results and any medical condition related to beryllium exposure that
requires further evaluation or treatment.
Section 850.34(e)(2) requires the SOMD to withhold from the
responsible employer, orally or in the written medical opinion,
specific findings or diagnoses not related to occupational exposure to
beryllium.
Two commenters (Ex. 23, 28) expressed concern regarding proposed
section 850.33(j)(2), which stipulated that the physician's written
medical reports be delivered within 15 calendar days after the
completion of a medical evaluation. The commenters noted that Be-LPT
tests are time-consuming and may exceed the 15-day time frame, and
suggested that the 15-day period should begin after receipt of the test
results. DOE agrees, and has revised section 850.34(f) to require the
SOMD to give beryllium-associated workers a written medical opinion
containing the results of all medical tests or procedures, an
explanation of any abnormal findings, and any recommendation that the
worker be referred for additional testing within 10 working days after
the SOMD's receipt of test results.
In section 850.34(f)(2), upon request by the beryllium-associated
worker, the responsible employer is required to provide the worker with
a copy of the information the responsible employer is required to
provide to the examining physician.
Section 850.34(g) requires the responsible employer to report on
the applicable OSHA reporting form (currently OSHA Form No. 200)
beryllium sensitization, CBD, or any other abnormal condition or
disorder of workers caused or aggravated by occupational exposure to
beryllium. Although not included in the proposed rule, this provision
reflects current practices and does not impose a new burden on
employers. Reporting abnormal conditions and disorders that are
occupationally caused and beryllium-related will contribute to the
development of occupational health statistics that eventually may lead
to improved disease prevention and medical intervention for beryllium-
associated workers. It will also provide DOE with information and data
helpful in assessing the effectiveness of the CBDPP rule and in
considering what, if any, modification should be made to the rule in
the future.
Section 850.34(h)(1) requires responsible employers to establish a
routine and systematic analysis of medical, job, and exposure data. The
purpose of this requirement is to collect and analyze information so
that the prevalence of disease can be accurately described and
conclusions reached on causes or risk factors for the disease. This
data analysis is an effective means of measuring performance under the
CBDPP, and for correcting and improving the CBDPP. Section 850.34(h)(2)
requires the responsible employer to use the results of these analyses
to determine which workers should be offered medical surveillance and
the need for additional exposure controls.
Section 850.35--Medical Removal
Section 850.35 (proposed as section 850.34) requires responsible
employers to establish medical removal protection (MRP) and medical
removal protection benefits (MRPB) as part of the CBDPP.
Medical surveillance can only be effective in detecting and
preventing disease if beryllium-associated workers: (1) voluntarily
seek medical attention when they feel ill; (2) refrain from efforts to
conceal their true health status; and (3) fully cooperate with
examining physicians to facilitate accurate medical diagnoses and
effective treatment. This sort of worker participation and cooperation
cannot be evoked by coercion; it will occur only where no major
disincentives to meaningful worker participation exist. Without such
participation, it would be much more difficult, if not impossible, to
adequately monitor workers' health and to identify workers who need
temporary or permanent medical removal.
[[Page 68894]]
MRP is a logical result of medical surveillance. Without MRP,
responsible employers would be free to maintain high-risk workers in
their current jobs, which would not be sufficiently protective of their
health. Alternatively, responsible employers could choose to terminate
workers or transfer them from higher-paying, beryllium-exposed jobs to
lower-paying, non-beryllium jobs. This might be protective, but it
would impair the workers' standards of living. In either case, the
effectiveness and integrity of the medical surveillance program would
be compromised.
With MRP, beryllium-associated workers are assured of being removed
to jobs where exposure to beryllium is low if such removal is
determined to be necessary to protect their health. With MRPB, workers
are assured that, if they fully participate in medical surveillance and
if the results of medical surveillance require removal from their
beryllium exposed jobs, their normal earnings and job status will be
protected for a pre-determined period.
Thirty-two commenters (Ex. 12 is a form letter submitted by 16
beryllium workers) commented on the proposed MRP and MRPB provisions in
the NOPR. They addressed a wide variety of issues and frequently
expressed opposing viewpoints. For instance, two commenters (Exs. 16,
26) stated that the proposed MRP provisions went too far (e.g., two
years of protection is too long; accepted applicants should not be
included under the provisions), while others (Exs. 3, 8, 12, 14, 17,
18, 22, 24, 28, 29, 31) stated that the provisions did not go far
enough (e.g., two years of protection is not long enough; one follow-up
examination is not enough; the training costs limits are too
restrictive; the rule should provide provisions for multiple physician
reviews). Several commenters (Exs. 20, 22, 31) argued against the
voluntary nature of the proposed provisions, stating that it would be
unethical to allow a worker with CBD to continue to be exposed to
beryllium, and suggesting that workers could be wrongfully pressured
into staying in beryllium-related jobs. Other commenters (Exs. 29, 30)
agreed with DOE's proposal to require employee consent, and requested
that DOE provide additional guidance to help workers make more informed
decisions regarding their medical removal. DOE has decided, consistent
with some of the comments, to use the provisions of OSHA's expanded
health standards as the basis for the MRP and MRPB provisions of the
final rule. DOE has modeled the MRP and MRPB provisions of this final
rule upon similar provisions in OSHA's Cadmium, Lead and Benzene
standards, 29 CFR 1910.27, 1910.1025 and 1910.1028, respectively. DOE's
rationale for each provision of section 850.35 in the final rule is
discussed below.
Section 850.35(a) requires responsible employers to offer a
beryllium-associated worker medical removal from exposure to beryllium
on each occasion that the SOMD determines in a written medical opinion
that medical removal is required. The SOMD's determination must be
based upon one or more positive Be-LPT results, CBD diagnosis, an
examining physician's recommendation, or any other signs or symptoms
the SOMD deems medically sufficient to show that the worker has a
medical condition that places the worker at increased risk of material
impairment to health from further exposure to beryllium.
Section 850.35(a)(1) deals with temporary removal. It requires the
responsible employer to offer temporary medical removal to a beryllium-
associated worker whenever the SOMD determines in a written medical
opinion that the worker should be removed pending a final medical
determination on the worker's health. The responsible employer must
offer to temporarily remove a worker regardless of whether a job is
available into which the removed worker may be transferred. If no such
job is available, the responsible employer must pay medical removal
protection benefits to the worker for up to one year. Section
850.35(a)(1) (iii) and (iv) require that for each time a beryllium-
associated worker is temporarily removed, the responsible employer must
maintain the worker's total normal earnings, seniority and other
employment rights as if the worker were not removed, either by
providing an appropriate alternative job or by paying MRPB, for one
year.
If a final medical determination is made that the worker does not
have a medical condition which places the worker at increased risk of
material impairment to health from exposure to beryllium, the temporary
MRP must be lifted so that the affected worker may return to his or her
normal duties.
Section 850.35(a)(2) requires the responsible employer to offer
beryllium-associated workers permanent medical removal whenever the
SOMD determines in a written medical opinion that the beryllium-
associated worker should be permanently removed from exposure to
beryllium. Once a worker is permanently removed, the worker will
receive the medical removal protection benefits specified in section
850.35(b) of this rule.
Section 850.35(a)(3) is intended to ensure that beryllium-
associated workers are given the information needed to make an informed
decision on whether to accept temporary or permanent removal from a job
with a potential for beryllium exposure.
Section 850.35(a)(4)(i) prohibits the responsible employer from
returning a beryllium-associated worker who has been permanently
removed to the worker's former job status, unless the SOMD has
determined in a written medical opinion that removal is no longer
necessary to protect the worker's health, or the exception in section
850.35(a)(4)(ii) applies. Under section 850.35(a)(4)(ii), if there are
special circumstances that make medical removal an inappropriate
remedy, or if the SOMD's professional opinion is that continued
exposure will not pose an increased risk to the worker's health (e.g.,
the potential decrements to the worker's lung function are not
projected to be any greater if the worker were permitted to continue on
the job than they would be if the worker were removed), the SOMD must
fully discuss the matter with the worker and, in a written medical
determination, may recommend returning the worker to his or her former
job status. The purpose of this exception is to provide some
flexibility where it is reasonably clear that returning the worker to
his or her normal job is unlikely to adversely affect the worker's
health. For example, a return to work may be justified if a worker who
is not experiencing a decrease in lung function, has been on medical
removal for 2 years and is about to retire, and the time that the
worker will continue to be occupationally exposed at or above the
action level is very limited. If the SOMD recommends return of the
worker in such cases, the SOMD may require the responsible employer to
provide the worker with additional protection, such as a supplied air
respirator operated in a positive pressure mode. In any event, a
decision to return the worker should be made only after the SOMD has
fully explained the relevant facts and prognoses to the worker.
Section 850.35(b) establishes the MRPB that must be provided to
removed workers. DOE believes that the establishment of MRPB is
critical to minimize the disability associated with CBD. Removal from
exposure and effective job-placement efforts, coupled with early
diagnosis and treatment, will increase the likelihood that affected
beryllium-associated workers will continue as productive members of the
DOE workforce. In addition, MRPB will encourage worker participation in
the
[[Page 68895]]
medical surveillance program by providing beryllium-associated workers
with a reasonable level of assurance that a finding of sensitization or
diagnosis of CBD will not lead to the loss of their employment.
Under section 850.35(b)(1), the responsible employer is required to
provide up to two years of MRPB to a beryllium-associated worker on
each occasion that he or she is medically removed from exposure to
beryllium in accordance with this part.
Section 850.35(b)(2) requires the responsible employer to provide
the ``total normal earnings, seniority, and all other workers rights
and benefits'' of a removed beryllium-associated worker as if the
worker had not been removed. The purpose of this requirement is to
ensure that a removed worker does not suffer economic loss due to the
removal. Thus, if a removed worker routinely earned overtime pay on the
job from which he or she was removed and would have continued to do so
during the removal period, then MRPB must include the amount of
expected overtime as part of the worker's ``total normal earnings.''
DOE selected 2 years as the maximum period during which the responsible
employer is required to pay MRBP to a worker who accepts removal
instead of the 18 month protection period established in OSHA's Lead
and Cadmium standards. DOE has established a different protection
period for beryllium because of the toxicological differences between
beryllium and the two metals covered in the OSHA standards.
Specifically, the early stages of the health impairments associated
with exposure to lead or cadmium will reverse in time with no
additional exposure, but beryllium sensitization and CBD will not. The
objective of OSHA's 18 month period is to provide workers with
sufficient recovery time so that they can return to their job. The
objective of DOE's 24 month period, however, is to allow beryllium-
associated workers who accept permanent medical removal sufficient time
to be retrained and placed in different job. DOE believes that this
period should be long enough to enable the majority of removed
beryllium-associated workers to be retrained and placed in another job
or, for those workers who can be returned to their former job status,
to be returned before their MRPB expire.
Under section 850.35(b)(3), if a removed worker files a claim for
workers' compensation payments for a beryllium-related disability, the
responsible employer must provide MRPB pending disposition of the
claim. The responsible employer receives no credit for the workers'
compensation payments received by the worker for treatment related
expenses.
In section 850.35(b)(4), the responsible employer's obligation to
provide MRPB is reduced by the amount of any compensation the
beryllium-associated worker receives from any other source for earnings
lost during the period of removal. This provision is necessary to
ensure that MRPB does not result in a ``windfall'' to the worker who
collects other compensation, including salary from another job, while
the worker is on medical removal from exposure to beryllium.
Section 850.35(b)(5) provides that the requirement that a
responsible employer provide MRPB is not intended to expand upon or
restrict any rights a worker has or would have had, absent medical
removal, to a specific job classification or position under the terms
of a collective bargaining agreement.
Section 850.35(b)(6) provides that a responsible employer may
condition the provision of MRPB upon the beryllium-associated worker's
participation in medical surveillance. Thus, although the rule does not
require worker participation in medical surveillance, it permits the
responsible employer to deny economic protection to workers who are
unwilling to participate in medical surveillance. Since the responsible
employer must bear the financial burden of medical removal, the
employer has a legitimate interest in minimizing the need for medical
removal. Unless workers participate in medical surveillance, the
responsible employer may not be able to identify workers whose exposure
to beryllium should be reduced to avoid the need for medical removal.
In providing the responsible employer the authority to condition
provision of MPRB upon a beryllium-associated worker's participation in
medical surveillance, DOE does not intend to permit an employer to deny
MRPB for insignificant lapses in such participation. The worker's
actions should be assessed reasonably, in light of the goal of
prevention of disease and the employer's interest in minimizing the
need for medical removal.
Section 850.36--Medical Consent
Section 850.36 (proposed as section 850.35) establishes the medical
consent provisions of the CBDPP. Because worker participation in the
medical surveillance program established by this rule is voluntary,
this section is necessary to ensure that beryllium-associated workers
receive adequate information to make an informed decision regarding
their participation in the program.
