Chronic Beryllium Disease Prevention Program
Federal RegisterDec 8, 1999
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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.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1980 to 1989 1990 to 1996
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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)
----------------------------------------------------------------------------------------------------------------
1984 to 1985 1986
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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.
------------------------------------------------------------------------
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\
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\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 p
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