Section 850.36(a) requires responsible employers to provide
beryllium-associated workers with a summary of the medical surveillance
program, the type and purpose of data to be collected, how the data
will be maintained, and protections for ensuring the confidentiality of
medical records. Responsible employers must provide this information at
least one week before any medical evaluation or tests, or when
requested by the worker.
Section 850.36(b) requires responsible employers to provide
beryllium-associated 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 examination or test. DOE expects responsible employers to make
reasonable efforts to help workers understand the material.
Accordingly, section 850.36(b) requires responsible employers to give
beryllium-associated workers an opportunity to ask questions and
receive answers before a medical evaluation is performed.
Section 850.36(c) requires responsible employers to have the SOMD
obtain the beryllium-associated worker's signature on the informed
consent form found in Appendix A to this part, before medical
evaluations or tests are performed.
Section 850.37--Training and Counseling
Section 850.37 (proposed as section 850.36) establishes
requirements for training and counseling workers regarding exposure to
beryllium, and the potential health effects associated with such
exposure. This worker training is necessary because the appropriate
implementation of the required workplace procedures of the CBDPP
ultimately rests upon the front-line workers who will be performing
work on, with, or near beryllium or beryllium-contaminated materials.
These workers cannot be expected to implement the required CBDPP
procedures if they are not aware or fully appreciative of the
significance of these procedures.
DOE expects that responsible employers will conduct training in a
manner that is easy to understand. Training material should be
appropriate in content and vocabulary to the education level, and
language background of affected workers. The goal of training is to
ensure that all workers, regardless of cultural or educational
background, have the knowledge necessary to reduce and minimize their
exposure to beryllium.
[[Page 68896]]
Section 850.37(a)(1) requires responsible employers to develop and
implement a worker training program for beryllium-associated workers
and all other individuals who work at a site where beryllium activities
are conducted, and ensure their participation in the program. DOE
recognizes that OSHA's Hazard Communication standard (29 CFR 1910.1200)
already requires that employers provide their workers with training
regarding the risks associated with all hazardous materials in the
workplace. DOE does not intend that employers would implement separate
and redundant training and information programs to comply with both
this rule and the Hazard Communication standard. Accordingly, sections
850.37(b)(1) and (2) require responsible employers' CBDPP training and
information programs to comply with the Hazard Communication standard
as well as address the contents of the CBDPP. Through this provision,
DOE intends for responsible employers to integrate their CBDPP training
and information efforts into their existing Hazard Communication
training program. This will minimize the burden on responsible
employers and provide for a consistent approach to worker training and
the communication of workplace hazards.
DOE added ``contents of the CBDPP'' to the training requirements in
section 850.37(b) because this information is essential for a worker to
understand how to effectively participate in the CBDPP. OSHA's Hazard
Communication standard (29 CFR 1910.1200) does not explicitly refer to
anything like a CBDPP. In the final rule, DOE has removed specific
mention of several subjects (beryllium health risk, exposure reduction,
and safe handling of beryllium and medical surveillance) that were
specifically identified in the proposed rule. These subjects are
adequately covered in the Hazard Communication standard.
One commenter (Ex. 3) recommended detailed training for workers who
have had, or are likely to have, exposures to beryllium because their
assigned tasks may have involved beryllium. DOE generally agrees with
the commenter and in the final rule has used a performance-based
approach to identifying the workers to be trained. Section 850.37(b),
paragraphs (1) and (2), require detailed training for beryllium-
associated workers.
In the NOPR (Section V, Request for Information), DOE stated that
it was considering including a requirement that responsible employers
develop and implement an outreach education program for family members
of beryllium workers. Commenters generally agreed on the need to inform
workers' families about beryllium hazards, but had different views
about how it should be accomplished. Two commenters (Exs. 16, 26)
recommended that an outreach requirement not be included in the rule
and, instead, that workers be relied upon to relay beryllium
information to their families. Several other commenters (Exs. 17, 28,
30, 31) recommended that DOE include an outreach requirement in the
rule, and require employers to provide beryllium information without
relying on the workers. After considering all of the comments, DOE has
added section 850.37(b)(3), which requires the responsible employer to
provide to its workers information about risks to family members. This
section relies upon the workers to relay the relevant beryllium hazard
information to their families. DOE encourages responsible employers to
provide beryllium-associated workers with information about beryllium
risks that is readily understandable to family members and others, as
well as to the workers.
One commenter (Ex. 4) recommended that the requirement for outreach
not be included as part of the rule, but that DOE provide outreach
information from a central point in DOE. The commenter felt that this
approach would be more efficient than having each responsible employer
develop and provide its own outreach information. DOE disagrees with
this comment, and is of the view that more effective outreach will be
provided if responsible employers include information about beryllium
risks to families and others as part of the detailed training provided
to beryllium-associated workers and those who use protective clothing
and equipment.
One commenter (Ex. 3) recommended general awareness training for
workers who are not beryllium-associated workers but who, at some time,
may be at risk because they work at a site where beryllium activities
are conducted. DOE agrees with this recommendation, and section
850.37(c) requires the responsible employer to provide general
awareness training about beryllium hazards and controls to these
workers.
Section 850.37(d) requires that the responsible employer provide
training to workers prior to initial assignment and at least every two
years thereafter to ensure that workers are appropriately prepared to
deal with the hazards and risks of working with beryllium. The initial
training requirement of this paragraph is important to ensure that
workers have the information they need to protect themselves before
they are actually subject to exposure or potential exposure hazards.
Periodic training is necessary to reinforce and update initial
training, especially with regard to the protective actions workers must
take at their current jobs to reduce their potential for exposure to
beryllium. DOE has established the frequency of two years as a minimum
requirement, rather than the proposed one year.
Section 850.37(e) requires the responsible employer to provide
additional training when the employer has reason to believe that a
beryllium worker lacks the proficiency, knowledge, or understanding
needed to work safely with beryllium. This situation could occur
because of changes in workplace operations, controls, or procedures or
the availability of new or updated information regarding the health
risk associated with exposures to beryllium. Also, a worker's
performance may show that the worker has not retained the requisite
proficiency. DOE used the retraining requirements of the OSHA scaffold
standard (29 CFR 1926.454(c)) as a model for section 850.37(e).
Section 850.37(f) requires the responsible employer to develop and
implement a worker counseling program to assist beryllium-sensitized
workers and workers diagnosed with CBD. The purpose of the counseling
program is to communicate to workers information that may help them
make important health-and work-related decisions and perform
administrative activities, such as filing workers' compensation claims.
This section also requires the responsible employer to communicate
information concerning the following topics: the medical surveillance
program; medical treatment options; medical, psychological, and career
counseling; medical benefits; administrative procedures and worker
rights under applicable workers' compensation laws and regulations;
work practices aimed at limiting worker exposure to beryllium; and the
risk of continued exposure after sensitization.
One commenter (Ex. 23) cautioned that the proposed language dealing
with workers' compensation counseling could have been interpreted as
imposing obligations that exceed employer obligations under states'
workers' compensation statutes. DOE has included in section 850.37(f)
the qualifying language ``administrative procedures and worker rights''
and ``under applicable workers' compensation laws and regulations'' to
make clear that DOE does not intend to establish any new workers'
compensation obligations. DOE understands that responsible employers
[[Page 68897]]
may develop such counseling programs in consultation with labor
organizations representing covered workers, and that employers may wish
to advise the workers to consult their own attorneys on these matters.
Another commenter (Ex. 22) recommended that beryllium training be
provided by organizations or persons who receive grants from DOE. This
commenter asserted that it is inappropriate for DOE contractors, who
are responsible employers, to conduct beryllium training because these
employers are not sufficiently independent. DOE does not agree with
this comment and has not adopted this recommendation. The vast majority
of DOE's safety and health training is currently being conducted
adequately by responsible employers, and it is common outside of DOE
for employers to provide safety and health training to their employees.
One commenter (Ex. 21) recommended that this section be revised to
include the adult education principles outlined in Appendix E of OSHA's
Hazard Communication standard (29 CFR 1910.1200) because these
principles have been effective when applied to training workers. While
DOE has not explicitly referenced this advisory Appendix in the final
rule, nothing in the rule prohibits its use. Although the Appendix
appears to be a good example of the use of adult educational principles
that an employer could use to train workers on their hazard
communication program, it does not expressly identify or describe these
principles. Responsible employers would have to infer the principles
from Appendix E and then apply those principles to their beryllium
training program. In addition, DOE believes that an explicit reference
to this Appendix in the rule would be confusing because this Appendix
is not specifically applicable to beryllium training.
Section 850.38--Warning Signs and Labels
Section 850.38 (proposed as section 850.37) requires responsible
employers to post warning signs and labels to ensure that the presence
and dangers associated with beryllium and beryllium-contaminated
materials or areas are communicated to workers. Section 850.38(a)
requires the posting of warning signs at all entranceways to
established regulated areas and that these signs bear the following
warning:
DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
The purpose of these signs is to minimize the number of persons in
a regulated area by warning workers prior to entry. The signs 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 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.
Sections 850.38(b)(1) requires responsible employers to label with
appropriate hazard warnings all containers of beryllium, beryllium
compounds, or beryllium-contaminated clothing, equipment, waste, scrap,
or debris to ensure that individuals who come in contact with the
containers are aware of their contents and 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
labels, section 850.38(b)(2) further specifies that labels bear the
following information:
DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD
Section 850.38(c) clarifies that the warning signs and labels
developed to comply with the CBDPP must also comply with the OSHA
Hazard Communication standard, 29 CFR 1910.1200. DOE believes this
clarification is needed to avoid duplication of effort. In addition,
DOE believes that ensuring that the content and format of warning signs
and labels comply with the Hazard Communication standard will result in
a consistent, recognizable, and comprehensive approach to alerting
workers to beryllium's potential to cause disease.
One commenter (Ex. 20) asked if DOE had given consideration to
requiring that warning signs and labels be provided in languages other
than English or the use of universal symbols to communicate
information. DOE notes that 29 CFR 1910.1200(f)(9) (OSHA's Hazard
Communication standard) states that employers with employees who speak
other languages may present the information in those other languages,
as long as the information is presented in English as well. DOE agrees
with this approach. Thus, section 850.38(c) requires that all warning
signs and labels comply with 29 CFR 1910.1200.
Another commenter (Ex. 23) noted that the warning signs provisions
specified in the NOPR differed slightly from those in DOE Notice 440.1,
and suggested that DOE retain the NOPR language in the final rule in
lieu of the language in the Interim CBDPP. DOE notes that the warning
signs and labels provisions of the NOPR were based on the provisions of
the Interim CBDPP, with minor modifications added to clarify the intent
of the requirements. DOE has retained these clarifications in section
850.38 of the final rule.
A third commenter (Ex. 9) was concerned that references to cancer
and cancer hazards in warning signs and labels may be misleading and
deceptive, and, noting that the reference did not represent the opinion
of a qualified medical professional, recommended that DOE obtain a
``qualified medical opinion'' to resolve this issue. DOE believes that
the action of the International Agency for Research on Cancer (IARC)
and ACGIH in classifying beryllium as a human carcinogen provides
sufficient basis for retaining the cancer warning on warning signs and
labels for beryllium-contaminated materials. DOE further notes that
NIOSH has classified beryllium as a potential occupational carcinogen
since 1977.
Section 850.39--Recordkeeping and Use of Information
Section 850.39 (proposed as section 850.38) requires responsible
employers to establish and effectively manage records that relate to
the CBDPP and to periodically submit to the Office of Environment,
Safety and Health a registry of beryllium-associated workers.
Section 850.39(a) requires the responsible employer to establish
and maintain up-to-date and accurate records of all beryllium inventory
information, hazard assessments, exposure measurements, exposure
controls, and medical surveillance data. DOE believes that up-to-date
and accurate records are essential for effectively implementing the
CBDPP, assessing its adequacy, and studying the relationship between
workplace conditions and CBD. Some of these records will be needed to
implement the
[[Page 68898]]
performance feedback provisions in section 850.40.
One commenter (Ex. 31) recommended that the final rule explicitly
reference OSHA's regulations at 29 CFR 1910.1200 and CFR 1910.1020.
OSHA regulations at 29 CFR 1910.1200 (Hazard Communication) already
require employers to keep records of beryllium inventory information,
and regulations at 29 CFR 1910.20 (Access to Employee Exposure and
Medical Records) already require employers to keep records of beryllium
hazard assessments, exposure measurements, and medical surveillance
data. DOE has not, however, included in section 850.39 references to
these OSHA standards. DOE believes that this rule's requirements for
maintaining and transferring CBDPP-related records, while ensuring
confidentiality of personal information, are stated in clear and
concise wording specifically related to the CBDPP that is preferable to
cross-referenced OSHA standards. Furthermore, one commenter's (Ex. 31)
primary concern was ensuring that workers have access to the
information that relates to their personal exposure and medical status.
DOE has addressed this concern in section 850.24(g), by requiring
responsible employers to notify affected workers of beryllium
monitoring results, and in section 850.34(d)(2), by requiring the SOMD
to provide to workers the results of medical tests and procedures.
DOE encourages responsible employers to take advantage of existing
recordkeeping systems to minimize the burden of implementing section
850.39. Responsible employers also may find that records that are
generated outside the CBDPP may be useful in implementing the CBDPP.
Examples are records of beryllium training, personnel demographics,
beryllium mission descriptions, and payroll records of projects that
can be used to link workers with potential beryllium exposure.
Section 850.39(b) requires Heads of DOE Departmental Elements to
designate all record series required to be generated under this rule as
federal records and, therefore, subject to all applicable federal
records management and access laws.
One commenter (Ex. 18), in commenting on the baseline inventory
provisions of the proposed rule, recommended that DOE require full
public disclosure of health and safety documents related to past
beryllium emissions and exposures. In the final rule, DOE is requiring
Heads of DOE Departmental Elements to designate the CBDPP-required
records as federal records. Federal records, except for records
containing specific types of sensitive information, are available to
the public under the Freedom of Information Act (FOIA) and related
federal policy. The FOIA requires the federal government to release
government records upon request, except for information that is
exempted from disclosure to protect an overriding interest, such as
privacy, national security, and trade secrets and other confidential
business information. The FOIA exemption for information in personnel
and medical files (5 U.S.C. 552(b)(6)) is especially important for DOE
CBDPP-required records, because many of these records contain medical
information that is protected from release by this FOIA provision and
other federal laws.
One commenter (Ex. 21) recommended that DOE address the retention
of records in this rule. DOE has added to section 850.39(b) the
requirement that Heads of DOE Departmental Elements ensure that the
record series generated as required under this rule are retained for at
least 75 years, which is consistent with DOE's policy on retaining
medical records. This requirement will ensure that required CBDPP
records that relate to workplace conditions will be available in the
future to correlate with the beryllium-associated workers' medical
records. Heads of DOE Departmental elements will be able to ensure that
they can comply with section 850.39(b) if the CBDPP-required records
generated by DOE responsible employer contractors are identified in the
relevant contracts as DOE-owned documents. Therefore, DOE expects that
Heads of DOE Departmental elements will direct their DOE contract
officers to stipulate DOE ownership of these documents in those
contracts.
The same commenter recommended that DOE address the transfer of
records to successive responsible employers. DOE agrees that this
information should be covered in the rule, and has added section
850.39(c) to require responsible employers to convey to DOE, or its
designee, all record series generated under this rule if the
responsible employer ceases to be involved in the CBDPP (e.g., ceases
to be a DOE contractor).
Section 850.39(d) requires that responsible employers create links
between data sets on workplace conditions and health outcomes to serve
as a basis for understanding the beryllium health risk. This linkage of
data will assist DOE and responsible employers in identifying unsafe
work practices and understanding the relationship between workplace
conditions and CBD.
Section 850.39(e) requires the responsible employer to ensure the
confidentiality of all records containing personal, private information
that are generated as required by this rule. Protecting the
confidentiality of these records is required by the Americans with
Disabilities Act (42 U.S.C. 12112(d)(4)), the Privacy Act (5 U.S.C.
552a) and other applicable laws. In addition, DOE recognizes that many
beryllium-associated workers will participate in some of the voluntary
components of the CBDPP only if they believe that their personal
information will be kept confidential.
Section 850.39(e)(1) explicitly requires responsible employers to
ensure that all records that are transmitted to other parties do not
contain names, social security numbers or any other variables, or
combination of variables, that could be used to identify individuals.
DOE recognizes that responsible employers must take these precautions
to prevent the violation of confidentiality laws because personal
information could be obtained from transmitted records, or inferred
from information other than personal identifiers in the records, unless
these precautions are taken.
One commenter (Ex. 4) stated that the rule's confidentiality
requirements could prevent industrial hygienists from obtaining the
health outcome information that is necessary to perform the linkage of
site workplace conditions and health outcomes required by section
850.39(d). DOE does not intend health outcome information that would
compromise confidentiality to be provided to industrial hygienists. DOE
believes that the linkage required by section 850.39(d) could be
performed after personal identifiers are removed from the health
outcome information, making it consistent with section 850.39(e)(1).
Another commenter (Ex. 16) recommended that the final rule require
the responsible employer to place beryllium medical records in the
custody of a medical director, as opposed to the proposed requirement
that medical records be held by the responsible employer. DOE
recognizes that beryllium medical records may be in the custody of
physicians involved in CBD studies other than the SOMD. DOE responds to
this commenter's (Ex. 16) concern in section 850.39(e)(2)(i) by
requiring responsible employers to ensure that individual medical
information generated by the CBDPP is either included as part of the
worker's site medical records and maintained by
[[Page 68899]]
the SOMD, or is maintained by another physician designated by the
responsible employer.
Section 850.39(e)(2)(ii) (proposed section 850.38(d)) retains the
proposed requirement that responsible employers ensure that individual
medical information generated by the CBDPP is maintained separately
from other records. A commenter (Ex. 19) recommended that the rule
require responsible employers to use only one data system, maintained
by the SOMD, to facilitate the analysis of the data and to increase
workers' confidence in the confidentiality of SOMD-maintained records.
DOE retained this requirement, however, because the separation of
medical and other records is good file management. Further, the
Americans with Disabilities Act (42 U.S.C. 12112(d)(4)(C)) requires
such separation for privately-owned medical information. DOE recognizes
that analysis of the data may be somewhat more difficult with
separately maintained medical records, but separation of these records
is required by law. There also are practical reasons to require the
separation of these records. Personnel officials would require
authorization from medical directors before accessing personnel records
that were stored with medical records. At the same time, the medical
directors would need a system to ensure that no confidential medical
information was mixed in with the personnel records that personnel
officials accessed. Employers eliminate these administrative burdens by
maintaining separate medical and personnel records.
Section 850.39(f) requires the responsible employer to maintain all
records required by this part in current and accessible electronic form
to permit ready retrieval of data in a format that maintains
confidentiality. This requirement is necessary to facilitate timely,
efficient, and cost-effective transfer and analysis of CBDPP-related
data. DOE has added the phrase ``in current and accessible'' to this
section because DOE's experience indicates that the ability to use
information held in electronic records is severely hampered if the
electronic systems are out-of-date or the records are difficult to
obtain. Similarly, DOE has added the phrase ``that maintains
confidentiality'' to this section because DOE's experience indicates
that transferring information while maintaining confidentiality cannot
practically be accomplished using systems that must be modified,
converted, or replaced before the transfer can occur.
A commenter (Ex. 21) recommended that the final rule require
responsible employer contractors to use the same record retrieval
identifiers that any predecessor contractor used. This would allow
current contractors easily to link their data to the predecessor
contractors' data on the same subject. DOE agrees that successive
contractor's use of the same record retrieval identifiers would make
exposure-health outcome and epidemiology studies easier to conduct.
Therefore, DOE encourages successor contractors to use the same record
retrieval identifiers as the predecessor contractor. DOE has not,
however, made this a requirement in the final rule because it would be
inconsistent with DOE's commitment to a performance-based rule to
mandate this practice. DOE's goal in developing this rule is to allow
the responsible employer maximum flexibility by specifying in the final
rule only those record system characteristics and practices that DOE
believes are essential for achieving successful CBDPPs.
Section 850.39(g) requires the responsible employer to transmit all
records required by this rule, in a format that protects the
confidentiality of individuals, to the DOE Assistant Secretary for
Environment, Safety and Health on request. DOE replaced
``Headquarters'' in the proposed rule with ``Assistant Secretary for
Environment, Safety and Health'' in the final rule to clarify that
DOE's Office of Environment, Safety and Health is the DOE organization
that is responsible for conducting occupational health studies that
involve DOE workers.
Section 850.39(h) requires the responsible employer semi-annually
to transmit to the DOE Office of Epidemiologic Studies, Office of
Environment, Safety and Health, an electronic registry of beryllium-
associated workers. The transmitted registry must protect
confidentiality and include (but is not limited to) the following
information for each worker in the registry: a unique identifier, date
of birth, gender, site, job history, medical screening test results,
exposure measurements, and results of referrals for specialized medical
evaluations. DOE's collection of this information conforms to DOE
Record System 88, ''Epidemiologic and Other Studies, Surveys, and
Surveillance,'' established as required by the Privacy Act. The Office
of Epidemiologic Surveillance is responsible for administrative and
policy decisions related to the beryllium registry and provides
technical support to the SOMD.
The medical records generated by the CBDPP will be kept in
appropriate agency Privacy Act systems of records, such as DOE-33,
``Personnel Medical Records,'' and/or DOE-88, and will be afforded the
protection provided by the Privacy Act. Should the agency receive a
request for these records, it will use every argument legally and
reasonably available to it, including the authority granted under the
FOIA and the Privacy Act and the agency's regulations implementing
those statutes, to protect the privacy of individuals in the records
generated by the CBDPP. DOE's policy expressed in 10 CFR 1004.3(e)(ii),
to maximize public disclosure of records that pertain to concerns about
the environment, public health or safety, or employee grievances, has
never been applied to jeopardize the privacy interests of individuals
in their medical records and will not be applied to jeopardize privacy
interests in records generated by the CBDPP.
Section 850.39(h) includes ``exposure measurements'' in the
registry as recommended by a commenter (Ex. 14). DOE had inadvertently
omitted exposure measurements in the proposed registry provision. Also,
section 850.39(h) includes beryllium-associated workers as recommended
by a commenter (Ex. 28), rather than the narrower category of beryllium
workers as proposed. DOE accepts this recommended change because it
recognizes that some DOE workers who currently do not perform tasks
involving beryllium are nonetheless at risk of contracting CBD (based
on past potential exposure to beryllium) and must be included to
complete the registry.
DOE proposed including beryllium-associated workers' names and
social security numbers in the data that would be included in the
beryllium registry. Several commenters (Exs. 16, 23, 28) argued that
including the names and social security numbers of the beryllium-
associated workers in the registry would compromise their privacy. DOE
has responded to these commenters' concerns by replacing the proposed
``names'' and ``social security numbers'' with ``unique identifier.''
The term ``unique identifier'' is defined in section 850.3(a) to mean
the part of a paired set of labels, used in records that contain
confidential information, that does not identify individuals except by
using the matching label. Only the SOMD will have the key to match the
unique identifier to the individual. This approach allows health and
safety professionals and researchers to access the registry data and
allows the SOMD to inform individuals of relevant study results, while
maintaining confidentiality at all times.
[[Page 68900]]
The beryllium registry will serve as a repository for information
on beryllium-associated workers. DOE will use the registry to determine
the exposure profile and disease status of beryllium-associated
workers, and provide feedback to the responsible employer on the
effectiveness of the CBDPP. The registry will give DOE the ability to
combine data from different facilities and perform analyses that are
impossible to perform with the small amount of data that is available
from each individual facility. The combined data may help DOE identify
risk factors for CBD and evaluate the predictive value of medical tests
such as the Be-LPT. Also, researchers may use the registry to conduct
further epidemiological studies to better understand the cause and
development of CBD and better identify those at risk.
One commenter (Ex. 26) recommended that DOE delete the beryllium
registry from the final rule because the commenter believes that: (1)
DOE has not adequately described the research for which it will be
used, and (2) implementing the registry will be costly. This commenter
suggested, as an alternative, that DOE retain the beryllium registry,
but include in the rule the specific research protocol that would be
used. DOE does not agree with the commenter. DOE is confident that the
registry as provided in the final rule will support the studies needed
to better understand the relationship between workplace conditions and
CBD. This knowledge should provide the basis for improved worker
protections. DOE also thinks that the expense of the registry is well
justified by these benefits. DOE also disagrees with the recommended
alternative of including the research protocols in this rule.
Stipulating research protocols in regulations that could only be
changed through notice-and-comment rulemaking could stifle research
activities.
One commenter (Ex. 19) expressed the concern that DOE's Office of
Environment, Safety, and Health use of the beryllium registry could
overshadow important site-specific studies. DOE believes that studies
at both the site and national level are important for understanding the
relationship between workplace conditions and CBD. DOE has included
section 850.39(d), which requires responsible employers to link data on
workplace conditions and health outcomes, in part to facilitate the
site level studies. The beryllium registry established by section
850.39(h) will be used by the Office of Epidemiologic Surveillance to
support national level studies.
Two commenters (Exs. 19, 23) recommended that the rule require that
a university or a university with input from an oversight board, or
other suitably qualified organizations design the epidemiological
analysis of the CBDPP-generated data. Although responsible employers
and DOE's Office of Environment, Safety and Health may use universities
or other suitably qualified organizations to design these analyses, DOE
thinks it would be inappropriate to specify the use of such
organizations in the rule. This recommendation is not adopted.
Section 850.40--Performance Feedback
The final rule requirements for performance feedback in section
850.40 are essentially the same as those proposed. Section 850.40(a)
requires that responsible employers conduct periodic analysis and
assessment of monitoring results, hazards identified, medical
surveillance results, attainment of exposure reduction and minimization
goals, and occurrence reporting data. DOE believes that the analysis of
these data is important for the continuous improvement of the program.
To ensure that all workers have the information needed to safely
perform their assigned tasks, section 850.40(b) requires that results
of performance assessments conducted in accordance with this rule be
provided to line managers, planners, worker protection staff, workers,
medical staff, and others.
List of Commenters
------------------------------------------------------------------------
Exhibit
No. Company/Organization
------------------------------------------------------------------------
1 Atomic Weapons Establishment (AWE)
2 Oak Ridge Institute for Science and Education (ORISE)
3 U.S. Department of Navy, Navy Environmental Health Center
4 Fluor Daniel Hanford, Incorporated
5 Burlin McKinney
6 Idaho National Engineering and Environmental Laboratory
(INEEL), Operated by Lockheed Martin
7 Freddy D. Marler Jr.
8 Alfred Glenn Bell
9 Lockheed Martin Idaho Technologies Company, INEEL
10 A Concerned American Citizen
11 Robert A. Gadon, CIH
12 Daniel R. Roberts, Danny Bush, Willie James Brooks, C.E.
Tilley, Robert Lang Freels, Edna & Ernest Hugart, Victoria L.
O'Sheel, Kenneth L. Moore, Cheryll A. Dyer, James M. Harvey,
J. R. Miller, Luis Revilla, Connie Willis, Bruce Lawson, Lynn
& Linda Cox, Roy & Debra Jones
13 American Industrial Hygiene Association (AIHA)
14 Gary Foster
15 Darrell Lawson
16 University of California, Laboratory Administration
17 Hanford Environmental Health Foundation
18 Serious Texans Against Nuclear Dumping (STAND), Incorporated
19 American College of Occupational and Environmental Medicine
20 Occupational Safety and Health Administration (OSHA)
21 University of Cincinnati Medical Center
22 Paper, Allied Industrial Chemical & Energy Workers Union
(PACE)
23 Kaiser-Hill Company, Rocky Flats Environmental Technology Site
24 Lockheed Martin Energy Systems, Incorporated, (Y-12 Facility)
25 Lockheed Martin Energy Research Corporation (Oak Ridge
Laboratory)
26 Brush Wellman, Incorporated
27 James Turner
28 National Jewish Medical and Research Center
29 National Institute for Occupational Safety and Health (NIOSH)
30 Consortium for Risk Evaluation with Stakeholder Participation
(CRESP)
31 International Chemical Workers Union Council of the United
Food and Commercial Workers International Union (ICWUC/UFCW)
32 Concerned Citizens for Nuclear Safety (CCNS)
33 Stanford Linear Accelerator Center (SLAC)
34 Fermi National Accelerator Laboratory (Fermi Lab)
35 United Steelworkers, Local 8031
36 U.S. House of Representatives, Van Hilleary
37 National Institute for Occupational Safety and Health (NIOSH)
38 Atomic Weapons Establishment (AWE)
38 Commodore Advance Science, Incorporated
40 Hanford Environmental Health Foundation
41 Oak Ridge National Laboratory
42 Argonne National Laboratory
43 Fluor Daniel Hanford, Incorporated
44 University of Cincinnati Medical Center
45 Gary Foster
46 Pantex Plant
47 Kaiser-Hill, Rocky Flats Environmental Technology Site
48 Paper, Allied Industrial Chemical & Energy Workers Union
(PACE)
49 Consortium for Risk Evaluation with Stakeholder Participation
(CRESP)
50 Brush Wellman, Incorporated
51 University of Cincinnati
[[Page 68901]]
52 Building & Construction Trades Department, AFL-CIO
------------------------------------------------------------------------
V. Procedural Requirements
A. Review Under Executive Order 12866
This rulemaking 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 proposed rule, which was made available to the public
when the NOPR was published in the Federal Register, was updated to
reflect changes made in the final rule.
Before conducting the assessment, DOE profiled the sites and
activities that will be affected by the CBDPP rule and estimated the
number of workers that will be affected by the rule. DOE estimates that
1,634 workers may be exposed or potentially exposed to airborne
concentrations of beryllium in the DOE complex. Furthermore, DOE
estimates that 1,236 of these workers (75.6 percent) are potentially
exposed above the action level or the PEL prescribed in the CBDPP rule.
DOE began the cost estimation by reviewing the rule to determine
which requirements of the rule will impose costs on affected entities.
DOE then determined the controls (e.g., implementation of procedures,
purchase of equipment) necessary for affected entities to be in
compliance with each requirement. DOE's assessment refers to these
determinations as compliance profiles. Since the goal of the compliance
cost estimation is to determine the incremental costs of compliance
(OMB Guidance, 1996), the compliance profiles were compared to the
procedures and controls that are currently in place at DOE facilities
affected by the rule (i.e., the baseline). Procedures and controls
required by the CBDPP rule that are not currently in place at DOE
facilities were considered new to the facilities, and thus would impose
incremental costs on the affected entities. The compliance profiles
were then adjusted to reflect only the required incremental controls.
The next step in DOE's assessment was to estimate the costs for
each compliance profile. DOE collected data on the cost of each element
contained in the compliance profiles. The profiles are designed to
reflect the full opportunity cost of compliance. For example, the
compliance profile for performing a Be-LPT test includes not only the
test itself, but also the labor time for the worker and physician to
conduct the test, shipping the sample to a lab, and analyzing and
interpreting the results of the test. The cost data was obtained from a
variety of sources, including CBDPP plans submitted under DOE Notice
440.1, a 1999 Environment, Safety and Health (EH) Cost Survey, contact
with DOE facilities subject to the CBDPP rule, trade publications, the
U.S. Office of Personnel Management (OPM) (e.g., for wage rates), and
previous economic analyses of other regulations (e.g., regulatory
impact analyses of OSHA health standards). This cost data was then
applied to the compliance profiles to determine the costs associated
with each profile, providing an estimate of the incremental cost for
each requirement.
DOE-wide cost estimates for each requirement were generated by
multiplying the number of units affected by each requirement by the
incremental cost for each requirement. Costs estimated in this step
were then annualized using a discount rate. Discount rates are used to
translate costs (and benefits) that are incurred in future years into a
present value. Following OMB Guidance (1992), DOE chose a 7 percent
discount rate. In the analysis, DOE uses the 7 percent discount rate
for three purposes: (1) To annualize the costs of equipment or other
program elements that have a lifetime of more than one year, (2) to
translate the costs incurred in future years into a present value, and
(3) to calculate the annualized cost of initial requirements of DOE N
440.1 and the CBDPP rule.
DOE estimated the total compliance costs of the CBDPP, including
the costs of the interim CBDPP under DOE Notice 440.1 and the costs of
this final rule. DOE estimates an $8.54 million annualized cost on DOE
contractors between July 1997 and December 1999 (compliance with DOE
Notice 440.1) and a $31.55 million annualized cost on DOE contractors
between December 1999 (the assumed effective date of the final rule)
and December 2009. This includes an initial (i.e., startup) cost of
$9.02 million incurred in July 1997 and another initial cost of $2.22
million incurred in December 1999.
DOE also assessed the potential benefits of the CBDPP for DOE, DOE
contractors, and workers. DOE assessed the following benefits of the
CBDPP rule: (1) Reduced medical costs; (2) reduced mortality; (3)
increased quality of life; (4) increased medical surveillance for
workers at risk; (5) increased work-life for beryllium workers; (6)
increased productivity; (7) reduced legal costs for DOE and DOE
contractors; and (8) a reduction in the externality associated with
beryllium exposure through a transfer of the medical costs from workers
to DOE contractors. Because sufficient information on the dose-response
relationship for beryllium is not available within the scientific
community, DOE could not relate reduced levels of exposure to a
specific reduction in CBD and beryllium sensitization. Nevertheless,
DOE estimates that the monetary benefits from reduced lifetime medical
costs could range from $10,100 to $16,093 for each avoided case of
beryllium sensitization or CBD.
DOE also assessed the potential economic impacts of the rule on the
provision of public goods that contain beryllium and the impact on the
market for beryllium. DOE assessed each of these potential impacts and
determined neither will impose a significant economic impact. DOE
determined that the potential reduction in the provision of beryllium-
containing public goods will be minimal and, consequently, the
reduction in demand for beryllium will also be small.
DOE's assessment of the potential costs and benefits of the final
has been placed in the rulemaking file (Docket Number EH-RM-98-BRYLM).
DOE also has placed in the rulemaking file a document that identifies
the substantive changes between the draft final rule submitted to the
OIRA for review and the final rule published today, including
identification of the changes suggested or recommended by OIRA. These
documents may be reviewed and copied at the DOE 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.
B. Review Under the Regulatory Flexibility Act
The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that an
agency prepare a regulatory flexibility analysis and publish it at the
time of publication of general notice of proposed rulemaking for the
rule. This requirement does not apply if the agency certifies that the
rule will not, if promulgated, have a significant economic impact on a
substantial number of small entities (5 U.S.C. 605(b)).
[[Page 68902]]
Today's action establishes DOE's regulations for a CBDPP to reduce
the number of DOE Federal and contractor workers exposed to beryllium,
minimize the levels of and potential for exposure to beryllium, and
establish medical surveillance requirements to ensure early detection
of disease. The contractors who manage and operate DOE facilities are
principally responsible for implementing the CBDPP. DOE has considered
whether these contractors are ``small businesses,'' as that term is
defined by the Regulatory Flexibility Act (5 U.S.C. 601(3)). The
Regulatory Flexibility Act's definition incorporates the definition of
``small business concern'' in the Small Business Act, which the Small
Business Administration (SBA) has developed through size standards in
13 CFR part 121. Small businesses are business concerns which, together
with their affiliates, have no more than 500 to 1500 employees, varying
by SIC category, and annual receipts of between $0.5 million to $25
million, again varying by SIC category. The DOE contractors subject to
the CBDPP requirements exceed the SBA's size standards for small
businesses. In addition, DOE contractors are reimbursed through their
contracts with DOE for the costs of complying with DOE health and
safety program requirements. They will not, therefore, be adversely
impacted by the requirements in the rule. For these reasons, DOE
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities.
C. Review Under the Paperwork Reduction Act
DOE submitted the proposed collections of information in this rule
to the Office of Management and Budget for review under section 3507(d)
of the Paperwork Reduction Act of 1995 (42 U.S.C. 3507(d)). The
information that DOE contractors are required to produce, maintain and
report is necessary to permit the Department to manage and oversee the
health and safety programs that control worker exposure to beryllium.
The Office of Management and Budget has not yet approved the
collections of information in this rule. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number (5
CFR 1320.5(b)).
D. Review Under the National Environmental Policy Act
DOE has reviewed 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 (40 CFR parts 1500-1508), and DOE's NEPA implementing
procedures (10 CFR Part 1021). DOE has completed an Environmental
Assessment, and on the basis of that assessment has determined that an
environmental impact statement is not required and issued a Finding of
No Significant Impact (FONSI) for this rule. In the Notice of Proposed
Rulemaking, the Department announced the availability of the draft
Environmental Assessment and requested comments on the Assessment. DOE
did not receive any comments on the draft Environmental Assessment. The
Environmental Assessment updates the draft Environmental Assessment
(DOE/EA 1249) to reflect changes in the final rule made in response to
public comments on the rule. The Environmental Assessment and FONSI are
available for inspection at the DOE Freedom of Information Reading
Room, 1E-190, 1000 Independence Avenue SW, Washington, DC 20585,
between the hours of 9 a.m. and 4 p.m., Monday through Friday, except
Federal holidays.
E. Review Under Executive Order 13132
Executive Order 13132 (64 FR 43255, August 4, 1999), imposes
certain requirements on agencies formulating and implementing policies
or regulations that preempt State law or that have federalism
implications. Agencies are required to examine the constitutional and
statutory authority supporting any action that would limit the
policymaking discretion of the States and carefully assess the
necessity for such actions. DOE has examined today's rule and has
determined that it does not preempt State law and does not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government. No further
action is required by Executive Order 13132.
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 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 the extent permitted by law, to
prepare a written assessment of the effects of any Federal mandate in
an 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
Federal intergovernmental mandate,'' and requires an agency plan for
giving notice and an opportunity for timely input to potentially
affected small governments before establishing any requirements that
might significantly or uniquely affect small governments. The final
rule published today applies only to activities conducted by or for
DOE, and its implementation will not result in an expenditure of $100
million in any year by State, local or tribal governments or the
private sector. Therefore, the requirements of Title II Unfunded
Mandates Reform Act of 1995 do not apply.
H. Review Under Small Business Regulatory Enforcement Fairness Act of
1996
As required by 5 U.S.C. 801, DOE will report to Congress
promulgation of this rule prior to its effective date. The report will
state that it has been
[[Page 68903]]
determined that the rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
Appendix A to the Preamble References
1. ``Beryllium Disease: Reducing the Risks.'' National Jewish
Medical and Research Center Website (http://www.nationaljewish.org/
beryllium/). 1999.
2. Green DM et al. ``Agency for Toxic Substances and Disease
Registry (ASTDR) Case Studies in Environmental Medicine, No.19.''
U.S. Department of Health and Human Services. 1992.
3. Hardy HL, Tabershaw IR. ``Delayed Chemical Pneumonitis Occurring
in Workers Exposed to Beryllium Compounds.'' Journal of Industrial
Hygiene Toxicology, Volume 28:197 (1946).
4. Powers MB. ``History of Beryllium.'' In Beryllium Biomedical and
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds.
Baltimore: Williams and Wilkins, 1991.
5. Eisenbud M et al. ``Non-occupational Berylliosis.'' Journal of
Industrial Hygiene Toxicology, Volume 31:282-294 (1949).
6. 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).
7. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium
Intoxication.'' Archives of Industrial Hygiene and Occupational
Medicine, Volume 4:123-157 (1951).
8. 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).
9. Tepper LB. ``Introduction.'' In: Beryllium Biomedical and
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds.
Baltimore: Williams and Wilkins, 1991.
10. Sprince NL, Kazemi H. ``Beryllium Disease.'' In: Environmental
and Occupational Medicine, 2nd ed. Room W, ed. Boston: Little,
Brown, 1992.
11. 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).
12. Kreiss K, Newman LS, Mroz MM, Campbell, PA. ``Screening Blood
Test Identifies Subclinical Beryllium Disease.'' Journal of
Occupational Medicine, Volume 31:603-608 (1989).
13. 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).
14. 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).
15. 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).
16. 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).
17. Kreiss K et al. ``Beryllium Disease Screening in the Ceramics
Industry.'' Journal of Occupational Medicine, Volume 35:267-274
(1993).
18. Health Assessment Document for Beryllium [Publication No. EPA/
600/8-84/026F] U.S. Environmental Protection Agency. (1987).
19. Stange AW et al. ``Possible Health Risks from Low Level Exposure
to Beryllium.'' Toxicology, Volume 111:213-224 (1996).
20. 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).
21. 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).
22. Kreiss K, Mroz M, Zhen B, Wiedemann H, Barna B. Risks of
beryllium disease related to work processes at a metal, alloy, and
oxide production plant. Occupational and Environmental Medicine,
Volume 54:605-612 (1997).
23. Cohen BS. ``Air Sampling.'' In: Beryllium Biomedical and
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds.
Baltimore: Williams and Wilkins, 1991.
24. Finch GL. ``In Vitro Dissolution Characteristics of Beryllium
Oxide and Beryllium Metal Aerosols.'' Journal of Aerosols Science,
Volume 19:333-342 (1988).
25. Newman LS. ``To Be2+ or Not to Be2+ :
Immunogenetics and Occupational Exposure.'' Science, Volume 262:197-
198 (8 October 1993).
26. Haley PJ. ``Mechanisms of Granulomatous Lung Disease from
Inhaled Beryllium: The Role of Antigenicity in Granuloma
Formation.'' Toxicologic Pathology, Volume 19:514-525 (1991).
27. 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).
28. Richeldi L et al. ``HLA-DPB1 Glutamate 69: A Genetic Marker of
Beryllium Disease.'' Science, Volume 262:242-244 (8 October 1993).
29. Eisenbud M. ``The Standard for Control of Chronic Beryllium
Disease.'' Applied Occupational Environmental Hygiene, Volume
13(1):25-31 (January 1998).
30. Pappas GP et al. ``Early Pulmonary Physiologic Abnormalities in
Beryllium Disease.'' American Review of Respiratory Disease, Volume
148:661-666 (1993).
31. Yoshida T et. al. ``A Study on the Beryllium Lymphocyte
Transformation Test and the Beryllium Levels in Working
Environment.'' Industrial Health, Volume 35(3):374-9 (Jul 1997).
32. Threshold Limit Value for Chemical Substances and Physical
Agents and Biological Exposure Indices, Notice of Intended Change
(1999).
33. U.S. Environmental Protection Agency: Integrated Risk
Information System, Substance File--Beryllium and Compounds, CASRN
7440-41; U.S. Environmental Protection Agency, Washington, DC
(1998).
34. Epstein WL. ``Cutaneous Effects of Beryllium.'' In: Beryllium
Biomedical and Environmental Aspects. Rossman MD, Preuss OP, and
Powers MB, eds. Baltimore: Williams and Wilkins, 1991.
35. Sanderson WT et. al. ``Beryllium Contamination Inside Vehicles
of Machine Shop Workers.'' Applied Occupational Environmental
Hygiene, Volume 14:223-230 (1999).
Appendix B to the Preamble--Questions and Answers Concerning the
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical
Records, and the Department of Energy (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 the beryllium in a specific way, the test results are ``positive.''
If they do not react to 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 that
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 a person is not sensitive or allergic to
beryllium. This is called a ``false positive'' result. It is also
[[Page 68904]]
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 that 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.
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.
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 additional tests,
if you so choose. Your employer will pay for all tests.
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. If you have a positive Be-LPT or have been diagnosed with CBD,
your employer may inform you that the SOMD has recommended that you be
temporarily or permanently removed from working with beryllium. You
will be given information and counseling to help you decide whether to
accept medical removal. If you agree to medical removal, every effort
will be made to offer you another job that you are qualified (or can be
trained for in a short period) to perform and where the beryllium
exposures will be as low as possible, but in no case above the action
level.
If you are temporarily removed, you will maintain your total normal
earnings, seniority, and other benefits until you are placed in another
job for 1 year, whichever comes first. If you are permanently removed,
you will maintain your total normal earnings, seniority, and other
benefits until you are placed in another job or for 2 years, whichever
comes first. 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 Normal 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 Be-LPT and other screening tests will be made
available to you and, with your consent, to your physician. The
information also will become part of your medical record, which the
clinic keeps.
The results of tests and examinations in your medical record will
be available to the physicians and nurses in this clinic, and possibly
to scientists conducting health studies. The test results in your
medical records 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; and
4. The Centers for Disease Control and Prevention and the 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.
What Laws Protect Me if I Consent To Participate in the Blood Be-LPT
Testing 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. It would also be available
as the Freedom of Information Act or Privacy Act provide, such as to
Congress, to an individual upon a showing of compelling circumstances
affecting the health and safety of an individual, etc. 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.
[[Page 68905]]
What Is the DOE Beryllium Registry?
Your health and the health of all workers is a major concern to
DOE. There is a need to learn more about chronic beryllium disease and
what causes some individuals to react more strongly than others do. A
DOE beryllium registry has been established to collect and maintain
information on workers who are exposed to beryllium. This registry is a
tool that 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 this information in conformance with the Privacy
Act of 1974, the Americans with Disabilities Act, and other applicable
laws. Your employer will establish a unique identifier for you that
will be included in the registry instead of your personal identifying
information (such as your name and social security number). The unique
identifier will be used to inform your employer of any study results
that you and your employer's Site Occupational Medical Director (SOMD)
should know about. The SOMD will know to whom the unique identifier
refers and will notify you of these results. At no time will your name
or other personal identifying information be included in any report.
The confidentiality of personal information in DOE records is protected
under the Privacy Act of 1974.
List of Subjects in 10 CFR Part 850
Beryllium, Chronic beryllium disease, Hazardous substances, Lung
diseases, Occupational safety and health, Reporting and recordkeeping
requirements.
Issued in Washington, D.C., on November 24, 1999.
Bill Richardson,
Secretary of Energy.
For the reason set forth in the preamble, Title 10, Chapter III of
the Code of Federal Regulations is amended by adding a new part 850 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 Permissible exposure limit.
850.23 Action level.
850.24 Exposure monitoring.
850.25 Exposure reduction and minimization.
850.26 Regulated areas.
850.27 Hygiene facilities and practices.
850.28 Respiratory protection.
850.29 Protective clothing and equipment.
850.30 Housekeeping.
850.31 Release criteria.
850.32 Waste disposal.
850.33 Beryllium emergencies.
850.34 Medical surveillance.
850.35 Medical removal.
850.36 Medical consent.
850.37 Training and counseling.
850.38 Warning signs and labels.
850.39 Recordkeeping and use of information.
850.40 Performance feedback.
Appendix A to Part 850--Chronic Beryllium Disease Prevention Program
Informed Consent Form.
Authority: 42 U.S.C. 2201(i)(3), (p); 29 U.S.C. 668; E.O. 12196,
3 CFR 1981 comp., p. 145 as amended.
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 operations or activities that
involve present or past exposure, or the potential for exposure, to
beryllium at DOE facilities;
(2) DOE contractors with operations or activities that involve
present or past exposure, or the potential for exposure, to beryllium
at DOE facilities; and
(3) Any current DOE employee, DOE contractor employee, or other
worker at a DOE facility who is or was exposed or potentially exposed
to beryllium at a DOE facility.
(b) This part does not apply to:
(1) Beryllium articles; and
(2) DOE laboratory operations that meet the definition of
laboratory use of hazardous chemicals in 29 CFR 1910.1450, Occupational
Exposure to Hazardous Chemical in Laboratories.
Sec. 850.3 Definitions.
(a) As used in this part:
Action level means the level of airborne concentration of beryllium
established pursuant to section 850.23 of this part that, if met or
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 activity means an activity taken for, or by, DOE at a DOE
facility that can expose workers to airborne beryllium, including but
not limited to design, construction, operation, maintenance, or
decommissioning, and which may involve one DOE facility or operation or
a combination of facilities and operations.
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-associated worker means a current worker who is or was
exposed or potentially exposed to airborne concentrations of beryllium
at a DOE facility, including:
(1) A beryllium worker;
(2) A current worker whose work history shows that the worker may
have been exposed to airborne concentrations of beryllium at a DOE
facility;
(3) A current worker who exhibits signs or symptoms of beryllium
exposure; and
(4) A current worker who is receiving medical removal protection
benefits.
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
[[Page 68906]]
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 regularly employed
in a DOE beryllium activity.
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 contractor means any entity under contract with DOE (or its
subcontractor) that has responsibility for performing beryllium
activities at DOE facilities.
DOE facility means any facility operated by or for DOE.
Head of DOE Field Element means an individual who is the manager or
head of the DOE operations office or field office, or any official to
whom the Head of DOE Field Element delegates his or her functions under
this part.
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 means the employment rights
established by section 850.35 of this part for beryllium-associated
workers who voluntarily accept temporary or permanent medical removal
from beryllium areas following a recommendation by the Site
Occupational Medicine Director.
Operational area means an area where workers are routinely in the
presence of beryllium as part of their work activity.
Regulated area means an area demarcated by the responsible employer
in which the airborne concentration of beryllium exceeds, or can
reasonably be expected to exceed, the action level.
Removable contamination means beryllium contamination that can be
removed from surfaces by nondestructive means, such as casual contact,
wiping, brushing or washing.
Responsible employer means:
(1) For DOE contractor employees, the DOE contractor office that is
directly responsible for the safety and health of DOE contractor
employees while performing a beryllium activity or other activity at a
DOE facility; or
(2) For DOE employees, the DOE office that is directly responsible
for the safety and health of DOE Federal employees while performing a
beryllium activity or other activity at a DOE facility; and
(3) Any person acting directly or indirectly for such office with
respect to terms and conditions of employment of beryllium-associated
workers.
Site Occupational Medical Director (SOMD) means the physician
responsible for the overall direction and operation of the site
occupational medicine program.
Unique identifier means the part of a paired set of labels, used in
records that contain confidential information, that does not identify
individuals except by using the matching label.
Worker means a person who performs work for or on behalf of DOE,
including a DOE employee, an independent contractor, a DOE contractor
or subcontractor employee, or any other person who performs work at a
DOE facility.
Worker exposure means the exposure of a worker to airborne
beryllium that would occur if the worker were not using respiratory
protective equipment.
(b) Terms undefined in this part that are defined in the Atomic
Energy Act of 1954 shall have the same meaning as under that Act.
Sec. 850.4 Enforcement.
DOE may take appropriate steps under its contracts with DOE
contractors to ensure compliance with this part. These steps include,
but are not limited to, contract termination or reduction in fee.
Sec. 850.5 Dispute resolution.
(a) Subject to paragraphs (b) and (c) of this section, any worker
who is adversely affected by an action taken, or failure to act, under
this part may petition the Office of Hearings and Appeals for relief in
accordance with 10 CFR part 1003, Subpart G.
(b) The Office of Hearings and Appeals may not accept a petition
from a worker unless the worker requested the responsible employer to
correct the violation, and the responsible employer refused or failed
to take corrective action within a reasonable time.
(c) If the dispute relates to a term or condition of employment
that is covered by a grievance-arbitration provision in a collective
bargaining agreement, the worker must exhaust all applicable grievance-
arbitration procedures before filing a petition for relief with the
Office of Hearings and Appeals. A worker is deemed to have exhausted
all applicable grievance-arbitration procedures if 150 days have passed
since the filing of a grievance and a final decision on it has not been
issued.
Subpart B--Administrative Requirements
Sec. 850.10 Development and approval of the CBDPP.
(a) Preparation and submission of initial CBDPP to DOE. (1) The
responsible employer at a DOE facility must ensure that a CBDPP is
prepared for the facility and submitted to the appropriate Head of DOE
Field Element before beginning beryllium activities, but no later than
April 6, 2000 of this part.
(2) If the CBDPP has separate sections addressing the activities of
multiple contractors at the facility, the Head of DOE Field Element
will designate a single DOE contractor to review and approve the
sections prepared by other contractors, so that a single consolidated
CBDPP for the facility is submitted to the Head of DOE Field Element
for review and approval.
(b) DOE review and approval. The appropriate Head of DOE Field
Element must review and approve the CBDPP.
(1) The initial CBDPP and any updates are deemed approved 90 days
after submission if they are not specifically approved or rejected by
DOE earlier.
(2) The responsible employer must 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. The responsible employer must submit an update of the
CBDPP to the appropriate Head of DOE Field Element for review and
approval whenever a significant change or significant addition to the
CBDPP is made or a change in contractors occurs. The Head of DOE Field
Element must review the CBDPP at least annually and, if necessary,
require the responsible employer to update the CBDPP.
(d) Labor Organizations. If a responsible employer employs or
supervises beryllium-associated workers who are represented for
collective bargaining by a labor organization, the responsible employer
must:
(1) Give the labor organization timely notice of the development
and implementation of the CBDPP and any updates thereto; and
(2) Upon timely request, bargain concerning implementation of this
part, consistent with the Federal labor laws.
Sec. 850.11 General CBDPP requirements.
(a) The CBDPP must specify the existing and planned operational
tasks that are within the scope of the CBDPP. The CBDPP must augment
and, to the
[[Page 68907]]
extent feasible, be integrated into the existing worker protection
programs that cover activities at the facility.
(b) The detail, scope, and content of the CBDPP must be
commensurate with the hazard of the activities performed, but in all
cases the CBDPP must:
(1) Include formal plans and measures for maintaining exposures to
beryllium at or below the permissible exposure level prescribed in
Sec. 850.22;
(2) Satisfy each requirement in subpart C of this part;
(3) Contain provisions for:
(i) Minimizing the number of workers exposed and potentially
exposed to beryllium;
(ii) Minimizing the number of opportunities for workers to be
exposed to beryllium;
(iii) Minimizing the disability and lost work time of workers due
to chronic beryllium disease, beryllium sensitization and associated
medical care; and
(iv) Setting specific exposure reduction and minimization goals
that are appropriate for the beryllium activities covered by the CBDPP
to further reduce exposure below the permissible exposure limit
prescribed in Sec. 850.22.
Sec. 850.12 Implementation.
(a) The responsible employer must manage and control beryllium
exposures in all DOE beryllium activities consistent with the approved
CBDPP.
(b) No person employed by DOE or a DOE contractor may take or cause
any action inconsistent with the requirements of:
(1) This part,
(2) An approved CBDPP, and
(3) Any other Federal statute or regulation concerning the exposure
of workers to beryllium at DOE facilities.
(c) No task involving potential exposure to airborne beryllium that
is outside the scope of the existing CBDPP may be initiated until an
update of the CBDPP is approved by the Head of DOE Field Element,
except in an unexpected situation and, then, only upon approval of the
Head of DOE Field Element.
(d) Nothing in this part precludes a responsible employer from
taking any additional protective action that it determines to be
necessary to protect the health and safety of workers.
(e) Nothing in this part affects the responsibilities of DOE
officials under the Federal Employee Occupational Safety and Health
Program (29 CFR part 1960) and related DOE directives.
Sec. 850.13 Compliance.
(a) The responsible employer must conduct activities in compliance
with its CBDPP.
(b) The responsible employer must achieve compliance with all
elements of its CBDPP no later than January 7, 2002.
(c) With respect to a particular beryllium activity, the contractor
in charge of the activity is responsible for complying with this part.
If no contractor is responsible for a beryllium activity, DOE must
ensure implementation of, and compliance with, this part.
Subpart C--Specific Program Requirements
Sec. 850.20 Baseline beryllium inventory.
(a) The responsible employer must develop a baseline inventory of
the locations 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, the responsible employer
must:
(1) Review current and historical records;
(2) Interview workers;
(3) Document the characteristics and locations of beryllium at the
facility; and
(4) Conduct air, surface, and bulk sampling.
(c) The responsible employer must ensure that:
(1) The baseline beryllium inventory is managed by a qualified
individual (e.g., a certified industrial hygienist); and
(2) The individuals assigned to this task have sufficient knowledge
and experience to perform such activities properly.
Sec. 850.21 Hazard assessment.
(a) If the baseline inventory establishes the presence of
beryllium, the responsible employer must conduct a beryllium hazard
assessment that includes an analysis of existing conditions, exposure
data, medical surveillance trends, and the exposure potential of
planned activities. The exposure determinants, characteristics and
exposure potential of activities must be prioritized so that the
activities with the greatest risks of exposure are evaluated first.
(b) The responsible employer must ensure that:
(1) The hazard assessment is managed by a qualified individual
(e.g., a certified industrial hygienist); and
(2) The individuals assigned to this task have sufficient knowledge
and experience to perform such activities properly.
Sec. 850.22 Permissible exposure limit.
The responsible employer must assure that no worker is exposed to
an airborne concentration of beryllium greater than the permissible
exposure limit established in 29 CFR 1910.1000, 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.
Sec. 850.23 Action level.
(a) The responsible employer must include in its CBDPP an action
level that is no greater than 0.2 g/m3, calculated
as an 8-hour TWA exposure, as measured in the worker's breathing zone
by personal monitoring.
(b) If an airborne concentration of beryllium is at or above the
action level, the responsible employer must implement Secs. 850.24(c)
(periodic monitoring), 850.25 (exposure reduction and minimization),
850.26 (regulated areas), 850.27 (hygiene facilities and practices),
850.28 (respiratory protection), 850.29 (protective clothing and
equipment), and 850.38 (warning signs) of this part.
Sec. 850.24 Exposure monitoring.
(a) General. The responsible employer must ensure that:
(1) Exposure monitoring is managed by a qualified individual (e.g.,
a certified industrial hygienist); and
(2) The individuals assigned to this task have sufficient
industrial hygiene knowledge and experience to perform such activities
properly.
(b) Initial monitoring. The responsible employer must perform
initial monitoring in areas that may have airborne beryllium, as shown
by the baseline inventory and hazard assessment. The responsible
employer must apply statistically-based monitoring strategies to obtain
a sufficient number of sample results to adequately characterize
exposures, before reducing or terminating monitoring.
(1) The responsible employer must determine workers' 8-hour TWA
exposure levels by conducting personal breathing zone sampling.
(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. The responsible employer must
conduct
[[Page 68908]]
periodic monitoring of workers who work in areas where airborne
concentrations of beryllium are at or above the action level. The
monitoring must be conducted in a manner and at a frequency necessary
to represent workers' exposure, as specified in the CBDPP. This
periodic exposure monitoring must be performed at least every 3 months
(quarterly).
(d) Additional exposure monitoring. The responsible employer must
perform additional monitoring if operations, maintenance or procedures
change, or when the responsible employer has any reason to suspect such
a change has occurred.
(e) Accuracy of monitoring. The responsible employer must use a
method of monitoring and analysis that has an accuracy of not less than
plus or minus 25 percent, with a confidence level of 95 percent, for
airborne concentrations of beryllium at the action level.
(f) Analysis. The responsible employer must 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 (AIHA) or a laboratory that demonstrates quality
assurance for metals analysis that is equivalent to AIHA accreditation.
(g) Notification of monitoring results. (1) The responsible
employer must, within 10 working days after receipt of any monitoring
results, notify the affected workers of monitoring results in writing.
This notification of monitoring results must be:
(i) Made personally to the affected worker; or
(ii) Posted in location(s) that is readily accessible to the
affected worker, but in a manner that does not identify the individual
to other workers.
(2) If the monitoring results indicate that a worker's exposure is
at or above the action level, the responsible employer must include in
the notice:
(i) A statement that the action level has been met or exceeded; and
(ii) A description of the corrective action being taken by the
responsible employer to reduce the worker's exposure to below the
action level, if practicable.
(3) If the monitoring results indicate that worker exposure is at
or above the action level, the responsible employer must also notify
DOE and the SOMD of these results within 10 working days after receipt.
Sec. 850. 25 Exposure reduction and minimization.
(a) The responsible employer must ensure that no worker is exposed
above the exposure limit prescribed in Sec. 850.22.
(b) The responsible employer must, in addition:
(1) Where exposure levels are at or above the action level,
establish a formal exposure reduction and minimization program to
reduce exposure levels to below the action level, if practicable. This
program must be described in the responsible employer's CBDPP and must
include:
(i) Annual goals for exposure reduction and minimization;
(ii) A rationale for and a strategy for meeting the goals;
(iii) Actions that will be taken to achieve the goals; and
(iv) A means of tracking progress towards meeting the goals or
demonstrating that the goals have been met.
(2) Where exposure levels are below the action level, implement
actions for reducing and minimizing exposures, if practicable. The
responsible employer must include in the CBDPP a description of the
steps to be taken for exposure reduction and minimization and a
rationale for those steps.
(c) The responsible employer must implement exposure reduction and
minimization actions using the conventional hierarchy of industrial
hygiene controls (i.e., engineering controls, administrative controls,
and personal protective equipment in that order).
Sec. 850.26 Regulated areas.
(a) If airborne concentrations of beryllium in areas in DOE
facilities are measured at or above the action level, the responsible
employer must establish regulated areas for those areas.
(b) The responsible employer must demarcate regulated areas from
the rest of the workplace in a manner that adequately alerts workers to
the boundaries of such areas.
(c) The responsible employer must limit access to regulated areas
to authorized persons.
(d) The responsible employer must keep records of all individuals
who enter regulated areas. These records must include the name, date,
time in and time out, and work activity.
Sec. 850.27 Hygiene facilities and practices.
(a) General. The responsible employer must assure that in areas
where workers are exposed to beryllium at or above the action level,
without regard to the use of respirators:
(1) Food or beverage and tobacco products are not used;
(2) Cosmetics are not applied, except in change rooms or areas and
shower facilities required under paragraphs (b) and (c) of this
section; and
(3) Beryllium workers are prevented from exiting areas that contain
beryllium with contamination on their bodies or their personal
clothing.
(b) Change rooms or areas. The responsible employer must provide
clean change rooms or areas for beryllium workers who work in regulated
areas.
(1) Separate facilities free of beryllium must be provided for
beryllium workers to change into, and store, personal clothing, and
clean protective clothing and equipment to prevent cross-contamination;
(2) The change rooms or areas that are used to remove beryllium-
contaminated clothing and protective equipment must be maintained under
negative pressure or located so as to minimize dispersion of beryllium
into clean areas; and
(c) Showers and handwashing facilities. (1) The responsible
employer must provide handwashing and shower facilities for beryllium
workers who work in regulated areas.
(2) The responsible employer must assure that beryllium workers who
work in regulated areas shower at the end of the work shift.
(d) Lunchroom facilities. (1) The responsible employer must provide
lunchroom facilities that are readily accessible to beryllium workers,
and ensure that tables for eating are free of beryllium, and that no
worker in a lunchroom facility is exposed at any time to beryllium at
or above the action level.
(2) The responsible employer must assure that beryllium workers do
not enter lunchroom facilities with protective work clothing or
equipment unless the surface beryllium has been removed from clothing
and equipment by HEPA vacuuming or other method that removes beryllium
without dispersing it.
(e) The change rooms or areas, shower and handwashing facilities,
and lunchroom facilities must comply with 29 CFR 1910.141, Sanitation.
Sec. 850.28 Respiratory protection.
(a) The responsible employer must establish a respiratory
protection program that complies with the respiratory protection
program requirements of 29 CFR 1910.134, Respiratory Protection.
(b) The responsible employer must provide respirators to, and
ensure that they are used by, all workers who:
[[Page 68909]]
(1) Are exposed to an airborne concentration of beryllium at or
above the action level, or
(2) Are performing tasks for which analyses indicate the potential
for exposures at or above the action level.
(c) The responsible employer must include in the respiratory
protection program any beryllium-associated worker who requests to use
a respirator for protection against airborne beryllium, regardless of
measured exposure levels.
(d) The responsible employer must select for use by workers:
(1) Respirators approved by the National Institute for Occupational
Safety and Health (NIOSH) if NIOSH-approved respirators exist for a
specific DOE task; or
(2) Respirators that DOE has accepted under the DOE Respiratory
Protection Acceptance Program if NIOSH-approved respirators do not
exist for specific DOE tasks.
Sec. 850.29 Protective clothing and equipment.
(a) The responsible employer must provide protective clothing and
equipment to beryllium workers and ensure its appropriate use and
maintenance, where dispersible forms of beryllium may contact worker's
skin, enter openings in workers' skin, or contact workers' eyes,
including where:
(1) Exposure monitoring has established that airborne
concentrations of beryllium are at or above the action level;
(2) Surface contamination levels measured or presumed prior to
initiating work are above the level prescribed in Sec. 850.30;
(3) Surface contamination levels results obtained to confirm
housekeeping efforts are above the level prescribed in Sec. 850.30; and
(4) Any beryllium-associated worker who requests the use of
protective clothing and equipment for protection against airborne
beryllium, regardless of measured exposure levels.
(b) The responsible employer must comply with 29 CFR 1910.132,
Personal Protective Equipment General Requirements, when workers use
personal protective clothing and equipment.
(c) The responsible employer must establish procedures for donning,
doffing, handling, and storing protective clothing and equipment that:
(1) Prevent beryllium workers from exiting areas that contain
beryllium with contamination on their bodies or their personal
clothing; and
(2) Include beryllium workers exchanging their personal clothing
for full-body protective clothing and footwear before they begin work
in regulated areas.
(d) The responsible employer must ensure that no worker removes
beryllium-contaminated protective clothing and equipment from areas
that contain beryllium, except for workers authorized to launder,
clean, maintain, or dispose of the clothing and equipment.
(e) The responsible employer must prohibit the removal of beryllium
from protective clothing and equipment by blowing, shaking, or other
means that may disperse beryllium into the air.
(f) The responsible employer must ensure that protective clothing
and equipment is cleaned, laundered, repaired, or replaced as needed to
maintain effectiveness. The responsible employer must:
(1) Ensure that beryllium-contaminated protective clothing and
equipment, when removed for laundering, cleaning, maintenance, or
disposal, is placed in containers that prevent the dispersion of
beryllium dust and that are labeled in accordance with Sec. 850.38 of
this part; and
(2) Inform organizations that launder or clean DOE 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
responsible employer to prevent the release of airborne beryllium.
Sec. 850.30 Housekeeping.
(a) Where beryllium is present in operational areas of DOE
facilities, the responsible employer must conduct routine surface
sampling to determine housekeeping conditions. Surfaces contaminated
with beryllium dusts and waste must not exceed a removable
contamination level of 3 g/100 cm\2\ during non-operational
periods. This sampling would not include the interior of installed
closed systems such as enclosures, glove boxes, chambers, or
ventilation systems.
(b) When cleaning floors and surfaces in areas where beryllium is
present at DOE facilities, the responsible employer must clean
beryllium-contaminated floors and surfaces using a wet method,
vacuuming or other cleaning methods, such as sticky tack cloths, that
avoid the production of airborne dust. Compressed air or dry methods
must not be used for such cleaning.
(c) The responsible employer must equip the portable or mobile
vacuum units that are used to clean beryllium-contaminated areas with
HEPA filters, and change the filters as often as needed to maintain
their capture efficiency.
(d) The responsible employer must ensure that the cleaning
equipment that is used to clean beryllium-contaminated surfaces is
labeled, controlled, and not used for non-hazardous materials.
Sec. 850.31 Release criteria.
(a) The responsible employer must clean beryllium-contaminated
equipment and other items to the lowest contamination level
practicable, but not to exceed the levels established in paragraphs (b)
and (c) of this section, and label the equipment or other items, before
releasing them to the general public or a DOE facility for non-
beryllium use, or to another facility for work involving beryllium.
(b) Before releasing beryllium-contaminated equipment or other
items to the general public or for use in a non-beryllium area of a DOE
facility, the responsible employer must ensure that:
(1) The removable contamination level of equipment or item surfaces
does not exceed the higher of 0.2 g/100 cm \2\ or the
concentration level of beryllium in soil at the point or release,
whichever is greater;
(2) The equipment or item is labeled in accordance with
Sec. 850.38(b); and
(3) The release is conditioned on the recipient's commitment to
implement controls that will prevent foreseeable beryllium exposure,
considering the nature of the equipment or item and its future use and
the nature of the beryllium contamination.
(c) Before releasing beryllium-contaminated equipment or other
items to another facility performing work with beryllium, the
responsible employer must ensure that:
(1) The removable contamination level of equipment or item surfaces
does not exceed 3 g/100 cm \2\;
(2) The equipment or item is labeled in accordance with
Sec. 850.38(b); and
(3) The equipment or item is enclosed or placed in sealed,
impermeable bags or containers to prevent the release of beryllium dust
during handling and transportation.
Sec. 850.32 Waste disposal.
(a) The responsible employer must control the generation of
beryllium-containing waste, and beryllium-contaminated equipment and
other items that are disposed of as waste, through the application of
waste minimization principles.
(b) Beryllium-containing waste, and beryllium-contaminated
equipment and other items that are disposed of as waste, must be
disposed of in sealed, impermeable bags, containers, or
[[Page 68910]]
enclosures to prevent the release of beryllium dust during handling and
transportation. The bags, containers, and enclosures that are used for
disposal of beryllium waste must be labeled according to Sec. 850.38.
Sec. 850.33 Beryllium emergencies.
(a) The responsible employer must comply with 29 CFR 1910.120(l)
for handling beryllium emergencies related to decontamination and
decommissioning operations.
(b) The responsible employer must comply with 29 CFR 1910.120(q)
for handling beryllium emergencies related to all other operations.
Sec. 850.34 Medical surveillance.
(a) General. (1) The responsible employer must establish and
implement a medical surveillance program for beryllium-associated
workers who voluntarily participate in the program.
(2) The responsible employer must designate a Site Occupational
Medical Director (SOMD) who is responsible for administering the
medical surveillance program.
(3) The responsible employer must ensure that the medical
evaluations and procedures required by this section are performed by,
or under the supervision of, a licensed physician who is familiar with
the health effects of beryllium.
(4) The responsible employer must establish, and maintain, a list
of beryllium-associated workers who may be eligible for protective
measures under this part. The list must be:
(i) Based on the hazard assessment, exposure records, and other
information regarding the identity of beryllium-associated workers; and
(ii) Adjusted at regular intervals based on periodic evaluations of
beryllium-associated workers performed under paragraph (b)(2) of this
section;
(5) The responsible employer must provide the SOMD with the
information needed to operate and administer the medical surveillance
program, including the:
(i) List of beryllium-associated workers required by paragraph
(a)(4) of this section;
(ii) Baseline inventory;
(iii) Hazard assessment and exposure monitoring data;
(iv) Identity and nature of activities or operations on the site
that are covered under the CBDPP, related duties of beryllium-
associated workers; and
(v) Type of personal protective equipment used.
(6) The responsible employer must provide the following information
to the SOMD and the examining physician:
(i) A copy of this rule and its preamble;
(ii) A description of the worker's duties as they pertain to
beryllium exposure;
(iii) Records of the worker's beryllium exposure; and
(iv) A description of the personal protective and respiratory
protective equipment used by the worker in the past, present, or
anticipated future use.
(b) Medical evaluations and procedures. The responsible employer
must provide, to beryllium-associated workers who voluntarily
participate in the medical surveillance program, the medical
evaluations and procedures required by this section at no cost and at a
time and place that is reasonable and convenient to the worker.
(1) Baseline medical evaluation. The responsible employer must
provide a baseline medical evaluation to beryllium-associated workers.
This evaluation must include:
(i) A detailed medical and work history with emphasis on past,
present, and anticipated future exposure to beryllium;
(ii) A respiratory symptoms questionnaire;
(iii) A physical examination with special emphasis on the
respiratory system, skin and eyes;
(iv) A chest radiograph (posterior-anterior, 14 x 17 inches)
interpreted by a National Institute for Occupational Safety and Health
(NIOSH) B-reader of pneumoconiosis or a board-certified radiologist
(unless a baseline chest radiograph is already on file);
(v) Spirometry consisting of forced vital capacity (FVC) and forced
expiratory volume at 1 second (FEV1);
(vi) A Be-LPT; and
(vii) Any other tests deemed appropriate by the examining physician
for evaluating beryllium-related health effects.
(2) Periodic evaluation. (i) The responsible employer must provide
to beryllium workers a medical evaluation annually, and to other
beryllium-associated workers a medical evaluation every three years.
The periodic medical evaluation must include:
(A) A detailed medical and work history with emphasis on past,
present, and anticipated future exposure to beryllium;
(B) A respiratory symptoms questionnaire;
(C) A physical examination with emphasis on the respiratory system;
(D) A Be-LPT; and
(E) Any other medical evaluations deemed appropriate by the
examining physician for evaluating beryllium-related health effects.
(ii) The responsible employer must provide to beryllium-associated
workers a chest radiograph every five years.
(3) Emergency evaluation. The responsible employer must provide a
medical evaluation as soon as possible to any worker who may have been
exposed to beryllium because of a beryllium emergency. The medical
evaluation must include the requirements of paragraph (b)(2) of this
section.
(c) Multiple physician review. The responsible employer must
establish a multiple physician review process for beryllium-associated
workers that allows for the review of initial medical findings,
determinations, or recommendations from any medical evaluation
conducted pursuant to paragraph (b) of this section.
(1) If the responsible employer selects the initial physician to
conduct any medical examination or consultation provided to a
beryllium-associated worker, the worker may designate a second
physician to:
(i) Review any findings, determinations, or recommendations of the
initial physician; and
(ii) Conduct such examinations, consultations and laboratory tests,
as the second physician deems necessary to facilitate this review.
(2) The responsible employer must promptly notify a beryllium-
associated worker in writing of the right to seek a second medical
opinion after the initial physician provided by the responsible
employer conducts a medical examination or consultation.
(3) The responsible employer may condition its participation in,
and payment for, multiple physician review upon the beryllium-
associated worker doing the following within fifteen (15) days after
receipt of the notice, or receipt of the initial physician's written
opinion, whichever is later:
(i) Informing the responsible employer in writing that he or she
intends to seek a second medical opinion; and
(ii) Initiating steps to make an appointment with a second
physician.
(4) If the findings, determinations, or recommendations of the
second physician differ from those of the initial physician, then the
responsible employer and the beryllium-associated worker must make
efforts to encourage and assist the two physicians to resolve any
disagreement.
(5) If, despite the efforts of the responsible employer and the
beryllium-associated worker, the two physicians are unable to resolve
their disagreement, then the responsible employer and the worker,
through their respective physicians, must designate a third physician
to:
[[Page 68911]]
(i) Review any findings, determinations, or recommendations of the
other two physicians; and
(ii) Conduct such examinations, consultations, laboratory tests,
and consultations with the other two physicians, as the third physician
deems necessary to resolve the disagreement among them.
(6) The SOMD must act consistently with the findings,
determinations, and recommendations of the third physician, unless the
SOMD and the beryllium-associated worker reach an agreement that is
consistent with the recommendations of at least one of the other two
physicians.
(d) Alternate physician determination. The responsible employer and
the beryllium-associated worker or the worker's designated
representative may agree upon the use of any alternate form of
physician determination in lieu of the multiple physician review
process provided by paragraph (c) of this section, so long as the
alternative is expeditious and at least as protective of the worker.
(e) Written medical opinion and recommendation. (1) Within two
weeks of receipt of results, the SOMD must provide to the responsible
employer a written, signed medical opinion for each medical evaluation
performed on each beryllium-associated worker. The written opinion must
take into account the findings, determinations and recommendations of
the other examining physicians who may have examined the beryllium-
associated worker. The SOMD's opinion must contain:
(i) The diagnosis of the worker's condition relevant to
occupational exposure to beryllium, and any other medical condition
that would place the worker at increased risk of material impairment to
health from further exposure to beryllium;
(ii) Any recommendation for removal of the worker from DOE
beryllium activities, or limitation on the worker's activities or
duties or use of personal protective equipment, such as a respirator;
and
(iii) A statement that the SOMD or examining physician has clearly
explained to the worker the results of the medical evaluation,
including all tests results and any medical condition related to
beryllium exposure that requires further evaluation or treatment.
(2) The SOMD's written medical opinion must not reveal specific
records, findings, and diagnoses that are not related to medical
conditions that may be affected by beryllium exposure.
(f) Information provided to the beryllium-associated worker. (1)
The SOMD must provide each beryllium-associated worker with a written
medical opinion containing the results of all medical tests or
procedures, an explanation of any abnormal findings, and any
recommendation that the worker be referred for additional testing for
evidence of CBD, within 10 working days after the SOMD's receipt of the
results of the medical tests or procedures.
(2) The responsible employer must, within 30 days after a request
by a beryllium-associated worker, provide the worker with the
information the responsible employer is required to provide the
examining physician under paragraph (a)(6) of this section.
(g) Reporting. The responsible employer must report on the
applicable OSHA reporting form beryllium sensitization, CBD, or any
other abnormal condition or disorder of workers caused or aggravated by
occupational exposure to beryllium.
(h) Data analysis. (1) The responsible employer must routinely and
systematically analyze medical, job, and exposure data with the aim of
identifying individuals or groups of individuals potentially at risk
for CBD and working conditions that are contributing to that risk.
(2) The responsible employer must use the results of these analyses
to identify additional workers to whom the responsible employer must
provide medical surveillance and to determine the need for additional
exposure controls.
Sec. 850.35 Medical removal.
(a) Medical removal protection. The responsible employer must offer
a beryllium-associated worker medical removal from exposure to
beryllium if the SOMD determines in a written medical opinion that it
is medically appropriate to remove the worker from such exposure. The
SOMD's determination must be based on one or more positive Be-LPT
results, chronic beryllium disease diagnosis, an examining physician's
recommendation, or any other signs or symptoms that the SOMD deems
medically sufficient to remove a worker.
(1) Temporary removal pending final medical determination. The
responsible employer must offer a beryllium-associated worker temporary
medical removal from exposure to beryllium on each occasion that the
SOMD determines in a written medical opinion that the worker should be
temporarily removed from such exposure pending a final medical
determination of whether the worker should be removed permanently.
(i) In this section, ``final medical determination'' means the
outcome of the multiple physician review process or the alternate
medical determination process provided for in paragraphs (c) and (d) of
Sec. 850.34.
(ii) If a beryllium-associated worker is temporarily removed from
beryllium exposure pursuant to this section, the responsible employer
must transfer the worker to a comparable job for which the worker is
qualified (or for which the worker can be trained in a short period)
and where beryllium exposures are as low as possible, but in no event
at or above the action level.
(iii) The responsible employer must maintain the beryllium-
associated worker's total normal earnings, seniority, and other worker
rights and benefits as if the worker had not been removed.
(iv) If there is no such job available, the responsible employer
must provide to the beryllium-associated worker the medical removal
protection benefits specified in paragraph (b)(2) of this section,
until a job becomes available or for one year, whichever comes first.
(2) Permanent medical removal. (i) The responsible employer must
offer a beryllium-associated worker permanent medical removal from
exposure to beryllium if the SOMD determines in a written medical
opinion that the worker should be permanently removed from exposure to
beryllium.
(ii) If a beryllium-associated worker is removed permanently from
beryllium exposure based on the SOMD's recommendation pursuant to this
section, the responsible employer must provide the worker the medical
removal protection benefits specified in paragraph (b) of this section.
(3) Worker consultation before temporary or permanent medical
removal. If the SOMD determines that a beryllium-associated worker
should be temporarily or permanently removed from exposure to
beryllium, the SOMD must:
(i) Advise the beryllium-associated worker of the determination
that medical removal is necessary to protect the worker's health;
(ii) Provide the beryllium-associated worker with a copy of this
rule and its preamble, and any other information the SOMD deems
necessary on the risks of continued exposure to beryllium and the
benefits of removal;
(iii) Provide the beryllium-associated worker the opportunity to
have any questions concerning medical removal answered; and
(iv) Obtain the beryllium-associated worker's signature
acknowledging that the worker has been advised to accept
[[Page 68912]]
medical removal from beryllium exposure as provided in this section,
and has been provided with the information specified in this paragraph,
on the benefits of removal and the risks of continued exposure to
beryllium.
(4) Return to work after medical removal. (i) The responsible
employer, subject to paragraph (a)(4)(ii) of this section, must not
return a beryllium-associated worker who has been permanently removed
under this section to the worker's former job status unless the SOMD
first determines in a written medical opinion that continued medical
removal is no longer necessary to protect the worker's health.
(ii) Not withstanding paragraph (a)(4) (i) of this section, if, in
the SOMD's opinion, continued exposure to beryllium will not pose an
increased risk to the beryllium-associated worker's health, and medical
removal is an inappropriate remedy in the circumstances, the SOMD must
fully discuss these matters with the worker and then, in a written
determination, may authorize the responsible employer to return the
worker to his or her former job status. Thereafter, the returned
beryllium-associated worker must continue to be provided with medical
surveillance under Sec. 850.34 of this part.
(b) Medical removal protection benefits. (1) If a beryllium-
associated worker has been permanently removed from beryllium exposure
pursuant to paragraph (a)(2) of this section, the responsible employer
must provide the beryllium-associated worker:
(i) The opportunity to transfer to another position which is
available, or later becomes available, for which the beryllium-
associated worker is qualified (or for which the worker can be trained
in a short period) and where beryllium exposures are as low as
possible, but in no event at or above the action level; or
(ii) If the beryllium-associated worker cannot be transferred to a
comparable job where beryllium exposures are below the action level, a
maximum of 2 years of permanent medical removal protection benefits
(specified in paragraph (b)(2) of this section).
(2) If required by this section to provide medical removal
protection benefits, the responsible employer must maintain the removed
worker's total normal earnings, seniority and other worker rights and
benefits, as though the worker had not been removed.
(3) If a removed beryllium-associated worker files a claim for
workers' compensation payments for a beryllium-related disability, then
the responsible employer must continue to provide medical removal
protection benefits pending disposition of the claim. The responsible
employer must receive no credit for the workers' compensation payments
received by the worker for treatment related expenses.
(4) The responsible employer's obligation to provide medical
removal protection benefits to a removed beryllium-associated worker is
reduced to the extent that the worker receives compensation for
earnings lost during the period of removal either from a publicly- or
employer-funded compensation program, or from employment with another
employer made possible by virtue of the worker's removal.
(5) For the purposes of this section, the requirement that a
responsible employer provide medical removal protection benefits is not
intended to expand upon, restrict, or change any rights to a specific
job classification or position under the terms of an applicable
collective bargaining agreement.
(6) The responsible employer may condition the provision of medical
removal protection benefits upon the beryllium-associated worker's
participation in medical surveillance provided in accordance with
Sec. 850.34 of this part.
Sec. 850.36 Medical consent.
(a) The responsible employer must provide each beryllium-associated
worker with a summary of the medical surveillance program established
in Sec. 850.34 at least one week before the first medical evaluation or
procedure or at any time requested by the worker. This summary must
include:
(1) The type of data that will be collected in the medical
surveillance program;
(2) How the data will be collected and maintained;
(3) The purpose for which the data will be used; and
(4) A description of how confidential data will be protected.
(b) Responsible employers must also provide each beryllium-
associated worker with information on the benefits and risks of the
medical tests and examinations available to the worker at least one
week prior to any such examination or test, and an opportunity to have
the worker's questions answered.
(c) The responsible employer must have the SOMD obtain a beryllium-
associated worker's signature on the informed consent form found in
Appendix A to this part, before performing medical evaluations or any
tests.
Sec. 850.37 Training and counseling.
(a) The responsible employer must develop and implement a beryllium
training program and ensure participation for:
(1) Beryllium-associated workers;
(2) All other individuals who work at a site where beryllium
activities are conducted.
(b) The training provided for workers identified in paragraph
(a)(1) of this section, must:
(1) Be in accordance with 29 CFR 1910.1200, Hazard Communication;
(2) Include the contents of the CBDPP; and
(3) Include potential health risks to beryllium worker family
members and others who may come in contact with beryllium on beryllium
workers or beryllium workers' personal clothing or other personal items
as the result of a beryllium control failure at a DOE facility.
(c) The training provided for workers identified in paragraph
(a)(2) of this section must consist of general awareness about
beryllium hazards and controls.
(d) The responsible employer must provide the training required by
this section before or at the time of initial assignment and at least
every two years thereafter.
(e) The employer must provide retraining when the employer has
reason to believe that a beryllium worker lacks the proficiency,
knowledge, or understanding needed to work safely with beryllium,
including at least the following situations:
(1) To address any new beryllium hazards resulting from a change to
operations, procedures, or beryllium controls about which the beryllium
worker was not previously trained; and
(2) If a beryllium worker's performance involving beryllium work
indicates that the worker has not retained the requisite proficiency.
(f) The responsible employer must develop and implement a
counseling program to assist beryllium-associated workers who are
diagnosed by the SOMD to be sensitized to beryllium or to have CBD.
This counseling program must include communicating with beryllium-
associated workers concerning:
(1) The medical surveillance program provisions and procedures;
(2) Medical treatment options;
(3) Medical, psychological, and career counseling;
(4) Medical benefits;
(5) Administrative procedures and workers rights under applicable
Workers' Compensation laws and regulations;
[[Page 68913]]
(6) Work practice procedures limiting beryllium-associated worker
exposure to beryllium; and
(7) The risk of continued beryllium exposure after sensitization.
Sec. 850.38 Warning signs and labels.
(a) Warning signs. The responsible employer must post warning signs
at each access point to a regulated area with the following
information:
DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
(b) Warning labels. (1) The responsible employer must affix warning
labels to all containers of beryllium, beryllium compounds, or
beryllium-contaminated clothing, equipment, waste, scrap, or debris.
(2) Warning labels must contain the following information:
DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD
(c) Warning signs and labels must be in accordance with 29 CFR
1910.1200, Hazard Communication.
Sec. 850. 39 Recordkeeping and use of information.
(a) The responsible employer must establish and maintain accurate
records of all beryllium inventory information, hazard assessments,
exposure measurements, exposure controls, and medical surveillance.
(b) Heads of DOE Departmental Elements must:
(1) Designate all record series as required under this rule as
agency records and, therefore, subject to all applicable agency records
management and access laws; and
(2) Ensure that these record series are retained for a minimum of
seventy-five years.
(c) The responsible employer must convey to DOE or its designee all
record series required under this rule if the employer ceases to be
involved in the CBDPP.
(d) The responsible employer must link data on workplace conditions
and health outcomes in order to establish a basis for understanding the
beryllium health risk.
(e) The responsible employer must ensure the confidentiality of all
work-related records generated under this rule by ensuring that:
(1) All records that are transmitted to other parties do not
contain names, social security numbers or any other variables, or
combination of variables, that could be used to identify particular
individuals; and
(2) Individual medical information generated by the CBDPP is:
(i) Either included as part of the worker's site medical records
and maintained by the SOMD, or is maintained by another physician
designated by the responsible employer;
(ii) Maintained separately from other records; and
(iii) Used or disclosed by the responsible employer only in
conformance with any applicable requirements imposed by the Americans
with Disabilities Act, the Privacy Act of 1974, the Freedom of
Information Act, and any other applicable law.
(f) The responsible employer must maintain all records required by
this part in current and accessible electronic systems, which include
the ability readily to retrieve data in a format that maintains
confidentiality.
(g) The responsible employer must transmit all records generated as
required by this rule, in a format that protects the confidentiality of
individuals, to the DOE Assistant Secretary for Environment, Safety and
Health on request.
(h) The responsible employer must semi-annually transmit to the DOE
Office of Epidemiologic Studies within the Office of Environment,
Safety and Health an electronic registry of beryllium-associated
workers that protects confidentiality, and the registry must include,
but is not limited to, a unique identifier, date of birth, gender,
site, job history, medical screening test results, exposure
measurements, and results of referrals for specialized medical
evaluations.
Sec. 850.40 Performance feedback.
(a) The responsible employer must conduct periodic analyses and
assessments of monitoring activities, 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, the responsible employer must
give results of periodic analyses and assessments to the line managers,
planners, worker protection staff, workers, medical staff, and labor
organizations representing beryllium-associated 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 this program is voluntary and I am free to
withdraw at any time from all or any part of the medical
surveillance program. I understand that the tests are confidential,
but not anonymous. 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 my employer will be notified of my
diagnosis only if I have a beryllium sensitization or chronic
beryllium disease. My employer will not receive the results or
diagnoses of any health conditions not related to beryllium
exposure.
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, the Site
Occupational Medical Director may recommend that I be removed from
working with beryllium. If I agree to be removed, I understand that
I may be transferred to another job for which I am qualified (or can
be trained for in a short period) and where my beryllium exposures
will be as low as possible, but in no case above the action level. I
will maintain my total normal earnings, seniority, and other
benefits for up to two years if I agree to be permanently removed.
I understand that if I apply for another job or for insurance, I
may be requested to release my medical records to a future employer
or an insurance company.
I understand that my employer will maintain all medical
information relative to the tests performed on me 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 under other law.
I understand that the results of my medical tests for beryllium
will be included in the Beryllium Registry maintained by DOE, and
that a unique identifier will be used to maintain the
confidentiality of my medical information. Personal identifiers will
not be included in any reports generated from the DOE Beryllium
Registry. 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 consent to having the following medical evaluations:
/ / Physical examination concentrating on my lungs and breathing
/ / Chest X-ray
/ / Spirometry (a breathing test)
/ / Blood test called the beryllium-induced lymphocyte proliferation
test or Be-LPT
/ / Other test(s). Specify:
[[Page 68914]]
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Signature of Participant:
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Date: ____________
I have explained and discussed any questions that the employee
expressed concerning the Be-LPT, physical examination, and other
medical testing as well as the implications of those tests.
Name of Examining Physician:
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Signature of Examining Physician:
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Dated: ____________
[FR Doc. 99-31181 Filed 12-6-99; 8:45 am]
BILLING CODE 6450-01-P
